THE U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
 

PUBLIC HEALTH SERVICE
 

CENTERS FOR DISEASE CONTROL AND PREVENTION
 

NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND HEALTH
 

convenes the
 

ADVISORY BOARD ON
 

RADIATION AND WORKER HEALTH
 

The verbatim transcript of the Meeting of the
 

Advisory Board on Radiation and Worker Health held
 

at The Westin Cincinnati, 21 East Fifth Street,
 

Cincinnati, Ohio, on March 7, 2003.
 

NANCY LEE & ASSOCIATES 

Certified Verbatim Reporters


P. O. Box 451196
 

Atlanta, Georgia 31145-9196
 

(404) 315-8305
 
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C O N T E N T S
 

March 7, 2003
 

REGISTRATION AND WELCOME
 

Dr. Paul Ziemer, Chair. . . . . . . . . . . . . . . . . 7


Mr. Larry Elliott, Executive Secretary . . . . . . . . .9
 

SPECIAL EXPOSURE COHORT - NOTICE OF PROPOSED RULE MAKING
 

Mr. Ted Katz. . . . . . . . . . . . . . . . . . . . . .12
 

DOSE RECONSTRUCTION REVIEW PROCESS WORKGROUP
 

Mr. Mark Griffon, Workgroup Chair .......... 60
 

BOARD DISCUSSION/WORK SESSION SPECIAL EXPOSURE COHORT - NPRM


. . . . . . . . . . . . . . . . . . . . . . . . . . . .82 


PUBLIC COMMENT PERIOD. . . . . . . . . . . . . . . . . . 153 


BOARD DISCUSSION/WORK SESSION SPECIAL EXPOSURE COHORT - NPRM


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ADJOURN. . . . . . . . . . . . . . . . . . . . . . . . .286
 

COURT REPORTER'S CERTIFICATION. . . . . . . . . . . . . 287
 
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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.
 

In the following transcript (sic) denotes an incorrect
 

usage or pronunciation of a word which is transcribed in its
 

original form as reported.
 

In the following transcript (phonetically) indicates a
 

phonetic spelling of the word if no confirmation of the
 

correct spelling is available.
 

In the following transcript "uh-huh" represents an
 

affirmative response, and "uh-uh" represents a negative
 

response.
 

In the following transcript "*" denotes a spelling
 

based on phonetics, without reference available.
 

In the following transcript (inaudible) signifies
 

speaker failure, usually failure to use a microphone.
 
 

 

4 

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

(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
 

ELLIOTT, Larry J.


Director, Office of Compensation Analysis and Support


National Institute for Occupational Safety and Health


Centers for Disease Control and Prevention
 

Cincinnati, Ohio
 

MEMBERSHIP
 

ANDERSON, Henry A., M.D.


Chief Medical Officer
 

Occupational and Environmental Health


Wisconsin Division of Public Health
 

Madison, Wisconsin 


ANDRADE, Antonio, Ph.D.


Group Leader


Radiation Protection Services Group


Los Alamos National Laboratory


Los Alamos, New Mexico
 

DeHART, Roy Lynch, M.D., M.P.H.


Director
 

The Vanderbilt Center for Occupational and Environmental


Medicine
 

Professor of Medicine
 

Nashville, Tennessee
 

ESPINOSA, Richard Lee


Sheet Metal Workers Union Local #49
 

Johnson Controls
 

Los Alamos National Laboratory


Espanola, New Mexico
 
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GIBSON, Michael H.


President
 

Paper, Allied-Industrial, Chemical, and Energy Union


Local 5-4200
 

Miamisburg, Ohio
 

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 L. (via telephone)


President
 

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
 

AGENDA SPEAKERS
 

Mr. Ted Katz, Special Exposure Cohort
 

Mr. Mark Griffon, Workgroup Chair
 

STAFF/VENDORS
 

CORI HOMER, Committee Management Specialist, NIOSH


STEVEN RAY GREEN, Certified Merit Court Reporter


KRISTIN JONES, Writer/Editor
 
6 

AUDIENCE PARTICIPANTS
 

Brock, Denise


Cofelt, Evelyn


Darnell, Peter


DeHart, Julia


DiMuzio, Martha


Fowee, Steven R


Henshaw, Russ


Herbert, Nichole


Hinnefeld, Stu


Homoki-Titus, Liz


Jones, Kristin Clark


Katz, Ted


Kotsch, Jeffrey L


McGowan, William J


Miller, Richard


Naimon, David


Neton, Jim


Presley, Louise S


Rolfes, Mark


Rutherford, LaVon


Sundin, David


Tabor, Bob


Taulbee, Tim


Tomes, Thomas


Toohey, R E


Toufexis, Rose


Ziemer, Marilyn
 
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P R O C E E D I N G S
 

8:30 a.m.
 

REGISTRATION AND WELCOME
 

DR. ZIEMER: Good morning, everyone. I'm going
 

to call the meeting to order. This is the twelfth
 

meeting of the Advisory Board for Radiation and
 

Worker Health. My name is Paul Ziemer, Chairman of
 

the Board. The Board members are before me here at
 

the table. We don't normally introduce them
 

individually. They do have placards in front of
 

them to help them remember who they are and to help
 

you identify them, as well.
 

We remind all of you, Board members, visitors,
 

Federal staff members, we would like to ask you to
 

be sure to register your attendance here today. The
 

registration book is just outside the door in the
 

corridor, so if you've not already done that, please
 

register your attendance with us here today.
 

Also members of the public who are interested
 

in making comment during the public comment period,
 

we ask that you sign up on the book that's so
 

designated so that we have some idea of the numbers
 

of individuals that wish to make public comment.
 

I would like to point out to you that it is my
 

intent to alter the agenda somewhat with respect to
 

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the public comment period. Incidentally, if you
 

don't have an agenda, there are copies of the
 

agenda, as well as other relevant materials, on the
 

table -- is that the table in the corridor, as well?
 

Yes. Or at the back of the room. Please pick up an
 

agenda if you don't have one.
 

We show on the agenda the public comment period
 

at the end of the meeting, but it occurred to me
 

that it would be beneficial to the Board to receive
 

public comments on the issue that's before us today
 

before we ended our deliberations, so it's my intent
 

to move the public comment period up to mid-day at
 

the 1:30 hour, which is when we reconvene after
 

lunch. So unless there are objections from either
 

the Board or members of the public who wanted to
 

comment, I will declare that that will be when we
 

have our public comment period.
 

Let the record show that all of the Board
 

members are present with the exception of Leon
 

Owens, and Leon -- sorry, could not be here in
 

person, but he's on the line. Leon, can you hear
 

us?
 

MR. OWENS: Yes, sir, I can, Dr. Ziemer. Thank
 

you.
 

DR. ZIEMER: Great, we can hear you very well,
 

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as well. Thank you.
 

One important piece of information is that the
 

restroom code -- you have to have a code to get in
 

the restroom -- the restroom code is posted on the
 

wall in the back by that house phone, so you can
 

check the code and then use the facilities, which
 

are down the hall going out the door to the right.
 

The focus of this meeting will be on the notice
 

of proposed rulemaking dealing with the Special
 

Exposure Cohort. That will be the primary focus.
 

We have at least one other item that will come
 

before us as we move along, but that will be our
 

primary focus today as we proceed.
 

Now I'd like to turn the mike over to Larry
 

Elliott for a few preliminary comments.
 

MR. ELLIOTT: While Dr. Ziemer's moving back to
 

his chair at the table, I'd like to welcome you all
 

to Cincinnati. It's nice to see you again. It
 

seems like we're meeting on a monthly basis. This
 

meeting will curtail that and we can jump to May.
 

We'll have two months perhaps between meetings, at
 

least for this -- the next one.
 

I appreciate you coming to town today for this
 

one-day meeting to discuss the notice of proposed
 

rulemaking on the petitioning process for adding
 

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classes to the Special Exposure Cohort. This has
 

been a long time in coming, I know. We are pleased
 

that it's finally here. We look forward to your
 

comments. We, as you know, produced a proposed rule
 

last summer and this rule that you have before you
 

today -- which is being published today by the
 

Federal Register, will be open for public comment
 

for 30 days hence -- is an outgrowth of the comments
 

that we received on the proposed rule last summer.
 

Because of the public comments that we received on
 

that rule last summer and the changes that we made
 

in addressing those comments, we are bound to come
 

out with a notice of proposed rulemaking rather than
 

finalize that rule from last summer. Had we done
 

so, had we finalized the rule last summer, we felt
 

it would have been unfair. This is totally a new
 

look to this rule. So that's the explanation on why
 

you have a notice of proposed rulemaking before you.
 

We're here today, Ted -- Ted Katz is here today
 

to give you a presentation on this new rule. He
 

will talk about how it is changed from the previous
 

rule. We will provide clarification for you. We
 

are not here to provide interpretation of intent in
 

the rule.
 

Okay. I think, unless there's questions for
 

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me, we have Ted up at the podium and I'll turn it
 

back over to Dr. Ziemer in case he has any further
 

opening remarks.
 

DR. ZIEMER: Thank you, Larry, and certainly
 

we're happy that the rule is in our hands in time
 

for the meeting. It would have been very difficult
 

to have this meeting on rulemaking without the rule,
 

or the proposed rule.
 

Let me ask a question. Are copies of the draft
 

available for the public on the table at this point
 

or is it dependent on its actual appearance in the
 

Federal Register today?
 

MR. ELLIOTT: No, there are copies of the
 

proposed rule on the table in the back.
 

DR. ZIEMER: Okay.
 

MR. ELLIOTT: It is in a format that is
 

different than what the Federal Register format will
 

be. Once it's published today, we will have on our
 

web site a Federal Register formatted copy, so we'll
 

put that up. It's probably going up this morning,
 

as we speak. And then upon request, anybody that
 

wants a Federal Register formatted copy, we will
 

provide that hard copy to anyone who lets us know
 

they'd like such.
 

DR. ZIEMER: Thank you. Ted, please proceed.
 

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SPECIAL EXPOSURE COHORT - NOTICE OF PROPOSED RULE MAKING
 

MR. KATZ: Thank you, Dr. Ziemer. Can you hear
 

me? Is this -- is this working?
 

DR. ZIEMER: Should be, yes.
 

MR. KATZ: Okay. I'm going to run through the
 

major elements of the rule and give you the context
 

for them, too -- meaning the sort of public comments
 

we received, what the Board has said about these, et
 

cetera. And then later today, when you get to the
 

point where you're going -- if you're going to do
 

this the way you've done the other rules in this
 

previously, if you're going to go section by section
 

in reviewing the rule, I would be happy to, if you
 

want me to, section by section explain what changed
 

and why. I'm not going to cover every little change
 

in the presentation I give now, but I can hit
 

actually every substantive change when we do that
 

section by section so you're sure that you recognize
 

everything that has been altered in this rule and
 

why.
 

So let me begin just with a reminder of -­

sorry about that.
 

Just to begin, a reminder that the two
 

statutory criteria that we're to abide by in
 

considering additions to the class here. One is
 

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that it's not feasible to estimate with sufficient
 

accuracy the radiation doses that the class
 

received. And secondly, that there's a reasonable
 

likelihood that such radiation dose may have
 

endangered the health of the members of the class.
 

So that is binding for us in what we propose in this
 

rule.
 

Now in the first NPRM we said in the preamble
 

that evaluating feasibility is not amenable to
 

discrete litmus-type tests. That's still true.
 

That's still true. You will not see in this rule a
 

formula for deciding whether a class is to be added
 

or not, and that it requires instead situation-


specific determinations which would be reviewed by
 

the petitioners, HHS and the Board. Again you'll
 

see this is true.
 

And we also said that whenever we can estimate
 

-- speaking of feasibility -- doses, our methods
 

will provide that such estimates will be
 

sufficiently accurate to support the fair
 

adjudication of claims.
 

And as you recall, what that means -- when you
 

think about how we do dose reconstructions, it means
 

if we don't have sufficient personnel monitoring
 

data and are pushed back to more limited data, as
 

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far back even to just information on the source term
 

and the processes involved, as we get pushed back
 

from specific to more general data, the benefit of
 

the doubt balloons in the favor of the claimant,
 

which is why we're in a position to be able to say
 

that we're not going to underestimate individual's
 

doses as that information becomes more general.
 

Now the Board gave us advice about feasibility.
 

It asked us to clarify in the preamble the criteria
 

for determining that it was not possible to complete
 

a dose reconstruction with sufficient accuracy.
 

What was in the preamble, you may recall, was
 

basically just a statement in effect that if there
 

isn't sufficient -- if there isn't sufficient
 

information to do a dose reconstruction, then we
 

cannot estimate with sufficient accuracy. We've
 

done better in this rule to clarify what that means.
 

And the Board also suggested we develop
 

operational guidelines outlining criteria, including
 

time limits, to address this issue of feasibility.
 

I'm just going to give you a sample, without
 

comment, of the public comments suggesting when
 

doses cannot be estimated. And these are -- they
 

range really enormously in terms of understanding
 

and perspective here from records are incomplete,
 

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only coworker data available -- when only coworker
 

data are available; in other words, you can't
 

estimate doses -- when the identify of the source
 

terms or solubility of energy is uncertain, when
 

records are falsified, when workers were employed in
 

multiple locations, when NIOSH cannot establish an
 

upper bound on the dose, when dose reconstructions
 

exceed a time limit. It's a pretty good
 

representation of the comments we received.
 

Now here's the proposal that we have now, how
 

this has changed. We say -- and this is consistent
 

with one of the comments we received I just
 

reviewed. It's feasible if we can -- if we have
 

access to sufficient information to estimate the
 

maximum radiation dose that could have been incurred
 

in plausible circumstances by any member of the
 

class. If we can put an upper bound on the dose to
 

the class, then we can do the dose reconstructions.
 

And again, sort of harking back to what I said
 

before, as all we're doing is putting an upper bound
 

on the dose, as we get to that point where we're so
 

limited, there's an enormous amount of benefit of
 

the doubt that's going to the claimants in that
 

circumstance.
 

We also -- there's another provision in here
 

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which is new, which is in some circumstances
 

feasibility could be cancer site specific and hence
 

cancer-specific.
 

Let me explain what's intended there. As you
 

know, dose reconstructions are tissue-specific. We
 

don't estimate doses generally. We estimate doses
 

to the tissue related to the cancer that has been
 

incurred. And hence, in fact in certain
 

circumstances, it's possible that feasibility will
 

hinge on which cancer site we're talking about. And
 

let me just give you two examples to get this
 

started.
 

An example of radon gas. If we can estimate
 

all the radiation doses for an individual except for
 

their exposure to radon, radon daughters, then the
 

tissue -- the organ that is exposed to radiation is
 

the lung. And for practical purposes, other
 

tissues, other organs are not exposed. And we can
 

do a -- in effect, cap the dose for those
 

individuals with cancers other than lung cancer. We
 

can't do it for lung cancer. And in that case, you
 

would establish a class that included anyone who has
 

or incurs in the future lung cancer and was exposed
 

-- was at the site, et cetera. But it would be lung
 

cancer-specific or lung tissue-specific, in effect.
 

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And for all other individuals, you could take all
 

their other doses, including this exposure to radon
 

gas, radon, and calculate a dose for them, do a dose
 

reconstruction for them.
 

Let me give you a second example. Instead of
 

an internal emitter, let's talk about external
 

exposure -- external dose where you have partial
 

body radiation exposure. Say, for example, an
 

individual -- individuals, workers, were exposed
 

through a glove box. Or another circumstance where
 

there's shielding and only a part of their body is
 

being exposed. With the glove box, their skin would
 

be exposed -- you know, their bones in their hand
 

would be exposed, and that could relate to possibly
 

three cancers: skin cancer, bone cancer and
 

leukemia, blood-forming tissues in the red bone
 

marrow in the hand. I mean those three cancers are
 

possibly associated.
 

But for individuals who incur lung cancer, for
 

example, you can do their dose reconstruction
 

because the exposure that we're concerned about here
 

that we can't estimate, in the glove box is not an
 

exposure to their lungs. And the same would go for
 

other organ site -- tissue sites.
 

Do you want me to pause on this or do you want
 

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me to run through -- I mean you have my
 

presentation. Do you want me to take questions as I
 

go or -­

DR. ZIEMER: Perhaps if questions pop up as you
 

proceed, let's just go ahead and indicate.
 

MR. KATZ: So -­

DR. ZIEMER: Otherwise -­

MR. KATZ: So I'll carry through, and then of
 

course we can visit all of this and will.
 

Okay. Now also the Board wanted us to give as
 

much guidance as possible to the public about
 

feasibility. And you know, in the hierarchy of
 

information that we outlined in 42 CFR is in effect
 

some of that guidance. It explains that, you know,
 

if we don't have personnel monitoring data, we go to
 

the next step and so on if we don't have good
 

personnel monitoring data.
 

We also stated -- made a couple of statements
 

in the rule that we thought would be helpful. This
 

first, in general, you must be able to specify the
 

types and quantities of radioisotopes to which the
 

workers were potentially exposed. Or must know the
 

design and performance information of radiation-


generating equipment, such as particle accelerators.
 

If we don't have such basic information, we may not
 

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-- we're very likely not able to do a dose
 

reconstruction, even doing that maximum dose that we
 

just talked about.
 

And we also make a statement to the contrary,
 

that in general -- you know, data from personal -­

personal dosimetry and area monitoring are not
 

essential. We thought it was important that the
 

public understand that there is this hierarchy in
 

effect and that while we prefer good personnel
 

monitoring data, we can do dose reconstructions and
 

they're fair to claimants based on more basic
 

information.
 

In addition, we also committed in the preamble
 

that we would publicize summaries of circumstances
 

in which doses cannot be estimated as these arise
 

from the dose reconstruction program. I mean so
 

these will be illustrative cases, again, to help the
 

entire public understand where our limits are, what
 

sort of circumstances result in our being unable to
 

estimate doses.
 

And we are of course committed to working with
 

this Board to do whatever we can to expand guidance
 

for the public on this topic.
 

Time limits. That's the other thing the Board
 

mentioned. It was mentioned in public comments, as
 

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well. And we'll consider establishing a time limit
 

-- or guidelines for completing dose reconstructions
 

once the dose reconstruction program reaches its
 

full operating capacity. By time guidelines, I just
 

mean to say -- I mean you may not want something so
 

rigid as a time limit in certain circumstances. You
 

may not want that if, for example, you could produce
 

the dose reconstruction close to the time limit.
 

So moving to the next major element of this
 

rule is how we deal with health endangerment. In
 

the first proposal we proposed that we judge whether
 

doses for a class could have exceeded a class-


specific threshold to be derived from the cancer
 

risk models from NIOSH-IREP.
 

And we also proposed that we would define a
 

duration of employment requirement and would use the
 

statutory criterion of 250 days as a default when we
 

lacked a basis to diverge from it. That statutory
 

criterion, that 250 days, relates to workers at the
 

gaseous diffusion plants. That's the duration
 

requirement that they have.
 

So that was in the first rule, both of these.
 

The Board advised us -- they were concerned that the
 

method of involving subjective judgment and cancer
 

risk models could produce arbitrary and unfair
 

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decisions. And you recommended, in general fashion,
 

to consider other suitable criteria, which we have.
 

Some of the public comments suggesting how to
 

determine health endangerment -- again, my intent is
 

for you to just have an understanding of how the
 

public viewed this subject. Use a qualitative
 

approach, do not use NIOSH-IREP or any quantitative
 

approach, provide more detail on how NIOSH-IREP were
 

to be used -- if it were to be used; I think that
 

was sort of a reluctant comment, if we were going to
 

go down that path -- use physician opinion. I mean
 

this comment was in effect to say treat it like you
 

do an individual Workers Compensation case and have
 

a physician make a determination. Use epidemiologic
 

comparisons or use badge and 250-day criteria
 

specified by Congress for the gaseous diffusion
 

employees.
 

Now I mean there are certain implications of
 

the dose reconstruction methods themselves that have
 

a bearing on this and allowed us to change course
 

here on this. When we can estimate at least a
 

maximum dose for a class, we'd conduct dose
 

reconstructions. When we can't estimate that
 

maximum dose, then there's absolutely no practical
 

benefit to quantifying this dose benchmark for
 

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health endangerment because in any case the doses
 

could actually have been above the benchmark, so
 

there's no value to establishing a benchmark when
 

we're talking about situations in which we can't put
 

a cap on the doses. Because then, by definition,
 

the doses could have been above the benchmark. That
 

would have operated -- if we had retained that
 

NIOSH-IREP provision in there, it would in effect
 

have been sort of a moot provision, in reality, as
 

we went through these petitions.
 

So what's our proposal for health endangerment.
 

Well, we did eliminate the use of cancer risk
 

models. There's no NIOSH-IREP in here. We limited
 

determination to an employee duration requirement
 

for exposed employees. We're not using the badge
 

criterion here. It doesn't make sense here because
 

we're being far more specific and can be far more
 

specific about which employees we're talking about.
 

We're retaining the 250-day requirement as a
 

default. Again, that was in the first rule, as
 

well, and we've kept it here. And we've allowed HHS
 

-- us -- to specify presence as sufficient
 

employment duration for discrete incidents in which
 

doses were likely to have been exceptionally high.
 

We had a variety of public comments on petition
 

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requirements. We had a request to expand the scope
 

of eligible petitioners to non-union organizations
 

such as LAPOWs. This is a informal organization of
 

workers at Los Alamos -- from Los Alamos. Requests
 

to eliminate the petition form, to eliminate the
 

requirement that petitioners obtain verification of
 

record deficiencies from DOE/AWEs. That was a
 

provision in the first NPRM which would have been
 

impractical for a number of circumstances, number of
 

situations, particularly with the AWE employees.
 

And we had a request to make independent health
 

physics expertise available to potential
 

petitioners, and this related to their concern that
 

petitioners wouldn't have enough knowledge to meet
 

the requirements for petitioning.
 

This is what we've proposed in response. We've
 

expanded the scope of eligible petitioners. Now
 

LAPOWs, any representative that's authorized in
 

writing by the workers or survivors could serve as a
 

petitioner. So I think that it is pretty wide open
 

now in terms of who can petition. We made the use
 

of petition forms voluntary, although I'll say I
 

think the petition forms will be of assistance to
 

petitioners and they'll probably see that they'll
 

benefit by using them. We eliminated the
 

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verification requirements. We eliminated the
 

requirement to address health endangerment in the
 

petition justification since, as you can see from
 

how I've described how we're dealing with health
 

endangerment, that's not going to have any value so
 

we're not burdening petitioners with speaking to it.
 

And we've simplified the petition justification
 

concerning feasibility to set specific discrete
 

options, in part responding to this concern that you
 

need to be a health physicist to petition.
 

These are the specifics that we -- specific
 

options that we address and a petition must support
 

one of these options, or it could support more, but
 

that exposures and doses were not monitored. And to
 

be clear here, we're not saying that all doses to a
 

class were not monitored. We're saying that there
 

are doses to a class that were not monitored, so
 

it's just -- if there's a subset of doses that were
 

not monitored, that would cover this. If records
 

were lost, falsified or destroyed. We also included
 

if there's an expert report on record limitations at
 

the facility and the necessity for dose
 

reconstructions, if petitioner group wishes to hire
 

a health physicist to make such a report, that could
 

satisfy our need. Or any published -- and this is a
 

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-- this came out of a Board recommendation, but any
 

published scientific report on record limitations
 

relevant to the petition could also serve. And
 

these are specified in more detail in the rule. You
 

can...
 

And another big issue, timeliness. Public
 

comments -- the public was very concerned about
 

expediting consideration of petitions for which
 

NIOSH has already found that dose reconstructions
 

are not feasible. You know, people have been adding
 

up how much time it takes us to do a dose
 

reconstruction and then concerned, rightly, how much
 

more time, once you get to that point, to then
 

evaluate a petition.
 

So this is what we've proposed. We have -- and
 

I'll be glad to explain it a little bit here -­

Section 83.14 is a procedure for minimizing the time
 

required to petitions for a class with an employee's
 

dose reconstruction we cannot complete. And the
 

basic strategy there is we will evaluate the
 

petition based on the information we already
 

collected from doing that -- attempting to do that
 

dose reconstruction. We will sort of -- there will
 

be no additional research on feasibility for that
 

petition. So all the information will be at hand
 

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for NIOSH to evaluate that petition. It in effect
 

will have evaluated the petition in attempting to do
 

the dose reconstruction and there'll be no time lost
 

there.
 

What that provision does to allow us to do this
 

is should -- in doing the reconstruction, should we
 

have leads that the class may extend beyond our
 

information, the information we have. In other
 

words, if the information we have from doing the
 

research allows us to define a class of only so
 

large, but we have some indication that it could
 

extend beyond that scope, we will then on our own
 

evaluate that issue of whether there's a greater
 

class than the class we've defined. But we will
 

move the petition on immediately based on the
 

research we have in-house, which will cover that
 

claimant who has cancer and all like-situated
 

employees. We'll move that on to the Board so the
 

Board can evaluate and -- one sec, Jim -- in a
 

sense, you have a bifurcated process, that that
 

petition will move on with that class as defined by
 

the research we have at hand, and we will consider
 

then, by doing additional research, whether there is
 

a further class of workers related to this first
 

petition who should be considered for addition to
 

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the Cohort. Jim?
 

DR. MELIUS: (Inaudible)
 

DR. ZIEMER: Use your mike there, Jim.
 

DR. MELIUS: Sorry. Clarification, since I
 

just got this yesterday I may have missed this in
 

reading through. But if I recall right, they would
 

still have to submit a petition, or is that not
 

true?
 

MR. KATZ: That's -- the original claimant?
 

DR. MELIUS: Yeah.
 

MR. KATZ: The original claimant would have to
 

submit a petition. It's a -- there's not much to
 

it, but -­

DR. MELIUS: Then the justification would
 

really be the communication back to the -- that
 

person saying that they couldn't -- it wasn't
 

feasible to reconstruct the dose.
 

MR. KATZ: That's right.
 

DR. MELIUS: Is that spelled out in the -­

MR. KATZ: It's spelled out in the rule,
 

absolutely.
 

DR. MELIUS: 'Cause it wasn't on your slide and
 

that's why I -­

MR. KATZ: Yeah. No, it's spelled out in the
 

rule, though.
 

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DR. MELIUS: Okay.
 

MR. KATZ: And all they're doing is affirming
 

that the dose reconstruction couldn't be done.
 

That's the entire justification for the petition.
 

MR. ELLIOTT: But we would help them with their
 

petition. As soon as we figure out we can't do a
 

dose reconstruction, we're going to notify that
 

claimant and say we need to work with you to put a
 

petition together.
 

MR. KATZ: Well, they -- I mean there's nothing
 

to do -- I mean they are submitting a petition which
 

is -- there's nothing to do on that petition.
 

DR. MELIUS: My clarification was just that the
 

four points you listed before that they would have
 

to provide -­

MR. KATZ: No, that doesn't apply.
 

DR. MELIUS: Yeah.
 

MR. KATZ: None of those apply.
 

DR. MELIUS: Exactly, that's what I was trying
 

to figure -­

MR. KATZ: None of those apply.
 

DR. MELIUS: Yeah. Okay.
 

MR. KATZ: Okay. And the other thing that
 

we've committed to that you'll love is that we will
 

convene you as often as necessary so that we can
 

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address these petitions on a timely basis.
 

DR. ZIEMER: Probably we would want that to say
 

as seldom as possible but as often as necessary.
 

MR. KATZ: Yes, something like that. We could
 

work on the wording.
 

DR. MELIUS: Maybe we'll put in a regional
 

rule. If the petition's from the northwest, we can
 

do it near -- up near Washington.
 

MS. MUNN: Thanks a lot.
 

MR. KATZ: Okay. We had Board advice and
 

public comments on the role of the Board and the
 

Secretary. One was to limit or eliminate the
 

Secretary's discretion to apply non-specified
 

procedures. As you recall, at the end of the rule
 

before the Secretary had the right to invoke such
 

procedures as were not specified, if need be. And
 

the Board recommended limiting the Board's role in
 

reviewing NIOSH decisions to deny evaluations of
 

petitions that do not meet the petition
 

requirements. A public comment, on the other hand,
 

recommended retaining the Board's role. So we did
 

eliminate the Secretary's discretion -- we took away
 

his power -- no. There are no non-specified
 

procedures left in this rule. And we eliminated the
 

Board's review of petitions that NIOSH decides do
 

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not meet the minimum requirements.
 

Thank you. That's it.
 

DR. ZIEMER: Okay, let's open it up now for
 

general questions on any of the items Ted has
 

covered, any clarification points. We will be going
 

through the document later in detail, but -- Jim?
 

DR. MELIUS: On that last point, I thought I
 

saw in there something about some sort of an
 

administrative review or something of a petition
 

that's been turned down. Can you speak a little bit
 

about that?
 

MR. KATZ: Yes, that's -- we asked for public
 

comment as to whether people thought we should have
 

an administrative review of these NIOSH decisions if
 

these are not going to come to the Board. Now I'd
 

just explain -- I mean the process has changed
 

somewhat in other ways, too, because if a petition
 

doesn't meet our requirements, we will go back very
 

specifically to the petitioner and identify why it
 

doesn't and provide them with guidance for what it
 

would require to make that petition meet our
 

requirements, and then it would have 30 days then to
 

address that. So in a sense, part of our process is
 

almost a check there because they have a second go
 

at it, based on very specific guidance as to what it
 

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would require to bring that petition up to
 

requirements.
 

DR. ZIEMER: Yes, Roy?
 

DR. DEHART: Would you expand just a bit on the
 

elimination of the cancer risk model?
 

MR. KATZ: Sure. I mean I don't know if I can
 

expand or if I'll just be repeating myself, but the
 

cancer risk models -- the whole purpose of the
 

cancer risk models was to establish a benchmark, a
 

dose level benchmark and then determine whether
 

doses could have exceeded it. If they exceeded it,
 

then that would satisfy the requirement that the
 

class may have been endangered. So that's what they
 

were in there for originally.
 

Now the situation is is that where we can do a
 

dose reconstruction -- where we cannot do a dose
 

reconstruction, I should say, we can't -- we can't
 

cap the dose. We can't put an upper threshold, an
 

upper limit on the dose that they might have
 

received. And if we can't do that, then the
 

benchmark becomes irrelevant because whatever the
 

benchmark, whatever the benchmark's at, the dose
 

could have been higher than that and they meet that
 

requirement. So we would have to go through a lot
 

of trouble, as some of you have thought through. To
 

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establish those benchmarks isn't that simple and it
 

would have no value, so it -- for which reason we've
 

eliminated it. It really -- I mean the only thing
 

it would have done is assured people that these
 

people -- that these individuals, you know, very
 

well could have had their health endangered, but it
 

had no practical value.
 

Does that -­

DR. DEHART: If I understand then, if there is
 

a way of doing some form of dose reconstruction,
 

you're not removing the cancer risk model. You're
 

only removing it when you're unable to make a
 

judgment.
 

MR. KATZ: Yeah, I'm sorry. If you can do the
 

dose reconstruction, you use the cancer risk model,
 

yes. No, this is only in terms of adding a class to
 

the Cohort there's no value to use this -- to use
 

cancer risk models to determine their health
 

endangerment, that's all. Everything else is the
 

same about how you do dose reconstruction and
 

probability of causation.
 

DR. ZIEMER: I'd like to add a comment on that
 

concept. It seems to me that if you did benchmark
 

it in the sense that we talked about before and you
 

found that every member of the class was way up here
 

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somewhere but there was a number, I think under this
 

change you're saying well, we -- this is a dose
 

reconstruction and it fits in the other category,
 

but you would end up in that circumstances in
 

compensating every individual in any event, as a
 

group. You just don't call it a Special Exposure
 

Cohort. It's a little bit semantics, to me, because
 

if everyone in the group qualifies under the dose
 

reconstruction for compensation -­

MR. KATZ: It's actually -- it's not quite
 

that. I mean what we're saying is we'll do the dose
 

reconstruction if we can cap the dose. But if we
 

can cap the dose, it doesn't mean that everyone -­

everyone who incurs that dose would incur cancer.
 

It means we'd do the dose reconstruction based on
 

that cap dose and it depends on what -­

DR. ZIEMER: Okay, and then the -- only the
 

cancer individuals would -­

MR. KATZ: It depends -- yeah, it depends what
 

cancer they incur whether they're compensated or
 

not.
 

DR. ZIEMER: Yes, of course.
 

MR. KATZ: So it's a little different.
 

DR. ZIEMER: But it keeps them in the dose
 

reconstruction category rather than -­

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MR. KATZ: That's true.
 

DR. ZIEMER: Yeah. Okay. Other general
 

comments or questions on Ted's presentation?
 

Okay, Mark, you're making a motion like you're
 

thinking -- and also -­

MR. GRIFFON: Where to begin.
 

DR. ZIEMER: -- while you're pulling the mike
 

up there -- also, Leon, if you have any questions,
 

just chime in. Okay?
 

MR. OWENS: Okay, Dr. Ziemer. Thank you.
 

DR. ZIEMER: Right. Mark.
 

MR. GRIFFON: I guess -- I guess I wanted to -­

to start and -- and I agree with Jim's comment.
 

Just receiving this less than 24 hours ago, maybe I
 

missed some nuances. But I'm trying to grapple with
 

this notion of tissue-specific cancer sites. And
 

there's a phrase in the prelogue (sic) here that
 

says -- one of the examples you gave was radon
 

progeny or uranium would only concentrate and
 

significantly irradiate certain organs and tissues.
 

And I guess what I was grappling with is how do you
 

define "significantly", and especially for this -­

this -- if you've gotten to this point you've
 

already admitted that you can't even establish a
 

maximum dose, so -- so then it further concerns me
 

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how you establish "significantly". 'Cause while I
 

would agree that in those two examples most of the
 

exposures are to certain targeted organs, there
 

probably are small fractions of dose to other
 

organs, as well. And if we don't know anything
 

about the intake or the exposure, we don't know how
 

large those small fractions could be. So I think
 

that's -- I just wanted to know how -- how you
 

define that "significantly" and -- or whether this
 

is like left open to this case-by-case analysis.
 

MR. KATZ: Well, I mean it will certainly come
 

DR. MELIUS: Could you just tell us what page
 

you're looking at 'cause -­

MR. GRIFFON: Oh, I was looking on page 15 in
 

the prelogue (sic) where it's discussed.
 

DR. MELIUS: Okay.
 

MR. GRIFFON: Not the rule itself.
 

MR. KATZ: It will certainly come before you
 

case by case because the Board will see each of
 

these petitions and the NIOSH evaluation for it, so
 

you'll certainly get it case by case. But for
 

example, with radon, "significantly" isn't really -­

I mean the colon, there would -- you would estimate
 

basically zero dose to the colon, regardless of not
 

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being able to put a cap on the radon daughters
 

exposure, for example. In practical terms, it would
 

be zero.
 

MR. GRIFFON: What does that mean, in practical
 

terms it would be zero? I mean are you saying the ­

-


MR. KATZ: Well, meaning -­

MR. GRIFFON: -- probability of causation is
 

zero?
 

MR. KATZ: Meaning that if the -- if you're
 

talking about, you know, point zero zero whatever
 

dose, you would say zero.
 

MR. GRIFFON: But you don't know the -- you
 

don't know the dose up front. That's -- that's the
 

point, I guess.
 

MR. KATZ: You don't know the dose up front,
 

but it doesn't matter that you don't know the dose
 

if -- you don't know the dose to the lung,
 

absolutely, which is why the lung would qualify.
 

But you do -- you can say absolutely that the dose
 

to the colon would be in effect zero.
 

MR. GRIFFON: Give your rationale for that.
 

Your radon exposure, you have -­

MR. KATZ: Let me let Jim -­

MR. GRIFFON: -- particular progeny in the lung
 

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which stay in there; they don't go anywhere else is
 

your argument?
 

MR. KATZ: Let Jim pitch here.
 

DR. NETON: Jim Neton, NIOSH. There's a
 

practical basis here. I mean one could argue -- we
 

could argue that there may be atoms of radon progeny
 

that move from the lung to the colon, but on a
 

practical basis we're talking multiple, multiple
 

orders of magnitude. I mean it just -- the dose
 

would be -- I don't want to give any quantitative
 

numbers, but it would be several orders of magnitude
 

below that, if not more than that, so that -- you
 

know, you have to be practical about this in a
 

certain situation. So yes, we can't cap the dose,
 

but it's certainly -- since the material does not
 

concentrate at all in that organ, say in the colon,
 

it's not -­

MR. GRIFFON: I guess -­

DR. NETON: -- plausible that their health was
 

endangered, which is the other criteria. You have
 

to meet two criteria; you can't cap the dose, and
 

their health would have had to have been in danger.
 

It's not plausible of health endangerment since
 

there is -­

MR. GRIFFON: But it seems like a roundabout
 

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way without using IREP to look at the risk side of
 

things. But -­

DR. NETON: Yeah.
 

MR. GRIFFON: -- I mean I guess my concern is
 

that you're admitting up front that you can't -- I
 

-- you can't establish the dose. But then you're -­

you're narrowing this to we can't establish the
 

radon dose for this group. I guess I -- you know,
 

those examples are okay. I'd be -- I wonder if it
 

makes sense for such -- these theoretical examples
 

to change this whole policy, you know, instead of
 

having just a list of specified cancers. Because,
 

you know, how -- I would say that, you know, if you
 

can't establish an individual -- if you don't know
 

-- I mean part of your criteria is you have to know
 

at least something about the source term and the
 

radionuclides involved to establish exposure. So
 

you're kind of saying okay, we don't even have that
 

baseline information. We don't have -- we can't
 

even get that far. But yet we're confident that
 

it's only radon that we -- you know what I'm saying?
 

