Status Update For The Implementation Of NRC Regulatory Authority For Certain Naturally Occurring And Accelerator-Produced Radioactive Material Addressees
– By Abby Gessner –
All U.S. Nuclear Regulatory Commission (NRC) material and fuel cycle licensees. All Radiation Control Program Directors and State Liaison Officers.
The NRC is issuing this regulatory issue summary (RIS) to inform recipients of the status of the agency’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.” No specific action or written response is required. The NRC encourages recipients of this RIS to share this information with known users of the newly defined byproduct materials resulting from the EPAct, who may not currently possess an NRC byproduct materials license. The NRC is providing this Regulatory Issue Summary (RIS) to Agreement States for their information and distribution to their licensees as appropriate.
On August 8, 2005, the President signed the EPAct into law. Section 651(e) of the EPAct expands the definition of byproduct material as given in section 11e of the Atomic Energy Act of 1954 (AEA), as amended. This change places additional byproduct material under the NRC’s jurisdiction, as defined in paragraphs 11e.(3) and 11e.(4) of the AEA. Thirty-Six States have previously certified that they have programs in place to properly regulate the newly defined byproduct materials.
Final Regulations Section 651(e) of the EPAct requires that the NRC issue final regulations that establish requirements for licensing and regulating AEA Sections 11e.(3) and 11e.(4) byproduct material, while cooperating with the States and using model State standards to the maximum extent practicable. The NRC published its final regulations on October 1, 2007 (Volume 72, page 55864, of the Federal Register (72 FR 55864)). These final regulations became effective on November 30, 2007, and can be accessed on the NRC’s Public Involvement Rulemaking Web site at http://www.nrc.gov/about-nrc/regulatory/rulemaking/public-involvement.html.
Waiver Issued on August 31, 2005 (70 FR 51581) As authorized by section 651(e) of the EPAct, the NRC issued a waiver on August 31, 2005, to allow the continued use and possession of naturally occurring and accelerator-produced radioactive materials (NARM) while it developed a regulatory framework for regulation of NARM
as a new type of byproduct material. The waiver was issued for a period of four years from the date of EPAct and will terminate on August 7, 2009. The NRC has begun terminating the waiver in phases. The first phase of waiver terminations occurred on November 30, 2007 (the effective date of the final rule). On this date, the NRC
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. The second phase of waiver terminations occurred on September 30, 2008. On this date, the NRC terminated the waiver for Idaho, Missouri, South Dakota, Vermont, West Virginia, Guam and all other territories and possessions of the United States that were not part of Phase 1. Upon waiver termination, all persons who possessed the new byproduct materials in these States, U.S. Territories, or areas of exclusive Federal jurisdiction were to be in
compliance with NRC regulations. Being in compliance means that such persons are responsible for the proper handling, transfer, and disposal of these new byproduct materials as specified in NRC regulations. The third and last phase of waiver terminations will occur on August 7, 2009, (74 FR 5797). This final phase will include Alaska, Connecticut, Hawaii, Michigan, New Jersey, and NRC licensees with headquarters in Canada. Additionally, the Commission terminated the waiver for non-Agreement States that entered into an Agreement with the NRC under Section 274b of the Atomic Energy Act of 1954, as amended, coincident with the effective date of such an agreement. The State of New Jersey has submitted an Agreement State application to the NRC. The New Jersey agreement may be completed prior to the waiver termination date at August 7, 2009. If their agreement goes into effect prior to the waiver termination date, then the waiver for New Jersey licenses will terminate to coincide the effective date of the agreement.
The NRC prepared and promulgated a transition plan (72 FR 59157), which was published in the Federal Register on October 19, 2007 to facilitate an orderly transition of regulatory authority with respect to the newly added byproduct material. As explained in the transition plan, under the final regulations, users of NARM in non-Agreement States and U.S. Territories are 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 byproduct materials license, or (2) submit a license application for the new byproduct material within 12 months from the date the waiver is terminated. Upon receipt of either a license amendment or a new license application, the respective NRC regional office will notify the applicant of its receipt of the request.
The notification will document that the applicant complied with this aspect of the regulations. Existing NRC licensees should note that the NRC will not amend licenses to include authorization to produce radioactive material using an accelerator; the agency will require a separate license for these activities. Therefore, existing licensees should contact their NRC Regional Office and prepare to submit a new license application to obtain authorization for the production of radioactive materials using an accelerator.
In addition, new NRC license applicants that are seeking authorization to produce radioactive materials using an accelerator should submit a license application for that authorization and should submit a separate license application for any other radioactive material authorizations they may seek (e.g., manufacturing of radiopharmaceuticals and medical use of byproduct material). Associated Supportive Activities
The NRC staff has finalized the guidance in NUREG-1556, “Consolidated Guidance about Materials Licenses,” Volume 9, Revision 2, “Program-Specific Guidance About Medical Use Licenses,” issued January 2008; Volume 13, Revision 1, “Program-Specific Guidance About Commercial Radiopharmacy Licenses,” issued November 2007; and the new Volume 21, “Program-Specific Guidance About Possession Licenses for Production of Radioactive Materials Using an Accelerator,”issued October 2007. The NRC staff is also planning to make minor revisions, which reflect the regulation of the new byproduct material, to other NUREG-1556 licensing guidance and related inspection procedures (IPs) (e.g., IP 87125, “Materials Processor/Manufacturer Programs,” and IP 87127, “Radiopharmacy Programs”). Information on NARM-related activities and recently issued Office of Federal and State Materials and Environmental Management Programs (FSME) generic communications are also available in the “NARM Toolbox” at the NRC’s FSME Web site at http://nrc-stp.ornl.gov/narmtoolbox.html.
This RIS requires no action or written response. Any action on the part of addressees in accordance with the guidance contained in this RIS is strictly voluntary and, therefore, is not a backfit under any regulation in Title 10 of the Code of Federal Regulations (10 CFR).
The NRC did not publish a notice of opportunity for public comment on this RIS in the Federal Register because this RIS is informational and does not represent a departure from current regulatory requirements.
RIS 2008-13, “Status And Plans For Implementation of NRC Regulatory Authority for Certain Naturally-Occurring and Accelerator-Produced Radioactive Material.”