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
 

ADVISORY BOARD ON
 

RADIATION AND WORKER HEALTH
 

The verbatim transcript of the Meeting of the
 

Advisory Board on Radiation and Worker Health held
 

via Teleconference on Thursday, May 1, 2003. 


NANCY LEE & ASSOCIATES 

Certified Verbatim Reporters
 

P. O. Box 451196
 

Atlanta, Georgia 31145-9196
 

(404) 315-8305
 
2 

C O N T E N T S
 

PARTICIPANTS (by group, in alphabetical order) ..... 3
 

PUBLIC COMMENTS:
 

BOARD DISCUSSION: 


SPECIAL EXPOSURE COHORT NOTICE OF PROPOSED RULEMAKING ­

Motion/Vote ................... 41/44


Motion/Vote ................... 56/61
 

CALL TO ORDER ...................... 6
 

INTRODUCTIONS .................... 7, 21
 

Ms. Jacquez ..................... 9
 

Ms. Gonzales ..................... 12
 

Mr. Miller ...................... 13
 

Ms. Shinas ...................... 18
 

FINALIZATION OF RECOMMENDATIONS ............. 22
 

CERTIFICATE OF REPORTER ................. 66
 
3 

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

(By Group, in Alphabetical Order)
 

ADVISORY BOARD MEMBERS
 

CHAIR
 

PAUL L. ZIEMER, Ph.D.


Professor Emeritus
 

School of Health Sciences
 

Purdue University


Lafayette, Indiana
 

EXECUTIVE SECRETARY
 

LARRY J. ELLIOTT
 

Director, Office of Compensation Analysis and Support


National Institute for Occupational Safety and Health


Centers for Disease Control & Prevention
 

Cincinnati, Ohio
 

MEMBERSHIP
 

HENRY A. ANDERSON, M.D.


Chief Medical Officer
 

Occupational and Environmental Health


Wisconsin Division of Public Health
 

Madison, Wisconsin
 

ANTONIO ANDRADE, Ph.D.


Group Leader, Radiation Protection Services Group


Los Alamos National Laboratory


Los Alamos, New Mexico
 

ROY LYNCH DeHART, M.D., M.P.H.


Director, The Vanderbilt Center for Occupational and


Environmental Medicine
 

Professor of Medicine
 

Nashville, Tennessee
 

RICHARD LEE ESPINOSA
 

Sheet Metal Workers Union Local #49
 

Johnson Controls
 

Los Alamos National Laboratory


Espanola, New Mexico
 
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P A R T I C I P A N T S
 

(Continued)
 

MICHAEL H. GIBSON 


President, Allied Industrial, Chemical, and Energy Union


Local 5-4200 


Miamisburg, Ohio 


MARK A. GRIFFON
 

President, Creative Pollution Solutions, Inc.


Salem, New Hampshire
 

JAMES M. MELIUS, M.D., Ph.D.


Director, New York State Laborors’ Health and Safety


Trust Fund
 

Albany, New York
 

WANDA I. MUNN
 

Senior Nuclear Engineer (Retired)


Richland, Washington
 

CHARLES L. OWENS
 

President, Allied Industrial, Chemical, and Energy Union


Local 5-5500 


Paducah, Kentucky
 

ROBERT W. PRESLEY
 

Special Projects Engineer


BWXT Y-12 National Security Complex


Clinton, Tennessee
 

GENEVIEVE S. ROESSLER, Ph.D.


Professor Emeritus
 

University of Florida


Elysian, Minnesota
 

DEPARTMENT OF HEALTH AND HUMAN SERVICES
 

ANNETTE GAY
 

CORRINE HOMER 


LIZ HOMOKI-TITUS 


TED KATZ
 
 

 

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DAVID NAIMON
 

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

(Continued)
 

JIM NETON
 

RENEE ROSS
 

DAVE SUNDIN
 

DEPARTMENT OF LABOR
 

JEFF KOTSCH 


CONTRACTORS
 

KIM NEWSOM, Nancy Lee & Associates, Certified Court Reporter
 

PUBLIC PARTICIPANTS
 

JANINE ANDERSON, K-25 Worker


CARMEN GONZALES, Survivor


EPIFANIA JACQUEZ, Survivor


RICHARD MILLER, Government Accountability Project


CHERYL MONTGOMERY, St. Louis, Missouri


BETTY JEAN SHINAS, Survivor


TIM TAKARO, University of Washington
 
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P R O C E E D I N G S
 

3:04 p.m.
 

[Preceding the call to order, a roll call of
 

the Board was taken. All Board members were
 

present.]
 

DR. ZIEMER: Let the record show that all the
 

Board members are present and accounted for, and
 

we will proceed.
 

I assume you all have the agenda, which just
 

has two items on it, the first of which will be a
 

public comment period, and then the deliberations
 

of the Board on the Special Exposure Cohort.
 

And again, let me ask that as individuals
 

speak be sure to identify yourselves. I know
 

that some of us, some Board members, are able to
 

identify each other by the sound of their voices,
 

but we do have the recorder, court reporter
 

aboard who will be taking the transcripts and
 

will need identities of all the speakers as we
 

proceed.
 

So with that, let us turn first to the public
 

comment period, and I will ask those members of
 

the public who wish to speak identify themselves,
 

and if appropriate their affiliation. We'd like
 

to ask you, since we only have a brief 15-minute
 

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period, I'd like to give priority to members of
 

the public who have not yet addressed the Board
 

in the past couple of conference calls. If
 

you've already addressed the Board on this issue
 

or pertaining to the Special Exposure Cohort,
 

your remarks are already on the public record and
 

the Board has heard those. And unless you have
 

additional or new information, we'd like to give
 

priority to any members of the public who haven't
 

had a chance yet to express their views or
 

comments either on the rulemaking or on anything
 

pertaining to the Special Exposure Cohort.
 

So with those comments, let me ask if there
 

are any members of the public on the conference
 

call who do wish to speak? Just please speak
 

right up and identify yourself.
 

MS. JACQUEZ: Epifania Jacquez, E-P-I-F-A-NI-A, J-A-C-Q-U-E-Z. I am a survivor.
 

DR. ZIEMER: Okay. Proceed.
 

MS. JACQUEZ: Thank you.
 

DR. ZIEMER: Proceed.
 

MS. JACQUEZ: Aren't you taking the names of
 

the people that want to comment? I'm just giving
 

you my name.
 

DR. ZIEMER: Oh, well -- yeah, we'll take the
 

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names. That's fine. And then we'll come back to
 

you. We'll take them in the order that they give
 

us the information.
 

Who else will wish to speak?
 

MS. SHINAS: My name is Betty Jean Shinas, SH-I-N-A-S, and I have spoken in the past but I'd
 

like a few comments.
 

DR. ZIEMER: Okay.
 

MR. MILLER: Richard Miller, Government
 

Accountability Project.
 

DR. ZIEMER: Richard.
 

Any others?
 

MS. GONZALES: Carmen Gonzales. I have also
 

commented previously, but you don't have too many
 

today, I'm sure you have time to listen to mine.
 

DR. ZIEMER: We will if we don't have too
 

many.
 

Are there any others? That's four so far.
 

MS. ANDERSON: Janine Anderson. I'm a former
 

K-25 worker on disability.
 

DR. ZIEMER: And any others?
 

[No responses]
 

DR. ZIEMER: Now of these five, the first two
 

individuals, have you spoken to the Board before?
 

UNIDENTIFIED: I have.
 

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UNIDENTIFIED: I have also.
 

UNIDENTIFIED: I have also.
 

DR. ZIEMER: Ms. Anderson, had you?
 

MS. ANDERSON: I have not.
 

DR. ZIEMER: If it's agreeable, then, let's
 

let Ms. Anderson go first, then we will go back
 

to the others.
 

MS. ANDERSON: If possible I'd like to wait
 

till the end.
 

DR. ZIEMER: Oh, you would?
 

MS. ANDERSON: I'm not prepared at this time.
 

DR. ZIEMER: Okay. Then let's hear from the
 

first individual, then.
 

MS. JACQUEZ: Okay. I guess that was me.
 

This is Epifania Jacquez.
 

And during our last conference call certain
 

subjects were raised, and one of them was the
 

special cohort. Our request was the Los Alamos
 

workers be included in this Special Exposure
 

Cohort. I'd like to know where the Board has
 

gone on this, if it has given any consideration
 

to this subject.
 

