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U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

CENTERS FOR DISEASE CONTROL

NATIONAL INSTITUTE FOR OCCUPATIONAL

SAFETY AND HEALTH 

+ + + + +

ADVISORY BOARD ON RADIATION AND

WORKER HEALTH 

+ + + + +

WORK GROUP ON SEC ISSUES

+ + + + +

WEDNESDAY

APRIL 18, 2012

+ + + + +

 The Work Group convened 

telephonically, at 1:30 p.m., James M. Melius, 

Chairman, presiding.

PRESENT:

JAMES M. MELIUS, Chairman

JOSIE BEACH, Member

GENEVIEVE S. ROESSLER, Member

PAUL L. ZIEMER, Member
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ALSO PRESENT:

TED KATZ, Designated Federal Official

TERRIE BARRIE

STU HINNEFELD, DCAS

JENNY LIN, HHS

JOHN MAURO, SC&A

DAN MCKEEL

JIM NETON, DCAS

LAVON RUTHERFORD, DCAS

JOHN STIVER, SC&A
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1 P-R-O-C-E-E-D-I-N-G-S 

2 1:35 p.m.

3 MR. KATZ: Okay, it's about time, 

4 so let's get started with roll call. It's the 

5 Advisory Board on Radiation and Worker Health, 

6 it's the SEC Issues Work Group.

7 (Roll call.)

8 MR. KATZ: Okay then, as I said, 

9 the agenda's posted on the website. It's very 

10 simple, one issue. And Jim, it's your agenda.

11 CHAIRMAN MELIUS: Welcome, 

12 everybody. And what we had talked about at our 

13 last Board meeting when we were discussing the 

14 implementation of NIOSH's ten year review 

15 recommendations, one of those recommendations 

16 had to do with developing a definition, at 

17 least an operational definition, for 

18 sufficient accuracy, which has been an issue 

19 that's come up repeatedly in the Board's 

20 review of the SEC evaluations.

21 And we were a little unclear what 

22 was the best place within the Board, how the 
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1 Board should approach this. And so, really 

2 what I want to do, and I don't expect this to 

3 be a very long conference call today, but is 

4 for us to see where NIOSH is in terms of 

5 working on this issue.

6 And secondly then, talking to some 

7 of the Work Group about how we might approach 

8 it and who should be involved from the Board 

9 or if there's anything we want our contractor 

10 to start working on at this point in that. 

11 So, Jim Neton, do you want to let us know 

12 where you are with this issue?

13 DR. NETON: I could. I was hoping 

14 Stu might take the lead on that. Stu, are you 

15 on the phone yet? Okay.

16 CHAIRMAN MELIUS: Stu's decided 

17 you are.

18 DR. NETON: I guess so. We have 

19 started, as part of our matrix of these action 

20 items that we've developed out of the ten year 

21 review, and it was a two part approach to 

22 this.
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1 One is to establish a review 

2 matrix looking at previous SEC decisions for 

3 examples of how past decisions were made. And 

4 that might inform us as to where we currently 

5 stand with sufficient accuracy, at least from 

6 a case history perspective.

7 And then from that we were going 

8 to develop a series of paragraphs to define 

9 some aspects of a definition, based on what we 

10 gleaned from where we think the case history 

11 informed us.

12 That's being worked on. But, 

13 honestly, I have not been doing that 

14 personally. I'm not familiar with where we 

15 are status-wise. But that's the approach that 

16 we've adopted.

17 CHAIRMAN MELIUS: Who's handling 

18 that for NIOSH, it's LaVon or Stu?

19 DR. NETON: Stu had the action 

20 item on the matrix. I'm not sure who would 

21 have been doing that.

22 MR. RUTHERFORD: I can up-date it. 
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1 This is LaVon, I can up-date it a little bit. 

2 We have pretty much pulled together most of 

3 the decisions from previous SECs. And we 

4 actually had already had that in place. So 

5 we've got a pretty good start on that portion 

6 of it.

