Reston, Virginia.The American College of Nuclear Physicians (ACNP) and the Society of Nuclear Medicine (SNM) today told the Director of the Office of Management and Budgets Office of Information and Regulatory Affairs (OIRA) that it welcomed his expression of concern "that the benefits of regulating medical uses of byproduct materials may not justify the costs of the Part 35 requirements."

Nuclear byproduct materials are used to produce some of the tracer elements injected into patients to conduct many potentially life-saving nuclear medicine procedures such as cardiac stress tests to analyze heart function; lung scans to verify blood clots; bone scans to diagnose orthopedic injuries, and to determine if cancer has metastasized.

OIRA Director John D. Grahams comments were made in a letter to ACNP regarding the Nuclear Regulatory Commissions proposed revision of 10 C.F. R. Part 35, which governs the medical use of byproduct material. Because the NRC is an independent regulatory agency, OMB cannot require it to conduct a regulatory analysis of its rule. OMB did, however, require the NRC to evaluate its program to consider further reductions in the burden imposed by its requirements, and encouraged the NRC to undertake a full evaluation of the benefits and costs of the various requirements of Part 35, and to consider alternatives such as third-party accreditation and increased reliance on State regulations and professional standards.

ACNP and SNM, which expressed support for OMBs position, nonetheless noted that they believe even this type of analysis is largely unnecessary, since the National Academy of Sciences/Institute of Medicine has already concluded, in a report sponsored by the NRC itself, that:

"Compared to the regulatory systems in place for the other 90 percent of medical use of ionizing radiation, the more detailed reporting and enforcement systems required for byproduct materials [subject to NRC regulation] do not seem
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Contact: William Uffelman
wuffelman@snm.org
703-708-9000
Society of Nuclear Medicine
19-Sep-2001

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