Also, I would like to -- I'm wondering if
 

there is going to be some process in motion to
 

speed up claims, because it's going very, very
 

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slowly. And I was present in Los Alamos. They
 

celebrated 60 years of the National Lab. And
 

that was mentioned by our state governor, that he
 

wishes that all of you would get on your toes and
 

start perhaps expediting this whole thing.
 

Because the claims that have been received, the
 

claims that have been paid, are just -- it's
 

almost a joke. And so I think that this needs to
 

be addressed.
 

And I know this -- it's not a question-andanswer session, but these things need to be
 

answered. And I know that your Board is right
 

there where they can address these issues.
 

And I guess the last one that I would like to
 

address is the fact that the 22 cancers that were
 

in the original Act need to be left in there,
 

because it is a law. And so I also want
 

(inaudible), the 22 cancers that (inaudible)
 

named in the law should be left in there because
 

that's what this whole thing is about.
 

So I'd like these issues addressed, or I'd
 

like some response from your Board.
 

DR. ZIEMER: Let me just indicate quickly -­

and I don't want to take all of the public
 

comment time -- but on your first comment asking
 

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what the Board has given consideration to since
 

the last telephone conference, and the answer is
 

the Board -- all the Board meetings are open to
 

the public, and the last conference call was the
 

last Board meeting. And so that meeting that you
 

were present at is the last consideration the
 

Board has had. This one today will follow up on
 

that. The Board does not meet privately between
 

these -- between its meetings, so this -­

MS. JACQUEZ: Well, this is perfect, then,
 

because you can address it while I'm on. I'd
 

like these things addressed, please.
 

DR. ZIEMER: Yeah. So that is the answer to
 

that first question.
 

The speeding up of the claims is the
 

objective of having the contractor aboard, and
 

that has already occurred. I don't think we have
 

time today to go into all the data on the rates
 

at which those are being processed, but that is
 

occurring now.
 

MS. JACQUEZ: Could I have one last comment,
 

please, and I know that you have other people
 

waiting. But there was some legislation that was
 

passed, HR-1758 by Ted Strickland, democrat from
 

Ohio, that puts like 180-day table, timetable for
 

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you to process these claims.
 

And again, if any of these things can be
 

addressed I would really appreciate it. And I'm
 

going to let somebody -­

DR. ZIEMER: I don't believe that will be
 

addressed today. That is not on the agenda.
 

MS. JACQUEZ: Well, then I'd like to get some
 

kind of response for this. You might give it
 

some thought and let us know when we can hear
 

about this.
 

DR. ZIEMER: Thank you.
 

MS. JACQUEZ: Okay.
 

DR. ZIEMER: The second speaker? Who was
 

second?
 

MS. GONZALES: I'll just go ahead.
 

Good afternoon. My name is Carmen Gonzales.
 

I'm a surviving daughter of Manuel Almeida -- and
 

if you would please spell that correctly I'd
 

appreciate it, that's A-L-M-E-I-D-A -- who worked
 

in Los Alamos, my father did, for 34 years.
 

My purpose today is not to comment but to
 

request the Board to seriously consider and put
 

forth every effort to include Los Alamos in its
 

special cohort. I am also requesting the Board
 

to adhere to the list of 22 cancers that were
 

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mandated by law in 2000.
 

And I'll be -- that's all I have to say
 

today, and thank you for your time.
 

DR. ZIEMER: Thank you.
 

Richard Miller?
 

MR. MILLER: Thank you, Dr. Ziemer. I have
 

three brief points to make.
 

The first was at the last Board call there
 

was a question raised about legislative intent.
 

And maybe the Board has already received this
 

information, but I will state it in any event,
 

that this question of whether it should be 22
 

cancers and whether the list is fixed or variable
 

was addressed in the Congressional record on
 

October 12th of 2000.
 

In a floor statement by Senator Bingaman, who
 

was one of the people in the conference who put
 

this legislation together -­

DR. ZIEMER: And Richard, let me interrupt
 

that that has in fact been distributed to the
 

Board.
 

MR. MILLER: Oh, okay. Thank you, Dr.
 

Ziemer.
 

And so I think it makes pretty clear what
 

legislative intent was, so I hope that's not a
 

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question for debate going forward. I would also
 

add that I think that message was conveyed to
 

NIOSH staff when they did briefings both on the
 

House and Senate side, it was a pretty clear
 

message delivered by those who were in the room
 

when the deal was done. Not that it carries as
 

much weight as something in writing on the
 

record, but it should be considered.
 

Secondly, I understand -- at least I heard
 

this morning -- that correspondence may have been
 

forwarded that I think I copied you on, Dr.
 

Ziemer, between myself and Ted Katz regarding
 

this question about whether or not it is possible
 

that people who have greater than a 50 percent
 

probability of causation and have a worst-case
 

dose estimate will necessarily be compensated.
 

And although the record clearly reflects Ted
 

Katz's comments at the March 7th meeting that
 

indeed people, if they did have a worst-case
 

estimate and their probability of causation was
 

above 50 percent and there was no other data
 

available to do anything other than a worst-case
 

estimate, that that would be used for
 

adjudicating claims.
 

And that provided some comfort until I looked
 

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at both the rule and the preamble to the rule
 

under Part 82, where I think at least the Board
 

may want to consider the ambiguities in Part 82.
 

And there are two parts of Part 82 that are
 

relevant. The first part is that it clearly
 

states that worst-case dose estimates will be
 

used under 82.10, subpart (k), when the
 

probability of causation is less than 50 percent.
 

But the preamble states that it would only be
 

with great difficulty to use a worst-case dose
 

estimate in the event that the probability of
 

causation exceeded 50 percent. And this all
 

becomes very relevant, it seems, if SEC petitions
 

are now going to be denied based upon the ability
 

to perform a worst-case dose estimate.
 

And so maybe it is all okay, and maybe as we
 

have been assured verbally that is the case. But
 

the rule itself does not provide explicit clarity
 

in that area, and probably could stand some
 

improvement.
 

DR. ZIEMER: And let me comment, I had
 

received your comments and thought it would be
 

useful to let the full Board hear those comments
 

as well as Ted's reply, because I was the only
 

one that I knew of at that point that had the
 

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benefit of those comments. So I did distribute
 

those a couple of days ago to the Board.
 

MR. MILLER: Good, good. I'm glad.
 

DR. ZIEMER: Or actually I sent -- I asked
 

NIOSH to, I -- no, I think I sent them out.
 

MR. MILLER: Whatever, it's fine. I have no
 

objection. But I do want to make sure that that
 

issue -­

DR. ZIEMER: So basically the question you're
 

raising now, I think the Board has some written
 

stuff on it from you.
 

MR. MILLER: Okay. Fine.
 

The third issue has to do with a question
 

that came up at the March 7th Board meeting, and
 

I bring this up because it was now in the
 

transcript which finally was posted in which the
 

question is whether the dose, when you do a
 

worst-case dose estimate, is it going to be a
 

point estimate or a constant value which you
 

would input to IREP, or will it be -- will the
 

worst-case be some part of a distribution? And
 

if it's part of a distribution, what we've
 

discovered is that if you -- whether you use a
 

triangular mode distribution as in the Bethlehem
 

Steel case or use a normal distribution,
 

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obviously if you put something at the tail end it
 

gets a lot less weight. And so I just wanted to
 

note that the Health Physics Society had
 

recommended that a constant value be used.
 

Hello?
 

DR. ZIEMER: Yeah, go ahead.
 

MR. MILLER: The constant value -­

DR. ZIEMER: The line is so good this time
 

that you're not sure it's still there, right?
 

MR. MILLER: Exactly right. I'm amazed. But
 

let's leave the static out, though.
 

So I would just raise for the Board the
 

question of whether or not to recommend the point
 

estimate or constant value which the Health
 

Physics Society recommended, or whether it would
 

be better to provide a distribution; and if so,
 

why would a distribution which provides less
 

weight to a worst-case estimate be applied if
 

you're trying to give the claimant the benefit of
 

the doubt?
 

And finally, I guess the only other question
 

I would have is that the Board probably has not
 

discussed, and maybe doesn't have time today, is
 

what do you do in cases where you have a non-SEC
 

cancer, but you have someone who is in an SEC?
 