DR. NETON: Yeah, it kind of gets into your
 

definition of capping, I suppose. I mean -- I
 

always have said in the beginning, I can always cap
 

a dose and say it's less than a million rem or
 

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something like that. I mean you can always do
 

something like that. And in some of those
 

situations actually that -- that disparate. I mean
 

you could make some wild assumption as the upper
 

limit in some of these other -- what we consider
 

non-metabolically-involved organs, the dose would be
 

extremely small and not even calculable probably to
 

the millirem levels or something like that, so -­

DR. ZIEMER: But you're probably going to have
 

to have specific cases to examine. Some of these
 

theoretical ones that we tried out -­

MR. GRIFFON: Right.
 

DR. ZIEMER: -- you know, they're not the real
 

live thing so it's a little hard to say how they'll
 

come out. I think Jim and then Tony -- oh, Tony's
 

next?
 

DR. MELIUS: Well, actually Tony's reached for
 

his microphone, so I'll -­

DR. ZIEMER: Tony?
 

DR. ANDRADE: No, I just wanted to provide
 

another example, perhaps one that -- well, I know
 

it's not listed either in the preamble or in the
 

rule. Let's take a case of plutonium. You may have
 

a petition from a person that believes that they
 

were exposed to plutonium, have no idea as to how
 

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much, have no records, but believes -- strongly
 

believes that they were exposed to that. If it is
 

plutonium, then we know. Okay? So I'm going to
 

propose here is that we have a scientific bases
 

already through physiological models that plutonium
 

tends to concentrate in the liver and in the bones.
 

And if they come forward with a brain cancer, then
 

it is -- or other people in the class may have had a
 

brain cancer, it's highly unlikely that that would
 

have been the cause. And so what I'm saying is that
 

these physiological models do exist. There is a
 

scientific bases for making these determinations and
 

I think what's being proposed is perfectly
 

reasonable.
 

DR. ZIEMER: Jim?
 

DR. MELIUS: My concern -- I have to agree with
 

Mark. What concerns me is two issues. One is that
 

yeah, we have this scientific basis and we would say
 

that the risk for plutonium is more likely from
 

certain organs, but we're applying -- with IREP
 

we're applying (inaudible) model to that, so -- and
 

then putting a dose to that model. Here we don't
 

have a dose. We've already said that in this
 

situation we don't have a dose to put in that model.
 

And I'm afraid that we're going to spend, this
 

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Board, a lot of time trying to decide where to make
 

the cutoff, which organ systems will be covered in
 

these situations, which organ -- cancers of other
 

organ systems will not be covered. And the
 

situation -- most of the situations we're dealing
 

with are not going to be simply plutonium or simply
 

radon, they're going to be much more complicated.
 

And we're going to be spending a lot of time trying
 

to figure out, you know, well, we have more than one
 

that we can't estimate, some that we say we can
 

estimate, which organ -- how do we add this up
 

without a dose term to -- even an estimate of a dose
 

term to be able to -- to weigh in with. And I don't
 

necessarily disagree with the simple examples, but
 

I'm not sure how practical those will be -- how
 

common those will be, but that when we -- if we
 

start applying this across the board to every
 

petition, then we're going to be making I think very
 

arbitrary assessments in situations where we've
 

already said we don't know the -- can't estimate the
 

dose.
 

MR. KATZ: Let me -- can I just respond a
 

little bit? This is an ability to address -- to use
 

this when appropriate. It is not across-the-board
 

procedure to apply. So the only situations I
 

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imagine when NIOSH is going to apply this procedure
 

is -- you know, you're talking about simple cases.
 

Well, it's -- it's sort of open and shut cases where
 

it's very clear. And for situations where you have
 

multiple exposures and so on, you're not going to
 

apply a policy like this, and it wouldn't be
 

applied. You wouldn't have any specificity about
 

tissue sites. You would only have it when you have
 

a situation, for example, with radon where that is
 

the only -- radon daughters are the only dose that
 

you can't calculate. And though you can't calculate
 

them for the lung, you can cap them for -- cap them
 

as -- if you're going to take into account
 

plausibility, you can cap them for other tissue
 

sites.
 

DR. ZIEMER: Any other comments? On any -- not
 

necessarily this issue, any of the issues Ted
 

raised.
 

Okay. Thank you. Ted, I think you can sit
 

down, but be on call here.
 

DR. MELIUS: Actually can I ask one more
 

question?
 

DR. ZIEMER: Sure, you bet.
 

DR. MELIUS: One of our -- and I may -- again,
 

may have missed this in the comments, but in reading
 

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through our comments from the last time, we raised
 

an issue about -- where we had cancer sites that
 

were not listed as part -- not eligible for the SEC
 

compensation, and then issues where part of a
 

person's work history can -- could be -- those could
 

be estimated, part would fall under -- into the
 

Special Exposure Cohort in sort of mixed situations.
 

If those -- in our comments we asked that NIOSH
 

address those situations in the follow-up. Are
 

those addressed in these regulations?
 

MR. KATZ: They're addressed. They're
 

addressed in the preamble, yes. Yes, so, for
 

example -­

DR. MELIUS: Could you give me -­

MR. KATZ: Yes -- no, I'm -- I wasn't going to
 

leave you hanging, Jim.
 

DR. MELIUS: Thanks.
 

MR. KATZ: So where the doses -- where an
 

individual has doses outside of the window for the
 

cohort, and couple that with they have a cancer that
 

is not compensable as a member of the cohort -­

that's what you're talking about, that situation -­

what you do -- what we have to do is a dose
 

reconstruction. And what we discuss in the
 

preamble is that we don't have an answer right now
 

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for what do we do with that window that -- when you
 

do the dose reconstruction they have this window,
 

you know, for which their colleagues were added to
 

the cohort, but because they don't have the right
 

cancer, they can't be compensated as a member of the
 

cohort -- they're part of it, but they can't be
 

compensated. What do you do with that window where
 

you can't estimate doses? And it's -- we address
 

that in the preamble that it's a problem that we're
 

going to need to discuss with you and it's a pretty
 

sticky wicket because we've made this determination
 

that we can't reconstruct dose for that window, and
 

yet there's this individual who had that exposure,
 

as well as the exposures that we can estimate with,
 

and we're going to have to do a dose reconstruction
 

for them, what do we do with that window to be able
 

to address this problem. You know, if we can
 

address this problem it will probably require
 

revising the dose reconstruction rule because right
 

now under the dose reconstruction procedures, you
 

know, we reach a dead end, we can't reconstruct a
 

dose. There would have to be a change to the dose
 

reconstruction procedures.
 

And you know, I'd be glad to engage with the
 

Board in the discussion of what sort of things you
 

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might think about in addressing that situation, but
 

what the rule says is it's not a part of this rule
 

because it's an issue of dealing with dose
 

reconstruction and not dealing with adding a class
 

to the cohort.
 

DR. ZIEMER: Mark?
 

MR. GRIFFON: I just wanted to -- just a
 

clarification on the definition on sufficient
 

accuracy. It is when you can calculate a maximum -­

MR. KATZ: Yes.
 

MR. GRIFFON: Can you re-- what is the -­

MR. KATZ: You want me to say it verbatim?
 

MR. GRIFFON: Well, not verbatim.
 

MR. KATZ: I mean it's in the rule, but yes,
 

it's if you can -- if you can calculate a maximum
 

dose to the class, then you still can do dose
 

reconstructions with sufficient accuracy. And
 

that's of course, you know, your least preferred
 

situation, but -­

MR. GRIFFON: And just to clarify that, the
 

maximum do-- if you can calculate a maximum dose,
 

then those maximum doses will be used in their
 

determination of -­

MR. KATZ: Yes.
 

MR. GRIFFON: -- probability of causation?
 

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MR. KATZ: Then they would have dose
 

reconstructions based on those maximum doses versus
 

something more accurate and lower.
 

DR. ZIEMER: Jim, and then -­

DR. NETON: I'd just like to maybe clarify what
 

Ted said. Not necessarily the maximum dose if we
 

could develop some sort of a distribution, but the
 

maximum credible dose would be used in the analysis.
 

It would not always be the maximum dose.
 

MR. KATZ: But it could be.
 

DR. NETON: It could be, sure.
 

MR. KATZ: Yes, which is -­

DR. NETON: But if one generated distribution,
 

a theoretical distribution of doses, that would be
 

the sampling that would be done to do that dose
 

reconstruction.
 

DR. ZIEMER: Jim?
 

DR. MELIUS: I believe this is a semantic
 

issue, but you've raised it a couple of times here
 

is that in a class if you can do this maximum
 

credible dose, whatever we want to call it, for any
 

individual in the class, then the class doesn't
 

qualify for a Special Exposure Cohort. But that
 

wouldn't necessarily mean that the dose could be
 

applied to everybody that worked in some -- you
 

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know, part of the class could be eligible and part
 

couldn't, so we could split that -- that class up,
 

so to speak -­

MR. KATZ: Right.
 

DR. MELIUS: -- the class -- the petition could
 

be split into a group that could be estimated and
 

doesn't qualify in a group that doesn't. Is that -­

MR. KATZ: That's correct, and that's still in
 

the rule. That was in the rule before and that's
 

still in the rule as it is.
 

DR. ZIEMER: Okay. Thank you. Oh, Mark, did
 

you have another item?
 

MR. GRIFFON: No.
 

DR. ZIEMER: Okay. Now what I'd like to do at
 

this point is develop a strategy on proceeding on
 

how we will evaluate the rule. I have a couple of
 

suggestions, but I want to get some feedback on
 

this. First of all, as Ted suggested, we do want to
 

have an opportunity to step through all of the
 

changes and identify what those are. There are a
 

couple of ways to do this. One is to simply do it
 

sequentially.
 

But the other thing that occurred to me -- and
 

I'd like you to think about this for a minute and
 

then we can discuss it -- would be to look at all of
 

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the Board's own items; that is, the items that we
 

raised, and ask how those were resolved to see if we
 

are satisfied in a sense, if I can use that
 

terminology -- if we are satisfied with the
 

resolution of the issues that we raised relative to
 

the earlier version of the rule. And then after
 

doing that, then go back and look at all of the
 

other items in terms of what other changes have been
 

made.
 

So I'm asking the Board, do you have any
 

preference one way or the other on how to proceed?
 

Tony?
 

DR. ANDRADE: Paul, there've been so many
 

substantial changes -- very good changes, in my
 

opinion -- to the rule that I would suggest that we
 

step through section by section. Some of them will
 

be -- will require very little time. Others will
 

address concerns that the Board raised and yet
 

others will address concerns that were brought up by
 

the public, and I think we will be giving due
 

diligence -- due diligence review to all of the
 

concerns that were brought up.
 

DR. ZIEMER: Richard?
 

MR. ESPINOSA: I kind of agree with the section
 

by section. Also I'm kind of concerned about the
 

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amount of time that we have to review this, as well
 

as the public comment period. I believe the public
 

comment period should be extended to 60 days. And
 

also is there anything in the works about having -­

in the last SEC stuff there was stakeholder
 

meetings. Is there anything in the works for a
 

stakeholders meeting over this?
 

MR. ELLIOTT: The public comment period will be
 

30 days. That's a Department decision and they're
 

going to stick with that. There are no town hall
 

meetings scheduled to deliver this notice of
 

proposed rulemaking like there was in the last one.
 

DR. ZIEMER: Roy and then Jim.
 

DR. DEHART: In addressing your suggestion, I
 

would prefer to see it as Tony has suggested,
 

sequentially go through, but identify as we do
 

clearly where the Board changes are occurring.
 

DR. ZIEMER: Jim?
 

DR. MELIUS: Just back to that point on public
 

participation, public access, I feel we should at
 

least go on record. I find this whole procedure to
 

be very unsatisfactory. We are given a rule to read
 

with substantial changes less than two days before
 

our meeting. We are -- there is no opportunity for
 

any members of the public to see the rule until they
 

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got to the meeting here today, no -- and I think a
 

lot of our -- some of our comments from before were
 

informed by comments from the public and from the
 

public participation. Given the major changes, I
 

just find it very unsatisfactory on the part of the
 

Agency to be putting such a strict time limit and to
 

preclude any public participation in this process.
 

And I also was a little concerned, does the
 

Board have enough time -- given our current planned
 

schedule, which is to review today and then to
 

finalize comments in a week -- for something -­

which means we will have seen and looked over a rule
 

for eight days and some of us -- I know many of us
 

have other things to do with our time, so we're not
 

-- let alone a chance to really discuss some of
 

these -- you know, some of these changes.
 

MR. ELLIOTT: I would like to react to one part
 

of your comment, Dr. Melius. The public has had as
 

much -- unfortunately, as much advance notice in
 

delivery of the rule as you all. We sent out four
 

e-mail distributions announcing the availability of
 

the rule. One of those was public-wide and included
 

everybody that signed up for -- through our OCAS web
 

site e-mailbox, callers who called in and wanted to
 

be notified when the rule appeared. I believe that
 

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-- Cori, correct me, but I believe that single
 

distribution notice was very lengthy in the number
 

of people that we touched.
 

I, too, share -- we're not happy that we got
 

this put on the table any earlier than we did. You
 

have a week from today for a teleconference. We
 

should talk about today whether or not you feel
 

you're going to need a second teleconference to
 

accomplish what you need to do before the end of the
 

comment period.
 

DR. ZIEMER: Okay. Wanda?
 

MS. MUNN: I'll have to admit, I groaned
 

audibly when I watched 91 pages crank off my
 

printer. But having thought about it, I recognize
 

that we can't have it both ways. I can't have the
 

time that I would like to have to assimilate every
 

aspect of this revised rule and at the same time
 

meet our I think generally-agreed criterion of
 

expediting this process as much as possible. So I
 

have no problem with the 30-day requirement. If
 

we're going to expedite, then we need to expedite.
 

I was not as smart as Dr. Melius and did not
 

think to bring a copy of our previous Board comments
 

with respect to the earlier rule. If it's possible,
 

if there's a copy of that around somewhere, it would
 

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be helpful to me as we go through this -- I hope
 

step by step -- to have -­

DR. ZIEMER: I think we can make these
 

available.
 

DR. MELIUS: I have a copy here if someone else
 

doesn't have -­

MS. MUNN: Good.
 

MR. KATZ: Also the comments are in the rule.
 

DR. ZIEMER: They are identified -­

MR. KATZ: They're actually in the preamble of
 

the rule, with responses to them, so -­

MS. MUNN: I saw them, but they were not in the
 

lump for -­

MR. KATZ: They're in a lump called the section
 

on -- the section on the Board is -- has all the
 

comments from the Board.
 

DR. ZIEMER: Jim?
 

DR. MELIUS: Yeah, I just want to -- I think
 

the Board's done a lot to try to expedite through
 

the process, but mind that NIOSH has had over six
 

months now, I believe, correct -- maybe five months
 

to revise this rule. And to then make us expedite
 

our review in -- whether it's two days or ten days
 

or whatever is being expected, I think is hardly
 

fair. We continually expedited the review of
 

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various regulations here on one-day notice or a few
 

days notice, whatever, going through and we're still
 

at a point on dose reconstructions where 17 I
 

believe have been completed and despite having
 

rushed through a rule a year and a half ago,
 

whenever it was. And I find it hard to believe that
 

a change in 15 days or 30 days in the comment
 

period, if it would help us to provide better
 

comments -- and I think that's something we should
 

discuss, would the extra time help us in this
 

process -- I think hardly makes any difference in
 

terms of the ef-- on the part of the effort of the
 

Board 'cause we do have a duty to fulfill in terms
 

of reviewing these comments and reviewing them
 

thoroughly and providing as good advice as we can,
 

and doing it in a very short time period may not
 

make that possible.
 

DR. ZIEMER: I suppose each person would have
 

to answer that for himself or herself. I know what
 

often happens in my case is if we have 60 days, then
 

that means I don't have to start on it for another
 

40 days or something and I end up using about the
 

same amount of review time. But that may not be
 

true of everyone.
 

One of the real issues is we do have -- people
 

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do have other commitments and may not, in a very
 

short time such as one week, be able to address this
 

very easily. So that would be more of a concern
 

that I would have than simply the scheduled issue
 

could be problematic. Jim?
 

DR. MELIUS: But there's also the issue of us ­

- of the Board being able to discuss and -­

DR. ZIEMER: Right, sure.
 

DR. MELIUS: -- respond to each other 'cause I
 

think we do -­

DR. ZIEMER: I understand.
 

DR. MELIUS: -- learn and modify our comments
 

in response to -­

DR. ZIEMER: Sure.
 

DR. MELIUS: -- other people's concerns, and
 

some people understand parts of this much better
 

than I do and I think it's -­

DR. ZIEMER: Rich has a comment.
 

MR. ESPINOSA: I absolutely agree with Dr.
 

Melius. After reading the public comments, it helps
 

me understand and kind of refine what we're going
 

through. And to have 30 days with the public
 

comment and then not even a meeting in between, a
 

face-to-face meeting in between is kind of
 

disturbing for me.
 

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DR. ZIEMER: Thank you. Other comments? Okay,
 

we'll kind of keep those issues in the back of our
 

minds as we proceed here. They may re-emerge as we
 

go along. I do believe that we've sensed perhaps an
 

agreement that we should -­

A pause just a minute. We've lost Leon,
 

apparently.
 

(Pause)
 

DR. ZIEMER: Leon?
 

MR. OWENS: Yes, sir.
 

DR. ZIEMER: We lost you somewhere along the
 

line, sorry.
 

MR. OWENS: Yes, Dr. Ziemer. Thank you.
 

DR. ZIEMER: We are discussing how to proceed
 

with the review. There also has been a brief
 

discussion on concerns about the -- both the 30-day
 

time period for public comment, as well as the
 

timetable for the Board to develop its own comments.
 

What I'm going to suggest is that we proceed
 

with reviewing and understanding what's in here, and
 

we will revisit as we go -- perhaps later in the day
 

to sort of see where we are and look at strategies
 

for the future telephone conferences and what we
 

think is needed for us to do our job. I think the
 

issue of opening it for public comment for a longer
 

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period is basically a Departmental decision, but
 

certainly the Board members can make their views
 

known on that item. We do need to determine at some
 

point today how we will proceed in terms of what we
 

think our ability is to get our comments done.
 

Now Rich, did you have another comment here as
 

MR. ESPINOSA: Yeah, I do on -- kind of on the
 

same subject. On Ted Katz's presentation he was
 

talking about a -- the verification requirements.
 

Can you explain a little bit on that? I didn't
 

understand that?
 

In other words, you didn't have to be specific
 

on the verification requirements for the SEC?
 

MR. KATZ: Sure, that was in the first -- that
 

relates to what was in the first NPRM, not what's in
 

here now. In the first NPRM we had a provision that
 

you would have to in effect verify from the employer
 

that they don't have the records that you are
 

asserting they don't have, and we took that out.
 

DR. ZIEMER: So the burden is not on the
 

employee anymore to -­

MR. KATZ: And so, for example, with an AWE
 

where you don't even have the employer anymore and
 

there's no one to go to, you're not going to them.
 

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Is that clear?
 

MR. ESPINOSA: Yes.
 

DR. ZIEMER: Are we in agreement that we would
 

-- in terms of reviewing the document, that we would
 

proceed then section by section?
 

Let me also note that the sections beginning
 

with the summary and the supplementary information
 

and so on, as well as the various definitions such
 

as what is a Special Exposure Cohort, what's the
 

purpose and so on, much of that is boilerplate
 

information that we probably don't need to dwell on
 

a whole lot. Also the summary of the comments is
 

what it is, and unless you think that they have not
 

summarized something clearly, we don't need to
 

fiddle with that much.
 

It is helpful to go through the preamble and
 

learn how they've dealt with the various issues. My
 

understanding is that the preamble is informational,
 

is not part of the rule. Is that correct, Ted? It
 

does not have -­

MR. KATZ: That's correct. The preamble is not
 

the rule. The preamble is informational and does
 

not get codified in the Code of Federal Regulations.
 

DR. ZIEMER: Now it certainly is conceivable
 

that as we go through the preamble Board members
 

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might have suggestions on clarifying issues or
 

making things more clear, but keep in mind those
 

items are not part of the rule but are intended to
 

help us understand the changes that have been made.
 

And for that reason it'll be very important to go
 

through them section by section and ask Ted and
 

other staff members to amplify and clarify the
 

various changes and we have the opportunity in each
 

case then to ask about those. And insofar as the
 

changes show up in the rule itself, then that
 

becomes very critical.
 

The rule itself then, if we could just clarify
 

where that begins. What constitutes "the rule" -­

and Ted or Larry, if you could help -- is it subpart
 

A? Is that the beginning of the -- subpart A -­

UNIDENTIFIED: It starts on page 64.
 

DR. ZIEMER: Okay, just ahead of subpart A is
 

the official text of the -- it says Text of the
 

Rule. That's the part, for which if we have
 

specific recommendations or comments, that we would
 

have to actually focus on. So we're talking about
 

-- as far as the rule is concerned, pages 64 through
 

90, so it's approximately a 25 or 26-page rule that
 

we're really focusing on. With a need, of course,
 

to understand what's going on in terms of what's in
 

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the preamble. Okay?
 

So what we will do, and I think we'll go ahead
 

and take our break first. But then we will start
 

in, section by section, to go through and start to
 

try to understand the scope and extent of all the
 

changes. I suppose -- I'm hopeful that as we
 

proceed and get a better feel for what is here and
 

what isn't here, how things have changed, that we
 

might also develop a good feel -- aside from the
 

sort of gut feeling we have about the short time, at
 

least develop a feel for what it's going to take for
 

us to get our work done. And you know, if we say
 

for some reason that it's just going to be
 

impossible in 30 days, in terms of our schedules and
 

what we think the extent of our comments are going
 

to be, then we'll just have to make that known.
 

On the other hand, we might say you know, these
 

changes are all so good, we just don't have very
 

much to do. I don't -- I'm probably looking at two
 

extremes here, but the point is that I think we'll
 

have a better feel for this rather than just our gut
 

reactions right now once we sort of get into it and
 

test the waters. So we'll proceed here for a while
 

and see how we do before noon, and then have also an
 

opportunity to hear some public comment perhaps
 

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early afternoon, and that will also help us shape
 

our thinking.
 

DR. MELIUS: Just schedule-wise, 'cause I
 

thought we were going to hear about the dose
 

reconstruction -­

DR. ZIEMER: Oh, we are, yeah. We're going to
 

do that. Do you want to do that before the break?
 

MR. GRIFFON: It doesn't -- Cori was making
 

copies, so I don't know if she has them yet, so
 

maybe -­

UNIDENTIFIED: After the break?
 

DR. ZIEMER: Let's go ahead and take our break
 

and, Leon, we're going to take about a 15-minute
 

break. Did we lose you?
 

MR. OWENS: No, sir, I'm still here, Dr.
 

Ziemer. Thank you.
 

DR. ZIEMER: Okay. We don't want to lose you
 

on the break, so -­

MR. OWENS: No, definitely not.
 

DR. ZIEMER: So I guess we'll leave the phone
 

line open -­

MR. OWENS: Okay, sir.
 

DR. ZIEMER: Okay.
 

MR. OWENS: Thank you.
 

(Whereupon, a recess was taken.)
 

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DOSE RECONSTRUCTION REVIEW PROCESS WORKGROUP
 

DR. ZIEMER: Now we have on our agenda the
 

report of the dose reconstruction review process
 

work group. Mark Griffon is chairing that work
 

group. Mark is going to bring us a status report
 

today on the activities of the group. They don't
 

have specific items for us to take action on today,
 

but will give us an update on their activities and
 

the outcome of their meeting yesterday. Mark?
 

MR. GRIFFON: Is this mike working?
 

DR. ZIEMER: Yes, it is. You might want to put
 

the lapel mike on just in case you're not close
 

enough to the other.
 

(Pause)
 

DR. ZIEMER: Okay, copies of Mark's slides were
 

just distributed to you. Leon, you probably don't
 

have copies unless we -- did we FAX any of these to
 

Leon?
 

MS. HOMER: No, I have not.
 

DR. ZIEMER: Are there copies for the public?
 

MS. HOMER: I've handed some out and there are
 

some back on the -­

DR. ZIEMER: There are some on the tables,
 

thank you. There are just six slides, so Mark, if
 

you'll make sure as you go through these to at least
 

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verbalize the points so that Leon has the benefit of
 

knowing what you're talking about here.
 

MR. GRIFFON: I will. I will. Okay, this is
 

the -- as the title indicates, a status report of
 

the dose reconstruction working group. We decided
 

last meeting we -- we were tasked to continue on as
 

a working group -- or a newly-established working
 

group to do several things on the dose
 

reconstruction review process, and these tasks were
 

develop draft procedures for the review process,
 

develop procedures for case selection, develop
 

individual task orders to be released after the task
 

order contract is awarded. And to do this, at the
 

last meeting we had some discussions that it might
 

be beneficial for us to come a day early to this -­

before this meeting -- to Cincinnati, to NIOSH's
 

offices and actually ORAU's office in this case and
 

go through their database and actual case files and
 

have sort of our draft procedure to walk through
 

some actual case records, case files, so that we
 

know sort of what the review team is going to be up
 

against when we actually start doing these. Okay?
 

UNIDENTIFIED: Thank you, Mark.
 

MR. GRIFFON: That's my status report.
 

(Pause)
 

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MR. GRIFFON: All right, so -- okay. What we
 

really focused on yesterday, we were at the ORAU
 

offices all day, pretty much from 9:00 till 3:00 or
 

so, and the focus was on the procedure side of
 

things, to look at -- at the last meeting Paul had
 

-- had put out a sort of template or a first cut of
 

a draft for the basic review, how the contractor,
 

along with the Board, are going to walk through a
 

review process for the basic review of a individual
 

dose reconstruction. And I -- I actually drafted -­

and these are in draft form. We're not even ready
 

to provide them, I don't think, to the full Board,
 

but I modified that somewhat, added to that somewhat
 

for a basic review and then advanced review. And
 

then we tried to take these procedures and walk
 

through while -- at the computers there at ORAU,
 

walk through actual cases and -- and go through the
 

questioning and see okay, exactly how is a reviewer
 

going to answer these criteria that we've laid out
 

in the RFP and in our procedures.
 

We looked -- we see this sort of as a part of
 

the basic review and advanced review. I think we're
 

going to have something -- we're going to have a
 

report form, an executive summary form and a Board
 

summary report. And the report form I envision as
 

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the report that the contractor primarily -- although
 

Board representatives will work with the contractor
 

-- but the contractor primarily will generate and
 

report that reviews the case.
 

The executive summary will just be -- just be
 

that. It'll be an executive summary of the case
 

review. It won't have as many details and that will
 

probably come back to the entire Board for
 

consideration. And then this last thing, this Board
 

summary report is what we envisioned as the Board's
 

report to the Agency, to HHS, and it would be sort
 

of a summary of aggre-- an aggregate number of cases
 

and were there any findings or concerns in aggregate
 

from the cases that have been reviewed in that
 

quarter, in that half-year or year or whatever that
 

time frame we decide.
 

We started off our day yesterday with a
 

briefing from NIOSH and walked through a couple of
 

cases, final cases, cases where decisions have been
 

made. And we looked at the databases, the NOCTS,
 

which is the NIOSH-OCAS Claims Tracking System.
 

That's the database and then the administrative
 

record for each case file, and we looked at the
 

various parts of this to see what kind of records
 

are actually captured in these. There's a dose
 

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reconstruction folder, there is a correspondence
 

folder, a DOE correspondence folder and -- I'm
 

forgetting one, there's -­

UNIDENTIFIED: DOL.
 

MR. GRIFFON: -- Department of Labor
 

correspondence file, so it's broken out kind of into
 

types of documents. And within those, all the
 

records used are captured -- all the records used
 

for the individual dose reconstruction case are
 

captured within those folders. Most of these are in
 

PDF format. I think there's only a few -- the one
 

file I can think of that's in an Excel format is the
 

actual IREP input file that would be used to run the
 

IREP analysis. All other forms are -- at this point
 

are in PDF format, meaning that if a reviewer was to
 

use this data they'd probably have to sort of hand-


enter any analytical files that they might want to
 

do. For instance, if they were going to do an
 

internal dose assessment, the data's there, but
 

they'd have to re-enter raw data and do their own
 

assessment that way -- something we did talk to
 

NIOSH about and there may be some things that
 

they're willing to add to make the process easier
 

for the reviewers -- to make Excel files for certain
 

things, then the reviewers can just use them that
 

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way instead of having to re-enter data.
 

Okay. And so we -- we spent most of our -- our
 

day going through these cases and -- and finding out
 

what was actually in these administrative records
 

and actually how to use this -- this database and
 

looked through this database.
 

Okay. The other thing we did discuss was the ­

- how to schedule the case reviews and the
 

coordination of the Board and the contractor or
 

contractors. We did talk as -- as in the past,
 

we've mentioned this notion of having designated
 

Board members, and this could be on a rotating basis
 

and -- and that -- that really -- we didn't really
 

hone in on that yet, but designated Board members
 

that will work with the contractor, and the Board
 

members would meet with the contractors on groups of
 

cases prior to the presentation back to the full
 

Board. So individual representatives from the Board
 

designated to work on a certain group of cases.
 

Those individual Board members would get the same
 

materials that the contractor would get at the same
 

time, far in advance. The contractor would proceed
 

to do the bulk of the legwork on it, but then the
 

Board members -- we -- we see the model as the Board
 

members would then have a chance -- an opportunity
 

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to work with the contractor ahead of time, before
 

presenting back to the Board, to question the
 

contractor on -- okay, you know, when I -- when we
 

looked at this we -- we found these things; did you
 

find these things, were there problems with certain
 

aspects of this. And then we may have a case where
 

the -- you meet with the contractor a day before a
 

Board meeting and you go through a pre-identified
 

set of 20 cases and we can see a situation where you
 

may have -- you may say okay, we agree with you on
 

17 of these cases and we think we should present
 

these to the Board. These other three cases we feel
 

-- we have questions that we didn't feel -- that the
 

contractor should re-examine further and they may
 

take those three back and not present those to the
 

full Board at that point so that that's sort of how
 

we see that -- you know, that way that -- every
 

Board member would not be involved in an in-depth
 

review of all of the cases that the contractor's
 

doing. It would be designated members would work on
 

designated cases.
 

And then the presentation of the final review
 

ports (sic) would go to the Board and the Board -­

ultimately the Board has the consideration of the
 

final cases, so...
 

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We also talked about the case selection
 

process. As we -- I just mentioned, we're talking
 

about only reviewing cases after final decision, so
 

we did have some discussion about how many cases
 

would be available and when, and we compared this
 

against the calendar and the timing with when the
 

contractor would be -- when the contract is likely
 

to be awarded and I have a little -- the last slide
 

I have is a little bit of a time line on how we see
 

this -- this going down the pike.
 

We talked more about case selection criteria
 

and by that I mean site exposure, cancer type, and
 

then our strategy for sampling and -- and we tried
 

to work with NIOSH yesterday and we -- we still have
 

to do some more legwork on this, but to characterize
 

the existing -- the characteristics of the cases
 

they have right now. As I estimated yesterday, Dick
 

Toohey from ORAU did provide us with a query of the
 

number of dose reconstructions by site, sorted by
 

site, and there's about 12,000 -- a little more than
 

12,000 cases I believe are currently in the system.
 

And this -- this gave us a sense -- and we further
 

asked well, can we -- can we sample -- in the
 

current database can we stratify this further by
 

these other parameters, and we're still -- we're
 

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still working through some of these things to see
 

how we might do that. So at least we got a sense of
 

by site where the major claims are and we're going
 

to proceed on -- use possible other strata and how
 

we might sample against that.
 

And then the final thing is develop individual
 

task orders, and we will probably focus on -- the
 

initial task orders we see as most urgent, I guess,
 

would be the basic review task order, the advanced
 

review task order and the procedures review task
 

order. And we -- we think that we can do this in
 

parallel so that we can have the final drafts of
 

these task orders ready by the time the contract is
 

awarded. And then as soon as the contract's awarded
 

we can release these task orders so that the
 

contractor or contractors can bid against those task
 

orders. You know, that's -- shortening the time as
 

best we can so that we can actually get some reviews
 

done. I think that was it for that.
 

The one thing on the task orders, we feel
 

pretty confident that the -- a lot of time and
 

effort went into the contract itself in specifying,
 

especially for basic review and advanced review,
 

specif-- there was a great level of detail and
 

specificity, and we don't think it's going to be a
 

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major leap to go from there to actual task orders
 

for those two particular things. For SEC petition
 

review and the -- and for the site profile reviews,
 

which -- I think they're still in there, they're
 

less defined right now in the -- in the overall
 

contract, so I think we have a little more legwork
 

to do. And we didn't have a rule at the time when
 

we were writing this so we -- you know.
 

And here's the time line I was talking about.
 

We -- the task order -- as I understand it, as of
 

yesterday this task order -- RFP should be published
 

by the end of March, sometime -- maybe a little
 

before the end of March.
 

MR. ELLIOTT: Could I speak to this time... I
 

can give you some harder dates.
 

MR. GRIFFON: Okay. I didn't want to commit
 

you to harder dates, Larry.
 

MR. ELLIOTT: No -- no, that's okay.
 

MR. GRIFFON: I was being -- I was being nice
 

up here.
 

MR. ELLIOTT: No, and I don't want to steal
 

your thunder, but I -­

MR. GRIFFON: I was going to put hard dates,
 

but -­

MR. ELLIOTT: You should write them down
 

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because you can hold me accountable for this because
 

I -- we sought yesterday from the contracting
 

officer what exactly could we say today to the
 

Board -­

MR. GRIFFON: Okay.
 

MR. ELLIOTT: -- about hard dates.
 

MR. GRIFFON: Okay.
 

MR. ELLIOTT: Let me just add one element to
 

your time line. The five-member technical
 

evaluation panel was identified and incorporated
 

into the contracting -- the procurement, and that
 

was done 2/18/03. It took us that long to finally
 

get the last person to commit.
 

On 3/18, March 18th, we will see the synopsis
 

of the RFP announced in the Commerce Business Daily.
 

What that means is your scope of work and your
 

evaluation guide will be presented for public
 

viewing in that -- in the Commerce Business Daily as
 

a synopsis. That'll happen on March 18th.
 

On March 21st the RFP -- or excuse me, May -­

or April 21st the RFP will be released for bid, so
 

they'll have 30 days to examine it and then they'll
 

have about another 30 days and at the end of May the
 

final proposals will be due. I don't have a date to
 

give you there. That'll be actually determined by
 

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the contracting officer.
 

MR. GRIFFON: Right.
 

MR. ELLIOTT: There's some -- several steps as
 

you see here in addition to those. There's a pre-


bid conference. That date has to be determined yet,
 

and it will require the presence of the Chair and
 

any other Board members that want to participate in
 

that, but it's your procurement so you need to at
 

least have Dr. Ziemer there and other Board members
 

who want to speak to questions about your intent.
 

Then the due date for receipt of proposals is
 

yet to be determined. That would happen after the
 

pre-bid conference.
 

MR. GRIFFON: Right.
 

MR. ELLIOTT: And then there -- the due date
 

for the technical evaluation panel report is yet to
 

be determined. The date for the award is yet to be
 

determined. There's a number of steps in between
 

all of these that the contracting officer has to
 

check off and do, so many more than you have there.
 

MR. GRIFFON: Yeah, yeah.
 

MR. ELLIOTT: But this is the critical time
 

line.
 

MR. GRIFFON: This -- yeah, thank you, Larry.
 

We -- and I had a couple of those dates from
 

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yesterday but I was -- I didn't want to hold you to
 

some -­

MR. ELLIOTT: I wanted to make sure what we
 

could have on the record and what we could share
 

with the Board.
 

MR. GRIFFON: Okay, right.
 

MR. ELLIOTT: I'd also remind the Board to send
 

in any names and addresses of potential bidders for
 

this solicitation to Martha DiMuzio. I sent an e-


mail out -- Cori sent an e-mail out last week for
 

me. We need those by Monday in order to keep on
 

track here. These are people you think might be
 

interested in seeing this RFP and we'll make sure
 

that they are so alerted.
 

MR. GRIFFON: And we -- and finally we also
 

estimated or ORAU gave us an estimate that by the
 

time of contract award or roughly therein -- or this
 

estimate that I have anyway on this time line, there
 

should be some 1,300 cases -- is that -­

UNIDENTIFIED: Probably closer to 2,000, but
 

they won't all be final.
 

MR. GRIFFON: Okay, they won't all be final,
 

right. Right. So probably -- probably 1,300 to
 

2,000 cases with dose reconstructions complete.
 

They may not be through the DOL process, but...
 

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MR. ELLIOTT: I would just qualify that with
 

what it takes to become a final dose reconstruction
 

ready for your review. And of course there's the 60
 

days after that the claimant receives their decision
 

for their appeal to happen, so you have to allow
 

that 60-day -­

MR. GRIFFON: Yes, and we did -­

MR. ELLIOTT: -- window to expire before you
 

could take it up as a completed case.
 

MR. GRIFFON: Larry, we considered that in
 

there, yes.
 

DR. NETON: It's a 30-day window, just to
 

correct that. I was wrong, I thought it was 60.
 

It's a 30-day window for the notice of appeal.
 

DR. ZIEMER: Thank you.
 

MR. GRIFFON: And I think that's -- that's it.
 

That's it.
 

DR. ZIEMER: Okay. Let's open the floor for
 

questions, any clarifications needed. Roy? Or
 

additional comments from others on the working
 

group, as well.
 

