1g"

~~ speculative.

63

out of the 60 there will be ten, just -- but I
talked to Hans a little bit -- where we're
going to have to do a little follow-up that
might --

DR. ZIEMER: Or we could even specify at scope
time that we'll allow up to some number,
whether it's five or ten, whatever.

DR. MAURO: Right, and that would be the easy
part. The harder part was well, okay, how far
we're going to have to go to bring it to
ground.

DR. ZIEMER: Right.

DR. MAURO: That's the big unknown. And so I
probably could put some nominal amount of
resources in there that would increase the
budget a little bit -- really not -- perhaps
not that much, but it would be very

DR. WADE: How does the Board wish to proceed
on this issue? Is there a sense -- do you want

to ask John

Is



29

1 (unintelligible) --

2 DR. MAURO: That's -- that's how we got this --

3 yeah, in fact, that might be -- that's a good

4 suggestion, by the ways. In our progress

5 reports for each one of these we will keep you

6 apprised of -- has anything new cropped up on

7 the O drive, new -- that -- that are not within

8 the scope of this.

9 Now that doesn't mean it's a problem. I mean

10 if we can -- if -- within the budget that we

i have, if we can take care of them, we'll take

12 care of them. But we'll keep you apprised of

13 new -- new -- see, for the purpose of pricing

14 this I just went with what we know.

15 DR. WADE: Right, that's fine. Perfectly

16 reasonable.

17 Jim Neton has joined us, David, as well -- for
—~-————the record. ra es

19 MR. STAUDT: Thank you.

20 DR. WADE: Okay.

2: DR. ZIEMER: You can proceed, John.

2 DR. WADE: With task three -- or task two, I

23 guess.

24 DR. MAURO: Next is task three. There is no

25 longer a task two.



CONTENTS

August 25, 2005

CLOSED SESSION —
WORK TASKS FOR SC&A CONTRACT FOR NEXT
DR. LEW WADE

COURT REPORTER’S CERTIFICATE

YEAR

105



13
14
15
16
17
rs .: as
19
20
21

7

23

72

about that.

DR. MAURO: I didn't underst-- I didn't hear
the question, I'm sorry.

DR. WADE: He wants to know if you have enough
money in hand to complete the first 60.

DR. MAURO: Yes.

DR. WADE: You do. Okay, yes. And so that's -
- that's the approach we'll take at this point.
Let's move on to the next topic.

DR. ZIBMER: Okay.

DR. MAURO: We'll move on to task five, which
is the SEC-related TORP. That's the one -- if
everyone -- again, if you could open up to page
eight of that proposal, Exhibit 3, what we've
been asked to do is to estimate what it would
cost to do a total of six -- we're calling it
either SEC petition -- the fundamental heart of
it’ --theré aré several tas-- there are several
tasks.

Sub-task one is to review procedures. That is,
there are currently a set of NIOSH/ORAU
procedures that are being used to review SEC
petitions. We've been asked to perform a
review of those procedures, deliver it within

one month of the date of authorization, and



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83

spending on doing actual case review and how
much money we're spending attending Board
meetings, because part -- what we were doing is
whenever we attended a Board meeting, we fill
out a time sheet. These hours -- my hours
right now, when I fill out my time sheet, is
going to go against task four. That's not a
good situation to be in.

So what I did is I said okay, beginning October
lst, at your request -- you sent us a TORP --
we will have a separate program management task
order, which basically will cover a number of
areas, and you can see the columns. The
columns are monthly progress reports --
basically I spend one day a month putting
together the progress reports that you folks

see. And then we have the Board meetings, I

may -- I assumed that we were going to have a
Board meeting every two months. They will
probably (unintelligible) four people,
sometimes five. There's the work hours to
support the Board meetings.

Records management, Kathy Behling and Nicole
Briggs* on our project team have been doing a

lot to help everyone else get the records that



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19

Bulletins. So when I say we're going to review
a site profile, that automatically has always
meant not only the site profile, the TBDs, the
chapters that make up the site profile, but
also the TIBs, any Technical Information
Bulletins that are -- that is -- so that's
within the scope of that first column, and
that's what it -- that's part of the cost that
we've incurred. So when I say about 1,000 to
2,500 work hours per site profile, that means
the review of not only the -- the various TBDs
or chapters, but also the Technical Information
Bulletins that support it, and of course all
the literature that's cited. I mean that's
part of the process.

But something new has arisen on the horizon is

that there are now a number of site-specific

“-“~ workbooks.” And as we discussed previously,

these workbooks are becoming increasingly
important because they're allowing NIOSH to do
realistic dose reconstructions as opposed to
these min/max. So more and more of these
workbooks are finding their way into the
Process. And in fact we have a listing as an

attachment -- the next page -- Exhibit 2 of



we ote

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~~~ originally talked about having help with our

78

and fairly complicated sites, and so it may
take that amount of time and so forth.

DR. ZIEMER: Of course in reality you're just
going to bill whatever it does take.

DR. MELIUS: Yeah, exactly. Exactly, yeah,

that's what I'm saying. It's not -- and we may
need the room -- those 1,500 hours or those
extra -- beyond that is going to be useful for
other --

DR. ZIEMER: Right.

DR. MELIUS: -- cases, I...

DR. ZIEMER: John or Board members, help me
remember. On task two -- not task two, but
item two of this task, on the so-called Board
procedures, were we thinking originally that
these procedures are the SC&A procedures that
they would use, or -- I thought we had

own procedures.

DR. WADE: I think so.

DR. MELIUS: They were both.

DR. ZIEMER: Or both.

DR. WADE: And they're so intermingled --

DR. ZIEMER: And John, was that your

understanding? I thought I heard you focusing



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7
t

19
20

21

36

one. But we are going to review the complex-
wide generic workbooks as part of task three.
Okay?

And that's -- basically covers the -- the
columns in the exhibit on work hours. And the
total -- the bottom line is 4,220 work hours to
perform that scope of work.

Let's move on to task four. Task four, as you
know, is the review of site -- cases. Again --
now there's a little bit of a story here, a
little bit more to the story that I think we
should talk about that might be important. But
let's start again as we did before, flipping
through the write-up -- I'm going to talk a
little bit about the write-up -- and go to
Exhibit 1, which is on page 7 of 8.

We -- we have gone through a process now where

wetre close to finishing up 60 cases, the
review of 60 cases. We've completed the
delivery of 38. You have the second set of 18.
Hans is about halfway through the last set.

DR. BEHLING: (Off microphone) More than
(unintelligible).

DR. MAURO: More than halfway through. We're

going to be delivering our final work prod--



we

a Ss)

2

23

25

43

DR. ZIEMER: Right.

DR. MAURO: Do you still want some --

DR. ZIEMER: No, you're not talking about the
blind, though.

DR. MAURO: No, I'm not. There were three --
if you recall, there were really three
different types of audits, basic, advanced and
-- and a blind. Blind is a very unique thing -
- we haven't done one yet -- where we don't
have the dose reconstruction report that -- we
haven't done one yet.

DR. ZIEMER: Right.

DR. MAURO: Right, so --

MR. GRIFFON: Just a comment on the -- on the
advanced. I mean I guess I've, you know, two
concerns with -- with putting it into the site

profiles. One is that we're going to review

some cases for smaller sités; for which there

is no site profile, so we might randomly get
some of these cases that they weren't -- it
wasn't a big enough site to get a --

DR. MAURO: Uh-huh.

MR. GRIFFON: -- a site profile for, so this
would in essence turn into a site profile for

that small site. And I -- you know, I think



ie)

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20 that lend themselves to being what you would
call having a need for an advanced review.

DR. MAURO: The -- in fact, I think it's the --
if you recall, the first set of 60 -- let's --
let's put the blind on the shelf for right now,
the parking lot. The first set of 60 -- first
-- first set of 20, second set of 20, they were
basic, and in theory the last ones, the ones
we're working on right now -- Hans is doing
right now -- are in theory advanced. The
concept of setting aside and saying okay, we're
going to make this last set advanced, it
inherently is a flawed idea, the reason being
what becomes advanced emerges during the
review. It's the case itself that dictates
whether we have something --

DR. ZIEMER: Whether you need to --

DR. MAURO: -- that it requires advanced
treatment.

DR. ZIEMER: Right, that's...

DR. MELIUS: I beg to differ. I think you have
made a unilateral determination to change the
scope of the work, and I find that very
disturbing. I find it very disturbing that we

first hear about this in a closed session, and



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-

39

experience that once we do all that, the
original big, thick book that we sent to you,
we have to fix that because it has to be
updated, revised, fixed because of all the
interaction that takes place, so we're going to
have to put another product out. In fact, on
the first set of 20 I believe we went through
that three times, so that -- I don't think it's
going to be that cumbersome in the future, but
we will have to do it once.

So basically this is the budget that we've set
aside to -- that we've proposed.

Now there is a new twist -- okay? -- to this
process. First of all, you know, we will be
very much including the workbooks, you know, in
our audits. So the workbooks are part and

parcel now of looking at this.

the site profile people, who have already

completed reviews 'cause now we have under our
belt -- we have -- are sort of standing on the
shoulders now of a lot of site profiles that
have been completed, so that's going to help us
-- make things a little bit easier, so that's

one of the reasons why we don't think we're



71

about this again, as I said, it's up to you.

Or the other option is to simply, at the
beginning of October, give them -- give them
some money and then we can put in ranges, if
you want to -- I hate to hard-line ten and ten,
you know. I prefer to have the "up to" or some
-- some ranges so there's some flexibility
based on the cases that are coming in. So I'm
not sure now, but I (unintelligible) put the --
put the contractor in a bind.

DR. WADE: Okay. So what we can do then, I
hear you say, David, is we can wait until the
October meeting when we would have proposals
from SC&A of the type we would ask for, and
then go into closed session and make a
decision, and then pick up the work after that

meeting. They would contin-- have the ability

~to continue to work to closure on the work that

they have in front of them in terms of the
first 60.

MR. STAUDT: Right, and I -- and I guess John
could maybe talk about the funding. I don't
know if they're going to, you know, burn more
(unintelligible). They (unintelligible) have

enough money right now. Maybe John can talk



w

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49

very quick judgment made by NIOSH or ORAU,
whoever's doing the dose reconstruc-- not to

pursue that information. And I don't think

4 that we want you just to sign off on that. I
5 think there ought to be some follow-up and so
6 forth. Now -- and I think until we've done

7 some of these, I don't -- I'm reluctant to have
8 -- have you somehow curtail what we were

9 originally asking you to do. I -- we -- I

10 think it's appropriate to -- for you to

VW exercise judgment on that. I think what you
12 did on Blockson was -- was fine. It's

13 explained how -- you're explaining how far you
14 went and so forth. But I don't like the idea
15 of this change in the scope of what we were

16 asking for.

17 DR. BEHLING: I'm going to just respond
1g—-— "briefly. I think, as John has already

19 mentioned, we have been doing pretty much a --
20 an advanced review all along. We have not

21 taken things at face value. Now we have

22 stopped in certain instances where we realized
23 we would have to contact people that we may or
24 May not have the authority to contact. And at
25 this point in time I would say we cannot make a



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91

DR. WADE: On these issues we're looking at the
scope or --

DR. ZIEMER: We're accepting the scope and cost
as provided -- or as proposed by the
contractor.

MS. HOMOKI-TITUS: Okay.