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What do you do with the dose that you can't
 

estimate that they received as a member of the
 

SEC when you're trying to estimate their dose
 

reconstruction for a non-SEC cancer? And so you
 

may have some dose within and some dose without
 

the SEC. And it wasn't clear how to assign dose,
 

and NIOSH's rule didn't really recommend any
 

methods for assigning dose. And so I just
 

thought I would put that on the table as an
 

unresolved issued from the rulemaking.
 

DR. ZIEMER: Okay, thank you, Richard.
 

Let's see -­

MS. NEWSOM: There was Betty Jean Shinas.
 

DR. ZIEMER: Betty Jean, yes, please. Go
 

ahead.
 

MS. SHINAS: The only comment I had, and I
 

may have misunderstood or misread something, that
 

the Advisory Board, that the term would be coming
 

to a close. Is that correct? And if so, what is
 

-- what's in motion to get that going again?
 

MR. ELLIOTT: Let me respond to that.
 

DR. ZIEMER: Yes, let the -­

MR. ELLIOTT: This is Larry Elliott.
 

DR. ZIEMER: Larry Elliott, the Federal
 

officer -­

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MS. SHINAS: And I'd like to just close, just
 

a few more words on that, as I feel that I am
 

thankful that we are being heard, but I think
 

this is about the only place that we've been able
 

to really comment. And I know the comments are
 

short, but at least it has been given us an
 

opportunity to do this as a family.
 

DR. ZIEMER: Right. Thank you.
 

Larry Elliott.
 

MR. ELLIOTT: Sure.
 

To respond to your question about the Board,
 

the charter does expire this August. And we are
 

in fact proceeding to renew that charter, and
 

will have it in place before the expiration date
 

so that the Board can continue its business as
 

required by statute and the delegated authority
 

through the Department.
 

Let me also say that -- so I hope that
 

answers your question. The Board is not going to
 

go away. Its charter expires, but we have full
 

interest and attempt underway to renew that
 

charter.
 

With regard to providing comments, we
 

continually continue to encourage everyone to
 

provide written comments to the docket. This
 

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forum of public comment during the Board meeting
 

is only one approach for the public to have their
 

voices heard. The real opportunity for the
 

public to comment on the proposed rule, however,
 

is by providing written comments as proscribed by
 

the rule.
 

Thank you.
 

MS. SHINAS: Thank you.
 

DR. ZIEMER: Thank you.
 

And then we have -- did that complete your
 

comment, Betty Jean?
 

MS. SHINAS: Yes, it did. I had just read
 

that, and it was a concern with me.
 

DR. ZIEMER: Thank you.
 

And then I think we have Ms. Anderson yet.
 

MS. ANDERSON: Yes, my questions have already
 

been answered, thank you.
 

DR. ZIEMER: They have? Okay, thank you very
 

much.
 

Actually, it is now time for us to move to
 

the Board deliberations. Members of the public
 

are still welcome to listen in on this. We are
 

not asking you to participate in the
 

deliberations since these are deliberations of
 

the Board, but you're certainly -- the
 

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discussions are public, and you are welcome to
 

continue to listen in.
 

MS. HOMER: Dr. Ziemer?
 

DR. ZIEMER: Yes.
 

MS. HOMER: This is Cori.
 

DR. ZIEMER: Yes, Cori.
 

MS. HOMER: I would like to -­

DR. ZIEMER: Do we need to get a roll call of
 

others?
 

MS. HOMER: If we could get a roll call of
 

the federal employees for the record.
 

DR. ZIEMER: Okay, either a roll call or ask
 

them to identify themselves.
 

MS. HOMER: Yes, please identify yourself for
 

the court reporter.
 

MR. NAIMON: This is David Naimon, and Liz
 

Homoki-Titus.
 

MS. HOMER: Thank you.
 

MR. KOTSCH: Jeff Kotsch with the Department
 

of Labor.
 

DR. ZIEMER: I'll ask the reporter, if you
 

need to hear names spelled just so indicate.
 

MS. NEWSOM: All right, thank you.
 

MR. NETON: This is Jim Neton from NIOSH.
 

MR. SUNDIN: Dave Sundin, NIOSH.
 

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MS. HOMER: And I guess Cori Homer, NIOSH.
 

MR. KATZ: I'm sorry, Ted Katz, NIOSH.
 

MS. ROSS: Renee Ross, Committee Management,
 

MASO.
 

MS. GAY: Annette Gay, Birth Defects, CDC.
 

DR. ZIEMER: Any others?
 

[No responses]
 

DR. ZIEMER: Okay, thank you very much.
 

MR. TAKARO: (Inaudible) other people on the
 

line. This is Tim Takaro at the University of
 

Washington (inaudible).
 

DR. ZIEMER: Okay. Any others that want to
 

identify themselves?
 

[No responses]
 

DR. ZIEMER: Okay, then we will proceed.
 

The focus of our attention today -- I want to
 

make a few preliminary remarks, and then we'll
 

get very specific. Our preliminary focus today
 

will be to finalize the comments and views of the
 

Board pertaining to Section 83.13.
 

Now in that connection there are two
 

particular sections that I see us as focusing on,
 

all of which are part or two particular portions
 

of the SEC that are subsets of Section 83.13.
 

Now I'm working fully out of the Federal Register
 

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copy today, if that's agreeable with everyone.
 

So Board members, you want to have your Federal
 

Register copy handy there so that if we give page
 

numbers that will be helpful to you.
 

Now I'm getting some echo. Something change
 

here? Okay, is that better?
 

UNIDENTIFIED: Yes.
 

DR. ZIEMER: Okay. In Section 83.13 there's
 

two particular subsections that I expect we will
 

focus on.
 

One of those is subsection (b)(1), which is
 

in the third column of page 11308, and this is
 

the issue relating to estimating doses with
 

sufficient accuracy. That was an issue that we
 

discussed at our last meeting, and remains an
 

issue which we have not yet come to closure on.
 

Then on page 11309 in column one, section -­

this would be paragraph (b)(1)(iv), Roman numeral
 

(iv) near the top of the page, which -- and then
 

that one, coupled with item (b)(2), Roman numeral
 

(iii) near the middle of the page, both of these
 

deal with the issue of specified cancer types and
 

the definition of an SEC class that involves
 

tissue-specific cancer sites. So that's
 

basically this issue of less than the 22 cancers,
 

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or to put it another way, one or more cancer
 

sites as being part of the class definition.
 

It seems to me those are the two main issues
 

we need to focus on today. In that connection,
 

you should have a couple of written items.
 

First, I want to make sure everyone on the
 

Board received what would be labeled the draft
 

comments on 42 CFR 83. I believe these are -­

this is a compilation of everything that we had
 

done to date, as well as some new items. It is
 

stamped in the upper right as “draft” with a date
 

of 4/24/03 on it. It should have been
 

distributed, I believe, within the last couple of
 

days by either Cori or by Nichole, and it has 13
 

numbered items on it.
 

Does everyone have that draft, or if you
 

don't speak up.
 

MS. MUNN: This is Wanda. Did that come by
 

mail?
 

DR. ZIEMER: Should have been by e-mail.
 

UNIDENTIFIED: Came by e-mail. Mine came in
 

at 1:28 p.m. today.
 

MS. MUNN: Oh. I haven't been online today.
 

I'd better check it.
 

MS. NEWSOM: Cori?
 

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MS. HOMER: Yes?
 

MS. NEWSOM: This is Kim. Would you mind e-


mailing that to me, please?
 

MS. HOMER: Absolutely.
 

MS. NEWSOM: Thanks.
 

DR. ZIEMER: Now while that's occurring, let
 

me point out to you that on that document the
 

first ten items are items that we have already, I
 

would say, come to closure on and agreed to.
 

It's items 11, 12, and 13 which pertain to the
 

topics that I just mentioned here -- that is, the
 

issue of specified cancer types and the issue of
 

sufficient accuracy.
 

Now the other document that you should have
 

was distributed a couple of days ago. These are
 

some comments that were developed by Jim Melius.
 

This was, I believe, a little over three pages
 

long. It has a title on it called “SEC
 

Comments,” and it specifically deals with this
 

Section 83.13. It includes actually two
 

recommendations. There's a lot of narrative, but
 

there are actually two recommended actions, in a
 

sense, both of which are underlined as action
 

paragraphs. One of those is on the third page of
 

Jim's document, and that's the issue of
 

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sufficient accuracy; and then on the fourth page
 

of Jim's document is a recommendation relating to
 

the limit on the provisions for limiting cancers
 

eligible for compensation in the Special Exposure
 

Cohort. So that is a document, as well, that I
 

think we need to have before us as we proceed.
 

