ML23048A244
| ML23048A244 | |
| Person / Time | |
|---|---|
| Site: | SHINE Medical Technologies (CPMIF-001) |
| Issue date: | 02/17/2023 |
| From: | Jim Costedio SHINE Medical Technologies |
| To: | Office of Nuclear Reactor Regulation, Document Control Desk |
| References | |
| 2023-SMT-0011 | |
| Download: ML23048A244 (1) | |
Text
3400 Innovation Ct
- Janesville, WI 53546
- 877.512.6554
- info@shinemed.com
- www.SHINEtechnologies.com February 17, 2023 2023-SMT-0011 10 CFR 50.90 U.S. Nuclear Regulatory Commission ATTN: Document Control Desk Washington, DC 20555
References:
(1) NRC letter to SHINE Medical Technologies, Inc., SHINE Medical Technologies, Inc. - Issuance of Construction Permit for Medical Isotope Facility, dated February 26, 2016 (ML16041A473)
(2) SHINE Technologies, LLC letter to the NRC, SHINE Technologies, LLC Request to Amend Construction Permit No. CPMIF-001, dated October 6, 2022 (ML22279A951)
(3) NRC electronic mail to SHINE Technologies, LLC, Request for Additional Information CP LAR, dated February 9, 2023 SHINE Technologies, LLC Request to Amend Construction Permit No. CPMIF-001 Response to Request for Additional Information Pursuant to 10 CFR 50.90, SHINE Technologies, LLC (SHINE) submitted a request to amend Construction Permit No. CPMIF-001 (Reference 1) to permit SHINE to receive and possess radioactive material necessary for the continued construction of the SHINE medical isotope production facility (Reference 2). The NRC staff determined that additional information was required to enable the staffs continued review of the SHINE amendment request (Reference 3).
provides the SHINE response to the NRC staffs request for additional information.
If you have any questions, please contact Mr. Jeff Bartelme, Director of Licensing, at 608/210-1735.
I declare under the penalty of perjury that the foregoing is true and correct.
Executed on February 17, 2023.
Very truly yours, James Costedio Vice President of Regulatory Affairs and Quality SHINE Technologies, LLC Docket No. 50-608 Enclosure cc:
Project Manager, USNRC SHINE General Counsel Supervisor, Radioactive Materials Program, Wisconsin Division of Public Health
Page 1 of 1 ENCLOSURE 1 SHINE TECHNOLOGIES, LLC SHINE TECHNOLOGIES, LLC REQUEST TO AMEND CONSTRUCTION PERMIT NO. CPMIF-001 RESPONSE TO REQUEST FOR ADDITIONAL INFORMATION The U.S. Nuclear Regulatory Commission (NRC) staff determined that additional information was required (Reference 1) to enable the staffs continued review of the SHINE Technologies, LLC (SHINE) license amendment request (LAR) (Reference 2). The following information is provided by SHINE in response to the NRC staffs request.
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.
SHINE Response The proposed Radiation Safety Officer (RSO) is Jim Franz. The information demonstrating that the proposed RSO is qualified by training and experience is provided in Attachment 1.
References
- 1. NRC electronic mail to SHINE Technologies, LLC, Request for Additional Information CP LAR, dated February 9, 2023
- 2. SHINE Technologies, LLC letter to the NRC, SHINE Technologies, LLC Request to Amend Construction Permit No. CPMIF-001, dated October 6, 2022 (ML22279A951)
2 pages follow ENCLOSURE 1 ATTACHMENT 1 SHINE TECHNOLOGIES, LLC SHINE TECHNOLOGIES, LLC REQUEST TO AMEND CONSTRUCTION PERMIT NO. CPMIF-001 RESPONSE TO REQUEST FOR ADDITIONAL INFORMATION PROPOSED RADIATION SAFETY OFFICER TRAINING AND EXPERIENCE
Page 1 of 2 Jim Franz Mr. Franz is a health physics professional who has over 19 years of experience including hands-on experience working with radioisotopes, experience applying radiation safety principles in an industrial setting, experience managing and implementing radiation protection programs, and experience in managerial and supervisory roles responsible for radiological hazards. Mr.
Franz has experience commensurate with the scope of the proposed activities, including:
Supervisor Health Physics, Washington River Protection Solutions at the U.S, Department of Energy (DOE) Hanford site (hereafter WRPS), responsible for implementing radiological controls and reviewing and developing radiological work permits and radiological survey reports to ensure compliance with the Hanford Radiological Control Manual (2009-2012).
Radiation Protection Supervisor and ALARA Supervisor, NextEra Energy at Point Beach Nuclear Plant, responsible for reviewing and developing radiological work permits, TEDE/ALARA evaluations, and radiological survey reports to ensure compliance with radiological procedures and the ALARA program (2012-2014).
Supervisor Health Physics, WRPS, responsible for providing radiological oversight for high radiological risk maintenance and remediation activities and ensuring compliance with the Hanford Radiological Control Manual (2014-2016).
Health Physicist, WRPS, responsible for developing and writing high radiological risk radiological work permits, ALARA planning documents, developing and maintaining the Project ALARA Plan, and ensuring implementation of radiological safeguards into technical work documents and procedures (2016-2021).
Manager of Radiological Engineering/Project Radiological Controls, WRPS, responsible for implementation and administration of the Hanford Radiological Control Manual, technical basis documents, procedures, and all other radiological documentation (2021-2022).
Senior Radiation Protection Specialist, SHINE Technologies, LLC (Agreement State-issued radioactive materials licenses), responsible for implementation and administration of the SHINE facility-specific radiation protection programs, technical basis documents, and procedures and providing direction, guidance, and oversight to radiation protection staff and radiological workers (2022-present).
Experience managing the security and control of licensed materials, monitoring inventory of licensed materials, and maintaining records.
Experience planning and conducting audits/evaluations (both internal and external) of radioactive materials license compliance.
Experience shipping and transporting radioactive material in accordance with U.S.
Nuclear Regulatory Commission and U.S. Department of Transportation regulations.
Direct hands-on experience working with radioactive materials including:
o Sr-90 (liquid and solid unsealed source) o Y-90 (liquid and solid unsealed source) o Cs-137 (liquid and solid unsealed source) o Pu-239 (liquid and solid unsealed source) o Am-241 (liquid and solid unsealed source) o Co-60 (solid unsealed source) o Tritium (liquid unsealed source) o Lu-177 (solid unsealed source) o Am/Be (sealed source) o Various other unsealed isotopes
Page 2 of 2 Mr. Franz has training commensurate with the scope of the proposed activities, including:
Bachelors Degree in Nuclear Technology from Excelsior College.
Masters Degree in Radiation Health Physics from Oregon State University.
Department of Energy Radiological Control Technician, provided by DOE Hanford.
On-site Radioactive Shipment, provided by DOE Hanford.
Dose Assessment Manager, Emergency Response, provided by DOE Hanford.
Radiation Protection Emergency Response, provided by NextEra Energy.
General Employee Training - Radiation Safety, provided by SHINE Technologies, LLC.
Radiation Worker Training, provided by SHINE Technologies, LLC.
Mr. Franz has direct working knowledge or specific training in radiation safety topics, including the following subjects:
Radiation Protection Principles Characteristics of Ionizing Radiation Units of Radiation Dose and Quantities Radiation Detection Instrumentation Biological Hazards of Radiation Exposure DOE, NRC, and Agreement State Regulatory Requirements and Standards Handling of Radioactive Materials Spill Response and Decontamination