DR. WADE: Right, the two -- scope issues will
be discussed in open session.

DR. ZIEMER: That's for task order one, three,
five and six, accept scope and task as bid by
the contractor.

MR. GRIFFON: Scope and cost, yeah.

DR. ZIEMER: Scope and cost. Are we okay on
that? Okay.

DR. MELIUS: Can I offer a friendly amendment?
I think we are approving this with the

understanding that we will have in place a task

-and-adequate—funding—for—individual—dose———_..—___..__

reconstruction reviews.

DR. ZIEMER: Yeah, I don't think that's
necessarily a friendly amendment. It's a --
it’s a contextual -- the context of our action
is with that assumption, that there will be an
ongoing task for dose reconstructions.

DR. MELIUS: Yeah, I would like it somehow



12

how the budgeting process works with Congress,
and I don't know when we'll have a budget for
next fiscal year. It is critical, in my view,
that we keep our contractor -- your contractor
-- working, in spite of being under a
continuing resolution or anything like that.
So I would like to have work understood and in
hand as we move into next fiscal year, and
we'll -- we'll deal with those vagaries.

I am aware of action on the Hill to set aside
$3.5 million for SC&A's efforts next year. I
don't know that that action will come to
fruition. There's no way for me to know that.
But I think it provides at least a number for
us to have in our consideration
(unintelligible) any other numbers that you
might come up with.

I-would tell you that if Gongréss does not take
that action, then it would be the intent of
NIOSH to proceed to provide funding at about
that level to the contractor. But again,
without Congressional action, we would need to
be involved in discussions with DOL, and we
will certainly have those discussions.

It always -- it's always possible that Congress



GRIFFON, Mark A.

President

Creative Pollution Solutions, Inc.
Salem, New Hampshire

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

New York State Laborers' Health and Safety Trust Fund
Albany, New York

MUNN, Wanda I.
Senior Nuclear Engineer (Retired)
Richland, Washington

OWENS, Charles Leon

: President

i Paper, Allied-Industrial, Chemical, and Energy Union
Local 5-550
Paducah, Kentucky

PRESLEY, Robert W.

Special Projects Engineer

BWXT Y12 National Security Complex
Clinton, Tennessee

ROESSLER, Genevieve S., Ph.D.
Professor Emeritus
University of Florida
Elysian, Minnesota

STAFF /VENDORS

LASHAWN SHIELDS, Committee Management Specialist, NIOSH
STEVEN RAY GREEN, Certified Merit Court Reporter



we We

-

46

no, this is an advanced review; that's your
job. We could do that. It will be very time-
consuming and it might be more -- and this is
really --

DR. ZIEMER: This is something the Board can
specify if we want a certain number of these
done with that kind of depth, and then I think
you would have -- your cost proposal would
change a bit then.

DR. MAURO: Yeah, I mean we could leave it at,
you know, the 70 hours ‘cause we don't know --
see, it's an unknown. Let's say -- it may turn
out a phone call. You know, what's a phone
call? It may turn out a site visit. Now we're
getting a little more expensive. Might have to
go to a records center and spend a few days to

go dig through certain things. In other words,

—----—--now-we're- getting into what—E-cati-the—mode—of—~-—-- -

operation we're in when we do a site profile,
which is a -- is 1,000 work hours per site
profile, so it is a big effort.

So we -- we can go either way. But right now
we've got the machinery working. We're moving
these site -- these case audits out nicely.

When we see a hole, such as we see a disparity



Ww

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77

project. So what we did is we set aside some
resources for special investigations where -- a
very focused direction we receive from you
folks, and we set aside 800 work hours so that
if in fact you want to call upon us to look at
a very focused issue within a broader scope, we
have some resources to do it.

So that's how we came to our scope and our
budget to support this task.

DR. ZIEMER: Okay, questions. Jim Melius.

DR. MELIUS: I -- just a comment. I think -- I
think -- I understand how difficult it was to
come up with these numbers, given our history
of dealing with SECs, evaluations and what
we've been sort of asking you to do under this
site profile thing at the same time. And I

guess I'm basically satisfied with your

estimates. “I guess one -- the only one I have
some questions on was the 1,500 for the -- the
naked review, only -- only in that I think

that's going to involve very small sites and I
don't think they're going to be that
complicated and so forth -- but who knows? You
know, there's some site profiles that haven't

been completed yet, involve fairly large sites



wo

+

86

everyone was aware --

DR.
MS.
DR.
MS.
DR.

WADE: On the agenda for tomorrow.

MUNN: -- that this was on our agenda for -

ZIEMER: Right.
MUNN: -- tomorrow.

ZIEMER: We do have that for tomorrow's

agenda, and I think Board members have received

from you, Wanda, a proposed policy --

Ms.
DR.
MS.
DR.
MS.

DR.

MUNN: Yes, and I have hard copies for --

ZIEMER: -- not a motion.

MUNN: -- those who want it, just --
ZIEMER: There is -- of course, as --
MUNN: -- just there.

ZIEMER: -- as John pointed out, in this

budget they have actually designated 72 hours

plus some travel --

-—--DR.- MAURO: And -I''d-be (unintelligibte)-

DR.
DR.
DR.
DR.
DR.
DR.

D.c.

ZIEMER: -- expenses --

MAURO: -- it's very modest, ‘cause --
ZIEMER: -- a couple of thousand --
MAURO: -- it's -- it's basically --
ZIEMER: -- dollars for travel.

MAURO: -- me getting on a train to go to



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

THIRTY-SECOND MEETING

ADVISORY BOARD ON
RADIATION AND WORKER HEALTH
VOL. ITEXEC
DAY TWO

EXECUTIVE SESSION MEETING

The verbatim transcript of the Executive
Session Meeting of the Advisory Board on Radiation
and Worker Health held at the Westin Hotel, st.

Louis, Missouri, on August 25, 2005.



PARTICIPANTS

(By Group, in Alphabetical Order)

BOARD MEMBERS

CHAIR

ZIEMER, Paul L., Ph.D.
Professor Emeritus

School of Health Sciences
Purdue University
Lafayette, Indiana

EXECUTIVE SECRETARY

WADE, Lewis, Ph.D.

Senior Science Advisor

National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention
Washington, DC

MEMBERSHIP

ANDERSON, Henry A., M.D.
Chief Medical Officer
Occupational and Environmental Health

Wisconsin Division of Public Health ..00

Madison, Wisconsin

ESPINOSA, Richard Lee

Sheet Metal Workers Union Local #49
Johnson Controls

Los Alamos National Laboratory
Espanola, New Mexico

GIBSON, Michael H.

President

Paper, Allied-Industrial, Chemical, and Energy Union
Local 5-4200

Miamisburg, Ohio



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15
16
17

~ = = - FR ee

34

task order which re-- which -- which shuts
down, terminates the old task order, which is
gone forever and -- along with any resources
that might be remaining in it and we pick up
from here. This is a contractual issue that
I'm not -- my experience in other task order
contracts, when the period of performance ends,
that -- it's over. Now I don't know if that's
the case here.

DR. ZIEMER: Maybe David can speak to that.

MR. STAUDT: Yeah, this is going to be a
modification. There should be no concern about
the funding. That money should be able to be
carried over -- 7

DR. MAURO: Excellent.

MR. STAUDT: -- and I don't see any -- any

issues there.

DR. MAURO: “Thank you.” That =
preferred way, as far as we see it, of course.
Okay. So again, going back to this exhibit on
the second page in the proposal of work -- so
the first column is putting some modest number
of work hours into -- to finish up the closeout
process.

But then we're going to move on to well, there



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\

DR. MELIUS:
DR. ZIBMER:
that context.
comment? Okay.

DR. WADE: Let’

Okay.

Wanda,

s go.

The record can show that it's in

you have an additional

93

MS. MUNN: (Off microphone) (Unintelligible)
discussion.

DR. ZIEMER: Okay, discussion?

MS. MUNN:

DR. ZIBMBR: Okay. I don't know if that's a

motion or a comment,

and ~



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4 four, five and six. Task two will cease to

3 exist or shows up as being budgeted as zero.

6 Task three will remain to be defined, I guess,
7 what did we --

8 DR. WADE: Or task four.

9 DR. ZIEMER: Is it four? Oh, individual dose
10 reconstructions.

Wl DR. WADE: Task four has been tabled,

12 basically.

13 DR. ZIEMER: Yeah, task three is really the

4 procedures review. So what -- what action is
15 needed now, Lew or -- or David? Do we need to
16 -- does the Board need to formally approve

17 these other tasks and the costs?

18 -—-- MRE STAUDDT:—-Yes;-i-~-- -yes;— I--_-I - — that+s———--._}-
19 what I would recommend.

20 DR. ZIEMER: Okay.

21 MR. STAUDT: And that's (unintelligible) I

2 would like done. If you would like, I can -- I
23 can put the new tasks -- two -- task order five
24 and six in place within the next week.

25 Otherwise it would have to wait till October.

88

DR. MAURO: That's it.
DR. ZIEMER: Or on any of the tasks now? So

what we have are basically task one, three,



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16

August 15, 2005.

DR. WADE: And just for the record, task one
is?

MR. STAUDT: Task order one is the site profile
reviews.

DR. WADE: Task order two?

MR. STAUDT: Case tracking. Task order three
is dose reconstruction, and task order four is
entitled individual dose reconstruction
reviews.

DR. ZIEMER: I think task three was actually
the procedures review.

MR. STAUDT: I think that was just a -- that
was like a kind of a title that was in there,
so you are correct.

DR. ZIEMER: Yes, it is the procedures review

task. Thank you. That's -- that's helpful I

so they have at least an intuitive feel of what
resources it's taken. We -- we know what
products have been developed through this
money, so that's helpful.

DR. WADE: And just on the record again, nine
site profile reviews complete or close to

complete, 62 individual dose reconstructions.

~ think just as a referénce point for the Board



58

1 ask it of the Board. Is it conceivable that we

2. could take the first round review on a set of

3 20 cases -- and the contractor might even

4 identify one or two or three that had these

5 characteristics -- and then we could make

6 | instructions during the early rounds to say

7 Please go back and drill down on this case or

8 these two cases or something like that, and --

9 DR. MAURO: Yeah. I think we could do it for
“10° the whole set. In other words, we're -- we're
i ab-- I mean -- and in -- and in theory, a

2 letter report could go out that will -- when we
13 deliver our next set -- our last set of 20

14 case-- 22 cases, we will have now the luxury to
15 say okay, we've been through 60 cases and in

16 light of the conversation we're having right

17 now, out of those cases, how many occasions did

—18—_ +-— _—_-_ we—have_where—drilling—down—would_—probably have—...—.|.

19 been a -- is a desirable -- to get closure, and
20 we could make a little table.

21 DR. ZIEMER: Yeah. Well, I'm sort of raising
» this to the Board as a methodology -- you know,
23 clearly the sentiment is we don't want to lose
24 the -- this option of -- of doing what we

25 called the advanced dose reconstruction, and



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DR. MBLIUS:

100

DR. 2IEMER: Jim?

DR. ZIEMER: I can understand why it's of

concern. Can -- John, can you tell us to what

extent-==— ~~

DR. MAURO: -



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79

mainly on your own procedures, but for example,

the Board may want to put in place some

3 procedures that spell out what -- for example,
4 what is -- what should be the status of a site
5 profile and its review before we consider a

6 petition. Or you know, what -- what degree of
7 open information would we allow before we move
8 forward and -- and so on. There are a lot of -
9 - I think we have internal procedures that we
10 may have to deal with, and was that part of --
HW you weren't thinking about us.

