Source: https://www.federalregister.gov/documents/2017/08/23/2017-17690/naturally-occurring-and-accelerator-produced-radioactive-materials
Timestamp: 2019-10-20 14:46:59
Document Index: 324063348

Matched Legal Cases: ['art 30', 'art 30', 'art 30', 'art 30', 'art 30', 'art 30', 'art 30', 'art 30', 'art 30']

Federal Register :: Naturally-Occurring and Accelerator-Produced Radioactive Materials
A Proposed Rule by the Nuclear Regulatory Commission on 08/23/2017
https://www.federalregister.gov/d/2017-17690 https://www.federalregister.gov/d/2017-17690
Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2017-0159. Address questions about NRC dockets to Carol Gallagher; telephone: 301-415-3463; email: Carol.Gallagher@nrc.gov. For technical questions contact the individual listed in the FOR FURTHER INFORMATION CONTACT section of this document.
Robert MacDougall, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-5175, email: Robert.MacDougall@nrc.gov.
Please refer to Docket ID NRC-2017-0159 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:
Federal rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2017-0159.
Please include Docket ID NRC-2017-0159 in your comment submission.
The membership of OAS consists of state radiation control directors and staff from the 37 Agreement States who are responsible for the implementation of their respective Agreement State programs. The purpose of the OAS is to provide a mechanism for the Agreement States to work with each other and with the NRC on regulatory issues associated with their respective agreements.
The petitioner request that the NRC amend its existing regulations in appendix B to part 30 of title 10 of the Code of Federal Regulations (10 CFR), to specifically add the appropriate radionuclides and their corresponding activities to the list of “Quantities of Licensed Material Requiring Labeling.” The requirements in 10 CFR 30.35, “Financial Assurance and Recordkeeping for Decommissioning,” refer to the list in appendix B to 10 CFR part 30 to determine the need for a decommissioning funding plan and the amount of financial assurance required for sealed and unsealed sources. The petition states that the list in appendix B to 10 CFR part 30 is outdated and does not include conforming updates Start Printed Page 39972resulting from the 2005 amendment of the Energy Policy Act. The OAS petition is available in ADAMS under Accession No. ML17173A063.
The petitioner believe that patient health and safety is being compromised due to licensing delays of important diagnostic and therapeutic products that utilize radioisotopes that are not listed in the appendix B table in 10 CFR part 30. The petitioner assert that when the Energy Policy Act was amended in 2005 to include discrete naturally-occurring and accelerator-produced radioactive materials (NARM) into the definition of byproduct material, that 10 CFR part 30, schedule B, exempt quantities for licensing was updated to include certain NARM isotopes. They note however that 10 CFR part 30, appendix B, “Quantities of Licensed Material Requiring Labeling,” which is the driver for the decommissioning funding plan and financial assurance, was not updated. As a result, the OAS believes that state regulators are forced to apply overly burdensome financial assurance obligations or evaluate on a case-by-case basis special exemptions for new products. They feel that this results in delays in using these improved products or discourages their development.
The petitioner point out that the NRC's Advisory Committee on the Medical Uses of Isotopes evaluated the financial assurance requirements for germanium-68 generators and concluded that these requirements were too restrictive and would prevent or deter the use of promising gallium-68 diagnostic imaging agents for patients. Authorization for granting specific exemption from the decommissioning funding plan requirement for Ge-68/Ga-68 generators was developed. A rulemaking action to provide a permanent regulatory solution has been initiated; however, the petition notes that the OAS is disappointed that the rule would address only this one isotope.
Rather than issue exemptions on a case-by-case basis, the petitioner assert the more appropriate way to address the inconsistency is to amend appendix B to 10 CFR part 30 to add appropriate radionuclides and their corresponding activities. The petition states that the failure to address this inconsistency puts an undue hardship on certain licensees with little or no radiation safety benefit, discourages the development of new beneficial products, and negatively impacts patient care.
The NRC staff is requesting public comment on the following specific questions:
1. What products or technologies, other than the germanium-68 generators cited in the petition, are being or could be negatively affected because the radioactive materials required for these products or technologies are not currently listed on the table in appendix B of 10 CFR part 30?
2. Please provide specific examples of how the current NRC regulatory framework for decommissioning financial assurance has put an undue hardship on potential license applicants. Explain how this hardship has discouraged the development of beneficial new products, or otherwise imposed unnecessarily burdensome requirements on licensees or members of the public (e.g., users of medical diagnostic or therapeutic technologies) that depend on naturally-occurring or accelerator-produced radioactive materials (NARM).
3. Given NRC's current regulatory authority over the radiological safety and security of NARM, what factors should the NRC take into account in establishing possession limits for any of these materials that should be listed in appendix B of 10 CFR part 30?
4. Does this petition raise other issues not addressed by the questions above about labelling or decommissioning financial assurance for radioactive materials? Must these issues be addressed by a rulemaking, or are there other regulatory solutions that NRC should consider?
Dated at Rockville, Maryland, this 16th day of August, 2017.
[FR Doc. 2017-17690 Filed 8-22-17; 8:45 am]