STEVEN RAY GREEN AND ASSOCIATES 

NATIONALLY CERTIFIED COURT REPORTING 

404/733-6070 

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 June 9, 2008. 
2

C O N T E N T S

June 9, 2008 

WELCOME AND OPENING COMMENTS 6 

DR. CHRISTINE BRANCHE, DFO 

INTRODUCTION BY CHAIR 9 

DR. JAMES MELIUS 

DRAFT DOCUMENT: CRITERIA FOR USE OF SURROGATE DATA 10 

COURT REPORTER’S CERTIFICATE 34 
3

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. 

-- ^ denotes telephonic interruption. 
4

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

(By Group, in Alphabetical Order) 

DESIGNATED FEDERAL OFFICIAL

BRANCHE, Christine, Ph.D. 

Principal Associate Director 

National Institute for Occupational Safety and Health 

Centers for Disease Control and Prevention 

Washington, DC 

BOARD MEMBERSHIP

BEACH, Josie 

Nuclear Chemical Operator 

Hanford Reservation 

Richland, Washington 

GRIFFON, Mark A. 

President 

Creative Pollution Solutions, Inc. 

Salem, New Hampshire 

1 LOCKEY, James, M.D. 

2 Professor, Department of Environmental Health 

3 College of Medicine, University of Cincinnati 

4 

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

6 Director 

7 New York State Laborers' Health and Safety Trust Fund 

8 Albany, New York 

MUNN, Wanda I. 

Senior Nuclear Engineer (Retired) 

Richland, Washington 
5

IDENTIFIED PARTICIPANTS

ADAMS, NANCY, NIOSH 

BARRIE, TERRIE, ANWAG 

BROEHM, JASON, CDC WASHINGTON 

BURGOS, ZAIDA, NIOSH 

CHANG, CHIA-CHIA, NIOSH 

ELLIOTT, LARRY, NIOSH 

HOWELL, EMILY, HHS 

KOTSCH, JEFF, DOL 

MAKHIJANI, ARJUN, SC&A 

MAURO, JOHN, SC&A 

MCGOLERICK, ROBERT, HHS 

NETON, JIM, NIOSH 
6

P R O C E E D I N G S

1 (11:30 a.m.) 

2 

WELCOME AND OPENING COMMENTS

DR. CHRISTINE BRANCHE, DFO

3 DR. BRANCHE: This is the Surrogate Data 

4 working group meeting of the Advisory Board on 

5 Radiation and Worker Health. I’m Dr. 

6 Christine Branche, the Designated Federal 

7 Official for the Advisory Board. 

8 Will the Board members participating 

9 on the call please state your name? 

10 DR. MELIUS: Jim Melius. 

11 MS. MUNN: Wanda Munn. 

12 DR. LOCKEY: Jim Lockey. 

13 MS. BEACH: Josie Beach. 

14 DR. BRANCHE: Mark Griffon, are you on the 

15 line? 

16 (no response) 

17 DR. BRANCHE: Are there any other Board 

18 members? 

19 (no response) 

20 DR. BRANCHE: We do not have a quorum so we 

21 can continue. 
7

1 NIOSH staff who are participating 

2 would you please state your name? 

3 MR. ELLIOTT: Larry Elliott, NIOSH/OCAS. 

4 DR. NETON: Jim Neton, NIOSH/OCAS. 

5 MS. ADAMS: Nancy Adams, NIOSH. 

6 MS. CHANG: Chia-Chia Chang, NIOSH. 

7 DR. BRANCHE: Any ORAU staff participating? 

8 (no response) 

9 DR. BRANCHE: SC&A staff? 

10 DR. MAURO: John Mauro. 

11 DR. MAKHIJANI: Arjun Makhijani. 

12 DR. BRANCHE: Are there any other federal 

13 agency staff on the line? 