And let me tell you that there's some
 

differences in these two. The document that I
 

distributed with the original set of comments was
 

-- the three points, 11 through 13, were sort of
 

summaries of where I thought we had sort of
 

agreed at the last meeting in terms of at least
 

identifying some issues, although we had not
 

fully come to closure on it.
 

Jim's documents relates to those, or Jim's
 

comments and recommendations relate to those.
 

They have a somewhat different specificity in the
 

case of the specified cancers. Jim's
 

recommendation is one of simply removing the
 

provision to limit. The words that I had used in
 

mine had to do with requiring that NIOSH
 

reconfirm or establish Congressional intent with
 

regard to that issue. So there's kind of
 

variations on the same thing, and we can discuss
 

a direction that the Board may or may not wish to
 

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go on that issue.
 

Similarly, on sufficient accuracy, Jim's has
 

a little more specificity in that the comment I
 

had, which is comment 13, was to ask for
 

clarification. Jim's has a little more
 

specificity in asking that some actual guidelines
 

be developed as NIOSH proceeds. So those are
 

sort of -- I just used that to kind of lay out
 

what's before us.
 

I want to make sure everybody has the
 

documents. Is there anyone that didn't get the
 

Jim Melius discussion?
 

[No responses]
 

DR. ZIEMER: Apparently everybody got that.
 

Okay.
 

Now let me also, as we get underway here, ask
 

the Board members -- and you can just comment on
 

this briefly if you wish -- do you agree that
 

those are the items we would like to come to
 

closure on today, and are there any other items
 

that you think have been left hanging that are
 

not -- that we didn't already cover?
 

[No responses]
 

DR. ZIEMER: Pro or con. I want to make sure
 

that we feel like we've captured all of the
 

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salient points in the proposed rulemaking that we
 

want to comment on, and what I'm saying is I
 

think these are the last two. Am I right, there?
 

Anyone think there are other issues we need to
 

comment on?
 

[No responses]
 

DR. ZIEMER: Yeah or nay?
 

MS. MUNN: Sounds good to me. This is Wanda.
 

I think these are the two we need to be
 

addressing.
 

DR. ZIEMER: Okay. Then I suggest that we
 

begin with the issue of sufficient accuracy since
 

that's the first paragraph to deal with under
 

83.13.	 It's the right-hand column of page 308.
 

DR. ANDRADE: Paul?
 

DR. ZIEMER: Yes.
 

DR. ANDRADE: This is Tony Andrade.
 

DR. ZIEMER: Tony.
 

DR. ANDRADE: I'd like to suggest that we
 

start with 83.13, Section (b)(1), little Roman
 

(iv), regarding the -­

DR. ZIEMER: Oh, on the cancer types?
 

DR. ANDRADE: -- the cancer tissues, cancer
 

types and tissues.
 

DR. ZIEMER: I'm fine with doing that. Is
 

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there a particular reason you want to go in that
 

order?
 

DR. ANDRADE: Well, I think that we have now
 

had three conference calls, and basically we end
 

up at a stumbling block with respect to this
 

particular issue.
 

And after doing much soul-searching about
 

kind of limitation, I've come to the conclusion
 

that reaching sufficient -- I hate to use the
 

word “sufficient” because it starts to tie us up
 

with the other topic, but let's put it this way:
 

You used the word “equity,” some level of equity
 

between the definition of a new SEC class that is
 

limited in this -- in the way it's described in
 

that paragraph with the SEC that's already
 

defined in legislation.
 

Well, frankly, I don't think we're ever going
 

to get there, because the way Congress described
 

or defined SEC, the SEC which included three
 

gaseous diffusion plants and some veterans that
 

were associated with weapons testing, they did us
 

all an injustice by a bunch of lawyers getting
 

together and deciding that an entire facility
 

should be designated as Special Exposure Cohort.
 

I'd really like to know, for example, what
 

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percentage of those entire facilities' work force
 

that were there for the requisite amount of time
 

are going to ever really present with cancer.
 

Ten to one, it's going to be 30 percent or less,
 

the specified cancers. So they put us off to a
 

bad start. So that forces us into a very
 

difficult situation insofar as determining
 

equity.
 

I would say, and I'd like to put this forward
 

for the rest of the Board to comment, the
 

following:
 

I believe that the only way that we're going
 

to ever satisfy ourselves, the public, and
 

Congressional intent, which I believe to be
 

simply stated in three words -- be fair, and be
 

claimant friendly -- is to simply include all 22
 

cancers that were listed in the original
 

legislation, and do away with any type of
 

limitation as a way to define or to specify a
 

group. In other words, get rid of any relation,
 

any -- get rid of small paragraph small Roman
 

(iv), and anything in the preamble that alludes
 

to limiting the number of cancers to anything
 

less than the 22.
 

DR. ZIEMER: Okay. Tony, are you asking for
 

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comment on this at this point, or am I to
 

understand this to be a formal motion on your
 

part?
 

DR. ANDRADE: I'm asking for comment at this
 

particular point in time.
 

DR. ZIEMER: Okay, thank you.
 

Let me ask how other Board members wish to
 

respond to that comment and view.
 

DR. MELIUS: This is Jim Melius.
 

That was basically what I was proposing, with
 

the -- I guess with the added change that should
 

it work out that in the future we feel that this
 

is inappropriate in some way in our actual
 

experience in designating cohorts that we can
 

always make later recommendations, whether it be
 

to Congress or to NIOSH, to work out ways of
 

addressing this.
 

I mean, I think there are reasons other than
 

the reasons Tony just gave, but then we all may
 

have obviously different reasons or weigh
 

different reasons differently. But I think that
 

it really is the best way to go forward at this
 

time given the equity issue, given the amount of
 

public concern, and given just some of the
 

potential difficulties of trying to make these
 

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decisions.
 

DR. ZIEMER: Thank you, Jim.
 

This is Ziemer again.
 

Jim, if I might also comment on the way you
 

had worded it, I think your last sentence there
 

dealing with the or suggesting that we might
 

later on change this in some way, seems to me
 

that once we go in this direction I don't think
 

there's much chance of turning back. It would be
 

like changing the criteria for probability of
 

causation, very difficult to go back the other
 

way, don't you believe? Or are you suggesting
 

that if experience showed that it would be
 

possible that you would restrict the cancers
 

again, having not done so initially?
 

DR. MELIUS: Presuming this meets
 

Congressional intent and sort of these legal
 

issues that are out there, assuming it addresses
 

that, I think we'd have to examine the experience
 

down the road and then make the determination.
 

Are we encountering situations where it is not
 

(inaudible; ongoing beeping) the Board doesn't
 

feel it's appropriate to be including all the
 

cancers in the cohort, then we would have a way
 

of redressing that (inaudible). Would it be
 

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hard? Yes. But it's obviously hard to do it the
 

other -- do it the way that's being proposed now.
 

So I guess I was just trying to indicate
 

there that I don't think we should necessarily
 

close off that possibility, but I just -- my
 

personal view is that it -- I think it's unlikely
 

we would go back, but we could.
 

DR. ANDRADE: This is Tony Andrade again.
 

Jim, again, one of the reasons that I am
 

proposing this for discussion at this point is
 

that if you read the Congressional record and you
 

try to pull out the intent, you really do come to
 

that conclusion that they want us to be fair, but
 

they also want us to be claimant friendly. And
 

so I really think that (inaudible) way of being
 

able to accomplish that in some equitable sense
 

is to define for life, from here on out, that all
 

22 cancers shall be considered.
 

DR. ZIEMER: Other comments? I got cut off
 

there briefly. I'm back on the line again. Jim
 

was talking when I lost it, but I'm back on.
 

Jim, did you say anything important?
 

[Laughter]
 

DR. MELIUS: I doubt it.
 

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DR. ZIEMER: I guess, Tony, you were
 

responding to something Jim had said?
 

DR. ANDRADE: Right, right.
 

DR. ZIEMER: Did we lose any other Board
 

members, or was it only -­

DR. DeHART: Yes, I think so. Everybody's
 

coming in now.
 

DR. ZIEMER: Coming back in?
 

