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:

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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 Materials Safety Arena:

Inspection Manual Chapter 2800, "Materials Inspection Program"

Summary Description

The revision of IMC 2800 allowed the addition of more flexible and logical extensions to the time between inspections, i.e., inspection intervals for material licensees. The 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. 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 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.

Risk-Informed Basis

Materials inspections continue to be risk-informed. IMC 2800 was revised to continue and enhance risk-informed, relative priorities for routine inspections of all licensees and a program of special inspection activities.

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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 several ongoing rulemaking projects related to NRC regulations of medical use of byproduct material. First, this rule amends the medical event definition for reporting and notification requirements for permanent implant brachytherapy. This rule also amends the training and experience (T&E) requirements to (1) remove the requirement to obtain a written attestation for an individual who is certified by a specialty board whose certification process has been recognized and (2) address a petition request filed to exempt certain board-certified individuals from certain T&E requirements (i.e., "grandfather" these individuals). Additionally, this rule amends the requirements for measuring molybdenum contamination; adds a new requirement for the reporting of failed technetium and rubidium generators; and allows licensees to name associate radiation safety officers (ARSOs) on a medical license. The proposed rule was published on July 21, 2014 (79 FR 42410) for 120-day public comment period. The proposed guidance was noticed on the same day.

FY 2015

The NRC staff considered public comments as they developed the proposed final rule.

FY 2016

The staff sent the proposed final rule to the Commission for their approval in SECY-16-0080.

FY 2017

The Commission approved the final rule on August 17, 2017, in Staff Requirements Memorandum M170817: Affirmation Session - SECY-16-0080 – Final Rule: Medical Use of Byproduct Material – Medical Event Definitions, Training and Experience, and Clarifying Amendments (RIN 3150-AI63: NRC-2008-0175). The NRC staff is finalizing the rule and estimates publication no later than early March 2018.

Risk-Informed Basis

This rule continues the risk-informed, performance-based framework already present in 10 CFR 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. The medical event criteria are being revised to more accurately reflect the different risks of different uses of byproduct material in medical applications. This will result in the NRC receiving notification of medical events that are clinically significant. 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 Thursday, May 10, 2018