NRC Meeting on COVID-19 Regulatory Relief for Medical/Materials Licensees

Morgan Lewis - Up & Atom
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Morgan Lewis - Up & AtomThe NRC held a public meeting on November 17 to review regulatory relief currently available to medical and other materials licensees, and to identify potential additional relief that the Staff is currently considering.

The Staff summarized existing pathways to regulatory relief developed during the early stages of the coronavirus (COVID-19) pandemic, which it outlined in its accompanying presentation. The Staff also recognized that because the pandemic is ongoing, licensees may continue to face challenges complying with regulatory requirements. Temporary relief from certain requirements remains available, as discussed in the Staff’s April 7 “All Licensees” letter, as does enforcement discretion for requirements under 10 CFR Parts 30-36 and 39 (where licensees have suspended the use of licensed material and placed it in safe storage) and emergency preparedness regulations. Licensees who apply for temporary exemptions from regulations, amendments to license conditions, and/or technical specifications may also request expedited Staff review, as outlined in the Staff’s May 5, May 15, May 20, and August 18 communications.

For emergency regulatory relief during off-hours, licensees should call the NRC Headquarters Emergency Operations Center at (301) 816-5100.

To date, the Staff has approved 35 temporary exemptions for medical and industrial materials licensees. These temporary exemptions include, among others, exemptions from periodic calibration, survey, material control and accounting, and leak test requirements, as well as exemptions from training requirements regarding annual radiation safety instruction related to patient release, annual operational and safety instructions to operators, and supervised work experience training for generator elutions.

The Staff does not currently intend to issue an Enforcement Guidance Memorandum (EGM) for Part 37 (although it issued an EGM for Parts 30-36, 39, and emergency preparedness regulations). It has, however, approved temporary exemptions related to annual training requirements under that Part and continues to review the impact of the pandemic on licensees’ implementation of Part 37.

Although its previous EGMs have articulated enforcement discretion that may be available to materials licensees that have suspended the use of licensed material and placed it in safe storage, the Staff is considering an additional EGM to address the needs of materials licensees that have continued or are restarting licensed activities. The Staff requested input from stakeholders regarding the potential development of this EGM.

 

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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