DR. DeHART: This is Roy.
 

DR. ZIEMER: Let me interpret -­

MR. ELLIOTT: This is Larry Elliott.
 

DR. ZIEMER: Cori, I wonder if we need to
 

take a roll call again?
 

MS. HOMER: Another roll? Okay, very well.
 

DR. ZIEMER: Let's take a roll call -­

MR. ELLIOTT: Cori, while you're doing that
 

I'm going to ask -­

DR. ZIEMER: -- (inaudible) losing people
 

here.
 

MR. ELLIOTT: Cori, while you're doing the
 

roll I'll have Nichole call the phone people and
 

make sure that we didn't lose a series of ports.
 

MS. HOMER: Okay, very well. Thanks.
 

Okay, Paul Ziemer?
 

DR. ZIEMER: Yes.
 

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MS. HOMER: Henry Anderson?
 

DR. ANDERSON: Yes.
 

MS. HOMER: Tony?
 

DR. ANDRADE: Here.
 

MS. HOMER: Roy?
 

DR. DeHART: Yes.
 

MS. HOMER: Rich?
 

MR. ESPINOSA: Here.
 

MS. HOMER: We know Larry's here.
 

Mike Gibson?
 

MR. GIBSON: Yeah, I'm here.
 

MS. HOMER: Mark?
 

MR. GRIFFON: Yeah.
 

MS. HOMER: Jim Melius.
 

DR. MELIUS: I'm here.
 

MS. HOMER: Okay. Wanda Munn?
 

MS. MUNN: Here.
 

MS. HOMER: Leon?
 

MR. OWENS: Here.
 

MS. HOMER: Bob?
 

MR. PRESLEY: Here.
 

MS. HOMER: Gen?
 

DR. ROESSLER: Here.
 

MS. HOMER: Okay.
 

DR. ZIEMER: Okay, good.
 

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MS. HOMER: Should I go through the list of
 

public?
 

DR. ZIEMER: Well, that would be fine.
 

MS. HOMER: Okay. Cheryl Montgomery?
 

MS. MONTGOMERY: Here.
 

DR. ZIEMER: But they're not required to stay
 

on.
 

MS. HOMER: Oh, okay. Well, I guess we can
 

go ahead and proceed with discussion.
 

DR. ZIEMER: Right. We're required to have a
 

quorum of Board members.
 

MS. HOMER: Yeah, exactly.
 

DR. ZIEMER: But public members can stay on
 

or not as they wish.
 

Okay, further discussion on this item?
 

DR. ANDRADE: Paul, very briefly, what I
 

mentioned, I guess when people started getting
 

cut off, was the fact that in responding to Jim
 

about perhaps leaving the door open on this, I
 

said if we really want to meet Congressional
 

intent -- and again, I take that to be, quote,
 

“fair and claimant friendly” -- then I think that
 

once and for all we should allow all 22 cancers
 

to be considered in any Special Exposure Cohort
 

petition.
 

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DR. ZIEMER: Okay. Other comments?
 

DR. DeHART: This is Roy.
 

I really never understood why we were
 

limiting the cancer. I couldn't understand it as
 

we went through the proposal to begin with.
 

And secondly, I have to agree with Tony, that
 

the intent is so strongly stated in the original
 

legislation that I think that we might very well
 

find that we're directed to go back to the 22
 

cancers.
 

So I think from the beginning we ought to
 

hold to it, and hold to it for the duration.
 

DR. ZIEMER: And Roy -- Ziemer here again -­

I was trying to point out in the comment that I
 

inserted in there on comment 11 that in fact,
 

scientifically and theoretically I believe it's
 

entirely possible that you could have an unknown
 

exposure situation where you could, in fact, say
 

that certain tissues could not have gotten
 

exposed. You might not know anything about
 

doses, but you might know enough to be able to
 

eliminate those.
 

But the real issue comes down to
 

Congressional intent and the equity issue, it
 

seems to me.
 

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DR. DeHART: Yes.
 

MR. GRIFFON: But Paul -- this is Mark
 

Griffon -- just one response, short response on
 

your comment.
 

You mentioned you may have reasons for
 

limiting it to certain tissues for certain
 

unknown exposures. I think the key there is that
 

you are dealing with unknown exposures, so it
 

seems a little contradictory to say that you can
 

DR. ZIEMER: Well, you notice I put it in
 

terms of theoretically. I think I could
 

(inaudible) a case where you could not figure out
 

dose, but you could -- but based on some
 

information -- I mean, we know about certain
 

things about different facilities. Even though
 

we may not know the dose, we know of some things.
 

But be that as it may, it's one thing to talk
 

theoretically and say yes, but scientifically it
 

could be possible. But there's kind of two sides
 

to this. One is what's possible scientifically,
 

and this other issue, which seems to be to some
 

extent overriding, is Congressional intent and
 

fairness.
 

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Who else has comments?
 

[No responses]
 

DR. ZIEMER: And I guess I'll add to that.
 

In fact, it's not clear in practice that they
 

would ever find such a situation, even though it
 

would be allowed for in the regulation.
 

MR. GRIFFON: I guess that's sort of where I
 

was going.
 

This is Mark Griffon again, I'm sorry.
 

I didn't want to accept that we're dismissing
 

science here. I think that even in the preamble
 

to this proposed rulemaking, page 11297 under the
 

Health Endangerment section, NIOSH says talks
 

about (inaudible) a factual basis for
 

establishing the possible level of radiation
 

exposure (inaudible) quantitatively evaluate
 

health endangerment. I think they're separating
 

health endangerment there from -- as opposed to
 

an organ, but I think they're very closely
 

related.
 

So my point is that if you can't establish an
 

upper bound you can't really specify which
 

tissues. You don't know enough about exposure to
 

specify which cancers, the tissues might be
 

affected.
 

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DR. ZIEMER: Okay. How about other comments,
 

anyone?
 

DR. ROESSLER: This is Gen.
 

I just want to go on the record as saying
 

that I think this proposal goes against common
 

sense from the scientific point of view, but yet
 

Tony was very persuasive in what he said. It
 

seems that we really have the goal or the
 

responsibility of meeting the Congressional
 

intent, and from that point of view we
 

possibility have no other choice.
 

DR. ZIEMER: Other comments?
 

MR. GIBSON: This is Mike Gibson.
 

I'd just like to say that given the site that
 

-- given the fact that some of these sites were
 

not even told that they were working with
 

radioactive material, given the fact of DOE's
 

poor recordkeeping and et cetera, I don't think
 

we can ever actually determine if a person was
 

correctly monitored for the correct isotope. So
 

they may be put in a special cohort because of
 

being exposed to a certain isotope, but in fact
 

there could be other isotopes in the mix that
 

were never, never -- employees were never
 

monitored for that could catch one of the other
 

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types of cancer.
 

DR. ZIEMER: Thank you. So you're arguing in
 

favor of including all the cancers, then?
 

MR. GIBSON: Absolutely, yes.
 

DR. ZIEMER: Other comments? Pro or con.
 

MR. PRESLEY: Paul, this is Bob Presley.
 

DR. ZIEMER: Bob.
 

MR. PRESLEY: I agree with Tony 100
 

(inaudible).
 

DR. ZIEMER: Okay.
 

Any others?
 

DR. ANDRADE: In that case, Paul, I think I'd
 

like to perhaps put forth a position to be voted
 

on in the form of a motion, and that is simply
 

that Section 83.13, subsection (b), subsection
 

(1), small Roman (iv), be removed, or that we
 

advise the Secretary that it is the sense of the
 

Board that this section be removed; and that all
 

other text, whether it be in the preamble or in
 

the rule itself, that relates to limiting cancer
 

types also be removed.
 

DR. ZIEMER: Okay. The motion has been made.
 

Is there a second?
 

MR. GIBSON: I'll second that. This is Mike
 

Gibson.
 

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DR. ZIEMER: Mike Gibson has seconded the
 

motion.
 

Is there any discussion, pro or con?
 

[No responses]
 

DR. ZIEMER: Is there anyone who wishes to
 

speak against the motion?
 

[No responses]
 

DR. ZIEMER: I hear none. Let me, before we
 

vote -- based on comments so far it appears that
 

there may be strong support for the motion.
 