DR. DEHART: I think the Board would be
 

interested to know that probably all of us will have
 

an opportunity to review these cases as they come
 

through the contractor, working with the contractor.
 

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And the information, as we understand it today, will
 

be available on disk, so everyone will get a disk
 

for those cases that they're reviewing, how many
 

number of reviewers that we have, two or three for
 

each cycle. And we would see this occurring on a
 

monthly basis and it means that we each are going to
 

have to have some time for an educational
 

opportunity to see how those data files exist, how
 

we access them and what they mean. So
 

August/September we're going to be learning how to
 

assess this.
 

DR. ZIEMER: Thank you, Roy. Jim, comment?
 

DR. MELIUS: Two -- actually two questions.
 

One is -- and I'm not sure you can answer this,
 

Larry, and you probably have answered it earlier,
 

but it's this issue of are there going to be one or
 

more than one contractor awarded and how that
 

determination is made. I can't remember what we -­

how we've dealt with this up to date, but are -­

MR. ELLIOTT: You can make a -­

DR. MELIUS: -- there criteria for that?
 

MR. ELLIOTT: You can make a multiple award
 

based upon who bids and how you -- how the technical
 

evaluation panel qualifies them. If there's two
 

equally technical, capable -- if you want to make
 

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I 

two awards or multiple awards, you can do that under
 

this procurement.
 

DR. MELIUS: And is that something the review
 

group recommends or is -- how is that dealt with?
 

just...
 

MR. ELLIOTT: I think that the technical review
 

group will get a charge from the contracting officer
 

that has to speak to that. The Board has to provide
 

some input to the contracting officer as to their
 

desire to see that level of evaluation occur. So
 

you need to be -- you'll need to be up front with
 

the contracting officer that, you know, we want to
 

see what comes forth in the proposals, and if there
 

are equally-weighted proposals after the technical
 

evaluation panel, we might be interested in making a
 

multiple award. It's between you and the
 

contracting officer at that point in time.
 

DR. MELIUS: And so where does this come back
 

to the Board then, this process? I guess that's
 

what I'm trying to...
 

MR. ELLIOTT: It would be after the technical
 

evaluation panel meets and provides their
 

information to the contracting officer. Contracting
 

officer would then get in touch with the Chair and
 

walk the Chair and, if you had a working group with
 

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the Chair or however you want to set this up so that
 

there's more than I think just one person looking at
 

this, it would be a decision made at that time.
 

DR. MELIUS: Okay.
 

MR. ELLIOTT: NIOSH -- of course NIOSH is not
 

going to be making that decision for you. This has
 

to be a decision of the Board how you want to
 

proceed with the award.
 

DR. MELIUS: And that's why I'm bringing it up
 

as an issue of scheduling and where this -- we have
 

to figure out how to fit that into the Board's
 

schedule so we're not holding this up.
 

MR. ELLIOTT: It comes at -- right before -­

there's a step called the best and final offer, and
 

so there's a negotiation process when you identify
 

the top proposer or proposers. Then you go into
 

what's called BAFO, best and final offer, and that's
 

at the point that the Board needs to interject do we
 

want two, three, six, one -- how many awards do we
 

want to make. And then you -- then the BAFO goes
 

forward with all of those reacting, or just one
 

reacting to provide a -­

DR. MELIUS: A related procedural question
 

concerns the task orders. Now we'll have -­

according to Mark's schedule, there'll be the -- the
 

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draft task orders from the work group around the end
 

of May or something. Is that something -- at what
 

point does the full Board discuss those? And then
 

I'm particularly concerned related to the issue of
 

the OMB review on terms of -- some point we have to
 

come to grips with the whole issue of how do we
 

review the interviews -­

MR. ELLIOTT: Sure. Sure.
 

DR. MELIUS: -- and to what extent we can talk
 

about that. And I think the plan, as I recall, was
 

that we would do that in terms of a specific task
 

order, and the task order would have to become a -­

be a public document, I think -­

MR. ELLIOTT: Right.
 

DR. MELIUS: -- for us to discuss it and move
 

it forward. Is there an option for only part of
 

that document to be public so that we could just
 

focus on the interview section without violating
 

whatever your procurement rules are and so how does
 

that fit in I guess is my question.
 

MR. ELLIOTT: You would need to take up Board
 

discussion of task orders after the proposals have
 

been submitted. And I need to check on this, but it
 

may -- maybe also after the best and final. I don't
 

know how much a task order development in a public
 

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forum would influence a best and final. So I'll
 

check with the procurement office about that.
 I
 

understand the dilemma, that if it's after the best
 

and final, that gets right up close to where the
 

award's -- it's probably a month before the award is
 

made. That doesn't give you a lot of time.
 

DR. MELIUS: Okay. Then at the time you check
 

that, could you also check about the possibility of
 

a partial task order being discussed here 'cause -­

'cause that's going to -- that's a process to move
 

that forward that could -- I mean the longer we get
 

-- delay getting that started, the long -- and I
 

think there needs to be discussion by the Board of
 

that issue and how to handle and so forth, but I
 

think we need to sort of understand the time line
 

here 'cause that could -- could conceivably get -­

delay that a long time and -- and could be a
 

problem.
 

DR. ZIEMER: Gen and then Tony. Or -­

DR. ROESSLER: It's Bob. We look a lot alike.
 

MR. PRESLEY: Well, I'd like to make a
 

recommendation that the Board, as a total, be given
 

the opportunity as soon as possible to go see what
 

we did yesterday so that the total Board will be
 

able to start this as soon as possible, just as soon
 

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as we get ready and everything gets done, so -­

because everybody's going to have to go through it.
 

DR. ZIEMER: Robert, we'll so note that.
 

Recognize our next meeting is in Oak Ridge, so it
 

can't happen then, and it would have to be perhaps
 

after that.
 

Okay, Tony.
 

DR. ANDRADE: Just a quick question for Larry.
 

Don't we have to disclose at the bidder's conference
 

whether there will be consideration for multiple
 

contractors?
 

MR. ELLIOTT: Yes. The answer is yes, at the
 

bidder's conference you -- thank you for that
 

correction 'cause you will have to have a -- you'll
 

have to have an open blanket statement that it will
 

be considered. It won't be -- you know, it's not a
 

final commitment, but it's a consideration the Board
 

will give to the proposals submitted, and we can
 

make that happen.
 

DR. ZIEMER: Other questions or comments? Any
 

other working group members have items they want to
 

input? Jim?
 

DR. MELIUS: Just back to the issue on the
 

review of the interviews, depending on what -- how
 

Larry gets back to us on what the answers are in
 

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terms of timing, I think that -- I guess in terms of
 

the next step coming up for the working group or new
 

working group, I'm not exactly sure how we're doing
 

this, would be I think really to look at what some
 

of the options are for reviewing the interviews,
 

that that get fleshed out in some way that we can -­

for now. You may have done it already, I don't -­

don't know what -- I didn't hear it described
 

yesterday, but -­

MR. GRIFFON: It didn't get described.
 

DR. MELIUS: Yeah, so I think that would be
 

helpful -- again, somewhat depending on what -- how
 

-- what Larry's answer back to us is when we can
 

openly discuss it, so...
 

MR. GRIFFON: Yeah, I expected it to come up
 

when we started fleshing out the basic and advanced
 

review, you know, that we would have to flesh out
 

that and look at options on how that could be
 

handled, so we will.
 

The only -- the only other thing I was going to
 

add is that -- before we leave today I'll try to get
 

hold of all the working group, maybe at a break, and
 

see if we can schedule a conference call down the
 

line here to meet before Oak Ridge. I think we
 

probably need to keep this thing moving, so...
 

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DR. ZIEMER: Okay. And we'll expect an update
 

then at Oak Ridge on the status of this effort.
 

Thank you.
 

BOARD DISCUSSION/WORK SESSION
 

SPECIAL EXPOSURE COHORT - NPRM
 

DR. ZIEMER: Any other comments on this topic?
 

If not, we'll return now to our Special Exposure
 

Cohort working session. And let's ask Ted to step
 

us through -- as we go through section by section,
 

ask Ted to identify what changes have been made in
 

that particular section. That will help us to
 

address these sequentially. So does everybody have
 

their copy now of the document? I'm looking to see
 

if there's anything on the first few pages that
 

anyone has any questions about, the supplementary
 

information, the statutory authority -- which is
 

simply -- basically describes the document and why
 

it's being prepared. The definition of the Special
 

Exposure Cohort on page 6 -­

MR. KATZ: Dr. Ziemer?
 

DR. ZIEMER: -- any -- yes.
 

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MR. KATZ: I'm sorry, the part I was going to
 

help you with -- I was going to walk you through the
 

actual rule itself. Is that -- are you going to go
 

through the preamble first?
 

DR. ZIEMER: I thought we would go through the
 

preamble 'cause that will help us. Is that a good
 

way to do it, Ted, from your perspective or did you
 

want to refer back and forth?
 

MR. KATZ: I mean that's fine, but there's no ­

- there's no role for me in terms of changes. The
 

preamble's completely different, basically because
 

it's dealing with the comments and so on. But if
 

you want -­

DR. ZIEMER: But the preamble does explain what
 

was done.
 

MR. KATZ: It does explain in response to
 

comments what was done. What I could do -- I mean
 

you can do it that way. Alternatively, I can walk
 

you through the sections and tell you section by
 

section exactly what was changed and why, and you'll
 

capture all that section by section versus sort of
 

issue by issue, comment by comment, which is how
 

you'll get it in the preamble. And the preamble
 

doesn't address other changes that weren't commented
 

on, either. So -- so if you want to do the preamble
 

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first, I'll -- I can step down from this now or if
 

you want to do the rule itself first.
 

DR. MELIUS: I think the rule would be easier.
 

DR. ZIEMER: Huh?
 

DR. MELIUS: I think the rule would be easier,
 

and then go back -­

DR. ZIEMER: Yeah, it sounds like we can start
 

with the rule itself and then use that as a
 

springboard to go back into the preamble as needed.
 

Okay.
 

But let me double-check. Are there any issues
 

before that actual preamble stuff, any questions on
 

the early part of the document? Okay.
 

Let's go into the rule itself then.
 

MR. KATZ: So at page 66 or thereabouts.
 

MS. MUNN: Page 64.
 

MR. KATZ: Well, I mean there's -- I mean this
 

is just -- it begins with the -- yeah, the table of
 

contents, which you probably don't -­

DR. ZIEMER: Anything on 64 or 65 that anybody
 

has questions on? Subpart A? Any questions or
 

comments?
 

MR. KATZ: And just let me say then, since
 

we're starting with 83.0, for 83.0 we just made
 

minor clarifications and added legal citations and
 

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there's nothing substantive changed from what you
 

reviewed before.
 

DR. ZIEMER: Questions or comments on that
 

section? The same for 83.1 and 83.2?
 

MR. KATZ: So 83.1, let me explain what changed
 

in 83.1. We added explanation to this section
 

clarifying that the SEC rule's not intended as an
 

alternative compensation avenue for cancer claims
 

that have received dose reconstructions and have
 

been denied under the non-Cohort procedures, and
 

indicate that there is a DOL procedure under 20 CFR
 

Part 30 for a claimant to contest a finding of a
 

NIOSH dose reconstruction. And this was a thing
 

that the Board actually recommended we make this
 

clarification. This was responding to the Board's
 

comment.
 

DR. ZIEMER: Let me again ask, any questions on
 

that change? It's near the bottom of 67, the last
 

few sentences, and is response to a Board comment.
 

No questions? Okay.
 

83.2?
 

MR. KATZ: Now this -- we've only made minor
 

clarifications to this. We did drop a section.
 

There was a -- in the original there was a section
 

83.2 that was entitled "How would cancer claimants
 

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be affected by the procedures in this part?" and it
 

was non-procedural and really redundant of other
 

explanation in the rule, so we took it out to make a
 

savings where we could.
 

DR. ZIEMER: Questions on that section? Okay,
 

Subpart B, anything under definitions, 83.5?
 

MR. KATZ: So do you want me to tell you about
 

some changes we made here? We revised the
 

definition of class of employees to delete the
 

requirement that the employees of a class be
 

similarly exposed to radiation. All that's
 

important is that we can't reconstruct their doses,
 

but they don't have to be similarly exposed to be
 

within the class.
 

DR. ZIEMER: Tony has a question.
 

MR. KATZ: Tony, sorry.
 

DR. ANDRADE: More of a comment, Ted. I don't
 

know if you want to jump into this here or not, but
 

under the definition of class of employees there is
 

hidden in there a very important piece, and that is
 

that one of the discussion points that we got caught
 

up on was what happens to employees that work at
 

multiple facilities. And in here we talk about
 

looking at employees that have worked at one
 

facility at a time and that have been potentially
 

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exposed at that given facility.
 

MR. KATZ: That's correct.
 

DR. ANDRADE: Am I correct in that?
 

MR. KATZ: It's still -- it was in the previous
 

version and it remains defined by a single facility,
 

class of employees employed at a facility, not
 

across multiple facilities.
 

DR. ZIEMER: Does that answer your question,
 

Tony?
 

DR. ANDRADE: I didn't know if we wanted to
 

discuss that any -­

DR. ZIEMER: Well, if you have an issue on it,
 

let's -- anyone? Okay, proceed.
 

MR. KATZ: Okay, let me tell you -- let's see,
 

there are more changes in definitions, as well.
 

Let's see, we deleted the definitions for
 

"endangered the health", IREP and "probability of
 

causation" since these are no longer needed, given
 

the way the rule is now constructed. We also
 

revised the definition of "specified cancer" to be
 

consistent with the definition under the DOL
 

regulation that was finalized this past I think
 

whatever, December or -- what it was, I think it was
 

December. And we also added a definition for
 

"survivor" under EEOICPA since this term's used in
 

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the rule. That's the extent of the changes to the
 

definitions section.
 

DR. ZIEMER: Any questions on that section?
 

Comments? There appear to be none.
 

Then Subpart C, procedures for adding classes.
 

DR. MELIUS: Can I just go back one second?
 

MR. KATZ: Yes.
 

DR. MELIUS: I'm catching up with you here, but
 

the section 83.2 which in the old rule which you've
 

deleted, I'm thinking -- I don't have any problems
 

with the deletion, but it was helpful to have some
 

sort of explanatory information for people. Now you
 

can -- in terms of what their options are and so
 

forth. Now it doesn't necessarily need to be in the
 

regulation 'cause I'm not sure people will read the
 

regulation, but in terms of your outreach materials
 

and what's on the web site and so forth, I think
 

it'd be important to include some of that same
 

information, obviously -­

DR. ZIEMER: I thought you said it was already
 

covered in other places.
 

MR. KATZ: It was redundant, in effect, of
 

other -- and it in fact confused -- you know, the
 

reason we thought to look at it even was because it
 

actually confused some commenters rather than
 

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clarified things for them.
 

DR. ZIEMER: By appearing in this section or
 

just in general?
 

MR. KATZ: By -- they were just confused by the
 

explanation. We -- they drew the wrong inferences
 

from the explanation we had there, too, so it was -­

it was misleading to them.
 

DR. ZIEMER: Okay, Subpart C, Ted.
 

MR. KATZ: Yes, section 83.6, all we've done
 

here is made minor clarifications. It's just
 

English.
 

Section 83.7, two changes here. One, we
 

clarified that the eligibility of one or more
 

employees or survivors of a petition on behalf of a
 

class, you know, is limited to members of the
 

proposed class or their survivors. In other words,
 

employees and survivors cannot petition on behalf of
 

a proposed class in which they're not included -- on
 

behalf of another class, in other words.
 

And second, we added -- as I discussed earlier
 

-- a third group of eligible petitions comprising
 

one or more individuals or entities authorized by
 

employees or survivors of the proposed class. And
 

that was responsive to the request from non-union
 

advocacy groups to have the authority to petition,
 

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as well, on behalf of a class. So we've given it as
 

broad a possible interpretation as we could.
 

DR. ZIEMER: And I'm looking for questions or
 

comments on that change.
 

MR. KATZ: Okay. Section 83.8 then, how is a
 

petition submitted. We made one change, which is to
 

eliminate the requirement for use of a petition
 

form. We had comments saying we shouldn't require
 

people to use the petition form, so we don't. It's
 

voluntary. They will have to address the
 

informational requirements of the petition either
 

way, but they don't have to use the form that we're
 

providing.
 

DR. ZIEMER: Okay, no comments on that? Larry?
 

MR. ELLIOTT: Ted, just so we can be specific
 

here and be on the record, this rule does not
 

present that form. That form is being worked up.
 

It has to go through OMB clearance before we can
 

actually use it and distribute it, so that's why
 

it's not attached to this rule.
 

MR. KATZ: That's right.
 

DR. ZIEMER: But just for clarification,
 

whatever form is developed becomes part of the rule
 

by reference then, or is it -­

MR. KATZ: No, it doesn't -­

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DR. ZIEMER: -- just that there is a form?
 

MR. KATZ: There is a form. It's voluntary -­

use is voluntary.
 

DR. ZIEMER: Voluntary anyway.
 

MR. KATZ: But -- and there will be
 

instructions, as well, for either -- whether you use
 

the form or not -- that will be useful to
 

petitioners.
 

So then hearing no more, on 83.9 there are a
 

whole number of changes. So we eliminated the
 

requirement for people who we attempted dose
 

reconstructions and they couldn't be completed, they
 

don't need to send us their report anymore. They
 

only need to indicate the basis of the petition.
 

That's the first change.
 

The second change, we eliminated the
 

requirement that the petitioners provide information
 

specifically related to the determination of health
 

endangerment. That's gone, and that information, as
 

I said earlier, is no longer useful, really.
 

The third change is we established these new -­

which I've presented -- maximally objective
 

requirements for the petitioners to justify their
 

concern that it might not be feasible for NIOSH to
 

estimate their radiation doses with sufficient
 

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accuracy.
 

The fourth change is we deleted a requirement
 

concerning the feasibility of dose reconstruction,
 

which was the verification -- requiring petitioners
 

to seek verification from DOE or an AWE with respect
 

to their information on what data's available.
 

And fifth, if a petition's based on an exposure
 

incident versus normal operations, we include the
 

option of requiring the petitioner to provide
 

evidence of the incident, although only in cases
 

where we can't confirm the occurrence of the
 

incident through other sources available to NIOSH.
 

We don't think this will be very common, but those
 

are the only circumstances where they would have to
 

do that.
 

DR. ZIEMER: Yes, Henry.
 

DR. ANDERSON: I see that it's a proposed -- as
 

part of the applications, a proposed case -- or
 

class definition and that ultimately HHS will decide
 

that?
 

MR. KATZ: That's correct.
 

DR. ANDERSON: I mean that kind of opens the
 

possibility -- what would happen if somebody files
 

this and then as part of your definition the person
 

is excluded, so now you don't have somebody
 

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proposing who's part of the final group? Is that a
 

possibility of happening? I mean -- it would still
 

go -- so you'd create a class, but there would be
 

nobody in it yet because the person who's applying
 

it wouldn't apply to anymore. Is that a -­

MR. KATZ: That is possible. I mean it is
 

possible that someone proposes a class that they're
 

in -­

DR. ANDERSON: That they think they're in but
 

they aren't.
 

MR. KATZ: -- and by the time -- by the time
 

we've done the research and so on, the class is
 

defined -- it might exclude them. That's true.
 

DR. ANDERSON: But then would it still go
 

forward as a class?
 

MR. KATZ: It would still go forward. I mean
 

once -- the point of a petition is to initiate the
 

consideration of a class that should be considered.
 

So whether the person who petitions and thinks
 

they're a part of the class initially, whether they
 

ultimately end up -- when I -- let me clarify. They
 

would -- their petition -- they would be part of a
 

class that would be considered in any event. What
 

might happen, though, is that if they petition to be
 

part of a class and we go into it, we do the
 

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research and what we find is in fact there are two
 

classes here, there's a class for whom we can do
 

dose reconstructions and a class for whom we can't
 

do dose reconstructions. And that individual that
 

petitioned might fall, in reality, into the class
 

for whom we can do dose reconstructions and hence we
 

may establish a class, add a class to the Cohort
 

that does not include the initial -- original
 

petitioner. That petitioner would still have
 

his/her class considered, but the result of that
 

consideration may be that they're not added.
 

DR. ANDERSON: But it would go forward to be
 

part of it. It wouldn't be -­

MR. KATZ: Oh, it would go forward.
 

DR. ANDERSON: Since the person isn't in it who
 

applied, it then is a denied petition?
 

MR. KATZ: No, no. So that class would go
 

forward and be considered by NIOSH, it would be
 

considered by the Board, considered by HHS and so
 

on. But there might be -- what I'm saying is it
 

might be two classes.
 

DR. ANDERSON: Yeah.
 

MR. KATZ: And that person may not be in the
 

class that ultimately gets added.
 

DR. ANDERSON: So you could add a class for
 

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which you don't yet know that there's anybody in it,
 

other than theoretically. I mean there's nobody
 

who's applied who would be part of -­

MR. KATZ: Right, nobody's applied, but we
 

would know that there were people who did the work
 

that's part of the class definition.
 

DR. ANDERSON: Okay.
 

MR. KATZ: Right? In the jobs and so on, so
 

we'd know that -­

DR. ANDERSON: It wouldn't be -- I wouldn't
 

want you to go to all that work and then, because
 

somebody's excluded -­

MR. KATZ: Right.
 

DR. ANDERSON: -- it then gets dropped.
 

MR. KATZ: Right. But I mean you could create
 

a class where no one ever incurs cancer, as well.
 

DR. ANDERSON: Yeah.
 

MR. KATZ: And you never end up compensating
 

anyone because no one incurs cancer.
 

DR. ZIEMER: Jim and then Tony.
 

DR. MELIUS: I haven't read through the new
 

rule enough to know what -- how you're handling
 

this, but in that particular case then who -- who
 

can represent that class in terms of should there be
 

a -- an appeal or some sort of a problem? Is it the
 

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person that gets turned down -- appeal or what -­

you know, who's sort of monitoring what's going on
 

and who has any sort of right to appeal or deal with
 

issues related to that petition?
 

MR. KATZ: Well, the petitioner -- as I said,
 

the petitioner's petition goes forward and they can
 

-- they can appeal their -- they can appeal their -­

you know, their handling by -- the results of the
 

petition process. They can appeal it -- they're not
 

excluded -- they're part of the process, they're
 

still the petitioner, they will -- if they don't
 

like the outcome, they can appeal it.
 

DR. MELIUS: Yeah, but what if there's another
 

part of the outcome that somebody else might object
 

to who's not a party to the original petition? Do
 

you split up the class in such a way that...
 

MR. KATZ: So -­

DR. MELIUS: -- that you have a -- but -- you
 

split it up, but you limit it in some way, but you
 

don't limit it in a way that affects the original
 

petitioner, and -- and you -- say you -- assume
 

you're correct, that that petitioner should be
 

turned down, that their dose or the class they're
 

proposed and that -- at least part of that class can
 

be reconstructed? It seems to me it just gets -­

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MR. KATZ: So then the petitioner who's out -­

I mean in this case, the petitioner then -- again,
 

the adverse outcome would be affecting the
 

petitioner and they would appeal. And then the
 

other class that you created that would be added to
 

the Cohort, I'm not sure what they'd be appealing.
 

DR. MELIUS: Well, what if there's also, in
 

essence, an adverse decision related to some other
 

part of that class -- proposed class? I just don't
 

understand the -­

MR. KATZ: Well, I mean -­

DR. MELIUS: -- procedure of the thing here.
 

MR. KATZ: I mean it -­

DR. MELIUS: It gets very complicated.
 

MR. KATZ: I mean you wouldn't -- it's not
 

complicated, I don't think. It's -- the possibility
 

is that you have identified a class, identified two
 

classes rather than one, one class for whom you can
 

do dose reconstructions and one class for whom you
 

can't. And in that case, if the petition is
 

adversely affected, they can appeal the decision.
 

Whether they're adversely affected or not, they can
 

appeal the final decisions of the Secretary.
 

DR. MELIUS: Okay.
 

MR. KATZ: But I think the class that's added,
 

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if that comes about, they're not going to be -- any
 

appealing.
 

DR. ZIEMER: Tony.
 

DR. ANDRADE: I would just like to comment that
 

on the other side of this issue that multiple
 

petitions can be filed by different people or groups
 

of people, and what HHS can do is actually combine
 

petitions if they're similar in nature.
 

DR. ZIEMER: Okay, thank you. Roy?
 

DR. DEHART: If NIOSH has evaluated a
 

claimant's dose and you're unable to establish
 

whether or not a -- you can't do a reconstruction -­

dose reconstruction, that individual will not
 

automatically be entered into a petition. Is that
 

correct? That individual must file specifically.
 

MR. KATZ: They must submit a petition is true.
 

We will -- when we -- when we determine that we
 

can't do a dose reconstruction, we will directly
 

encourage the individual to submit the petition and
 

provide them with the form to submit the petition.
 

So -- I mean I envision they will always submit a
 

petition, having found that they can't have a dose
 

reconstruction. But -­

DR. DEHART: You've answered my question.
 

MR. KATZ: Yes.
 

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DR. DEHART: They're not -- they're not just
 

hanging out there.
 

MR. KATZ: No, they're not hanging out there,
 

and we will be encouraging them -- I mean that's a
 

class we want to deal with, right, because we know
 

we have a problem.
 

DR. ZIEMER: Other comments?
 

DR. MELIUS: Just -­

DR. ZIEMER: Yes, Jim.
 

DR. MELIUS: Back to my previous confusing
 

question, 'cause I'm confused. I guess the example
 

I come up with would be that if we're going to do
 

this organ-specific cancer, that the petitioner may
 

have one cancer, they may get allowed. But what
 

happens to all the people that have kidney cancer
 

that get turned down who aren't really represented?
 

There's never -- there's not an appeal. They would
 

have to then petition as a new class in order to
 

appeal the -- the rejection by the Board 'cause
 

there may be additional information, whatever. I
 

mean it just -- I don't know. I think we'll have to
 

work -- see how this works out through -­

procedurally, but it seems to me it's potentially
 

problematic.
 

DR. ZIEMER: Are there other changes in this
 

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section, Ted, that you want to highlight? As you
 

proceed, be sure to identify any of these that are
 

related to Board comments.
 

MR. KATZ: Yes. There are no other changes to
 

this section, but -- yeah, okay. So I don't think
 

any of these were -- well, the Board also discussed
 

this issue of verification.
 

DR. ZIEMER: Right.
 

MR. KATZ: I'm not sure it was in there, their
 

comments.
 

DR. ZIEMER: I think Henry has a comment.
 

DR. ANDERSON: Yeah, do you foresee, as these
 

begin to accumulate, that now a -- another person
 

files, they don't know that they're actually part of
 

a class. Will you be able to up front identify that
 

-- that they might -- so that you don't go through
 

all of the attempting to reconstruct, only to find
 

out after the fact that you can't?
 

MR. KATZ: That they're part of a class?
 

DR. ANDERSON: Yeah.
 

MR. KATZ: No, I think -- we're going to be
 

able to -- DOL will -- I mean it won't even come to
 

us.
 

DR. ANDERSON: Okay.
 

MR. KATZ: DOL will identify them as part of
 

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that class.
 

DR. ANDERSON: So we won't -­

MR. KATZ: So it won't even come to NIOSH as a
 

-- for a dose reconstruction.
 

DR. ANDERSON: So once you define the class,
 

it'll be sufficiently tight that they'll be able to
 

spot that when somebody comes in who doesn't know
 

they're part of -­

MR. KATZ: That's right. It's very -- it'll be
 

very precise, so they won't know they're going in as
 

a member of the Cohort, but they'll be treated as a
 

member of the Cohort by DOL.
 

DR. ANDERSON: Yeah. Okay.
 

MR. KATZ: And then it's entirely possible -­

we're going to do as much as we can to get the word
 

out to the claimant population that we've added a
 

class to the Cohort. We're going to work that as
 

hard as we can, but in any event, even if they don't
 

know, if they incur cancer, they make a claim,
 

they'll be treated as a member of the Cohort.
 

DR. ZIEMER: Jim.
 

DR. MELIUS: Yeah, I'd just like to point out,
 

I think you've also done some reorganization of the
 

way the information is presented about short term
 

over incidents of exposure, you've reworded some of
 

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that, I think, and at least moved it around
 

organizationally within this section on petitions.
 

MR. KATZ: Okay, I'm not saying I didn't
 

gerrymander paragraphs or whatever, but -­

DR. MELIUS: I'm not accusing, I'm just
 

pointing it out, Ted. People -- people on the Board
 

should take a look at that and see if it's clear -­

MR. KATZ: Okay.
 

DR. MELIUS: -- if we're going to -- something
 

we need to consider commenting on 'cause it confused
 

me when I first read it.
 

MR. KATZ: Okay. So are we -­

DR. ZIEMER: Let me just ask for clarification
 

there. Simply because of the position in the
 

document, it may look like something was deleted
 

when it was simply moved or -- is that the kind of
 

thing you -­

DR. MELIUS: Well, I think as they -- in terms
 

of adding some of these new criteria and
 

information, they've sort of reworked some of this
 

stuff, and I haven't really had a chance to read it
 

in detail to know if it's better or worse. But it
 

confused me when I first read it.
 

DR. ZIEMER: Yeah, Leon, I guess we lost you
 

and you're back?
 

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MR. OWENS: Yes, sir, Dr. Ziemer. Thank you.
 

DR. ZIEMER: Okay. I feel like a fisherman,
 

I'm losing him, but he's back on the line.
 

MR. KATZ: Okay, so -­

DR. ZIEMER: Thank you, Jim, for that comment.
 

MR. KATZ: -- now we're on section 83.10. Is
 

that right? Yes. It's 83.10, if a petition is -- I
 

suppose I -- let me just -­

MR. GRIFFON: Can I just go back to 83.9?
 

MR. KATZ: Oh, yes, I'm sorry.
 

MR. GRIFFON: Sorry. On page -- I'm looking at
 

these two sections, it's on page 75. It's I think
 

number (2)(iii) and (iv) -­

MR. KATZ: Yes.
 

MR. GRIFFON: -- on page 75. And at the end -­

I guess I'm just a little -- okay. And I -- I
 

haven't walked this across with our past -- with the
 

past proposed -- proposal and the -- and our Board's
 

comments actually so, you know, I'm flying blind a
 

little here. But my concern is that are we putting
 

the hurdle a little too high for information to come
 

-- or for -- for these petitioners? And
 

specifically I say in section (iii) there at the end
 

of it, it says that they -- if they have a health
 

physicist or other individual with expertise in dose
 

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reconstruction documenting the limitations of
 

existing records on radiation exposure at the
 

facility as relevant to the petition and -- and this
 

is where I have a little concern maybe -- and
 

specifying the basis for finding these documented
 

limitations might prevent the completion of dose
 

reconstructions for members of the class. I wonder
 

if the first part wasn't sufficient enough that they
 

get ex-- you know, we're asking -- I'm just
 

concerned that we're putting a high demand on the
 

petitioners when they may not have access to as much
 

relevant information. They -- they may have a very
 

valid petition, but they can't meet that second half
 

because they don't have enough facts to, you know...
 

And then the same goes for section (iv). I'm
 

not sure what a scientific government agency is, and
 

then I'm also worried about published in a peer-


reviewed scientific journal, specifically because of
 

that last clause. It says "and also finds that such
 

information might be essential to produce such
 

estimates." Again, that language makes me think
 

that geez, these -- you know, I don't know of many
 

peer-reviewed journ-- art-- journal articles that
 

are going to be that specific for that subgroup of
 

workers at a certain facility that they can be even
 

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used, so would it even be sub-- and I know of a lot
 

of published documents, from DOE, for instance. I
 

don't know if that's a scientific government agency.
 

I would assume it would be -- sorry, editorial
 

comment -- but you know, would, you know -- I'm just
 

concerned that a couple of these phrases make it
 

look to me like the burden of proof here is higher
 

for these potential petitioners. I don't know if
 

that's different than the language previously
 

included or not.
 

MR. KATZ: Let me respond to those. One,
 

number (iv) wasn't there. That was actually put in
 

there at the behest of the Board, and it's a
 

either/or -- the -- it's not only peer-reviewed.
 

The DOE would come in under this. They don't have
 

to be published in a peer review. They could also
 

be a government report, unpublished -- you know, in
 

a journal or whatever. It wouldn't be published. A
 

scientific report by a government agency would also
 

qualify, so it's either/or, not a both together
 

requirement. Right. So to cover those DOE -­

DR. ZIEMER: Part of this -­

MR. KATZ: -- reports that you're discussing.
 

DR. ZIEMER: Ted, I think part of this is a
 

wording issue. I think a scientific government
 

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agency is not a recognized -- it may even be an
 

oxymoron, who knows? But I think the intent here is
 

that it's a scientific or technical report from a
 

government agency, so the wording at some point will
 

need to be clarified there. And then I believe Mark
 

is asking whether or not a peer review report has to
 

in fact include the conclusion that the information
 

is essential -- let's see, how is this worded -­

MR. GRIFFON: Finds that such a -- finds that
 

such information may be essential to -­

DR. ZIEMER: Well, it may very well be a peer-


reviewed report that's not directly addressing the
 

issue of dose reconstruction, but might in fact
 

contain information very important to this issue or
 

a special cohort -­

MR. GRIFFON: Yeah, or -­

DR. ZIEMER: -- so it may not make the
 

conclusions that you're talking about here per se.
 

MR. GRIFFON: Or it may not be completely
 

class-specific, you know, it may -- but it may be
 

tangentially relevant to the -­

DR. ZIEMER: Right, right, but I -­

MR. GRIFFON: -- topic, something like that -­

DR. ZIEMER: -- suspect this is more of a
 

wording issue. I think the intent of both the
 

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Agency and the Board is the same here. We may need
 

to do some word clean-up at some point here.
 

Jim, you have a further comment?
 

DR. MELIUS: Yeah, actually continued down on
 

that page, bottom of page 75 over to the top of page
 

76, this is in relationship to the exposure incident
 

thing I was speaking to earlier. And two comments,
 

I think one's a little confusing because this is a
 

section that talks about what needs to be in the
 

petition and you actually have a requirement for
 

exposure incident that only -- as I understand it,
 

is only triggered if NIOSH is unable to obtain
 

records or confirmation of the exposure incident
 

from other sources. And then you require -- have a
 

requirement that the petitioner -- I'm not sure who
 

has to provide this, but someone needs to provide
 

either the medical evidence that one or more members
 

of the proposed class were -- had medical evidence
 

of acute overexposure or there's an affidavit from
 

two employees who witnessed the incident. And I
 

don't recall if that -- those -- those were
 

requirements from the earlier, but it seems out of
 

place here when we're talking about what's in the
 

petition. It seems to be more informational and it
 

also ought to be fleshed out in terms of what is
 

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confirmation of the incident 'cause seemed to me the
 

technical reports, government reports, so forth
 

could be qualified in sort of what the process -­

but it seems to me that this isn't part of the
 

petition. This is part of the evaluation of the
 

petition.
 

MR. KATZ: No, it actually -­

DR. ZIEMER: Ted, can you address that?
 

MR. KATZ: It actually -- I mean if -- if an
 

incident's being alleged that -- and we go out and
 

we can't find any information to indicate that the
 

incident occurred, that's when we come back to the
 

petitioner and they have to demonstrate in effect,
 

one way or the other, that the incident -- they have
 

information to suggest that the incident occurred.
 

DR. MELIUS: Well, I have two points. One is
 

that this is included in a section, what information
 

must a petition include, so it's in the section on
 

the petition and you're requiring information that
 

they can only get after NIOSH has evaluated the
 

petition and is unable to confirm -­

MR. KATZ: No, I mean -­

DR. MELIUS: -- that such an incident took
 

place.
 

MR. KATZ: It's being -- I mean NIOSH would
 

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have to go out and determine whether that incident
 

occurred, if there are records on it and so on -­

DR. MELIUS: I -- I -­

MR. KATZ: Right.
 

DR. MELIUS: I'm not -­

MR. KATZ: That's not the NIOSH -- that's not
 

the NIOSH evaluation of the petition as a whole,
 

that's the evaluation of -- we're evaluating one
 

issue which is -­

DR. ZIEMER: It may be a sequential thing.
 

MR. KATZ: -- is this a documented incident.
 

DR. ZIEMER: The original petition may not have
 

that information 'cause they don't know at that
 

point -­

MR. KATZ: Right.
 

DR. ZIEMER: -- that NIOSH can't confirm it.
 

Is that what you were saying?
 

DR. MELIUS: Exactly. Yeah, exactly, so this
 

is -­

MR. KATZ: Right, it would not be in the
 

original -- in the original petition -­

DR. ZIEMER: And NIOSH would go back and ask -­

MR. KATZ: -- but we would come back to the
 

petitioners -­

DR. ZIEMER: -- them to provide additional
 

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information.
 

MR. KATZ: That's correct.
 

DR. MELIUS: Right, and there's a section
 

83.11, what happens if it does not satisfy
 

requirements, that -- it seems to me it's just out
 

of place and it's going to be confusing to a
 

petitioner. They're not -- you know, why is it in
 

the section on what should be in a petition?
 

MR. KATZ: Because -- because we have to -- we
 

have to confirm first that we have -- that we have
 

an exposure incident.
 

DR. MELIUS: Right, and that's the evaluation
 

of the petition.
 

DR. ZIEMER: Jim is asking why shouldn't that
 

paragraph be under 83.11, what happens -- it's sort
 

of like what are the next steps.
 

MR. KATZ: Well, it could go under 83.11.
 

DR. ZIEMER: I think the point's been raised -­

MR. KATZ: I'm sorry.
 

