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supporting information that we have obtained. This will be like the system of
records the research at NIOSH is done from, so a grantee or coop agreement
holder will be able to get it. Workers’ privacy will be protected, but the worker
will be about to access the information for their own records and their case.

9. Re: claims volume and efficiency of processing them:

a. How long do we anticipate processing a claim before deciding whether or not it’s
feasible to complete DR? How will we decide when the site has given all the records
they have?
N: That’s not been determined at this point, on either question. It will be done on
a case-by-case basis.

b. What will we do if we later unearth new information? Who will notify claimant that
we have new science to address claims?

N: NIOSH will have to go back when. we unearth new information. And there is
aneed to have an automated system to keep track of that.
Comment: perhaps we should prioritize claims with respect to health status - e.g., alive
or dead.
Comment: can’t emphasize enough the importance of setting up formal arrangements
with-DOE to get this process (records retrieval) as soon as possible.

c. Will you go back (update) to claims that you already processed?
N: Yes, but only those that were denied.

d. Who will do notification if we have new science to address claims? :
N: That will be DOL’s responsibility. NIOSH would inform them and ask them
to refer cases denied back to us.

C. Presentation on Probability of Causation (PC) rule by Mary Schubauer-Berigan:
Powerpoint slides were used for this presentation and accompany this summary. Copies of
those slides were made available to the participants in this discussion. The following
surnmary does not reiterate the basic points of that presentation, but covers the questions and
comments that were made in the discussion of that presentation.

1. Will we do this for those seeking compensation under state programs?
N: No, only those coming in from the federal program.

2. How will we deal with individual susceptibilities in the calculation of PC?
N: No consideration of this in these models. Factors of age and gender are included.
Smoking has been included for lung cancer only. Q. what about asbestos or other


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8. What’s the timeline for the NIOSH version of IREP, to be reviewed and in place?
What is the process for getting that reviewed and approved?
N: Hopefully by mid-summer, but the over-riding goals is to have it ready when
we start processing claims. Advisory Board will be the stamp of approval; It
doesn’t have to run through OMB because it’s policy, not rule. The Adv. Bd
meeting on that would be public meeting.

D. Other (miscellaneous) items:
1. Discussion of relationship between NIOSH/HERB and NIOSH/OCAS.

a. Will NIOSH utilize information and coordinate studies from the existing NIOSH/DOE
epidemiological studies (NIOSH/HERB) with the compensation effort?
N: Yes, key staff are from HERB and our understanding of compensation issues
can now be used to drive HERB research agenda.
b. What sites does NIOSH/HERB have good data on?
N: Hanford, Idaho, Femald, SR, Rocky Flats, others.....
c. Did we revisit the DOE data we inherited? Verify back to hard copy data?
N: yes, those data were revisited, and this included looking at the dosimetry
program records, including things like administratively assigned dose.

Comment: only thing that NIOSH should look into that they have not in this presentation
- is the adjustment for smoking in the IREP.

2. SEC process: What’s the time frame for this?
N: after we get the other 2 reulations out of the gate. NIOSH expects in early
July to ask these folks to get together again. Need additional discussion on this,
but they will be called back later for that step.

3. Physician Panels: Where are we in this process? Have we received many nominations?
N: Request for nominations was sent out widely - June 15 due date. Then
NIOSH will set up a selection process, working with DOE to plan for
appointments. DOE plans to have 10 “virtual” panels, with 3 members per panel,
with an option for specialists on an “as needed” basis. DOE is producing the
guidelines for panels.

Comment: Please send the draft request for nominations to Knut Ringen.

Submitted by Greg Lotz


chemical exposures? N. Interactions with other agents (besides radiation) are not
included in the models at this point.

3. What will the input data be for PC calculation by IREP, e.g., median dose?
N: Not just the median dose, but using the input uncertainty as well. Q. Is the
distribtuion the uncertainty of dose? N. it includes all the uncertainties related to that
model, not just that in dose.

4. Discussion of DDREF considerations, e.g., wrt thermal neutrons.

Why does IREP (NCI version) use lower RBE for neutrons than used by ICRP?
Comment: NIOSH needs to include protons because of many DOE accelerators. -
N; It’s factors like this why NIOSH will not use the NCI IREP directly, but
instead will produce a NIOSH IREP that addresses unique aspects of DOE worker
exposures and illnesses.

5. Discussion of modification and use of IREP by NIOSH for EEOICPA use. This
dicussion included the hypothetical example of the use of IREP for case in which we know
DOE workers have increased risk of cancer, e.g. multiple myeloma.
a. Does smoking adjustment make a big difference for lung cancer?
N: Yes.
b. What will you do with a case that has the upper bound on PC at 49%?
N: that would be one to be revisited on appeal.
¢. Will DOL use the NCI or NIOSH version of IREP?
N: NIOSH-IREP.
d. What will NIOSH do if there is a dispute between the claimant information on
exposure and theDOE or obtainable records information?
N: Process will be designed to give worker benefit of the doubt, but ultimately, if
the dispute cannot be resolved, a third party review might be used.
d. What would be used if claimant had two cancers? .
N: If there are two primary cancers, NIOSH will provide an organ-specific ,
process to calculate the PC for each, and a statistical process to use both to
determine a final PC. If only one cancer is a primary cancer (the other is
secondary), then only the primary cancer site is considered.

