The US Nuclear Regulatory Commission (NRC) Staff hosted a public meeting via teleconference on April 22 to discuss available regulatory relief pathways for medical licensees during the coronavirus (COVID-19) public health emergency (PHE).
During its presentation, the Staff referenced an April 7 letter (on which we reported) outlining options for materials licensees to seek regulatory relief during the PHE. Among other things, the letter addressed exemptions to regulations and license conditions, as well as emergency regulatory relief.
The Staff specified that although it is prepared to grant exemptions for periods up to 90 days, licensees can request longer exemption periods. The Staff will specify the date on which an extension will expire. Licensees may request extensions to previously granted exemptions as may become necessary in light of the rapidly developing PHE.
The Staff also referenced the NRC’s April 10 memorandum to regional directors regarding how to process certain anticipated exemption requests from medical use licensees. As we previously reported, the memorandum and accompanying documents included a template letter that may allow NRC regions to efficiently process certain exemption requests. The Staff clarified that, consistent with NRC regulations, licensees may request exemptions from any regulation or license condition, and that the regulations identified in the memorandum and accompanying documents are only those that the Staff has evaluated and determined might be eligible for expedited review.
The Staff estimated that they have responded to requests for exemption within a day or two of receiving the request, and observed that licensees may—and frequently have—requested exemptions from more than one regulatory requirement in a single application.
Importantly, the Staff posted a template of an online form that will help licensees submit their exemption requests. According to the Staff, licensees should include the following information with their requests:
- A description of activities and parts of the facility that are shut down or where staff access is limited
- A description of activities and parts of the facility that are operational
- A description of any other COVID-19-related circumstances that affect the licensee’s ability to comply with certain regulatory requirements
- The regulations, license conditions, or license commitments for which the licensee is seeking temporary relief
- A description of the compensatory measures being taken to ensure that licensed material is being stored and used safely
- The length of time shutdown or restriction to the facility is expected and actions to be taken when restart occurs
To date, Region I has received requests for exemptions involving licensee-mandated, no access or limited access to facilities, as well as for requirements associated with radiation safety programs, including the following:
- Area surveys
- Source inventories
- Source leak tests
- Instrument calibration
- Dosimetry exchanges
- Routine doorlock checks
- Environmental air sampling
- Research protocol renewals
- Vendor activities (e.g., source exchange)
Although the Staff expects licensees to submit requests in writing, the Staff noted that licensees may request emergency exemptions via email or phone. Directors of the regional Divisions of Nuclear Materials Safety can provide verbal authorization of the requested exemptions if immediate relief is needed and they deem the request appropriate.
If a request is made orally, licensees must follow up with a written request within 24 hours. In urgent, off-hours cases, licensees should contact the Headquarters Emergency Operations Center at +1.301.816.5100.
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.