7 The other portion of it, the 

8 paragraphs, I know nothing about that at this 

9 point. And I can tell you the matrix itself, 

10 with past decisions, is well on its way.

11 CHAIRMAN MELIUS: Well, LaVon, I 

12 should tell you that when I talked to Stu the 

13 other day about something else we talked very 

14 briefly about this meeting. And he threw you 

15 in also. So I didn't hear you in the 

16 background or I would have put you on the spot 

17 first.

18 MR. HINNEFELD: Dr. Melius, this 

19 is Stu Hinnefeld.

20 CHAIRMAN MELIUS: Oh, yes, okay.

21 MR. HINNEFELD: Time got away from 

22 me for a little bit there. I didn't realize 
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1 it was 1:30, I'm sorry.

2 CHAIRMAN MELIUS: That's okay. We 

3 started more quickly than we usually do. 

4 LaVon or Stu, whoever, Jim, do you have a time 

5 table for when this matrix might be available?

6 MR. RUTHERFORD: I'll jump in on 

7 this, Stu. I think the matrix itself, that 

8 with the past decisions, that will be 

9 available, I would say, probably by the Board 

10 meeting, close to the Board meeting anyway.

11 CHAIRMAN MELIUS: Okay.

12 MR. RUTHERFORD: Because, to be 

13 honest with you, we ran with this. The 

14 decisions that we made on previous SEC 

15 petitions, we pulled them together into a SEC 

16 petition matrix a long time ago.

17 It's just now we're going through 

18 trying to determine, we need to determine 

19 whether the details there, to really see our 

20 decisions that were made, as well as we need 

21 to for this.

22 So I'm going to work with Stu and 
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1 Jim on that, to take a look at that, and to 

2 see if we need to pull in more detail or not.

3 CHAIRMAN MELIUS: Personally, I 

4 think that's a good way of starting on this. 

5 Because I think that it would allow you to 

6 classify the decisions and see, in what 

7 circumstances, how the issue of sufficient 

8 accuracy comes up in terms of making SEC 

9 decisions, both from the NIOSH perspective as 

10 well as the Board.

11 And again, I don't know where you 

12 are with it. But it might be interesting to 

13 identify where the basis for the SEC decision 

14 recommendation by NIOSH, and then if the Board 

15 didn't agree with that decision, where were 

16 the issues for the Board. And from what cases 

17 was sufficient accuracy a factor in the 

18 Board's disagreement with NIOSH?

19 And otherwise it's usually very 

20 straight forward because there's usually a 

21 history. And there's more information that 

22 comes up and it's complicated. But it would 
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1 seem to me that would help to identify where 

2 we're having the most difficulty.

3 MR. HINNEFELD: This is Stu. If I 

4 could just offer, the volume of the material 

5 is a difficult thing here and the 

6 understanding in a particular case, 

7 particularly where we've had one opinion and 

8 the Board had a different opinion about 

9 feasibility of dose reconstruction.

10 That sometimes takes a lot of 

11 careful study to really remember and pull back 

12 up and summarize the heart of the issues 

13 there.

14 And so it's a little time 

15 intensive to, once we've got these things 

16 entered, it's a little time intensive to 

17 really understand and put some sort of 

18 interpretation on each of these. So that's 

19 the difficult part about this.

20 CHAIRMAN MELIUS: I can see that. 

21 And I'll even think that, even before you've 

22 reached the interpretation section, because 
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1 even where you've identified the broad 

2 outlines of where there was a difference, it 

3 would be helpful to just discuss those.

4 Because your recollection may 

5 differ from ours and other factors. I mean, 

6 these are complicated decisions. But I think 

7 having the matrix also allows you to go back 

8 and say, well, this is where we agreed and 

9 this is a similar situation. What's the 

10 difference between the two?

