ML20168B090
| ML20168B090 | |
| Person / Time | |
|---|---|
| Issue date: | 06/24/2020 |
| From: | Lizette Roldan-Otero NRC/NMSS/DMSST |
| To: | Derstine T State of PA, Dept of Environmental Protection |
| Beardsley M | |
| Shared Package | |
| ML20153A774 | List: |
| References | |
| Download: ML20168B090 (3) | |
Text
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 June 24, 2020 Mr. Terry Derstine, Chair Organization of Agreement States Radiation Protection Program Manager Pennsylvania Dept. of Environmental Protection Southeast Regional Office 2 E. Main Street Norristown, PA 19401
Dear Mr. Derstine:
We have reviewed the Organization of Agreement States (OAS) legally binding requirements, i.e. license conditions regarding the NorthStar Medical Radioisotopes, LLC, Radiogenix' Molybdenum-99/Technetium-99m Generator System, received by our office on May 29, 2020.
These legally binding requirements were reviewed by comparison to Revision 1 of the Northstar Medical Radioisotopes, LLC, Radiogenix' Molybdenum-99/Technetium-99m Generator System, Licensing Guidance For Medical Use Licensees, Medical Use Permittees, and Commercial Nuclear Pharmacies (Licensing Guidance) issued in State and Tribal Communications Letter (STC) STC-20-006. We discussed our review of the legally binding requirements with you and Jenny Goodman on June 16, 2020.
As a result of our review, we have the following comment:
Regarding license condition 2 as stated in your letter, the required timeframe for the licensee to inform the State of the installation of a model upgrade was left blank. The Licensing Guidance referenced above requires the licensee to notify the NRC within 30 days of any model upgrades.
The OAS should insert a timeframe less than or equal to 30 days to meet the Compatibility Category C designation assigned to the Licensing Guidance.
Please note that we have limited our review to the legally binding requirements required for compatibility and/or health and safety. We have determined that if these requirements are revised, incorporating our comment and without other significant change, they would meet the compatibility and health and safety categories established in the Office of Nuclear Material Safety and Safeguards (NMSS) Procedure SA-200, Compatibility Categories and Health and Safety Identification for NRC Regulations and Other Program Elements.
We request that when you revise your legally binding requirements to address our comment, a copy of the revised legally binding requirements be provided to us for review. As requested in NMSS Procedure SA-201, Review of State Regulatory Requirements, please highlight the location of any changes made by OAS, in response to our comment, and provide a copy to Division of Materials Safety, Security, State, and Tribal Programs, NMSS.
This letter is posted on the NMSS State Communication Portal:
https://scp.nrc.gov/rulemaking.html.
If you have any questions regarding the comment, or the compatibility and health and safety categories used in the review, please contact Michelle Beardsley, State Regulation Review Coordinator, at 301-415-0275 (michelle.beardsley@nrc.gov).
Sincerely, Jacob Zimmerman, Deputy Director Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards Lizette Roldan-Otero Digitally signed by Lizette Roldan-Otero Date: 2020.06.24 12:40:04
-05'00'
SUBJECT:
06/24/2020 Organization of Agreement States (OAS) Proposed Legally Binding Requirements re: NorthStar Medical Radioisotopes, LLC, Radiogenix' Molybdenum-99/Technetium-99m Generator System DISTRIBUTION:
DIR RF (20-26)
Duncan White, NMSS Lisa Dimmick, NMSS[
OFFICE SALB OGC NLO via email SALB:BC MSST:DD NAME MBeardsley JGillespie LRoldan-Otero JZimmerman (LRoldan-Otero)
DATE 6/1/20 6/16/20 6/24/20 06/24/20 ML20168B090 OFFICIAL RECORD COPY Package ML20153A774