12 DR. MAURO: No. I was -- I was thinking that -
13 - what is it that as -- as -- I guess as your
i4 contractor, what procedures --

15 DR. ZIEMER: What would you do.

16 DR. MAURO: -- would we use --

17 DR. ZIEMER: Yeah.

18 ~~~ ~""DR. MAURO? “== to answer the -- to determine ~~
19 the degree to which the petition --

20 DR. ZIEMER: Yeah.

21 DR. MAURO: -- in fact satisfies 42 CFR Part

2 83.

23 DR. ZIEMER: Right.

24 DR. MAURO: That's -- and what procedures would

we follow.



is)

—

40

going to need as many work hours as we
originally needed.

But there is another little bit of a twist,
though. We are going to be doing realistic
cases. We haven't seen any yet. Oh, we've
seen a little bit of it, but we really haven't
seen them, and we're a little bit un--
uncertain. So what I did -- that's why I
picked 70 work hours. It's really a little
less than -- it's between that original 50 and
the 100 that we experienced. As I say, 70 is
not a bad number.

One other twist that is important to mention,
and -- as you may recall, when the original
scope of work was laid out we had basic and
advanced reviews. The intention of that
distinction was -- was well understood. In
fact; in our proposal you'll notice we've
actually laid it out. Here's what a basic
review consists of and here's what an advanced
review consists of. Well, in reality what we
actually did, and which you've all experienced
with us, we went through it together, was we
actually went through a process which was not a

basic review, it was more than a basic review,



()

By

first round of reviews and are at that stage

where we're having our one-to-one interactions

3 where we -- the two or three-person teams are

4 talking to Hans and Kathy and the team about

5 that case. Okay? And during that conversation

6 Hans says by the way, we've got one of these

7 where there's a problem, where I think we --

8 there -- it looks like there might be some data

9 out there, that should be out there, based on

10 the CATI infor-- whatever the information is --

il where I think we've got to go the extra yard

12 and this is one of our findings. Perhaps at

13 that point -- and since we don't know what --

14 which ones that's going to be and how important

15 ~- and it might turn out not to be important.

16 I mean I'm not sure. But I'm saying that one

17 way to get to the problem on a real time basis
—~—--—— 18 ~—————-~—ts~to engage that issue at the time of the

19 dialogue with you folks at that in-between

20 point before we deliver our product as being a

21 practical way to get through this process.

2 DR. MELIUS: Again, if I may speak, I think

23 that is -- may be workable, but I think we'd

24 have to have some sort of a -- I don't if we

25 call it a quote or what, that only certain



Ww

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37

reconstructor chose to say well, he's covered
by the 28 radionuclide hypothetical case and

that takes care of it. Under the advanced

4 review we might want to look at the

5 radiological incident and say are you sure, and
6 then try to do a scoping calculation that says
7 we agree or we don't agree.

8 In the past we've said well, there's an issue
9 here. The radiological incidence was not --
10 not necessarily documented and followed through
W in terms of dose calculation, but that's your
12 problem, NIOSH. We --

13 MR. GRIFFON: (Off microphone) And that was

14 (unintelligible) .

15 DR. BEHLING: -- may now -- yeah, and we would
16 stop. At this point I may choose to say let's
17 go and take a look at the radiological

18. incident, whether it's an intake or skin

19 contamination or something else, and then look
20 at the potential doses that might result from
21 such an incident and compare that to the 28

22 radionuclide hypothetical and come to a

23 conclusion as to whether or not that judgment
24 call was correct.

25 DR. ZIEMER: Let me ask this question -- I'll



i)

rr)

53

numbers would be pursued because I think that
process could get out of -- get out of hand.
And I think there's issues of sort of who's
involved in making those decisions and so
forth. I think we would need some criteria for
doing that.

DR. ZIEMER: Okay. Wanda and then Robert.

MS. MUNN: One gets the feeling that we do have
a criterion which we have perhaps not
addressed. It seems to me that the process
that John and Hans are suggesting is ideal,
with one small glitch. The Board review team
does not at this juncture have the authority,
nor have we even considered, so far as I know,
authorizing the contractor to go seek the
additional information that might be called for

under our current concept of an extended -- an

advancéd review. This would appear to be a
fairly crucial point for us to address, and I'd
like to see us think about that and perhaps
come to some conclusion about that. There's
not any question in my mind that that would be
a very efficient way to identify an advanced
review. But without the full Board's

acknowledgement that it's approved --



wot

-

15
16
17
_- 1 8-

82

higher level framework.

DR. WADE: I think the Board will need to
advise you -- I think this will be something
we'll work together on. I was comfortable that
your proposal was responsible to the scope.

DR. MAURO: Yeah, we actually wrote a -- unlike
the others, which are really letter proposals,
this was pretty detailed. We actually have a
checklist, we have -- you know, we did a lot
here, so you have a pretty good idea what we
had in our minds. If that's what -- not
adequate --

DR. WADE: I was comfortable with that, given
the fact that it will happen as a partnership
between you and the Board.

Okay, what about the next one?

DR. MAURO: We're almost done. This should be

~very-quick:— The tast one is our new task six,

which is our project management task. As you
recall previously, all of what I call over-
arching support, program management activities,
was billed against task four -- budgeted and
billed against task four. Created a cumbersome
situation because it was difficult to

distinguish between how much money we're



ie)

3
4
5
6
7
8
9

92

attached to our motion because I -- I don't
think we would want to go forward with a -- I
think our decision might change, depending --
if -- and how we would allocate money or
whatever if there were not as much -- enough
money or whatever, the budget changes, and we
want to make sure that individual dose
reconstruction reviews, which is our -- our
major charge from Congress and the legislation,
is included.

DR. ZIEBMER: I guess my concern is if we put a
contingency on here that will prevent the
contracting officer from coming to closure,
because we won't have the next task in place
till the -- till the October meeting.

DR. MELIUS: It's not a contingency, it's just

-- I think it's part of that -- it's an

—~understanding—that-it's—part--of —~-—-—-. _____._._.

MR. GRIFFON: A sense.

DR. MELIUS: -- a sense when we --

DR. ZIEMER: Right, it's a sense of the motion,
though. That's why I say it's contextual.
Everybody understands that that's the context.
Is there any -- I don't think it requires an

amendment to the motion, is what I'm saying.



47

between the dose reconstruction and the CATI,
looks like some follow-up work might be needed

over here or over here, we just point that out

4 and we leave it up to NIOSH and the Board to

5 decide what do you want to do about it.

6 By the way, to -- but one -- I have one more --

7 and I'll turn it over -- I -- one more -- we

8 have had -- in fact, it turns out,

9 coincidentally, I was the one who reviewed the

10 cases for Blockson -- we had a case for

il Blockson Chemical Company and Huntington, both

12 of which were AWEs that had site profiles, and

13 so in order for me to review that case I

14 effectively performed a review of the site

15 profile. Now I performed a review of the site

16 profile to the extent that I felt necessary to

17 say something intelligent about whether I
wo FE thought théy did a good job or not on their

19 dose -- on their dose reconstruction. But I

20 would not say that I performed a site profile

21 review. I went as far as I thought I should

22 go, and I made that clear in my -- in my

23 report, this is what I did.

24 DR. ZIEMER: Right.

DR. MAURO: So -- but if I were to take on



TRANSCRIPT LEGEND

The following transcript contains quoted material.
Such material is reproduced as read or spoken.

In the following transcript: a dash (--) indicates
an unintentional or purposeful interruption of a
sentence. An ellipsis (. . .) indicates halting speech
or an unfinished sentence in dialogue or omission(s) of
word(s) when reading written material.

-- (sic) denotes an incorrect usage or pronunciation
of a word which is transcribed in its original form as
reported.

-- (phonetically) indicates a phonetic spelling of
the word if no confirmation of the correct spelling is
available.

-- "uh-huh" represents an affirmative response, and
"uh-uh" represents a negative response.

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

“without reference available.
-- (inaudible)/ (unintelligible) signifies speaker
failure, usually failure to use a microphone.
In the following transcript “off microphone”
refers to microphone malfunction or speaker's neglect

to depress "on" button.



15
16
17

- === g-——- ee

19

70

they come out with on the next 20. If they
come back to us and say we tried to do an
advanced -- I don't accept that, but I think
it's a scope discussion and I don't accept that
advanced cases dictate when an advanced is
needed. I mean if -- I -- I think that's a
scope discussion, though.

DR. WADE: Jim?

DR. MELIUS: Well, we are next meeting the
middle of October. My understanding was that
this was not going to be renewed until after
the first of October anyway, this particular
task -- if I heard Dave correctly. So I mean

we're talking about two weeks, so are we better

off scheduling a closed session -- an open
session and then a closed session to deal -- I
mean I don't know what procedures -- or do a

“conference call or something to talk about the
scope, a Board meeting by conference call to
discuss this before the --

MR. STAUDT: This is Dave. I think we're
actually good on this task until the end of
October, so I'm not so sure that we have to
immediately push out on this. If you -- you

know, if you want to take some time to think



te ow te

— -

56

for one case. You can put in that -- in your
report that we have this finding. We want to -
- we want to do a drill-down on it back to
source data, but we have a site profile pending
DR. MAURO: Uh-huh.

MR. GRIFFON: -- and we're going to do it under
that process. And I think that -- I think we
can work from that. That's my opinion, anyway.
But I don't want to lose the smaller sites or
the -- or the CATI information. Especially the
CATI stuff I think is important when we get
into the best-estimate cases. I know we've had
mostly overestimates and underestimates so far,
but...

DR. BEHLING: Let me give you a good example as
to where I would consider an advanced case as

being diff t£ basic.—_For_instance,-in——-_|.

the past if I had seen, for instance, a CATI
report that says I was involved in radiological
incidents, or even documentation to that
effect, in the DOE records. But rather than
pursue the issue of what might that dose have
been that would have been assigned to an

unmonitored radiological incident, the dose



105

1 CBRTIFICATE OF COURT REPORTER

STATE OF GEORGIA
COUNTY OF FULTON

I, Steven Ray Green, Certified Merit Court
Reporter, do hereby certify that I reported the
above and foregoing on the day of August 25,
2005; and it is a true and accurate transcript
of the testimony captioned herein.

I further certify that I am neither kin
nor counsel to any of the parties herein, nor
have any interest in the cause named herein.

WITNESS my hand and official seal this the

7th day of October, 2005.

STEVEN RAY GREEN, CCR
CERTIFIED MERIT COURT REPORTER
CERTIFICATE NUMBER: A-2102



Ww

ew

30

DR. WADE: Okay.

DR. MAURO: In fact, we -- maybe we -- fora
moment -- should -- I know you want to go
quickly, so we won't talk about task two.
Let's move on to task three.

Again, task three -~ as you --

DR. ZIEMER: Excuse me.

DR. MAURO: Yes.

DR. ZIEMER: What about case tracking, though,
in the future? What -- why -- is that -- is
that covered under the management task?

DR. MAURO: No -- let's talk about it then.
DR. ZIEMER: Okay.

DR. MAURO: Originally task two set aside
$30,000 for SC&A to prepare a database
management system for tracking cases. Okay?