11 MR. HINNEFELD: Right.

12 CHAIRMAN MELIUS: And I think it 

13 would be helpful. Of course, other Work Group 

14 Members have any comments on that?

15 MEMBER BEACH: Jim, this is Josie. 

16 The one thought that really comes to mind is 

17 having a really usable report. Because I 

18 think, like Stu said, this is going to be a 

19 lot of volume. So just having it in a way 

20 that we can go through it is going to be 

21 important.

22 MEMBER ROESSLER: This is Gen. I 
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1 think this matrix that they're putting 

2 together is extremely important because I 

3 think one of the things that we have to look 

4 at is the uniformity or consistency of 

5 decisions.

6 And in order to do that, we 

7 certainly have to go back in time and look to 

8 see, first of all, if they were consistent 

9 from one place to another and then whether we 

10 can derive something to apply that consistency 

11 to the future.

12 CHAIRMAN MELIUS: Yes, and what 

13 factors went into how the decision was made 

14 from one incidence to another. Paul, do you 

15 have any comments?

16 MEMBER ZIEMER: Yes. One thing 

17 that I'm wondering is once we've done that, 

18 and that certainly will help us understand 

19 those issues, but at some point it might turn 

20 up, then, to be helpful if there's a 

21 formalization of what we actually mean.

22 It turns out to be very difficult 
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1 because the accuracy that we're talking about 

2 here is quite different from the usual 

3 definition of accuracy in mathematics, 

4 particularly since we had the one side of the 

5 number is based on bounding.

6 And the other side of the number 

7 you can't go below what you think the true 

8 value is. So it's an interesting concept from 

9 that point of view.

10 But it would be good if we can go 

11 from seeing what we've done to formalizing, in 

12 some way, what we really mean so that we can 

13 compare future decisions against something 

14 that's a little more like a gold standard 

15 versus an intuitive.

16 CHAIRMAN MELIUS: Yes. I think 

17 you have not only a little different approach 

18 or use of accuracy and then you have the 

19 qualifier in there of sufficient, which 

20 loosens it up.

21 MEMBER ZIEMER: What is it that 

22 makes it sufficient in this application.
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1 CHAIRMAN MELIUS: Yes.

2 MEMBER ROESSLER: Jim, this is Gen. 

3 I have an additional couple other thoughts. 

4 As I think about sufficient accuracy, and 

5 doing it properly, I think back to when this 

6 whole program was put into place.

7 And whoever wrote this must have 

8 had some idea as to what that meant. And I 

9 don't even know who that was. But can we 

10 elicit some of that background information to 

11 see whether, in fact, we're following through 

12 on what the intent of the program was.

13 MR. HINNEFELD: We do know the 

14 author and I think we could get her to provide 

15 us that kind of information. If you like that 

16 in an oral discussion at some meeting at some 

17 point or --

18 MEMBER ROESSLER: I'm not talking 

19 about the ten year review, I'm talking about--

20 MR. HINNEFELD: The ten year review 

21 author?

22 MEMBER ROESSLER: Pardon?
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1 MR. HINNEFELD: Is that who you're 

2 talking about?

3 MEMBER ROESSLER: No, I'm talking 

4 back at the beginning --

5 MEMBER ZIEMER: The original.

6 MEMBER ROESSLER: -- when the 

7 program was put into place. Somebody sat down 

8 and said here's how we're going to do it. And 

9 then there's probably a case where you cannot 

10 calculate dose and then came up with this 

11 sufficient accuracy terminology.

12 I'm just wondering what the writer 

13 or the writers of that original document 

14 that's in the rule, what their thought was as 

15 to how that should be done or what that means.

16 MR. HINNEFELD: You're talking 

17 about the language that's in the rule then, 

18 the --

19 MEMBER ROESSLER: Yes.

20 MR. HINNEFELD: -- regulation?

21 CHAIRMAN MELIUS: This is Jim 

22 Melius. And Jim Neton, Paul and others, jump 
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1 in on this. But there's a sufficient accuracy 

2 was in the law. And I don't believe that 

3 there's any background, at least helpful 

4 background, on that in terms of Congressional 

5 intent or other language that helps to 

6 interpret that.

