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Radiation in Medicine: A Need for Regulatory Reform (1996)
Institute of Medicine (IOM)

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. "5 Alternative Regulatory Systems." Radiation in Medicine: A Need for Regulatory Reform. Washington, DC: The National Academies Press, 1996.

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Radiation in Medicine: A Need for Regulatory Reform

Educating the public. The actual risk involved in ionizing radiation in medicine is small compared to what is believed to be the public's perception of the risk. One activity of such a federal agency could be to correct this imbalance through education and information dissemination. It could also perform a valuable service by informing patients about measures that physicians should take to minimize the dose or risk from certain procedures, for example, avoiding x-rays during pregnancy and using gonadal shielding. This type of public education program could assist in putting radiation risk in a more accurate and balanced perspective.

Monitoring the effect of deregulation. This agency could monitor the effects of the shift in power and responsibility to the states. It could function as a data gatherer itself or as a clearinghouse for data collected by states or other federal agencies, with the task of issuing reports on how well the new regulatory scheme is working.3

Collecting risk data. Scant data are currently available on the risks of ionizing radiation in medicine, as discussed in Chapter 4. Byproduct misadministrations are reported to the NRC and adverse events for investigational drugs and blood products must be reported to the FDA, but data on adverse events involving other sources of ionizing radiation in medicine are reported on a voluntary basis, and are therefore either not available for comparison or underreported. This federal agency could gather such data (or act as a clearinghouse). Over time, this would enable the CRCPD and states to fine-tune their regulations more effectively.4

Conducting research. This federal agency could study, investigate, or conduct or fund research on the impact of new technology. In this way, it could help to reduce exposure and the risks of new technology. It could also identify high-priority areas for research and encourage other federal agencies, such as the National Institutes of Health, to support such work.

As noted previously in this report, the majority of states have some form of regulatory program in place. The approach assumed for Alternative D could have the effect of encouraging all states and federal health facilities (e.g., those administered by DOD, VA, PHS) to expand the scope of their existing regulations to cover all ionizing radiation in medicine, including byproduct material.

3  

The committee is not recommending the use of performance indicators as the concept is understood by the NRC, because this alternative does not retain the current Agreement/Non-Agreement State distinction.

4  

Data collection on the effects of long-term, low-dose exposures to radiation would not fall within the purview of this agency, but could be addressed by the scientific community.

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