And we did one, and we delivered it. You have

-it.--iIt was based-on our vision of what we ~~~ ~~

thought a good case tracking system would be.
Okay? And it exists. And it contains a
tremendous amount of capability to do just
about anything you would want to do by way of
sorting -- it's an access database, and we
could populate the -- popul--

DR. ZIEMER: It's not the actual tracking, it's



on)

-

Sr Ly

- $8—

“reports réviéwing those workbooks.

26

DR. MAURO: -- for everything on this list.
Now that list may grow, and then we'll have to
DR. ZIEMER: But it does include some sites
where they have --

DR. MAURO: And it certainly includes sites
that we've already -- site profiles that we've
already reviewed, but we have not reviewed the
workbooks.

DR. MELIUS: Does that -- I mean --

DR. ZIEMER: So it's not just the six work--
six sites in the --

DR. MELIUS: Yeah, that's what I was trying to
get -- try to understand.

DR. MAURO: It's very simple. Here they are.
We're going to review those. And it's going to

cost -- we estimate 2,000 work hours to write

DR. MELIUS: This is a small comment, but for
example, Iowa is listed there. Is there --
like is there really a need to do Iowa, given
our decisions on Iowa?

DR. WADB: I would think, unless it has impact
upon other sites, the answer would be no.

DR. MELIUS: Right.



38
1 over to the next column in Exhibit 1 is the
2 expanded review cycle. This is the process now
3 where we meet with NIOSH and the Board in
4 working group session and we -- we have our
5 checklist, we have our matrix, we go through
6 the matrix. We try to come to closure on
7 issues. That sometimes is an iterative
8 process, so we've set aside some work hours for
9 the expanded review cycle so that we can get as
lo: close as we can to closure, fill in the matrix,
Wo: goes into the database and your -- and as we
12 know right now, for the first set of 20 we're
i3 real close to bringing that one home. That is,
14 I think that NIOSH right now is looking at a
15 few open items that are -- will eventually be
16 closed out. And as I understand it, that makes
7 -- that will be the work product that will be
18 "~~~" ~"~“sent to HHS, heré's what we managed to.
19 accomplish and here's where -- you know, and so
20 a report. And so that's the expanded review
21 cycle to get us to the point where we have
22 completed the matrix -- okay -- the matrix and
230: the checklist that goes with every one of these
24 cases.
25 The -- the last column is -- it's been our



wot

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13
14

15

62

DR. WADE: I would like --

MR. GRIFFON: So I think there are examples,
but I -- I also want to make one point is I
think we need to have this discussion, 'cause
this is a scope discussion, and I don't think
it belongs in the closed --

DR. WADE: I agree with that, so I wanted to
say that. I think -- but I also want to leave
this closed session with the ability to extend
the contract, so I would ask the Board to -- to
consider how it would want to proceed. But I
think we're -- we've gotten far down into the
technical issues and that needs to happen in an
open session.

DR. ZIEMER: But in terms of the closed
session, though, the issue I think would arise,

does it impact on the -- on the assignment of

time and éffort, because if it does -- you —

know, we don't necessarily have to define here
that scope, but if we are going to keep this as
an option, does it impact on the time and
effort issue.

DR. MAURO: The answer would be, if I were
redoing this now, in light of this

conversation, I would probably say let's assume



we ot

+

ee ey

19
20
2

22

80

DR. ZIEMER: And I think --

DR. MAURO: You just described something --
DR. ZIEMER: -- when we wrote this original
scope thing, we were thinking about the extent
to which you could help us --

DR. MAURO: Yeah.

DR. ZIEMER: -- develop our own procedures. I
mean --

DR. MAURO: I missed the boat. Okay? I did
not write that -- that's not the proposal I
wrote.

DR. ZIEMER: Well, I'm asking. That seemed to
me that we had talked about that and can --
DR. MELIUS: Yeah, but to me it's the same --
they're so closely --

DR. ZIEMER: We're intertwined.

DR. MELIUS: -- interconnected, it doesn't --

“DR. ZIEMER: “We're intertwined, because when we

talk about us reviewing -- say a site profile -
- relative to an SEC petition, we're asking you
to do it. But we may have to have some
internal rules that are Board rules.

DR. MELIUS: Or we may only ask SC&A to focus
on a particular aspect of what we have to

evaluate as a Board.



v

CO MN DH ew

32

that document is an expression of that
particular database that she's developed, and
it really is part of task four now.

DR. MAURO: Okay, let's move on now to task
three, which is procedures. And it's good to
think in terms of generic -- okay? -- in terms
of procedures, as opposed to site-specific.
What I've -- what I've done here is say okay,
there -- first of all, we're going to have to
go through the closeout process. That is --
right now -- a matrix is being put together.
We talked about it. We have resources right
now that we're using and have available to us
to continue to work on that matrix. We have
the resources necessary to meet with NIOSH and
go through the closeout process in an

unencumbered way, so we have the resources to

move right through the month of September right

into October.

But we believe that process is going to
continue, and continue in terms of closing out
the issues that we're going to be discussing
that are reflected in our task three report,
but there also -- so there is an expanded re--

what I call the expanded review. That's what I



iP)

oO OND NH we ow

is
i5
16
7

98

guess they are. We do have -- there's a kind
of buffer in the system, because everything
that comes to us has to go through the folks
that are here. And so -- and you know, I look
at John Mauro, look at Arjun, at Joe
Fitzgerald, at Hans, and anything that comes to
us has to pass muster with them, regardless of
where it generates in their system.

Henry.

DR. ANDERSON:

DR. ZIBMER: Well, thanks, Henry.

_——_—____]& ______________DR..__ANDERSON:—_And_I'm not—a—— you-know;—a—~-—

19
20



13

i could come back with a smaller or a bigger

w

number. I worry about a smaller number and how

3 that might inform this discussion. I don't

4 think that's a likelihood, but we have to

5 prepare for that. Congress has also a history

6 of allocating monies, appropriating monies, and

7 then doing across-the-board rescissions, and we

8 need to understand that that's a possibility.

9 So we need to be flexible as we go through the

10 year. I just don't want to be in a position

Vl where we are not able to keep your contractor

12 working on October ist. There are too many

13 issues hanging of importance here for us.

14 So those are numbers that you can consider. I

15 had those numbers in mind as we tasked -- David

16 and I tasked the contractor.

17 David, is there anything you would like to say
- -H~-—------—- ~~ about “actions following this meeting and what

19 needs to happen for you to have a contract in

20 Place for next fiscal year?

21 MR. STAUDT: (Via telephone) I just want to say

22 that the task one, three and four we will

23 probably act on in October and issue funding in

24 October. The one that will probably need to be

25 funded soon will be the ones for the SC&A (sic)



81

1 DR. WADE: I think it is the same.

2 DR. MELIUS: Yeah, so -- I -- I actually raised

3 this question when I first saw this proposal

4 and I was confused, also. I --

5 DR. ZIEMER: I want to make sure that the

6 contractor understands that -- that it -- and

7 maybe they are sort of the same, but we -- we

8 have to have some framework under which we

9 proceed with you.

10 DR. MAURO: Yeah.

W DR. MELIUS: Yeah.

12 DR. MAURO: I suspect there is probably a delta

13 between the procedures that we were thinking in

14 terms of writing on your behalf to review the

15 technical merits of an application and -- et

16 cetera, and the issues. And -- but there may

17 be higher level questions that you folks have
78 -—- ———to-come to grips with that 22 ~ _

19 DR. ZIEMER: Oh, yes, yes.

20 DR. MAURO: -- that we -- we -- and that you

21 will need some type of framework within which

22 to make those decisions.

23 DR. ZIEMER: Right.

24 DR. MAURO: I have to say, when we sat down and

25 wrote this we were not thinking within that



87

1 DR. ZIEMER: Right. And you know in the past

Ww

I've -- I've been concerned that in a sense

it's costing us money to have our contractor go

we

4 up to the Hill periodically. In essence, if

3 this is in the budget and it's a budget that

6 the Hill is providing, then they are providing
7 the resources to do that, so I think that's

8 appropriate ‘cause -- ‘cause we are going to,
9 in any event, keep the Hill apprised. They --
10 it is a kind of prerogative we have to honor,

W and this does provide some resources to do

12 that.

13 The issue of us accompanying and so on, we'il

14 handle in the open session. Jim?

15 DR. MELIUS: And I would just add that

16 approving this task or the budget for this

7 task, you know, is -- it will be -- they'll
ABS en HET “against it and it depends” onthe number of ————

19 meetings and so forth and however it's decided

20 to proceed, so I don't think what we decide

21 later should affect what we're doing here now.

22 DR. ZIEMER: All right. Any other questions on

23 this one?

24 (No responses)

25 Okay. Thank you.



ie)

we

a

a 2

closed session.

As can happen in these sessions, we might want
to get into some issues that are related. I
think -- I'll stop you or counsel will stop us
and remind us if we're going too far. We can
reserve those issues for open discussion
certainly.

I would think when we come back into open
session we would report out on any
accomplishments that we've realized during
this, and I hope there will be many to report.
I would also say to the record as we begin this
that I am the technical project officer for the
SC&A contract. David Staudt is the contracting
officer. He's the one who the money flows
through. He's the one who actually makes the

decisions.

- From-my~rolé as” technical project officer, I've

been very pleased with the performance and
responsiveness of your contractor. I can only
Say positive things about their efforts and
would want to be on the record speaking to
that.

I've sent you many things in the last weeks,

but the thing that I'm going to sort of put you



ee

00

85

who wrote the procedures that -- all the
conflict of interest, quality assurance
procedures that you folks have before you in
your files, so I -- I allocated some work hours
for him to continue in that mode and continue
that kind of support.

So the bot-- and that's how we came to the
scope of work that -- and it's 1,584 work
hours, program management oversight.

DR. WADE: Thank you, John.

DR. ZIEMER: Okay. Jim, then Wanda.

DR. MELIUS: No, actually do Wanda first. I'm
DR. ZIEMER: Wanda.

DR. MELIUS: -- I'm going to stand prepared to
disagree with her.

DR. ZIEMER: Wanda?

"~~~ "MSs" MUNNI-Hé knew as Soon as it went up.

DR. MELIUS: I saw when it went up.

MS. MUNN: Yeah. Although I have -- the amount
of funding seems to be appropriate, there is an
issue which the Board needs to address outside
of this purview with respect to the interaction
with folks on the Hill, and others, not just

that one, that I wanted to make doubly certain



w

ww

96

DR. WADE: Well, let's -~ I think, David, let's

get the sense of the Board. I mean I think

4 what Jim suggests is --

5 MR. STAUDT: Yes.

6 DR. WADE: I mean I'm aware of the issue. I

7 think I need to get a sense of the Board as to

& how you would want us to proceed on this issue.

9 DR. ZIBMER: The other part of this I suppose

10 is based in part on previous --

i : |

12 |
|

13 !
|

4 |

15 MS. MUNN: Yes.

16 DR. ZIEMBR: But again, that's very -- very

17 much subject to individual views. So you know,

8—-——----yeu'ze-—— you" Fe-going-to--—~—youtze-going-te-be————

19 - vont |

20

21

2 ~

23

24

25



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16
17
aa
19
20

64

there a sense at this point?