DR. MELIUS: Yeah.
 

DR. ZIEMER: -- and at some point we might -­

DR. MELIUS: And the comment -­

DR. ZIEMER: -- do that.
 

DR. MELIUS: -- is that it should go in there.
 

MR. KATZ: It should go in 83.11, okay.
 

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DR. MELIUS: Yeah.
 

DR. ZIEMER: So it's a matter of where it is in
 

the structure here in a logical sense. Okay.
 

Tony and then Henry.
 

DR. ANDRADE: I agree with Dr. Melius.
 

However, I think it's a simple addition to 83.11
 

that says that further information contained in this
 

particular section may be requested during the
 

period of time that NIOSH assists with the
 

development of a petition.
 

DR. ZIEMER: It's readily fixable. We don't
 

need to dwell on it at this point. We're trying to
 

identify issues.
 

DR. ANDERSON: Yeah, that was the only thing I
 

was going to say was rather than require the person
 

as a part of the petition to go out and find
 

support, I would just put here that if they allege
 

an incident, they need to know that as part of the
 

validation they may want to -- to do that, so -­

MR. KATZ: Right, we're just letting them know
 

that we may come back to them.
 

DR. ANDERSON: Yeah.
 

MR. KATZ: And I agree, 83.11 is -­

DR. ANDERSON: That a -­

MR. KATZ: -- another place is -­

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DR. ANDERSON: -- claim must be -­

MR. KATZ: -- probably better for this.
 

DR. ANDERSON: -- substantiated with -- with
 

other -- with somebody else, as well.
 

MR. KATZ: Section 83.10 then, if we're -- if
 

we can -- if we're moving on. This is a new
 

section, so you didn't have it in your old rule.
 

And it's intended to clarify the distinction between
 

the role of petitioners in providing sufficient
 

justification for a petition and the role of HHS in
 

determining whether or not to add a class to the
 

Cohort. Some members of the public are under the
 

impression that meeting the petition requirements -­

the petitioner was proving that the class -- making
 

the case that the class needs to be added and that's
 

not -- that burden is not on the petitioners and
 

really not within their means on their own, in
 

normal circumstances. That's the role of the Board
 

and NIOSH and we'll be doing a lot of research and
 

so on to address those.
 

DR. ZIEMER: So this is not a change so much as
 

a clarification.
 

MR. KATZ: Yes.
 

DR. ZIEMER: I mean it's an addition, but it's
 

a clarification -­

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MR. KATZ: It is.
 

DR. ZIEMER: -- of roles.
 

MR. KATZ: It is, but it responds to really
 

confusion we heard from the public on this.
 

DR. ZIEMER: Okay, 83.11 then?
 

MR. KATZ: Section 83.11 there are a number of
 

changes. First of all, this and the following
 

section were split out of the original 83.10. We
 

wanted to separate the procedures for dealing with
 

inadequate petitions from the procedures for
 

notifying interested parties of petitions that
 

qualified for evaluation. There's a notification
 

component. We wanted to break that out of it 'cause
 

it's cumbersome the way it was. And more clearly
 

explained the way it is now, I think.
 

The second thing we did is we no longer
 

require, as we discussed, the Board to consider and
 

recommend the disposition of petitions that NIOSH
 

finds do not meet the basic requirements.
 

And the third change, and we've discussed that
 

I think already, we indicate that NIOSH will provide
 

guidance and assistance to petitioners in addressing
 

the deficiencies of their petitions.
 

Those are all the changes for 83.11.
 

DR. ZIEMER: Do we have comments on this
 

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section? There appear to be none. Okay, let's go
 

ahead then -­

MR. KATZ: Okay.
 

DR. ZIEMER: -- to 83.12.
 

MR. KATZ: 83.12, we simplified the provisions
 

concerning NIOSH/Board interactions on the
 

development of evaluation plans. The Board's
 

involvement in evaluating petitions inherently
 

provides for the Board to review the NIOSH
 

evaluation and provide NIOSH with related
 

recommendations if more research is needed and so
 

on. It was really unnecessary.
 

DR. ZIEMER: Comment? Here's Henry.
 

DR. ANDERSON: Recognizing this is going to go
 

on over time, let's say a petition comes in and they
 

haven't met their -- you know, the criteria, so it's
 

-- it goes back or it's basically denied. If
 

somebody else comes in at a later date with a
 

similar petition, what would you do then?
 

MR. KATZ: Well, it would depend on whether
 

they brought forth new information or not.
 

DR. ANDERSON: Okay.
 

MR. KATZ: But if they came forward with the
 

same information that wasn't sufficient, it would
 

get the same result.
 

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DR. ANDERSON: But you would evalu...
 

MR. KATZ: Yes.
 

DR. ANDERSON: Okay. What are the -- I mean my
 

point really was, it wouldn't be a precedent thing,
 

that a precedent has been made -- I mean, for
 

instance, if somebody said there was an event and
 

you were unable to get multiple people and then
 

subsequently somebody comes along and says they
 

found somebody -­

MR. KATZ: Right.
 

DR. ANDERSON: -- because it was denied
 

earlier, you wouldn't -­

MR. KATZ: We wouldn't -­

DR. ANDERSON: -- just summarily be dismissed.
 

You'd actually -­

MR. KATZ: No, no -­

DR. ANDERSON: -- go through and look at what's
 

in it.
 

MR. KATZ: But that's new information, yes, and
 

then moreover, we would get back in touch with the
 

original petitioner, as well.
 

DR. ZIEMER: Tony?
 

DR. ANDRADE: Henry, I think that's covered
 

under 83.11(c).
 

MR. KATZ: Yes, based on new information.
 

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That's correct. Thank you, Tony.
 

DR. ZIEMER: Any other comments on 83.12?
 

DR. ANDERSON: I mean my -- my point was, the
 

petitioner -- the subsequent petitioner may not know
 

it's new information.
 

MR. KATZ: Right.
 

DR. ANDERSON: For instance, a subsequent
 

petitioner may file that there was an incident.
 

It's a different person filing, and now all of a
 

sudden -- they didn't know the first person. The
 

first person didn't know them and so there's has to
 

be an integrating function at NIOSH rather than
 

we've looked at this incident. We couldn't -­

MR. KATZ: I see what you're saying.
 

DR. ANDERSON: You see what I'm saying?
 

MR. KATZ: Right, right. We'd have to put two
 

and two together.
 

DR. ANDERSON: So that's still one person and
 

they -­

MR. KATZ: Right, or one and one, as it is.
 

DR. ANDERSON: -- don't know the others exist,
 

and as long as somebody in fact will go through it
 

and look for that versus you get back to the person
 

and say you need to find somebody else to verify
 

this and they say we can't, now you've denied two
 

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that if you -­

MR. KATZ: Right, in other words -- I mean we
 

need a tickler system -­

DR. ANDERSON: Yes.
 

MR. KATZ: -- so that we know when we're
 

getting the same allegation.
 

DR. ANDERSON: Yeah.
 

MR. KATZ: By affidavit. Yes.
 

DR. MELIUS: Can I just go back to
 

clarification on that issue, 'cause I think it's
 

relevant here. When you say confirmation by
 

affidavit from two employees who witnessed the
 

incident, does that include the petitioner if the
 

petitioner witnessed the incident? I mean that's...
 

UNIDENTIFIED: Two others.
 

DR. ZIEMER: Right, you're not -­

DR. MELIUS: Is it two others? 

DR. ZIEMER: You're not specifying who the two 

are, are you? 

DR. MELIUS: Yeah, I'm just -­

MR. KATZ: We're not specifying who the two
 

are. I think you'd read that as confirmation,
 

meaning of the petitioners, by two individuals, so I
 

think that would be read as two individuals in
 

addition to the petitioner, yes.
 

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DR. MELIUS: Two in addition to -­

MR. KATZ: The petitioner.
 

DR. MELIUS: See, I would read -- you could
 

read it that -- if it's a labor union, say, that put
 

it in, a representative put it in who would not have
 

witnessed, but if you have a person who witnessed
 

who's the petitioner, why do they need to get -- why
 

do you have to have three? Is the criteria two or
 

three, I guess is -­

MR. KATZ: So I think you'd read this as the
 

criteria is three.
 

DR. MELIUS: I disagree with that and we'll
 

talk about that later.
 

DR. ZIEMER: It's probably not fully clear here
 

which it is. Whether it's two or three, it needs to
 

be clear.
 

DR. MELIUS: Clear, and I think we need to talk
 

about what's -­

DR. ZIEMER: Right.
 

DR. MELIUS: -- given -- situation.
 

DR. ZIEMER: Okay, thank you.
 

DR. MELIUS: That's a pretty big burden for an
 

incident.
 

DR. ZIEMER: Then perhaps in that context one
 

could ask about sort of legal frameworks for what is
 

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needed to establish something in terms of witnesses.
 

DR. MELIUS: Yeah, yeah. No, it's a...
 

DR. ZIEMER: And I don't know what the answer
 

to that -- I always thought it was two or more, but
 

DR. MELIUS: Yeah.
 

DR. ZIEMER: Well, two or more -- three, as
 

much as you want. Okay. Mike here.
 

MR. GIBSON: What if, just as Jim brought a
 

labor organization or something or trying to make
 

the petition and it's for say old AWE site or
 

something to where there's not -- there might not be
 

witnesses around yet, it may be for survivors?
 

MR. KATZ: I'm sorry, can you just run that by
 

me one more time?
 

DR. ZIEMER: Yeah, it's an issue of what if
 

there aren't witnesses around. Is that right, Mike?
 

MR. GIBSON: Like a labor organization brings
 

forth a petition for a facility and it's from years
 

ago and there may not be survivors that are readily
 

available to verify that they witnessed the event,
 

it's mainly for survivors -­

MR. KATZ: And so the labor union is bring it
 

forward with -- on what basis, because survivors
 

told the labor union that an incident occurred?
 

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MR. GIBSON: Correct. And then say you guys go
 

back and you try to look for two or three witnesses
 

and maybe they -- you know, you can't find them
 

based on it was an old facility, it's been gone for
 

years.
 

MR. KATZ: All right, well, this -- clearly -­

clearly they would not -- the survivor would not
 

qualify as a witness.
 

MR. GIBSON: No, I'm asking -- this would -­

this could preclude them from -- this could
 

eliminate them from becoming a special cohort.
 

MR. KATZ: It could -- it could preclude them
 

from making the case that the incident occurred if
 

there are no records and only survivors are
 

asserting that the incident occurred, that's
 

correct. You're right. That's what it says.
 

DR. MELIUS: But just to elaborate on that, but
 

this is just for the purposes of qualifying. If
 

there were say six widows or whatever that, you
 

know, had -- you know, knew that their spouses had
 

reported this or whatever, if there was sort of
 

credible evidence from them, would -- couldn't that
 

be evaluated in some way? I mean they -- do they -­

this doesn't automatically make them a Special
 

Exposure Cohort. This is just to qualify, and I
 

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would think that a less stringent requirement could
 

be put in here and then there'd be an evaluation of
 

that, is this a -- are these credible accounts of -­

of what happened, is it sufficient, it's hard to -­

DR. ZIEMER: It's almost like how do you handle
 

what might in courts be called hearsay. It's
 

removed from the direct evidence -­

DR. MELIUS: Yeah.
 

DR. ZIEMER: -- and sometimes that can be
 

established as being credible -­

DR. MELIUS: Right.
 

DR. ZIEMER: -- depending on the situation.
 

DR. MELIUS: Because it's a consistent story,
 

you know.
 

DR. ZIEMER: It may be an issue that will have
 

to be dealt with -­

DR. MELIUS: Yeah.
 

DR. ZIEMER: -- in some way.
 

DR. MELIUS: Yeah.
 

DR. ZIEMER: Thank you for raising that point.
 

DR. MELIUS: Yeah.
 

DR. ZIEMER: Okay.
 

MR. KATZ: Okay. Where are -- sorry, where are
 

we?
 

DR. ZIEMER: Well, let's see, that -­

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MR. KATZ: Are we on 83.13 now?
 

MS. MUNN: We're on 83.13, yeah.
 

MR. KATZ: Okay.
 

DR. ROESSLER: Did we do 12?
 

MR. KATZ: Yes, I think we did.
 

DR. ROESSLER: Can we go back to 12?
 

DR. ZIEMER: Hold on then, I think Dr. Roessler
 

has an item on 12.
 

DR. MELIUS: I don't think we did 12.
 

MR. KATZ: Oh, no, we didn't do 12. I'm sorry.
 

Oh, yeah, we did. We did -- at least I spoke about
 

12.	 You may not have commented -­

DR. MELIUS: I missed it, too.
 

DR. ROESSLER: I just now looked at something
 

that I think I want clarification on and that's the
 

difference under 83.12 between (c) and (d). I mean
 

I see the difference, but I guess I would like an
 

example of when (d) would be acted upon rather than
 

(c). Can you give me some circumstance where the
 

NIOSH may initiate work to evaluate a petition
 

without going to the Board?
 

MR. KATZ: Yes, I certainly think -- I mean it
 

depends really just on the coincidence of timing
 

that we'll want to get to work on these petitions as
 

quickly as possible. And whether we have a Board
 

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meeting scheduled for 45 days hence, I don't think
 

we want to wait that Board meeting to propose to the
 

Board our plans for evaluating that petition. We
 

would just -­

DR. ROESSLER: You'd start on it and then it
 

would come to the Board after -­

MR. KATZ: We'd trundle on and when we'd see
 

what the Board -- we'd tell you what we're doing,
 

but wouldn't hold it up for -­

DR. ROESSLER: Okay, good.
 

MR. KATZ: -- for the Board, so I think that's
 

all -- I think that's all that's intended there.
 

DR. MELIUS: Would you -- but you wouldn't
 

publish a Federal Register notice at that point, or
 

what's the -­

MR. KATZ: Excuse me?
 

DR. MELIUS: I guess you would -- I guess you
 

would -- no, I take it back. I guess you would. It
 

just wouldn't be accepted by the Board yet.
 

MR. ELLIOTT: We would publish a Federal
 

Register notice indicating what the Board is going
 

to look at -­

DR. MELIUS: Yeah, that's true. Okay.
 

MR. ELLIOTT: -- and there would be perhaps
 

petitions that we'd already started work on and
 

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petitions that just recently come to us before the
 

Federal Register notice went out and we hadn't
 

started work.
 

DR. MELIUS: Yeah, okay.
 

MR. KATZ: Okay. So we -- forward, 83.13? So
 

first change here is we made the determination of
 

health endangerment contingent on finding that it's
 

not feasible to conduct dose reconstructions. So in
 

the prior rule, those -- analysis of health
 

endangerment was parallel with whether you could
 

reconstruct doses. It doesn't make sense in this
 

situation. We're just -- if -- if we can't
 

reconstruct doses, then we make the health
 

endangerment determination. It has no value
 

otherwise since if we can reconstruct doses, that's
 

the end of the story -- and recalling what health
 

endangerment means here.
 

And we -- secondly, we clarified the criterion
 

for finding that dose reconstructions are feasible,
 

and we've discussed that. And we provided other
 

guidance and we've discussed that, concerning that.
 

The third change is -- we've also discussed to
 

some extent, which is we included provisions to
 

allow for a determination that it's not feasible to
 

estimate radiation dose that is specific to one or a
 

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limited set of cancer sites.
 

The fourth change we made here -­

DR. ZIEMER: Ted, could you -- specifically for
 

the Board and for the record -- tie those different
 

items to the sections here that are before us so we
 

have that in the record? If you wouldn't mind going
 

back to the beginning.
 

MR. KATZ: No, I wouldn't. I wouldn't, that'd
 

be fine. Each change you want -­

DR. MELIUS: Yep.
 

DR. ZIEMER: Each of those changes, I think
 

it's important in the record that we be able to link
 

that to sections here.
 

MR. KATZ: Okay. So -- so change one was that
 

we made the determination -- we made the
 

determination of health endangerment contingent on
 

finding that we can't estimate doses, and that is -­

is found under -- right, under section -- these are
 

hard to follow, as you can tell, because -­

DR. ZIEMER: That's why I'm having to put you
 

on the spot, because -­

MR. KATZ: But it's under -­

DR. ZIEMER: -- it's also hard for us to tell.
 

MR. KATZ: Right, it's under section -- look at
 

number (2) -­

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DR. MELIUS: Page 80.
 

DR. ZIEMER: Page 80.
 

MR. KATZ: -- how should -- page 81, this is
 

the area, how should the class be defined, and if
 

you turn the page to 82 -- wait, 81, the bottom of
 

81, item number (3), if it is not feasible to
 

estimate with sufficient accuracy radiation doses
 

for members of the class as provided under paragraph
 

(b)(1) of this section, then NIOSH must also make
 

the following determination as required by statute:
 

Is there a reasonable likelihood that such radiation
 

doses may have endangered the health of members of
 

the class. So that's where it specifically makes it
 

contingent. Is that -- is everybody with me where
 

that is? It's the bottom of 81 and the top of 82,
 

if we have the same...
 

Okay? And then change number two was the
 

criterion for finding that dose reconstructions are
 

feasible, and those are found under -- on the page
 

80, beginning with (b)(1), and continuing through
 

the bottom of the page. Actually continuing through
 

the top of page 81.
 

Section (iv), Roman numeral four, is the last
 

part of this section.
 

MS. MUNN: Comment?
 

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MR. KATZ: Okay.
 

DR. ZIEMER: Question -- Wanda has a question.
 

MS. MUNN: Yes, I had a comment. Again, it's
 

semantics only. At the bottom of page 80, item
 

(iii), when reading through that, my first
 

impression was that the wording was very dismissive
 

of dosimetry and area monitoring data. Again, I
 

guess it's how you define necessary. I guess my
 

thought was -- I can understand why we would want to
 

say that those data are not the defining factor in
 

estimating, but to say that it's not necessary is
 

almost as though you're saying who needs it. And I
 

guess -­

MR. KATZ: Well, it's specifically not
 

necessary to estimate the maximum radiation doses
 

that could have been incurred, which is different
 

from saying not necessary to do a very focused dose
 

reconstruction.
 

MS. MUNN: I understand. That's why I said
 

it's purely semantics. It's just that it struck me
 

as being dismissive of the data.
 

DR. ZIEMER: I think the suggestion here is
 

there might be a way to word this that takes away
 

that connotation, without changing the -- Jim?
 

DR. MELIUS: I don't know how you want to
 

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handle this procedurally, but it seems to me this
 

section has three major issues that we need to spend
 

some time discussing. Two of them are old, one's
 

new. The old ones are this issue of not feasible to
 

-- with sufficient accuracy -- dose reconstruction,
 

which again we've been provided with a very vague
 

definition of that and with very little guidance in
 

the draft regulation. Personally I have a lot of
 

problems with that and continue to, but I think we
 

need to discuss that.
 

The second is the top of page 81, this organ-


specific determination that's going to be made,
 

which is new and again is described very, very
 

briefly and without any guidelines. And I think we
 

need to spend some time talking about that.
 

And then the third issue is the health
 

endangerment where there's been a major change from
 

the approach used before to a way of defining class
 

by duration of work and two -- or duration of
 

exposure at a -- an exposure incident, and I think
 

we need to spend some time discussing that -- the
 

adequacy of that. I don't know if we want to do it
 

now or just keep going along, but I'd like to raise
 

those points.
 

DR. ZIEMER: My intent here during this morning
 

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session is to identify, as you have just done, the
 

issues that we want to revisit in depth. And by
 

walking through this and seeing the changes and then
 

doing what you just said, we can flag those items
 

and then once we're done sort of reviewing the whole
 

thing, then we can spend time on the issues that are
 

of major concern to the Board. I think -- rather
 

than try to solve them on -- as we're going through
 

here on the first cut. Is that agreeable with
 

every...
 

DR. ROESSLER: Could he go over the three again
 

and point out exactly where they are?
 

DR. MELIUS: Yeah, the first one is -- in the
 

order they go through is the -- starts on -- near
 

the top of page 80, and that's the whole issue of
 

when is it feasible or not feasible to estimate a
 

dose with sufficient accuracy, and there's been a
 

change in that and that -- I won't editorialize at
 

this time.
 

The second issue is on page -- the top of page
 

81. It's a relatively -- it's a major change, but
 

described very briefly and that's the organ-specific
 

issue.
 

And then the third issue is the issue of health
 

endangerment, which really starts on 81, section -­

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paragraph (2) and goes over into page 82, for the
 

most part, I believe, which is the health
 

endangerment which is being talked about how do you
 

define a class. Well, they're talking about in
 

terms of duration of work or duration of exposure at
 

a exposure incident -- or incidents.
 

DR. ZIEMER: Ted had defined -- or had
 

identified two of the changes.
 

MR. KATZ: Yeah, so the third change -­

DR. ZIEMER: The third one.
 

MR. KATZ: -- Jim and I are a little bit out of
 

sync, but the third is on the top of page 81.
 

That's that one that Jim -- one of the ones Jim just
 

raised, the tissue-specific -­

DR. ZIEMER: The tissue-specific organ issue.
 

MR. KATZ: So that's change number three.
 

Change number four is -- we've omitted the use of
 

IREP, so you can't find it in here. We're not using
 

cancer risk models.
 

And change number five is health endangerment,
 

which Jim also mentioned, which begins on -- where I
 

had identified it for you before, begins on the
 

bottom of 81, number (3), and continues through the
 

next page until you get to item (c) at the very
 

bottom of page 82.
 

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DR. ZIEMER: Could you repeat that again?
 

Where does that begin?
 

MR. KATZ: I'm sorry. So it begins on the
 

bottom of 81, item (3).
 

DR. ZIEMER: Item -­

MR. KATZ: Item (3) at the very bottom of 81,
 

it begins "If it is not feasible to estimate".
 

DR. ZIEMER: Yeah.
 

MR. KATZ: And it continues through till you
 

get to item (c), which is another -- so this
 

addresses the discrete incidents versus the default
 

health endangerment definition.
 

And that covers it for this section in terms of
 

changes for section 83.13.
 

DR. ZIEMER: Comment? Mark, comment?
 

MR. GRIFFON: Sure, I have -- it's more
 

specific I think and I think we've identified the
 

right issues in this section so we're going to come
 

back to them -­

DR. ZIEMER: Something you want to flag at this
 

point?
 

MR. GRIFFON: Huh?
 

DR. ZIEMER: Something you want to flag at this
 

point?
 

MR. GRIFFON: Well, I just had a -- a note of
 

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comparison for this definition of sufficient
 

accuracy as defined in this versus on page 13 in the
 

preamble. I wanted somebody to interpret a sentence
 

for me there where it says basically hence -- about
 

halfway down the page it says (reading) hence for
 

the purposes of a compensation program a dose
 

estimate is sufficiently accurate if it is
 

reasonably certain to be at least at high as the
 

highest dose that could plausibly have been
 

received.
 

And that wording is slightly different -- a
 

little more confusing to me, actually, than the
 

wording in the regulation itself. And I wondered if
 

there was -- if they meant exactly the same thing or
 

if I'm reading something wrong.
 

MR. KATZ: Well, they do mean the same thing.
 

DR. ZIEMER: Or at least intended to.
 

MR. KATZ: And the rule is what's binding.
 

DR. ZIEMER: Point noted. Okay. Let's go
 

ahead then. Where are we, at section -­

MR. KATZ: 83.14.
 

DR. ZIEMER: -- 83.14.
 

MR. KATZ: This is a new section. And this is
 

what I discussed, this is a section to deal with
 

petitions arising when we cannot complete a dose
 

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reconstruction out of that situation. And I've
 

discussed the provisions of it already. I don't
 

know if you -- I don't think you want me to
 

reiterate -­

DR. ZIEMER: The whole section is new.
 

MR. KATZ: Entirely new -­

DR. ZIEMER: Let's just see -­

MR. KATZ: -- that's right.
 

DR. ZIEMER: -- if the Board has any questions
 

on it or comments at this point, items to flag.
 

Apparently not at the moment. Let's go ahead,
 

83.15?
 

MR. GRIFFON: Everybody's thoroughly confused.
 

MR. KATZ: Okay.
 

DR. ZIEMER: Deals specifically with -­

DR. MELIUS: Does anybody -- I just feel like
 

we need to flag that section and come back to it.
 

I'm confused by it and I -- but I think we can do it
 

better after we've talked about some of the other
 

issues.
 

DR. ZIEMER: Thank you. Okay, 83.15, Ted.
 

MR. KATZ: 83.15, we did -- there are three
 

changes here. We clarified that the Board can
 

consider information it considers appropriate in
 

addition to the petition and the initial NIOSH
 

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evaluation report, and that's authorized
 

specifically in EEOICPA.
 

DR. ZIEMER: And that -­

MR. KATZ: That was a public commenter who
 

interpreted the rule as it was written before to
 

prevent the Board from considering such information,
 

although the rule back then said that the Board
 

could tell us to go do more homework.
 

DR. ZIEMER: Okay. And that's showing up in
 

which part of 83.15?
 

MR. KATZ: 83.15 -­

UNIDENTIFIED: (d).
 

MR. KATZ: -- (c). (Reading) (c) In
 

considering the petition the Board may obtain and
 

consider additional information not addressed in the
 

petition or in the initial NIOSH evaluation report.
 

DR. ZIEMER: Wanda has a question or comment.
 

MS. MUNN: And it may have absolutely no
 

bearing here, but as I was reading this and thinking
 

in terms of having petitioners appear before the
 

Board in open meetings, the question arose in my
 

mind whether there were any privacy issues involved
 

in that process that we should be considering, or
 

whether there was any way around that particular
 

mode.
 

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DR. ZIEMER: Can any of the staff -- the
 

question had to do with privacy issues and
 

petitioners appearing before the Board.
 

MR. ELLIOTT: If the petitioner is a claimant
 

and wants to talk about their claim, they can do so
 

at their own volition. However, if the petitioner
 

wants to talk about others that are in the system,
 

we can't talk about that. So we would have to
 

preclude that discussion and not hold that kind of a
 

discussion with a petitioner in a public forum. I
 

think, unless -­

MR. KATZ: Yeah, I'm just assuming -- I mean we
 

haven't really thought about this situation you're
 

raising, that a petitioner has private confidential
 

information to provide, but most certainly the
 

petitioner could provide that information
 

confidentially to us. The Board could have access
 

to that information and so on. So I mean we can
 

make provisions for -- to address that, but
 

obviously we would protect privacy for public
 

sessions with the Board, but...
 

DR. ZIEMER: Keep in mind the earlier version
 

of the document, it appeared to the Board that the
 

petitioner was appearing before us in a kind of
 

hearing mode.
 

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MS. MUNN: Yes, yes.
 

DR. ZIEMER: Whereas this has softened
 

considerably with the idea if there is information
 

that the petitioner wants to bring orally to the
 

Board, they're welcome to do that. It's not a
 

hearing.
 

MR. ELLIOTT: Let me add that in the petition,
 

if there is information that's submitted and it's
 

Privacy Act-related information, we will protect
 

that and that -- you know, the petition will be
 

summarized to the Board in a fashion that won't
 

reveal the confidential information.
 

Secondly, if the petitioner wants to -- again,
 

what I said earlier, if the petitioner wants to talk
 

about their individual claim and the demographics
 

associated with that that's Privacy Act-related,
 

they could do so. But we're -- we, as a staff and
 

as the Board members, are not going to engage in a
 

back-and-forth discussion with that person about
 

their particular claim. They can speak about it,
 

but we can't react and speak back to them about it,
 

if I'm clear. I hope I'm clear in that regard. Or
 

question them about it, I guess.
 

DR. ZIEMER: Jim?
 

DR. MELIUS: One thing we need to work on down
 

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the road -- one is sort of a procedure and a set of
 

-- how the information goes back to the petitioner
 

explaining this information so it's not -- you know,
 

doesn't come as a surprise at the meeting.
 

Secondly, and this may -- this is just a
 

clarification and I may have missed it in some
 

earlier section, but this talks about how do we get
 

our decisions -- Board's recommendations to the
 

Secretary. I presume that the petitioner will also
 

be advised of those or it would be sent to them in
 

some way at a -- it doesn't say it in this section
 

and it -- I'm hoping it says it in another section,
 

or at least it should say it someplace.
 

MR. KATZ: ... Board's recommendations. I -­

frankly, I can't tell you whether I wrote that in or
 

not, but -­

DR. ZIEMER: Well, the Board's recommendations,
 

first of all, are public. Beyond that -­

MR. KATZ: It would send it directly to the -­

DR. ZIEMER: -- there's certainly nothing to
 

preclude the Board from individually transmitting a
 

decision to a petitioner.
 

DR. MELIUS: Yeah, I mean just -- agree they're
 

public, but the petitioners may not be here. By the
 

time they become -- it becomes publicly available -­

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I mean it just would be nice to have a provision in
 

here that the -- NIOSH will notify the petition, and
 

it may already be in here. I don't -- I'm not...
 

MR. ELLIOTT: Well, I don't think it's there.
 

I don't think that is there. I think what is here
 

is that once the Secretary makes a decision, 83.16
 

says the Secretary will notify the petitioner, as
 

well as the Board, et cetera.
 

MR. KATZ: But at that point the petitioner
 

will get -­

MR. ELLIOTT: But your point is, whatever the
 

Board's deliberation is, that needs to be
 

transmitted back to the petition, so yeah.
 

DR. ZIEMER: But keep in mind, the Board's
 

decision or the Board's recommendation is not the
 

decision.
 

DR. MELIUS: Correct.
 

DR. ZIEMER: It's a piece of information the
 

Secretary uses in making the final decision. Just
 

as the staff's input would be weighed.
 

Yes, Roy.
 

DR. DEHART: As I read this with regard to the
 

petitioner addressing the Board, it will be by
 

invitation, so if you should have 100 petitioners,
 

the Board could control that number, since it would
 

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be by invitation. Is that correct? Is that a
 

correct assumption?
 

MR. KATZ: I don't think we would preclude the
 

petitioners from coming to any -- we wouldn't
 

preclude any petitioners from coming to a Board
 

meeting.
 

DR. ZIEMER: Yeah, the rule says we would
 

invite any petitioner, does it not?
 

MR. KATZ: Yes.
 

DR. MELIUS: Yeah, but what I was trying to
 

make before, we should have a procedure so that the
 

petitioner understands, you know, how the -- how the
 

process works so they know -­

DR. ZIEMER: We can control the scheduling of
 

that since the invitation would say come to this
 

meeting if you wish to present additional
 

information -- I presume.
 

DR. MELIUS: And I would think there would be a
 

procedure where they would -- there would be a time
 

set aside, you know, at the same time the Board is
 

discussing that petition or the NIOSH staff and so
 

forth so that they can -- if they wish to speak to
 

the Board, they wouldn't wait till the end of the
 

session or -­

MR. ELLIOTT: I think the language here is
 

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flexible enough for the Board to interpret it as you
 

see fit. You may -- "invite" may mean invite
 

comment, written comment. It may mean if you can
 

attend the Board meeting, you can attend and present
 

your written comments. You know, "invite" means, as
 

I read it here, we want your input. If you come,
 

that's one way. If you want to write it, that's
 

another way.
 

DR. MELIUS: And I guess all I was saying, it's
 

not -- doesn't have to be in the regulation, but we
 

ought to have proced-- work it out and let everybody
 

know.
 

DR. ZIEMER: Other comments? Anything else in
 

this section, Ted?
 

MR. KATZ: The other two changes are we
 

eliminated -- and it relates to what you said, Dr.
 

Ziemer. We eliminated the use of the term
 

"evidence". We didn't want -- the Board commented
 

about this not being an adjudicatory forum, in
 

effect, and we also eliminated -- that was change
 

number two.
 

Change number three was we eliminated the term
 

"consensus", which was -- it was used to
 

characterize the recommendations of the Board. It
 

was confusing to the public what that meant and was
 

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unnecessary, so we eliminated it.
 

DR. ZIEMER: Henry?
 

DR. ANDERSON: Yeah, I just -- again, this may
 

be subsequently in a procedural issue, but just
 

given the track record of us getting things a day or
 

two before the meeting, this thing saying that the
 

person would be -- or petitioner to -- invited to
 

also comment on the petition and NIOSH evaluation of
 

findings, will there be a minimum amount of time?
 

Will they get the findings? Will the findings be
 

part of the notice of the meeting so there'll be a
 

minimum of a two-week -- somewhere there needs to be
 

-- not just it'll be at the meeting, but they need
 

to know what your findings are that are going to be
 

discussed so that they could -- they may decide not
 

to come because you're saying this is a fine
 

petition and we're going to recommend it. I'm just
 

-- I don't know if you need it here, but I think we
 

want to be sure that the petitioner gets notice with
 

sufficient time to, one, be able to decide what they
 

want to do rather than have it come up and they
 

don't really know what's going to be here.
 

MR. ELLIOTT: It is a procedural issue that we
 

need to put in place. Hopefully -- I think
 

everybody agrees, we want to get into a meeting
 

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cycle that is practical and appropriate and not so
 

rushed. Traditionally and typically and -- we're
 

supposed to have a Federal Register notice out 30
 

days in advance of your meeting. Now I'm not -­

I've been not doing too well at that, as you know,
 

because we've been meeting so frequently and in such
 

a rushed fashion. But that 30-day -- if we can
 

achieve that 30-day Federal Register notice, you
 

know, there's things that have to happen in order to
 

make that be put into play that would trigger
 

notifying the petitioner, as well as the Board, as
 

well as the public, about what's going to happen at
 

a meeting.
 

DR. ANDERSON: I don't think it needs to -- my
 

question is should this be in the rule or is this
 

just something we'll establish, and I'm just saying
 

when we do establish it, the 30 days certainly would
 

be sufficient. But that's my only concern.
 

MR. ELLIOTT: It's something for procedural
 

development here, not -- not in the rule.
 

MR. KATZ: And we have discussed that very
 

issue. It wasn't unthought of.
 

DR. ZIEMER: Okay. Any other items on 83.15?
 

How about 83.16?
 

MR. KATZ: 83.16, there are a number of changes
 

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here. We clarified that the Secretary will take
 

into consideration the NIOSH evaluation, the Board
 

report, and they also take into account information
 

presented to the Board in its deliberations. This
 

is -- the Board recommended HHS clarify that the
 

Secretary is not relying solely on the Board
 

recommendation. This was -- this came out of a
 

recommendation that you made to us. Do I need to
 

find that for you or -­

DR. ZIEMER: It's in paragraph (a) of 83.16.
 

MR. KATZ: Right. Change two is we revised the
 

reporting provisions to report all decisions to the
 

Secretary at this time, including affirmative
 

decisions to add classes. We had a public comment
 

suggesting that we add this, so we have.
 

DR. ZIEMER: That's item 83.16 -­

MR. KATZ: That's -­

DR. ZIEMER: -- (c), is it?
 

MR. KATZ: Yes, it is, at the bottom of (c),
 

and particularly that was raised -- before, as we
 

had it, we would only be notifying affirmative
 

decisions after Congress had acted. But the comment
 

that we received was people may want to have a
 

chance to interact with Congress who were affected
 

by the decision, and so agreed and we added it.
 

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Let's see, the third change is one I've
 

discussed, which was -- so you can't find it 'cause
 

it's not there, but we eliminated the Secretary's
 

discretion to employ procedures and consider factors
 

not specified in this part.
 

DR. ZIEMER: Tony has a comment or a question.
 

DR. ANDRADE: I think this is the only part of
 

the rule I became a bit confused on. Referring back
 

to 83.11, therein it states that if a petitioner -­

if a petitioner -- well, a petitioner will receive
 

guidance in developing relevant information, et
 

cetera to -- to propose or to put together a
 

petition. And after 30 calendar days from the date
 

of notification of this section of -- well, after 30
 

days of review, NIOSH will notify the petitioners of
 

its decision to evaluate the petition or its final
 

decision that the petition has failed to meet the
 

requirements. It goes on to clarify that based on
 

your information, NIOSH may reverse this decision.
 

However, in 83.16 it looks like -- or it
 

appears that either the Secretary is the one who
 

bears this burden on the notification and/or it is
 

really not final. There is no final decision
 

because a petitioner can actually submit in writing
 

information that either they believe that factual or
 

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procedural errors have occurred in the evaluation of
 

their petition.
 

Now question number one is, how in the world is
 

the petitioner going to know whether factual or
 

procedural errors have occurred? So what I'm asking
 

for is a kind of a claimant-friendly explanation for
 

that.
 

And then finally down towards the bottom of
 

83.16 it doesn't give a date or time period for
 

which -- during which the Secretary has to respond
 

to the claimant or to the petitioner, as is done so
 

for NIOSH in 83.11. So all of this is a bit
 

perplexing for me.
 

MR. KATZ: This -- they're really quite
 

separate. 83.11, if we decide the petition doesn't
 

go forward, it's never evaluated, it's never -­

never comes to the Secretary. The Secretary doesn't
 

make any decisions on it, so it is us who -­

DR. ZIEMER: That's a final decision on the
 

evaluation -­

MR. KATZ: That's a final decision.
 

DR. ZIEMER: -- not a decision -­

MR. KATZ: On whether -­

DR. ZIEMER: -- on the -­

UNIDENTIFIED: Merits.
 

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DR. ZIEMER: -- on the merits. It's -- right?
 

MR. KATZ: That's correct. It's a final
 

decision that the petition didn't -­

DR. ZIEMER: It's a decision that the petition
 

itself was not adequate to be evaluated.
 

MR. KATZ: To be evaluated, so that -­

DR. ZIEMER: So it's before all the other
 

stuff. The petition is inadequate, period. There's
 

no Board input at that point, doesn't go to the
 

Secretary. That's -­

MR. KATZ: That's right.
 

DR. ZIEMER: In that sense, it's final.
 