Comment: NIOSH should look at the paper by Tom Mancuso on Hanford workers that
found that death ertificates underreported cancer.

Comment: NIOSH needs to carefully justify any changes from the NCI IREP, or the HP
community will fight the NIOSH changes (e.g. in RBE).

7. What if child claims cancer from in utero exposure?
N: That would not be covered. Offspring are not “covered employee.”


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NIOSH OCAS Trip Report ;
Discussion with AFL/CIO representatives of NIOSH role and plans for EEOICPA

Date/Location of Meeting: May 16, 2001, 1:00 - 5:00 pm, NIOSH Headquarters,
Hubert H. Humphrey Building, Room 735G, Washington, D.C.

Attendees (Affiliation):
Larry Elliott, Ted Katz, Alice Kelley, Greg Lotz, Jim Neton, Mary Schubauer-Berigan
(NIOSH)
Jim Ellenberger, Jordan Barab, Bill Kojola (AFL/CIO)
Scott Schneider (Laborers Health & Safety Fund)
James Platner, Knut Ringen (CPWR)
Liz Bottinger, Pete Strader (PACE)
Mark Griffin (CPS/PACE)
Mike Watson (Teamsters S&H)
David Mallino, Jim Melius (LIUNA)
John Morawetz (ICWUC)
Joe Abshire (IAM & AW)
Bob Alvarez (IPS)
Larry Edginton (IUOE)
David Michaels (George Washington University)

Objective: Provide an overview of NIOSH activities under OCAS and obtain stakeholder input
from organized labor representatives on the program and NIOSH efforts.

Meeting Summary: The NIOSH team, led by Larry Elliott, Jim Neton, Mary Schubauer-
Berigan, and Ted Katz provided a briefing of the labor representatives that consisted of an
overview of the NIOSH activities under the (EEOICPA) compensation program, the general
issues and plans for the dose reconstruction rule, and the general issues and plans for the rule for
probability of causation, and comments on the rule for Special Exposure Cohort (SEC)
consideration. Stakeholder representatives were afforded the opportunity to ask questions and
make suggestions. Ideas were exchanged in a fruitful discussion. The information received by
the NIOSH team will be used in the further development of the rules and guidelines for this
program.

Specific issues discussed:

A. General overview, presented by Larry Elliott, with questions raised and comments received.
The basic approach for NIOSH is one that is claimant-friendly, interactive, based on a principle
of reasonableness, and gives the benefit of the doubt to the claimant. NIOSH will contact the

claimant, and use a computer-assisted telephone interview (CATI) to collect information the
claimant has to provide.


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NIOSH & AFL-CIO Meeting on EEOICPA
Hubert H. Humphrey Building, Room 735G
1:00 - 5:00, May 16, 2001

Introductions & Overview

Rule for Dose Reconstructions

a Basics of dose reconstruction for compensation.

b. Federal experience - Department of Defense

c Similarities and differences for DOE workers

d. Duration of dose reconstructions

e Claims volume and efficiency

£ Readiness to conduct dose reconstructions

g Periodic updates resulting from progress in science

Rule for Probability of Causation

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Basics of probability of causation for compensation
Federal experience - NIH/Department of Veteran Affairs _
Update of NCI epidemiologic tables and IREP

Limitations of IREP for DOE workers

Strategy for meeting the needs of DOE workers

Periodic updates resulting from progress in science

Special Exposure Cohort Procedures

a.
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c.

Timing
Form of policy (rule or internal policy)
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Comment: the report needs to have a detailed explanation with it to explain where these
results come from. .

5. What models are being used to calculate internal dose? How will NIOSH deal with
insoluble alpha emitters, where the issue of dose heterogeneity to the organ is of
concern?
N: The models NIOISH will use are based on ICRP 66. We are having a software
program rewritten to calculate individual annual doses to individual organs. ICRP 66
models are particularly valuable in dealing with insoluble alpha emitters, which are a
concern in this worker population. ICRP 66 has better lung model, and that gives you
more flexibility of solubility, organ distribution, etc.

6. Discussion on comparisons to DOD/VA experience with Atomic Veterans.
Comment: the VA compensation program did not begin in 1979 when dose
reconstruction work began. Compensation effort didn’t begin until 1990's. Instead
there was resistance to compensation all that time.