MS. MUNN: My --

DR. ZIEMER: I have a suggestion in that
regard, since even the number 70 is somewhat
speculative, and we can always change the task
later on, that we simply make it known that we
do want to retain this option; and if we
identify cases where we believe that should
happen, we should do it within this -- within
the scope. There's budget money here to go
quite a ways into the year. If we have to
modify it later, we can.

DR. MAURO: I'd like to add one point. We're
refer--

DR. ZIEMER: I guess we can.

DR. MAURO: We're referring to what we have

been doing as a basic. It's not. It's -- I

We're doing audits --

DR. ZIEMER: Yes.

DR. MAURO: -- on each and every line item.
That was --

DR. ZIEMER: Right.

DR. MAURO: So we -- we really have been doing

this in-between thing.



Pa)

orm Dn Ww

60

a radiological incident ‘cause there was no
record of it, but there should have been a
report from the first aid station on-site that
treated this person, as we now know people do
in fact -- when they get injured on the job, it
is -- there is a record for it. And I was --
and I wrote it up in the report. I said now
this is an unresolved issue. But at this
point, if this was an advanced review, I would
go back and say let's go take a look at the
record. Obviously the infirmary would probably
have a report on this individual. He claims
that there were coworkers who were witness to
this. But again, there was no confirmation to
that effect. And if it turns out that this
incident really did take place, one would have

to look at this a little more carefully and say

-is-this-the- exact location that you-potentially ~~ >

may have been exposed to internally, especially
if it was an introduction of radionuclides into
that area, and it may have been the etiological
factor for your -- or is this
something that you just kind of back-fitted in
order to strengthen your claim. I mean I'm not

going to pass judgment here.



ie)

we

4

22

DR. ZIEMER: Right, it's a new kind of
document.

DR. MAURO: Right, and they merged and became
part of the process as we matured into the
process, and they're becoming more and more
important, especially when we move into
realistic cases.

The third column of numbers is called the
expanded review cycle. This is the -- the area
where it's very -- there's a great deal of
uncertainty. What we basically said was where
we have for next fiscal year six site profiles
we'll do, but we really right now have in the
wings five that we've already done that we
haven't acted on, like Savannah River, Hanford.
My expectation is -- and this what I assumed --
that there will be five left-overs that are

going to ‘be coming
s

ver
And what I said is well, let's set aside 150
work hours per expanded review. So we have 11
-- six for the new ones, five carryovers from
last year -- total of 11, 150 work hours per
expanded review, and that's the basis for the
1,650 work hours. So put -- we are in effect

putting that aside.

into next fiscal year. ~



Si

turn out to be a very complete and thorough
dose reconstruction which obviates the need for
an advanced review. So it's really -- I won't
know until I look at the data before I come to
the conclusion that maybe a more thorough
investigation is warranted here.

DR. MELIUS: Yeah, but it seems to me that
that's arguing for the method by which we
select cases for advanced review, or that we
have -- develop criteria that would -- as one
does a review that would triage cases into an
advanced versus a basic review. But part of
the idea of the audit is for us to, you know,
learn how to do that and -- and to make sure
that, yeah, there's going to be some -- may be
some wasted effort. May turn out that things

shouldn't -- shouldn't be pursued, but I think

"we want to confirm that and confirm at the same

time that, you know, NIOSH or whoever made the
decisions on that made the right decisions. So
I guess I'm -- again, as I say, I'm very
reluctant to...

DR. MAURO: Could I make a suggestion? As a
practical matter, maybe the way to work this

problem is let's envision Hans completes these



know, we don't want to have duplication of

te

effort, certainly. So if you're doing an

55

3 advanced review, we've run into the case of

4 Savannah River where we have findings, but I

5 don't think -- and I would slightly disagree

6 with Hans 'cause I don't think we -- in those

7 first 20 cases we didn't take those Savannah

8 River --

9 DR. MAURO: Although I --

10 MR. GRIFFON: -- to use Jim Neton's term, to

in : ground.

12 DR. MAURO: To ground, sure.

13 MR. GRIFFON: Right?

14 DR. MAURO: That's true.

Ss; MR. GRIFFON: We didn't, we deferred it to the

16 (unintelligible) --

17 DR. MAURO: Defer to the site prof-- exactly
——— - — 18---- - -right.—That’s-where -we--are. a

19 MR. GRIFFON: In an advanced review I would

20 argue that you would, but -- but also, for an

21 operational standpoint, say we got to be

22 reasonable about this, and if we -- if we have

33 a situation where we've got a site profile

24 coming for that site, let's not -- let's not

25 have a dose reconstructor out there doing that



84
1 they need from wherever they have to get them
2 and has been -- so I put in some modest number
3 of work hours so they could continue in that
4 role.
5 House and Senate meetings. As you know, we get
6 a phone call every so often from a
7 Representative or from the Senate or the House,
8 and -- either myself, Arjun or Joe will -- or
9 the three of us go over and meet with these
10 folks and spend two or three hours with them,
WW : so I put -- I put in place 72 work hours for
12 next year to continue to do that kind of thing.
13 It's a modest budget.
14 QA -- the last three items I call QA, conflict
15 of interest and Privacy Act. We have in house
16 our procedures and requirements to make sure
17 everyone that works on this project, every

— 8... contractor that works on this project, fulfills |

19 our QA requirements, our conflict of interest
20 requirements and our Privacy Act requirements.
21 This requires time on the part primarily of
2 Steve Ostrow, who is our manager of these
23 issues. He's -- in fact, he's the one who's
24 putting together right now our Scsa database
25 with all the bio sketches on it. He's the one



is)

tw

17

Okay, the next thing that I would propose,
Paul, is possibly to ask John Mauro to just
very briefly walk us through each of the
proposals.
DR. MAURO: Perhaps the best way to do this is
if you all have the proposals, we could start
with task one, and the best way to do that is
to go to Exhibit 1 in -- for the proposal for
task order one. It's on the third page. I
think that's the best way to identify the scope
and the budget and get an idea what this is all
about .
So if you have Exhibit 1 for task order one in
front of you, you'll notice that what we've
done here is we've been asked throughout the
TORP, task order request for proposal, to
prepare a proposal to do six site profiles for
-—~—next fistal year.” “And thé scope of work, the
way you should look at it is the -- of course
the first column gives the names of the
individuals that will be working on those six
site profile reviews. The second column gives
the work hour allocation that we designated for
doing the six site profile reviews.

You'll notice if you look at the bottom line



te

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- e

59

the question is how to identify such cases and
when to do it.

Wanda.

MS. MUNN: John, do you have any feel, right
off the top of your head -- or Hans -- about --
I'm unaware -- none of the cases that I looked
at were left in such a state that I felt they
should -- personally -- be pursued further. Do
DR. BEHLING: Yeah, let me --

MS. MUNN: -- what's your gut-level feeling?
DR. BEHLING: Yeah, let me give you an example,
and I don't know it's the last -- the third set
or the second set where I had a case where a
person had a .. And he, in
his CATI interview, identified an incident
where he was injured and several years later he

developed,--on-_theexact-location, —

And he is now basically implying that the event

that took place where

., and yet there was no record. And of
course I've -- my first question is -- this
happened probably

and even though it was never considered



PARTICIPANTS

BEHLING, HANS, SC&A
PITZGERALD, JOSEPH, SC&A
HINNEFELD, STUART, NIOSH
HOMOKI-TITUS, LIZ, HHS
HOWELL, EMILY, HHS
LIPSZTEIN, JOYCE, SC&A
MAKHIJANI, ARJUN, SC&A
MAURO, JOHN, SC&A _
NETON, JIM, NIOSH
NUGENT, MARY, GAO
SAMSON, BOB, GAO

STAUDT, DAVID, CDC
TOOHEY, RICHARD, ORAU



w

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76

1,500 concept for SEC petition support, the
actual reviews.

Then fin-- the next step is, we assumed that

4 there will have to be some meetings, working

5 board meetings. Now -- not -- not Board

6 meetings. Any full Board meeting that we have,
7 such as this one, is part of task four -- I'm

8 sorry, task six, which we'll talk about ina

9 minute. But we believe that there's going to
10 be a need for several -- and I think we assumed
W three -- meetings where there's going to be

12 working group meetings, either in Cincinnati or
13 in McLean, so we put in a budget for that, so -
14 - so actually that's what sub-task four is.

1s There's some level of effort required to

16 support working group meetings.

17 And then finally, in accordance with the TORP,
18—-—-— ~~" “we yealizéd that there are going to be

19 circumstances where there will be SEC-related
20 issues where you're not going to want us to

21 review the petition in its entirety, or a NIOSH
2 report in its entirety, but there may be a very
23 narrow issue -- perhaps a particular time frame
24 or a particular technical issue -- that you'd
25 like us to take a look at, like a special



bw ow

Co MYA

31

the system, yeah.

DR. MAURO: No, but the -- what we ended up
really doing under -- and billing it under task
four is Kathy Behling worked very closely with
Mark and prepared the checklist and the matrix
tracking system that was used very effectively
recently in getting through the first set of 20
cases. So ina funny sort of way, I think that
that tracking system, and any other tracking
system that is developed, whether it's in
support of task three, whether it -- or task
one to track issues is going to emerge as part
and parcel of that task, as opposed to task
two, which was I think well-intentioned. The
tool is there. The degree to which we will
eventually use that tool is really uncertain

right now.

for you is a product of that -- I think you

have a four-page document that was made
available, and that's just an example of the
database that she's setting up that she can
instantly sort on who -- which facilities,
which types of cancers, what percentage, et

cetera, et cetera. So what you're seeing in



age

i)
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74

these reviews is going to differ substantially
if, one, there is in place already a TBD. And
not only a TBD, a TBD where SC&A has performed
a review of the TBD. If -- if that turns out
to be our direction, please do a review of an
SEC petition or report dealing with -- let's
say it turns out Hanford. Well, we have a
Hanford TBD, we reviewed Hanford; we're in
great shape, 500 work hours. Okay?

If it turns out, though, that you ask us to do
a review of a petition where there is a TBD but
SC&A has not performed a review of the TBD,
1,000 work hours -- which is very much like the
review of a TBD.

Finally, if you ask us to perform a review of a
petition where there is -- where there is no

TBD and where there -- well, there is no TBD,

“we estimate we would require 1,500 work hours.

So that's how we came at this problem. In
other words, we're coming -- in other words,
we're going to be coming at it naked. We're
going to have to look at all the records
without the benefit of there being a TBD.

We were asked to price out a TORP whereby there

were five SEC petition reviews that have a TBD,



wo

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67

and how we want to proceed with these reviews,
and that should include an evaluation of what's
gone on to date in this context.

DR. WADE: That's what we'll do then.

MR. GRIFFON: And I would -- I would argue
maybe we should authorize the 20 or 22, but
instead of going (unintelligible) basic or --
er what you're saying is in between, let's do
ten advanced, and then we can evaluate to see
if there's actually any difference or not.
Maybe -- maybe John's on the mark saying we
don't need more of these, but I think maybe we
should do ten on the advanced reviews as a
trial out of those 20, you know --

DR. ZIEMER: Ten out of the -- well, they're
bidding on what, 60?

DR. WADE: Sixty, but --

~~ YR ZIEMER:  They’re bidding on 60.

DR. WADE: We have selected the first 20. We
could proceed with the first 20 as basic. We
could proceed with the first 20 as Mark is
suggesting, ten of each. It's how would the
Board like to proceed.

