NRC Guidance Authorizes Granting of Exemption Requests to Medical Use Licensees in Response to COVID-19 Pandemic

Morgan Lewis - Health Law Scan
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Morgan Lewis - Health Law Scan

The US Nuclear Regulatory Commission’s (NRC’s) Office of Nuclear Materials Safety and Safeguards (NMSS) issued an internal memorandum on April 10 to its regional directors describing a process that could be used to review medical licensees’ requests for temporary exemptions from certain NRC regulations due to the coronavirus (COVID-19) pandemic. Enclosed with the memorandum is a template letter that regions can use to streamline granting temporary exemptions.

Also enclosed with the memorandum is a table identifying the regulations NMSS has evaluated and deemed appropriate for temporary exemptions during the COVID-19 pandemic. The table includes information that medical licensees could rely on in support of the exemptions that NMSS has concluded would be appropriate for licensees to request. The regulations identified in the table and the activities covered by those regulations are summarized below.

Regulation

Activity

10 CFR 35.60(b)

Calibration of Certain Instrumentation

10 CFR 35.61(a)

Annual Calibration of Survey Instruments

10 CFR 35.67(b)(2)

Leak Testing of Sealed Sources and Brachytherapy Sources at Intervals Not to Exceed Six Months at Other Approved Intervals

10 CFR 35.310(a)

Annual Radiation Safety Instruction to Personnel Caring for Patients or Human Research Subjects Who Cannot be Released under 10 CFR 35.75

10 CFR 35.410(a)

Annual Radiation Safety Instruction to Personnel Caring for Patients or Human Research Subjects Who Are Receiving Brachytherapy and Cannot be Released Under 10 CFR 35.75

10 CFR 35.610(d)(2)

Annual Operational and Safety Instructions to Individuals Who Operate Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units

10 CFR 35.630(a)

Periodic Calibration of Dosimetry System

10 CFR 35.633(a)(3)

Quarterly Calibration for High Dose-Rate, Medium Dose-Rate, and Pulsed Dose-Rate Remote Afterloader Units with Sources Whose Half-Life Exceeds 75 Days

10 CFR 35.633(a)(4)

Annual Full Calibration for Low Dose-Rate Remote Afterloader Units

10 CFR 35.635(a)(3)

Annual Full Calibration for Gamma Stereotactic Radiosurgery Units

10 CFR 35.655(a)

Periodic Inspection and Servicing of Teletherapy Unit/Gamma Stereotactic Unit

The memorandum notes that the table does not contain an exhaustive list of regulations from which medical licensees might request temporary exemptions, and notes that NMSS intends to revise the table “in the coming days” to identify additional regulations from which temporary exemptions might be appropriate.

Recognizing that the regions may need to request additional information from medical licensees in connection with their exemption requests, NMSS notes that the regions may request such additional information via email, or, if written communication is impossible due to the urgent need for the exemption, via telephone. In cases where a portion of a requested exemption must be denied or requires additional consideration, the regions can grant partial exemptions while the remainder of the request is undergoing further review. Importantly, the memorandum does not discuss whether the NRC intends to exercise – or is even contemplating the use of – enforcement discretion should medical licensees violate the NRC’s regulations. Accordingly, medical licensees should continue completing required activities in the absence of an approved exemption request.

Coronavirus COVID-19 Task Force

For our clients, we have formed a multidisciplinary Coronavirus COVID-19 Task Force to help guide you through the broad scope of legal issues brought on by this public health challenge. We also have launched a resource page to help keep you on top of developments as they unfold. 

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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