1

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

UNITED STATES OF AMERICA

CENTERS FOR DISEASE CONTROL

+ + + + +

NATIONAL INSTITUTE FOR OCCUPATIONAL

SAFETY AND HEALTH

+ + + + +

ADVISORY BOARD ON RADIATION AND

WORKER HEALTH

+ + + + +

77th MEETING

+ + + + +

THURSDAY

MAY 26, 2011

+ + + + +

The meeting convened at 8:30 a.m., 

Central Daylight Time, in the Crowne Plaza St. 

Louis-Downtown, 200 North Fourth Street, St. 

Louis, MO, James M. Melius, Chairman, 

presiding.

PRESENT:

JAMES M. MELIUS, Chairman

HENRY ANDERSON, Member

JOSIE BEACH, Member

BRADLEY P. CLAWSON, Member*

R. WILLIAM FIELD, Member

RICHARD LEMEN, Member

JAMES E. LOCKEY

WANDA I. MUNN, Member
2

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

PRESENT: (continued)

ROBERT W. PRESLEY, Member

GENEVIEVE S. ROESSLER, Member

PHILLIP SCHOFIELD, Member

PAUL L. ZIEMER, Member*

TED KATZ, Designated Federal Official
3

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

REGISTERED AND/OR PUBLIC COMMENT PARTICIPANTS:

ADAMS, NANCY, NIOSH Contractor

AL-NABULSI, ISAF, DOE

DANIELS, DOUG, NIOSH

ELLISON, CHRIS, DCAS

GLOVER, SAM, DCAS

HINNEFELD, STU, DCAS

KOTSCH, JEFF, DOL

KINMAN, JOSH, DCAS

LEITON, RACHEL, DOE

LEWIS, GREG, DOE

LIN, JENNY, HHS

MAKHIJANI, ARJUN, SC&A

McFEE, MATT, ORAU Team

NETON, JIM, DCAS

RABINOWITZ, RANDY 

RAFKY, MICHAEL, HHS

ROLFES, MARK, DCAS

RUTHERFORD, LAVON, DCAS

STEINBERG, GARY, DOL

STIVER, JOHN, SC&A

TAULBEE, TIM, DCAS

WADE, LEW, NIOSH Contractor

*Participating via telephone
4

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

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

2 CHAIRMAN MELIUS: Good morning 

3 everybody. We'll get started now. Relatively 

4 -- as I told you relatively short agenda for 

5 this morning. 

6 MEMBER MUNN: We're here for the 

7 party.

8 CHAIRMAN MELIUS: Here for the 

9 party? Is there a party later? I was going 

10 to say we're all probably out at the airport. 

11 By the way, if any of you are interested, 

12 Mark Griffon did make it out of town last 

13 night, so he made it to Washington.

14 Few hours late, but he emailed me 

15 late and said that he -- he did make it. We 

16 had saved a place at dinner for him thinking 

17 that he would be coming back and join us. But 

18 he did make it to that.

19 This morning we have just one 

20 agenda item. But first, Ted, do your --

21 MR. KATZ: Right. We have a very 

22 short agenda here. We're just doing quality 
5

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 of science review, the ten year program 

2 review. But let me check on the line and see 

3 if we have Board Members with us.

4 MEMBER ZIEMER: Paul Ziemer here. 

5 MR. KATZ: Welcome, Paul.

6 MEMBER CLAWSON: Brad Clawson.

7 MR. KATZ: Welcome, Brad. Any 

8 other Board Members? Very good. Let's get 

9 going. 

10 CHAIRMAN MELIUS: Okay, this 

11 morning we're going to talk about one -- one 

12 report that on the quality of science, part of 

13 the ten year review.

14 And Doug Daniels was good enough 

15 to change his itinerary and come into -- just 

16 that be able to come in and present to us 

17 today. I think it's a interesting report, and 

18 I thought it would be like helpful in some of 

19 the things we need to consider as well as give 

20 us a chance to ask questions and -- and 

21 understand it better.

22 So, Doug. Thank you. Welcome.
6

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 MR. DANIELS: Well, thank you. 

2 And I'd like to thank everyone for inviting me 

3 here. I had a wonderful day of travel last 

4 night. And that's the first time I've ever 

5 traveled 300 miles, at 1,400 miles. So it was 

6 great. Fantastic. 

7 But I'm glad to be here this 

8 morning --

9 CHAIRMAN MELIUS: Where'd you come 

10 through?

11 MR. DANIELS: Well, I flew from

12 Cincinnati to -- to St. Louis via Louisiana. 

13 CHAIRMAN MELIUS: Well, thank you 

14 for taking -- taking the trouble. Lew came 

15 via Peoria.

16 MR. DANIELS: My name is Robert 

17 Daniels. I am a NIOSH employee. I'm not 

18 assigned to the Division of Compensation 

19 Analysis and Support. I work with a -- a 

20 colleague, Dr. Henry Spitz, University of 

21 Cincinnati professor of Nuclear Engineering, 

22 to do the quality of science element of the 
7

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 ten year program review report. 

2 Just briefly on this slide, Dr. 

3 Howard initiated this program review in 

4 February of last year as part of his -- our 

5 commitment to the highest quality science and 

6 NIOSH programs, and also to recognizing the 

7 importance of program transparency and the 

8 need to be responsive to stakeholders and 

9 members of the public and claimant.

10 So -- so it was an effort put in 

11 place to improve the program. The quality of 

12 science was a key element of this program 

13 review. There are several facets to the 

14 review. 

15 The one we're talking about today 

16 is the review on the quality of science, which 

17 is a rather broad term. So the -- at the 

18 time, there were many questions on using 

19 exposure proxies and dose reconstruction. And 

20 so we thought that the best focus for our 

21 review was to also look at methods of indirect 

22 exposure assessment.
8

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 As you know, NIOSH is charged with 

2 providing reasonable estimates of dose to 

3 cover employees under the Act. So for us, 

4 reasonable, we determine to mean well based in 

5 science, obviously is an important tenet as 

6 well as timely and fair.

7 And that's the essence of NIOSH 

8 dose reconstruction. NIOSH is charged with 

9 evaluating the completeness of the individual 

10 monitoring data for -- for claimants and 

11 providing remedies when there are gaps in that 

12 information.

13 And that therein lies the use of 

14 indirect methods to fill these data gaps. So 

15 the scope and conduct of the review, quality 

16 of science, as I said, is a very -- is very 

17 broad.