MR. KATZ: That's correct.
 

DR. ZIEMER: Except that there is a remedy.
 

MR. KATZ: Right.
 

DR. ZIEMER: Something's missing, so come back
 

with more information.
 

MR. KATZ: That's right.
 

DR. ANDRADE: Okay. So in fact this is
 

actually another opportunity for the petitioner to
 

have a case reviewed.
 

MR. KATZ: No.
 

DR. ANDRADE: No?
 

DR. ZIEMER: It's only that the petition didn't
 

satisfy the requirements of a -- it isn't a -­

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MR. KATZ: Right.
 

DR. ZIEMER: -- valid petition at that point.
 

Is that -­

MR. KATZ: It's only -- that's right, it's not
 

a petition at that point. It's only -- this is only
 

a remedy for people whose petitions have been
 

evaluated.
 

UNIDENTIFIED: Is that 83.11, Tony?
 

DR. ANDRADE: No, I'm back on 83.16.
 

UNIDENTIFIED: They're talking about 83.11.
 

MR. KATZ: Right.
 

DR. ZIEMER: 83.11 is -­

DR. ANDRADE: Okay, let's say -- let's say a
 

petition has been denied. NIOSH has made the
 

decision that it doesn't rise to the standards that
 

we have defined.
 

DR. ZIEMER: I don't think the petition is
 

denied. Is that correct?
 

MR. KATZ: That's right, the petition is -­

DR. ZIEMER: What's denied is the petition
 

doesn't meet the requirements of a petition. It's
 

not even -- it's only been evaluated to see if all
 

the information's there that's needed and so on.
 

MR. KATZ: That's correct, so -­

DR. ZIEMER: Like did you fill in all the
 

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blanks on the form.
 

DR. ANDRADE: Right, and that's clear, and they
 

have -- NIOSH will assist in putting together a
 

proper petition. Okay? But then within 30 calendar
 

days, NIOSH will come back with a decision on
 

whether or not that petition will be -- a decision
 

on that petition will be final. All right?
 

DR. ZIEMER: Whether -- they make a decision -­

MR. KATZ: In 30 days -­

DR. ZIEMER: -- they're going to evaluate it.
 

MR. KATZ: Right.
 

DR. ANDRADE: Okay, whether it will be
 

evaluated. If the choice has been made not to
 

evaluate it, it appears that in 83.16 the petitioner
 

has another opportunity to present the case directly
 

to the Secretary.
 

MR. KATZ: No, no, it's not -­

DR. ZIEMER: 83.16 only deals with evaluated
 

petitions.
 

MR. KATZ: 83.16 -- the Secretary is proposing
 

and transmitting decisions on petitions that have
 

been evaluated, section (a) there, and then provides
 

those petitioners 30 days. So it's only those
 

petitioners for petitions that have been evaluated
 

that are in this basket here in 83.16. It is
 

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completely segregated from 83.11. It's only those
 

petitioners for petitions that have been evaluated
 

by NIOSH, evaluated by the Board, the Board has made
 

recommendations and they've come to the Secretary.
 

At that point the Secretary evaluates all this
 

information, makes a preliminary decision,
 

communicates that to the petitioner and the
 

petitioner then has the opportunity to contest the
 

Secretary's decision -- proposed decision.
 

DR. ANDRADE: Okay. I think I understand the
 

nuance there.
 

DR. ZIEMER: It may be that since this led to
 

some confusion there that maybe there is some
 

wording that needs to be added to clarify those two
 

cases, and so you've flagged something that -- if
 

it's confusing to the Board, it'll be confusing to
 

others.
 

DR. MELIUS: Yeah, I think some of the subheadings I've noticed throughout the document are a
 

little bit confusing if you look at them, like
 

outcome of a petition. Well, thinking about the
 

petition as it comes in, not -- and really this is
 

an evaluated petition. I don't know if we've come
 

up with a name for it yet, that's the problem.
 

DR. ZIEMER: Okay, Tony? Yeah. 83.17, role of
 

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Congress, that's spelled out in the -- you haven't
 

changed -­

MR. KATZ: It's spelled out, but what we did do
 

-- we did make a change, which is we reduced from 20
 

to five days the time allowed for HHS to report to
 

DOL the results of any Congressional action, or lack
 

thereof, concerning the Secretary's decision. So
 

this is an action by Congress. This is -- we had a
 

public comment saying you don't need 20 days, and we
 

agreed that we could -­

DR. ZIEMER: It shortened -­

MR. KATZ: -- we can do it in less time.
 

DR. ZIEMER: -- your own time. Questions on
 

that? This affects the staff there.
 

83.18?
 

MR. KATZ: We made changes. We added
 

provisions to the section to specify that the Board
 

would -- it wasn't in there in the -- although no
 

one commented on this, but it was not in the rule,
 

the first NPRM, but that the Board would advise the
 

Secretary in these cases and that members of the
 

class would be provided opportunity to contest such
 

decisions.
 

DR. ZIEMER: And that's 83.18 item (3), I
 

believe -- or it's -­

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MR. KATZ: I'm sorry, so it's -­

DR. ZIEMER: -- (b)(3) -- (b)(3). It's on the
 

very last page. Correct?
 

MR. KATZ: So it's (b)(3) and (b)(4).
 

DR. ZIEMER: And (b)(4).
 

MR. KATZ: Those are new.
 

DR. MELIUS: Just for clarification, does this
 

section or this modification happen before it goes
 

to Congress, simultaneous with it going to Congress,
 

what's the -­

MR. KATZ: This is a -- this is not a decision
 

to add a class to the Cohort.
 

DR. MELIUS: Right.
 

MR. KATZ: This is for modifying or...
 

DR. MELIUS: After Congress. So you're saying
 

the Secretary, after Congress has not acted, I
 

guess, then the Secretary can then modify?
 

MR. KATZ: This is for -- this is for a class
 

that's already been added to the Cohort.
 

DR. ZIEMER: And you later find you can do dose
 

reconstruction -­

MR. KATZ: We later find a cache of records -­

this is a hypothetical situation here, it's not one
 

we know what will happen, but -- and we find a cache
 

of records that we didn't know existed that lets us
 

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reconstruct doses for a class of workers for whom we
 

couldn't before because no one knew the existence of
 

this information. So -­

DR. MELIUS: Okay.
 

MR. KATZ: Is that -­

DR. MELIUS: No, that clarifies it.
 

MR. KATZ: Okay. Thank you.
 

DR. ZIEMER: Other comments? Okay. Now we've
 

been able to flag a number of items that the Board
 

will wish to consider in further depth. We're all
 

ready for a break. It's the lunch hour, so we're
 

going to recess till 1:30. At 1:30 when we
 

reconvene we'll -- again I'd like to remind folks,
 

particularly if you weren't here during the opening
 

of this session this morning, that our intent is to
 

have the public comment period at 1:30 rather than
 

at 4:00 so that the Board will have the benefit of
 

any input from the public that might be of use as we
 

deliberate on the proposed rulemaking.
 

Also a reminder to sign in and register your
 

attendance, if you haven't already done so.
 

Any other housekeeping announcements, Cori?
 

MS. HOMER: Hold on just a second.
 

DR. ZIEMER: And Leon, take a lunch break.
 

MS. HOMER: Don't leave valuables in the room.
 

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DR. ZIEMER: Don't leave valuables in the room.
 

MS. HOMER: And if there's anything that's been
 

presented that the Board or the audience doesn't
 

have a copy of, please let me know.
 

MR. GRIFFON: And what about our valuable notes
 

on the rulemaking, can we -­

MS. HOMER: I think you can leave those.
 

DR. ZIEMER: We can leave them. Okay. Thank
 

you. We're recessed till 1:30.
 

(Whereupon, a recess was taken.)
 

PUBLIC COMMENT PERIOD
 

DR. ZIEMER: I call the meeting back to order.
 

As indicated this morning when we discussed the
 

agenda, it's my intention to move the public comment
 

period up so that the Board could benefit from
 

comments and discussion by members of the public, so
 

we'd like to move to that now. I have received -­

too late, Bob -- I have received three, now four
 

names of individuals who wish to comment.
 

We'll just take them in the order that they
 

signed up, beginning with Evelyn Cofelt. Evelyn is
 

-- identifies herself as a claimant and she is from
 

Missouri. Evelyn, are you prepared to proceed?
 

MS. COFELT: My name -- good afternoon. My
 

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name is Evelyn Cofelt. My husband was Chris Davis,
 

who worked at Mallinckrodt for 15 years -­

DR. ZIEMER: I'm sorry, is this mike on?
 

MR. PRESLEY: I don't believe it is.
 

UNIDENTIFIED: Maybe it needs to be lowered.
 

MS. COFELT: Maybe I had it up too high.
 

UNIDENTIFIED: That's good.
 

DR. ZIEMER: Okay, try again.
 

MS. COFELT: Hi, my name is Evelyn Cofelt and
 

my husband was Chris Davis, who worked at
 

Mallinckrodt in St. Louis, Missouri for 15 years and
 

died of lung cancer, so I'm going to turn this mike
 

over to my daughter 'cause I get too emotional.
 

Thank you.
 

MS. BROCK: Hi, I'm Denise. She's emotional;
 

I'm nervous.
 

DR. ZIEMER: And this would be Denise Brock -­

MS. BROCK: Denise Brock.
 

DR. ZIEMER: -- for the record, also from
 

Missouri.
 

MS. BROCK: Yes. And this is a narrative that
 

my mother has written, so if it's okay, I'm just
 

going to read this.
 

(Reading) I would just like to take the
 

opportunity to say a few things. My husband's name
 

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was Christopher Davis. He was employed by
 

Mallinckrodt Chemical Company, (inaudible) Street,
 

St. Louis, Missouri. He worked there from 1945
 

until 1958. In 1967 my husband was diagnosed with
 

lung cancer. That day our whole family's world
 

turned upside down. The world and our lives as we
 

knew them were never the same. This cancer was
 

catastrophic for our entire family.
 

My husband had his left lung removed and could
 

no longer work. I cannot even begin to tell you the
 

emotional and physical distress that this caused
 

him. He was in the hospital repeatedly. Our family
 

spent many holidays, including Christmases and
 

birthdays, in hospital rooms. When my husband was
 

able to be home, he was on oxygen. He could barely
 

walk from one room to the next without becoming
 

winded.
 

I had to juggle working every day, raising two
 

small children who were six and seven at the time of
 

his diagnosis, with trying to be at the hospital
 

with my terminally ill husband. And even though I
 

held a full-time job, we eventually lost our home
 

and I could no longer afford to pay tuition for my
 

two younger children to attend Catholic school, nor
 

pay a baby sitter to keep them for the long hours I
 

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had to be gone. I had no choice but to relocate.
 

I have an older daughter, Sharon, who at the
 

time of my husband's diagnosis was newly married and
 

had two small children of her own. I had to move to
 

Lincoln County, which was about an hour from St.
 

Louis. I moved onto property that she owned next
 

door to where she lived. That daughter had to carry
 

the burden of watching her younger brother and
 

sister -- that would be me and my brother; we
 

weren't very good, either -- while I worked and went
 

to the hospital with my husband.
 

I was worried about Denise and Chris, even when
 

they were in school. Their father was dying and I
 

was hardly ever home. They were uprooted from their
 

home, friends and school. I was exhausted. This
 

was a long, horrible illness. He suffered
 

tremendously.
 

His cancer spread into the right side. He
 

later developed leukemia. He had an obstruction of
 

the superior vena cava and the inferior vena cava.
 

He would be up at night in so much pain. His legs
 

eventually turned black. They looked tarred. He
 

had to wear these elastic stockings, and when I
 

would take them off of him, his skin would just rip
 

off. The doctors were going to amputate both legs.
 

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All of this affected his self-esteem. He felt
 

emasculated and he was very frightened. At this
 

time there was no hospice. There was no home health
 

care, nurses or cancer counseling. Eventually my
 

husband was told that there was nothing more that
 

could be done.
 

My youngest daughter, Denise, was a senior in
 

high school, my son Chris a junior. Bills were
 

piling up and I had to work, so my son decided that
 

he would quit -- I'm sorry, that he would help. He
 

insisted on quitting school to take care of his
 

father while I worked through the day. Then while I
 

was at home at night, both kids worked. I even got
 

a job at the hospital that my husband had been
 

frequenting to try to be close to him.
 

On April 27th, 1978 while I was at work, Denise
 

was at school, my son was home with his father. I
 

received a call from Chris stating that his dad
 

wasn't breathing and he had called an ambulance. He
 

said that his dad had been lying down on the couch
 

and sat straight up, clutched his chest, reached for
 

those stockings and fell back. My husband died in
 

our son's arms.
 

To this day I feel so guilty that I couldn't
 

find a way to be in two places at once. If I would
 

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have been home my son wouldn't have had to had that
 

horrific experience.
 

My son then went to his sister's school while I
 

waited with my older daughter at the hospital for my
 

husband's body. My son went directly to Denise's
 

classroom and she was told that her father had just
 

died.
 

This happened two weeks prior to her graduation
 

and just a few weeks prior to her getting married.
 

My husband didn't see any of that.
 

That afternoon when we came home from the
 

hospital, some of our furniture was knocked over.
 

There were remnants of paramedics in the house. I
 

even had to get rid of the sofa that my husband
 

passed away on -- too many memories.
 

Mallinckrodt did this to my family. It isn't
 

just the loss of a loved one, it's the loss of a
 

family, a home, life experiences for everyone
 

involved. It's financial devastation. I will be 80
 

years old in April. I live on Social Security and
 

up until a month ago I worked full time. My health
 

will no longer permit me to do that. I've had a
 

quadruple bypass and I am in poor health.
 

My husband gave all that he had to that company
 

and this government. He was one of the cold war
 

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warriors, or were they victims? I'm tired and I
 

have worked my whole life.
 

Originally I thought that this compensation
 

would bring some quick relief. There's nothing
 

quick about it. And trying to come up with medical
 

records and employment records, many of which have
 

long been destroyed, just makes a program that is
 

rough justice even harder. It's like reliving those
 

early years all over again.
 

I received a letter stating that dose
 

reconstruction could take months, even years. Do
 

you think that I should work until I'm 95 or 100
 

waiting to see if I might get compensated?
 

DR. ZIEMER: Thank you for presenting that.
 

I'd like to ask if any of the Board members have
 

questions for Denise or for her mother, or comments?
 

And Denise, do you have additional items that you
 

want to bring or would you like to wait?
 

MS. BROCK: No, I'm okay.
 

DR. ZIEMER: Okay.
 

MS. BROCK: And I scribbled all over mine
 

because as I was sitting here, I took notes, so kind
 

of bear with me -- and then I've read hers, so I
 

don't guess I need to introduce myself.
 

Today I have a few comments to make, as well as
 

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some issues or questions that I would like to raise
 

with the Board. First of all, I wanted to let
 

everybody know that I've talked to over 700 people
 

in reference to this, and I can't call everybody.
 

So as I told Mr. Elliott, I had to actually send
 

letters out, so I bought a copy machine and my whole
 

family helped me staple and stuff envelopes and
 

whatever it took and we got the letters out. And
 

since I've been here, my daughter -- my youngest
 

daughter said she had 150 calls, which I don't know
 

if she just means the phone won't stop ringing, or
 

she actually had that many. And that's just -­

basically the letter was stating -- updating what
 

the last meeting was and me coming here and to that
 

effect.
 

I've also been in touch with some local unions,
 

and I actually put together a packet that I sent to
 

them and it consisted of a summary of this program ­

- because I understand there's subcontractors that
 

are covered under this -- and I sent a flyer. I did
 

like a flyer for them to send to their members, as
 

well as the bill that was reintroduced into
 

Congress. I also sent a fact sheet and a
 

frequently-asked question brochure, a Paducah toll-


free number -- what else did I put in there -- oh,
 

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and a list of the -- over 300 facilities. So I'm
 

assuming that there's going to be a lot more claims
 

generated. I bet you guys are real happy about
 

that.
 

And I would also like to state that while I was
 

at the South Carolina meeting, two more Missouri
 

workers or claimants passed away, Don Sheats* and
 

Tom Bruning*, and they passed away while waiting for
 

their claim to be processed. Now their spouses have
 

the extra burden of refiling these claims, and it's
 

not an easy task or a priority after burying a loved
 

one. And because so many of these workers are dying
 

and because claims are getting letters from the
 

Department of Labor stating that it could be months,
 

even years, for a dose reconstruction to be
 

completed on their claim, I started videotaping
 

them.
 

They wanted their stories to be heard. Many of
 

these men, my father included, were paid above
 

average scale for the time to carry out the -­

excuse me -- to carry out the government's mission
 

producing atomic warfare. They were expected to
 

work in secret, and most did, carrying their secrets
 

to the grave. These men represented themselves as
 

common men with not-so-common destiny. Ironically,
 

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the government's efforts to produce a powerful
 

weapon supply after the atomic bomb, took some of
 

the very lives they intended to save.
 

And to the letter that it could take months,
 

even years, to complete dose reconstruction, as I
 

believe I stated at the previous meeting, these
 

people do not have months or years. We assumed this
 

would be quick justice and there's nothing quick
 

about it.
 

And I'm kind of going over some of this -- and
 

my mom, like most of these claimants, is in her
 

seventies. And the problem goes beyond time. I
 

believe that workers from Mallinckrodt downtown
 

plant were exposed to things that they were never
 

monitored for -- I know that, actually -- and I
 

imagine there still hasn't been a site profile
 

completed yet.
 

I understand that NIOSH is doing all that they
 

can do, but again I must ask, when does dose
 

reconstruction become not feasible? In a situation
 

where you have workers exposed to things that they
 

were never monitored for; and in that same situation
 

there is documentations that workers were grievously
 

over-exposed, and in one particular case 34 workers
 

over-exposed for a year and nobody told them; and
 

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when it's impossible to use coworker data because
 

people had multiple job titles; and due to the lack
 

of monitoring for all radiation exposures, just as a
 

lay person I would assume that this would be just a
 

few reasons to state that dose reconstruction would
 

be beyond difficult, if not impossible, and
 

definitely not feasible.
 

And I think most of you know that I'm
 

interested in Mallinckrodt becoming part of the SEC
 

status, and I've read through the notice of proposed
 

rulemaking and, as I said, it was 91 pages and I
 

have no background for this. And I took it in as
 

well as I could and it did help today I think when
 

you did the summary. I mean it helped inform me
 

somewhat, but I feel that I have to go back and
 

maybe explain to some of these people and I -- I can
 

do the best I can, but one thing I would like to
 

ask, and I don't know if it's possible -- please, if
 

you could come to St. Louis possibly and do a public
 

hearing or something where maybe somebody that knows
 

what they're talking about could do this instead of
 

me, and maybe have time for public comment. I just
 

-- we have so many people there that have a lot of
 

questions.
 

And I know I'd asked Larry, too, if -- I
 

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understand you have a radon model and I think we had
 

talked about having a radon smoking model because I
 

did research on -- I think we talked about that
 

being synergistic with the smoking.
 

And then the questions I wrote down, under
 

section 83.7, page 72, who can submit on behalf of a
 

class of employees. I guess maybe I just didn't
 

understand this. There's just me, and if I want to
 

do that for my mom, I'm assuming I can do that -­

I'm guessing. But what if I've got like all these
 

people calling me and they don't have any help. Can
 

I do that? Can I do that on their behalf? Do I
 

have to do a class or person by person, or can I
 

even do it?
 

DR. ZIEMER: Denise, do you want to go through
 

your questions and then have them answered, or we
 

can take -­

MS. BROCK: How -- it's up to you, however you
 

would prefer to do it.
 

DR. ZIEMER: Maybe if there's some simple
 

responses, obviously we can't deal with the case
 

itself here in the public forum, but in the general
 

sense of -­

MS. BROCK: Of petitioning, I mean can I
 

petition for these people?
 

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DR. ZIEMER: Under this rule, who can petition
 

MS. BROCK: I can? Good deal.
 

DR. ZIEMER: -- you can.
 

MS. BROCK: Okay. Well, that's my answer for
 

that one.
 

The next one -- this is a little peculiar.
 

This would be referring to page 77, 83.9, for the
 

incidence or recurrence. I'm trying to think how to
 

word this to make sure I understand this. If
 

somebody is applying for the SEC status and you're
 

talking about an incident or incidence or occurrence
 

had happened, like maybe you've got an explosion in
 

a used solution plant or maybe somebody -- like my
 

father was burned, or had a dust bag burst over him,
 

he's deceased. The biggest part of these records
 

are gone, and I have filed requests, probably like
 

12. They're probably ready to kill me. I had to
 

file a fee waiver. I don't even know what I'm
 

doing, so they're going to get all this information.
 

What if that's not there? Hospital records are
 

destroyed after ten years, so this burden is falling
 

upon people -- I do this 'cause I'm kind of nutty,
 

but you've got people that are 80 -- 70, 80 years
 

old, they don't know how to do this stuff. I'm -- I
 

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mean I'm helping them -- as many people as I can do
 

this. I'm going to try to start workshops to help
 

them. But I mean this is -- what -- how much -- how
 

specific do we have to be if there's no information?
 

Do you want to wait to answer that or...
 

DR. ZIEMER: Let me start this and just in
 

general terms, it would be my understanding of the
 

proposed rule that the incidents that they are
 

talking about are specifically radiation incidents.
 

That is, incidents that lead to exposure that would
 

impact on the calculation of the dose. We -- one of
 

the issues we talked about this morning and the
 

Board will probably address more is the question you
 

are asking, what if the direct -- individuals who
 

directly experienced the incidents are no longer
 

there, what secondary evidence can be used. We'll
 

certainly be trying to address that to the best of
 

our extent. I don't think, other than that, we know
 

the answer to what is certainly a very important
 

question.
 

MS. BROCK: Okay. I know I had something else
 

with that one, but I just -- I can't remember what
 

it was. I should have written it down.
 

And then I'm kind of confused -- I don't even
 

know where this was at in the rule, I should have
 

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written it down. If you had multiple job titles, do
 

you have to have 250 days -- say you were a
 

maintenance man, do you have to -- or -- yeah, do
 

you have to be in a specific spot 250 days to
 

petition for this or for this to -- or did I
 

misunderstand that if you had multiple job titles.
 

Maybe you were there seven years, but you were never
 

in one job 250 days. Is that...
 

DR. ZIEMER: This is being recorded, Ted.
 

MR. KATZ: Yes, so it would really depend on -­

depend on what class -- what the class is that's
 

defined. I mean the class could be defined to cover
 

any number of job categories.
 

MS. BROCK: So like if you're talking about
 

radon exposure -­

DR. ZIEMER: Speak into the microphone, please.
 

MS. BROCK: Sorry. If you're talking about
 

radon exposure -- like at Mallinckrodt, there were
 

three different types of radon, three types of
 

radium, so I guess I'm very confused. I'm not
 

really sure -- I don't even know how to ask the
 

question, I guess.
 

MR. KATZ: So if the exposures were -- wherever
 

the exposures occurred, you could define the class
 

to cover whatever that entire area is for which
 

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there were exposures that you believe you cannot
 

estimate the doses for. So it could cover any
 

number of jobs over multiple locations at the site
 

and so on -- at the facility and so on.
 

DR. ZIEMER: Perhaps Denise's question was -­

MR. KATZ: Is that -­

DR. ZIEMER: -- what if each job was say 200
 

days -­

MS. BROCK: That's it.
 

DR. ZIEMER: -- and there were multiple such
 

jobs, but no one of them, by itself, was -- met the
 

250 criteria, I think is the question that's being
 

asked. Is that correct?
 

MS. BROCK: Yes.
 

MR. KATZ: But if -- the question is really
 

whether all those jobs are covered by the class or
 

not. If all those jobs -- it's unreconstructable
 

dose, then they're all bundled together.
 

DR. ZIEMER: Then they would bundle together is
 

what he's saying.
 

MS. BROCK: Oh, okay. Okay, makes sense. I
 

see.
 

DR. ZIEMER: Right.
 

MS. BROCK: I was -- unless they had maybe
 

three different job titles and only one had radon
 

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exposure and that was 200 days, then they're not
 

covered.
 

MR. KATZ: If -- I mean the only thing that
 

wouldn't be covered is a job that was -- for which
 

we can reconstruct the doses. That wouldn't be
 

covered. But for any job they were in that had
 

these exposures that we can't reconstruct, it
 

wouldn't matter how many days in each job, they
 

would all be covered, whether they were working -­

just because they were working in the general area
 

and those exposures occurred to all these people in
 

all these different job categories, but they were
 

still in the same area and incurring the same
 

exposures.
 

DR. ZIEMER: But also keep in mind -- again,
 

Ted is talking somewhat generically. Whether or not
 

it applies to your specific case, I don't think he'd
 

want to characterize it that way, so you need to be
 

sure that you understand, he's not necessarily
 

talking about a case. He's trying to be generic.
 

MS. BROCK: And that's what I was asking, too,
 

in that form. I just was curious because if I have
 

to relay this back to somebody, I kind of want to at
 

least have some sort of guideline as to what I'm
 

explaining to them.
 

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The other thing -- I remembered what I was
 

going to ask about the occurrence. I understand
 

that you need witnesses in reference to the Special
 

Exposure Cohort. Does that -- is that the same for
 

dose reconstruction? Say you have a phone interview
 

and you're sending in supplemental information that
 

has occurrence reports, and if I would have
 

occurrence reports stating that there was an
 

explosion here or 16 workers over-exposed here, but
 

I cannot specifically place a worker there, just
 

know that he was there during that time period, is
 

that burden of proof on me to say hey, he was there?
 

DR. NETON: I think in the dose reconstruction
 

process we would rely on coworker monitoring data at
 

that point, and we would try to ascertain the names
 

of workers who were present at that incident. And
 

if they were still alive and able to be interviewed,
 

we would pursue that. But we would have to have
 

some sort of evidence that the event actually
 

occurred.
 

MS. BROCK: And you do take like occurrence
 

reports on that? Okay.
 

And the only other thing I had, and I don't
 

know if anybody can help me with this. We also have
 

a hematite facility and it's my understanding that
 

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years of coverage at this hematite facility only go
 

until 1968. I guess -- I understand they were no
 

longer under DOE contract. The interesting thing
 

about this is I believe there's residual
 

radioactivity there or contamination. These people
 

have technetium in their water. They can't drink
 

their water. Their water's bottled in and these
 

workers or some of the workers there, even in the
 

nineties, I have huge lists of people that have
 

cancer. What do they need to do to get I guess
 

expanded coverage? Do I go through Department of
 

Energy? Is that even a possibility? Because
 

there's residual contamination there.
 

DR. NETON: Yeah, I think one thing is we need
 

to discuss a little bit about what coverage means.
 

I'm not familiar with the exact facility that you're
 

talking about, but if the Department of Energy has
 

established that the facility was under contract at
 

a certain period of time, say 1958 through '64, that
 

is the eligibility window for a person to be
 

eligible to file a claim. But the dose
 

reconstruction would actually be performed through
 

that period up until the date of diagnosis. So if a
 

person contracted cancer in 1968, the dose
 

reconstruction would actually consider any dose that
 

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may have been there from continuing operations, if
 

we could determine that, up until that period.
 

I think the other issue, though, that you
 

brought up is should other workers be eligible to
 

file a claim if their employment started after say
 

our hypothetical 1964 date. And the answer is NIOSH
 

does not set that window, although we do have in
 

progress a residual contamination study that will
 

inform Congress as to the types of contamination
 

that may have continued, but -- beyond the contract
 

dates, but we do not set that date.
 

MS. BROCK: Okay, 'cause I do know that they -­

oh, I'm sorry.
 

MR. ELLIOTT: But if you -- let me add to Jim's
 

comment, Denise. If you have information -- I think
 

you mentioned a moment ago you might have
 

information about the hematite facility. We don't
 

expect claimants to be burdened with trying to find
 

that, but if you have it in your hands, we'd like to
 

have it so that we can do our study most efficiently
 

and most comprehensively.
 

MS. BROCK: Oh, absolutely. I don't have a
 

problem -­

MR. ELLIOTT: If you'd share with us -­

MS. BROCK: Absolutely.
 

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MR. ELLIOTT: -- we'll factor that into our
 

study findings.
 

MS. BROCK: But the information that I have
 

actually would be residual contamination now. They
 

have I think -- it's my understanding they have 200
 

unlined, uncapped pits, one that I think contains
 

like a Studebaker. I mean this is -- and apparently
 

there's this runoff and these people cannot drink
 

their water, a lot of these area residents. So my
 

concern is if in fact Mallinckrodt or whatever had
 

-- do you know what I'm saying? -- that that
 

originated there, then perhaps -- and anything I
 

have, I would be happy to share. I mean of anything
 

that would expedite this or help claimants. Thanks.
 

DR. ZIEMER: Thank you. Again I'll ask the
 

Board -- Dr. Melius has a question.
 

DR. MELIUS: I'd like to thank both you and
 

your mother for making the long trip here and like
 

-- your mother -- we certainly understand how
 

difficult, even maybe years later, it can be to deal
 

with these issues. And I guess I had two questions
 

for -- I think they're for Larry, but one is really
 

I think for Department of Labor. I think what
 

you're saying is if a claimant dies and the file has
 

to be restarted, a new claim has to be filed -- I
 

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know this is a Department of Labor issue and not
 

you.
 

MR. ELLIOTT: It is, and I know Jeff and we
 

have another Department of Labor -- Rosa -- Rosa's
 

back there, but I'll get -- they can correct me if
 

I'm wrong. You don't have to start the file from
 

scratch. You just have to submit an EE2 or 3. It's
 

a form that a new survivor would have to put in just
 

to establish their authority as a survivor.
 

DR. MELIUS: My second question is -- for you,
 

Larry, is this issue on the interviews. And if I
 

recall right from an earlier meeting, you do try to
 

expedite interviews for people that are ill or may
 

become incapacitated -- in a sense you try to move
 

them up in the queue if that is requested? If you
 

don't, I would think it would be something you ought
 

to consider because certainly getting information
 

from a -- you know, a living person who had worked
 

there is certainly probably preferable to -­

MR. ELLIOTT: Absolutely.
 

DR. MELIUS: -- getting it from -­

MR. ELLIOTT: It is our intent to capture the
 

story of the individuals, and if their death is
 

imminent and we're made aware of that, we do attempt
 

in all cases to capture their interview as quickly
 

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as possible. And we have done that.
 

DR. MELIUS: Okay. And can we -- claimants
 

informed of that I guess is the -- are they aware of
 

that issue. As this gets up to whatever it is,
 

11,000 claims in the queue now or whatever, then I
 

-- I'm not sure we can rely on them calling in and
 

obtaining -- you know, notifying you of the
 

situation. But I think some consideration has to be
 

given to some way of making that known in a way that
 

-- I mean you don't want the process abused, either,
 

but -- 'cause that wouldn't be fair to other
 

claimants, but at least making them aware that if
 

that is an issue, it could be done.
 

MR. ELLIOTT: Well, as we interact with the
 

claimant population, as they call us, as we -- they
 

talk to us about the status of their claim, as the
 

situation is identified, we react.
 

DR. MELIUS: Yeah. And I guess what I'm
 

recommending you consider being a little bit more
 

proactive in your notification to the claimants or
 

on your web site, whatever, all -- information is
 

saying should these circumstances occur, let us know
 

and we would try to expedite that -- that process.
 

DR. ZIEMER: Okay. Thank you for that comment.
 

Yes, Richard.
 

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MR. ESPINOSA: You said there was 150 phone
 

calls. What was the most general concern from these
 

phone calls?
 

MS. BROCK: I think they were just interested
 

in -- in maybe what was actually found out. I mean
 

the rule. People are very curious about that.
 

Like I said, it's 91 pages. It's hard for me to
 

take all that in and I know that the Special
 

Exposure Cohort, when people look at that, they're
 

assuming that that's one way to avoid timely dose
 

reconstruction. I mean they're -- like I said,
 

they're just very concerned with the time period in
 

itself and the data, maybe a lot of that not being
 

there. And I think that was the biggest part of it,
 

wanting to know, you know -- and basically letting
 

me know they got the letters.
 

I want to ask one more thing while I was up
 

here. Could anybody give me an answer on the St.
 

Louis thing? I mean is that a possibility that you
 

would consider coming to St. Louis and having a
 

meeting?
 

DR. ZIEMER: I think the Board is open to
 

considering any such invitation. We are committed
 

in our next meeting to Oak Ridge. We also have to
 

consider another meeting here for the training of
 

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the Board in the use of the computer system, but I
 

think I can speak for the Board that we're certainly
 

open to considering that. It certainly would be -­

it's probably a good location. It's pretty
 

centrally located, so in that respect -­

MS. BROCK: Okay. Thank you.
 

DR. ZIEMER: -- yes. I might insert here,
 

maybe ask a question as to whether or not NIOSH has
 

considered some kind of a simplified brochure, once
 

the rule is in place, that would describe in
 

laymen's terms the content of the -- that would -- I
 

think would meet what appears to be Denise's effort
 

to share what this is about with the public, maybe a
 

piece and possibly you've already considered
 

something that could be developed for distribution
 

so that the burden's not on folks such as Denise who
 

may not have all the technical details that are
 

needed to completely capture -­

MR. ELLIOTT: Yes, thank you for that. We have
 

anticipated this. We have an effort underway to
 

develop a tri-fold brochure. Can you imagine it
 

being in lay language? I don't know what -- we're
 

going to try to do our best there. It'll be tough.
 

And we've had somebody working on this for the past
 

month and a half, two months almost, making tweaks
 

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to it and as the rule that we wrote changed and
 

things come to light and going back and forth about
 

lay level language and sixth grade reading level, et
 

cetera.
 

I also want to say that we certainly appreciate
 

people out there like Denise who have just taken on
 

a huge challenge themselves in trying to help
 

communicate and educate the complexities of this
 

whole program. And we certainly don't want to see
 

that effort diminished and we stand ready to help in
 

any way we can. And I would suggest that -- you
 

know, use our web site, Denise. Have folks send in
 

questions or give us a phone call if they've got
 

questions. Once we're through the rulemaking phase
 

on this and we put the rule -- it's a final rule,
 

we'll be able to answer those specific questions
 

about how does this all work, and we'll be at the
 

ready to help you.
 

MS. BROCK: Thanks.
 

DR. ZIEMER: Okay. I have next Richard Miller
 

has requested time to speak. Richard?
 

MR. MILLER: Good afternoon. I was watching
 

the chimes, the wave in the wind over the table.
 I
 

don't know if others of you noticed it, but it's a
 

bit eerie. Yeah, think about that.
 

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DR. ZIEMER: It started moving a lot when you
 

started talking.
 

MR. MILLER: The record will reflect that.
 

DR. MELIUS: The audience stopped.
 

MR. MILLER: Good point. Good afternoon.
 

Richard Miller with the Government Accountability
 

Project, and just to follow up on the point that
 

Denise had raised about St. Louis, I thought the
 

question that you asked was not could you have an
 

Advisory Board meeting in St. Louis, but could there
 

be some public information session on the rulemaking
 

for the Special Exposure Cohort. Is that correct?
 

MS. BROCK: That's correct.
 

MR. MILLER: The record will reflect she's
 

nodding. And so the question -- I guess I'll just
 

reiterate it. I don't know, you know, Larry, or
 

what your staff -- I understand is doing many things
 

at one time, but I have to confess, I pay attention
 

to this stuff as part of my job, and I did try to
 

wrap my mind around this rule, and it still hurts.
 

And I have a lot of questions and I'm still very
 

confused about it, and I think the idea of a public
 

information session somewhere to solicit some kind
 

of public input -- random sampling of normal human
 

beings listening to this, you know, sometimes brings
 

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sort of reasonable people's minds to reasonable
 

questions, and so I would encourage you. I don't
 

have a specific place. I think St. Louis is great
 

if Denise thinks that's the place to do it. If you
 

want to do it in Washington, D.C. 'cause you would
 

get organizational interest to participate, but I
 

would encourage you all to think about a public
 

information meeting with a public comment period
 

that would be afforded. And if it extends the
 

rulemaking period, I think getting it right is more
 

important than rushing it out.
 

I know that you all worked diligently after the
 

last rulemaking to revise this rule, and I fully
 

appreciate that it wasn't you who was responsible
 

for leaving us with 36 hours to read a rule and
 

comment on it intelligently, and that you did more
 

than your best efforts to get it available sooner
 

and -- several months ago, I might add, let the
 

record reflect. So we are not assigning a
 

responsibility to you or to NIOSH for having taken
 

so much time to get it out. But I think getting it
 

right is more important than getting it out for the
 

sake of getting it out just because somebody says
 

gosh, it's two years and four months since the law's
 

been enacted; how come you don't have a rule?
 

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Well, the good news is you listened to public
 

comments and reworked your rule. The bad news would
 

have been if you took that same mindset and put out
 

an unworkable rule six or eight months ago. So I
 

mean I think you all are to be commended, having
 

read through the rulemaking record, that you did
 

some serious listening to the full array of
 

comments. And not that I fully agree with what you
 

came up with, I think that process of percolation is
 

extremely valuable and I would want to encourage
 

both NIOSH at the leadership level and HHS at the
 

leadership level to think about extending the
 

comment period and having a public forum to take
 

some public input on this. It's too important a
 

part of this statute -- it was the core of the
 

compromise of this legislation between putting
 

everybody in a Special Cohort like RICA was, versus
 

relying on some science-based approach and what
 

happens when that fails. This is the grand
 

compromise of this legislation. So I've made my
 

pitch on page two about extending comment period.
 

I would like to address, in order of the rule
 

as best I can, several technical points that I did
 

not hear addressed today. And let me start with the
 

really easy one, which was the 250-day provision for
 

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asserting or establishing the endangerment
 

threshold.
 

