May 07, 2020

NRC Regulatory Relief for Medical Use Licensees During COVID-19 Pandemic

The following information is for educational purposes only. Stakeholders with additional questions should contact the Nuclear Regulatory Commission (NRC) at MedicalQuestions.Resource@nrc.gov.

What you need to know

  • NRC medical use licensees can apply for temporary relief from requirements they are unable to comply with during the COVID-19 pandemic.
  • These requests should be sent by a senior level licensee manager with decision-making authority to the director of the relevant regional division of nuclear materials safety.
  • The NRC is reporting a turn-around time of a matter of days for such requests.

What relief is being offered?

The NRC sent a letter on April 7, 2020 to all materials licensees (including medical use licensees) describing regulatory relief that could be applied for on a case-by-case basis.  A follow-up letter with additional clarifications was sent to medical use licensees on May 5.

The NRC maintains a document compiling a list of regulatory requirements for which the NRC may consider expedited requests for temporary exemption(s).

Licensees seeking relief for other NRC requirements not included in this document can apply through the same process.

How do NRC medical use licensees apply?

A “senior level licensee manager with decision-making authority” can apply for exemptions in writing to their relevant NRC regional division. One can apply via email or this online form. The region-specific recipients for emailed requests are as follows:

  • Region I-originated materials licenses: James Trapp, RI/Division of Nuclear Materials Safety (DNMS), James.Trapp@nrc.gov
  • Region III-originated materials licenses: David Pelton, RIII/DNMS, David.Pelton@nrc.gov
  • Region IV-originated materials licenses: Mary Muessle, RIV/DNMS, Mary.Muessle@nrc.gov

For an immediate decision on an exemption request, licensees can call their project manager, licensing point of contact, or the cognizant branch chief. If after hours, call the NRC Headquarters Emergency Operations Center at 301-816-5100. Phone requests will need to be followed up within 24 hours with a written request.

What should the written request include?

The requests for relief should include the following details and justifications:

  • A statement that the licensee expects that it will no longer be able to comply with the requirements of the specific subsection(s) of 10 CFR Part 19, 20, 30, and 35;
  • The site-specific reason that the COVID-19 PHE prevents the licensee from being able to meet the specific regulatory requirement from which it is seeking an exemption; and
  • The specific regulatory provision from which the licensee is seeking an exemption.

To date, the NRC has granted exemptions for periods of 30, 90, or 120 days. At the end of the designated exemption period, licensees are expected to come into compliance or obtain an additional exemption. 

What about (non-NRC) Agreement State licensees?

Agreement State licensees should access their own state-specific COVID-19 response resources. The Organization of Agreement States provides an online Agreement State resource library.

Other resources