18 We narrowed it to indirect 

19 exposure assessment methods, and more 

20 specifically, looking at -- at coworker and 

21 surrogate data use. Now, the dose 

22 reconstruction program makes a distinction 
9

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 between those where surrogate data is 

2 referring the information from facilities 

3 other than the covered facility of the covered 

4 worker.

5 And coworker data, as you would 

6 expect, it's -- it's exposure data from 

7 similar workers within the facility. There 

8 were two of us working on it, myself and Dr. 

9 Spitz. 

10 I focused on issues related to 

11 coworker models, and Dr. Spitz, working 

12 independently, was looking more into the 

13 issues of surrogate data. So you could 

14 imagine if you read the report, there -- there 

15 certainly is a lot of redundancy where we --

16 we talk about the same -- the same things a 

17 number of times throughout the report. 

18 That's to be expected given the 

19 fact that we were actually working independent 

20 for most of the time on the report until we 

21 brought it together in a single document.

22 It has been reviewed. It's still 
10

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 draft. I consider it still draft anyway, 

2 because the public -- the docket's still open 

3 for public comment. So -- so as we get public 

4 comment, I've been making revisions. 

5 I think the latest revision has 

6 been posted on the -- on the docket for -- for 

7 continued review. And however, it's -- it's 

8 not finalized yet. It was reviewed by my 

9 management team as the internal review.

10 We did have some scientific peer 

11 review on it. We did not have any review or 

12 comment from members of Office of Compensation 

13 Analysis and Support. So it's -- it's 

14 independent of that office. 

15 And of course, public comment is 

16 ongoing. So the structure of the report is --

17 is -- there are three key elements. The first 

18 is the general program where we discuss our 

19 findings regarding the scientific basis of --

20 of the dose reconstruction program's use of 

21 indirect exposure assessment methods, the 

22 quality of the documentation that's used in 
11

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 conducting those reconstruction, and the 

2 review process that is part of that system.

3 The second part was -- was 

4 specifically looking at external radiation 

5 coworker analysis. So again, I'm parsing 

6 things down to look very narrowly at a single 

7 component of the dose reconstruction program, 

8 which is external radiation coworker analysis.

9 We looked at the scientific 

10 methods that were used as well as we 

11 replicated a model that was used by the NIOSH 

12 dose reconstruction program for -- for the Oak 

13 Ridge gaseous diffusion plant.

14 The third element was public 

15 comment. We reviewed a number of comments 

16 that were received in regard to the -- the 

17 program review. This is prior to the first 

18 publication of the draft report we have now. 

19 And I summarized those comments in the -- in 

20 the back portion of the -- of the report to 

21 give you an idea of stakeholder concerns.

22 And then there is a summary of the 
12

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 findings and recommendations. And then 

2 finally, there is an appendix on surrogate 

3 data use in the end of the report. 

4 So, general findings, first it's 

5 noteworthy that the dose reconstruction 

6 program has made a number of accomplishments 

7 since its beginnings. There have been over 

8 24,000 dose reconstructions at the time of the

9 report. 

10 The report is -- is getting close 

11 to a year old now. So certainly that number 

12 has increased since. The group itself has 

13 made several advancements in exposure 

14 assessment methods. 

15 And they've made these methods 

16 available to other researchers outside of dose 

17 reconstruction. So they have contributed to 

18 the scientific literature in a number of ways. 

19 And many of the methods that were developed 

20 essentially in support of the compensation 

21 program are now being used in other sciences. 

22 So that's a key accomplishment. 
13

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 They gathered an enormous amount of 

2 information on the U.S. Atomic Weapons Workers 

3 program. I do believe there's hundreds of 

4 thousands of images. 

5 I think the last count was 300,000 

6 images on the Department of Energy documents 

7 that have been collected in support of this 

8 program as well as other key sources of 

9 information.

10 That will be useful for science as 

11 well as compensation. And they've developed 

12 and published over 100 technical documents on 

13 dose reconstruction, and made these documents 

14 available to the public and other researchers. 

15 General findings on authority, it 

16 was obvious that epidemiologic studies also 

17 rarely benefit from complete exposure 

18 information. So it wasn't a stretch to see 

19 that many of the methods that are used under 

20 dose reconstruction were developed during 

21 epidemiologic studies. 

22 And they basically have started 
14

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 with those methods and enhanced them 

2 specifically to support individual dose 

3 reconstruction for compensation purposes. So 

4 there's a lot of similarities in the science 

5 with regard to methods of indirect exposure 

6 assessment.

7 There's a firm foundation within 

8 the Act for using the supplement data for 

9 indirect exposure assessment. The use of 

10 information from coworkers is clearly 

11 authorized.

12 And although it's not specifically 

13 stated in the Act, the use of data from other 

14 facilities, it -- it seems to be referred to 

15 such that you can provide data to complement, 

16 but not supplant to plan information from --

17 from preferred sources.

18 So there's a hiearchical tree of 

19 data used. And where there are gaps it seems 

20 perfectly acceptable, at least from a 

21 scientific perspective, to use data from other 

22 facilities and other workers to fill these 
15

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 gaps in our information.

2 General findings and documentation 

3 of the -- the program itself uses a -- a 

4 process that's similar to standing -- standard 

5 operating procedures that you would see in a 

6 high functioning industrial setting.

7 There's a very layered structure 

8 of policies, plans and procedures. They have 

9 systems in place to standardize the use of 

10 terms and the format of the documents. The 

11 documents are internally reviewed prior to 

12 issuance. 

13 There are sign offs. There are --

14 they are controlled. Nevertheless, given the 

15 vast number of documents and the vast number 

16 of document authors, there were some 

17 inconsistencies between documents.

18 And the content of documents, in 

19 some cases, varied markedly, even though they 

20 had similar uses. So -there could be room for 

21 improvement in future revisions to maybe clean 

22 some of that up.
16

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 One other noteworthy component of 

2 this was we noted that even those these are 

3 controlled documents that are -- and industry 

4 settings, standard operating procedures are 

5 routinely reviewed and revised, given the 

6 dynamics of a system. 

7 We would expect that those 

8 reconstruction could be dynamic as well. And 

9 so we -- we thought that perhaps revisions, in 

10 some cases, were infrequent and there could be 

11 improvements made there. 

12 Methods, it's very clear that in 

13 dose reconstruction, there's a graded approach 

14 applied that attempts to balance precision and 

15 accuracy with fairness and efficiency. So 

16 there's a give and take with respect to the 

17 scientific rigor that's done for dose 

18 reconstruction.

