Consolidated Guidance About Materials Licenses. Program-Specific Guidance About Possession Licenses for Production of Radioactive Material Using an Accelerator. Final Report

摘要

On August 8, 2005, the Energy Policy Act of 2005 (EPAct) gave NRC new regulatory authority over additional byproduct material. This new byproduct material now also includes naturally occurring materials, such as discrete sources of radium-226 (Ra-226), and accelerator-produced radioactive materials (NARM). This guidance document provides assistance to applicants in preparing a license application for a specific possession license for the production of radioactive material using an accelerator. This guidance document should be used for activities that take place once radioactive materials are produced by the accelerator, which include material in the target and associated activation products in the accelerator along with its associated shielding (if applicable), to the point of transfer or distribution of material to another license or licensee, for preparation of the final product (e.g., radioactive drugs). This document does not include information for the operation of the accelerator, as NRC does not regulate the accelerator or its operation. Also, neutron accelerators and other types of accelerators (e.g., linear accelerators) that are used to produce particle beams and not radioactive materials will not be covered in this document. This report also provides guidance to applicants in applying for authorization for the production and noncommercial distribution of Positron Emission Tomography (PET) radioactive drugs to medical use licensees in a consortium. This document describes both the methods acceptable to NRC license reviewers in implementing the regulations and the techniques used by the reviewers in evaluating the application to determine if the proposed activities are acceptable for licensing purposes.