7. Discussion of NIOSH gathering of information and records related to exposures.

a. Will NIOSH conduct a standardized interview with the claimant?
N: yes, but not until after we get the initial records.
b. Will we consider work history for the individual?
N: yes,
c. Can the individual submit information obtained from union health and safety records
(e.g., for construction workers, whose work history was transient on many sites.)
N: Yes, those sources will be acceptable.
N: how difficult is it to access union holdings?
A. generally only get information on which employer the person was sent to work
for, not very helpful detail on what they did.
d. Who will pay for getting information (records) from the DOE sites? Hw will NIOSH
deal with it when the site says they don’t have the funds to complete the records research
needed?
N: NIOSH has the understanding that DOE has the funds in the EEOICPA to pay
for this. Issues of supporting the work at the sites will to be covered in the MOU
and get DOL involved, if necessary.

e. What if the employee worked in the nuclear power industry as well?
N: That is not covered by EEOICPA. Only exposures that resulted from work in
the nuclear weapons programs are covered by the Act.

8. How transparent will your process be to the outside? Will the records be
accessible? Will the individual worker have access to this process?
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1. What if there are no exposure records? What are some of the tools for dealing with

missed dose? How will NIOSH integrate knowledge of work processes into the DR

effort? Will NIOSH report a range of doses or a single value?
N: if no worker data, use co-worker data, or environmental surveys, air sampling, etc. In
case where there is no monitoring program at all, we would have to go back to process
knowledge. Process information, including source term, will be used if there is no
monitoring information - how much, isotopic composition, location. Construct a
deterministic model. Precision would be imprecise but we would develop a range. For
missed dose, there was a NIOSH workshop that dealt with those tools, including.
statistical methods, and NIOSH would use the tools addressed in the proceedings of that
workshop. [attendees asked for copies of that workshop proceedings, which were later
sent to them by mail.] A list of information developed by NIOSH that indicated what
would be needed or thought to be valuable was also discussed. This list had been
provided previously to DOE, and was subsequently provided to participants of this
meeting as well.

2. What happens to the dose range?
N. we will provide a knowledge of central tendency - best estimate, but include
uncertainty, or arange. That will be the input data to the PC calculation.

3. Has there been a discussion of the role sharing between NIOSH and DOE on
development of DR information for a claim?
N: Yes. It is anticipated that a MOU will be created, defining this arrangement, so that
NIOSH can get the information it needs for DR efforts from DOE records.

Comment: the bigger problem will be with data for DR for subcontractors at DOE site,
not simply with outsourcing contractors (e.g. AWEs).

Comment: use the more current data from site abatement survey results to give insight
into the value of older surveys on the same site.

4. Questions regarding the sample report slide of hypothetical DR results:

a. Could you have multiple acute exposures in one year?
N: Yes. This example was simple with plutonium in mind.

b. What does this report mean to the claimant? Will the outreach offices have staff that
can explain it?

N: You can tell total dose, but you can’t tell what the outcome of the claim will be. It’s
not likely that the outreach offices will have staff who can explain it, at least not in first
few years. We’ll have to develop ways to explain where these numbers come from.
Comment: this report will lead the claimant to see affirmation by the government that he
has a covered illness, that he was exposed, and thus, should receive compensation.
Denials will then lead to resentment and outcry.


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The following points summarize the questions or comments raised in the meeting.

1. There was concer about whether the NIOSH CATI would be redundant with efforts
by the DOE Office of Worker Advocacy (OWA) and whether there will be interagency
coordination. The DOE former worker surveillance program may also be gathering
similar information.

2. - Will we focus on only individual DR or also consider collective DR?
N: Both. We will have periodic updates on DR, with internal quality assurance
checks on the work of contractors. Each DR will be reviewed by our NIOSH
technical experts.

3. How is NIOSH involved in the physician panels to be set up under EEOICPA?
N: NIOSHis to appoint physicians to those panels, which are set up, funded and
operated by DOE.

4. What is happening with respect to the Radiation Worker Advisory Board, and
it’s role in rule development under EEOICPA?
N: The Advisory Board has not yet been appointed. Recommendations for that
Board have been forwarded to HHS for action. NIOSH is still deliberating over
the sequence of the review by the Board in the development of the regulations, but
is proceeding with that development so that they will be ready when the Board is
appointed.

5. What is the projected timeline for NIOSH development of the dose
reconstruction (DR) and probability of causation (PC) rules?
N: The goal at this time is to get a draft of the.two regulations into HHS review by
6/15.

6. What is the projected length of time to process a dose reconstruction after the
claim is received by NIOSH?
N: This will vary widely, depending on the complexity of the case, but NIOSH
projects that it will take 2 to 8 weeks to process a claim. NIOSH is working to
design a process that is as efficient as possible.

7. Will the appeals of DR results go to DOL or NIOSH?
N: DOL.

B. Presentation on plans for the DR regulation and procedures, by Jim Neton.
Powerpoint slides were used for this presentation and accompany this summary. Copies of
- those slides were made available to the participants in this discussion. The following
summary does not reiterate the basic points of that presentation, but covers the questions and
comments that were made in the discussion of that presentation.

2


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