19 It's also clear that when in doubt 

20 there's always attempts made for claimant 

21 favorability and decisions and assumptions 

22 that are made. However, even though claimant 
17

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 favorability, in most cases, could be 

2 intuitive, it has rarely been quantified in 

3 NIOSH dose reconstruction.

4 So we feel that there is room for 

5 improvement in this area to where they could 

6 start looking at trying to quantify a margin 

7 of claimant favorability in certain 

8 circumstances. 

9 Better assessment of bias may 

10 greatly improve the competence of the program 

11 and reinforce assertions of claimant 

12 favorability. What I'm speaking of here is 

13 it's recognized in the case of NIOSH dose 

14 reconstruction in contrast to epidemiologic 

15 research.

16 We're interested in risk to 

17 individual. So small biases could play a 

18 large role in adjudication. So I think it's 

19 important to -- to give more emphasis in 

20 trying to quantify these biases.

21 So in the -- in the end of the 

22 report there was series of specific findings 
18

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 and recommendations. We had two on 

2 documentation. There were two on peer and 

3 stakeholder review. And there were seven on 

4 methods validation.

5 I'm briefly going to go over these 

6 methods a little bit now. They're quite 

7 detailed in the report. So in documentation, 

8 we found that the system provided documents 

9 that were clear and concise and relevant to 

10 the points of views.

11 However, we did note several, or 

12 not several, there were errors and 

13 inconsistencies among some of the documents. 

14 One of the key findings, at least with regard 

15 to documents, is the fact that they use a 

16 hiearchical system of records where they have 

17 a parent Technical Basis Document.

18 And then in turn, they derive more 

19 site specific information from that. And they 

20 will refer back to the parent, which is a good 

21 approach to -- to eliminate redundancy in 

22 documentation.
19

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 However, it's also -- there are 

2 pitfalls there to where you can carry on 

3 inconsistencies in children documents, or 

4 perhaps you revise the parent and not revise 

5 the documents that are referring the parent. 

6 And so you have inconsistencies. 

7 So we thought they could improve 

8 upon that by developing a system to monitor 

9 layered documents and effectively revise 

10 documents. Have a way to trip which documents 

11 are affected by revision of another.

12 Revisions lack timeliness, and in 

13 some instances appeared unresponsive to 

14 concerns raised in previous reviews. Again, 

15 this goes back to the revision process. 

16 One of the things we found was as 

17 in any scientific process, there's a very 

18 deliberate manner in which certain science 

19 issues are resolved between the Board and the 

20 Division of Compensation Analysis and Support 

21 staff, as well as the Board's contractor, 

22 which is great.
20

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 That process itself has really 

2 benefitted the quality of certain documents. 

3 But it does slow the revision process down. 

4 Another problem that appeared during our 

5 review is there was a concern that certain 

6 revisions could trigger more work, even if 

7 that revision really didn't play a key role in 

8 dose reconstruction or the dose estimates that 

9 are provided under that document.

10 So what I'm saying here is that 

11 it's recognized that if we make changes to our 

12 methods that we have to evaluate the impact on 

13 the program from those changes.

14 And there's a very deliberate 

15 process in doing that, which if the worse 

16 substantive changes, which would require 

17 reopening a claimant's file, then there is a 

18 process in place to do that.

19 But on the other hand, when there 

20 are revisions that are necessary, which are 

21 minor technical inaccuracies, let's say, that 

22 are well known, that have been identified by 
21

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 stakeholders or other members of the public, 

2 there's a reluctance to make those changes 

3 early on, waiting for more substantive changes 

4 later because it invokes this process of 

5 reevaluating the claims.

6 So that doesn't seem to be an 

7 efficient way of handling certain non8 substantive revision. It would seem prudent, 

9 especially given the fact that these documents 

10 are available and these inconsistencies have 

11 been identified by claimants and other members 

12 of the public that we could better revise 

13 those in a more timely manner without, you 

14 know, waiting for the final substantive 

15 revision.

16 And of course, another -- another 

17 finding was that many of these documents have 

18 not been reviewed since they've been first 

19 issued. Some of these documents have gone 

20 five or six years and haven't been revised or, 

21 to our knowledge, reviewed for revision.

22 So although several documents, 
22

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 well over 130, let's say, documents have been 

2 reviewed by the Board, and well over 500 

3 findings have come as a result of those 

4 reviews, and a lot of those documents have 

5 been revised, there still are a great number 

6 that are left to be reviewed and revised. 

7 So our key recommendations were to 

8 put in place some sort of process to recognize 

9 interrelationships between documents and avoid 

10 these transfers of technical inaccuracies that 

11 we found on our review. 

12 We suggest including periodic 

13 reviews by subject matter experts to uncover 

14 inconsistent and erroneous text. And we 

15 suggest avoiding delays in correcting 

16 technical inaccuracies, especially if they 

17 really clearly have no impact on the 

18 claimant's dose estimates.

19 The review process -- the current 

20 review process for dose reconstruction 

21 documentation is internal only, although the 

22 documents are all available for review by the 
23

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 Board. And the Board has reviewed many of 

2 them.

3 So there is no requirement for 

4 external scientific or stakeholder review. We 

5 noted that many of the documents have 

6 benefitted from the Board's review, although, 

7 as I mentioned before several have not been 

8 reviewed. 

9 Information is inconsistently 

10 sought from stakeholders and only after 

11 publications. So we were a little bit 

12 concerned in the instance where we -- it 

13 seemed in the sake of expediency. 

14 We published a number of documents 

15 to get the process going. And then after the 

16 documents were available there were comments 

17 received by former workers and other members 

18 of the public, which suggested that we could 

19 have done a better job.

20 So at this point it seems like 

21 there was advantages, at least from a 

22 scientific perspective, to get more feedback 
24

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 prior to publication. Now that we have a 

2 working body of documents, it would seem the 

3 emphasis should be placed on getting that 

4 feedback and organizing that feedback to where 

5 we can effect revision as needed. 

6 Right now there's a weekly define 

7 process for comment resolution. When I say 

8 that that's mostly in regard to public 

9 comment. We'll receive several comments from 

10 the public and former workers.

11 And they're handled individually, 

12 usually by a letter. It would be better to 

13 track these, if possible, in a more efficient 

14 means, and to see if it's necessary to effect 

15 changes to these documents based on the new 

16 information that's provided.

17 This was a problem with another 

18 dose reconstruction program from DETRA. They 

19 also had a number of comments about weekly 

20 taking advantage of worker input. 

21 So here's an opportunity to 

22 improve the signs by improving the use of 
25

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 worker input in the -- in the current 

2 documentation. We recommend that you seek 

3 external peer review on science documents that 

4 have not been reviewed by the Board.

