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. Graham’s comments were made in a letter to ACNP regarding the Nuclear Regulatory Commission’s 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 OMB’s 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 to result in even a marginal decrease in risk to providers, patients, or members of the public." National Academy of Sciences-Institute of Medicine, RADIATION IN MEDICINE - A NEED FOR REFORM at p. 171 (1996).
ACNP President-elect Gary L. Dillehay, M.D. also noted that "Despite repeated promises to us and to the Congress that it would do so, the NRC continues to impose an unnecessary and excessively expensive regulatory scheme on diagnostic nuclear medicine." Dillehay also noted that ACNP and SNM believe that proposed regulations by the NRC will have a seriously adverse affect on the production of nuclear byproduct materials.
"In the interests of our patients and the Nation’s health care system, we will continue to work to assure that diagnostic nuclear medicine is subject to an appropriate regulatory scheme," he added.
In its letter to NRC OMB did approve the paperwork collection requirements of the proposed revision.
Approximately 13 million nuclear medicine procedures are performed on patients each year, and the average American receives 3.8 nuclear medicine procedures during his or her lifetime.
The Society of Nuclear Medicine is an international scientific and professional organization of more than 13,000 members dedicated to promoting the science, technology, and practical application of nuclear medicine. The American College of Nuclear Physicians represents the socio-economic interests of the nuclear medicine community. SNM and ACNP are based in Reston, Virginia. For more information, visit the SNM web site at www.snm.org. or the ACNP web site at www.acnponline.org