Radioactive material is commonly used in the oil & gas and petrochemical industries and by cancer treatment providers. The use, storage, and transfer of radioactive material are often managed by companies’ health, safety, and environment personnel.

On September 8, 2017, the NRC Staff recommended that the NRC pursue only a limited rulemaking, and not the more burdensome and costly rulemaking that it had been considering. In addition, the NRC Staff will continue to evaluate the effectiveness of the general license program and will include recommendations regarding a rulemaking as to that program in the forthcoming integrated rulemaking plan. The results of this further evaluation will likely be significant.

Regulation of radioactive material is designed to minimize the risks posed by loss, theft, inadvertent exposure, and potential misuse by bad actors.

In response to a Government Accountability Office sting operation1 which identified certain regulatory weaknesses, the NRC Staff has been evaluating whether it should revise regulations and/or processes related to the security and accountability of Category 3 sources.2 During the past nine months, the NRC Staff has evaluated the risks posed by these sources under the current regulatory framework. On September 8, 2017, the NRC made public the NRC Staff’s report to the NRC Commissioners which, among other things, provides the NRC Staff’s concerns, conclusions, and recommendations.

The NRC Staff identified the following four overarching concerns related to the security and accountability of Category 3 quantities of radioactive material. Each concern is followed by the NRC Staff’s conclusions regarding the concern.

  • Concern 1: The ability to obtain a valid license using a fictitious company or by providing false information.

Staff Conclusions: The Staff determined that the Pre-Licensing Guidance Working Group’s (PLWG) rulemaking and non-rulemaking-related recommendations sufficiently addressed the concern and should be undertaken. Specifically, the PLWG recommended rulemaking to amend 10 CFR Parts 30, 40, and 70 to require safety and security equipment to be in place before granting a license to an unknown entity. This requirement would apply to all unknown entities applying for a radioactive material license regardless of the quantity of licensed material requested (i.e., all quantities and types of radioactive material). The PLWG also identified several non-rulemaking-related recommendations to enhance licensing guidance and processes. These recommendations are being implemented by the NRC.

  • Concern 2: The ability to alter a valid license to obtain more or different radioactive material than authorized or to counterfeit a license to obtain radioactive materials illicitly.

Staff Conclusions: The Staff determined that the risks arising from this concern do not provide a basis to require license verification through either the License Verification System (LVS) or the regulatory authority for Category 3 quantities of radioactive material, or a basis to require license authentication for all quantities of radioactive material.

  • Concern 3: The ability to accumulate or aggregate Category 3 sources to a Category 2 quantity of radioactive material requiring enhanced security.

Staff Conclusions: The Staff concluded that the risks arising from this concern do not justify the costs associated with the inclusion of Category 3 sources in the NSTS or through imposing additional physical security measures on licensees possessing Category 3 sources.

  • Concern 4: The limited accountability, lack of pre-licensing evaluations, and lack of routine oversight of Category 3 sources contained within generally licensed devices.

Staff Conclusions: The Staff determined that changes to the General License (GL) program are not warranted on the basis of security and accountability. The NRC Staff, however, noted that it will conduct further evaluation of the existing GL program to ensure that it continues to provide protection of public health and safety.

In order to address its conclusions regarding Concern 1, the Staff recommended that the Commission approve a limited rulemaking to (1) bolster the prelicensing verification processes where the applicant is unknown and to (2) clarify license verification methods for transfers involving quantities of radioactive material that are below Category 2.3 Should the Commission direct the Staff to pursue a rulemaking in this area, the resulting regulations are not expected to be unduly burdensome or costly for most licensees.

In order to address its conclusions regarding Concerns 2 and 3, the Staff recommended that the Commission not direct the Staff to amend the regulations to:

  • Require license verification through the License Verification System (LVS) or regulatory authorities for transfers of Category 3 quantities of radioactive material;
  • Require inclusion of Category 3 sources in the National Source Tracking System (NSTS);
  • Impose security requirements to prevent aggregation of Category 3 sources to a Category 2 quantity of radioactive material; or
  • Limit the quantity of byproduct material in a generally licensed device to ensure the security of radioactive materials.

Should the Commission direct the Staff to pursue a rulemaking in this area despite the Staff’s recommendation to the contrary, the resulting regulations will likely be burdensome and costly for most licensees.

Finally, in order to address its conclusions regarding Concern 4, the Staff proposes to conduct additional evaluation of the existing GL program to ensure that it continues to provide protection of public health and safety.

First, stakeholders should understand that while the Commission is likely to approve the Staff’s recommendations, it is possible that it will reject them (in full or in part) or direct the Staff to conduct additional evaluations.

Second, and in the event the Commission directs the Staff to pursue a rulemaking to amend 10 CFR Parts 30, 40, and 70, stakeholders should participate in that process to the extent that the rulemaking is relevant to their activities.

Third, and perhaps most importantly, stakeholders should continue to follow the NRC’s additional evaluation of the existing GL program. The Staff will be conducting this evaluation internally and will not conduct further outreach as a part of its activities. Further, the NRC Staff notes that should it determine “that regulatory changes to the GL program are needed . . . [it] will include such rulemaking recommendations” in the same rulemaking plan that addresses the recommendations provided in its report to the Commission; the NRC Staff anticipates submitting that plan within 5 months of receiving the Commission’s direction on its report. To the extent that the rulemaking plan proposes revisions to the code regarding the GL program, stakeholders should be prepared to consider how those revisions would affect their operations, and should be prepared to interact with the NRC as might be desirable based on that consideration.

The report and enclosures / attachments thereto are available here.