Byproduct materials comprise one of two sub-arenas that the staff of the U.S. Nuclear Regulatory Commission (NRC) identified in considering which areas of the materials safety arena to target for greater use of risk information. This page summarizes the following aspects of this sub-arena with expanding menus:
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Objective
Utilize risk information on a case-by-case basis for byproduct material regulation, licensing, and oversight.
Basis
NUREG/CR-6642, "Risk Analysis and Evaluation of Regulatory Options for Nuclear Byproduct Material Systems," documents an assessment of risks for various byproduct material systems. (This report is not publicly available.) The assessment was used to support NRC staff activities, as described in SECY-00-0048.
In June 2001, the NRC published NUREG-1717, "Systematic Radiological Assessment of Exemptions for Source and Byproduct Material," which documents the staff's assessment of doses associated with byproduct and source material exemptions. NUREG-1717 also includes dose assessments for certain devices that are currently used under general or specific licenses that have been identified as candidates for use under exemptions. In addition, staff activities identified in SECY-07-0147, "Response to U.S. Government Accountability Office Recommendations and Other Recommendations to Address Security Issues in the U.S. Nuclear Regulatory Commission Materials Program," will address possible revisions to the agency's regulatory framework.
Goals
The staff has established the following goals for risk-informed and performance-based activities in this sub-arena:
- Continue making incremental improvement (as practicable) to enhance the risk-informed and performance-based nature of rulemaking and guidance development, licensing, and oversight activities for byproduct materials.
- Encourage the industry and NRC licensees to use a risk-informed and performance-based approach in demonstrating compliance with the NRC's risk/dose criteria.
List of Risk-Informed and Performance-Based Activities
This list shows the ongoing licensing initiatives, projects, and activities that the staff of the U.S. Nuclear Regulatory Commission (NRC) has targeted for greater use of risk information in the Byproduct Materials Sub-Arena within the Materials Safety Arena:
Decommissioning Financial Assurance for Sealed and Unsealed Radioactive Materials Rulemaking (10 CFR Part 30, Appendix B)
The NRC is conducting a rulemaking to revise Appendix B, "Quantities of Licensed Material Requiring Labeling," to Part 30, "Rules of General Applicability to Domestic Licensing of Byproduct Material," which is used to determine the amount of decommissioning financial assurance for a given radionuclide with a half-life greater than 120 days. The rulemaking would revise Appendix B to include more risk-informed values for the existing radionuclides and would add naturally occurring and accelerator-produced radioactive material (NARM) radionuclides that are not currently listed in the Appendix. Additionally, the NRC would remove all radionuclides with a half-life of 120 days or less from the revised Appendix B because these radionuclides are not considered when applying decommissioning financial assurance requirements. Finally, to clarify the purpose of Appendix B, the NRC would change the title of the appendix to reflect its use in determining decommissioning financial assurance requirements. This action is being taken in response to a petition for rulemaking submitted by the Organization of Agreement States.
For more information see Planned Rulemaking Activities - Rule webpage.
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Inspection Manual Chapter 2800, "Materials Inspection Program"
Summary Description
The completed revision to IMC 2800 in FY 2017 allowed the addition of more flexible and logical extensions to the time between inspections, i.e., inspection intervals for material licensees. This revision included: (1) increasing the current 25 percent buffer to 50 percent for inspection timeliness; (2) extending the initial inspection period if licensees are not in possession of material; and (3) allowing extensions of inspection intervals based on good performance on a case-by-case basis.
Previous Fiscal Years
FY 2016
The staff started efforts to review and update IMC 2800 per Commission direction in SRM-SECY-16-009.
FY 2017
On September 19, 2017, the revised IMC 2800 was issued.
FY 2018
In FY2018, staff restarted efforts to assess and potentially adjust inspection frequencies for many types of material licenses based on historical risk-informed information, enforcement data, and inspection staff expertise. The flexibility and logical extensions to the inspection intervals of material licenses is not expected to have an adverse impact on the health and safety of the public, and the NRC's ability to plan and conduct inspection activities will continue to be consistent with the NRC's mission, values, and the principles of good regulation including a risk-informed and performance-based oversight process.
FY 2019
Materials inspections continue to be risk-informed. Staff has drafted a complete revision to IMC 2800 to further risk-inform overall inspection guidance using material risk insights and previous inspection performance data. The staff is working on additional changes to several other materials IMCs and Inspection Procedures to further risk-inform and modernize the materials inspection program.