5 So as I said before, there a 

6 number of documents that haven't been 

7 reviewed. It would seem to be wise to look 

8 for independent scientific peer review on 

9 those documents as a means to sort of catching 

10 up and cleaning shop, with respect to external 

11 science review.

12 Expand reviews to systematically 

13 solicit input from peers and stakeholders on 

14 important scientific individuals prior to 

15 publication. Again, better use of -- of 

16 information from former workers and other 

17 members of the public. 

18 And develop a more formal process 

19 to handle comment resolution. That would 

20 readily document the resolution that has been 

21 made, the actual comment, the source of the 

22 comment and what changes have been made. 
26

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 Methods. Dose estimates from 

2 independent modeling were comparable, but on 

3 average less than the dose reconstruction 

4 results. So what I'm talking about here, we 

5 did a replication model of the K-25 coworker 

6 study, and using the methods that are outlined 

7 by the Division of Compensation Analysis and 

8 Support, but using other data sources and 

9 other means to complete that replication.

10 And in essence, we got the same 

11 answers. We got the same estimates that DCAS 

12 came to in their models, although on average 

13 they were less than. So the conclusion is

14 that their coworker models are reproducible, 

15 and supported their claim of claimant 

16 favorability. 

17 However, we did note that there is 

18 room for improvement in these models. Some 

19 models lack information on source data 

20 assumptions, statistical methods and

21 limitations.

22 These types of things, I think, 
27

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 would be readily identified in scientific peer 

2 review. Validation was inconsistent or absent 

3 from some models.

4 So I think from a take-home 

5 message, if I really wanted to stress any 

6 facet of this report, the most important 

7 finding was that a great number of things have 

8 been done in support of the program in 

9 expeditious manner and keeping with timely and 

10 efficient dose estimates for covered workers.

11 However, the time might be now to 

12 focus more on validating these methods. There 

13 has been limited work done in the -- in the 

14 indirect exposure assessment methods that have 

15 been used in trying to validate the margin of 

16 safety, if you will, for claimant 

17 favorability.

18 I think that's the key here. How 

19 bounding is bounding? So if I were -- on this 

20 slide if I were to just emphasize one point, 

21 it would be the validation was inconsistent or 

22 absent and where there is room for improvement 
28

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 in this area.

2 So of course that goes back to 

3 recommendations as I just said. We think you 

4 could -- we could do a lot more in assessing 

5 the validity of these estimates. And there 

6 were some wonderful comments raised by Dr. 

7 Richardson on this area, suggesting using some 

8 of the modeling that has been done in 

9 epidemiologic research as a gold standard, if 

10 you will, and making comparisons. 

11 And that's somewhat what was done 

12 in this report. But it gives an idea of how 

13 much the bias is away from the null, assuming 

14 that we do have claimant favorability in our 

15 dose estimates.

16 So we think that we could do more 

17 in quantifying the coverage anomalies and 

18 limitations in the data that are selected, you 

19 know. In any model, the model is only as good 

20 as the data that's going in it. 

21 So there should be some more 

22 discussion in these coworker models and some 
29

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 more review -- some more critical review on 

2 the data that are being used.

3 Examine between and within worker 

4 variance components of the coworker models. 

5 What I'm speaking of here is a lot of the 

6 coworker models are based on standard 

7 statistical models, which rely on dose 

8 distributions.

9 And what isn't really clear is the 

10 fact that those distributions within a worker 

11 group, let's say millwrights compared to an 

12 office worker, are going to differ.

13 So there's opportunities to 

14 improve the estimates based on looking at 

15 different strata. And so we're suggesting to 

16 look at those between worker strata as well as 

17 looking at within worker, because the 

18 statistical models may assume there's no 

19 correlation from year to year for a worker.

20 And in fact that's not the case. 

21 In some cases it has been identified that some 

22 workers are dose-prone. So you really need to 
30

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 consider correlations. 

2 I think intuitively when we look 

3 at the external coworker model, which the 

4 premise is you take the 95th percentile of 

5 each year. And if you were to sum those up 

6 over all years, that would be a conservative 

7 estimate. 

8 But there are ways that you can 

9 judge the amount of conservatism in that 

10 estimate, based on looking at these different 

11 strata. Use well defined gold standards. 

12 Again, this goes back to the issue 

13 of using epidemiologic information as sort of 

14 a gold standard to do your comparisons and to 

15 judge validity. And it goes back to what I 

16 said very early on in the discussion, quantify 

17 the degree at which claimant favorability is 

18 achieved.

19 You know, we talk about it all the 

20 time. It's inferred. Some of the estimates 

21 are clearly claimant-favorable estimates, yet 

22 we haven't really spent enough time, I 
31

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 believe, in trying to quantify that claimant 

2 favorability.

3 At the very end of the report --

4 oh, sorry. Excuse me. Okay. At the very end 

5 of the report I tried to summarize the 

6 stakeholder comments that were on the docket 

7 at the time that I did the report.

8 And in essence, and these 

9 certainly aren't surprising, but it was 

10 recognized that dose reconstruction is a 

11 lengthy and complicated process. And we know 

12 that. We know that it's very difficult to do 

13 individual dose reconstruction in a way that's 

14 simple to understand. 

15 So I'm not quite certain how much 

16 we can work to improve upon that. But it is 

17 recognized that that, of course, is an issue 

18 with the claimants. And then the second one 

19 is comments were wary of differences and 

20 facility and jobs that may be inadequately 

21 addressed in current models, using coworker or 

22 surrogate data.
32

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 So this goes back to really two 

2 issues. One issue is the use of input from 

3 the workforce in the models that have been 

4 developed. Have we assessed all the 

5 scenarios? Are there other scenarios that are 

6 put out by the workforce that may not be 

7 covered under the current model?

8 Those types of things, a 

9 systematic approach to that, and weeding out 

10 those things would improve this bullet, I 

11 believe. And the second thing is a judgement 

12 on claimant favorability.

13 If we're going to assert that we 

14 are claimant-favorable, then some efforts to 

15 validate these dose estimates in a means to 

16 quantifying that claimant favorability would 

17 go a long way in doing that.

18 So with that I believe that was 

19 the end of my slide. And thank you.

20 CHAIRMAN MELIUS: Thank you. And 

21 Wanda, then Jim.

22 MEMBER MUNN: Mr. Daniels, I want 
33

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 to thank you for the obvious effort that you 

2 and Dr. Spitz have put into this. I have so 

3 much to say about it that I would delay the 

4 departure of about 90 percent of this Board if 

5 I were to actually launch into it. 

6 And I hesitate to do that, 

7 specifically because I have not given the 

8 original document the amount of study that I 

9 need to do. But the tension that is 

10 frequently spoken of here, with respect to 

11 timeliness as opposed to completed science, is 

12 more than amply demonstrated by your notes 

13 here.

