ML20170B126

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Letter to T. Derstine OAS Final Legally Binding Requirements for the Northstar Medical Radioisotopes, LLC, Radiogenix Molybdenum-99/Technetium-99m Generator System
ML20170B126
Person / Time
Issue date: 07/07/2020
From: Jacob Zimmerman
NRC/NMSS/DMSST
To: Derstine T
State of PA, Dept of Environmental Protection, Bureau of Radiation Protection
Beardsley M
Shared Package
ML20179B104 List:
References
Download: ML20170B126 (3)


Text

UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 July 7, 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 June 17, 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 24, 2020.

As a result of our review, we have no comments. We have determined that the OAS legally binding requirements 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.

This letter is posted on the NMSS State Communication Portal:

https://scp.nrc.gov/rulemaking.html.

T. Derstine 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, Acting 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: 2020.07.07 10:47:24

-05'00'

T. Derstine

SUBJECT:

Letter to T. Derstine re: OAS Final Legally Binding Requirements for the Northstar Medical Radioisotipes, LLC, Radiogenix' Molybdenum-99/Technetium-99m Generator System DISTRIBUTION:

DIR RF (20-29)

Duncan White, NMSS Lisa Dimmick, NMSS[

OFFICE SALB OGC SALB:BC MSST:DD NAME MBeardsley NA LRoldan-Otero JZimmerman (LRoldan-Otero for)

DATE 6/17/20 07/07/20 07/07/20 ML20170B126 OFFICIAL RECORD COPY Package ML20170B104