DR. ZIEMER: There's a suggestion, though, I

think -- conceivably you may have none in that



is)

3
4
5
6
7
8
9
0

24

DR. MELIUS: Can I ask a question?

DR. MAURO: Yeah.

DR. MELIUS: I notice in -- under Exhibit 2
that a number of the site-specific workbooks
have to do with site profiles that are already
in review or have been completed.

DR. MAURO: Right.

DR. MELIUS: Are those -- have you already
reviewed these workbooks or --

DR. MAURO: No.

DR. MELIUS: Are -- is there a plan to -- for
example, Hanford calculation workbook, that's
not been reviewed to date?

DR. MAURO: No. The only time I -- a workbook
has found -- has become reviewed is when Hans
has it available when he's doing a case. In

other -- in order to

- in other words, in

order for him to do a casé, in order for him to”

check a number, and if we find out that there
was in fact a workbook and we could get our
hand on that workbook, then we make use of it.
But workbooks were not reviewed as part of task
one. Okay?

DR. MELIUS: So another vulnerability, so to

speak, would be that in the course of our



is)

2?

23

41

but it wasn't quite an advanced review, either.
In fact, there were two things we didn't do,
otherwise it would -- these all would have been
advanced reviews, and that is we did not
interview anybody. We didn't go to any sites.
And we didn't try to go into rec-- other
records that may be buried away somewhere. So
I would say what we did -- the actual cases
that were reviewed -- we've given it a new
name, a comprehensive review. It really is
midway between the basic and an advanced. We
think it makes more sense for these two aspects
of an advanced review, namely going to the
sites, interviewing people, going to exotic
sources of data -- that's more appropriately
part of the site profile reviews.

To tie up the audit of a case to try to track

individual cases I think is -- you know the
product you've received. You know, you -- we
think that's the product that serves your
purposes. These audit reports, the checklist,
the matrix, I think it works.

To burden that process by saying well, we want

you to take it -- when you do the advanced



Ww

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OD YH WH be

13
14
15
16
17

tg

19
20

21

61

DR. ZIEMER: Yeah, well, generically how
frequently do we -- are we seeing like one per
20 or ten --

DR. BEHLING: Yeah, there've been a few where I
have raised a question --

DR. ZIEMER: So it's not a large number and we
could --

DR. BEHLING: No, it's not a large number.

MR. GRIFFON: I have -- I mean I think there's
-- there's -- I don't know, I mean I don't have
a number, but I'd say seven or eight out of 20,
of the first 20, because we deferred them to
site profile.

DR. ZIEMER: Yeah.

MR. GRIFFON: So -- so right there, you know --
you know, you're saying we stopped with

Savannah River because we said high five -- you

know, it’s likely to be very claimant-
favorable, the -- you know, these are
overestimate techniques, but we had questions
about the validity of the database, et cetera.
But we deferred it. We didn't go any further.
DR. ZIEMER: Right.

MR. GRIFFON: So are there drill-- sure,

there's CATI ones, too. I mean --



27

1 DR. WADE: I think we -- we have to leave that

is)

decision to a more detailed evaluation on your

3 part, but I would see no reason to review Iowa,

4 if Iowa has been dealt with and there is no

5 reason -- there is no impact upon another site.

6 DR. MAURO: That's your -~- if that's your

7 instruction, that's fine.

8 DR. WADE: I'm not giving it as instruction,

9 I'm just presenting it as a logic line.

10 DR. MELIUS: I would also suggest -- and I

W don't think it's resolvable here -- but that we

12 also try to develop a list of what's going to

3 be forthcoming from NIOSH and ORAU in terms of

14 workbooks that -- so that we sort of -- at

15 least terms of scheduling, but also the amount

16 of effort that's going to be involved, we -- we

7 come up with a better estimate. I don't think
—— 18—---— ~-—- -~--¢t--should affect what we do heré;~ but “I think ~~ ~~~

19 in terms of looking at our forward work that I

20 think we need to try to look ahead a little

21 bit.

2? DR. MAURO: I guess -- Hans just reminded me of

23 something that might be relevant here. Let's

24 talk Iowa that's got its SEC. My expectation,

25 though, is there are a number of cancers that



94

vw

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, a a

10 MS. MUNN: As well it should be.
Wo: DR. ZIBMER: weet

15 MR. STAUDT: --

WB — a -— a



we ote

-

14
15
16
17

Oe

19
20

“into that, and --"that, and I am reluctant to

48

Blockson as if I were doing a site profile
during the process of doing a case review, that
becomes an open-ended -- a large job. It
becomes a site profile, which is 1,000 hours,
not 70, so we've got ourselves -- what's the
best way to deal with it. We have our opinion
on how best to deal with it and that's how I
wrote our proposal.

DR. MELIUS: Yeah, I -- I have some serious
concerns about that. I don't think we want to
ask you to repeat work you've done during a
site profile, and I don't recall us telling you
to look for obscure documents and, you know, go
to -- travel around the world and turn over
every stone and try to find every little piece
of information. But I think we did want a

more comprehensive and a little more effort put

change my mind about our -- what we've asked
you to do un-- until you come back to us and
actually show us that it's not an efficient
way, that you're not learning much. I mean the
point with the CATI interviews, I think it's
more than just discrepancies. There's issues

where things just aren't being -- there's a



te

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89

DR. ZIEMER: Okay, let me ask for a motion to
approve tasks one, three, five and six with the
costs as provided by the contractor.

MR. ESPINOSA: So moved.

DR. ZIEMER: Moved by Espinosa. Seconded --
MR. OWENS: Second.

DR. ZIEMER: -- by Owens.

MS. HOMOKI-TITUS: (Off microphone)
(Unintelligible) motion (unintelligible).

DR. ZIEMER: No.

DR. WADE: Wait a minute, I'm about to get
yelled at here.

DR. ZIEMER: We don't -- okay. Counsel has --
we have a procedural issue here.

MS. HOMOKI-TITUS: Since we're in closed
session that was closed for cost issues -

DR. ZIEBMER: Oh, we get -- the motion --

MS. _HOMOKI-TITUS: ~--"your motion should only

be on cost. You --

DR. ZIEMBR: -- can take place --

MS. HOMOKI-TITUS: -- can't do a motion on
scope until you've --

DR. ZIEMER: Gotcha.

MS. HOMOKI-TITUS: -- had that discussion

publicly.



wo

66

proposal sometime --

DR. ZIEMER: Well, let me ask --

DR. MELIUS: -- last week.
DR. ZIEMER: -- David Staudt if he can guide us
on what -- what we need for decision today on

the current document relative to this issue.
David, are you --

MR. STAUDT: Well, I think -- you know, this
all goes to time, as far as when the next Board
will get together and we just want to make sure
that, you know, there's no -- there's no lag
here. So I mean we certainly -- if you want to
just have just the minimum amount of work to
continue and if there needs to be further
discussion, we can add that work later on. I
don't have a problem with that. So if you want

to minimize or limit to what -- what is

authorized t6 move forward for a while on this
task, I'm fine with that.

DR. MELIUS: Then I -- then I would suggest
that we then just authorize whatever it is, the
20 or the 22 --

UNIDENTIFIED: (Off microphone) Basic.

DR. MBLIUS: -- and that we also then schedule

time and so forth to discuss the scoping issue



Ww

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90

DR. WADE: Right, so this is a motion on cost.
DR. ZIEMER: So Liz, the correct motion would
be to approve the costs, as -- as -- do we need
a motion at all in closed session?

MS. HOMOKI-TITUS: You need a motion
(unintelligible) --

DR. WADE: Could I --

DR. ZIEMER: Can the motion --

DR. WADE: -- counsel in public -- I mean we've
closed the meeting to finalize contractor cost
and work scope issues, so to me, we're defining
work scope issues and cost, as they relate.

MS. HOMOKI-TITUS: Right, as they relate, but I
think you all have gone -- had a scope
discussion and you're looking to expand scope -

DR. WADE: No --

~DR.- MELTUS: —No7—we*re- not rn

DR. ZIEMER: No.
DR. WADE: -- no, we're not, we're --

MS. HOMOKI-TITUS: You're not.

DR. WADE: -- not doing that.
DR. ZIEMER: Not on these -- not on these
items.

MS. HOMOKI-TITUS: Okay.



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35

are a lot of new procedures. If you could flip
a little bit, you'll see I have a number of
exhibits. There's Exhibit 1, Exhibit 2,
Exhibit 3 and Exhibit 4, and these exhibits
were downloaded off the web site, the OCAS web
site, as a set of generic procedures and
workbooks. Okay? There's procedures and
workbooks that are alive and well right now.

So what we did was we said okay, since these
are generic we will estimate what it'll cost to
continue our review of procedures and -- but
also add in -- ‘cause these are all new
procedures that have been added since we
originally did our first set of review, which
included about 35 procedures. Also there isa
set of generic --

In fact, if you want to flip toward -- a few

pages in you'll séé Exhibit 4 where you see
workbooks. You'll notice that I broke them up
into two categories. There's the complex-wide
workbooks and the site-specific workbooks. I
put the site-specific workbooks here just as a
piece of information. We're not going to
review the site-specific workbooks as part of

task three. That's going to be part of task



be woiW

w

W

things and -- for example -- well, we'll get
into them each. But there's one -- one for
each of the existing orders and then for task
six there is one, and I believe for task five
there is a separate -- since this is a new
task, a separate document called Technical
Support for the Advisory Board, et cetera. And
then it says task order proposal response
request for proposal Special Exposure Cohort
petition review task order and has some
additional words. And then volume one of that
is the technical proposal and volume two is the
cost proposal. So you should have all of those
documents. I think that's all and we can
proceed.

DR. WADE: Right.

DR. ZIEMER: And Lew, I guess I'll ask you if

you" ==~catl you lead us through this or should
David lead us through this or what -- how shall

we proceed?

DR. WADE: I mean I'll try and lead us through
this. But let me open with some comments about
funding, and I apologize for the murkiness of
my comments, but those of you who've been in

this country for any length of time understand



w

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50

prediction that these cases will all be
advanced reviews based on -- on the discussion
we just had. It's almost up to the individual
case, and we don't know what they may be.

In other words, if I see a dose reconstruction
case in which all of the dosimetry for the
entire employment period is there, that there
was comprehensive bioassay data, and that
everything was done well, you could almost say
why would there be a need for anything other
than be sure that all the numbers jive and all
the things are correct.

Now on the other hand, if I open up a file and
I realize that there are years of employment
for which there are no data, and the person in
the CATI report states that he was certainly

monitored both by -- by -- for external as well

“as bioassay,
review we categorically now raise a question,
is this dose reconstruction complete. And if -
- if there are potential for missing data, then
I should pursue it. But I can't tell that in
advance. In other words, I can't look at a
folder before I look at it and say this will be

an advanced review, because it may very well

“now under the more comprehensive ~



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10

in mind of is this package. It begins with an
e-mail that I -- that involves my communication
to you, and it has a table at the bottom of it
that relates to some funding scenarios that
we'll be talking about. So if you have that in
front of you -- if you don't have that, I can
certainly get copies of that. Copies?

DR. ZIEMER: Okay, this is an e-mail dated
August 19th, and basically the table that was
being referred to lists the six proposed task
orders -- there's four existing ones, a new one
called Special Exposure Cohort and a sixth one
and a new one called Program Management. The
table gives the proposed funding for the next
fiscal year on each of the six tasks, together
with the total funding.