14 It raises an enormous number of 

15 questions, not the least of which from some 

16 perspectives would be how would you propose to 

17 do some of the things that you are suggesting 

18 be done here?

19 For example, the quantification of 

20 how favorable is favorable, boggles the mind 

21 when one begins to imagine how one would 

22 address that question. I have a very simple 
34

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 question to begin with. This is an easy one.

2 Over on your general findings 

3 authority you said epi studies rarely benefit 

4 from complete exposure information. Are you 

5 saying they rarely enjoy complete exposure 

6 information? 

7 Am I misreading the word benefit? 

8 I cannot imagine how one would not benefit 

9 from complete exposure information if one 

10 could only get it. 

11 MR. DANIELS: Well, I agree with 

12 your statement at the end there. Yes, what I 

13 meant to say was that --

14 MEMBER MUNN: The last one.

15 MR. DANIELS: Right. An 

16 epidemiologic study, especially an 

17 occupational epidemiologic study, we very 

18 rarely have complete monitoring information on 

19 any individual.

20 MEMBER MUNN: That's all I needed 

21 to hear. The use of the word benefit was what 

22 raised the question in my mind. Why would it 
35

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 not benefit. You're saying you seldom enjoy 

2 that --

3 MR. DANIELS: That's correct.

4 MEMBER MUNN: That plethora of 

5 information that we would all like to have. 

6 Did either of the preparers go so far as to 

7 suggest some metric by which this assessment 

8 of quantity of bias could be addressed?

9 MR. DANIELS: Right. That's a 

10 very good question. And I do understand the 

11 difficulties that I raise by suggesting 

12 improved validation of these methods. 

13 It's impossible to truly validate 

14 because we don't have true dose. However, 

15 putting that aside, if you really look at what 

16 was done through the report, I took a very 

17 crude approach to validating the K-25 external 

18 coworker model.

19 What I did was I replicated the 

20 model with another data source and compared 

21 those results to measured value. And then by 

22 looking at that, I can judge whether or not 
36

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 you would expect, in the case of the coworker 

2 model that is based on a claimant favorability 

3 that the values would be biased high from the 

4 coworker model compared to my model.

5 And they were. So that was a very 

6 crude approach. What I'm suggesting could be 

7 done is more detail -- is given the fact that 

8 in epidemiologic analysis, let's say the 

9 Savannah River cohort for example.

10 There was a cohort study. And 

11 there was great efforts made in doing dose 

12 assessment and constructing exposure estimates 

13 for every individual at Savannah River, based 

14 on their measured data as well as missed dose 

15 from non-measured doses.

16 That could be a gold standard, 

17 which could be used as a basis for comparison 

18 to estimates derived from a coworker model. 

19 That would be one way of determining, you 

20 know, if there is claimant favorability in the 

21 estimates, and to what degree.

22 Now, certainly there is 
37

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 uncertainty in that estimate of claimant 

2 favorability. But at least you get an idea. 

3 Are we talking about a factor of two or are we 

4 talking about a factor of three?

5 It would be, I think, important to 

6 at least try to get our arms around that to 

7 some extent. So there are a number of methods 

8 that could be used to independently -- and I 

9 would suggest that this would be done 

10 independent of -- not within DCAS, but perhaps 

11 look at other persons to take a crack at 

12 validating their models.

13 And I think that would go a long 

14 way in assurances of claimant favorability. 

15 So that's just one example. I think, you

16 know, that was the reason why we replicated 

17 the K-25 coworker model, was first off, wasn't 

18 reproducible. 

19 And I get the same numbers. And 

20 second off, are the estimates accurate? And 

21 when I say accurate, in the context of biased 

22 high, biased away from the null. So that's 
38

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 kind of what were trying to do with that part 

2 of the analysis. 

3 CHAIRMAN MELIUS: Okay, Gen? 

4 MEMBER MUNN: Oh, I haven't 

5 anywhere near stopped. However, as I -- as I 

6 said to begin with, this could go on from this 

7 chair for a long, long time. And I don't want 

8 to do that. There were several more questions 

9 that I have -- if we run out of time. Go 

10 ahead.

11 CHAIRMAN MELIUS: We had said we'd 

12 go to 10:30. 

13 MEMBER MUNN: Go ahead.

14 CHAIRMAN MELIUS: But I wanted --

15 I assumed you were just going to do one 

16 question.

17 MEMBER MUNN: No. I have about 

18 eight. But that's --

19 CHAIRMAN MELIUS: You can submit 

20 more to the record.

21 MEMBER MUNN: We won't attempt to 

22 do that. I=ll provide written comments.
39

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 CHAIRMAN MELIUS: Gen?

2 MEMBER ROESSLER: I think one of 

3 the really high points in this whole program 

4 has been in the advances in science that have 

5 come about through this, particularly in 

6 retrospective dose assessment.

7 I think you call it exposure 

8 assessment. But I'm going to -- I'm going to 

9 call it dose assessment. And in fact, I think 

10 we should recognize the peer review 

11 publications that have come about as a result 

12 of some of the science. 

13 And I'm familiar with the ones 

14 that have appeared in Health Physics. My 

15 question is have there been publications in 

16 other peer reviewed journals?

17 MR. DANIELS: Yes. Of course you 

18 are referring to the one special series that 

19 was published in the Health Physics B

20 MEMBER ROESSLER: Well, I'm -- in 

21 particular. But there have been other ones 

22 too.
40

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 MR. DANIELS: Certainly. And as 

2 well, the recent report by the NCRP on dose 

3 reconstruction has a large section devoted to 

4 dose reconstruction for compensation purposes, 

5 which is largely a result of the work that the 

6 Division of Compensation Analysis and Support 

7 has done.

8 CHAIRMAN MELIUS: Henry? 

9 MEMBER ANDERSON: My question was 

10 most of your slides here in presentation 

11 focused on coworker models. And I'm more 

12 interested in the surrogate data use. And if 

13 you could give us some examples of other 

14 surrogate data use.

15 NIOSH has industry-wide studies 

16 that, you know, have studied across all sorts 

17 of industries. I'm just not that familiar 

18 with that surrogate data -- using data at one, 

19 you know, chemical factory has been assigned 

20 to do epi studies at another chemical factory 

21 manufacturing the same products and things 

22 like that.
41

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 So what were your comments 

2 regarding surrogate? Coworker is pretty well 

3 recognized and has been used. But going 

4 afield for surrogate data is somewhat unique, 

5 I think, to this program. 

6 MR. DANIELS: Yes. It's very 

7 interesting you say that, because in the 

8 exposure assessment sciences they really don't 

9 distinguish between surrogate and coworker 

10 data. It's all forms of indirect exposure 

11 assessment.