Let me suggest that if the motion carries -­

and I want you to look at item 11 on the draft
 

comments that refers to this section -- and let
 

me ask you if you were to take everything down to
 

the second to last line where it says
 

“accordingly,” and if you were to cross out all
 

the words following “accordingly” and insert the
 

Jim Melius statement that says, so it would say
 

“Accordingly, the Advisory Board recommends that
 

DHHS remove the provision to limit cancer
 

eligible for compensation for a particular class
 

being conducted for Special Exposure Cohort
 

status,” and insert that in place of the
 

statement that asks NIOSH to determine this, and
 

then that would be followed by an identification
 

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of the particular section to be removed or
 

altered.
 

DR. ROESSLER: Paul, this is Gen.
 

Then in Melius's suggested substitution there
 

we would not put in the part that says that later
 

experience with the program shows and continuing
 

on, that would not be a part of it?
 

DR. ZIEMER: What I'm going to suggest is
 

that we act on this without that at the moment,
 

and then if someone wishes to modify it by adding
 

that, so that we can deal with this main issue
 

and then ask whether you want to allow the later
 

possibility -- the possibility of a later change.
 

Would that be agreeable? I don't want to get two
 

issues mixed up on a fairly critical vote here.
 

DR. ANDRADE: That, I think, splitting that
 

off would certainly meet the intent of -- the
 

full intent of the -­

DR. ZIEMER: Of your motion?
 

DR. ANDRADE: Of my motion.
 

DR. ZIEMER: What I'm suggesting, your motion
 

would still hold. I'm suggesting how it might be
 

worded in the transmittal.
 

DR. ANDRADE: That's fine, Paul.
 

DR. ZIEMER: Unless anyone sees any major
 

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change -- and what I've done in suggesting this
 

is allow the little narrative statement that says
 

that we recognize the scientific and theoretical
 

possibility that this could occur. And if you
 

don't like that statement, I need to know that.
 

DR. ANDRADE: I think that that's fine.
 

DR. ROESSLER: I like leaving it in.
 

DR. ZIEMER: Although that in itself is not
 

part of your motion, but I was trying to look at
 

how we would actually present it. And we could
 

present it just as exactly the way you stated it
 

without this other stuff, if people were
 

uncomfortable.
 

UNIDENTIFIED: I think it helps other people
 

understand the discussions we've gone through.
 

DR. ZIEMER: Okay. Are you ready to vote on
 

this motion?
 

[No responses]
 

DR. ZIEMER: Okay, I'm going to take a roll
 

call vote.
 

Cori, if you will begin the roll call, and I
 

will vote last.
 

MS. HOMER: All right.
 

Henry Anderson?
 

DR. ANDERSON: Yes.
 

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MS. HOMER: Antonio Andrade?
 

DR. ANDRADE: Yes.
 

MS. HOMER: Roy DeHart?
 

DR. DeHART: Yes.
 

MS. HOMER: Richard Espinosa?
 

MR. ESPINOSA: Yes.
 

MS. HOMER: Mike Gibson?
 

MR. GIBSON: Yes.
 

MS. HOMER: Mark Griffon?
 

MR. GRIFFON: Yes.
 

MS. HOMER: James Melius?
 

DR. MELIUS: Yes.
 

MS. HOMER: Wanda Munn?
 

MS. MUNN: I abstain.
 

MS. HOMER: Okay. Leon Owens?
 

MR. OWENS: Yes.
 

MS. HOMER: Bob Presley?
 

MR. PRESLEY: Yes.
 

MS. HOMER: And Genevieve Roessler?
 

DR. ROESSLER: Yes.
 

MS. HOMER: Okay.
 

DR. ZIEMER: Okay, the motion carries.
 

MS. HOMER: Okay. Ziemer, would that be a
 

yes?
 

DR. ZIEMER: Pardon me?
 

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MS. HOMER: Would that be a yes from you?
 

DR. ZIEMER: Oh, yeah. I will vote to
 

support the motion.
 

MS. HOMER: Okay.
 

DR. ZIEMER: Now the Chair will also now
 

entertain, if anyone wishes to make a motion to
 

add to this, Section -- the statement suggested
 

by Dr. Melius, “If later experience with the
 

program shows that including all eligible cancer
 

types is problematic for a significant number of
 

Special Exposure Cohort classes, then the Board
 

is prepared to recommend steps to address this
 

issue.”
 

DR. MELIUS: This is Jim Melius.
 

I actually personally don't feel that that
 

sentence is then necessary since we've already
 

talked about this, that it's theoretically
 

possible and so forth. I think that really
 

covers the same concept, and I think it's implied
 

that we can change our minds later. Whoever
 

wants to, a new board or whatever, can change
 

their minds and make other recommendations. So I
 

DR. ZIEMER: So you're not suggesting we -­

DR. MELIUS: I don't believe it's necessary.
 

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DR. ZIEMER: Anyone else? Anyone want to add
 

that?
 

[No responses]
 

DR. ZIEMER: It appears not.
 

Am I correct, now, that the main sections in
 

addition to the preamble this will deal with are
 

those that I had previously identified, which
 

would be (b)(1) Roman numeral (iv), and (b)(2)
 

Roman numeral (iii), both of which are -- there
 

may be some others, but -­

UNIDENTIFIED: Yes, those are the two main
 

ones, Paul.
 

DR. ZIEMER: There are some other places
 

where specified cancer comes up also, so -- but a
 

general statement, if it's agreeable in terms of
 

just editing, I can add that into the comment.
 

DR. ANDRADE: This is Tony, Paul.
 

Yeah, I believe that would be good, because
 

there is substantial text in the preamble that
 

needs to be removed as well.
 

DR. ZIEMER: Okay. Well, of course, then the
 

-- I think in -- the final rulemaking actually is
 

going to have discussion on issues that are made,
 

and depending on the outcome of the final
 

rulemaking there would possibly still be a
 

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discussion of this issue and how NIOSH ultimately
 

handled it. So I don't anticipate we would ask
 

NIOSH not to discuss this issue in the preamble,
 

and they will ultimately deal with how -- they
 

will ultimately discuss with -- how they finally
 

handle it. Right?
 

UNIDENTIFIED: That is correct.
 

DR. ZIEMER: Yeah. So I don't think we need
 

to get into asking them to revise the preamble.
 

It's going to be different anyway in the final
 

copy, because they have to deal with all the
 

comments that have -- this preamble dealt with a
 

lot of comments from the earlier document, so
 

those will all change anyway.
 

Okay, then I think we're ready to deal with
 

the issue of sufficient accuracy.
 

I'm looking at -- and actually, again we have
 

two possible things, two possible wordings, one
 

of which is simply more or less a simple
 

statement asking NIOSH to clarify the meaning of
 

that. This is -- on the draft I distributed it's
 

item 13. But those sections include the concept
 

of not feasible to estimate doses with sufficient
 

accuracy, the idea of sufficient accuracy not
 

completely clear or obvious. It would be helpful
 

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for NIOSH to provide additional clarification,
 

whereas the Melius proposal is a little more -­

has a little more specificity and asks for
 

guidelines, that guidelines be developed. And as
 

I see it, the guidelines could be developed later
 

on.
 

I don't, Jim -- and you can clarify -- I
 

don't think that you were asking that the
 

guidelines be in the rule.
 

DR. MELIUS: No, no. That the rule could
 

reference or the preamble to the rule, however,
 

could reference the development of guidelines,
 

and that the guidelines would be reviewed by the
 

Board. This is not dissimilar to how we've
 

handled the IREP changes in the dose
 

reconstruction rules changes. The same, really
 

the same -­

DR. ZIEMER: Yeah. But so there's actually
 

-- in a sense there's two kinds of options, and I
 

think there's probably a third. But one option
 

is just to point out the issue and ask NIOSH to
 

address it; the second option is to pin it down a
 

little closer and ask for the development of
 

specific guidelines; another option would be that
 

if people weren't concerned about this we don't
 

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address it at all; and a fourth option would be
 

to do something other than those three things.
 

And again, let me open it in general for
 

Board discussion, and we can get some feeling for
 

what direction you wish to go on this.
 

DR. MELIUS: Let me just -- Jim Melius.
 

Let me just speak to -- the reason I like to
 

follow the pattern we did with the prior rules in
 

terms of developing guidelines is I just think
 

they provide more consistency to the process.
 