7 And way back when the Board was 

8 first meeting and NIOSH was developing the 

9 regulations on SECs and dose reconstruction, 

10 we had fairly extensive discussions on this 

11 issue and, I guess, how to implement it would 

12 be a fair way of putting it.

13 And I know that NIOSH struggled 

14 with that also, coming up with what was a way 

15 of making that operational for the purposes of 

16 making SEC evaluations, and really came up 

17 with the bounding, that became at least part 

18 of what was making that definition 

19 operational.

20 But then we ended up with how to 

21 then interpret what a plausible bound was. 

22 And so we've, I think, gone back and forth 
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1 interchangeably between is it a plausible 

2 upper bound or it's a surrogate for, in our 

3 discussions, although it's in the regulation, 

4 for sufficient accuracy.

5 So I hesitate to claim that our 

6 initial discussions would be helpful now but 

7 they might be. It's been obviously a long 

8 while. It's ten years. And I certainly 

9 haven't gone back and looked at those 

10 discussions.

11 MEMBER ROESSLER: It might be good 

12 to revisit them if we could find them.

13 CHAIRMAN MELIUS: They're there on 

14 our website.

15 MEMBER ROESSLER: But to locate the 

16 right spot.

17 MS. LIN: Dr. Melius, this is Jenny 

18 Lin with HHS.

19 CHAIRMAN MELIUS: Yes?

20 MS. LIN: I think what you're 

21 asking in terms of the regulatory history, I 

22 think the very first place that we should look 
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1 at is the regs themselves and then going back 

2 to look at the reg's preamble, the intent 

3 language of what the Agency has intent, the 

4 sufficient accuracy to mean.

5 And it actually does have a 

6 definition in there. I think the question the 

7 Work Group has tried to answer is a practical 

8 application of that term.

9 So I'll be happy to provide an 

10 excerpt from the preamble because it's a more 

11 definitive history of the regulation on the 

12 record as opposed to seeing individual authors 

13 opinions of what that sufficient accuracy 

14 actually means. So I'll be happy to provide 

15 that to the Work Group and to the Agency as 

16 well.

17 CHAIRMAN MELIUS: But, Gen, you 

18 weren't involved then. But you should know 

19 that, if I recall correctly, the Board's 

20 comments on those regulations were quite 

21 critical, particularly in the fact that you 

22 didn't have a adequate definition of 
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1 sufficient accuracy.

2 MEMBER ROESSLER: I think, 

3 actually, I've been involved since the 

4 beginning. But that's been ten years and I 

5 don't remember that.

6 But I think if Jenny can provide 

7 what she's just suggested, of course then the 

8 practical application of the term is what we 

9 can get some hints from by looking back at the 

10 Board's discussions of it.

11 CHAIRMAN MELIUS: Yes, I guess what 

12 I was recommending was that there's their 

13 discussions. And I think there were two 

14 attempts at the regulations and that there 

15 were a set of Board comments, plus some 

16 individual comments on the regulations, that 

17 would be useful to review again. Obviously, 

18 after ten years I think it changes but it 

19 maybe helpful as background.

20 MEMBER ROESSLER: Plus, we've 

21 learned a lot in the ten years that we've been 

22 doing this. So it might be beneficial to look 
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1 at that again.

2 CHAIRMAN MELIUS: At least we hoped 

3 we've learned something, right? Anybody else 

4 have comments or thoughts on that?

5 DR. MAURO: Dr. Melius, John Mauro. 

6 I just had another thought. Early on, when we 

7 were on the Board, we were asked to write a 

8 procedure for doing SEC Petition Evaluation 

9 Report reviews, which is quite detailed.

10 And it was reviewed extensively by 

11 the Board. And it has a lot of language in 

12 there regarding completeness of data, accuracy 

13 of data, that sort of thing.

14 Basically it's the test that we use 

15 when we do a scientific review of 

16 completeness, et cetera. There may be some 

17 language in there that will be helpful, also 

18 as a source of information to shed light on 

19 how we've been coming at this problem in the 

20 past.

21 CHAIRMAN MELIUS: It's a good 

22 point, John. And I think it comes to wrestle 
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1 with the plausibility. I interpret a 

2 plausible upper boundless was one of the 

3 issues.

4 But it doesn't provide a direct 

5 definition, or a criteria, as much as a set of 

6 what needs to be evaluated and a procedure for 

7 that evaluation.

8 DR. MAURO: I could say that 

9 procedure, which goes back a ways, does not 

10 talk about plausibility. Plausibility 

11 actually emerged when we worked on the 

12 surrogate data question that became front and 

13 center, which was quite a bit later than when 

14 we wrote the procedure for the SEC reviews.

15 CHAIRMAN MELIUS: Any other 

16 comments, Paul or Josie?

17 MEMBER ZIEMER: No, I think it'll 

18 be helpful to gather this information 

19 together. And we can proceed to determine 

20 whether it's really feasible at some point to 

21 develop a more formalized definition or 

22 structure against which we measure future 
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1 decisions.

2 CHAIRMAN MELIUS: Yes, I just want 

3 to make sure we were moving this along and not 

4 ignoring it. And I think waiting wasn't 

5 something we should be doing and --

6 MEMBER ZIEMER: No, I think we're 

7 waiting for NIOSH to complete their first step 

8 on this, right?

9 CHAIRMAN MELIUS: Yes, that's what 

10 it sounds like. And I don't want to give you 

11 an exact date, Stu, but I think if we could 

12 have that matrix sometime around the time of 

13 the June meeting, or say by the end of June or 

14 whatever, and then we could set up a Work 

15 Group meeting to focus on that and to provide 

16 further discussion.

17 Same time we could, Jen, you said 

18 you could help us and pull together the 

19 regulatory history and so forth, that would be 

20 useful also. I don't know if the old dockets 

21 are kept online, hidden away someplace or --

22 MS. LIN: Actually, I have them. 
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1 That's how I felt that the Board's comments 

2 were all captured in this regulatory document.

3 CHAIRMAN MELIUS: And I believe 

4 that our comments were submitted to the 

5 Secretary at the time. I can't remember 

6 exactly what the capacity was then but I know 

7 we came to an agreement.

8 And I think there were some other 

9 maybe helpful comments that were submitted on 

10 those regulations also that would be useful.

11 MEMBER ROESSLER: Could Jenny send 

12 those to Work Group Members?

13 CHAIRMAN MELIUS: Yes, we could put 

14 together a package of information or make it 

15 available on the O: drive or something.

16 MS. LIN: Okay, I can work on that.

17 CHAIRMAN MELIUS: Yes, good.

18 MEMBER BEACH: Sounds like a good 

19 start.

20 CHAIRMAN MELIUS: Okay, any other 

21 comments or suggestions? If not I think that 

22 really accomplishes at least what I wanted to 
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1 accomplish today.

2 And just long as I promised it 

3 would be short. But I think we needed to get 

4 organized and get coordinated with NIOSH in 

5 order to be able to do this.

6 And let's move forward with that 

7 plan and assume that we'll have a Work Group 

8 meeting sometime after the June meeting in 

9 Santa Fe. And then let's see where we go from 

10 there.

11 I think pull hard until we've sat 

12 down and met and had time to go through this. 

13 Good, thanks everybody for taking the time. 

14 Ted, do you have anything else you need to --

15 MR. KATZ: No, that's good. Thank 

16 you, Jim.

17 CHAIRMAN MELIUS: Thanks and guess 

18 I'll talk to everybody again next Thursday 

19 next week. Okay, thanks. Have a good day, 

20 everybody.

21 (Whereupon, the meeting was 

22 concluded at 1:58 p.m.)