ML23041A040

NRR E-mail Capture - Request for Additional Information Construction Permit (Cp), License Amendment Request (LAR)

ML23041A040
Person / Time
Site:	SHINE Medical Technologies
Issue date:	02/09/2023
From:	Michael Balazik NRC/NRR/DANU
To:	Bartelme J SHINE Technologies
References
L-2022-LLA-0163
Download: ML23041A040 (4)

Text

From: Michael Balazik Sent: Thursday, February 9, 2023 1:12 PM To: Jeffrey Bartelme Cc: Josh Borromeo; Holly Cruz

Subject:

Request for Additional Information CP LAR

Dear Dr. Piefer and Mr. Bartelme:

By letter dated October 6, 2022 (Agencywide Documents Access and Management System Accession No. ML22279A951), SHINE Technologies, LLC (SHINE) applied for an amendment to Construction Permit No. CPMIF-001 for its Medical Isotope Production Facility. The license amendment request (LAR) proposes to receive and possess special nuclear material necessary for the continued construction of the SHINE Medical Isotope Production Facility. Consistent with Title 10 of the Code of Federal Regulations (10 CFR) 50.90, Application for amendment of license, construction permit, or early site permit, an application to amend the construction permit must fully describe the changes desired and follow, as far as applicable, the form prescribed for original applications.

During the U.S. Nuclear Regulatory Commission (NRC) staffs review of SHINEs LAR, questions have arisen for which additional information is needed. The enclosed request for additional information (RAI) identifies information needed for the NRC staff to continue its review of the SHINE LAR.

It is requested that SHINE provide responses to the enclosed RAI within 30 days from the date of this letter. To facilitate a timely and complete response to the enclosed RAI, the NRC staff is available to meet with SHINE to clarify the scope of information and level of detail expected to be included in the RAI response. SHINE may coordinate the scheduling and agendas for any such meetings with the responsible project manager assigned to this project.

In accordance with 10 CFR 50.30(b), Oath or affirmation, SHINE must execute its response in a signed original document under oath or affirmation. The response must be submitted in accordance with 10 CFR 50.4, Written communications. Information included in the response that is considered sensitive or proprietary, that SHINE seeks to have withheld from the public, must be marked in accordance with 10 CFR 2.390, Public inspections, exemptions, requests for withholding. Any information related to safeguards should be submitted in accordance with 10 CFR 73.21, Protection of Safeguards Information: Performance Requirements. Following receipt of the additional information, the NRC staff will continue its evaluation of the subject chapters and technical areas of the SHINE operating license application.

Based on the response period provided above, the NRC staff expects to complete its review and make a final determination on the LAR by April 14, 2023. This date could change due to several factors, including a need for further RAIs, unanticipated changes to the scope of the review, or unsolicited supplements to the application. If the forecasted date changes, the NRC staff will notify you in writing of the new date and an explanation of the reason for the change. In the case that the NRC staff requires additional information beyond that provided in the response to this RAI, the NRC staff will request that information by separate correspondence.

If SHINE has any questions, or needs additional time to respond to this request, please contact me at 301-415-2856, or by electronic mail at Michael.Balazik@nrc.gov.

OFFICE OF NUCLEAR REACTOR REGULATION REQUEST FOR ADDITIONAL INFORMATION REGARDING CONSTRUCTION PERMIT AMENDMENT FOR SHINE TECHNOLOGIES, LLC CONSTRUCTION PERMIT NO. CPMIF-001 SHINE MEDICAL ISOTOPE PRODUCTION FACILITY (EPID NO. L-2022-LLA-0163)

DOCKET NO. 50-608 Applicable Regulatory Requirements and Guidance Documents The NRC staff is reviewing the SHINE LAR, which describes special nuclear material to be received and possessed in connection with the construction of the SHINE facility, using the applicable regulations, as well as the guidance contained in NUREG-1556, Consolidated Guidance About Materials Licenses, Vol. 17, Rev. 1, Program-Specific Guidance About Special Nuclear Material of Less Than Critical Mass Licenses.

ITEM 7 - Individual(s) Responsible for Radiation Safety Program and Their Training and Experience

RAI 1

Paragraph (a)(2) of 10 CFR 70.23, Requirements for the approval of applications, states that an application for license for special nuclear material will be approved if [t]he applicant is qualified by reason of training and experience to use the material for the purpose requested in accordance with the regulations in this chapter.

The guidance in NUREG-1556, Vol. 17, Rev. 1 states that [t]he Radiation Safety Officers (RSOs) must have training and specific experience appropriate for the types and quantities of licensed material to be authorized on the license. While the LAR describes general qualifications and training expected of individuals responsible for radiation safety, the LAR does not identify specific individuals and qualifications of such individuals that will act as a radiation safety officer.

Provide the name of the proposed RSO and information demonstrating that the proposed RSO is qualified by training and experience.

This information is needed for the NRC staff to determine whether SHINE is qualified by training and experience to receive and possess the SNM in the LAR.

Best Regards, Michael Balazik Project Manager/Inspector

Non-Power Production and Utilization Facility Licensing Office of Nuclear Reactor Regulation U.S. Nuclear Regulatory Commission Michael.Balazik@nrc.govl Tel: (301) 415-2856

Hearing Identifier: NRR_DRMA Email Number: 1945 Mail Envelope Properties (PH0PR09MB8795198DDC0F6CC17D232740EAD99)

Subject:

Request for Additional Information CP LAR Sent Date: 2/9/2023 1:11:47 PM Received Date: 2/9/2023 1:11:00 PM From: Michael Balazik Created By: Michael.Balazik@nrc.gov Recipients:

"Josh Borromeo" <Joshua.Borromeo@nrc.gov>

Tracking Status: None "Holly Cruz" <Holly.Cruz@nrc.gov>

Tracking Status: None "Jeffrey Bartelme" <jeffbartelme@shinefusion.com>

Tracking Status: None Post Office: PH0PR09MB8795.namprd09.prod.outlook.com Files Size Date & Time MESSAGE 5457 2/9/2023 1:11:00 PM Options Priority: Normal Return Notification: No Reply Requested: No Sensitivity: Normal Expiration Date: