United States Nuclear Regulatory Commission - Protecting People and the Environment

Byproduct Materials Sub-Arena

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:

Objective

Utilize risk information on a case-by-case basis for byproduct material regulation, licensing, and oversight.

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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.

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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.

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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 Reactor Safety Arena:

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Medical use of Byproduct Material (10 CFR Part 35) – Medical Event Definitions, Training and Experience, and Clarifying Amendments

Summary Description

In this rulemaking, the NRC addresses three ongoing rulemaking projects and several other related topics. First, this rule amends the reporting and notification requirements for a medical event for permanent implant brachytherapy. Second, the rule: (a) amends the training and experience (T&E) requirements for authorized users, medical physicists, Radiation Safety Officers, and nuclear pharmacists; (b) amends the requirements for measuring molybdenum contamination and reporting for failed technetium and rubidium generators; and (c) allows Associate Radiation Safety Officers to be named on a medical license. Third, the rule amends the T&E requirements to address a request filed in a petition for rulemaking PRM-35-20, to exempt certain board-certified individuals from certain T&E requirements (i.e., "grandfather" these individuals) so they may be identified on a license or permit for materials and uses that they performed on or before October 24, 2005, the expiration date of the prior T&E requirements. The proposed rule was published for public comment on July 21, 2014 (79 FR 42410) for 120 day public comment period. The proposed guidance was noticed on the same day. The NRC Staff is considering and responding to comments and preparing the final rule.

FY 2015 Status

The staff is developing the final rule. More information is on the agency's Medical Licensing Tool Kit Web site.

Risk Category

"Rulemaking Applications Using Risk Insights" – This rule continues the risk-informed, performance-based framework already present in Part 35. The reporting and notification requirements for medical events are being updated as part of this rulemaking and the underlying requirement differs based on the event. There is an inherent recognition of the different consequences of different types of medicals events. Furthermore, the training and experience requirements are being updated and differ based on type of use and radioisotope involved in the treatment. The administration of certain drugs represents a lower risk significance than others and this is reflected in the training and experience requirements of 10 CFR Part 35.

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Page Last Reviewed/Updated Wednesday, July 06, 2016