And then, Lew, if I may just add to that, Board

--members” should also thén have the individual

proposals, all of which are -- have a cover
letter from SC&A signed by John Mauro. These
are letters directed to David Staudt, and the
Board is copied on them, and then following
each letter is the proposed work for the
upcoming year for the existing tasks -- gives

the hours and the rates and those kinds of



wot

>

44

there's an argument to be made that that's
important.

The second is that I think some of the stuff we
found in the first phase on the CATI interviews
was not really looked into very far, and I'm
wondering if we're going to lose that aspect of
-- and that wouldn't necessarily come up in a
site profile review.

DR. BEHLING: Yeah, if I were to say anything
at this point that differentiates the basic
from an advanced it's that up to this point in
time we have not gone into anything beyond the
records that are basically supplied to us. I
think in this third set there are instances
where I've looked at it and I said you know,
they made a decision that these records really
don't exist, even though there's a discrepancy
betweén the CATI statement and what is in the
records. And I think this is one area where I
believe we're going to go and take the next
step and said we're going to contact the DOE
people and say are these really -- is this a
case of missing records, or was the person
really not monitored, and hopefully resolve

that open-ended question.



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5
6
7
8
9

23

Now that being said, the actual cost to do the
expanded review and closeout cycle is
unfortunately pretty open-ended, as we've
experienced with Mallinckrodt. Mallinckrodt --
I'm not quite sure where we are right now; I
don't have the numbers ‘cause we're still in it
-- has been a very cost-- costly process. I
expect that's not going to be the case across
the board. But -- so I've set aside 150 work
hours for each expanded review cycle. It may
average out to that, but there's an area where
I'd like to let everyone know that we have some
vulnerability. And as soon as I have -- as we
go through the work and the actuals start
coming in and we start work on Hanford and
Savannah River, as soon as I get an inkling
that wait a minute, I think we've got a
problem, I- will let everyone know right away.
But that really boil-- that's the bottom line

on task one.

DR. WADE: That's fine.

DR. MAURO: Okay?

DR. WADE: Let's move on. We want to try and
finish your comments no later than 2:00, John.

DR. MAURO: Okay, I -- should I --



18

number, what we're saying is it's going to cost

6,200 work hours -- we won't talk dollars right
now. That's -- I think it's -- to get a feel
for -- to do the six site profiles. That

number comes from actuals. Our actual
experience has been, to prepare the ones we've
prepared to date, it costs anywhere between
1,000 and 1,500 work hours of this mix of
people to complete the product that gets out
into your hands before the expanded review
cycle.

In other words, so you get this big book, and
then the expanded review cycle begins. Okay?
So in effect, what we're saying is well, we'll
-- we're probably going to be in that same
pace, so I allocated 6,200 work hours, a little

over 1,000 work hours per site profile, to do

the six.
The next column over you'll -- is a new column.
Here's where the scope of work has expanded,
and this is as a result of the conversation
that we had one of our previous meetings.

We're assuming that we're -- part of the --

part and parcel of a site profile review has

always been review of the Technical Information



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PROCEEDINGS

(IN EXECUTIVE SESSION)
(1:07 p.m.)

DR. ZIEMER: Just for the record, the full
Board is here with the exception of Roy DeHart,
who's on travel in Europe or other Parts of the
world, and Henry Anderson, who's here at the
meeting but is not with us for the first part
of this session. The rest of the Board members
are here, together with our court reporter and
with Dr. Wade, our Designated Federal Official.
And then in addition, we have a number of
individuals from the contractor office, and
perhaps what we should do for the record and
for the court reporter is ask everyone here to

identify by name and affiliation who they are.

John, you can start --

right here, and David, you can --

DR. MAURO: John --

DR. ZIEMER: -- hopefully hear these.

DR. MAURO: John Mauro, Sanford Cohen &
Associates.

DR. WADE: I think that microphone comes out,
John, and you can just pass it around.

DR. BEHLING: Hans Behling, S. Cohen &

John Mauro. will begin...



5:

73

we've set aside 300 work hours to do that --
pretty straightforward.

The second thing we've been asked to do, which
is a little bit more -- I guess -- we -- we --
to write our own procedures. And the way the
Statement of work was written is we're really
writing the procedures that SC&A proposes to
the Board that we use to review either SEC
petitions or NIOSH's review of the SEC
petitions. So they're sort of two different
kinds of things, as I understand it and as I
interpreted the TORP. That is, we will have --
SC&A, on behalf of the Board, will be putting
in place a set of procedures that we recommend
be used to either review an SEC -- SEC petition
ourselves or to review the report that NIOSH

prepares with respect to that petition. So my

-understand-- and -- now -- so that would be
sub-task two. Okay? And we set aside -- what
did I say here -- 240 work hours to prepare

that procedure.

Now the next step is where we will actually --
sub-task three where we actually do the review
of these petitions and/or reports. And what --

what I basically said is the cost to do one of



is)

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28

are not covered by SEC, so there might be dose
reconstructions, there might be procedures,
there might be workbooks that are going to be
put into play for dose reconstructing cases
which fall outside of the cancers that are
include -- so I mean that that would be a

rationale why it might be a good idea to leave

it in. Not that it should be, but --

DR. WADE: I think we should let common sense
guide us through this as we go.

DR. MELIUS: Yeah.

DR. ZIEMER: Okay, proceed.

MR. GRIFFON: I want just to follow up on Jim's
comment that there's a -- and I think you guys
probably reviewed this as part of putting this
package together, but there is a -- on the 0
drive there's -- I think it's on ORAU's

—-— ~——-~controlled documént whatéver that a fairly —-

they keep it fairly up-to-date as far as
current procedures and it -- and it even has
the status, whether they're under review -- you
know, so it sort of gives us an indication of
what's coming up.

DR. MAURO: Yeah.

MR. GRIFFON: And I'm -- I hope you



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14

and the program management. I'm certainly
ready to move on those very quickly, get those
in place before the end of the CDC fiscal year,
which is next Wednesday. So I was hoping for
at the end some overall guidance and I want to
be able to walk away with knowing that if I can
go ahead and take care of the tasks, the new
tasks, this week and early next week, and then
I can just worry about tasks one, three and
four that are already in existence and fund
those the first thing October lst.

DR. WADE: Okay. Just for the record, David,
you did what I did often. You misspoke. You
talked about an SC&A task; I think you meant an
SEC task. The new tasks that we're looking at
are an SEC task and a program management task.

MR. STAUDT: Exactly.

“DR. ~ZIEMER: David or Lew, also, just as a

reference point, could you bring the Board up
to date on where we are on expenditures with
existing tasks. We had originally a set-aside
of around $3 million for what was originally a
five-year plan. But in any event -- and we
recognize how things have changed in the

meantime, but it might be of interest to the



how ot

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33

just described. I put in 340 work hours in the
expectation that in order to complete the
expanded review cycle of the report that we've
already delivered to you, we will -- we will
draw upon the resources that we currently have
left in the -- in the -- on the project, and --
and I've asked for another 340 work hours to
allow that to continue into next fiscal year.
One of the questions I wasn't quite sure of,
and this is more -- a question for David, I
would -- I believe, is that the -- right now
there's a certain number of resources remaining
in task order three to continue to work. When
Septem-- the end of September comes, on many of
the other task order contracts I work with --
other Federal agencies -- that date comes,

that's the end of it. That task order's over.

_~"Tf-there's monéy Ieft in it) Gt dies on the

vine. That money disappears and we start with
the -- you know, the next -- the next task
order, the one we're talking about right now.

Or is that money available to us to carry over

as part of -- in other words, is -- is this
approval -- let's say it is approved -- simply
a -- a mod to our task three, or is this a new



i)

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102

Say geez, within the vast array of things we
look at, you may want to take a little closer

look over here.

4 DR. ZIEMER: Okay. Well, the issue's -- the
3 issue is out there. I think we've heard from
6 the Board. I don't know if we need to pursue
7 it any further at this time.

8

9 . -

“10 We need to vote on -- we have a motion before
iB} us that we can I think proceed on, and the

12 motion is to approve the cost and scope of

13 these -- one, two, three, four -- everything
i4 but task four.

1s All in favor, aye?

16 _

17 All opposed, no?

Bo — _

19 Any abstentions?

20 (Indicating)

21 Okay, then we will report out that --

22 DR. WADE: For the record,

23

24 -

DR. ZIEMER:



95

4 (unintelligible) --

5 DR. ZIEMER: Wanda, do you want to elaborate at
6 all on that issue?

7 MS. MUNN: +

8

9

10 :

14 DR. ZIEMER: Okay. Dr. Melius?
SN; DR. MELIUS:

22 MR. STAUDT:



Board to know where we are on the expenditure
of the original $3 million relative to the
tasks completed so far.

DR. WADE: David, could you do that? You have
the numbers in front of you.

MR. STAUDT: Well, yeah, I could -- you know,
just based off the most recent SC&A invoice
that came in this week, the cumulative that has
been -- that is being billed is $2.394 million
out of what we have authorized them.

DR. ZIEMER: Thank --

MR. STAUDT: And so --

DR. ZIEMER: -- David, we --

MR. STAUDT: -- from a -- how much money you
have over all related to total funding, we've
authorized those -- authorized them $2.975
million, but collectively they've -- they've
billed $2,394 millis6n- 7

DR. WADE: Could you break that out by task,
David?

MR. STAUDT: Yes, I can. Task one to the
dollar is $1,284,035. Task two they've billed
$28,551. Task order three, $195,369. And
finally task order four, $886,163. And that is

on about -- your invoice 19, which is dated



101

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Oo OM YR Ww b&w

13 DR, ZIEMER: -

So: DR. MAURO: --

17 DR. ZIEMER: Yeah.

__ 18___________pr,-magre:——--—— -
19
20



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69

-- I just...

DR. WADE: Okay. Okay, so we need to move on
to the next tab. I would propose that we -- we
have two options. We suspend work on dose
reconstruction reviews, or we task them to do
20 basic reviews to start the year, with a more
detailed discussion and proposals at our next
meeting.

DR. ZIEMER: Bob?

MR. PRESLEY: I would like to see us do our 20
basic reviews and see how much we spend on that
before we start asking them to do more. Let's
see -- let's see what it costs to do the basic.
DR. ZIEMER: Now let -- let me clarify here.
When we talk basic, we're asking the contractor
to back away from the present methodology which
they're calling -- what, intermediate or --

DR. MAURO: “Compréhensive. = =
DR. ZIBMER: Comprehensive?

MR. GRIFFON: I mean I would still argue for
the ten and ten, proceed -- I still -- I want
to move with dose reconstruction, certainly. I
don't want to stall on that. I would say stick
with our current scope, and if they find that

that's -- you know, we'll -- we'll see what



we

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75

5,000 work hours, and -- about 5,000 work
hours. I'm using -- there's actually a range
I've used here. And one where we're coming at

it what I call naked, where there is no TBD,
and that's the 1,500 -- approximately 1,500
work hours.

