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:
This page includes links to files in non-HTML format. See Plugins, Viewers, and Other Tools for more information.
Utilize risk information on a case-by-case basis for byproduct material regulation, licensing, and oversight.
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.
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:
Inspection Manual Chapter 2800, "Materials Inspection Program"
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.
Animal Release Following Veterinary Treatment
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.
Once approved, the Exubrion license application template will be incorporated into individual NRC or Agreement State veterinary license amendment applications, increasing the effectiveness and efficiency of the regulatory review and approval process, and supporting consistency across the National Materials Program.
Page Last Reviewed/Updated Monday, January 04, 2021