NRC inspections: risk-informed and performance-based.

In 2002, the U.S. Nuclear Regulatory Commission (NRC) revised its regulations governing the use of byproduct materials for medical purposes (10 CFR Part 35). These changes were the result of a detailed, 4-year examination of the issues surrounding the medical use program of the NRC and are stated in the latest revision to its medical policy statement, published in the Federal Register on August 3, 2000. As part of an overall program for revising its regulatory framework for medical use, the NRC revised its medical policy statement in keeping with the goal of focusing regulation on those medical procedures that pose the highest risk and structuring the regulations to be risk-informed. NRC inspection procedures were also revised to focus on high-risk activities through a performance-based approach, that is, through observations and interviews with licensee personnel performing NRC-regulated tasks. The purpose of this article is to inform the radiation worker (nuclear medicine technologist or authorized user physician) of the revised focus of the medical use program of the NRC and inspection procedures relative to nuclear medicine-licensed activities. After reading this article, the radiation worker should be able to describe the concept of risk-informed, performance-based regulations and inspections, identify areas of high-risk activities in the nuclear medicine laboratory, and describe techniques used by the NRC inspector to determine the licensee's compliance with the regulations.