The U. S. Nuclear Regulatory Commission (NRC) has published its final rule expanding the definition of byproduct material subject to its regulatory authority, implementing certain provisions of the Energy Policy Act (EPAct) of 2005. The final regulation establishing requirements for licensing and regulating Section 11e.(3) and 11e.(4) byproduct material, as required by Section 651(e) of the EPAct, was published on October 1, 2007 (Volume 72, pages 55863-55937, of the Federal Register (72 FR 55863)). It adds certain naturally occurring and accelerator-produced radioactive material (NARM) to the definition of “byproduct material” in the NRC’s regulations. These final regulations became effective on November 30, 2007. The final regulations can be accessed from the NRC’s Public Involvement Rulemaking web site.
As authorized by Section 651(e) of the EPAct, the commission issued a waiver on August 31, 2005, to allow continued use and possession of NARM while the commission developed a regulatory framework for regulation of the new byproduct material. The commission plans to terminate the waiver in phases, beginning November 30, 2007, and ending on August 7, 2009. On November 30, 2007 (the effective date of the final rule), the commission terminated the waiver for federal government agencies, federally recognized Indian tribes, Delaware, the District of Columbia, Puerto Rico, the U.S. Virgin Islands, Indiana, Wyoming, and Montana.
At this time, the NRC has not established the timing and schedule for waiver terminations for the remainder of the non-Agreement States and U.S. Territories. Notices in the Federal Register will be published approximately 6 months before the effective dates of the waiver terminations to notify users of their waiver terminations and implementation dates of the rule.
Upon waiver termination, all persons who possess the new byproduct material in these states, U.S. Territories, or areas of exclusive federal jurisdiction must be in compliance with the NRC regulations. However, the rule provides authorization for continued use of the new byproduct material prior to obtaining a license or license amendment, as long as applications are made within specified times. Such persons will either be required to 1) apply for license amendments for the new byproduct material within 6 months from the date the waiver is terminated, if they hold an NRC specific license, or 2) submit a license application for the new byproduct material within 12 months from the date the waiver is terminated.
In conjunction with the effective date of the final rule, the NRC intends to terminate the waiver for all 34 Agreement States that provided a certification from their governor to the NRC as described in the EPAct and the NRC’s Transition Plan mandated by the EPAct. Users of the new byproduct material in Agreement States should contact their respective Agreement State regulatory agency with any questions related to the regulation of these materials.
The EPAct requires the NRC to prepare and publish a transition plan that addresses both Agreement and non-Agreement States to facilitate an orderly transition of regulatory authority with respect to the newly added byproduct material. The draft transition plan is available for review via the NRC’s Agency-wide Documents Access and Management System (ADAMS); click on the web-based access link. The document is available in ADAMS under Accession No. ML062990137. The NRC anticipates that publication of the final transition plan in the Federal Register, which will not be substantively changed from the draft transition plan, will occur before the effective date of the final regulations.
Additional details about the implementation of the final rule on NARM can be found in a recently issued Regulatory Issue Summary (RIS). RIS 2007-22 was issued on October 16, 2007, to inform recipients of the status of the NRC’s efforts to implement the requirements of Section 651(e) of the Energy Policy Act of 2005 (EPAct) on “Treatment of Accelerator-Produced and Other Radioactive Material as Byproduct Material.” This RIS updates the information contained in RIS 2007-05, “Status and Plans for Implementation of NRC Authority for Certain Naturally Occurring and Accelerator-Produced Radioactive Material,” dated March 20, 2007. This RIS is available for review on-line.
NRC staff is finalizing revisions to the NUREG-1556 guidance for Volume 9, “Program-Specific Guidance about Medical Use Licenses”; Volume 13, “Program-Specific Guidance about Commercial Radiopharmacy Licenses”; and the new Volume 21, “Program-Specific Guidance about Possession Licenses for Production of Radioactive Materials Using an Accelerator.” The NRC provided stakeholders with an opportunity to comment on these NUREGs in the spring/summer of 2007. The NRC intends to finalize the licensing guidance in conjunction with the effective date of the final rule.
For more information on NARM-related activities, please go to the “NARM Toolbox” at the NRC’s Office of Federal and State Materials and Environmental Management Programs (FSME) web site.
Contacts: Kim Lukes (301-415-6701) or Duane White (301-415-6272), U.S. Nuclear Regulatory Commission, Office of Federal and State Materials and Environmental Management Programs.