ML21085A736: Difference between revisions

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{{#Wiki_filter:Enclosure 2 Summary of the General Licensing Modernization Working Group As directed by the Office of Nuclear Materials Safety and Safeguards (NMSS) management.
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The staff continued its evaluation of the General License (GL) program from a broader perspective. As part of its evaluation the General Licensing Modernization Working Group (GLMWG) built on the efforts of General License Re-Evaluation Working Group. The working group was tasked with determining whether the National Materials Program should continue to have a GL program, and if the GLMWG determined that the GL program should continue, evaluate and consider potential changes to improve the program.
As part of its evaluation the working group considered ways to improve the accountability of generally licensed devices not subject to the annual registration requirements in Title 10 of the Code of Federal Regulations (10 CFR) 31.5, Certain detecting, measuring, gauging, or controlling devices and certain devices for producing light or an ionized atmosphere, how certain devices were treated internationally, and obtained feedback, in the form of a survey, from the Agreement States about what the GLMWG considered.
In the survey the GLMWG posed several questions regarding the GL program in order to get feedback on what the GLMWG was considering. Thirty Agreement States responded to the survey. Most of the States that responded, supported an expanded registration program, the States did identify that rulemaking could be a challenge. However, several States noted that if the NRC proceeded with rulemaking it would be easier for them, to seek rulemaking in order to remain compatible with the NRCs regulations. In some instances, States are already implementing an expanded registration program.
The working group developed the following considerations:
: 1. No change
: a.      No change in safety
: b.      No improvement in accountability
: 2. Expand the Registration Program
: a.      Same isotopes, no minimum limit (help with accountability)
: b.      Rulemaking/Additional cost to NRC and licensees (estimate 600 additional registration)
: c.      Provide relief - in the form of distribution reporting requirements and reporting requirements for low risk devices
: 3. Modified Specific License Program
: a.      Subset of GLs which would become modified specific licenses (receive an actual license)
: b.      Added burden to GLs and regulators (inspection program/license generation)
: c.      Provide relief - in the form of distribution reporting requirements and reporting requirements for low risk devices
: 4. Right Sizing the GL Program
: a.      Combination of an expanded program and modified SL program
: b.      Cost associated with a significant program change
: c.      Provide relief - in the form of distribution reporting requirements and reporting requirements for low risk devices
: 5. Increased Communication
: a.      The NRC has no routine communication with GLs beyond those that require annual registration Enclosure 2
: b.      Establishing routine communications may help remind GLs of the regulatory requirements
: c.      Depending on the frequency and form of increased communication the cost could be prohibitive The GLMWG supported expanding the registration program, while providing relief for reporting requirements for certain general licensees and distributors of generally licensed devices.
Conclusion The GLMWG could not identify a reason for not continuing the GL program. Similar to the previous working group, the GLMWG concluded that the annual registration program is working, however accountability could be improved for lower activity devices for those same isotopes that are currently registered. The working group also concluded that other devices that currently distributed as GL devices could potentially be distributed as products under an exempt distribution license, however that would require that a distributor submit an application. In addition, the working group discussed the use of exit signs containing tritium with representatives from the Canadian Nuclear Safety Commission and a major distributor of exit signs containing tritium. This was part of the working groups efforts to obtain a better understanding of how tritium exit signs are regulated outside of the United States. Based on these discussions the working group identified that in most countries, tritium exit signs are treated as exempt products with no regulatory requirements imposed on the end users. It should be noted that the NRC would consider the application of an exit sight containing tritium to be distributed as an exempt product. However, in order to be distributed as an exempt product the exit sign must meet the requirements set in 10 CFR 32.22.
The working group recommended rulemaking. The rulemaking would expand the annual registration requirements that would require registration of all of the current isotopes in 10 CFR 31.5(c)(13)(i) without a lower activity limit. The recommendation would also have removed certain reporting requirements for users and distributors of GL devices using other isotopes.
This would have included not requiring GL device users to repot lost, damaged, or the proper disposal of non-registered devices as well as not requiring distributors to report if no distributions have been made in a quarters, the changes would have also only required those distributors to report distributors of registered devices. The GLMWG did have support from the Agreement States for the suggested rulemaking. The staff performed a high-level cost analysis and determined that there was a low probability that the recommendation would be cost effective.
NMSS Management decided that since there was no operating experience that warranted a change, it could not support rulemaking at this time, in addition the cost of the rulemaking had a very low probability of being cost justified. Staff estimated that rulemaking would cost the NRC approximately $1.1 million, the Agreement States $1.1 million, $1.5 million for industry to implement, and approximately $370 thousand annually based on unpublished analysis performed by the GLMWG. NMSS management noted that the staff did not have any deliverables to the Commission until the staff receive direction on SECY-17-0083, Re-Evaluation of Category 3 Source Security and Accountability in Response to SRM-COMJMB-16-000-1.
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Revision as of 22:09, 17 January 2022

Enclosure 2: Summary of the General Licensing Modernization Working Group (Glmwg)
ML21085A736
Person / Time
Issue date: 04/30/2021
From: Thi Herrera
NRC/NMSS/DMSST
To: Kevin Williams
NRC/NMSS/DMSST
HERRERA T/NMSS/MSST
Shared Package
ML21085A733 List:
References
Download: ML21085A736 (2)
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