MAY 18 oan

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Risk Assessment Corporation
Larry J. Elliott (R-45), Acting Director 417 Till Road, Neeses, South Carolina 29107
Office of Compensation Analysis and Support phone 803.596.4885 fox 609.534. 995
National Institute of Occupational Safety and Health . :
4676 Columbia Parkway
Cincinnati, OH 45226

May 7, 2001

Dear Larry:

Thank you for your letter of April 18, asking about my ideas for implementation
of the Occupational Illness Compensation Act of 2000 and Executive Order 13170. I
appreciate your asking and will try to convey a few initial thoughts on this.

As I have mentioned previously, it would be worthwhile for NIOSH to look at the
process and procedures being used for compensation of the veterans exposed during
atomic bomb testing. I served on a National Academy of Sciences committee that looked
into using dosimetry information collected on the veterans for epidemiological purposes.
Our conclusion was that this dosimetry could not be used for a number of reasons.
Among them were the lack in consistency in the methodology used and the failure to
adequately account for uncertainties. My experience on the Academy committee was
very enlightening and pointed out a number of mistakes we seem to be making with
regard to dosimetry. Although the dosimetry information collected over nearly 20 years
was not intended to be used for epidemiology, it still seems prudent that we should have
considered this possibility in the compensation program. Nevertheless, there are a
number of issues that I will pass along briefly. These are listed below.

1. Development of a defensible methodology for dose reconstruction. The
foundation for any compensation program must be based on a defensible
methodology. This methodology must include the latest scientific techniques for
calculating doses and uncertainties and must include thorough consideration for
all historical records. The best approach for doing this is to start with one facility
that might best represent the different facilities included in the program. Use this
location as the model for the methodology and expand the methodology to other
sites. Starting small, developing the correct technical methods, then expanding the
scale is critical to success. This will take time and resources but is worth it.

2. Develop dosimetry that can be used for epidemiological studies. As you
determine your technical approach for calculating doses, be sure to assume they
may need to be included in an epidemiological study. By making this assumption,
you serve two purposes. First, workers will get a good estimate of their exposure
and dose (and ultimately probability of causation). Second, we have crucial data
that can be used in an epidemiological study to help us better understand the risk.



Larry J. Elliott page 2

3. Beconsistent in the dose assignment process. Once a good methodology is
established, be consistent in how it is applied. This issue is of great importance,
not only to the workers who may have been exposed but also in the value of the
data in the future. Should new methods become available, and the methodology
require updating, the entire set of records should be reevaluated to account for
changes. Although this may seem difficult, it is not if the methodology is
designed correctly from the beginning.

4. Decide early on how uncertainties will be handled. It is imperative that in
estimating doses, uncertainties must be addressed. Uncertainty analysis is a
quantitative process and must be handled as such for each dose calculated. As part
of this issue, you must also decide the level of confidence you wish to use as the
basis for compensation. I suggest something like the 95" percentile, but this is a
technical and a policy decision.

5. Include the workers from the beginning in the design and implementation of the
process. Again, a critical component of success. It would be a huge mistake to

develop the process for compensation with the workers being included in the
design of the methodology and also playing a role in its implementation. On the
other hand, I strongly urge you to clearly establish the groundrules for worker
involvement at the beginning so everyone knows what is expected of them.

6. Incorporate peer review. Be sure to include a strong peer review team for the
development of the methodology and for implementation of the program. Use of
the National Academy of Sciences or some other independent body is strongly
recommended. By doing this from the beginning, it you will avoid criticism later
on that could lead to bring in reviewers when the program is already underway
and changes would be very costly.

These are just a few of the most important things to look out for. Above all, I suggest
you get help in the historical dose reconstruction area to develop a methodology and see
that the technical approach is laid out correctly. Not doing this from the beginning could
be devastating to your plan and your overall success. There is no question that this
science has evolved tremendously over the past decade and you must take advantage of
what we have learned.

I hope these ideas will be useful. Each topic above is almost a course in itself and I
apologize for not having the time to say more. I am sure you will do a great job with the
program and wish you success.