So this is how we came to our cost and -- with
that general starting point. Now what happened
was, during negotiations -- there was a certain
degree of negotiations on the cost and so forth
-- we -- we reworked our numbers and it came

down a bit. That's why the number's a little

lower. So we are -- in fact, I don't know if
you're -- we went through a process where we
submitted to David Staudt a -- and Lew, and I

believe perhaps all the Board members, I'm not

sure if you received the original proposal, but

then there was a negotiation process where we
discussed -- where some of the scope was cut
back in terms of the number of -- of TBDs. I
think it went down from -- there was a previous
number that came down to six. But in any
event, there was a process and -- but as a
general rule of thumb, for the purpose of --

when we cost this, we went with the 500, 1,000,



~-—~“in’ task thrée as procedurés réview?

20

what we believe the -- they -- are the current
workbooks, spreadsheets, that are being used.
So our review of each site profile now will
include a review of the applicable workbooks.
And I've broken that out separately, as a
separate item, since it's a new item. And
basically to review those list, which is about
20 of these right -- 19, I estimated about
2,000 work hours, or about 100 work hours per
workbook.

DR. ZIEMER: John, I want to ask you a question
on that, and maybe ask David, also, this
question. The review of the workbooks, in a
sense, is a kind of procedures review. And is
it easier or does it make more sense to keep it
here as part of the site profile review as

opposed to separating it out and including it

DR. MAURO: Yeah, I think it's important --
DR. ZIEMER: It gets probably commingled with
the site in a way that's probably harder to
track separately. Right?

DR. MAURO: Yeah, it's critical that we link
the -- see, in -- in effect the TIBs, the site

profile and the workbooks, they're all the same



w

103

DR. ZIEMER: Okay, thank you. I missed that, I

3 -- sorry, one abstention. So we've approved

4 those tasks and scopes.

3 We will take action at -- hopefully in the

6 October meeting on the scope and task of the

7 individual dose reconstruction reviews. In the
8 meantime, it's our understanding that they are

9 able to continue over the next month or

10 ; whatever it is -- month and a half -~-- under the
iW existing funds.

12 DR. WADB: That's right. I would like to see
13 us have some discussion in the open session as
14 to what we might want to see in October from

15 the contractor so we can make sure we have the
16 right material, but that needs to happen in

17 open session.
—18 F'm-sorry to have-pushed so hard; but we needed
19 to -- to stick to task and we needed to get

20 some things done.

21 DR. ZIEMER: Right. And does that -- David,

2 are -- David Staudt, are you okay now on where
23 we stand?

24 MR. STAUDT: Absolutely.

25 DR. ZIEMER: Okay. Thank you very much for



25

resolution of comments on the Hanford site
profile, for example, we're going to get into
these Hanford workbooks, and you may very well
-- you know, you and your staff spend time
reviewing them, that's not been included in
these calculations -- estimates.

DR. MAURO: The --

DR. MELIUS: The time on the Hanford workbooks,
‘cause those are things that were in last --
MR. GRIFFON: In the last --

DR. MELIUS: -- round.

DR. ZIEMER: The question is, do these site-
specific workbook times simply reflect the six
new reviews, or do they also include the ones
that have to be done from the previous site.
DR. MAURO: Oh, the -- I'll answer the question
in a simpler way. New work for next fiscal
year that we've includéd under task one is the
review of these workbooks. That has not been
done yet.

DR. ZIEMER: That's the 2,000 hours that you've
billed.

DR. MAURO: That's -- and we're going to bill -
- we expect to bill 2,000 work hours --

DR. ZIEMER: For everything on the list.



ie)

we

4 DR. ZIEMER: And as a practical matter, if you
5 -~- take worst case, you have all six teams

6 deciding that all three of their cases should

7 have an advanced review and suddenly you have

8 20 advanced reviews. So we would have to have
9 a well-defined procedure for making the

10 decision. :

W Robert.

12 MR. PRESLEY: Point well taken. I -- I won't
13 keep on on it. This is something that the full
14 Board needs to take up and not just a three-

15 person committee.

16 DR. ZIEMER: Further discussion on that point,
7 er shall we proceed? I think we're aware of
18 --—--~—_ — the issue. We may need to address it in some
19 way by specifying either numbers of cases that
20 -- or the parameters under which such a case

21 would move into that category.

22 MR. GRIFFON: I -- I also think maybe we -- you
23 know, from an operational standpoint -- we've
24 al-- we've already run into some of these

25 questions where -- and I -- I don't want -- you

54

authorized for the contractor to go outside the
communication lines between themselves and

NIOSH, I'd hesitate to agree to that.



to

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i ee

DR. ZIEMER:

Okay.

Gen Roessler.

99



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37

our work product to you in the month of
September. And then of course we have the next
set of 60. One -- now we -- the way I broke
out the cost was what is it going to cost to do
each review. And we looked at our actual
experience. Originally we said it would cost
about 50 work hours, on average, per -- this
one goes right back to our original proposal --
about 50 work hours per case review.

In reality, we experienced something closer to
100 work hours. I think -- we know -- we don't
need 100 work hours. We need something in
between. So I estimated that it's going to
take about 70 work hours to deliver the
product.

Now remember, the delivering of the product is
not -- has a lot of fine structure. Once Hans'
team puts together thé big book, then we have
that conference call, and then we get feedback.
And then once we -- then we deliver the report
really officially. After we have our
conference call with the individual teams, as
we just designated before. Then the report
goes out to the Board, everybody, and NIOSH.

Then we go over to -- and -- and then we go



()

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4

~~ are-a-procedure ct

21

thing.

DR. ZIBMER: Yeah.

DR. MAURO: The reality is, the workbook really
is the tool that's going to implement -- and
it's not generic. The workbooks that I listed
here are specific to a site, so you really
don't want to put the site-specific workbooks
into task three. You want to keep it right
here. That's where it makes sense.

DR. ZIEMER: I just want to make sure that
everybody's okay on that, and I think for the
contracting officer -- although this is a
procedure review, it is so integrally tied in
with the site that it would be most difficult
to track it as a -- even track the time
separately, it would seem to me.

DR. MAURO: To a large extent, even the TBDs

DR. WADE: And I raised the question with David
when it first came up, and David did not see
this as an expansion of the scope of this task.
So I think we're within the scope of the task.
DR. MAURO: I could understand that -- bear in
mind, however, that the -- when we began there

were no workbooks. They be--



rn)

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65

DR. ZIEMER: Right, understood.

DR. MAURO: We're real cl-- in fact, I would
say we're closer to an advanced than we are to
a basic.

DR. ZIEMER: Right.

DR. WADE: Let's hear from --

DR. MAURO: That's what we've actually been
doing.

DR. WADE: We really have to keep to task.

Jim?

DR. MELIUS: Yeah, and that's my concern here
is we -- we are being asked to approve
something that's a significant change in scope.
And I mean I don't think we should do that
without a more complete discussion, and I worry
-- I mean worry that we're doing it at -- under

the pressure of trying to get a cost proposal

~~“approved, but for a scope that we've never

discussed in open session, that we've never
really sort of evaluated and thought about what
our options are. And I'm not sure what we're
approving, and I real-- I don't think that's
fair to the -- the process and so forth. And
for this to come up at -- I mean I noticed it

when I read the proposal, but we all got the



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CO DW te

Associates.

DR. MAKHIJANI: Arjun Makhijani, SC&sA.

DR. LIPSZTEIN: Joyce Lipsztein. I'm working
for SC&A.

MR. FITZGERALD: Joe Fitzgerald, SC&A team.
MR. SAMSON: Bob Samson, GAO, Washington
office.

MS. NUGENT: Mary Nugent, GAO, Chicago office.
MS. HOMOKI-TITUS: Liz Homoki-Titus with Health
and Human Services.

MS. HOWELL: Emily Howell, Health and Human
Services.

MR. HINNEFELD: Stu Hinnefeld, NIOSH/OCAS.

DR. ZIEMER: Okay, thank you. I mentioned all
the Board members. Actually just joining us
here is Mike Gibson. I overlooked Mike, but

he's with us now. So we can proceed, I --

‘DR. WADEY “Maybé I should wake a brief comment.

Again, this is the closed portion of the
meeting. It'll proceed from 1:00 p.m. to 3:00
p-m. The closed portion of the meeting will
involve a review with discussion of the
finalization of contractor -- read SC&A -- cost
and scope of work issues for the next fiscal

year. That's all we'll talk about in the



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7
8
9

97

system, I think.

Is that a fair statement, I --

MS. MUNN: That's a fair statement.

DR. ZIEMER: Yes.

MR. GIBSON: I'd just like to state, in
response to that -- I would say 95 percent of
the claimants probably think that this system's
flawed because of the people doing the dose
reconstructions came out of this DOR work, too.
DR. ZIEMER: Yes, that's a fair statement. Yes
-- and Leon.

MR. OWENS: Dr. Ziemer, I'm in full support of
SC&A. I think they've done an excellent job as
our contractor. I do not question any of the
individuals that are part of the team that have
brought us this top quality work. [I think that

the Board itself is made up of not just

technical persons;—but—atso-those that-have——-———

represented labor, and if that is one of the
prerequisites for conflict of interest, then I
think there are probably several of us that --
around this table that would be conflicted.
DR. ZIEMBR: Yeah. And actually it's -- it's
probably -- I don't know if our contractor is

considered fully a technical contractor, I



we ote

be

SR <a

42

reviews, we'd like you to, you know, go into
all of these other remote sources of records,
go track them down, find out and turn over
every rock, perhaps make some site visits -- in
our opinion, this is our recommendation to you
-- we believe that aspect of the advanced
review is more appropriately part of a site
profile review, not part of an audit. So
that's what we propose.

So the idea of an advanced versus basic, we're
saying let's put in -- that into the past and
call this thing a comprehensive review, and it
will be the review that you folks have been
experiencing right along the -- the way.

DR. ZIBMER: There is another aspect of the
advanced, and that is the -- not having in

advance the end product that NIOSH got. It was

=="you gét the Same résult as NIOSH. In other
words, you don't know the POC or the doses.

DR. MAURO: Ah, you're bringing up something --
a topic we haven't talked about yet.

DR. ZIEMER: (Off microphone) That's a blind
(unintelligible).

DR. MAURO: We haven't done any -- we haven't

done any blind dose reconstructions yet.



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10
i

13
4
15
16
17

104

being with us today.

I think that completes our business then, does
it not? Okay, then we will recess and have a
break before we go back to open session. Thank
you all very much.

MR. STAUDT: Thank you, Dr. Ziemer.

DR. WADE: Thank you, David. I'll talk to you
later.

(Whereupon, the Executive Session concluded at

2:55 p.m.)



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45

MR. GRIFFON: That -- that was mainly what --
yeah, I agree.

DR. MAURO: Okay.

DR. MELIUS: Well, I'm confused then because
what -- what are you going to do I guess is the
question.

DR. MAURO: We have a contradiction here, and
you -- you're right, we have a contradiction.
DR. ZIEMER: What you've ended up with you've
indicated is probably more than we originally
thought the basic review would be --

DR. MAURO: Absolutely.

DR. ZIEMER: -- but not quite what an advanced
would be.

DR. MAURO: I'11 give you an example. As Hans

just pointed out, we -- we read a CATI and we
find out that there -- there's certain
----~—information wheré --"wheré there's a need to do

a coworker investigation. Okay? Let's say --
geez, there's some information here that sounds
like it'd be worth finding out more. What
we've been doing is pointing that out as a
finding and leaving it really up to NIOSH to
achieve closure on that.

Now alternatively, one could argue oh, no, no,