14 MS. HOWELL: This is Emily Howell with HHS. 

15 MR. McGOLERICK: Robert McGolerick, HHS. 

16 MR. KOTSCH: Jeff Kotsch with Labor. 

17 MR. BROEHM: Jason Broehm, CDC Washington 

18 office. 

19 DR. BRANCHE: Are there petitioners or their 

20 reps on the line? 

21 (no response) 

22 DR. BRANCHE: Are there any workers or their 

23 representatives on the line? 

24 MS. BARRIE: This is Terrie Barrie with 

25 ANWAG. 
8

1 DR. BRANCHE: Thank you, Ms. Barrie. 

2 Are there any members of Congress or 

3 persons representing their offices on the 

4 line? 

5 (no response) 

6 DR. BRANCHE: Are there any others who would 

7 like to mention their names? 

8 MR. GRIFFON: Hi, Christine, it’s Mark 

9 Griffon. I just joined. I don’t know if you 

10 called Board members already. 

11 DR. BRANCHE: I did. And thank you for 

12 letting me know that you’re on the line. 

13 Are there any others who would like to 

14 mention their names? 

15 (no response) 

16 DR. BRANCHE: Before we get started I do ask 

17 for the purpose of telephone etiquette but 

18 also because everyone is participating by 

19 phone and we need to make certain that 

20 everyone can hear all of the discussion. So 

21 only when you’re speaking please un-mute your 

22 phone. 

23 If everyone will please mute their 

24 phones, it will help us all to hear the 

25 dialogue. And when you are ready to un-mute 
9

1 your phone, rather when you’re ready to speak, 

2 please un-mute your phone. If you do not have 

3 a mute button, then please use star six. 

4 Thank you very much. 

5 Dr. Melius. 

6 INTRODUCTION BY CHAIR

7 DR. MELIUS: The purpose of this call is, I 

8 think actually the sole focus of this call is 

9 the draft document on the criteria for the use 

10 of surrogate data which was circulated some 

11 time ago. And we had comments, actually some 

12 written comments from Jim Lockey and from 

13 Wanda, Mark Griffon in an earlier draft. And 

14 so I think the purpose of this call is to try 

15 to resolve those comments. And I think it is, 

16 should be relatively straightforward to do. 

17 We’ll see. 

18 DR. BRANCHE: Jim, before you get started, 

19 are you the person who’s in a public place? 

20 DR. MELIUS: I hope not. 

21 DR. BRANCHE: Okay, well, there’s someone 

22 who is and if that person could please mute 

23 your phone, we’d appreciate it. Thank you 

24 very much. 

25 Sorry, Jim. 
10

1 DRAFT DOCUMENT: CRITERIA FOR USE OF SURROGATE DATA

2 DR. MELIUS: What I propose doing, there are 

3 a large number of comments. I think just sort 

4 of work paragraph by paragraph in terms of 

5 dealing with these. 

6 MR. ELLIOTT: Dr. Melius, this is Larry 

7 Elliott. I wonder if before you get started 

8 working through the comments if you could just 

9 give a sense, your sense, of how this document 

10 would be utilized. Who it would be used by 

11 and just state for the record what your intent 

12 and purpose is in this document. 

13 DR. MELIUS: The purposes of this document, 

14 intent for the use of the document would be, 

15 it would be a document adopted by the Board 

16 that the Board would use for the review of 

17 NIOSH site profiles, SEC evaluations and 

18 procedures that would provide a set of 

19 guidance for the Board’s review, similar to 

20 the document that we have developed for the 

21 review of SEC evaluation reports. So it would 

22 set out as a series of general guidance. 

23 (Interruption occurs.) 

24 DR. BRANCHE: Excuse me. Someone is in an 

25 airport? If you could please mute your phone 
11

1 it would be very helpful I think. No, I know 

2 it would be very helpful to us, but it’s very 

3 clear that the person who’s challenging our 

4 ability to hear is at an airport. 

5 Dr. Melius, can you still hear me? 

6 DR. MELIUS: I can hear you fine. I don’t 

7 know if people could hear me. 