12 Exposure proxies. And in some 

13 cases, the proxies are coming from, you know, 

14 other buildings, other facilities within the 

15 industry. One key example is in the petroleum 

16 industry looking at benzene.

17 A lot of the exposure matrices 

18 that were developed in support of the health 

19 effect studies for that industry are based on 

20 maybe one facility that actually had some 

21 monitoring data.

22 And then they would just as we've 
42

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 done in dose reconstruction, apply those in 

2 similar work locations across the industry. 

3 And so it's more common than you would expect.

4 I do list in the report, in the 

5 section discussing epidemiologic methods, 

6 several studies that have been done using both 

7 nearby methods, coworker methods and surrogate 

8 data use.

9 So there's a number of examples in 

10 there.

11 CHAIRMAN MELIUS: Dr. Lemen?

12 MEMBER LEMEN: To follow up on Dr. 

13 Anderson's comments of which go along the same 

14 lines that I have, first of all I'd like to 

15 say you've put in a lot of work on this. And 

16 I appreciate that.

17 And it's a very useful document 

18 for the Board to have. As far as surrogate 

19 data though, when you state -- I think on page 

20 A-12 is just an example that the use of 

21 surrogate data to estimate occupational radon 

22 exposure for workers who were unmonitored or 
43

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 inadequately monitored is a conventional 

2 practice that is successfully used by 

3 governmental agencies in epidemiological 

4 studies to determine risk to humans.

5 I wouldn't totally disagree with 

6 that. But I would say is that I still think 

7 that NIOSH has not understood, in this 

8 program, that we're not doing epidemiological 

9 studies.

10 What we're doing is compensating 

11 people. It may fine to use the surrogate data 

12 for an epidemiological study with all the 

13 caveats that are connected with that so that 

14 the reader can do it. 

15 But when we're dealing with 

16 compensating individuals in individual 

17 facilities, to me I still have a major problem 

18 with the surrogate data usage. And I think 

19 that it may be a welcome tool to 

20 epidemiological studies.

21 But I don't think it's a welcome 

22 tool to those that are going to be 
44

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 compensated. And I'd really like to see this 

2 report focus more on the pitfalls of surrogate 

3 data than it has. Thank you.

4 CHAIRMAN MELIUS: I mean, another 

5 way I thought about that is, because I share 

6 some of Dick's concerns, is that I wouldn't 

7 necessarily view what's been going on in the 

8 exposure assessment in epidemiological studies 

9 translate into dose assessment, and for this 

10 program, is necessarily the gold standard. 

11 But I think the methods that -- I 

12 think it may be the silver standard or it's --

13 it ought to be at least as good as that. And 

14 the way I thought what your recommendations 

15 were very helpful were helping to think about 

16 the kind of validation and the kind of 

17 evaluation that needs to go on at least 

18 achieve that.

19 It ought to include that, because 

20 when we have disagreements within the Board or 

21 our contractor and DCAS over, it's usually 

22 questions of whether it's uncertainty or lack 
45

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 of information and we're trying to apply a new 

2 method or a different approach.

3 And we really haven't undergone 

4 the kind of review and validation in a broad 

5 sense that would be helpful for that. And I 

6 thought that your comments were -- some of the 

7 analysis that you were very helpful in that 

8 regard. 

9 You know, thinking of the example 

10 you used on benzene. And actually, in 

11 epidemiology you have the same sort of problem 

12 we face. It's limited data in a lot of 

13 facilities. 

14 And if you look at, at least, the 

15 criteria the Board came up with, and I believe 

16 somewhere with NIOSH came up with for 

17 evaluating surrogate data, those criteria for 

18 evaluating are similar.

19 You know, how similar are the 

20 facilities? Were they built the same time, 

21 same kind of industry. I think it's -- may be 

22 more variabilities or pretty special 
46

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 facilities. 

2 You know, the DOE facilities, if 

3 you're familiar with. But, you know, there 

4 are similarities to what may be found in 

5 industry. There are other studies. I can 

6 think of where, you know, you may be doing 

7 epidemiologic study at multiple facilities. 

8 You may have good exposure information for 

9 three or four. You apply that to the two that 

10 don't, you know, that have weaker data.

11 Or you may do it on the basis of 

12 who have done a better assessment of a certain 

13 part of the workforce or something. And it's 

14 clearly a gradation.

15 It's not, you know, yes or no or 

16 black and white in terms of evaluating that. 

17 But -- but I think some of that thinking 

18 transferred over, I think, would be very 

19 helpful.

20 MR. DANIELS: I agree. You know, 

21 and I do understand your concern about using 

22 surrogate data for individual risk assessment, 
47

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 you know. The slides -- I tried to keep the 

2 slides short. 

3 But there is a section on the 

4 report talking about differences between 

5 epidemiologic approaches and individual risk 

6 assessment. I think key to this is the fact 

7 that, you know, small biases and individual 

8 exposure assignments in support of an 

9 epidemiologic study really won't play a large 

10 role in the outcome of the risk that you get 

11 from that health effect study.

12 But that's not true in the case of 

13 individual exposure assessment. Small biases 

14 could certainly have an effect on 

15 adjudication. So when you're working in the 

16 tail end of an exposure distribution, as you 

17 are in the case of trying to determine 

18 bounding doses, you know, a lot of the 

19 assumptions that you make in modeling fall 

20 apart.

21 And so we got to be wary of that. 

22 And that's why, I think, the validation 
48

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 component is so important, because we aren't 

2 working with means and medians anymore. We're 

3 working at the tail of distribution. And we 

4 need to be sure that what we say is bounding 

5 is indeed bounding. 

6 CHAIRMAN MELIUS: No, I thought 

7 that was a very good way of looking at --

8 looking at that. The other part of your 

9 report that I thought was -- was helpful, and 

10 I don't know if there's others have reaction 

11 to, was sort of the document updating issue 

12 and then science and so forth, because I think 

13 due, you know, largely to how busy and how 

14 much work there is in this program, we've not 

15 kept up with that.

16 And I think, frankly, the Board is 

17 at fault also. You know, we've -- we've 

18 tended to divide up our reviews. We do dose 

19 reconstructions reviews. We look at certain 

20 issues. We do Site Profiles. We look at 

21 certain issues. 

