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.

Whistleblowers and nuclear medicine.

Healthcare facilities that practice nuclear medicine are subject to federal "whistleblower" protection laws when an employee reports a potentially unsafe radiological condition. This article addresses enforcement of the applicable sections of the Atomic Energy Act and the Nuclear Regulatory Commission's regulations in order to help such facilities avoid running afoul of those laws, which can result in fines, generate civil lawsuits by the claimant, and significantly disrupt the operation of a healthcare facility.

License terms for medical use licenses--NRC. Final rule.

The Nuclear Regulatory Commission is amending its regulations pertaining to the medical use of byproduct material to eliminate the 5-year term limit for medical use licenses. License terms for licenses issued under these regulations will be set by policy. Other materials licenses are issued for up to 10 years. The NRC will issue some licenses for shorter terms if warranted by the individual circumstances of license applicants. The amendment reduces the administrative burden of license renewals on a 5-year cycle for both NRC and licensees and supports NRC's goal of streamlining the licensing process.

License term for medical use licenses--NRC. Proposed rule.

The U.S. Nuclear Regulatory Commission is proposing to amend 10 CFR part 35 to eliminate the five-year term limit for medical use licenses in 10 CFR 35.18. License terms for licenses issued pursuant to part 35 would be set, by policy up to ten years, as are the license terms for other materials licenses. The NRC would issue some licenses for shorter terms, if warranted by the individual circumstances of license applicants. The amendment would reduce the administrative burden of license renewals for both NRC and licensees, and would support NRC's goal of streamlining the licensing process.

Where do we stand with the International Commission on Radiological Protection Report 60?

We have examined the implications of ICRP60 for nuclear medicine. Radiation doses to staff are currently low and reduction of the dose limits will have little impact. However, the proposed figures for the fetus may have implications for pregnant women where the workloads are high. With nursing staff on the ward, laboratory staff or indeed departmental porters there seems little problem. Radiation dose to the fingers is, however, a key factor, and ensuring that no further restrictions are placed on the proposed dose limits is important. The concept of constraints is becoming clearer but will need further thought, particularly with regard to exposure of the general public. The previous basis for declaring controlled and supervised areas has been abandoned, and the situation is now less clear. A most important area of debate will be the patient who is a controlled area, and great care will have to be taken to ensure that the number of patients in this category is not increased so that many more patients need to be kept in hospital. Exposure of the general public is also an issue and expanding the concept of medical exposure to include carers is an important development. This should prevent a number of unnecessary restrictions and adds weight to the point that two waiting rooms are not justified in nuclear medicine departments. ICRP recommendations will soon be incorporated into the legislation of member states and it is import for everyone to ensure that drafts are read carefully and that national proposals are not too restrictive.

Quality management program and misadministrations; NRC override of OMB disapproval of NRC information collection request--Nuclear Regulatory Commission. Final rule.

The Commission has voted to override the Office of Management and Budget (OMB) disapproval of the information collection requirements imposed in the final rule entitled "Quality Management Program and Misadministrations" (July 25, 1991; 56 FR 34104). As part of this final rule, the Commission is amending its regulations to reflect OMB's assignment of a new control number to these information collection requirements. The Commission reevaluated the need for this final rule and the information collection requirements it contains. The Commission continues to believe that its requirements for written quality management programs and misadministration reports, if complied with, have a reasonable likelihood of decreasing misadministrations (e.g., wrong dose or wrong patient) with a small incremental cost to licensees. Without the reporting and recordkeeping requirements, it would not be possible to implement and enforce these regulations effectively.

Revision of fee schedules; 100% fee recovery, FY 1992--NRC. Final rule.

The Nuclear Regulatory Commission (NRC) is amending the licensing, inspection, and annual fees charged to its applicants and licensees. The amendments are necessary to implement Public Law 101-508, signed into law on November 5, 1990, which mandates that the NRC recover approximately 100 percent of its budget authority in Fiscal Year (FY) 1992 less amounts appropriated from the Nuclear Waste Fund (NWF). The amount to be recovered for FY 1992 is approximately $492.5 million.

Limited revision of fee schedules--NRC. Final rule.

The Nuclear Regulatory Commission (NRC) is amending its regulations to make two limited changes to its assessment of license and annual fees. The final rule assesses license fees, which are based on the full-cost method, quarterly instead of semiannually and establishes a lower tier small entity annual fee for those licensees that are small entities with relatively low annual gross receipts or supporting populations. These final amendments are intended to improve NRC financial management and further mitigate the impact of the annual fee on small licensees with relatively low annual gross receipts or supporting populations.