FY 2020
On March 2, 2020, staff issued a major revision to Inspection Manual Chapter (IMC) 2800, "Materials Inspection Program" (ADAMS Accession No. ML20062A002). This revision enhanced coordination and communication among the NRC regional offices and the regional offices and the Agreement States, revised the documentation of materials inspections, allowed flexibility for in-office reviews, and incorporated reciprocity inspection information from IMC 1220. These changes further risk-informed the materials inspection program. Also, in FY2020, staff started revising other inspection manual chapters and procedures to implement modern risk-informed approaches to the materials inspection program. These changes will enhance the inspection program and incorporate new risk and performance insights into the program. Additionally, staff are incorporating strategies to address low safety-significant issues in the materials inspection program, processes, and procedures and potentially adjusting inspection frequencies for several types of materials licensees (see associated cross-cutting topic "Consideration of Safety Significance in Addressing NMSS Licensing Basis and Potential Violation Questions").
FY 2021
Staff is currently updating implementing inspection procedures to further risk inform the inspection guidance provided for nuclear materials inspections
FY 2022
To further risk-inform nuclear materials inspection guidance, staff revised 10 inspection procedures in FY 2022. The revised procedures incorporate distinct risk modules specific to the modality being inspected. These inspection procedures used to have the same common focus elements regardless of the material use and modality. While those focus elements still represent important radiation protection and safety elements, the staff recognized that the risk profile for each modality could be different and therefore deserved the development of distinct risk modules per procedure. As part of incorporating more risk insights into our oversight program, staff divided the inspection guidance among risk modules, which focus the inspector’s attention to the areas of a licensee’s safety program that have the greatest potential to impact public health and safety and security. The risk modules that carry the highest risk components should always be reviewed in an inspection. Additional inspection elements that carry less risk can be found as an Appendix to these inspection procedures. These additional elements are not required to be reviewed every time as part of a risk-informed inspection approach but may be reviewed if the additional elements are related to safety issues identified in the risk-modules, or if multiple violations were identified through review of the applicable risk-modules.
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Animal Release Following Veterinary Treatment
Summary Description
In early 2020, staff received and commenced the evaluation of a proposed license application template (ML20142A291 and ML20178A654) from Exubrion Therapeutics (Exubrion) for the use of Synovetin OA®, a radioactive tin (Sn-117m) colloid, to treat osteoarthritis in a dog's elbows. Exubrion's proposed license application template would support individual license amendment requests by veterinary licensees to administer the Sn-117m colloid. In their application, Exubrion provided a proposed release procedure that relies upon pre-screening criteria and pet owners following veterinarian's instructions to a greater extent than previously practiced by the NRC.
Exubrion proposes using pre-screening criteria to determine if a dog is a candidate for treatment based on normal interaction patterns with humans. If a dog is a candidate, the licensee will use the information gathered in the pre-screening questionnaire to develop household specific instructions which would ensure public dose limits are not exceeded if followed. Any behavior modifications described in the specific instructions will be made in discussion with the owner and the procedure only allows scheduling and treating the dog if the licensee is confident all members in the household can follow these instructions. Staff has implemented a risk-informed decisionmaking approach using the Be riskSMART framework to review Exubrion's proposal. The framework is: Spot what can go right or wrong, Manage what you can, Act on a decision, Realize the result, and Teach others what you learned.
Staff has noted that even partial adherence to the instructions prescribed by the veterinarian following treatment would drastically reduce the dose to the owner and other persons. The use of both the pre-screening criteria and the reliance on instructions from the veterinarian helps manages the risk that the public dose limit will not be exceeded. The Be riskSMART framework has provided the NRC staff confidence in accepting well-managed risks in its decision making without compromising the NRC's mission.
The use of the license application template allows individual NRC or Agreement State veterinary licensees to request approved template procedures for release of the dogs following treatment in the licensees’ amendment applications, increasing the effectiveness and efficiency of the regulatory review and approval process, and supporting consistency across the National Materials Program.
Previous Fiscal Years
FY 2020
Staff drafted a technical review report (TER) to document the staff’s review of Exubrion’s proposed license application template. The findings in the TER will be used are being used by the NRC and/or Agreement States when reviewing individual license amendment requests by veterinary licensees to administer Synovetin OATM. The staff’s TER will be was issued in early FY2021.
FY 2021
On October 30, 2020, the staff issued its technical evaluation report which documents that the staff found Exubrion’s proposal adequate to protect the public’s health and safety.
FY 2022
The NRC established a working group to develop a rulemaking plan to seek Commission approval to establish a regulatory framework for the release of animals that have been administered radioactive material as part of veterinary procedures. In a separate effort, the Commission approved resources for the staff to develop regulatory guidance for release of animals administered radioactive material.
FY 2023
The NRC deferred the issuance of its rulemaking plan to establish a framework for release of animals administered radioactive material as part of veterinary procedures to address other high priority rulemaking efforts. The NRC is undertaking the addition of animal phantoms to existing codes to assist in the development of regulatory guidance.
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Page Last Reviewed/Updated Monday, February 12, 2024