8 DR. BRANCHE: Anything before my 

9 interruption, and while that interference was 

10 going on from the airport, I didn’t hear you. 

11 DR. MELIUS: I think I had finished up, but 

12 briefly summarized, this would be a guidance 

13 document similar to the Board’s guidance 

14 document on the review of SEC evaluation 

15 reports. So it will provide a set of 

16 guidelines for our review. 

17 MR. ELLIOTT: Thank you. 

18 DR. MELIUS: Any other sort of general 

19 questions before we start? 

20 (no response) 

21 DR. MELIUS: And I just would add clearly at 

22 this point it’s a draft document. It’s not 

23 even been adopted by the work group and at 

24 some point needs to go to the Board for their 

25 review and adoption. 
12

1 I’m going to start with the first 

2 paragraph, and I’m working off actually Jim 

3 Lockey’s draft document he sent with comments 

4 which I re-circulated to the work group and 

5 some of the other staff involved in this 

6 program. And Jim had a comment about, the 

7 last sentence of that first paragraph, which I 

8 actually agree to, that’s not very artfully 

9 worded. 

10 And I would propose some sort of 

11 rewording to the effect of it’s more often 

12 used during the early years -- this is 

13 referring to the use of surrogate data -- 

14 early years of some DOE facilities because of 

15 the lack of reliable monitoring methods, et 

16 cetera, and just try to make it more specific 

17 than that. 

18 And again, I’m not asking people to 

19 adopt specific wording because I think you 

20 should see it in front of you, but it’d be 

21 something like that. I think it does need to 

22 be clarified. It’s not an overly broad 

23 version there. 

24 DR. MAKHIJANI: Dr. Melius, I have a 

25 question about this. This is Arjun. Did you 
13

1 intend to add AWE sites to that or restrict it 

2 to DOE facilities? 

3 DR. MELIUS: To be both AOE (sic) and DOE 

4 facilities. 

5 DR. MAKHIJANI: Okay. 

6 DR. MELIUS: The next comment we have under 

7 criteria number one, which is the hierarchy of 

8 data, and this comment comes from Wanda. And 

9 it is regarding the, I think it’s sort of a 

10 critical point though. I think there are ways 

11 of dealing with it. And I think it refers to 

12 the third sentence there, “In general, 

13 surrogate data should not be used to replace 

14 available data from site inspections as a 

15 higher level of hierarchy.” 

16 And I think what Wanda’s comment would 

17 remove that, change that a level so to speak 

18 that in really taking the last sentence there, 

19 if I understand Wanda’s comments right, is she 

20 would sort of move it down a level and say 

21 that it would be used to replace data in the 

22 next level if certain criteria were met. 

23 Is that capturing your comment, Wanda? 

24 MS. MUNN: I am now un-muted. That was my 

25 general thinking. I’m at a slight 
14

1 disadvantage because I don’t have the 

2 documents in front of me, and I’m not at a 

3 place where I can pull them up on my computer. 

4 But if memory serves, that’s roughly my intent 

5 with that slight change in wording. I don’t 

6 think I changed it very much. 

7 DR. MELIUS: No, it was simply changing that 

8 level. And I guess I would have two responses 

9 to that. One is that I think the criteria to 

10 use it at a next level would be stricter than 

11 if one were, more stringent than if one were 

12 using it at the same level. Because I can’t 

13 imagine circumstances, I believe we’ve 

14 encountered some of these where we may have a 

15 small amount of sampling, personal sampling 

16 data, from a site for some particular 

17 exposure. And, however, that by itself is not 

18 adequate for doing dose reconstruction. 

19 However, we may have some data from 

20 another site, what we refer to as surrogate 

21 data, that may be at the next level of the 

22 hierarchy, but it’s particularly robust -- and 

23 I hate to use a word you don’t like, Wanda -- 

24 but it would be, we might want to utilize that 

25 data. I think that we would then make the 
15

1 justification for using this, the lower level 

2 of hierarchable data for dose reconstruction. 