The rule says 250 days in a facility. Let me
 

give you an example of a multi-facility where
 

employees went from facility to facility to facility
 

-- Oak Ridge, at Y-12, X-10 and K-25. You had a
 

common project labor agreement at that site going
 

back to the Manhattan Project. You had a common set
 

of workers who moved from completely different
 

facilities, some of which -- they were even managed
 

under different contractors.
 

The Act, as it has been interpreted by the
 

Labor Department with respect to Special Exposure
 

Cohorts -- this is the DOL rulemaking -- says that
 

you can accrue your 250 days by working in more than
 

one gaseous diffusion plant, even though it says "a
 

facility" in the Act. In other words, when you look
 

in the definition of Special Cohort it says you have
 

to work 250 days in a facility. The Labor
 

Department has chosen to interpret "a facility" to
 

mean any of those three gaseous diffusion plants, in
 

order to accumulate the necessary time.
 

And I would like to encourage you to think
 

about how you apply that 250 days and whether the "a
 

facility" limitation as it is expressed here is
 

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necessarily delimited by Congressional intent or
 

not, because I don't think the Labor Department has
 

read the law so narrowly and cramped because they
 

wanted to fulfill its intent, and I don't think you
 

should, either, in the 250-day threshold.
 

Secondly, I'd like to jump to this question of
 

whether or not the -- NIOSH is properly and
 

appropriately limiting the list of diseases. And in
 

-- I think it's in section 83 -- let me just get the
 

section here and the page number so I can refer you
 

to -- the section I'm referring to -- 83 -- is that
 

13? -- 13, thank you. And on the bottom of page 81,
 

it's little subpart (iii), and in this section which
 

says (reading) if applicable, the identification of
 

a set of one or more types of cancers to which
 

NIOSH's finding that it was not feasible to estimate
 

radiation doses with sufficient accuracy is limited.
 

And so what's being proposed here I believe is
 

what we heard earlier in the presentation to say
 

there'll be certain organs for which -- will not be
 

included in the Special Exposure Cohort. Now what
 

this phrase, if -- of limiting it to certain organs
 

is a disease cohort. This is not an exposure cohort
 

criteria. And by a disease cohort, what I'm
 

suggesting is that if you only have certain of these
 

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184 

diseases, you will then be in a Special Exposure
 

Cohort.
 

Congress created 20 -- a list of 22 cancers.
 

They didn't write in there, under the list of
 

specified cancers, 22 cancers unless NIOSH deems
 

otherwise. And it doesn't say in the definition of
 

a Special Exposure Cohort, if you have a covered
 

cancer and it is defined -- rather than -- rather
 

than the criteria for Special Cohort, if it is not
 

feasible to estimate dose to the organs which NIOSH
 

deems it wants to select.
 

Now I'm not trying to swim against the tide and
 

say that all organs are equally affected, for
 

example, by internal dose. What I'm suggesting is
 

is that -- from the presentation I heard this
 

morning with the two examples that were provided,
 

the radon example and the glove box example -- in
 

both of these cases there was going to be some
 

probability of causation from -- ranging from -- if
 

you were to, for example, look at a biokinetic model
 

and say okay, let's take radon and lung, well, lung
 

is going to have some amount. But you have the
 

daughters and the daughters are particles. The
 

daughters are not exhaled as gases. The particles
 

are alpha particles. You may, through the
 

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mucocilliary* effect, have them come up into your
 

throat. They may wind up lodging in your larynx or
 

in your pharynx or in your salivary gland, or you
 

may swallow them or they may go into your colon and
 

a certain portion of them will excrete.
 

Now all I'm saying is is that to assume a zero
 

probability of causation for a whole set of cancers,
 

which Congress didn't authorize you to do, invites
 

some degree of controversy. And I think the
 

controversy that's invited here is that Congress
 

didn't say is it feasible to estimate dose to a
 

narrow individual group of organs. They said -- so
 

I'll just leave it at that. I think what's happened
 

is is that you've strayed way far past your mandate,
 

beyond the Exposure Cohort, to create disease
 

cohorts. And I would suggest that we give some
 

really hard thought to whether or not Congress
 

intended to authorize NIOSH to start carving out
 

cancers from the list of 22. Certainly didn't
 

authorize NIOSH to add any, and it didn't authorize
 

them to take them away, either.
 

The second question that I have has to do with
 

how you know whether or not you can, to use the
 

phrase we've heard today, to cap out the maximum
 

dose. And as Jim Neton said today -- well, you
 

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know, you can always estimate it was a million rem,
 

but you really can't support it. Right? Or
 

whatever some lethal dose is. How do you know
 

you've estimated the maximum dose? In other words,
 

is there a checklist? In other words, this is
 

almost like an epistomological* question. How do
 

you know, given this sort of sparse data that you're
 

working with and you're saying well, we're going to
 

give it the worst case on solubility and then maybe
 

we'll give it the -- we don't really know what all
 

the source terms are, but we'll think what they
 

could be and we'll kind of give them the worst and
 

then -- where -- where do you draw the line on the
 

worst case? In other words, how do you know that,
 

so that if a claimant were to look at your -- say I
 

come in with a petition for Special Cohort and this
 

is a practical problem, and I say geez, you say you
 

can cap out the dose. I say you guys haven't looked
 

at 16 different things, or vice versa, how do you
 

know that when you've capped it you've really looked
 

as far as you can look?
 

Now we heard today that -- we sort of heard
 

today that if you had capped out the dose, whatever
 

that number is, that would be the number NIOSH would
 

give to DOL to adjudicate for a given claim. Is
 

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that right, Jim?
 

DR. NETON: No.
 

MR. MILLER: It's not right.
 

DR. NETON: No.
 

MR. MILLER: Okay. Subject to a distribution
 

around it?
 

DR. NETON: It depends on the case.
 

MR. MILLER: Well, let's go through the case,
 

because it seems to me it's really important to
 

understand whether we're leaving a hole in the logic
 

here. And the hole in the logic that I'm worried
 

about is that if you're not prepared to adjudicate a
 

claim based on this maximum potential dose, but
 

you're also prepared to say you're not going to put
 

them in the Special Exposure Cohort, then who falls
 

out in the middle here? Maybe you can address that
 

it would be more constructive.
 

DR. ZIEMER: And could I suggest that -- and
 

you can address this in general -- in a general
 

sense, Jim. I think the point is being raised with
 

the Board to consider, as we go through the rule -­

I don't -- I'm a little uncomfortable with -­

DR. NETON: You don't want me to get into very
 

-- specifics?
 

DR. ZIEMER: Right.
 

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DR. NETON: Richard said a lot, and I'm not
 

sure I can remember all the points he raised, but -­

DR. ZIEMER: But he's raised some -- you know,
 

a particular case and so on -­

DR. NETON: The particular question related to
 

what -­

DR. ZIEMER: Generically you can answer, but I
 

think -- more importantly, the issue's being raised
 

for the Board to consider, and that's the point.
 

DR. NETON: I understand. But the issue of
 

whether or not we would use a distribution or a
 

maximum value really depends upon the data that are
 

available to evaluate the case. If we had some
 

monitoring information at all that would allow us to
 

generate a distribution with some best estimate of
 

the exposure, we would assign a distribution.
 

Lacking that information, though, we would be
 

required to do some upper bound maximum dose that
 

would not likely have a distribution. So it really
 

is a case-specific scenario based on the amount of
 

data available. And I'm reluctant to get into
 

hypotheticals because we could go on and on with
 

that, but that's the short answer.
 

DR. ZIEMER: No, but I think we hear your point
 

and that's the -­

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MR. MILLER: Right, I mean you understand the
 

conceptual point, which is, is there a gap in the
 

logic there.
 

I also would like to -- bear with me a second
 

here -- oh, I'd just like to talk a little bit about
 

the administrative procedures that were discussed a
 

little in the Q and A. It seems to me you have
 

three choices -- maybe there are more available. In
 

terms of what happens if somebody submits a petition
 

and doesn't satisfy all the relevant requirements,
 

and this is the section under 83.11. In other
 

words, they give you -- you give them 30 days,
 

you've got to update the petition, you've got to
 

give them the data that's needed. Then in the
 

preamble to the rule it invites the Board, I
 

believe, to discuss the idea of should there be any
 

kind of administrative review or appeals process for
 

the claimant at that stage. I mean a petitioner -­

excuse me, a petitioner. And in the preamble, you
 

know, it doesn't say what the range of choices that
 

the Board could consider, but it seems to me there's
 

three easy ones to think about.
 

The Board could decide that individuals could
 

bring, on some informal basis, their case to the
 

Board and say geez, you know, I -- you kicked me
 

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190 

out. I think I satisfied all the relevant criteria
 

and requirements and I don't think I've been treated
 

fairly by NIOSH and I'd like you to at least hear
 

it, so you can advise them accordingly if you want
 

to.
 

Another choice is you could have NIOSH, using
 

the HHS various adjudicatory offices, of which there
 

are a limited number sort of within the branch of
 

CDC that Larry's in, but -- or NIOSH is in, but you
 

know, they do have like an Office of Contract
 

Appeals, so they do have hearing officers, a small
 

hearing officers branch which could hear that kind
 

of appeal. In other words, you just take it to a
 

neutral third party.
 

DOL, I'm reluctant to suggest anything given
 

they haven't been volunteering any new ideas about
 

how to expand their program lately, but to the
 

degree and extent that they have ALJ's and, you
 

know, Decisions 'R' Us over there, it's kind of
 

their business, you know, that might be another
 

vehicle, though it's taking it outside the ambit of
 

the HHS decision and agencies are usually reluctant
 

to make decisions for agencies that they don't
 

control -- it's an extra -- outside their agency.
 

But it does -- but I do think there ought to be
 

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191 

some answer as to whether if after 30 days someone
 

responds and you all say look, your petition just
 

doesn't cut it, is that a final agency action, and
 

then their only recourse is judicial review at that
 

point? Do you want to send that kind of stuff to
 

court? Would you rather have some kind of either
 

formal or informal review process in between? And
 

all I'm saying is that the rulemaking opens the
 

question for the Board to think about and I'm
 

suggesting -- it's not clear what the choice points
 

are. It would be helpful maybe if NIOSH could give
 

you some choice points about kind of
 

administratively what's workable or not without
 

speculating.
 

Likewise -- yeah.
 

DR. ZIEMER: Could you clarify -- are you
 

talking about inadequate petitions?
 

MR. MILLER: 83.11, Dr. Ziemer, yes.
 

DR. ZIEMER: Okay. I just wanted to make sure
 

I understood.
 

MR. MILLER: Now -- right, because -­

DR. ZIEMER: Because there is spelled out the
 

next step if it's turned down.
 

MR. MILLER: Oh, yes, but that's after you've
 

had an effort to petition to be evaluated. This is
 

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the pre-evaluation process, and what the rulemaking
 

invites in the preamble is should or should you not
 

have some kind of review process after NIOSH makes a
 

determination under 83.11 that's adverse. And I'm
 

-- you know, I know the Board has said look, we
 

don't want to be in the business of reviewing every
 

single one of these, let's streamline this a little
 

bit and that's certainly understandable. The
 

question is what are you going to do with the
 

denials. Do you want to just have them die at that
 

point and then if people are really aggrieved, they
 

go to court? Or do you want to have some sort of
 

intermediate process that they could go to, one way
 

or another? Or take it to the Secretary of HHS, for
 

all that matters. I'm sure they'd love to have more
 

work. That was my opinion. And...
 

With respect, though, I want to then jump to
 

the second administrative review question which sort
 

of came to mind, which is will the same person in
 

the Secretary's Office who is involved or signing
 

off on the denial, say of a petition for dose
 

reconstruction -- say it comes out of NIOSH, it goes
 

up through the Advisory Board and then the
 

Secretary, for whatever reason, one way or another,
 

whether they accept or reject you advice, say nope,
 

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we ain't going to approve this petition, not even
 

going to guess how it could happen. But it could,
 

and there you are and the claimant says I'm going to
 

write in my appeal and you've got this process that
 

you specify in the rule. To whom does it go? Is
 

the Secretary reviewing their own decision again?
 

Or is it that the Deputy Secretary makes the first
 

decision and then the Secretary's people review the
 

second? Is the same person going to be reviewing
 

their own decision a second time, based on an
 

appeal? And I don't know if that -- administrative
 

decisions have been made or not, but it seems like
 

it would be helpful to spell out some separation
 

between the individual who denies it and the person
 

who may want to review it. Just a thought. I mean
 

I could easily see what the appeal would look like
 

if it went to court. Right? They had a kangaroo
 

court.
 

I think that's the appeals process. Oh -- and
 

I think that if there's going to be a process to
 

contest these in the Secretary's Office, I don't
 

know if there's a specific procedure that the
 

Secretary has -- I know like at DOE if you get
 

turned down with your physician's panel, you go to
 

the office of hearings and appeals and they've got
 

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their own little sort of administrative process that
 

you follow. Is there going to be some sort of -­

sort of clear process that's followed here beyond
 

what's spelled out in the rules administratively
 

within HHS for appeals that would be taken, or for
 

reconsideration of denials? And if there is, could
 

you spell that out in the rule? I guess that would
 

just be helpful to those who need to meander this
 

turf the first few times.
 

Those are I guess the big -- the big question.
 

I think I heard Mark Griffon bring this up earlier,
 

and it struck me, as well. On page 15 of the -- and
 

it's on the preamble, about the fifth or sixth line
 

from the bottom, it talks about the rationale for
 

whether or not to exclude certain organs in the
 

Special Cohort. And the words that it says here are
 

(reading) only those -- you will only include those
 

in the Special Exposure Cohort if they significantly
 

irradiate certain organs and tissues.
 

And so now this is sort of a qualitative
 

phrase, and does that mean it is greater than a zero
 

probability of causation? Is it one-tenth of one
 

percent? Is it a 20th of a percent? Is it a 50th
 

of a percent? Once you get into this
 

"significantly" thing, it almost feels like IREP is
 

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creeping in the back door into determining the
 

feasibility of dose estimation, when IREP is a risk-


based approach for determining endangerment, not for
 

determining sufficiency of accuracy. And you're
 

having this risk-based approach climb in the back
 

door to look at the question about the sufficiency
 

of accuracy because you're saying which dose is
 

affected.
 

I think -- again, it's sort of ill-founded, but
 

if you're going to stay with this, and I'm not
 

suggesting that you do -- in fact, I strongly urge
 

you not to, but if you're going to stick with it,
 

please pin down what you mean by "significantly".
 

Those are the thoughts. Thank you.
 

DR. ZIEMER: Thank you. That last point was
 

one we discussed earlier in the Board and something
 

we flagged for further discussion, as well, so thank
 

you, Richard, for your comments. They're always
 

helpful to the Board and -- as we go forward.
 

I think Bob Tabor also indicated -- Bob,
 

please. Thank you.
 

MR. TABOR: My name's Bob Tabor, Fernald Atomic
 

Trades and Labor Council, work at the Fernald site,
 

have been attending these sessions for some time
 

now. I know most of you probably, you know,
 

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somewhat personally or seen you enough to say -­

call you by your first name.
 

Richard's a tough act to follow there and he
 

certainly can articulate this. At least I can
 

understand what he's saying. I don't know if I can
 

articulate or regurgitate it in the same manner, so
 

to speak, to express what I have on my mind. But
 

this thing instead -- he mentioned -- I wrote down
 

his quote here. He says I wrapped my mind around
 

this rule and it still hurts. Well, I wrapped my
 

mind around this rule, it not only hurts, mine's
 

just about numb. I think I'm getting more confused
 

as time goes on here in trying to learn something
 

about this proposed rule.
 

It seems to me that the initial Act, as it came
 

out under subtitle B, as I call it, covering
 

silicosis, berylliosis and the 22 cancers, you know,
 

with concern being radiological cancers, that you
 

had certain sites that were covered and called
 

Cohorts. And then we have the balance of the
 

nuclear network out here and possibly workers who
 

have cancers that might be similar to those who are
 

identified in the initial cohorts, and we say well,
 

how do we deal with those? So we have this thing
 

now called SEC, Special Exposure Cohort, and this is
 

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the avenue or mechanism or tool by which to get some
 

type of consideration.
 

But again it appears to me that we're looking
 

at -- or trying to look at apples and oranges, and I
 

do not really see where the equality as far as
 

criteria in evaluating, you know, individuals'
 

claims. I would think that there would be more
 

balance between the rule -- I mean, you know, the
 

Act relative to the Cohorts and the criteria for the
 

SEC. What I'm hearing here today is, or what I
 

thought I knew, was 22 cancers. What I'm hearing
 

here today makes me believe that we're trying to
 

develop this SEC criteria based around maybe an
 

affected organ dose, and I just really am having a
 

difficult time wrapping my arms around, you know,
 

how this really relates and I'm seeing apples and
 

oranges once again and not a lot of equality as far
 

as the criteria between the two.
 

I would think, and I guess it's not, but I
 

would think it would be as simple is well, you've
 

got these 22 cancers. Now you're not in the initial
 

Cohorts. You come over here to the SEC, it's going
 

to require dose reconstruction. But I would think
 

you would still be talking about the 22 cancers.
 I
 

don't know if we are or we aren't. It doesn't sound
 

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like we are anymore. So this is getting very
 

complex in my mind.
 

And on that note, what I'm wondering is how in
 

the world do you explain this to an applicant?
 

Listen, I'm talking to applicants out there that are
 

having difficulty with their applications, as a
 

union representative, trying to, you know, help
 

them. Not as an authority and not as anybody that
 

says hey, this is what is going to happen, only as
 

somebody to assist them with where you can go to get
 

the correct advice from the people that know if they
 

have difficulty. And I have -- I have worked with a
 

number of people who have made application, and it
 

is a confusing process.
 

In fact, I just got off the phone yesterday
 

talking to the Cleveland office to try to get some
 

interpretation that came from a letter of final
 

decision out of Washington. And on one hand they
 

say well, it's done. On the other hand they say
 

you've still got another 30 days. Well, do I or
 

don't I? It's done or it isn't. Well, I got my
 

interpretation and they were very helpful and I was
 

thankful for that. But you know, if I can't
 

interpret this stuff, and I've been to every one of
 

these sessions, I can assure you that some of these
 

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applicants certainly don't understand it. And if
 

you have to go back and try to explain this stuff to
 

them, I mean it really gets complex.
 

Now that's the simple stuff that's complex.
 

What do I do with the stuff that's really complex,
 

like what we're talking about here today? I would
 

just beseech you folks to try to make this as simple
 

as we can, and if it can't be simple, that we figure
 

out some way that we're going to be able to
 

communicate it, because it is beyond me, you know,
 

at this particular point.
 

That would be mostly my comment. I think
 

Richard probably covered the balance of things that
 

I had some concerns over but would not begin to be
 

able to hardly articulate it as well as he did, but
 

I would concur, you know, with his comments, that
 

they're well worthwhile working through those things
 

and getting some strong consideration. Thank you.
 

DR. ZIEMER: Thank you, Bob. Do any of the
 

Board members have questions for Bob?
 

That's okay. And Bob, Larry's staff is going
 

to prepare that brochure that we talked about
 

earlier. It's going to explain all this stuff, that
 

even the Board will understand what it's all about.
 

Now actually the other point that you raised is
 

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one that, again, was identified earlier. It's that
 

issue of the cancer location and the organ that -­

exposed. In simple terms, of course, the analogy is
 

sort of like the smoking analogy. One would not
 

attribute to smoking a cancer other than lung
 

cancer, typically. Well, there may be an exception
 

or two to that. In principle, it goes like that.
 

So we may have to struggle, though, with the
 

ramifications of that. I think Mark raised it early
 

this morning, Jim has raised it, others have. What
 

does that mean, that insignificant exposure to other
 

organs.
 

But anyway, we thank all the members of the
 

public who have provided the comments to us today.
 

It's been very helpful.
 

Are we needing a break before we plow ahead? A
 

small break, a little comfort break, it looks like.
 

Let's try to keep it to about ten minutes and then
 

reconvene.
 

(Whereupon, a recess was taken.)
 

DR. ZIEMER: We'll reconvene. Oh, let's see, 

Mark is -- is Mark in the room? 

UNIDENTIFIED: Here he comes. He's here. 

DR. ZIEMER: Leon, are you there? Leon is not
 

here. We've lost Leon.
 

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(Pause)
 

Okay, we're back on line. Leon's rejoined us.
 

I'm proposing now we return to the document itself.
 

Let me try something out on you because it's not
 

clear exactly how to proceed -- that is it's not
 

clear to me. It may be very clear to you, but I
 

think we can go back and step through section by
 

section. We've already flagged a number of areas
 

that we need to work on. I think those that require
 

only minor rewording in terms of some clarification,
 

perhaps we can identify what that is today.
 

Others where there's conceptual issues we need
 

to deal with, we'll just have to start debating them
 

and see where we come out. Is that agreeable? And
 

we'll -- we can go on for a while. Gen Roessler has
 

to leave us at 3:30 in order to get her plane.
 

DR. ROESSLER: Unless you want me to stay
 

overnight, then we'd have to do some -­

DR. ZIEMER: How many are in favor of Gen
 

staying overnight?
 

DR. ROESSLER: Can we get my family's vote?
 

DR. ZIEMER: Any opposed?
 

UNIDENTIFIED: I abstain.
 

DR. ZIEMER: One abstention. Well -­

MR. ELLIOTT: I need some dose reconstructions
 

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done. You want to stay and do a few for us?
 

DR. ROESSLER: It could be interesting.
 

DR. ZIEMER: Well, in any event, we'll plow
 

ahead here for a while and just -- I'd like to
 

remind you that we've scheduled a -- I believe a
 

three-hour conference call. It's already on the
 

schedule. Check your schedule now, I believe it's
 

next week on Friday, a week from today. So we have
 

the opportunity for a follow-on session there. It's
 

quite possible we would need an additional session,
 

I don't know, but we may have to look at our
 

calendars now and keep that in mind as a
 

possibility.
 

There has also been -- we've heard some
 

expressions from some members of the public about
 

the 30-day period. We've had some expressions from
 

Board members. It may be possible to get an
 

extension on that and I've asked Larry to go back
 

and sort of ping the system, as it were, to see how
 

difficult it might be to extend the 30-day comment
 

period, either by another two weeks or four weeks.
 

But in the meantime, we need to move ahead as
 

expeditiously -- regardless of whether it's 30, 45
 

or 60 days. I think it is important for the
 

petitioners that a rule be in place at the earliest
 

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possible time. But as has also been suggested, we
 

want to be sure to get it right at the same time.
 

DR. MELIUS: Yeah, along those lines and -- I
 

agree that we need to just move on and assume and -­

I think -- but I think we ought to consider the
 

Board making a formal recommendation to Larry, to
 

NIOSH, that they extend the comment period. I think
 

there's been -- we've discussed it before. There's
 

a number of issues that have come up. I think that
 

we're -- the general public as well as the Board's
 

deliberations would benefit from that extension and
 

I think it would be helpful to formalize that -­

that recommendation. While at the same time I think
 

we have to obviously move forward and consider as -­

act as if we're not going to get an extension. But
 

I think it would be helpful and I wanted to do that
 

while Gen was still here, we make that decision.
 

DR. ZIEMER: Is that just a comment or are you
 

DR. MELIUS: I'd make that a -­

DR. ZIEMER: -- now proposing -­

DR. MELIUS: -- formal recommenda-- as a
 

motion.
 

DR. ZIEMER: You're making that as a formal
 

motion. Is that -- does someone wish to second
 

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that?
 

MR. OWENS: I second that, Dr. Ziemer.
 

DR. ZIEMER: Okay, Leon. Let the record show
 

that Leon is seconding that. You beat several
 

others to the punch here, actually. That's good.
 

Now might I suggest as -- to the group as a
 

friendly amendment that we couch that in terms of
 

recognizing, particularly comments from the general
 

public, as well, that indicated a willingness to
 

have a slight extension of the time -- 'cause
 

recognize that in one sense it's the petitioners who
 

are also wanting this to come to closure, so this
 

extends the time.
 

DR. MELIUS: No, I -­

DR. ZIEMER: But we've heard comments from the
 

public, so if your motion could be couched in the
 

form that in recognition of the sentiment that we
 

heard that indicates that it would be helpful in
 

getting the rule right to extend slightly, two to
 

four weeks, so -­

DR. MELIUS: That was what I thought I said -­

I was trying to say -­

DR. ZIEMER: So it's in that framework. Okay.
 

UNIDENTIFIED: Discussion.
 

DR. ZIEMER: The motion is open for discussion.
 

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Tony.
 

DR. ANDRADE: I would just like to ask the
 

question, and it's more procedural than anything
 

else. Maybe Larry -- Larry can answer this or Ted.
 

Would the motion need to be specific at this point
 

in time or could we actually act on the motion and
 

vote at a later date, say maybe during our
 

conference call? I'm just asking in terms of what
 

is necessary procedurally.
 

DR. ZIEMER: Let me answer your question from a
 

parliamentary point of view. The motion could of
 

course be tabled by -- by motion for vote at a later
 

time. That certainly can be done. The motion, if
 

passed, is simply a motion to convey to NIOSH and
 

thus to the Agency the desire to extend this time.
 

It does not mandate it because they are -- it is in
 

fact the call of the Agency, I believe. This would
 

be simply advice or a recommendation from the Board.
 

Larry, did you have a comment?
 

MR. ELLIOTT: Certainly the Board can do what
 

you wish here and -- with regard to this motion. My
 

counsel to you would be to allow me to have an
 

opportunity to explore the Secretary's pleasure on
 

this before you took action on your motion. If you
 

knew -- let's say before you took a vote on this -­

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that the Secretary would consider it, that might
 

change some people's votes. If you knew the
 

Secretary's pretty adamant that this rule needs to
 

be out on the street in its final form as soon as
 

possible and doesn't see a need to extend the
 

comment period, that he's satisfied with this, then
 

that may change -- change how you might vote anyway.
 

I don't know. But I would think you'd want to have
 

a sense of what -- where the Secretary's at. We
 

will convey to the Secretary's Office that there
 

were some Board members who expressed concern about
 

this and there was some public comment heard about
 

this topic, and we can get back to Dr. Ziemer with
 

what we understand to be the Secretary's position.
 

DR. MELIUS: And I guess my concern is I would
 

like to make the recommendation for the Board
 

stronger than just that Larry heard from the general
 

public and from some members of the Board, that
 

there's a formal Board vote and -- on this -- making
 

this recommendation that the Agency ask for an
 

extension.
 

Now the Board doesn't agree -- other members of
 

the Board don't agree with that, then I think we'd
 

like to at least see a vote or some indication, and
 

I don't see where delaying it to see what the
 

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Secretary's pleasure is or disposition is towards
 

this particular thing really would help. I think a
 

request has to be made fairly soon, as well as
 

notification to the public 'cause this is mainly to
 

benefit and improve the public participation in this
 

-- in this particular rulemaking and to improve the
 

public comment.
 

DR. ZIEMER: Okay.
 

DR. MELIUS: And waiting till the 29th day
 

isn't going to necessarily help that.
 

DR. ZIEMER: Are there other comments on the
 

motion, pro or con? An option would be to go ahead
 

and have the vote. An option would be to table
 

until a week from today, by which time one might
 

have the information, and all that would be would be
 

an informal indication up through the system that
 

this sentiment, at some level, exists. It would not
 

have -- would not have the thrust of a formal motion
 

if you did that, so those are the options.
 

Okay, Tony.
 

DR. ANDRADE: I'd like to make my position
 

quite clear. I'm not trying to -- I'm not
 

advocating that we move quickly to not communicate
 

the fact that we are -- that we don't wish -- or
 

that we don't wish to consider other comments. But
 

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what I'm saying is that in our deliberations today,
 

as well as the deliberations that are going to take
 

place next week, I think we're going to learn a lot
 

more about the details and specifics about the rule,
 

and that both ourselves as a Board and the public
 

will have had a chance to consider issues with the
 

proposed rule, and that at that point in time we
 

might better be able to send our -- our advice up to
 

the Secretary as to whether or not we should really
 

extend the comment period. I don't wish to cut it
 

off. That's -- at this point in time.
 

DR. ZIEMER: Roy.
 

DR. DEHART: I'm not sure that a week's delay
 

will impact, and in view of Larry's comments, there
 

may be some political advantage perhaps with a
 

delay, so I will move to table this motion to a time
 

certain, next Friday week.
 

DR. ZIEMER: Is there a second?
 

DR. ANDRADE: I second.
 

DR. ZIEMER: Okay. This is not a debatable
 

motion. We must vote immediately up or down. If
 

you vote in favor of the motion, then you are voting
 

to delay the actual vote on the main motion until
 

next week. If you vote no, we return to the motion
 

that's before us. Is that clear? We're voting to
 

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table.
 

All in favor of tabling -- oh, and this
 

requires a two-thirds majority to table. Okay? By
 

Robert's Rules.
 

All in favor say aye.
 

(Affirmative responses)
 

DR. ZIEMER: All opposed, no.
 

(Negative responses)
 

DR. ZIEMER: Okay, let me see hands on the
 

ayes. One, two, three, four, five ayes.
 

And let me see hands on the no's. I -­

MR. OWENS: My hand is raised, Dr. Ziemer.
 

DR. ZIEMER: Leon, I see your hand there. Your
 

virtual hand is raised -- one, two, three, four,
 

five, six -- does not have two-thirds, so the motion
 

is not tabled. The Chair did not vote, but the
 

Chair doesn't have to, it still doesn't have two-


thirds.
 

You probably want to know what the Chair was
 

going to vote. I was going to vote to table, so
 

that just makes it even.
 

Therefore the motion to table fails and we're
 

back to the main motion, which will be a motion to
 

-- is it to ask NIOSH to consider extending the
 

comment period to -­

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DR. MELIUS: Either fif-- another 15 or 30 -­

DR. ZIEMER: -- 45 or 60 -- yeah, a total of 45
 

or 60 days -- HHS to extend -- in light of the
 

comments that we've heard today concerning -­

DR. MELIUS: Yeah, in order to -­

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

on this motion or are there -- okay, I'm sorry. We
 

have two more comments, Henry and -- are you
 

speaking to the motion?
 

UNIDENTIFIED: Yes, I'm speaking -­

DR. ZIEMER: Speaking in support of the motion?
 

MR. ESPINOSA: Yeah, I'm in support of the
 

motion, but along with the motion I do believe it
 

would help out the Board to have a public comment
 

meeting such as the stakeholder meeting. I believe
 

it probably could be held in -- I believe we're
 

meeting in Oak Ridge in -- what is it, in March?
 

DR. ZIEMER: The meeting in Oak Ridge is after
 

the 60-day period would be over, so -­

MR. ESPINOSA: I still believe that there
 

should be some type of stakeholder meeting for -- to
 

where the Board can review the comments from the
 

public, not just the e-mails and stuff.
 

DR. ZIEMER: Okay. You're not asking at this
 

time for any change in the motion itself -­

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MR. ESPINOSA: No, I'm not asking for any
 

change in the motion, just a suggestion.
 

DR. ZIEMER: Just a comment, okay. Henry?
 

DR. ANDERSON: I was mostly just going to
 

comment on the -- we haven't had an opportunity too
 

much to hear public comments and I guess I had it,
 

as in the past, we were closer to the end period we
 

may have been able to hear more, I think. We
 

probably, as a Board, could put in the time to get
 

out comments together, but I think it would be
 

helpful potentially to hear more from the public,
 

which is why I was looking at the time. I think
 

we've identified issues. We heard some -- or at
 

least early confusion by a few individuals in the
 

public, so I think it might be helpful to get the
 

word out on that and so we may hear some more from
 

-- they may not have their opportunity to comment if
 

they first see this in the next week or two. So
 

that's my only feeling is I think we could probably
 

get out comments in, but I'm -- I think it is a -­

at this time of the year, anyway -- a short time for
 

the public, without a whole lot of roll-out like we
 

had with the last ones with the public comment
 

period. So I think it could be extended. It might
 

benefit us, but I think it mostly would benefit the
 

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public.
 

DR. ZIEMER: Is there anyone who wishes -- I'll
 

do this evenly -- anyone wish to speak against the
 

motion? Just comments? I think Wanda was next and
 

then...
 

MS. MUNN: Obviously one could make a case for
 

extending comment periods and extending revision
 

periods for almost any length of time in order to
 

get every knot that we can possibly think of out of
 

the string. But I've heard lots of public comments,
 

and I've read some other public comments, and the
 

most public comment that I hear most frequently,
 

over and over, from every site that I'm aware of, is
 

will you please get on with what you're doing. So
 

when we talk about hearing public comments and being
 

concerned about inadequate time to review the
 

materials that are in front of us, I can't help but
 

be aware that the overwhelming majority of what I
 

hear still is please move forward with what you're
 

doing.
 

For that reason, I oppose extensions of time
 

that we do not feel absolutely necessary for
 

whatever reason. And in this case, it appears to me
 

that it would -- it's a matter of convenience for us
 

to request more time. We would all like to have
 

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more time, but I hear the public saying please move
 

forward.
 

DR. ZIEMER: Thank you. So you speak against
 

the motion.
 

MS. MUNN: I speak against the motion.
 

DR. ZIEMER: Okay. Now, Mike.
 

MR. GIBSON: You know, I'd just like to say
 

that there's -- seems like there's been some
 

substantive changes to the draft regulation, and so
 

-- you know, I've heard almost 100 percent from the
 

public today that they want an extension of this
 

because -- because of these potentially significant
 

changes in certain areas that need to be fleshed out
 

and thought about and have ample time to comment on.
 

DR. ZIEMER: Thank you. Yes, Tony.
 

DR. ANDRADE: As I mentioned earlier, I'm not
 

against holding back the process, and I agree with
 

Wanda that there is -- there's certainly pressure
 

from even the petitioners and the public to move
 

forward.
 

On the other hand, I think Mike has a very good
 

point here. There have been substantive changes.
 

Hence I think I would support the motion if it
 

became specific and it gave us time to force us to
 

go home and do our homework, get our comments
 

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together and allow the public to get their comments
 

together, but do so quickly. In other words,
 

provide this issue the attention that it is due.
 

And so I would be in support of the motion if Dr.
 

Melius would say limit the time period to say 15
 

days.
 

DR. ZIEMER: Tony, are you asking for -- I
 

think the motion as it stands was a 15 to 30-day
 

extension but it wasn't specific, and you're asking
 

to perhaps amend the motion to be more specific?
 

DR. ANDRADE: Yes.
 

DR. ZIEMER: Is that the case, or is this -­

I'm not sure it's a friendly amendment or only semi-


friendly, but -­

DR. MELIUS: Before we try to characterize the
 

amendment, just to clarify, I'm assuming that we go
 

forward with our meeting next Friday and that we go
 

-- 'cause I don't think we're going to hear in a
 

week necessarily that they've changed this. And I
 

think we have to assume that we have to move forward
 

in the meanwhile to start preparing our comments.
 

think the question may come that as we've prepared
 

comments and start to discuss them, do we want to -­

should be period be extended, do we hold off on the
 

-- finalize our comments to when the public's had
 

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more time to participate and understand what's going
 

on, which is to some extent what happened with the
 

public participation sessions the last time. I
 

don't feel strongly about 45 or 60 days. I don't
 

know much procedurally about how that gets played
 

out. I -- always -- usually it's been 30-day
 

increments, but maybe Larry or somebody can explain
 

that to me, if there is any... Usually my sense has
 

been they give a 30-day extension simply because the
 

-- they usually wait till 28 or so days have gone
 

by.
 

MR. ELLIOTT: Well, it can be a 15-day
 

extension or 30-day or 45. It's whatever time they
 

want to designate. I guess that answers your
 

question.
 

DR. MELIUS: Yeah.
 

MR. ELLIOTT: Okay. I'll shut up.
 

DR. ZIEMER: If it's a 15-day extension, that
 

gives us approximately five weeks after our meeting
 

next week to come to closure. If it's a 30-day,
 

obviously it gives us about seven weeks.
 

DR. ROESSLER: But now three weeks.
 

DR. ZIEMER: Okay. Is that right? It's four
 

weeks from today. If you added two, that's six
 

weeks. And if we meet again -- I said -- it may be
 

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late in the day. I was thinking that after next
 

week there would be five more weeks. Isn't that
 

right? One and five still six? Yeah. Well, Gen
 

and I can work out our calculus. In any event, it
 

gives us more breathing room. That's the point.
 

And we may have to have another session before Oak
 

Ridge if we're not able to come to closure a week
 

from today, which is entirely possible, I suppose.
 

Larry, you have a comment?
 

MR. ELLIOTT: Our rulemaking experience is that
 

comments are filed to the docket on the last few
 

days of the comment period. And so if that
 

tradition holds in this rulemaking experience, if
 

you're looking for those comments that come forward,
 

you're not likely to see the bulk of them until the
 

last week anyway.
 

DR. ZIEMER: That's probably true. And in my
 

mind, the main thing we gain is a little breathing
 

space on getting our work done.
 

DR. MELIUS: But also by -- I mean I felt last
 

time that by -- from both the public participation
 

sessions as well as our deliberations and our
 

conference calls and so forth, our meetings, we -­

we got some feedback from the public about our views
 

that helped to inform them -­

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DR. ZIEMER: You mean the public -- or in the
 

telephone -­

DR. MELIUS: We informed the public's view, and
 

I think people decide well, okay, that's being
 

addressed by the Committee. I don't need to address
 

that. They're already aware of this issue and it
 

also I think helped the public understand what was
 

in the regulations and so forth.
 

