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Testimony on Radiation Research by William F. Raub, Ph.D.
Deputy Assistant Secretary for Science Policy
Office of the Assistant Secretary for Planning and Evaluation
U.S. Department of Health and Human Services

Before the Senate Committee on Governmental Affairs, Permanent Subcommittee on Investigations
September 16, 1998

Madame Chairman, Senator Glenn, other members of the Subcommittee: I am William Raub, Science Advisor to the Secretary of Health and Human Services. I am pleased to be here today to discuss the perspective of the Department of Health and Human Services on the conduct of two studies designed to examine the effects of exposure to Iodine-131 following nuclear testing or accidents. My colleagues and I appreciate the time and attention the Subcommittee staff has devoted to its review of these studies. We share your desire that our research be conducted both rigorously and efficiently and that outcomes be used to promote national policies that are protective of the public health.

The studies selected for review by the Subcommittee involve attempts to understand the effects of two major cases of radiation exposure: one, the program of nuclear bomb atmospheric tests conducted at the Nevada Test Site by the former Atomic Energy Commission; and two, the Chernobyl nuclear power plant accident. In both cases, people were exposed to Iodine-131 and other radionuclides for reasons beyond their control and, for many individuals, without their knowledge. The Department recognizes as understandable and legitimate the frequently expressed concern that the exposed populations in both cases may be at higher risk of diseases of the thyroid, particularly cancer.

The National Cancer Institute is the appropriate organization to direct research toward resolving this concern. It has the requisite expertise and experience. In particular, its staff includes leading international authorities on radiation epidemiology and radiation dosimetry.

You have raised important questions about our response to Public Law 97-414, which directed the Department to "(1) conduct scientific research and prepare analyses necessary to develop valid and credible assessments of the risks of thyroid cancer that are associated with thyroid doses of Iodine 131; (2) conduct scientific research and prepare analyses necessary to develop valid and credible methods to estimate the thyroid doses of Iodine 131 that are received by individuals from nuclear bomb fallout; and (3) conduct scientific research and prepare analyses necessary to develop valid and credible assessments of the exposure to Iodine 131 that the American people received from the Nevada atmospheric nuclear bomb tests ....". NCI clearly took too long to complete the study. We have learned important lessons about use of resources and the setting of priorities as a result of our experience with the Iodine-131 study. The Department will review its procedures for monitoring such major studies, and where necessary, will institute reforms to ensure that we do not repeat the experience of the Iodine-131 study.

As you know, the Institute of Medicine (IOM) reviewed the NCI study and recently issued its own report. IOM assessed the soundness of NCI's analyses and assumptions and its estimates of risk of thyroid disease from Iodine-131 fallout. IOM also analyzed the issues associated with population-based screening for thyroid cancer and the challenges associated with providing clear and useful information about the risks of both radiation and screening to those who have been exposed. We are currently studying IOM's report so that the Department can be responsive to its findings.

I call your attention to the fact that IOM did not recommend population-based screening for people exposed to radiation fallout. Testimony earlier today from the Agency for Toxic Substances and Disease Registry (ATSDR), however, indicates that it recommends medical monitoring for people exposed to radiation from the Hanford nuclear reactor. In his testimony, Dr. Johnson of ATSDR compared his agency's recommendation with the IOM findings. He correctly noted that ATSDR and the NCI studies differ considerably with regard to circumstances, methodology, outcomes, and requirements.

On their face, the ATSDR and IOM conclusions do not appear to be in conflict. However, the Department will review policies and practices at the Centers for Disease Control and Prevention (CDC), ATSDR, and NCI to identify significant differences, if any, in their respective approaches to dose reconstruction and determinations regarding the need for and feasibility of population-based screening or medical monitoring. If we find any differences that we believe jeopardize the Department's ability to be protective of the public health, we will initiate corrective action.

The ongoing NCI study of the Chernobyl disaster is a unique opportunity to examine the effects of radiation on people. We have confidence that the Institute is on course toward identifying proper cohorts, estimating exposure, and assessing risks of disease.

The Department is aware of the difficulties of conducting such research in countries that had been part of the former Soviet Union. The science of epidemiology is not as uniformly well developed there as here; in many cases, resources and experience lag far behind those available in the United States; and managing a major international study in an area of the world that is experiencing significant political and economic instability is a difficult undertaking. As a consequence, I do not think we should judge the progress of the Chernobyl study using the same standards that we would apply to a study conducted in the United States.

Nevertheless, the Subcommittee has raised several important management issues related to the Chernobyl research. Because this research is so important and, we hope, the only opportunity we ever have to study such exposure to human beings, the Department wants to be certain that the Chernobyl work is done as effectively and efficiently as possible. We recognize the concerns of the Subcommittee, and we take them seriously. I will work with NCI staff to arrange for an independent review of the Chernobyl project to identify any problems associated with the way the work is planned, organized, conducted, and overseen.

Our plan to seek an independent review does not mean we lack confidence in NCI. To the contrary, we believe NCI is the right place to conduct this research; and we are intent upon doing everything reasonable toward ensuring that the project remains appropriately oriented and proceeds as expeditiously as circumstances allow. We will await the outcome of the independent review with an open mind.

Thank you for the opportunity to testify today.

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