3 We would probably be more stringent about that 

4 than we would if we were using data from the 

5 same level. 

6 And so what I would propose doing in 

7 that paragraph is adding a sentence to that 

8 effect. Right now it states, in general, 

9 surrogate data should not be used to replace 

10 available data that are a higher level. Only 

11 we should replace data at the same level and 

12 blah-blah-blah. 

13 Then I would say add a sentence that, 

14 however, there may be specific instances where 

15 data from a, surrogate data may be used to 

16 replace data that’s at a higher level. 

17 However, that needs to meet more stringent 

18 criteria, et cetera. 

19 MS. MUNN: Why don’t we try having you 

20 (telephonic interference) truly want to say. 

21 DR. MELIUS: No, that’s fine. I’m not 

22 asking you to approve anything over the phone. 

23 Anybody else have comments on that? 

24 (no response) 

25 DR. MELIUS: And I think it just reflects, I 
16

1 mean, this has lots of different factors that 

2 go into judging what data is useful, not 

3 useful and so forth. And I think we need to, 

4 and we’re struggling to come up with a simple 

5 way of stating that, what’s often a 

6 complicated situation. 

7 MS. MUNN: Usually a complicated situation 

8 lately. 

9 DR. MELIUS: Anyone else have comments on 

10 that? 

11 (no response) 

12 DR. MELIUS: The next paragraph called 

13 Exclusivity Constraint, I agree, very 

14 stringently is an overkill and not necessary. 

15 So we can take out the very stringently 

16 justified and make it just stringently 

17 justified. And then Wanda had a comment about 

18 in the last sentence I think, again, some of 

19 these grammatical -- it currently reads the 

20 judgment needs to take into account not only 

21 the amount of surrogate data being relied on 

22 relative to data from the site, but also the 

23 quality of the surrogate data relative to data 

24 available to the site in question. And I 

25 think the second one is relative, relative to 
17

1 data available at the site is somewhat 

2 redundant (inaudible). 

3 DR. BRANCHE: Jim, the last few words that 

4 you said were lost. 

5 DR. MELIUS: What I said was that the second 

6 relative to data available for the site in 

7 question is a bit redundant. But I’ll correct 

8 that and include that when I re-circulate the 

9 document. 

10 Any questions on that paragraph? 

11 (no response) 

12 DR. MELIUS: Paragraph number three, which 

13 is titled site or process similarities, Jim 

14 Lockey had one small change in that which is 

15 fine. Wanda had a number of changes, most of 

16 which were, I think all of which would be 

17 clarifications of that paragraph. And again, 

18 I’ll just rewrite that and circulate it. I 

19 don’t think it makes any significant 

20 differences to that. 

21 Anybody else have questions or 

22 comments on that? 

23 DR. LOCKEY: Hey, Jim, Jim Lockey. When I 

24 read this over the weekend, there was one 

25 sentence that maybe can be redone. That’s 
18

1 under number three, and it’s the second, 

2 actually, it’s the last sentence in that 

3 paragraph. And it starts, surrogate data 

4 should not be used if the equivalency, 

5 equivalent air claimant favorability. 

6 And I understand what you’re trying to 

7 do with claimant favorability, but maybe it 

8 should be at the beginning. It took me a long 

9 time to figure out why that sentence was, why 

10 the claimant favorability was in that 

11 position. It’s just a wording issue I think. 

12 DR. MELIUS: I agree, thanks. 

13 MS. MUNN: You’re going to rewrite it 

14 anyway, right, Jim? 

15 DR. MELIUS: Yes, correct. 

16 MS. MUNN: Sounds good. 

17 DR. MELIUS: Paragraph number four is 

18 temporal considerations, and I had no, 

19 received no comments on that. I don’t know if 

20 anybody has any at this point. 