DR. ZIEMER: Any comments -­

DR. MELIUS: And having said all this, and I
 

didn't mean to have this thing take as long as it
 

has -­

DR. ZIEMER: That's all right.
 

DR. MELIUS: -- and I don't want Gen to have to
 

spend the weekend -­

DR. ZIEMER: I'm not sure whether Tony made a
 

formal motion to amend or not.
 

DR. MELIUS: But I would take it as a friendly
 

amendment and let's -- if that can make this move
 

forward.
 

DR. ZIEMER: A friendly amendment, so what
 

about the seconder? Leon, as the seconder -- I
 

think you were the seconder.
 

MR. OWENS: Yes, sir, that's right, Dr. Ziemer.
 

DR. ZIEMER: Jim has accepted as a friendly
 

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amendment Tony's suggestion that we be specific and
 

make it simply a 15-day extension. Is that -­

MR. OWENS: That's acceptable to me, also.
 

DR. ZIEMER: Okay. So the motion that's before
 

us, as amended in an amicable way, is to request a
 

15-day extension, or we recommend a 15-day
 

extension. Are you ready to vote?
 

All in favor of this recommendation, say aye.
 

(Affirmative responses)
 

DR. ZIEMER: And opposed?
 

(No negative responses)
 

MS. MUNN: I'll abstain.
 

DR. ZIEMER: Abstaining? Okay. One
 

abstention. Then that motion carries and that does
 

-- that is our recommendation.
 

BOARD DISCUSSION/WORK SESSION
 

SPECIAL EXPOSURE COHORT - NPRM
 

DR. ZIEMER: Now if we could -- how are we
 

doing on time here? Let's go to Subpart A. I just
 

want to step through this by section and make sure
 

there aren't any sort of -- even on sections where
 

we didn't address anything. Are there any changes
 

that anybody has identified in 83.0 that need to be
 

made -- background information. I'm going to go
 

through these pretty fast till we get to the -- yes.
 

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DR. ANDERSON: I just had one question early
 

than that and as we went through it I didn't see it
 

addressed, and that's in the preamble on page 49.
 

Now we talked a little bit about kind of windows and
 

how that fits in, and they have here that NIOSH will
 

discuss with the Board this option to assign doses,
 

and I'm not -- I'm not sure what that means. I
 

don't think there is a mechanism built in in the
 

rule anywhere for that as a...
 

MR. KATZ: Yes, I actually did address this,
 

but -- yes, this is the question that Jim Melius
 

raised about what do we do about folks with other
 

cancers and with experience outside the window. And
 

that is not an issue for this rule. It's an issue
 

for dose reconstruction, which is why it's not
 

addressed in this rule.
 

But yes, and I'd offered to talk about thoughts
 

about that issue, but I think we're holding that off
 

until you've finished your work with this.
 

DR. ZIEMER: It's not a part of this rule, yes.
 

Okay. So I'm back to 83.0 subpart A is the section.
 

That's called background information on the
 

procedures in this part. Any comments?
 

Then I'm going to move forward. 83.1, what is
 

the purpose of the procedures. Are there any
 

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wording changes or other concerns?
 

I'll keep moving until somebody stops me.
 

83.2, how will DOL use the designations established,
 

et cetera.
 

Then we come to Subpart B, the definitions.
 

MR. GRIFFON: Just one -- one question on the
 

definitions. I think, Ted, you mentioned that the
 

definition of endangered health was dropped. Can
 

you -- is that worthwhile including, 'cause it's
 

been -- it's been changed.
 

MR. KATZ: There's no point in including it
 

because it's not -- it's not operative in this rule.
 

There are procedures for dealing with health
 

endangerment, but there's no -- it's not being used
 

as a term that needs to be defined. It's defined by
 

the procedures themselves how you address that.
 

We're not defining health endangerment in any way,
 

as we were before using NIOSH-IREP, so it has no
 

value as a definition.
 

DR. ZIEMER: Now the terminology shows up
 

several times on page 82 -- satisfying the health
 

endangerment criteria.
 

MR. KATZ: Right, which is the procedures in
 

the rule addressing.
 

DR. ZIEMER: Okay. The first place it shows up
 

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is an actual quote from the statute. This is at the
 

top of page 82 where it quotes from the statute,
 

(reading) is there a reasonable likelihood that
 

radiation dose may have endangered the health of
 

members of the class.
 

The paragraph after that sort of generically
 

uses the same term. It's the middle of the page,
 

(reading) NIOSH will assume for the purpose of this
 

section that any duration of unprotected exposure
 

could cause a specified cancer and hence may have
 

endangered the health.
 

So again that's just a contextual use of the
 

term, not an official -­

MR. KATZ: Let me just explain -- I mean in the
 

old NPRM we gave a technical definition for health
 

endangerment, which is why we had it in the
 

definitional section, because we were using IREP to
 

establish a benchmark. Since that all falls out,
 

there's no -- there's no definition really possible
 

for health endangerment here. It's only used
 

generically, and then there are clear procedures for
 

what you do to address health endangerment in the
 

procedures, which are very simple, but -- so there's
 

nothing to define besides the generic meaning that
 

people would take from it, reading it.
 

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DR. ZIEMER: Mark, are you okay on that?
 

MR. GRIFFON: I think it's okay. I mean it's
 

defined in this section anyway, so I'm not sure -­

and I'm not sure you can put a -­

DR. ZIEMER: Well, it's defined generically
 

because it's not an official concept that's used to
 

make a determination, the way it was in the original
 

document.
 

Anything else in the definition section? Then
 

we are -- come to Subpart C.
 

DR. ANDERSON: Why isn't there an 83.3 and 4?
 

DR. ZIEMER: 83.6 is the overview of the
 

procedures. There were some minor wording changes
 

in here to make it more clear. Are there any issues
 

that anyone has with that section in terms of the
 

way it's written now?
 

There appear not to be. 83.7, who can submit a
 

petition. One of the comments during the public
 

comment periods had to do with that issue, but I
 

believe this clarifies it, does it not? Is there in
 

anyone's mind any issues on this -- apparently not.
 

Okay.
 

83.8, how is a petition submitted. Roy?
 

DR. DEHART: This section addresses the form
 

which is yet to be created. I just feel it would be
 

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helpful for us to ask that we see that form as soon
 

as it is created.
 

DR. ZIEMER: And the form itself does not get
 

codified as a part of the rule, so it could be
 

adjusted readily outside the rule as you gain
 

experience with the form. Is that not correct,
 

Larry or Ted?
 

MR. KATZ: Well, it can always be adjusted,
 

yes. The procedure you have to go through, though,
 

is once OMB approves the form, you have to get
 

approval for making changes to the form.
 

DR. ZIEMER: That's just an OMB issue,
 

though -­

MR. KATZ: That's right.
 

DR. ZIEMER: -- it's not -­

MR. KATZ: That's right.
 

DR. ZIEMER: -- a public rulemaking and so -­

MR. KATZ: It's entirely -­

DR. ZIEMER: That was my point, though.
 

MR. KATZ: Yes.
 

DR. ZIEMER: It's really a form that has -­

it's a little more flexible than if you put it in
 

here, so you're just -- Roy's just asking to see
 

what it looks like.
 

DR. DEHART: That's correct, yes.
 

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DR. ZIEMER: No changes here that anyone's -­

thank you. Yes, Tony.
 

DR. ANDRADE: Just a question for my own
 

edification. Will the form, as currently drafted or
 

being drafted, will it essentially contain the
 

questions that are in 83.9?
 

MR. KATZ: Yes, it's that same information that
 

follows right along with the regulation, but it also
 

provides a lot of explanation to help the petitioner
 

understand what's being asked for.
 

MS. MUNN: And -­

DR. ZIEMER: Wanda.
 

MS. MUNN: -- approximately what is the time
 

element involved with the OMB approval normally,
 

just roughly? Big guess.
 

MR. KATZ: Well, that depends. No, it's -- if
 

you were to change the informational burden, then it
 

takes a lot more time because then you actually have
 

to make public notice of the new burden and so on
 

and get an opportunity for the public to comment on
 

the burden and so on, so that could get lengthy.
 

But otherwise, if you're fiddling with the
 

instructions and so on, how much time it takes -- I
 

haven't had to do that. I haven't had to go back to
 

OMB so I can't really tell you, but they have -- I
 

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just have to say, they've dealt with our issues
 

under this program very quickly. Although they have
 

the prerogative to take more time, they haven't. So
 

you know, in -- they've dealt with these things -­

in forms, for example -- in matters of weeks and so
 

on.
 

DR. MELIUS: That's in government time,
 

relatively -­

MR. KATZ: Well, we -- yes, we're in government
 

and so we're speaking of government time.
 

DR. MELIUS: To clarify.
 

DR. ZIEMER: Any others on that section? Okay.
 

The section 83.9, what information must a petition
 

include. I have a note that on page 75 item Roman
 

numeral (iv) needs some cleanup in the wording.
 

Does anyone have anything prior to that item on 75?
 

MR. GRIFFON: Just the paragraph right above
 

that, also.
 

DR. ZIEMER: Paragraph (iii)?
 

MR. GRIFFON: Yeah, which I had talked about.
 

DR. ZIEMER: Okay. What was the issue on
 

paragraph (iii)? Well, hold on. Anything before
 

(iii)? Okay, on (iii), Mark?
 

MR. GRIFFON: I just think it's worth
 

considering possibly editing that sentence, as well,
 

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maybe deleting everything after "as relevant to the
 

petition" where it says "and specifying the basis
 

for finding these documented limitations might
 

prevent the completion" -- so forth, so on. I guess
 

my notion is to -- to not make the hurdle higher for
 

information coming in, you know, for potential
 

viable petitions.
 

DR. ZIEMER: Let's see, this is a health
 

physicist who's been specifically retained, is it,
 

to address the issue -­

MR. GRIFFON: Yeah.
 

DR. ZIEMER: -- report, or an expert. It
 

doesn't have to be a health physicist.
 

Actually, isn't that in fact what the person is
 

going to be addressing anyway? I mean that's
 

basically the nature of...
 

MR. GRIFFON: Yeah, I just -- I don't know, I
 

just -- the way I -­

DR. ZIEMER: The documentations -­

MR. GRIFFON: -- read that -­

DR. ZIEMER: -- of the records -­

MR. GRIFFON: Yeah, again -­

DR. ZIEMER: -- and -­

MR. GRIFFON: I guess the way I -- it depends,
 

I suppose, on how you read that sentence that
 

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"specifying the basis for finding". I mean I'm sure
 

they will provide an argument why these -- this
 

limitations in the data therefore necessitate that
 

this group be considered for an SEC, but -- but they
 

may -- I guess -- I guess it looked to me init-- in
 

the initial read that that was presenting a higher
 

hurdle, that they would have to have more subs-- you
 

know, documents that they may not have access to, to
 

support their -- their petition or their -- their -­

their claim here that there's lacking information
 

which may affect the ability to be able to calculate
 

doses for that Cohort.
 

DR. ZIEMER: So your suggestion is to drop that
 

last part of the sentence.
 

MR. GRIFFON: That's a -- yes.
 

DR. ZIEMER: That's a solution. Let's -­

others want to weigh in on this particular one, pro
 

or con? Is there a simple way to -- I don't think
 

we're necessarily arguing with the intent of it.
 

You're -­

MR. GRIFFON: No.
 

DR. ZIEMER: -- with the extent to which -­

that doesn't mean even to specify the basis.
 

MR. GRIFFON: I mean if other people don't have
 

trouble with it, you know, I'll just -- maybe I'm
 

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reading it too -- as a hurdle and other people don't
 

see it that way. I'll accept that, as well.
 

DR. MELIUS: It would seem to me if you're
 

going to put that in there that it would be -- and
 

I'm not necessarily recommending this, so -- it
 

would be a general requirement for the other types
 

of documentation that could be submitted. 'Cause if
 

you look at the top of that page, number (i), that
 

doses were not monitored; number (ii), that they
 

were falsified. But neither of those is there a
 

requirement that the petitioner then specify why
 

that would interfere with dose reconstruction -­

those -- or those individuals. All they'd point out
 

is that there were some -- then the evaluation would
 

explore that and -- further.
 

DR. ZIEMER: Oh, I see now. I would have
 

interpreted "specifying the basis" as in fact doing
 

one of those, sort of saying well, it's -- those are
 

the kinds of bases that you have available. This
 

person would be specifying which of those. That's
 

how I interpreted.
 

DR. MELIUS: Yeah, that could -- that's how -­

I understand, okay.
 

DR. ZIEMER: That's exactly the same
 

requirement, which of these are you alleging. But
 

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we're all seeing it different ways. Tony.
 

DR. ANDRADE: So what I would like to propose
 

as a potential simple solution to this is to take
 

the wording down at the bottom of little -- the
 

(iii) paragraph, "for specifying the basis for
 

finding the limitations that might prevent the
 

completion of dose reconstructions" et cetera, and
 

placing that in the sentence preceding these
 

subsections.
 

DR. ZIEMER: I'm having a little trouble
 

tracking where you are there.
 

DR. ANDRADE: Okay, I'm on page 75, subsection
 

(iii).
 

DR. ZIEMER: Right.
 

DR. ANDRADE: Okay?
 

DR. ZIEMER: Okay. And doing what now?
 

DR. ANDRADE: And doing the following, in
 

general. Right where there's a comma and it says
 

"and specifying the basis" -­

DR. ZIEMER: Yeah, so that whole phrase what -­

DR. ANDRADE: Right, taking that -­

DR. ZIEMER: -- was saying that -­

DR. ANDRADE: Basically taking that phrase and
 

adding it up to -­

UNIDENTIFIED: (2).
 

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DR. ANDRADE: No, to the sentence at the very
 

top of the page.
 

UNIDENTIFIED: So (2).
 

MR. ELLIOTT: At the end of (2) -- (2) starts
 

on 74 and ends with your sentence on -­

DR. ANDRADE: There you go, uh-huh.
 

DR. ZIEMER: Must include one of the following
 

elements and specify the basis for finding -­

DR. ANDRADE: To -- to specify the basis.
 

DR. ZIEMER: To specify. Does that solve it?
 

MR. KATZ: Dr. Ziemer, can I try to help here?
 

DR. ZIEMER: Yeah.
 

MR. KATZ: Ted Katz, I'm sorry. But I wouldn't
 

move it up there. The items above are self-


sufficient already and that's really confusing.
 

What's intended here -- I mean it's said, but
 

obviously it's open to interpretation or it wouldn't
 

be getting multiple interpretations, but all that's
 

intended here is that if you're going to hire a dose
 

reconstructionist of some sort to evaluate and put
 

together a petition for you, evaluate the
 

suitability of records to be able to complete dose
 

reconstructions under -- as they're completed under
 

this program, then your dose reconstructionist that
 

you're hiring needs to document whatever record
 

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limitations the reconstructionist has found and
 

indicate why these limitations might prevent NIOSH
 

from doing dose reconstructions according to the
 

procedure it uses to do them. So it's -- this is
 

when you're hiring a person to do exactly what -­

make the case. That's what it's intended to say, at
 

least.
 

DR. ZIEMER: Wanda?
 

MS. MUNN: May I suggest that one of the
 

problems is that the sentence itself appears
 

convoluted. Perhaps a great deal of it could be
 

served by putting a period after "petition" and then
 

saying this report should specify the basis for
 

finding the documented limitations -- a couple of
 

words need to be changed to accommodate that, but
 

leave the phrase essentially as it is, but make a
 

new sentence out of it, starting with "this report
 

should specify".
 

DR. ZIEMER: That certainly simplifies the
 

reading. It's not clear to me that it necessarily
 

addresses Mark's comments 'cause he thought it was
 

an additional burden. As I said, I thought it was
 

simply explaining what it is he's already doing,
 

but -­

MR. GRIFFON: I guess it is. I'm also thinking
 

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of the health physicist who might assist, who is on
 

the outside of the loop here, who will necessar-­

most likely not have access to as much information.
 

I'm relieved by the word "might" in the middle of
 

that sentence. You know, "might prevent the
 

completion of dose reconstruction". Yeah, I guess
 

the first read-through for me was that, you know,
 

they have a -- a health physicist might have a
 

collection of documents that they suspect would make
 

it very difficult for this cohort's doses to be
 

reconstructed. But then would they give technical
 

basis that would assure -- you know, but it does say
 

"might prevent" so I'm relieved by that. So -- you
 

know, maybe I'm picking at this too hard. I just -­

I just wanted to do it to make sure that we weren't
 

DR. ZIEMER: We can revisit this. Let me
 

suggest that we leave it in, but change it the way
 

Wanda has suggested for now. That would simplify
 

the reading -­

MR. GRIFFON: Yeah, the reading's easier that
 

way. I -­

DR. ZIEMER: We would simply delete the word
 

"and" and maybe say "the report should specify the
 

basis" and then -- and then, Mark -­

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MR. GRIFFON: Yeah, I think -­

DR. ZIEMER: -- I'm going to put the burden on
 

you between now and next week, if you'd study this
 

more -­

MR. GRIFFON: Yeah, okay.
 

DR. ZIEMER: -- and when we get to that -- no,
 

'cause we need -- we can't do all the wordsmithing
 

as a group -­

MR. GRIFFON: Right.
 

DR. ZIEMER: -- so if you would specifically
 

look at that for next week, and then when we get to
 

that point, if you're still -­

MR. GRIFFON: Yeah.
 

DR. ZIEMER: -- uncomfortable, maybe you would
 

propose an alternative wording on it that would
 

clarify it. Would that be agreeable to everyone?
 

I'm just -- I don't want to -- I want to get to the
 

issues that are a little more -­

MR. GRIFFON: I agree.
 

DR. ZIEMER: -- needy for us or weighty. Mike.
 

MR. GIBSON: Well, and also it -- you know, it
 

says "health physicist or other individual with
 

expertise in dose reconstruction documenting the
 

limitation of existing records". Certainly -- I'm
 

not a health physicist, but I've been around the DOE
 

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long enough to know the limitations in the records,
 

but I wouldn't be able to specify the basis of the
 

finding. I would just -- so I don't see how -­

DR. ZIEMER: Well, the basis of the finding is
 

the limitation if you can identify what that is. So
 

I suspect that's the whole point of the report,
 

isn't it? To identify the limitations that might
 

lead to the -­

MR. GIBSON: I guess I was just trying to say
 

providing the documentation that demonstrates that
 

the records are inadequate, rather than writing a
 

report, is all that I was trying to suggest.
 

DR. ZIEMER: Well, I guess however -- whatever
 

form that takes, that's the report. Whatever that
 

person submits for that purpose, so -- okay, comment
 

noted.
 

The next paragraph, we also had a little
 

problem on the wording, that we thought it should be
 

cleaned up. I have a suggested cleanup on it, but
 

maybe Roy has one, also.
 

DR. DEHART: The way I would word it, very
 

quickly, a scientific report published by a
 

governmental agency or published in a peer-reviewed
 

scientific journal that identifies dosimetry and
 

related information that is otherwise unavailable -­

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parenthetical phrase -- for estimating the radiation
 

dose of employees covered by the petition, period,
 

full stop.
 

DR. ZIEMER: Okay. I had almost exactly the
 

same wording, with the exception of adding the word
 

"technical", a scientific or technical report that
 

-- some people distinguish between those -- by a
 

governmental agency or published in peer-reviewed
 

scientific journal, et cetera.
 

Mark.
 

MR. GRIFFON: And did you -- did you -- I
 

missed the end of that sentence. Did you drop off
 

the "and also finds"?
 

DR. DEHART: Yes.
 

DR. ZIEMER: Because that report may, as we
 

discussed before, may not necessarily be dealing
 

with this issue head-on. It may be for some other
 

purpose and may not have such a finding in it, per
 

se, but could be used for that.
 

DR. DEHART: In fact in reviewing the records
 

yesterday, we found such a report that dealt with
 

cancers. Cancer was unrelated to the individual,
 

but the doses that were in there were related
 

(inaudible) no value to the individual.
 

DR. ZIEMER: Okay. Is that recommended change
 

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agreeable? Can we take it by consent for just a
 

clarification of the wording. Okay.
 

Let me ask the reporters if they got the
 

wording. They probably did, they're very good.
 

Okay. The other item that I had flagged here
 

was the very end of the this section. It would be
 

at the top of -- yes, 76, where we said that those
 

items identified as Roman (i) and (ii) might
 

actually become part of 83.11. That would be the
 

whole item (3), and -- Ted has suggested that in
 

that case it would be the whole item (3).
 

Ted, have you had a chance to look at this
 

further? Is it your judgment that in fact it should
 

be moved? I mean does it make more sense to be
 

under 83.11 in terms of the -­

MR. KATZ: Yeah, I can't speak for -- that's -­

actually I'm not supposed to say what -­

DR. ZIEMER: All right.
 

MR. KATZ: -- what should be, but I can see how
 

it could go in there and work in there, yes.
 

DR. ZIEMER: Looking at the titles of the
 

topics, is it under the right topic? It's what
 

information must a petition include, versus what
 

happens to petitions that do not satisfy.
 

MR. KATZ: Right.
 

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DR. MELIUS: I think, having looked this over,
 

I think the problem is it sort of falls in between,
 

because it -- as I would see the process, a petition
 

could be initially accepted and NIOSH goes to get
 

further information on it and is unable to confirm
 

that the exposure incident took place. Then it goes
 

back to the -- NIOSH goes back to the petitioner
 

seeking this additional information.
 

DR. ZIEMER: Well, let me ask this. Is it
 

confusing to leave it here or is it okay here?
 

DR. MELIUS: I think it's potentially
 

confusing, simply because it's -- people are going
 

to look at it and think it is part of the original
 

petition. It's not part of the original -­

DR. ZIEMER: But on the other hand, is it -­

DR. MELIUS: -- but it -­

DR. ZIEMER: -- confusing if it's under 83.11,
 

if it falls in between?
 

DR. MELIUS: Depends on how -- I think in both
 

places it depends on how it's written, and I think ­

- I think our recommendation should be that it
 

should be clarified. I think NIOSH, as it redrafts
 

the final regulation, should just clarify and
 

determine what the best position is for it. I don't
 

think we -­

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DR. ZIEMER: Okay, so we might be comfortable
 

with just pointing this out -­

DR. MELIUS: Yeah.
 

DR. ZIEMER: -- and asking that that be
 

clarified.
 

DR. MELIUS: Right.
 

DR. ZIEMER: Obviously we're not asking that it
 

be changed, but it needs to -­

DR. MELIUS: Well -­

DR. ZIEMER: -- integrate better.
 

DR. MELIUS: -- we -- I'm also asking that
 

point (ii) there, confirmation from two employees
 

who witnessed, be changed. I don't think that is a
 

fair -­

DR. ZIEMER: Oh, we flagged that, that's -­

DR. MELIUS: -- requirement. That's a -­

that's a separate issue, no matter where it -- this
 

ends up, yes.
 

DR. ZIEMER: Where it is. Okay. But we can
 

agree to simply -- our recommendation on the whole
 

section will be to clarify -­

DR. MELIUS: Yeah.
 

DR. ZIEMER: -- in terms of where that fits in.
 

Now let's talk about the (ii) versus the -­

confirmation by affidavit from two employees who
 

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witnessed the incident. Couldn't the -- couldn't
 

the petitioner be one of the two?
 

MR. KATZ: Well, I -­

DR. ZIEMER: This does not preclude that, does
 

it?
 

DR. MELIUS: Well, we were told it does, that
 

the interpretation was -- has that changed?
 

DR. ZIEMER: If the petitioner witnessed it -­

MR. KATZ: I really can't speak authoritatively
 

as to how it would be interpreted, but certainly you
 

can raise whatever concern you have as to what that
 

should mean.
 

DR. MELIUS: I think we should recommend that
 

it be -- it include the petitioner.
 

DR. ZIEMER: It may include -­

DR. MELIUS: May include the petitioner. But I
 

also am concerned about the situation which an
 

incident occurred a number of years ago. There
 

could be situations where the people exposed no
 

longer are surviving, but there certainly could be
 

credible evidence from their spouses about -- who
 

may not -- or other workers who may not have
 

witnessed the incident but heard about the incident,
 

whatever. I think the credibility of that
 

information has to be evaluated in some way, but I
 

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-- given how far back we're going with some of
 

these, particularly AWE facilities and how -- I
 

think how poor the documentation is, that we have to
 

leave open the possibility that records may not be
 

found yet there could be credible information that
 

such an incident did -- did take place.
 

DR. ZIEMER: I would understand the thrust of
 

this to be, at the outset, that if you had the two
 

witnesses, whether it's the person plus one other,
 

you sort of -- you're already in. But the case
 

where you had one or even none is not really
 

addressed.
 

DR. MELIUS: The problem, though, is that
 

they've approached this and I think it's awkward.
 

I'm not sure there's a -- what the best way is.
 

What they're doing is saying first NIOSH is going to
 

go and look for the documentation. When it can't
 

find the documentation, it's going to go back and
 

look for this medical evidence, which is -- actually
 

comes from the first announcement of proposed
 

rulemaking. And then secondly this confirmation by
 

affidavit, which I think is new. I don't remember
 

that being in the first one. It may have been, but
 

I missed it if it was. So this is comes second. I
 

agree with you that it could also be supplied up
 

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front, either sets of information, so it is
 

confusing. And no matter what we decide on this or
 

recommend on this, that -- somehow this process
 

needs to be clarified. Maybe it's a separate
 

section. Maybe it can be part of the petition or
 

with an alternative to provide it later or whatever.
 

But if you look at the top of the page, "if NIOSH is
 

unable to obtain records or confirmation of the
 

occurrence of the incidence from sources independent
 

of the petitioner" -- a fellow worker and -- I
 

understand what they're trying to get at, but
 

it's -­

DR. ZIEMER: No, it's the case where this
 

incident doesn't show up anywhere until all of a
 

sudden this particular case mentions an incident
 

that -­

DR. MELIUS: Yeah.
 

DR. ZIEMER: -- is not identified anywhere
 

else.
 

DR. MELIUS: Right.
 

DR. ZIEMER: Then you go back and say okay, is
 

there someone else that's witnessed this.
 

DR. MELIUS: Yeah, and then I -­

DR. ZIEMER: Or is there medical evidence.
 

DR. MELIUS: Right.
 

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DR. ZIEMER: And either of those, NIOSH is now
 

saying we will consider those as evidence to go
 

forward. They don't say it will qualify, but it
 

may. So it takes them the next step. But beyond
 

that, a single witness or no witnesses and this
 

third -- this thing we talked about earlier, the
 

hearsay evidence, I don't know what we do with that
 

but we may want to address that, also.
 

Roy has a comment.
 

DR. DEHART: I understand totally the reason
 

for the two employees that we're talking about now.
 

My only question would be is there a standard of
 

legal evidence that requires this to be two in
 

addition to the actual case filer. So I think
 

somebody should look into that. If it's not an
 

issue, certainly two...
 

DR. ANDERSON: It doesn't have to be an
 

individual petitioner. The petitioner could be a
 

union, in which case if they had an individual that
 

reported to them the case or the incident, then that
 

person reporting and another, so it doesn't -- it
 

would seem -­

DR. ZIEMER: That's the two people, yeah,
 

right.
 

DR. ANDERSON: (Off microphone) (Inaudible)
 

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Yeah, if you're the person that's actually, on your
 

behalf, filing, you shouldn't be penalized because
 

somebody else who has a third party filing on their
 

behalf would get to count them, so I think the two
 

is somebody plus the initial reporter is probably
 

useful.
 

DR. MELIUS: Yeah, then I think if we had a
 

number (iii) if -- under there, if -- you know,
 

employees, you know, present at the time of the
 

incident are not -- or have died or otherwise not
 

able to locate them, that other -- you know, other
 

types of, you know, verbal reports, you know, could
 

be submitted and would be evaluated.
 

DR. ZIEMER: Okay. Let me see if there's any
 

consensus on the (ii) being two, any two, including
 

if the petitioner's a -- as a recommendation. We
 

can ask for clarification, but -­

DR. MELIUS: Yeah.
 

DR. ZIEMER: -- is there anyone that thinks it
 

ought to be two beyond the petitioner -- assuming
 

the petitioner's a single person. Apparently not.
 

DR. DEHART: (Inaudible) suggesting changing
 

the wording them from two employees to two -- well,
 

we're saying it could be -- the petitioner could be
 

the surviving wife. Is that what you were
 

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intending?
 

DR. ZIEMER: Two witnesses, one of whom could
 

be the petitioner if the petitioner actually
 

witnessed it.
 

UNIDENTIFIED: Not just hearsay, yeah.
 

DR. ZIEMER: And then there's a separate
 

suggestion that perhaps a section (iii) be added
 

dealing with the issue of lack of a second witness
 

or lack of any witnesses.
 

UNIDENTIFIED: (Inaudible)
 

DR. ZIEMER: And I don't think we can wordsmith
 

that here, but -- and I don't even know from a legal
 

point of view what makes sense. My intuition is
 

that we ought to try to grapple with it, but -­

DR. MELIUS: I'll give it a try and then the
 

lawyers can go at it.
 

DR. ZIEMER: You want to try to come up with
 

some wording?
 

DR. MELIUS: They're just lawyers.
 

DR. ZIEMER: Well, give us a -- this is a straw
 

man -- this is a straw man, what do we do in the
 

case where there isn't -­

DR. ANDERSON: (Off microphone) I mean if there
 

isn't, the likelihood of it actually getting
 

ultimately approved, there's probably -­

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DR. ZIEMER: Probably low, but there ought to
 

be a mechanism for dealing with these cases where
 

there's survivors who've heard of -- of something.
 

Okay. So you'll take a crack at that.
 

I'm going to pause a moment and see how we're
 

doing on time. It's 4:00 o'clock. We're scheduled
 

to go till 5:00 and we can continue to plow ahead.
 

Are there other travel concerns? Anyone going to be
 

needing to leave to go catch a plane?
 

DR. MELIUS: A number of us have to leave at
 

5:00 so -- we have a 7:00 o'clock flight, so...
 

DR. ZIEMER: Okay, no later than 5:00.
 

MR. ESPINOSA: (Off microphone) (Inaudible)
 

schedule for the next meeting?
 

DR. ZIEMER: We have scheduled a telephone
 

conference a week from today. Does everyone have
 

that on their calendar, 1:00 to 4:00 p.m. Eastern
 

Standard Time. We have scheduled a meeting in May
 

in Oak Ridge, May 19th and 20th. It's -- it
 

probably would be prudent to schedule -- in fact we
 

should schedule it today if we're going to -- even
 

if we -­

MR. ELLIOTT: Another teleconference.
 

DR. ZIEMER: Another teleconference.
 

MR. ELLIOTT: I'd like to get it in the Federal
 

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Register.
 

DR. ZIEMER: And it would be prudent if we
 

scheduled that no later than first week of April.
 

DR. MELIUS: A conference call.
 

DR. ZIEMER: And I'm basically out of the loop
 

all -- till the 3rd, so -- no, I'm out of the loop
 

through the 3rd.
 

How does the 4th look to folks? Any -- Leon,
 

are you still on the line? Did we lose Leon?
 

MR. GRIFFON: Can I ask, while he's dialing,
 

Larry, the Oak Ridge meeting, is that -- have you
 

got a location for that?
 

MR. ELLIOTT: It is in Oak Ridge.
 

MR. GRIFFON: It is in Oak Ridge, not
 

Knoxville?
 

MR. ELLIOTT: It is in Oak Ridge at the Garden
 

Plaza -- is where your lodging would be, but the -­

I believe the meeting room is going to be over at
 

the mall.
 

DR. ZIEMER: Yeah, Leon?
 

MR. OWENS: Yes, sir.
 

DR. ZIEMER: I don't know why we keep losing
 

you here, but -­

MR. OWENS: Dr. Ziemer, I've checked my phone
 

to make sure and I don't know what's going on,
 

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but -­

DR. ZIEMER: Well, it may be at this end. In
 

any event, we're talking about a follow-on telephone
 

conference call, possibly for April 4th.
 

MR. OWENS: April the 4th?
 

DR. ZIEMER: Yeah. Were there any conflicts
 

here in April?
 

UNIDENTIFIED: What time?
 

DR. DEHART: I would be happy to call in if
 

NIOSH will provide me with a satellite phone. I'll
 

be in China.
 

DR. ZIEMER: Make us feel bad. Make us feel
 

bad.
 

DR. MELIUS: Let's see, if we did in the
 

afternoon, what time would that be in China? We may
 

want to offer you the -­

DR. DEHART: I'll call in.
 

MS. MUNN: It'll be early morning the next day.
 

DR. ZIEMER: Those that are going to be in this
 

country, what -- is the 4th okay? Shall we do a
 

1:00 to 3:00 again, is that -- or 1:00 to 4:00?
 

Okay. We're back to the document itself, 83.9
 

on page 77. It's a brief new section. Any comments
 

on it? Or actually it's 10, I'm sorry.
 

DR. MELIUS: There's a misprint there.
 

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DR. ZIEMER: No, it's -- no, it says it
 

satisfies all relevant requirements under 83.9.
 I
 

just read the wrong number. It's 83.10 -- 83.10,
 

top of 77.
 

Okay, how about 83.11? Okay, I had flagged -­

and actually this is now covered by Jim's item
 

(iii). I had flagged on page 78 that we would need
 

to consider the issue of what to do if -- about
 

witnesses if there are -- or the survivors if
 

witnesses are deceased from a, quote, incident. So
 

I guess that part's covered. Anything else on
 

83.11?
 

DR. MELIUS: I think there's the issue in the
 

preamble. I believe this is the place. It is the
 

review of petitions that don't satisfy and do we
 

want to recommend an administrative process for
 

that.
 

DR. ZIEMER: Okay, this is paragraph (b), is it
 

not, after 30 days -- (reading) the date of
 

notification NIOSH will notify the petitioner of its
 

decision to evaluate the petition, or its final
 

decision that the petition has failed -- is that the
 

part that...
 

Now -­

DR. ANDERSON: We have said we don't want to
 

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review those.
 

DR. ZIEMER: Right.
 

DR. ANDERSON: Should there be an
 

administrative process.
 

DR. MELIUS: Wasn't it originally that they -­

everything came to here.
 

DR. ZIEMER: This is basically responsive to
 

our previous recommendation, that NIOSH will handle
 

these -- and basically they are petitions which in
 

some way or another are inadequate and get sent
 

back, that they're not -- unevaluated petitions.
 

DR. MELIUS: I think what -- and Larry, correct
 

me -- I think NIOSH is asking the public to comment
 

on should there be a process -- administrative
 

process, and I think Richard laid out some of the
 

options -- Richard Miller -- some of the options for
 

that, one of which is the Board, and the other would
 

be administrative remedies within or outside the
 

bar-- are there others that -- I guess I'm asking
 

Larry, Ted or somebody...
 

MR. KATZ: I mean we don't have other ideas, if
 

that's what you mean, other than it's either going
 

to be in HHS, an administrative group in HHS is
 

going to review it or -- I mean you made a decision
 

about the Board before, but you can of course revoke
 

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that decision. I mean -­

DR. MELIUS: Well, the decision about the Board
 

was that we wouldn't review all of them. If we have
 

a review process or -- they're going to come up
 

anyway.
 

MR. KATZ: I mean this actually was abiding by
 

the Board's directions very directly. It was we're
 

going to get all the positive ones anyway that pass
 

muster. It was what should happen with the ones we
 

DR. MELIUS: Well, we expect you to provide an
 

answer, not another question.
 

MR. KATZ: Well -­

DR. MELIUS: I mean now you're kicking it back
 

to us.
 

DR. ZIEMER: What's being asked here really is
 

what does the petitioner -- what options does the
 

petitioner now have. Is there a way to appeal -­

obviously they can provide more information and have
 

it reconsidered, because part (c) actually allows
 

for that. (Reading) Based on new information,
 

NIOSH, at its discretion, may reconsider a decision
 

not to select.
 

That's one option that's built in here, it
 

appears, that the petitioner has additional
 

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information. Are you asking what if there's no
 

additional information but they just don't think the
 

decision was the right one, that the petition in
 

fact is adequate and should have been considered.
 

DR. MELIUS: They feel that it -- the
 

petitioner feels that it's adequate and maybe not in
 

a position to obtain more information or whatever to
 

satisfy what NIOSH said is wrong with it or why it
 

doesn't qualify, and I think the question is should
 

there be an appeal mechanism.
 

DR. ZIEMER: Maybe we can frame it this way. I
 

don't know that the Board has to come up with the
 

answer to that. We may raise that as a question to
 

be considered going forward, ask the staff to
 

consider what appeal mechanism there would be for a
 

petition that was -- what I'm saying is we don't
 

have to come up with the change for the rule. We
 

can direct the staff -­

DR. MELIUS: No, well, I think we have to make
 

a -- we have to decide whether we want to make a
 

recommendation that there should be a process. And
 

my personal feeling is that there ought -- there
 

should be a review process on that, an appeal
 

process, that should be within the Department.
 

DR. ZIEMER: Do others want to weigh in on that
 

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and if we reach a consensus then we can include
 

that. Okay. Tony?
 

DR. ANDRADE: Perhaps I'm just being dense this
 

afternoon at this hour, but again, I refer people to
 

83.16. Recall the fact that we talked about, quote,
 

evaluated petitions, whether positive or not, and
 

that -­

DR. ZIEMER: But these are unevaluated. These
 

are unevaluated.
 

DR. ANDRADE: Once they are evaluated. Okay.
 

Once they are evaluated.
 

DR. ZIEMER: No, we're talking about the ones
 

that do not get evaluated. They simply get turned
 

down because -­

DR. MELIUS: It's incomplete.
 

