CRITIQUE OF THE DRAFT REPORT THE BIOLOGICAL EFFECTS OF IONIZING RADIATION The Committee on Federal Research on the Biological Effects of Ionizing Radiation of the National Academy of Sciences/National Research Council (hereinafter called the FREIR Committee) was charged by the DHEW/NIH to review and comment on a preliminary research agenda prepared by the DHEW (Interagency Committee)1. The May 5, 1980 draft of a Federal Strategy for Research into the Biological Effects of Ionizing Radiation (hereinafter called the Draft Report) was accordingly reviewed by the FREIR Committee at a meeting held in Washington, D.C., on May 29 and 30, 1980. During the meeting, the committee had the opportunity to discuss the Draft Report with those who coordinated its preparation and with a number of representatives of federal agencies involved in research the biological effects of ionizing radiation. At the conclusion of its meeting, the FREIR Committee asked each of the chairmen of its. four principal subcommittees to prepare critiques of the Draft Report from the viewpoints of their respective areas of responsibility, namely medical and environmental radiation sources, human effects, biological effects, and research management. This critique report summarizes the discussions of the committee. The attached reports of the subcommittees reflect specific concerns from their unique perspectives, discuss some clear errors of fact in the Draft Report, and provide editorial comments. In general, the FREIR Committee finds the Draft Report to be an inadequate guide for federal research into the 1Contract NCI- CO 95466 between the National Cancer Institute and the National Academy of Sciences dated 07/20/79 attachment A p.2. related why the biological effects of ionizing radiation and topics. The goals of the Draft Report are not clearly stated, nor is the range of coverage clear. This needs to be corrected. For example, is it to cover biological effects only? I s the consideration directed primarily to Occupational exposures or to the general population? Was the intention to cover routine conditions only, or are accidents included? If accidents are to be included, restrict the coverage to nuclear power plants? Was intention to include the control of radiation sources? I f So why were medical and dental X-rays excluded (the explanation for their omission is inadequate)? Why is so much coverage devoted to radionuclide transport within the environment but not to the production, movement and release of radionuclides from nuclear power plants? That is, was it the intention of the drafters of the Draft Report to omit discussion of the source term? Why is there no detailed discussion of the technologically enhanced natural background (i.e., use of radioactive water in the home, natural radionuclides in building materials, etc.)? Why discuss the mitigation of biological effects but not of environmental transport? The Draft Report neither addresses systematically the state of knowledge in radiation biology nor sets forth the specific questions that remain to be answered by future research. Because the reasons for pursuing the research programs recommended by the report are often unclear, an ordering of priorities is not possible, nor is it possible to specify how the the research might be implemented. Because such specification is essential to the development of useful strategies by which needed research can be effectively undertaken and pursued, this omission causes those portions of the report dealing with specific research to lack credibility. The FREIR Committee also finds the report to be undesirably narrow in scope and to deal with the the selective subject material in too general, nonspecific terms. Research plans are limited largely to those that are useful in the regulation of radiation hazards. Consequently, there are a number of serious substantive omissions. For example, there is no discussion of the sources of ionizing radiation used in diagnostic medical practice and and the risks risks to humans exposed to radiation from these sources. This omission is difficult to understand because diagnostic medical sources are the greatest contributors to radiation exposure of the public from man-made sources. Certainly, research programs designed to improve benefit-to-risk relationships of radiation usage in medicine must be important components of research strategies to minimize risk and enhance benefits of ionizing radiation. Furthermore, there is no discussion of the manpower and financial resources needed to carry out the several research programs proposed in the report. This oversight puzzles the FREIR Committee because Congressional directives seemed to mandate that these matters be addressed. A strategy for research must be considered incomplete without consideraton of the plan's funding requirements and manpower needs, including programs for research training. The FREIR Committee perceives a distressing unevenness with which the various subjects are addressed in the report. Particularly weak are those sections dealing with epidemiological studies and genetic effects. This imbalance suggests the absence of expertise in these disciplines among the authoring group. If true, serious questions must be raised regarding the process by which members of the group were selected. It is quite possible that many of the criticisms contained in this critique and its attachments stem directly from a deficient selection that resulted in the appointment of an unbalanced group. agencies ionizing Finally, there is no discussion of how responsibility for various components of the research program should be allocated or shared among the several federal concerned with the biological effects of radiation. Perhaps this is unavoidable, but a research strategy that fails to name the roles of the principal players falls short of what may reasonably be expected. the The unquestionably harsh criticisms levelled against Draft Report in the foregoing paragraphs will inevitably raise doubts as to whether anything can be salvaged. The Committee believes it can. The members of the FREIR Committee were generally impressed with the quality of most of the Issue Papers and Science Projections Papers that were prepared as a basis of the report. Although the material was not used effectively by the authors of the Draft Report, perhaps due to the limited time available for preparation, it can certainly be used in any rewriting effort that may now be undertaken. The only serious omission noted among the Issue Papers is a discussion of the ethical questions faced by the scientific community and by those who form public policy when deliberating the issues of benefit and risk from exposure to ionizing radiation. A thoughtful paper on this subject could provide invaluable perspective on the biological effects of ionizing radiation to those charged with formulating research policies. In conclusion, the FREIR Committee wishes to express its willingness to be of every possible assistance to the Director of the National Institutes of Health representing the Secretary of the Department of Health and Human Services, to whom this critique is addressed, are directed toward the development of report. Our mutual interests as well as public demand an excellent report as soon as as efforts an improved those of the feasible. REPORT OF SUBCOMMITTEE II: MEDICAL AND ENVIRONMENTAL RADIATION SOURCES The Draft Report is far more of an apologia for the status quo of federal research programs than a blueprint for future directions. In many instances, the status quo is defensible; however, the defense would have been improved by a balanced critique of present federal directions in this area. neither the International Commission on I f Radiological Protection (ICRP) nor the National Council on Radiation Protection and Measurements (NCRP) were used as sources, why not? If they were, they should be listed on page 1 with the other sources of information. Certainly, this report contains statements from NCRP reports. Moreover, a specific mention of the ICRP appears on page 24. Public concern is mentioned on line 1, page 2 of the Draft Report. This kind of concern should be encouraged because it is a rational response to the unknown hazards of exposure to high levels of ionizing radiation. in recent years. However, anxiety in in the public is not rational and has a negative impact. Unfortunately, anxiety has been more pervasive Government agencies, particularly those involved in regulation, should be aware of public concern, and they should help the public place such concern in a proper perspective rather than engender anxiety. An example of this problem is the almost inadvertant implications found in the statement on page 2 of the Draft Report where only exposures resulting from handling radiation sources are emphasized. In fact, most radiation exposures result from cosmic radiation and from naturally occurring radioactive elements in environment. In addition to routine and accidental irradiation from the nuclear industry that is inadequately treated in the Draft Report, and from the manufacture of consumer products, there is also radiation from medical and dental sources. of prime importance to any overall research agenda is the recognition of the spectrum and degree of current radiation hazards. The lack of mention of the benefits derived from radiation might be a matter for reconsideration in a section of the report that could place the hazard question in perspective. our |