21 (no response) 

22 DR. MELIUS: If not, then the other comment 

23 I had from Wanda actually concerns the SC&A 

24 report, and her comment was about the items 

25 described as type two in that report. And I 
19

1 guess I’m at a little bit of a loss of what to 

2 say about that. 

3 What I tried to do was, basically, I 

4 think Wanda’s comment basically goes to the 

5 concept that surrogate data has been widely 

6 used in the development of standards, exposure 

7 limits and so forth. Somehow that SC&A 

8 document by calling it type two as a 

9 classification was calling into question those 

10 standards. 

11 And what I tried to do in the, in our 

12 criteria was make sure that we’ve got that, 

13 the first sentence of this draft document 

14 says, for the purpose of this report the term 

15 surrogate data will refer to the use of 

16 exposure data from one site for individual 

17 dose reconstruction for workers at another 

18 site. And basically say this is not referring 

19 to the use of data from one site being used in 

20 the development of radiation standards or 

21 limits or whatever work practice criteria, 

22 whatever, that may be taken from one site, nor 

23 the experience learned at one site being used 

24 at another site. That the focus is purely on 

25 dose reconstruction. 
20

1 Now if somebody could come up with a 

2 better word for surrogate data that would 

3 clarify that difference, I think it may be 

4 helpful. But short of that I think we’re 

5 trying to keep our focus on that, and not a 

6 focus or questions on the use of data from one 

7 site being used in the development of 

8 standards and so forth. That’s a different 

9 operation. It has a different set of 

10 scientific considerations and weighting of 

11 those scientific considerations and how that’s 

12 done. Our focus is on dose reconstruction 

13 which has a whole set of other technical and 

14 other issues in the context of this program. 

15 DR. MAKHIJANI: Dr. Melius, this is Arjun. 

16 The way, I have the SC&A report before me, and 

17 John might want to comment, too. The way, at 

18 least in some of the entries -- I haven’t 

19 recently reviewed all of them, but the type 

20 two was used was whether generic assumptions 

21 were used for dose reconstruction and 

22 development of parameters for dose 

23 reconstruction at a particular site. 

24 So, for instance, the first one is 

25 about recycled uranium, and we said some 
21

1 generic assumptions are used for medical dose 

2 prior to 1977, and recycled uranium data prior 

3 to mid-1980s are based on DOE complex 

4 collective process knowledge. So this is 

5 actually data from collective process 

6 knowledge that has been proposed for use in 

7 individual dose reconstruction for Fernald in 

8 this case. And I just, I’m a little confused 

9 based on what you said as to how that, 

10 conversation you’ve just been having, would 

11 apply to individual dose reconstruction and 

12 the RU data at Fernald. 

13 MS. MUNN: Arjun, these kinds of concerns 

14 were what I was thinking of, I believe, at the 

15 time that I tried to make additional comment 

16 about ^. Even though we tried earlier to 

17 specify what we’re talking about here ^ 

18 limited specifically to the uses that we have 

19 identified. 

20 It still is very easy to have this 

21 type of a policy document used in other venues 

22 and other kinds of reviews once it’s been 

23 established. So I’m very concerned that we 

24 are more than just casually specific about how 

25 we’re going to ^ surrogate data and that we 
22

1 not find ourselves in the position like the 

2 one you just described which was, I think, 

3 detrimental to all of the people involved. 

4 DR. MAURO: Wanda, Dr. Melius, from this 

5 conversation, I think what I’m hearing is the 

6 definition or the criteria that’s under 

7 consideration right now seems to be oriented 

8 more toward the use of air sampling, bioassay 

9 and external dosimetry data. 

10 In other words really, when you want 

11 to use surrogate data for those types of 

12 dosimetric problems, Arjun and I agree that 

13 recycled uranium, minimum detectable levels, 

14 medical X-ray exposures, there’s a lot of 

15 generic weapons complex-wide information 

16 that’s used across the board collectively. 