DR. ZIEMER: -- they're incomplete. The
 

petition never really gets evaluated. NIOSH says
 

there's not enough information here -- or you don't
 

meet the requirements for having a petition. Yes,
 

that is a form of evaluation.
 

DR. MELIUS: It gets evaluated as to whether it
 

meets the requirements. It doesn't get evaluated as
 

to whether it -- the class qualifies as a Special
 

Exposure Cohort.
 

DR. ZIEMER: Yeah, and maybe we need a
 

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different term 'cause this talks about evaluating
 

the petition and that other section talks about
 

evaluating the petition. One is an evaluation -­

MS. MUNN: This is an application.
 

DR. MELIUS: Wait another half-hour, we'll
 

confuse you even more.
 

DR. ZIEMER: That in itself is perhaps a
 

semantics issue that needs to be clarified. The
 

ones in section 83.16 do have an appeal process.
 

They have been evaluated as a petition. These are
 

ones where they have decided not to evaluate them.
 

There's a petition and it is not going to be
 

evaluated 'cause it's inadequate or incomplete,
 

which in itself is an evaluation, so...
 

So the question right now is does the Board
 

feel that there should be some mechanism for
 

petitioners whose petitions fail to meet the
 

requirements for evaluation to be reviewed -- for
 

that decision to be reviewed. Jim has suggested
 

there should be.
 

Wanda, you're...
 

MS. MUNN: At some juncture there has to be a
 

no. And if we're not going to accept this no as
 

no, then of course what's the next step is the
 

question here. And my question is, and is that next
 

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step then the no? Where does no become no?
 

DR. ZIEMER: Just like with your kids, is it
 

the first no that really counts?
 

MS. MUNN: Uh-huh, or is it the second no or
 

the third no?
 

DR. ZIEMER: When is no really no? I don't
 

know.
 

DR. MELIUS: I think actually Bob's ahead of
 

me, so -­

DR. ZIEMER: Bob, go ahead.
 

MR. PRESLEY: When this petition is turned down
 

at this time, do they get any type of a notification
 

that says why they're being turned down?
 

UNIDENTIFIED: (Inaudible)
 

MR. PRESLEY: Okay, then if -- then it's
 

explained.
 

DR. ZIEMER: Rich and then -­

DR. MELIUS: If I re-­

MR. ESPINOSA: Go ahead, go ahead.
 

DR. MELIUS: I'm sorry. As I recall from our
 

previous discussions of this, the Board wanted to
 

remove itself so that we wouldn't be into -- it was
 

in some sense an issue of time involved, also, that
 

we wouldn't be repeatedly reviewing, saying go back
 

for more information and then come back -- and so
 

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this would -- process would stretch out, that the
 

process would be facilitated by having NIOSH
 

directly dealing with the issue of obtaining -­

determining whether or not these petitions contained
 

adequate information to qualify. And I think that
 

-- I think that makes sense. We shouldn't be -- the
 

Board doesn't need -- have to be involved in
 

continually reviewing all these petitions.
 

At the same time I feel that the general public
 

should have some measure of appeal from a -- you
 

know, an arbitrary decision or a bad decision made
 

by a governmental agency and that providing some
 

process within the government for people doing that
 

is appropriate and fair -- doesn't necessarily
 

involve us in the...
 

DR. ZIEMER: Rich?
 

MR. ESPINOSA: With the recommendation that Dr.
 

Melius made, I'm in favor of -- the main reason why
 

is on page 25, second paragraph, operations of
 

concerns, as a building and construction trade
 

member, you know, a lot of times I don't understand
 

what's being done in the facility or facilities, for
 

that matter. And you know, to be real specific of
 

the operations in the -- of the -- of the stuff
 

going on in the facility, I don't know if it can be
 

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done from a person from the building and
 

construction trades or janitors or the guards, for
 

that matter.
 

And the same goes with -- you know, on page 27
 

it almost kind of seems -- you know, you've got to
 

be real specific for the petition not to get thrown
 

out, and I'm not sure how specific some -- some of
 

these claimants are going to be.
 

DR. ZIEMER: Henry?
 

DR. ANDERSON: I mean it seems to me there's
 

kind of two decisions. One, do you want a formal
 

mechanism or do you want to have -- based on new
 

information. New information could be NIOSH looks
 

at it and says boy, this is a tough call. I come to
 

the Board and say what do you guys think, and we say
 

well, why don't you go ahead. I mean that's new
 

information, we have given some information, but it
 

isn't the formal appeal process where you have to
 

file documentation or something like that. I mean
 

that -- I would -- seem to me there's enough in here
 

that if somebody really felt it was an egregious
 

problem, that could in and of itself be new
 

information. So it's a matter of if you -- do you
 

want to have a formal process, which would be -- it
 

goes into a process that the petition might then
 

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feel they have to hire legal assistance to go
 

through that process or not. I don't know what
 

other sorts of decisions are appealed, but that
 

could have financial ramifications on the individual
 

that might -- if we say formally you're going to
 

have this process, then that is the process they
 

have to follow.
 

DR. ZIEMER: Let me insert something here, make
 

sure we're all in the same place. I believe that
 

this is already the second no. The first no is in
 

item (a) where -- what happens to petitions that do
 

not satisfy the requirements. NIOSH notifies the
 

petitioner of any requirements that are not met and
 

assists them in getting new information and gives
 

them another 30 days to revise it. Then a new -­

then the clock starts again. And this thing called
 

the final decision is no a second time. So I
 

believe what we would be talking about now is, is
 

there yet another loop, 'cause this has two loops in
 

it already. So an additional appeal, if you want to
 

call it that, I think is yet a third no.
 

Now is -- are we all on the same page on that?
 

Do I understand this correctly, and that was your
 

understanding when you raised the issue that -­

DR. MELIUS: And I think the issue is that
 

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there are -- they've received two no's from NIOSH
 

and then should they have the right to have that
 

second no reviewed by another party.
 

DR. ZIEMER: Somebody, and it may be the Board.
 

DR. MELIUS: Originally the party was going to
 

be the Board. The Board said -- it was a little bit
 

more complicated, a different way, but the Board
 

said we didn't want to be the reviewer and have to
 

deal with all these and there's some other
 

procedural issues, so should there be a -- you know,
 

an out -- a third no, a review of that second no by
 

another group. And if there's an administrative
 

process within the Department for doing that, that's
 

another possibility and I think some of our struggle
 

with this is that we're not real sure what the
 

process is within the Department.
 

At the same time I think we don't want to be -­

have to -- if that review becomes an automatic or
 

that -- then it's going to end up being that much
 

more that we have to do. Is that practical, and
 

maybe that may -- it's an option.
 

DR. ZIEMER: I think we also have the issue of
 

the defined role of this Board. We do have a very
 

specific role in recommending Special Exposure
 

Cohorts. We don't -- I think we don't have a role
 

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in sort of -- if I can call it adjudicating
 

Departmental decisions. It's quite true that this
 

decision does have something to do as to whether a
 

Special Cohort is recommended, so we're not
 

completely out of the loop, perhaps. But I've
 

expressed this concern before that we not get
 

involved in the staff work of NIOSH, that we are
 

focused on our sort of legislated responsibility, so
 

-- you know, whatever -- if there's a review
 

process, I would hope it would be something within
 

the Agency. But it looks like there -- one review
 

has already occurred and, you know.
 

DR. MELIUS: Well, but so -- but the two no's
 

are from -- the first two no's come from -- come
 

from Larry, I guess. And I guess if somebody seeks
 

a third -­

DR. ZIEMER: So the third time, go ask your
 

mother.
 

DR. MELIUS: Well, who's Larry's mother, and if
 

they can tell us who his mother is, you know, that's
 

-- that process would be -- and I agree with you.
 

At the same time it's sort of a gray area since I
 

guess our role is -- of the Board is to review the
 

point of views, but the evaluation of those
 

petitions and the final recommendations and -- once
 

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they're accepted. And I'm unclear how much we
 

should be involved in accepting them.
 

DR. ZIEMER: Okay. The issue is, should there
 

be this additional appeal; and if so, who. And I'm
 

going to suggest we leave it there right now.
 

Unless -- unless somebody's -- really knows how -­

what the answers to those are, 'cause we can revisit
 

it next Friday. And maybe we'll all have bright
 

ideas.
 

Okay, that's 83.11. 83.12 -- oh, I'm sorry,
 

Rich. Did you have something else and then -- I'm
 

sorry.
 

MR. ESPINOSA: Can we step back to 69 real
 

quick and -­

DR. ZIEMER: Sixty-nine?
 

MR. ESPINOSA: Paragraph (c), class of
 

employees. Can we change facility to facilities?
 

DR. ZIEMER: Where are you again?
 

MR. ESPINOSA: Page 69, class of employees, a
 

group of employees who worked or work at the same
 

DOE or AWE facility, can we change that to
 

facilities?
 

DR. ZIEMER: Let me ask if this language is
 

from the legislation or where does this definition
 

of class of employees come from? Because that in
 

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part might tell us whether we can -­

MR. KATZ: Can you hold one second for that?
 I
 

need to find a piece of paper.
 

DR. ZIEMER: Okay.
 

(Pause)
 

MR. KATZ: Okay, thank you. This is -- I mean
 

this is the issue that Richard raised about multiple
 

facilities. That's what -- that's what's being
 

proposed here, that we say multiple facilities
 

instead of, you know, facility. And Richard pointed
 

to then language that has to do with specified
 

cancers -- let me find you the language -- bullet
 

down here -- yes, the difference between DOL using
 

multiple facilities to aggregate 250 days and our
 

using -- requiring it be at a facility under this
 

rule is that it's different sections of this
 

legislation with slightly different language that
 

makes the requirement at a facility, and our
 

language has no wiggle room, is sort of the bottom
 

line. Our language leaves, you know, no room for
 

interpretation that it could be multiple facilities,
 

whereas the DOL language has some wiggle room and
 

they were able to interpret it as multiple
 

facilities, or I believe that's how that occurred,
 

you know, though I haven't -­

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DR. ZIEMER: So you're saying this definition
 

comes from the legislation which defines it this
 

way?
 

MR. KATZ: So that -- so the legislation
 

specifically talks about that these are classes at a
 

facility and at that facility, singular. Which we
 

explain and you'll see that discussion in the
 

preamble, and that's why we were constrained to
 

limit it to a single facility, but it's -- we had
 

different statutory language to deal with than DOL.
 

DR. ZIEMER: Thank you. So at the moment then
 

I guess that suggests that -- that it may have to
 

stay that way because of the definition in the law.
 

Okay. Thank you.
 

83.13, page 79. Okay? Moving ahead? 83.13,
 

top of 80, I've got a flag here. Item (1) near the
 

top of the page.
 

DR. MELIUS: I'm not sure that we're capable of
 

discussing this at this point in time on a Friday
 

afternoon, but -­

DR. ZIEMER: No, but -- but we can -­

DR. MELIUS: -- it's a big issue.
 

DR. ZIEMER: We can frame the issue so that
 

people can give it some thought between now and next
 

Friday.
 

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DR. MELIUS: And that's what I was about to...
 

Right, yeah.
 

DR. ZIEMER: Jim, I think you raised it, so you
 

want to reframe it for us?
 

DR. MELIUS: And I think the framework for that
 

issue is the same framework from our previous
 

comments, that NIOSH has not really defined in any
 

detail how this operates, how they will make this
 

determination. They've changed it somewhat from the
 

last time, but there's still a very vague framework
 

for making this determination that a dose can or
 

cannot be reconstructed with sufficient accuracy.
 

And I think the framework for the question is have
 

the changes that they've made and has the currently
 

language adequately defined that, and I certainly -­

I don't believe it still does.
 

They -- I should point out that it -- I think ­

- believe it points out in the preamble that -- some
 

later steps that NIOSH will do to try to clarify
 

some of this issue and -- including providing some
 

examples. But we've -- we were also told that last
 

time and we still don't have the examples to go
 

over, so -- and that -- so if we're going to do it
 

on a case by case basis with sort of a case law that
 

would develop from these examples, I think that
 

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leaves us -- to me it's still problematic.
 

DR. ZIEMER: Could you clarify for me the
 

nature of the issue? Is it -- it's more than a
 

wording issue. It is an issue of whether or not in
 

fact what is described here can be done. Is that
 

correct?
 

DR. MELIUS: Whether it provides adequate -­

DR. ZIEMER: Or if they're -­

DR. MELIUS: -- guidelines -­

DR. ZIEMER: -- telling us how -- how it will.
 

DR. MELIUS: Yeah, that it could lead to
 

arbitrary conflicting decisions because as this is
 

applied that I don't believe that there would be -­

arbitrary and inconsistent decisions, because as
 

this is applied it doesn't provide enough of a
 

framework or guidance for determining whether or not
 

a dose can be determined with sufficient accuracy.
 

DR. ZIEMER: In which case the comment might be
 

along the lines of what you had just said.
 

DR. MELIUS: Correct.
 

DR. ZIEMER: Without saying what -- how you
 

would change it to address it, but raising the
 

issue.
 

DR. MELIUS: Correct.
 

DR. ZIEMER: Tony?
 

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DR. ANDRADE: I really believe that this is an
 

issue of a definition of sufficiency. I think NIOSH
 

has done a very nice job in the following sub-


bullets in pointing out examples of the types of
 

information that might provide sufficient accuracy.
 

However, it's -- if you think about it, there can be
 

an infinity of particular situations. And I think
 

that this is going to have to be handled on a case
 

by case basis. And if we belabor this or if we try
 

to put down exact definitions of what constitutes
 

sufficiency, we're going to end up with a 1,000-page
 

document. So I think that we've got to keep in the
 

back of our minds that most of these petitions are
 

really going to be unique situations.
 

DR. ZIEMER: Who else has comments on this one?
 

Okay, we'll -- we'll plan to revisit it Friday.
 

The bottom of the page I have a note -- I
 

think, Wanda, this was yours -- that -­

MS. MUNN: Yes, it was.
 

DR. ZIEMER: -- the wording here gives the idea
 

that dosimetry data are not important or something
 

along that line. That's not what we want to convey,
 

but -- we want to convey that -­

MS. MUNN: Right. I had suggested language
 

that I can throw out next Friday.
 

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DR. ZIEMER: Okay. So Wanda will reword -- or
 

give us some suggested language Friday. Thank you.
 

Top of 81 I've flagged. It's the issue of not
 

feasible to estimate radiation doses. Jim, I think
 

that was also possibly your issue?
 

DR. MELIUS: Well, the -- that was actually I
 

think the first issue, but I think what the issue
 

there is in section (iv) and in section (iii) at the
 

bottom of the page is the tissue-specific cancer
 

site issue, that what they're proposing is that this
 

will somehow be limited to particular cancer sites
 

and I think it's stated more directly at the bottom
 

of the page under number (iii), (reading) NIOSH's
 

finding that it was not feasible to estimate
 

radiation dose with sufficient accuracy -­

(inaudible) one or more types of cancer, that whole
 

section there. (Reading) identification of a set of
 

one or more types of cancers to which NIOSH's
 

findings that it was not feasible to estimate
 

radiation doses with sufficient accuracy.
 

DR. ZIEMER: And the issue is centered around
 

the debate on whether or not, if you could -- if you
 

can't estimate the dose for a particular organ, say
 

the lung, can you do it for any other organs.
 

DR. MELIUS: Yeah, or -­

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DR. ZIEMER: In essence is what it does, other
 

than saying it's got to be very low and therefore
 

insignificant.
 

DR. MELIUS: Yeah. Yeah, what is the test
 

going to be to evaluate why -- when you can't -­

you've already determined you can't do it for one
 

organ system, how can you say you can do it for
 

another? It really -- actually let me restate -- I
 

don't think I stated that correctly, is that when
 

you made a determination you cannot determine the
 

dose with sufficient accuracy, how can you then
 

limit that to just an organ system or a series of
 

organ systems.
 

DR. ZIEMER: And Jim may be able to comment on
 

that. Actually I can probably think of some ways
 

that could be done, and others might -­

DR. MELIUS: I think two.
 

DR. ZIEMER: But let's hear from Jim.
 

DR. NETON: I just want to say one thing. I
 

think that we have to insert the key word
 

"plausible" in there, a "plausible" dose, which is
 

not -- well, it's not an implausible dose, by
 

definition. You know, it has to be a plausible dose
 

that you could come up with to reconstruct that
 

makes sense.
 

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The converse of that, though, is if there were
 

implausible doses that don't pass the reasonableness
 

test that one could assign and do a dose
 

reconstruction for other organs, one could do that.
 

I mean it's -­

DR. MELIUS: But I have trouble -­

DR. NETON: And do a dose reconstruction.
 

DR. MELIUS: Without belaboring this, but have
 

trouble when distinguishing how you separate -- if
 

it's not feasible to do with sufficient accuracy,
 

then what is a plausible dose -­

DR. NETON: Let's take the case of a uranium
 

inhalation where it's plausible to -- it's
 

implausible to come up with an upper limit -- it's
 

plausi-- you could come up with an upper limit based
 

on -- you have no monitoring data at all. You know
 

the person worked with uranium and you know that
 

uranium concentrates in the lung, so lung cancer.
 

You could do a -- you couldn't do a dose
 

reconstruction for the lung. However, you could
 

come up with implausible exposure scenarios where
 

one would have to inhale five pounds of -- if one
 

inhaled five pounds of uranium, which would be
 

biologically -- choking the person, and one could
 

still calculate a dose and demonstrate that the dose
 

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reconstruction was done and the probability of
 

causation was very small for certain remaining
 

organs, then you've done that. I mean you have to
 

be able to pass the reasonableness test here.
 

One cannot assume people inhaled five pounds of
 

uranium and say that those cancers should be
 

considered part of the Special Exposure Cohort -- or
 

those doses, those organs.
 

DR. MELIUS: Can I just add, though, I think
 

you're -- that's what you're intending to do, then I
 

think you need to state that much more clearly in
 

these regulations. I mean I can agree with the
 

concept. I have trouble seeing how you
 

operationalize it and how you make that
 

determination from going from -- in different
 

situations and if my recollection's right, these two
 

paragraphs on page 81 is the only place where you
 

describe how you will do that. You don't define
 

these terms and this just -- so I think an
 

alternative is not that we reject this, but also is
 

DR. ZIEMER: Or maybe spell it out, and
 

actually I -­

DR. MELIUS: Spell it out.
 

DR. ZIEMER: You actually -- you end up going
 

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in reverse. You say okay, if I had a cancer in this
 

organ, what kind of loading in this other part of
 

the body do I need to deliver sufficient dose to
 

this other -- to this organ. And if it's, for
 

example, takes five pounds of uranium in the lungs
 

to give you some -­

DR. NETON: This is a real example -­

MR. GRIFFON: These are all -­

DR. NETON: -- this could happen.
 

MR. GRIFFON: The thing that we -- and I've
 

talked to Jim during the break on this and yesterday
 

a little bit, too, but I mean -- I mean the question
 

then I have is you didn't have adequate information
 

about the radiation source term to make a maximum
 

estimate, and yet now you're telling me in this
 

example that it was only natural uranium that was -­

you know, so we're loading with uranium, almost five
 

pounds -­

DR. NETON: Well, I was -­

DR. ZIEMER: Oh, no -­

MR. GRIFFON: -- when in fact if -­

DR. NETON: Well, the source term would have to
 

be known, but I mean at least in terms of its type.
 

MR. GRIFFON: And then if the source term's
 

known, in many examples you're going to be able to
 

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estimate a maximum pretty well.
 

DR. NETON: No, no -­

MR. GRIFFON: I mean I -­

DR. NETON: That's not correct. If we don't
 

know what type of operation was done -- grinding,
 

welding, cutting and there's fumes all over the
 

place -- we have no idea of knowing what reasonable
 

or -- what's the word we're talking about -­

plausible doses could have been received by this
 

person. But we do know that the person could not
 

physically inhale five pounds of uranium -- I don't
 

care how much uranium was there, but we would have
 

to know, you're correct, that uranium was present
 

and there were no other radionuclides in the mix.
 

Remember, we're not saying that we're going to
 

do this for every case. This just allows us the
 

option to set, in those circumstances where we can
 

clearly define it, the option to do that so that we
 

don't end up granting SEC status for cancers that
 

are implausible under these exposure circumstances.
 

So they have to pass the reasonableness test, in my
 

mind. You cannot -­

MR. GRIFFON: Yeah, but -­

DR. NETON: You cannot grant SEC status for a
 

person who would have to inhale an unreasonable
 

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amount of material to develop that cancer.
 

MR. GRIFFON: I don't disagree with that, but
 

you -- you see the logic, also, that if you have
 

insufficient information, you don't have dosimetry,
 

you don't -- you know, you're limited on dosimetry
 

data, you're limited on source term data, you can't
 

even calculate a maximum -­

DR. NETON: We're not saying we would do
 

that -­

MR. GRIFFON: -- and then you're turning around
 

and saying you have a pretty -- pretty tight handle
 

on -­

DR. ZIEMER: You're not saying you don't have
 

any data. Right?
 

MR. GRIFFON: -- (inaudible) involved.
 

DR. NETON: No. If we knew it was a uranium
 

facility and there was -­

DR. ZIEMER: But you don't know anything about
 

DR. NETON: -- a transuranic contamination -­

DR. ZIEMER: -- the magnitude of the amount.
 

DR. NETON: Right.
 

MR. GRIFFON: Or -- but I mean that -- that's
 

the question I have is that, in the absence of all
 

that other data, how -- you know -­

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DR. ZIEMER: Well, I guess -­

MR. GRIFFON: -- how -- how sure are we that -­

that these are the only isotopes involved? I'll
 

give you a -­

DR. NETON: That's a different issue.
 

MR. GRIFFON: I mean not to -­

DR. ZIEMER: That's a different scenario,
 

though, than you're talking about.
 

DR. NETON: That's a different issue.
 

DR. ZIEMER: Then in fact you in fact open the
 

door to all the others anyway, don't you?
 

DR. NETON: I suppose. That's what the Board
 

would weigh in on once we provide -- move the
 

petition forward.
 

DR. ZIEMER: But what you're asking for is
 

guidance on how they would do what they're
 

describing here right now.
 

DR. MELIUS: Yeah, it looks like -­

DR. ZIEMER: You're -­

DR. MELIUS: Personally, unless I see more
 

detail how this would be operational as to how these
 

determinations would be made, I find it very hard to
 

accept this approach, but -- you know, I think we're
 

open and...
 

MR. ELLIOTT: For Mark's scenario it wouldn't
 

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be a cancer-specific class definition.
 

DR. ZIEMER: If you had all -­

MR. ELLIOTT: We would go with an SEC, the
 

whole -- I mean the whole presumptive list.
 

DR. NETON: Yeah.
 

MR. ELLIOTT: Because we don't know what the
 

radionuclide in the mix is.
 

MR. GRIFFON: Right, right, right, but I'm
 

turning it -- I'm turning it around and saying give
 

me an example where you would know the mix but you
 

couldn't calculate a maximum. I think Jim attempted
 

to do that -- I still have to think through some of
 

these what-ifs myself, but -­

DR. NETON: This would be used on a limited
 

basis when we knew there were certain scenarios that
 

did not pass some reasonableness test. I think
 

radon is another one of those we talked about, or
 

any situation -- it's not just internal exposure.
 

It's any situation where you have partial body
 

irradiation. The entire body is not uniformly
 

irradiated, which happens most of the time in
 

internal exposures, especially with these actinide
 

elements that only deposit in two or three organ
 

sites to any appreciable degree. We're not saying
 

the dose is zero, but we're saying that we feel that
 

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there are going to be certain circumstances -­

MR. GRIFFON: And they had -­

DR. NETON: Okay.
 

MR. GRIFFON: And they had no other exposures
 

or the other exposures can't be reconstructed.
 

DR. NETON: We would have to be very sure that
 

there were no other exposures that we could identify
 

MR. GRIFFON: I mean I'm just -- I'm just
 

wondering how often that scenario is even plausible
 

and whether -­

DR. NETON: But do we need -­

MR. GRIFFON: -- it's worth going down this
 

path.
 

DR. ZIEMER: May not.
 

DR. NETON: All we're saying is we're allowing
 

for that possibility. We're not saying we're going
 

to exercise it in every case or required to exercise
 

that in every case, but we need to -- think that we
 

should have the option available to do that.
 

DR. ZIEMER: Okay. The issue's been framed and
 

we know what kind of question to ask on that. I
 

think -­

MR. GRIFFON: (Inaudible) -­

DR. ZIEMER: Yeah.
 

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MR. GRIFFON: -- one more thing on that.
 I
 

think that -- and this is part of the reason I would
 

be -- more time is helpful for me, also. In the
 

preamble -- I know the Health Physics Society
 

commented on this, those comments must be on the -­

on the web site?
 

MR. ELLIOTT: Oh, yeah.
 

MR. GRIFFON: Okay. So it might be -- that
 

might be useful for us to look at before the
 

conference call.
 

MR. ELLIOTT: Yes, the -­

MR. GRIFFON: So we get a sense of what their
 

rationale was for -­

MR. ELLIOTT: The previous NPRM and the docket
 

that contains all the comments are on the web site.
 

DR. ZIEMER: Yeah. And incidentally, that
 

would be useful if you would all look at that before
 

the next conference call to acquaint yourself with
 

those comments.
 

Now on page -- oh, I'm sorry. Henry.
 

DR. ANDERSON: I just read it as not
 

permissive, but as will. And if you look at top of
 

81, it says if it's not feasible to estimate the
 

dose with sufficient accuracy, will also determine
 

whether such finding is limited at tissue-spe-- so
 

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it says in each case you will determine that as
 

opposed to you may. I don't know if that -- so in
 

every -- every instance, you will consider that,
 

that it might be limited.
 

UNIDENTIFIED: (Inaudible)
 

DR. ZIEMER: On page 82 I had flagged the
 

endangerment to health, but I think we've discussed
 

that already. It's used generically here. Were
 

there any other issues on that?
 

Okay. Anything on 83? On 84 we -- on 83.14 we
 

had the issue of evaluating a petition by a claimant
 

whose dose reconstruction could not be complete
 

under 42 CFR 82. I guess we've already discussed
 

the issues pertaining to that, so this section in
 

itself -- I don't think there was anything there,
 

unless somebody can identify it for me. I'm sort of
 

just marking which ones look like they're okay as
 

they stand here.
 

83.15, Ted pointed out some things there that
 

were new, but are there any items there of concern?
 

Okay. 83.16? 83.17?
 

DR. ANDRADE: On 83.16, just a minor point.
 

DR. ZIEMER: Uh-huh.
 

DR. ANDRADE: On item (c), it says HHS will
 

issue a final decision on the designation and
 

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definition of the class. It just doesn't say how
 

long it'll take the Secretary to do so.
 

DR. ZIEMER: So you're suggesting there should
 

be a time limit in there?
 

DR. ANDRADE: Right.
 

DR. ZIEMER: Let me ask the staff if they can
 

sort of react to that. Would that be helpful and
 

wouldn't there ordinarily be a time value in there?
 

Let's see, you have 30 days -- going back to
 

(b), provide the petitioner 30 days to contest a
 

decision. And then, Tony, you're asking after the
 

30 days -­

DR. ANDRADE: After the 30 days.
 

DR. ZIEMER: -- is this a year later, a month
 

later, that day or -­

DR. ANDRADE: Right.
 

DR. ZIEMER: -- or is there a need for -­

DR. ANDRADE: Given the importance of this
 

whole SEC rule to the public, I think that -- it
 

might not please the Secretary, but it would be
 

prudent to put in there a deadline.
 

DR. ZIEMER: Without us specifying it, could -­

what the number of days is, could we suggest that
 

that be considered and an appropriate...
 

UNIDENTIFIED: I think so.
 

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DR. ANDERSON: (Off microphone) If the
 

petitioner has 30 days to file an appeal, the
 

Secretary ought to have 30 days to respond.
 

DR. ZIEMER: Well, I'm suggesting that our
 

comment not specify what the time should be, but -­

right. Okay.
 

DR. MELIUS: Thirty-one.
 

DR. ZIEMER: Fair's fair, right.
 

DR. MELIUS: Thirty-one.
 

DR. ZIEMER: 83.17, I guess we all begrudgingly
 

agreed that we can't change the role of Congress.
 

DR. ANDERSON: (Off microphone) But we can
 

limit them to five days.
 

DR. ZIEMER: They limited themselves to five
 

days. That is, the staff did.
 

83.18? Okay, I think we've pretty well framed
 

out the issues that we need to discuss next time. I
 

commend you all on -- we're going to get done here I
 

think by 5:00.
 

Let me ask if there are any final comments on
 

the document before we leave it today. I know
 

there's a fatigue factor that sets in. You're all
 

in favor of -­

UNIDENTIFIED: There's a document?
 

MULTIPLE SPEAKERS: (Inaudible)
 

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DR. ZIEMER: No, I think it's been very
 

helpful. There are just a few items we need to
 

spend some time on. It might very well be that we
 

can be pretty close to closure at the next meeting.
 

Wanda has a comment.
 

MS. MUNN: Do we anticipate addressing the
 

prologue during our discussion?
 

DR. ZIEMER: Well, keep in mind, the prologue
 

or whatever the proper term is -- preamble, is not
 

really part of the rule. However, if there are
 

errors or changes that should be made in that, I
 

suppose we should try to identify those. There's no
 

reason we shouldn't. Right? So certainly that's
 

game for comment, to say you know, this statement in
 

the preamble is wrong or should be revised in some
 

way. But it's not part of the rule.
 

MS. MUNN: I understand.
 

DR. ZIEMER: It's just an explanation of how
 

they proceeded and dealt with the comments.
 

Okay. Let me ask if there are any housekeeping
 

items -- I think Cori's gone. You can turn in your
 

prep hours for this meeting to Larry. Turn in your
 

travel vouchers to Cori as soon as possible. Any
 

other items to come before us?
 

Leon, are you still there? We've lost Leon
 

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again. Well, Leon will figure out that the meeting
 

has ended.
 

We have some information on our next meeting at
 

Oak Ridge.
 

MR. PRESLEY: (Off microphone) One other thing,
 

do we want to come up with a date when we want to
 

come up here and do some training -- another meeting
 

in Cincinnati?
 

UNIDENTIFIED: The whole Board.
 

MR. PRESLEY: The whole Board?
 

DR. ZIEMER: This would be a date after the Oak
 

Ridge meeting, I presume. And therefore -- the Oak
 

Ridge meeting is May 19. We would be talking
 

perhaps about -- this is strictly training? It
 

wouldn't be a -- would this be a -- this doesn't
 

have to be an announced session of the Board and
 

open to the public to come? That presents some
 

problems in terms of viewing records and so on.
 

MR. ELLIOTT: You've got some Privacy Act
 

issues.
 

DR. ZIEMER: I guess we can identify a date and
 

-- but not have Cori execute anything until we find
 

out how that can be done.
 

MR. ELLIOTT: I think it is important for the ­

- all Board members to experience what those
 

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yesterday in the working group experienced. My
 

suggestion to you would be, to get around this -­

the Privacy Act constraints that we all are going to
 

operate under here -- that you identify a -- maybe
 

two working groups to do the same thing that the
 

working group did yesterday. Just get familiarized
 

with the information that you're going to see. That
 

way you won't have a quorum of the Board. It
 

doesn't have to be a public forum. You can look -­

DR. ZIEMER: We won't be conducting business.
 

MR. ELLIOTT: Won't be conducting business. It
 

is a working group session to familiarize, as an
 

individual, yourself with the administrative record.
 

That would be how I would suggest you go about it.
 

That way we can accommodate that with real finished
 

cases and full administrative record to support the
 

decision.
 

DR. ANDERSON: How long a training period? Or
 

could we do this as -­

DR. ZIEMER: One day.
 

DR. ANDERSON: A whole day or -­

UNIDENTIFIED: Five or six hours.
 

MR. ESPINOSA: Or two half-days.
 

DR. ANDERSON: No, I was just wondering, if we
 

broke up into two groups, we could -- if one came in
 

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one day and the other the next day -­

MR. ELLIOTT: That's fine.
 

DR. ANDERSON: -- we wouldn't have to -­

DR. MELIUS: 'Cause we didn't meet -­

DR. ANDERSON: -- disrupt your group too
 

much -­

MR. ELLIOTT: No, no.
 

DR. ANDERSON: -- by scheduling groups in on
 

different days.
 

DR. ZIEMER: But they wouldn't necessarily have
 

to be back to back, either, if we had -­

MR. ELLIOTT: No.
 

DR. ZIEMER: -- people that had schedule
 

conflicts.
 

MR. ELLIOTT: No, we had essentially -- let's
 

see, five -- six of you go through yesterday.
 

Right?
 

UNIDENTIFIED: Five.
 

MR. ELLIOTT: Five? Well, Dr. Ziemer was there
 

DR. ZIEMER: But I didn't go through the first
 

part with them. I only was there for the -­

MR. ELLIOTT: Okay, so we -­

DR. ZIEMER: -- discussion on the procedures.
 

MR. ELLIOTT: -- got five done -- We got five
 

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done. You have seven more individuals who should go
 

through this experience. If you break that out into
 

two groups, you could come any time you wish.
 

DR. ZIEMER: Right.
 

MR. ELLIOTT: As a group. I'd just ask that.
 

I don't want to get seven individual dates where we
 

DR. MELIUS: Can you circulate some possible
 

dates and see if we can all fit into them for -- for
 

these visits?
 

MR. ELLIOTT: I will ask Cori to tap you for
 

your availability, right.
 

DR. ZIEMER: But let me ask, on working groups
 

don't I have to actually appoint them and charge
 

them with a task?
 

MR. ELLIOTT: Yes, you do.
 

DR. ZIEMER: And so it might be helpful simply
 

to get three of you and four of you and have a
 

working group chairman for each, and that chairman
 

can work with the other two or three and with Jim
 

and find a common date and we don't have to sit here
 

in the full group. Who is it that needs -- it would
 

be Tony, Jim, Wanda -- and I would be involved
 

'cause I haven't gone through a full session. And
 

Leon and Henry. Okay. So Tony, are you willing to
 

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be the group leader -­

DR. ANDRADE: Yes.
 

DR. ZIEMER: -- for one of the groups? It
 

would be you, Jim, Wanda and -- is that one group?
 

UNIDENTIFIED: Leon.
 

DR. ZIEMER: Okay, and let's say -- and Leon.
 

DR. ANDRADE: Okay.
 

DR. ZIEMER: And then you simply find a -- work
 

with Jim and find a date.
 

DR. ANDRADE: Okay.
 

DR. ZIEMER: Okay. And then Henry -- and you
 

be the chair of the other group? Okay, and then
 

it's you and Mike and Roy -­

DR. DEHART: No.
 

DR. ZIEMER: No, you were there already.
 

You're -- he's going to be in China -- and me.
 

DR. ANDERSON: Okay.
 

DR. ZIEMER: The three of us. Right?
 

DR. DEHART: Paul, I would suggest this be
 

later than sooner. It needs to be closer to the
 

time you're actually going to be starting again.
 

DR. ANDERSON: So after Knoxville -- or after ­

-


DR. ZIEMER: Yeah, this could be in -- this
 

could be June, July time.
 

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DR. MELIUS: Yeah, that's what I was going -­

DR. ZIEMER: So there's no big urgency.
 

DR. ANDERSON: We can talk about it at the next
 

meeting.
 

DR. ZIEMER: Okay, so those are the two working
 

groups and they are simply charged with the
 

responsibility of learning the system. Okay?
 

Is there any other business to come before us
 

today?
 

MR. ESPINOSA: For the -- for the meeting after
 

Oak Ridge, after the May -- I found it a lot easier
 

on me if -- you know, we're kind of scheduling two
 

meetings in advance and it's been a lot easier for
 

me to move my stuff around. Is it possible that we
 

can schedule the next meeting now?
 

DR. ZIEMER: Sure. Or we can at least identify
 

and have -- Cori would have to confirm it.
 

DR. MELIUS: There were some issues I thought
 

that came up regarding the task order business and
 

timing and so forth. I thought Larry had to clarify
 

those.
 

MR. ELLIOTT: I would ask that you hold off on
 

scheduling your following meeting until we get into
 

May. Let's -- if we can do that at May, it would
 

make a lot more sense to me -­

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DR. ZIEMER: But it's probably not going to be
 

till July.
 

UNIDENTIFIED: (Inaudible) time frame.
 

DR. ZIEMER: Yeah.
 

DR. MELIUS: Well, if you could even start
 

circulating something beginning of May when you -­

when you feel you're comfortable in terms of timing.
 

MR. ELLIOTT: Yeah. Yeah, we could do that.
 

Maybe at -- in advance of the May meeting. First of
 

May we could tap everybody's availability. We'll
 

have it at the May meeting.
 

MR. ESPINOSA: It's just, you know, if we could
 

schedule a lot more in advance.
 

DR. ZIEMER: Right. Anything else for the good
 

of the order? Then this meeting is adjourned.
 

(Meeting adjourned)
 

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C E R T I F I C A T E
 

STATE OF GEORGIA )


)


COUNTY OF FULTON )
 

I, STEVEN RAY GREEN, being a Certified Merit
 

Court Reporter in and for the State of Georgia, do
 

hereby certify that the foregoing transcript was
 

reduced to typewriting by me personally or under my
 

direct supervision, and is a true, complete, and
 

correct transcript of the aforesaid proceedings
 

reported by me.
 

I further certify that I am not related to,
 

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

attorneys, or counsel involved herein; nor am I
 

financially interested in this matter.
 

WITNESS MY HAND AND OFFICIAL SEAL this _____ day
 

of April, 2003.
 

STEVEN RAY GREEN, CVR-CM


GA CCR No. A-2102