And I think as opposed to purely a case-by-case
 

approach, which is what NIOSH has talked about,
 

all the guidelines does is make you sort of
 

categorize your cases a little bit better, and
 

think about making sure that you're consistent in
 

the application of -- as you review different
 

claimants that you're treating them fairly and
 

equitably in that process, and guidelines just
 

assist that.
 

And then as you develop experience with
 

particular situations, they allow you to catalog
 

that experience and organize them in a way that
 

helps you to, I think, handle the claims, I
 

think, both more efficiently but also more
 

fairly.
 

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And I think since it's called for in the
 

original legislation, I think it's helpful that
 

there be some record of what -- of how sufficient
 

accuracy is being considered, and some record of
 

how the feasibility of doing a dose
 

reconstruction or not being able to do a dose
 

reconstruction is considered. I sort of suspect
 

that NIOSH would end up doing this gradually
 

anyway. I just think this adds a little bit more
 

focus on that.
 

And also, I think it's fairer for the
 

claimants because they would then understand that
 

their claims are being treated the same as
 

similar claims; there's some rule or some
 

guidance document to go back to that sort of
 

fills in. It becomes more than just a case-bycase or the judgment of an individual dose
 

reconstructer and the people reviewing that
 

particular case.
 

DR. ZIEMER: Now let me ask if any of the
 

Board members require any additional
 

characterization or clarification of the issue
 

itself. Does everybody understand how this
 

arose?
 

And this also relates to comments that -- the
 

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comments that Ted Katz was making and that Dr.
 

Miller was making on this whole issue of
 

sufficient accuracy. This deals with that worst-


case business, where if there's a worst-case
 

estimate and the probability of causation is
 

greater than -- less than 50 percent, then in a
 

sense if you've shown that there's no way that
 

the person could have met the 50 percent
 

probability of causation criteria, in a sense
 

you've completed a sort of dose reconstruction
 

and you're done.
 

But if they're over 50 percent they don't
 

automatically meet the criteria of a dose
 

reconstruction, because you at that point have
 

only used worst-case estimate and haven't really
 

done enough research, and additional
 

information's called for. They might end up in a
 

Special Exposure Cohort, but they also might not.
 

And that was kind of the issue at that point.
 

But does anyone wish to make any specific
 

motions or ask for additional clarification, or
 

just comments, pro or con?
 

DR. ANDRADE: Paul, this is Tony.
 

By way of comment, I believe that Jim and Ted
 

and others probably have a fairly clear
 

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understanding of what they mean by sufficient
 

accuracy, and I'm sure that it's consistent among
 

the health physicists there at NIOSH.
 

Nevertheless, the way it came through in the
 

proposed legislation or proposed rulemaking, it
 

did suffer from lack of clarity. So what I guess
 

I'd like to see is follow-through on your item
 

number 13, that includes as the last sentence
 

that it would be helpful if NIOSH could provide
 

additional clarification of this concept either
 

through the development of guidelines, further
 

definition of the term, or through specific
 

examples.
 

Now I'm sure they'll be able to come through
 

on this.
 

DR. ZIEMER: Okay, other comments?
 

DR. MELIUS: This is Jim Melius.
 

I would, speaking up, but I could very well
 

see guidelines that would rely on specific
 

examples as the way that they would sort of
 

communicate the guidelines. So I don't think
 

that's inconsistent.
 

DR. ANDRADE: No, I don't think that's
 

inconsistent either.
 

DR. ZIEMER: Tony, does your -- what you kind
 

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of recommended there would be to start out with
 

the paragraph 13, and then kind of move into
 

Jim's words about developing specific guidelines
 

within a reasonable period of time and so on, or
 

were you not wanting to be that specific on it?
 

DR. ANDRADE: I didn't want to be too
 

terribly specific and tie their hands, but I
 

think what Jim is saying is a perfect example.
 

It could be guidelines that use specific
 

examples. And so I want to leave the concept
 

open enough for the real technical people to take
 

a stab at being a little bit more clear about the
 

definition.
 

DR. ZIEMER: Other comments?
 

[No responses]
 

DR. ZIEMER: Let me ask a general question.
 

Is there general concurrence amongst Board
 

members that you would like us to ask for more
 

specificity on this issue of sufficient accuracy?
 

Or do you think it's okay as it is?
 

MR. GRIFFON: This is Mark Griffon.
 

DR. ZIEMER: Mark.
 

MR. GRIFFON: Yeah, I think -- I'm not sure
 

if we can -- I agree with Jim Melius's asking for
 

guidelines and actually having an opportunity for
 

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the Board to review those guidelines.
 

I think the reason for that, I would like
 

more specificity and possibly in the rulemaking,
 

but I think we've had two cracks at it here in
 

two proposed rulemakings, and I'm not sure that
 

there's that much more clarity. So I think this
 

might take a little longer, and might be better
 

suited to guidelines -­

DR. ZIEMER: As opposed to a rule?
 

MR. GRIFFON: Yes. So I think -- but I
 

think, in this proposed rulemaking, I think we
 

should recommend that NIOSH should develop
 

guidelines and have input from the Board helping
 

those guidelines.
 

DR. ZIEMER: Okay. Other comments?
 

[No responses]
 

DR. ZIEMER: Does anyone wish to make any
 

specific motions?
 

[No responses]
 

DR. ZIEMER: Nobody wants to make any
 

specific motions?
 

DR. MELIUS: I'm trying to combine the two
 

here -- this is Jim Melius, Paul -- so that we
 

can -­

DR. ZIEMER: I was going to suggest something
 

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similar, Jim, as it were, just take where I said
 

it would be helpful if NIOSH could provide
 

additional clarification of this concept,
 

accordingly the Advisory Board recommends -­

DR. MELIUS: And then use -­

DR. ZIEMER: -- then move into your
 

statement. In fact, let me suggest this, and
 

then somebody can move it.
 

If you look at the Melius underlined
 

paragraph on page 3 -- Jim, I think the words
 

“DHHS reexamine the proposed approach to dose
 

reconstruction and special exposure cohort
 

designation,” I don't know that we need all that.
 

Just say “The Advisory Board recommends that
 

guidelines addressing feasibility and sufficient
 

accuracy be developed.”
 

DR. MELIUS: That's fine.
 

DR. ZIEMER: And then “These guidelines
 

should be developed within a reasonable time
 

period,” which is pretty flexible, “after
 

promotion [sic] of the regulation and should be
 

submitted to the Board for review. Appropriate
 

changes should be made in the regulation to
 

indicate the planned development of these
 

guidelines and the process for their
 

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development.”
 

Is this too much, now? “Appropriate changes
 

in the dose reconstruction regulations should be
 

made to address,” and where it says “the
 

potential conflict,” there's kind of an
 

assumption there that there is -- there's an
 

assumption that I'm uncomfortable with that there
 

is a potential conflict. Just could generalize
 

it, and say “any potential conflict between this
 

rule and 42 CFR 82.”
 

DR. MELIUS: That's fine with me.
 

DR. ZIEMER: That could leave some claimants
 

ineligible for either individual dose
 

reconstruction or Special Exposure Cohort status.
 

Do you want to make such a motion?
 

DR. MELIUS: This is Jim Melius.
 

I so move.
 

DR. ZIEMER: Is there a second?
 

DR. DeHART: This is Roy.
 

I'll second.
 

DR. ZIEMER: So what we have now is the
 

statement kicks off with item 13, but it drops
 

the last part of the sentence on 13 that says
 

“either through definition of the term or through
 

specific examples,” and just moves into “It would
 

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be helpful if NIOSH could provide additional
 

clarification of this concept,” and then it would
 

stop there.
 

And then it would say “Therefore,” and we'd
 

continue with the Melius statement, but we'd
 

delete from his first sentence “DHHS reexamine
 

the proposed approach to dose reconstruction and
 

special exposure cohort designation and that.”
 

Right there's where you would delete, and then
 

you would continue with “guidelines addressing
 

feasibility and sufficient accuracy be
 

developed.”
 

And then skipping down to the last sentence
 

would say, “Appropriate changes in the dose
 

reconstruction regulations should be made to
 

address any potential conflict between this rule
 

and 42 CFR 82 that could leave some claimants
 

ineligible for either individual dose
 

reconstruction or special exposure cohort
 

status.”
 

This that your motion, Jim?
 

DR. MELIUS: Yes, it is. Very good.
 

UNIDENTIFIED: Well stated.
 