17 And I think that what I’m hearing is in this 

18 particular instance there’s an intent to 

19 embrace, define surrogate data in a narrower 

20 sense at least for the purposes of bioassay, 

21 air sampling and film badge data. Would that 

22 be a correct statement? 

23 DR. MELIUS: No. 

24 DR. MAURO: Okay. 

25 DR. MELIUS: I don’t think so to the extent 
23

1 that other types of information are being used 

2 as a basis for dose reconstruction. 

3 DR. MAURO: Under those circumstances then, 

4 the issues that Arjun just mentioned, there 

5 are a large number of -- I wouldn’t call them 

6 NCRP, ICRP or standard dosimetric guidelines 

7 that come out from national committees, but 

8 there is a lot of generic work. And I’ll 

9 mention three of them. 

10 I think the three that come to mind 

11 immediately are recycled uranium; I think the 

12 high-fired plutonium is another example, and 

13 X-ray, minimum detectable levels both for 

14 bioassay and for film badges. These are all 

15 assumptions that are part of the process of 

16 doing dose reconstruction that goes toward 

17 those reconstructions that are being applied 

18 site specifically but do come from collective 

19 knowledge done by resource ^ done by NIOSH’s 

20 contractor. So if we are ^ to that, then you 

21 know that we’re engaging in a more challenging 

22 set of criteria. 

23 DR. MAKHIJANI: You’ve just mixed up a 

24 couple of different things. My question was a 

25 little bit narrower than using a Super-S model 
24

1 that’s specific to Super-S Plutonium. Super-S 

2 Plutonium isn’t different at Fernald or Rocky 

3 Flats or Hanford or Savannah River Site. So 

4 I’m not talking about the model, and I share 

5 Wanda’s concern about that. And I think that 

6 clearly, there’s a model that generally is 

7 applicable at a time. 

8 But what I was asking about and what 

9 I’m still confused about, maybe Jim has just 

10 clarified it, is that from recycled uranium 

11 data from Hanford as to radioisotopes ^ 

12 recycled uranium as being applied to Fernald, 

13 then that seems to meet Fernald dose 

14 reconstructions. And that seems to fall into 

15 process data from another site being applied 

16 to dose reconstruction. 

17 And I just wanted to ask whether you 

18 can narrow the question, whether process 

19 information from some other site as opposed 

20 to, say, medical X-ray characteristics of some 

21 piece of equipment or something like that, can 

22 be used as surrogate data on what those 

23 criteria would be. The process information is 

24 part of FR-82^ in the hierarchy of data if I 

25 remember correctly. 
25

1 Am I right, Jim? I’m not looking at 

2 the regulation. I’m saying that from memory. 

3 Jim Neton? 

4 DR. NETON: Yeah, that’s correct. I don’t 

5 want to say anything much here, but I think 

6 we’re getting into the area of the 

7 differentiation between what I call supporting 

8 surrogate data, actual data and then also in 

9 the development of what I would call 

10 analytical models ^ used quite extensively. 

11 MS. MUNN: And you’re correct. The reason I 

12 brought the issue up, Jim, is that if we are 

13 going to be using these criteria that we’re 

14 establishing in one way now but broadening 

15 them as we go along, then we do get into a 

16 situation where we confuse those three items. 

17 And I wanted to make very sure that we were 

18 not saying or doing anything in our policy 

19 statement that would lead us to, for example, 

20 reject the minimum quantities that have been 

21 established and used widely as a profession as 

22 not being adequate because they were not 

23 developed at the site where we were at that 

24 moment. ^. 

25 So I think it’s a very real concern, 
26

1 and I would hate to think that these criteria 

2 might later be used in some way other than 

3 what we intended at the time I believe Jim 

4 wrote these. How we clarify that more 

5 distinctly than just simply saying -- well, 

6 it’s in the first sentence -- I’m not sure, 

7 but I feel the question is more than relevant. 

8 I think it bears on our ability of statements 

9 that we might make for the Board to approve. 

