ML20100D408
| ML20100D408 | |
| Person / Time | |
|---|---|
| Issue date: | 04/10/2020 |
| From: | Michael Layton NRC/NMSS/DMSST |
| To: | Mary Muessle, David Pelton, James Trapp NRC Region 1, NRC/RGN-III, NRC Region 4 |
| Tapp K | |
| Shared Package | |
| ML20100D405 | List: |
| References | |
| Download: ML20100D408 (3) | |
Text
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 April 10, 2020 MEMORANDUM TO:
James M. Trapp, Director Division of Nuclear Materials Safety Region I Dave Pelton, Director Division of Nuclear Materials Safety Region III Mary Muessle, Director Division of Nuclear Materials Safety Region IV FROM:
Michael C. Layton, Director Division of Materials Safety, Security, State and Tribal Programs Office of Nuclear Materials Safety and Safeguards
SUBJECT:
TEMPORARY EXEMPTION TEMPLATE FOR MEDICAL USE LICENSEES DURING THE COVID-19 PANDEMIC This memorandum provides the temporary exemption template letter that regions can use to grant exemptions for their medical use licensees. Also included is a spreadsheet with specific temporary exemptions that my staff has evaluated and determined would be appropriate given the current public health emergency caused by the Coronavirus Disease 2019 (COVID-19) pandemic. This spreadsheet provides standardized language to maintain consistency that regions can use to fill out the template for these specific exemptions. Please note the following:
Medical use licensees will need to provide a basis as to why they need these exemptions prior to the U.S. Nuclear Regulatory Commission (NRC) granting them. The spreadsheet includes examples of safety bases that would be deemed acceptable.
If the licensee did not provide enough information, then you can ask for additional information similar to the normal request for additional information process. You can request this additional information by e-mail or, if written communication is not possible due to the urgent need for the exemption, then over the phone. If you request additional information over the phone, then document and save the conversation in writing.
Prior to issuing exemptions using this template, you should request a legal review from Esther Houseman at Esther.Houseman@nrc.gov of the Office of the General Counsel and cc your regional counsel. Ms. Houseman and your regional counsel will coordinate CONTACT: Katie Tapp, NMSS/MSST 301-415-0236 Michael C. Layton Digitally signed by Michael C.
Layton Date: 2020.04.10 10:35:07 -04'00'
J. Trapp, et al.
2 to ensure timely review of the exemption. Please include the exemption, the incoming exemption request, and any additional information that the licensee sent to support its request.
If even after gathering all of the information you need from the licensee to review the request you think that you must deny a portion of an exemption request, then move forward with issuance of the portion of the exemption request that you can grant and state that the remainder of the exemption request is still under NRC review. Consult with your regional counsel or Ms. Houseman on the exemption request denial and then issue the denial separately. You would need to provide a specific basis to support the decision to deny the exemption request.
The regulations in the spreadsheet are the only ones the staff has evaluated at this time.
Please note this spreadsheet will likely be updated in the coming days with more regulations. I will provide these updates as soon as I can. If a licensee includes exemption requests for regulations not listed in the spreadsheet, e-mail those request to members of my staff, specifically Lisa Dimmick at Lisa.Dimmick@nrc.gov and Katie Tapp at Katherine.Tapp@nrc.gov, for further evaluation as appropriate if the request is not an emergency. Regions may issue exemptions to regulations contained in the spreadsheet while others are being evaluated further, if necessary.
Regions may authorize temporary exemptions to NRC regulations or license conditions without referral to my division in an emergency, in accordance with the guidance in NUREG-1556, Volume 20, Consolidated Guidance about Materials Licenses: Guidance About Administrative Licensing Procedures, Section 4.13, Processing of Exemptions for Material Licensees.
However, please coordinate with my staff whenever possible. If an exemption is needed in a case of an emergency, please inform my staff as soon as possible but no later than 3 days after issuing the exemption to ensure we can coordinate with other regions as necessary.
Enclosures:
- 1. Temporary Exemption From U.S. Nuclear Regulatory Commission Regulation, Title 10 Code of Federal Regulations (10 CFR) [List Section(s)].
J. Trapp, et al.
2
SUBJECT:
TEMPORARY EXEMPTION ACCEPTANCE TEMPLATE FOR MEDICAL LICENSEES DURING THE COVID-19 PANDEMIC DATE: April 10, 2020 DISTRIBUTION:
Joseph Nick, RI Christine Lipa, RIII Linda Howell, RIV Donna Janda, RI Bob Orlikowski, RIII Heather Gepford, RIV Lisa Dimmick, NMSS Katie Tapp, NMSS ML20100D405
- via e-mail OFC NMSS/MSST NMSS/MSST NMSS/MSST NMSS/MSST NAME KTapp*
LDimmick*
CEinberg*
MLayton*
DATE 4/9/20 4/9/20 4/9/20 4/10/20 OFFICIAL RECORD COPY