Medical Use of Byproduct Material-Amendments/Medical Event Definitions
The Nuclear Regulatory Commission (NRC) is proposing to amend its regulations that govern medical use of byproduct material related to reporting and notifications of medical events (MEs) to clarify requirements for permanent implant brachytherapy. The proposed amendments would change the criteria for defining an ME for permanent implant brachytherapy from dose-based to activity-based; add a requirement to report, as an ME, any administration requiring a written directive (WD) if a WD was not prepared; clarify requirements for WDs for permanent implant brachytherapy; and make certain administrative and clarification changes. These amendments regarding permanent implant brachytherapy are being proposed in response to several incidents involving therapeutic use of byproduct material. The proposed changes are based in part on recommendations from NRC's Advisory Committee on the Medical Use of Isotopes (ACMUI) and the NRC's Medical Radiation Safety Team. This proposed rule would affect all medical licensees that perform procedures using byproduct material that require completion of a WD.
Office of New Reactors;
The NRC is soliciting public comment on its Proposed Interim Staff Guidance (ISG) DC/COL-ISG-06 (ADAMS Accession No. ML081850160). This ISG is to clarify the U.S. Nuclear Regulatory Commission (NRC) position on what is an acceptable level of detail and content for demonstrating compliance with Title 10 of the Code of Federal Regulations Section 20.1406 (10 CFR 20.1406). Regulatory Guide (RG) 4.21, ``Minimization of Contamination and Waste Generation: Life Cycle Planning,'' provides an acceptable method of demonstrating compliance. This ISG provides further clarification on the evaluation and acceptance criteria that will be used by NRC staff in reaching a reasonable assurance finding that a Design Certification (DC) or Combined License (COL) applicant has complied with the requirements of 10 CFR 20.1406. The NRC staff issues DC/COL-ISGs to facilitate timely implementation of the current staff guidance and to facilitate activities associated with review of applications for DC and COLs by the Office of New Reactors. The NRC staff will also incorporate the approved DC/COL-ISG-006 into the next revision of the Standard Review Plan and related guidance documents.