10 DR. MAURO: Wanda, this is John. There was 

11 a reason I made the distinction in my original 

12 draft that not only in the criteria draft but 

13 also in the compendium. We ^ very large 

14 compendium ^ where surrogate data was used 

15 where I did make a distinction between type 

16 one and type two because I realized that this 

17 challenge would confront us. That is, we may 

18 want to make a distinction between type one 

19 and type two. 

20 Type one refers to straightforward 

21 bioassay, film badge, air sampling data. Type 

22 two would go more toward the kind of things 

23 that Jim Neton just referred to as research 

24 information that has broad applicability. 

25 This is a tough question, and I think what 
27

1 you’re saying is correct. I think the nature 

2 of the definitions of the four criteria that 

3 we are embracing now are more oriented toward 

4 type one than type two. 

5 MS. MUNN: I remember the size of those 

6 compendia. I do not remember the content. 

7 I’d have to go back and take a look again. 

8 DR. MELIUS: This is Jim Melius, two 

9 comments. One is I think it’s, one of the 

10 issues we have to deal with is are there 

11 different criteria for reviewing type one 

12 versus type two or can we capture them all in 

13 one set of criteria, and I don’t know the 

14 answer to that. But one of the reasons I was 

15 advocating that before we finalize the 

16 criteria we try applying it to some limited 

17 number of examples would be so that we make 

18 sure that we’re setting the boundaries on it 

19 right and that we’ve captured the appropriate 

20 factors that are going in and weighed in the 

21 criteria. 

22 We’ll never get everything just given 

23 how complicated this is, but we need to, may 

24 be able to refine these in a way that avoids 

25 some of the potential pitfalls that Wanda’s 
28

1 concerned about, and at the same time make 

2 this useful in terms of dealing with dose 

3 reconstruction issues. And I think that if 

4 you remember right, the SEC evaluation 

5 criteria were built from our experience, 

6 actually, some of our problems in evaluating 

7 SEC evaluation reports. 

8 The need to systematize that I think, 

9 maybe working through some of the examples and 

10 so forth would help to address these issues 

11 also and make sure that, one, we’re not 

12 missing somehow an important set of things 

13 that should be reviewed. At the same time 

14 we’re not including things that are 

15 inappropriate to being reviewed. 

16 DR. MAURO: Jim, this is John Mauro. When 

17 we did apply the four criteria, and they 

18 served us very well, when we did Blockson, and 

19 we’re in the middle of doing it also for Texas 

20 City; however, when we applied the criteria, 

21 the framework within which we were working, 

22 dealt mainly with external dosimetry and air 

23 sampling data. 

24 We really never engaged issues that I 

25 would call type two surrogate data. So right 
29

1 now I could say, at least in the two instances 

2 where we attempted to apply the fourth 

3 criteria, Blockson and Texas City, it served 

4 us very well when it came to type one 

5 criteria, type one surrogate data. 

6 DR. MELIUS: ^ once we’ve agreed on the 

7 draft criteria, then I think applying them to 

8 some other examples including some type two I 

9 think would also be helpful. What my 

10 proposal, before we start down that road is 

11 that I will rewrite the document, circulate it 

12 to the work group, and given the timeframe and 

13 so forth, I think that I’ll wait to hear, see 

14 what people’s comments are. People can get 

15 back to me individually. If necessary, we’ll 

16 schedule another meeting. 

17 Hopefully, we can ^. I’ll have 

18 captured people’s comments well enough that 

19 we’ll have a draft document and can move 

20 forward. And then my proposal would be that 

21 we then apply this to some examples and so 

22 forth. But I also would like to circulate it 

23 to the Board, at least for some informal 

24 comments before we do that. 

25 DR. MAURO: Jim, if I may make one 
30

1 observation, we did learn something important 

2 when we went through Texas City that I think 

3 does bear on the four criteria. Something 

4 that certainly the work group may want to ^ 

5 and that is the possibility of what I would 

6 call a fifth criteria that might serve us 

7 well, and I like to call that plausibility. 