DR. ZIEMER: Now let me ask if the Board, in
 

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connection with that, wants to retain any of the
 

other narrative that appeared in the Melius
 

document, or is this sufficient?
 

I think the narrative was largely there to
 

help to Board think about this, as opposed to
 

being part of what you wanted to put in the
 

recommendation.
 

Is that correct, Jim?
 

DR. MELIUS: Correct.
 

DR. DeHART: My second is as stated earlier.
 

DR. ZIEMER: Okay. So what you're saying is
 

then we would not need to include all of the
 

narrative that's in the document.
 

DR. MELIUS: Correct.
 

DR. ZIEMER: Okay. Now let me -- we have a
 

motion on the floor before us.
 

I want to see now if there are any comments,
 

pro or con. Anyone wish to speak in support of
 

this motion or in opposition to the motion? And
 

please feel free to do either. You won't hurt my
 

feelings. I know you won't hurt Jim's feelings.
 

UNIDENTIFIED: We don't mind hurting Jim's
 

feelings.
 

[Laughter]
 

DR. ANDRADE: This is Tony.
 

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I support the motion. I think that tying
 

this back to former legislation and ensuring that
 

there's consistency is important, and the way it
 

is stated -- I can't think of a better way to
 

state it than the way y'all worked it out. So
 

I'm in support of that.
 

DR. ZIEMER: Others, pro or con?
 

DR. ANDERSON: This is Andy.
 

I'm in support of it.
 

DR. ZIEMER: Okay. If anyone has got any
 

major heartache with this one then get it out,
 

because that might be helpful. Maybe we're
 

overlooking something, so don't hesitate if
 

you're uncomfortable or antsy about it.
 

MR. PRESLEY: Bob Presley.
 

I like it.
 

DR. ZIEMER: You're okay by it. Okay.
 

MS. MUNN: This is Wanda.
 

It isn't that I necessarily dislike where we
 

are here. I guess at this juncture I'm having a
 

little concern with what I perceive to be, and
 

perhaps inaccurately perceive to be, a movement
 

away from knowledge that we have based on the
 

best science available, and acceptance of the
 

responsibility that we have given our overseeing
 

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agencies to perform their duties properly.
 

I recognize the desire that's been expressed
 

here repeatedly. The term “specificity” must
 

have been used 15 times already. I recognize the
 

desire for that, and I'm certainly not opposing
 

the language that's been presented. I just have
 

some very severe heartfelt reservations about
 

some of the directions that I see the Board
 

making with respect to how the Agency is going to
 

address these things, and what “fair” means.
 

That having been said, I have no objection to
 

the wording as stated.
 

DR. ZIEMER: And Wanda, let me add that it
 

seems to me that as a practical matter, in fact
 

some guidelines are going to be developed anyway
 

along these lines, perhaps explicitly or maybe
 

implicitly. But, I mean, there has to be some
 

methodology that's developed as we go forward.
 

And I think in a sense it seems to me we're
 

simply asking for a better understanding of how
 

those decisions are made in these cases where you
 

have these worst-case estimates made on the one
 

hand for the efficiency issues in the dose
 

reconstruction, and as opposed to the issues of
 

the special cohort which is a somewhat different
 

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situation.
 

MS. MUNN: Yes.
 

DR. ZIEMER: Okay. Other comments?
 

[No responses]
 

DR. ZIEMER: Let me ask if the Board is ready
 

to vote on this item.
 

[No responses]
 

DR. ZIEMER: Anyone not ready to vote?
 

[No responses]
 

DR. ZIEMER: Okay. Then we're going to vote
 

on this motion, and all in favor will say “aye”
 

when the roll is called.
 

And Cori, you're ready to call the roll?
 

MS. HOMER: Okay.
 

Henry Anderson?
 

DR. ANDERSON: Aye.
 

MS. HOMER: Antonio Andrade?
 

DR. ANDRADE: Yes.
 

MS. HOMER: Roy DeHart?
 

DR. DeHART: Aye.
 

MS. HOMER: Richard Espinosa?
 

MR. ESPINOSA: Aye.
 

MS. HOMER: Mike Gibson?
 

MR. GIBSON: Aye.
 

MS. HOMER: Mark Griffon?
 

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MR. GRIFFON: Aye.
 

MS. HOMER: Jim Melius?
 

DR. MELIUS: Yes.
 

MS. HOMER: Wanda Munn?
 

MS. MUNN: Okay.
 

MS. HOMER: Leon Owens?
 

MR. OWENS: Aye.
 

MS. HOMER: Robert Presley?
 

[No responses]
 

MS. HOMER: Bob?
 

DR. ZIEMER: Did we lose Robert?
 

MS. HOMER: Uh-oh.
 

MR. PRESLEY: Yeah. Can you hear me?
 

MS. HOMER: Yes.
 

MR. PRESLEY: Aye.
 

MS. HOMER: Okay. And Genevieve Roessler?
 

DR. ROESSLER: Yes.
 

MS. HOMER: Dr. Ziemer?
 

DR. ZIEMER: Yes, and the Chair will vote
 

aye.
 

MS. HOMER: Okay.
 

DR. ZIEMER: So the motion carries, and we
 

will incorporate that combination statement into
 

the last item on the list of comments.
 

Now one more time, let me ask the Board
 

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members, are there additional comments that you
 

believe should be included in the comments sent
 

to the Secretary of HEW -- HHS, not HEW. HHS.
 

[No responses]
 

DR. ZIEMER: It appears not.
 

I also have provided you with the draft cover
 

letter. That will be revised to reflect the fact
 

that there were three conference calls rather
 

than two on this subject, in the second to last
 

paragraph, so I will update that.
 

The cover letter itself, we don't need to
 

vote on. But if you have any grammatical things
 

or something like that that you want to pass on
 

to me before it goes to final form, why, you can
 

do that individually.
 

Okay. Now it's my judgment that we have
 

completed action on all the comments we want to
 

comment on for the proposed rulemaking. Is
 

everybody of the same understanding? Any that
 

think there are additional things that we need to
 

address at this point?
 

[No responses]
 

DR. ZIEMER: Apparently not.
 

I will ask Cori if you have any housekeeping
 

issues relating to our upcoming meeting.
 

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MS. HOMER: No. I think I've asked everybody
 

for their travel arrangements.
 

I do have a question for you, if you could
 

just go ahead and forward whatever comments in
 

the final to me.
 

DR. ZIEMER: I will do that. And our
 

comments are due in to the Secretary by what
 

date, again?
 

MR. ELLIOTT: May the 6th.
 

DR. ZIEMER: May 6th, okay. Very good.
 

Now, let's see. Cori, just for the record,
 

give us the dates of our next meeting again in
 

Oak Ridge.
 

MS. HOMER: Okay. Our next meeting is
 

scheduled for May 19th and 20th.
 

DR. ZIEMER: That will be -­

MS. HOMER: In Oak Ridge at the Garden Plaza
 

Hotel.
 

DR. ZIEMER: Okay, thank you very much.
 

MR. PRESLEY: Cori, are the meetings going to
 

be at the Garden Club?
 

MS. HOMER: Yes, they are.
 

MR. PRESLEY: Wonderful.
 

MS. HOMER: Yes.
 

DR. ZIEMER: Okay. I think that then
 

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completes our meeting, and I will declare us
 

adjourned.
 

Thank you, everyone, very much.
 

[Whereupon, the meeting was adjourned at
 

approximately 4:21 p.m.]
 

NANCY LEE & ASSOCIATES
 
 

 

 

67 

C E R T I F I C A T E
 

STATE OF GEORGIA )


)


COUNTY OF DEKALB )
 

I, KIM S. NEWSOM, being a Certified Court
 

Reporter in and for the State of Georgia, do hereby
 

certify that the foregoing transcript, consisting of
 

65 pages, was reduced to typewriting by me personally
 

or under my direct supervision, and is a true,
 

complete, and correct transcript of the aforesaid
 

proceedings reported by me.
 

I further certify that I am not related to,
 

employed by, counsel to, or attorney for any parties,
 

attorneys, or counsel involved herein; nor am I
 

financially interested in this matter.
 

This transcript is not deemed to be certified
 

unless this certificate page is dated and signed by
 

me.
 

WITNESS MY HAND AND OFFICIAL SEAL this 7th day of
 

May, 2003.
 

KIM S. NEWSOM, CCR-CVR


CCR No. B-1642
 

[SEAL]