22 We do procedures. We look at 
49

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 certain issues. We don't always pull those 

2 altogether. And we often do those reviews in 

3 isolation. And we struggle with the issue of 

4 continually updating and -- and so forth. 

5 And I think some more systematic 

6 approach that would involve, you know, you 

7 said not only -- so the current structure of 

8 the Board, the Board's contract. But 

9 additional, you know, external peer review, I 

10 think, would be very helpful to this program.

11 Dr. Ziemer, Brad Clawson you're on 

12 the phone? I don't know if you have 

13 questions. I'll give you the opportunity 

14 then. Got a couple more.

15 MEMBER ZIEMER: Paul Ziemer here. 

16 And I just have a couple I'll at least have, 

17 you know, one question and make a comment if 

18 that's all right. 

19 CHAIRMAN MELIUS: Go ahead.

20 MEMBER ZIEMER: Well, first I 

21 wanted to thank Dr. Daniels for an excellent 

22 presentation. My sort of question right now 
50

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 is I like the question you raised, how 

2 bounding is bounding. 

3 In your mind, is that the same 

4 issue as the quantitation of claimant 

5 favorability? Is that another way of stating 

6 it or are you thinking of two different things 

7 here?

8 MR. DANIELS: No. That was the 

9 same. That's the same.

10 MEMBER ZIEMER: Okay. That's --

11 that's what I thought, but I wanted to make 

12 sure that that was just another way of talking 

13 about quantitating claimant favorability.

14 The other -- if I can just have 

15 one other minor question right now. And this 

16 relates to slide 14 and the -- the discussion 

17 on -- on what you call the weakly defined 

18 process comment resolution.

19 I did notice that you were 

20 focusing a lot there on public comment 

21 resolution, which we're starting to do a 

22 little better, I think, with our matrix of 
51

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 tracking these. 

2 But is -- were your comments here 

3 today mainly focused on that sort of thing or 

4 what -- what was the -- what was your 

5 conclusion in terms of comment resolution as 

6 it's formerly done with our contractors and 

7 the agencies and the Board?

8 We have a rather elaborate -- it's 

9 not necessarily well-defined. It may be 

10 weakly defined. But it operates much like 

11 peer review in science where you have a -- a 

12 give and take and try to resolve specific 

13 issues and questions.

14 Did you have any particular 

15 comment on that part of the -- of the 

16 methodology that is used to resolve scientific 

17 issues?

18 MR. DANIELS: Yes. We did look 

19 into that, and we noted that the Board tends 

20 to resolve -- have scientific debate in 

21 resolve issues in a Work Group format. And 

22 not all Work Groups are equal. Not all Work 
52

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 Groups manage themselves the same way. 

2 So what happens in some cases is -

3 - is there have been instances where comments 

4 have -- have come about, which may have been 

5 transferred to another Work Group or may be 

6 sitting in a Work Group or may be or not as 

7 well documented in that Work Group, the 

8 process of resolving them as another Work 

9 Group.

10 So there's a lot of, you know, 

11 personal -- the Work Groups themselves, 

12 there's a lot of individuality in the Work 

13 Groups. So what we're suggesting is a better 

14 way, maybe would be at least reporting to a 

15 centralized place to where you could track 

16 these comments and track the resolutions 

17 accordingly, and -- and show some, you know, 

18 expediency in getting things revised.

19 So -- so that's what we saw in 

20 that part B

21 MEMBER ZIEMER: Right. It seems 

22 to me that that may be every bit as important 
53

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 as the process for handling the public 

2 comments, many of which in the public arena 

3 have to do with how the program operates 

4 rather than necessarily scientific issues.

5 But certainly some consistency 

6 from Work Group to Work Group in terms of 

7 identifying those issues and having a more of 

8 a structured process for resolving them. And 

9 thank you. 

10 CHAIRMAN MELIUS: Brad, do you 

11 have questions?

12 MEMBER CLAWSON: Well, yes. I 

13 would also like to thank him for bringing his 

14 report, because, you know, it's given us all 

15 food for thought on this and while we were 

16 just talking about of the Work Groups being 

17 individual differences.

18 You know, we can always see that 

19 and we can always improve. I'd like to echo 

20 what Dr. Lemen said that I have an awful lot 

21 of issues. I know that we have to be able to 

22 use coworker data and so forth like that.
54

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 But one of the other ones that 

2 bothers me is the coworker data. When a lot 

3 of these plants were looking back, 40, 50 

4 years, the names have changed and so forth 

5 like that. 

6 And working in the industry 

7 myself, I've seen so many times that you may 

8 call somebody a chemical operator or a fuel 

9 handling operator or whatever. But their name 

10 has changed and their tasks have changed over 

11 time of what -- what they actually did and 

12 where they went.

13 They sometimes feel that because 

14 they can put this name on them and put them 

15 into these buildings. But these, you know, we 

16 need to spend a little bit more time. And I 

17 feel to check out where they've been.

18 I know that we've got to use 

19 coworker data. But sometimes we generalize 

20 them too much, and I don't think that we 

21 really capture what really goes on in there. 

22 But I -- I think as -- as what you said, the 
55

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 Board takes a little bit of criticism on this 

2 too.

3 I know this was a NIOSH review. 

4 But also two of those areas we can improve. 

5 And I appreciate what was brought to us 

6 instead. That's it.

7 CHAIRMAN MELIUS: Phil?

8 MEMBER SCHOFIELD: I'd like to 

9 think coworker data particularly gives me a 

10 lot of -- I'm a little suspect at times on 

11 that. But surrogate date, in particular 

12 though, because you have the issues of time, 

13 distance and shielding. 

14 And from one facility to another, 

15 even with similar materials there's a good 

16 chance of large variabilities, particularly 

17 when you're looking back 20, 30 years or more. 

18 This becomes a real factor and what people 

19 are exposed to, in particular when it comes to 

20 their compensation.

21 CHAIRMAN MELIUS: Wanda, would you 

22 like the last -- no? Bill?
56

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 MEMBER MUNN: I think not. 

2 Futile. Thank you.

3 CHAIRMAN MELIUS: I knew you'd 

4 never forgive me. 

5 MEMBER FIELD: Dr. Daniels, I 

6 thank you. I think this is -- this is very 

7 helpful to have a fresh look. Someone coming 

8 from of sort of the outside and giving it a 

9 fresh look and sort of a different 

10 perspective.

11 I have a question on slide number 

12 seven. I just -- probably just more of a 

13 clarification. But at the bottom it says the 

14 use of surrogate data is an acceptable 

15 scientific approach provided that the data 

16 complement but not supplant information from 

17 preferred sources.