8 One of the things we found in Texas 

9 City is that surrogate data were used, both 

10 external exposures and inhalation exposures, 

11 that were drawn from datasets that resulted in 

12 implausible exposures. In a strange sort of 

13 way what happened was the scenarios and the 

14 exposure settings in the surrogate data that 

15 was used overestimated the potential for 

16 exposures at Texas City to such an extent that 

17 one could question whether or not such 

18 exposures are plausible and perhaps challenge 

19 the use of surrogate data from the perspective 

20 that it is unrealistically high. It’s not 

21 plausible. 

22 Because there is language in the rule 

23 that says that the dose reconstruction 

24 scenarios must be plausible. And one of our 

25 concerns, and you’ll see when our report comes 
31

1 out, is that in an effort to try to place an 

2 upper bound, sometimes the assumptions are so 

3 conservative that they’re no longer plausible. 

4 That may be a fifth criteria (sic) that might 

5 serve us well. I just wanted to put that on 

6 the table for your consideration. 

7 DR. MELIUS: This is Jim Melius. I actually 

8 haven’t read the Texas City report yet, and my 

9 general comment is that I think we’ve always 

10 viewed criteria as sort of cutting both ways. 

11 That it’s possible to be overestimating or 

12 underestimating within the context of this 

13 program. 

14 So I guess I have some general 

15 questions about having that as a separate 

16 criteria (sic). I always thought of that as 

17 sort of a fundamental criteria or basis of our 

18 approach here. But let me look over the 

19 report and the situation before I generalize. 

20 Any other comments or questions? 

21 (no response) 

22 DR. MELIUS: So everybody agreed that I’ll 

23 be writing, taking account comments plus the 

24 verbal comments we received here, circulate it 

25 to the work group, and then hear back from the 
32

1 work group. And before taking any other 

2 action, I will check with the work group. 

3 MS. MUNN: That’s certainly appropriate from 

4 my point of view. I guess the concern that’s 

5 raised with respect to the use of data being 

6 so far away from any accuracy even when being 

7 used as a bounding limit or is one that I 

8 don’t think we did address very well in the 

9 four items that we put there. Whether or not 

10 it’s a thought that needs to be incorporated 

11 at some point whether as a fifth item or not I 

12 haven’t had an opportunity ^ get my thinking, 

13 but certainly the next step obviously is the 

14 one you have outlined, Jim, I think. I think 

15 that’s appropriate. 

16 DR. MELIUS: Mark, or Jim Lockey or Josie, 

17 any comments? 

18 MR. GRIFFON: Sounds good. 

19 DR. LOCKEY: I’m fine with this. 

20 DR. MELIUS: Josie. 

21 MS. BEACH: Sounds great with me, too. 

22 DR. MELIUS: Okay. 

23 Christine? 

24 DR. BRANCHE: Yes, sir. 

25 DR. MELIUS: We’re done, with the call. 
33

1 DR. BRANCHE: I knew what you meant. 

2 Well, I hope you all can stay cool 

3 today. If you’re going to be in climates that 

4 are anything like what we’re expecting here in 

5 the D.C. metro areas, stay indoors and drink 

6 plenty of fluid. Thank you very much for a 

7 productive call. It seemed to be from what I 

8 observed. And, Jim, we’ll hear from the group 

9 soon. 

10 DR. MELIUS: Correct. 

11 DR. BRANCHE: Thanks so much. Have a great 

12 day. 

13 (Whereupon, the working group meeting 

14 concluded at 12:15 p.m.) 

15 

16 
34

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 June 9, 2008; 

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 

7th day of August, 2008. 

___________________________________ 

STEVEN RAY GREEN, CCR, CVR-CM, PNSC 

CERTIFIED MERIT COURT REPORTER 

CERTIFICATE NUMBER: A-2102