ML20065M802: Difference between revisions

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{{#Wiki_filter:March 9, 2020 APPLICANT: Eden Radioisotopes, LLC
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==SUBJECT:==
 
==SUMMARY==
OF JANUARY 30, 2020, MEETING WITH EDEN RADIOISOTOPES, LLC (EPID NO. L-2019-LLL-0027)
On January 30, 2020, a Category 1 public meeting was held between the U.S. Nuclear Regulatory Commission (NRC) staff and representatives of Eden Radioisotopes, LLC (Eden) at NRC Headquarters, One White Flint North, 11555 Rockville Pike, Rockville Maryland. The purpose of this meeting was to discuss licensing topics regarding Edens proposed medical radioisotope project. The meeting notice and agenda, dated January 17, 2020, are available in the Agencywide Documents Access and Management System at Accession No ML20017A281.
A list of meeting attendees is provided as an Enclosure 1 to this summary. No presentation was made at the meeting, however, a list of topics discussed is provided in Enclosure 2.
Eden first shared a brief update on its project status, including plans to request additional pre-application meetings to discuss proprietary information related to the designs and key technical areas. Eden discussed its interpretation of the definition of production facility in Title 10 of the Code of the Federal Regulations (10 CFR) 50.2, Definitions. Specifically, Eden discussed paragraphs (3)(ii) and (3)(iii) of the production facility definition and how its interpretation could affect Edens licensing path. Eden then discussed the possibility of submitting an application under 10 CFR Part 50, Domestic Licensing of Production and Utilization Facilities, for its proposed reactor, target processing, and target fabrication. Eden stated that this licensing approach could provide consistency and operational flexibility throughout the facility.
The NRC staff discussed historical precedence of licensing under 10 CFR Part 50 and 10 CFR Part 70, Domestic Licensing of Special Nuclear Material. The NRC staff also indicated that 10 CFR 50.31, Combining applications, allows for an applicant to combine in one several applications for different kinds of licenses under 10 CFR Part 50, and 10 CFR 50.52, Combining licenses, states that the Commission may combine in a single license the activities of an applicant which would otherwise be licensed separately. The NRC staff informed Eden that it could submit a request for written interpretation of the definition of production facility, as used in 10 CFR 50.2, to provide for a stable licensing process for its project. Eden then discussed approaches to performing accident and hazard analyses.
 
Three members of the public participated in this meeting but provided no comments. Please direct any inquiries to me at 301-415-4103, or by electronic mail at Linh.Tran@nrc.gov.
                                                /RA/
Linh Tran, Senior Project Manager Non-Power Production and Utilization Facility Licensing Branch Division of Advanced Reactors and Non-Power Production and Utilization Facilities Office of Nuclear Reactor Regulation Project/Docket No. 99902077
 
==Enclosures:==
 
As stated cc: w/enclosures:
Mr. Bennett Lee, CEO/Co-Founder Eden Radioisotopes, LLC 6100 Indian School Road NE Suite 125 Albuquerque, NM 87110
 
ML20058A742 Pkg ML20017A281 Mtg. Notice ML20065M802 Mtg. Summary            *concurred via email OFFICE    NRR/DANU/UNPL/PM      NRR/DANU/UNPL/PM        NRR/DANU/UNPL/LA*
NAME      MGavello              LTran                  NParker DATE      3/9/2020              3/92020                3/9/2020 OFFICE    NRR/DANU/UNPL/BC      NRR/DANU/UNPL/PM NAME      GCasto                LTran DATE      3/9/2020              3/9/2020 LIST OF ATTENDEES JANUARY 30, 2020, MEETING WITH EDEN RADIOISOTOPES, LLC.
1:00 P.M. - 4:00 P.M.
Name                              Organization Linh Tran                          U.S. Nuclear Regulatory Commission Molly-Kate Gavello                U.S. Nuclear Regulatory Commission Brian Smith                        U.S. Nuclear Regulatory Commission Greg Casto                        U.S. Nuclear Regulatory Commission Mitzi Young                        U.S. Nuclear Regulatory Commission Robert Schaaf                      U.S. Nuclear Regulatory Commission Steven Lynch                      U.S. Nuclear Regulatory Commission Yawar Faraz                        U.S. Nuclear Regulatory Commission Reginald Augustus                  U.S. Nuclear Regulatory Commission Mary Woods                        U.S. Nuclear Regulatory Commission Michael Balazik                    U.S. Nuclear Regulatory Commission Ed Parma                          Eden Radioisotopes, LLC Bennett Lee                        Eden Radioisotopes, LLC Dick Coats                        Eden Radioisotopes, LLC Milton Vernon                      Eden Radioisotopes, LLC Paul Helmick                      Eden Radioisotopes, LLC Ryan Lighty                        Morgan Lewis Thomas Eiden                      Atomic Alchemy Jordan Hill                        Atomic Alchemy Joe Laprad                        SHINE Medical Technologies, LLC Enclosure 1
 
Discussion Topics for Eden Meeting January 30, 2020
* Schedule/Status Update
* Production facility definition (hot cell facility, target fabrication facility)
* Potential Licensing under Title 10 of the Code of Federal Regulations (10 CFR)
Part 50 (all three) o Final Safety Analysis Report/One-step licensing for 10 CFR Part 50 o Maximum Hypothetical Accident vs. Independent Safety Analysis methodologies o Including Target Fabrication activities in B chapters as a subsection Enclosure 2}}

Latest revision as of 17:30, 30 March 2020

Summary of Meeting with Eden Radioisotopes, Llc., to Discuss Licensing Topics Regarding Eden'S Proposed Medical Radioisotope Project
ML20065M802
Person / Time
Site: 99902077
Issue date: 03/09/2020
From: Linh Tran
Office of Nuclear Reactor Regulation
To:
Eden Radioisotopes
M, Gavello, NRR/PRLB, 415-0565
Shared Package
ML20058A742 List:
References
Download: ML20065M802 (5)
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