18 And I'm just wondering for the 

19 word supplant, do you mean take the place of?

20

21 MR. DANIELS: Yes.

22 MEMBER FIELD: Okay. And what --
57

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 what happens in the case from your reviews if 

2 you don't have data to complement, that 

3 there's just a lack of data?

4 MR. DANIELS: Well, I think 

5 there's a process in place. If you don't have 

6 data to do dose reconstruction then that --

7 that process is Special Exposure Cohort. So I 

8 think that's what's laid out in the Act. And 

9 that would be the direction to go.

10 CHAIRMAN MELIUS: I believe Dr. 

11 Wade wants the last comment.

12 DR. WADE: I'd like to just very 

13 quickly. Four things. I'd like to Doug 

14 personally for his efforts in coming here and 

15 being with us. Doug did end his opening speak 

16 to the fact that he was focusing on indirect 

17 exposure assessments. 

18 But I think if you read the report 

19 he was commenting upon the quality of science 

20 in the program overall. And the lastly, with 

21 regard to comments, the external review of the 

22 document is open.
58

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 So if anyone would like to make a 

2 comment or a suggestion, I'm sure that Doug 

3 would take that to heart and modify his report 

4 based upon what you would say. So I think you 

5 have the ability to impact the substance of 

6 Doug's report.

7 We then have the ability to impact 

8 what John Howard would do relative to the 

9 recommendations that Doug makes by commenting 

10 upon those as well. So there's opportunity 

11 for this process to continue to improve in 

12 ways that Board Members might like to see it. 

13 And I would ask you to take 

14 advantage of that. And thank you again.

15 CHAIRMAN MELIUS: Yes. Yes. 

16 Thanks very much. I told Lew that I and maybe 

17 others had questions about sort of using 

18 internal people to do some of these -- these 

19 reviews. And I thought that your report, and 

20 in fact, some of the others also sort of

21 showed that someone withing NIOSH could do a 

22 fair and, you know, I thought very good 
59

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 assessment of the program.

2 So in the spirit of peer review, 

3 which I think we're used to, but it's not 

4 always done in other settings as well. But it 

5 was a very good -- good report that you and 

6 Dr. Spitz did.

7 And I thought some very good 

8 recommendation, very perceptive about -- about 

9 the program. And we do appreciate that. 

10 MR. DANIELS: Thank you.

11 CHAIRMAN MELIUS: We have anything 

12 else? Okay. Yes, Josie?

13 MEMBER BEACH: I just wanted to 

14 make sure that we had tasked SC&A for Sandia 

15 National Labs. It wasn't really clear to do a 

16 -- the Site Profile Review and prepare a 

17 matrix.

18 CHAIRMAN MELIUS: Yes, we did it 

19 yesterday.

20 MEMBER BEACH: Okay. I just 

21 wanted to make sure.

22 CHAIRMAN MELIUS: We set up the 
60

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 Work Group.

2 MEMBER BEACH: Well, the Work 

3 Group was going to be set up at the next 

4 meeting.

5 CHAIRMAN MELIUS: Meanwhile we 

6 tasked SC&A. Yes.

7 MEMBER BEACH: Just wanted to be 

8 clear. Thank you.

9 CHAIRMAN MELIUS: SC&A has already 

10 done the Site Profile. 

11 MEMBER BEACH: The review would be 

12 just do the matrix?

13 CHAIRMAN MELIUS: The matrix, 

14 correct. Yes.

15 MEMBER BEACH: Okay. Thanks.

16 CHAIRMAN MELIUS: Good. Anyway, 

17 thanks, everybody. And hope everyone makes it 

18 out of here fine. And we will see you all in 

19 -- for an extended -- possibly extended visit 

20 to, hopefully not extended by the weather, but 

21 extended by the agenda in the Tri-Cities.

22 MEMBER MUNN: In the Tri-Cities. 
61

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 And I will make every effort to see that the 

2 day prior to our meeting is a tour day. 

3 Something quick. Which I think we all should 

4 take into consideration in planning our --

5 I'll try to get back to you on that as quickly 

6 as possible. But you should keep it in mind.

7 MR. KATZ: I mean DOE is working 

8 on setting up a tour --

9 MEMBER MUNN: Yes.

10 MR. KATZ: -- for the day before. 

11 So that's -- that's a fact. And folks that 

12 are interested in having that tour on the 

13 Board, please let me know, as well as folks 

14 from SC&A who would like to join that and 

15 folks from DCAS.

16 It would probably be good to get a 

17 head count of how many people are interested.

18 MEMBER CLAWSON: Hanford has asked 

19 me that as soon as we can get a head count 

20 they'd appreciate it so they would be able to 

21 accommodate how many people want to be able to 

22 go.
62

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 MEMBER MUNN: Brad, if you're 

2 doing this, I'm not.

3 MEMBER CLAWSON: Well, I started 

4 this a couple of months ago for the tour. And 

5 I've been in contact with our point out there, 

6 and she -- we've already got it set up for the 

7 day before, but she just wanted to get a head 

8 count the closer we got to this so she could 

9 make sure if she needs big bus or just a van.

10 So I would really encourage, 

11 especially the new Board Members that haven't 

12 been there. This is an excellent tour that 

13 they do. And Hanford's marvelous site, and 

14 they've accomplished a lot of things in their 

15 in their life up there. I highly recommend it 

16 to anybody.

17 MEMBER MUNN: Brad, why don't you 

18 send an email and tell me what you have 

19 planned, because I would like to coordinate 

20 your plan with what I had anticipated for the 

21 rest of the day. Thank you.

22 MEMBER CLAWSON: Okay. I'll be in 
63

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

1 contact with you.

2 MR. KATZ: I'd like to be the loop 

3 too, please. So let's all get coordinated 

4 here on this. Thanks.

5 MEMBER MELIUS: I can just 

6 envision the three tour buses crashing into 

7 each other meeting at the -- the B

8 MEMBER CLAWSON: We just had a --

9 we just had comments on this about how we're 

10 suppose to get together. So I'll let you know 

11 when I've got, I believe her name is Spills --

12 Spells or something like that, that I've been 

13 dealing with up there.

14 And she basically set up B

15 CHAIRMAN MELIUS: Brad, why don't 

16 you do this offline with everybody okay?

17 MEMBER CLAWSON: Okay.

18 CHAIRMAN MELIUS: Get coordinated 

19 with them. Thank you. Bye. Meeting is 

20 adjourned.

21 (Whereupon, the above-entitled 

22 matter was adjourned at 9:35 a.m.)