ML21124A182
| ML21124A182 | |
| Person / Time | |
|---|---|
| Site: | 07007031 |
| Issue date: | 05/04/2021 |
| From: | Frank T NRC/RGN-III/DNMS/MLB |
| To: | Document Control Desk |
| References | |
| License-624914-143800 | |
| Download: ML21124A182 (2) | |
Text
From:
Tran, Frank To:
Bill Peters
Subject:
Request for additional information for NRC License No. 21-35144-04 Date:
Tuesday, May 04, 2021 11:38:00 AM
Dear Dr. Peters:
This refers to the license amendment request (the application) dated March 15, 2021 for Niowave Inc., NRC License No. 21-35144-04. We have reviewed the application and will need additional information.
- 1. Tittle 10 of the Code of Federal Regulations (10 CFR) 30.32(i) requires the applicant/licensee who will possess a quantity of radioactive material in excess of the quantities in § 30.72, "Schedule CQuantities of Radioactive Materials Requiring Consideration of the Need for an Emergency Plan for Responding to a Release," to provide an emergency plan for responding to a release of radioactive material in accordance with 10 CFR 30.32(i)(3) or an evaluation showing that the maximum dose to a person offsite due to a release of radioactive materials in a worst case accident event would not exceed 1 rem effective dose equivalent or 5 rems to the thyroid in accordance with 10 CFR 30.32(i)(2). Your requested radioactive material appears to meet the requirement above; however, we have not received information as required by 10 CFR 30.32(i). For your references, NRC regulations and guidance related to emergency plan requirements are in 10 CFR 30.32(i) and Regulatory Guide 3.67, Standard Format and Content for Emergency Plans for Fuel Cycle and Materials Facilities, Revision 1, issued April 2011, respectively.
- 2. NRC regulations in 10 CFR 30.33(a)(1) and 70.23(a)(1) state, in part, that an application will be approved if the application is for a purpose authorized by the Atomic Energy Act of 1954, as amended (the Act). Your application requests the possession of radium-226 and low enrichment uranium (LEU) for storage only. Based on NRC regulations, storage of radioactive material only is not a principle activity which is essential to achieving the purposes of use in the Act. Please note that, the NRC may occasionally authorize radioactive material for storage only, if and only if, the radioactive material has been authorized on the license for a principle activity; however, the licensee has decided to cease that licensed activity (due to a loss of user(s), end of contract, etc.) and requests to place the licensed material in safe storage only with intent to dispose of or in standby status. Therefore, we cant authorize your request to acquire and possess of radium-226 and low enrichment uranium (LEU) for storage only.
- 3. It appears that Items AR and AS in Table 6.1 of the application are the same. Please provide a clarification.
- 4. This refers to Item 1 in the application. Please note that, your license currently authorized to distribute licensed material to person authorized to receive the licensed material in accordance with the terms and conditions of a specific license issued by the NRC or an Agreement State, as reflected in Item 9 of the license. Program code 3214 associated with Fee category 3.B has been added to your license since the
initial issuance of the license. Your license is not a radiopharmacy license (a radiopharmacy license is a license issued in accordance with NUREG-1556, Volume 13, Revision 2); therefore, your licensed material cant be distributed as drugs to the end users (by prescription of an Authorized User as defined in 10 CFR part 35).
To continue review of your application, we request that you submit your response with date and authorized signature to this correspondence by June 3, 2021. In your response, please refer the license number, docket number and Mail Control No. 624914. We will assume that you do not wish to further pursue this licensing action if we do not receive a reply within the specified timeframe noted above.
If you have questions, require additional time to respond, or require clarification on any of the information stated above, please contact me at 630-829-9623 or reply to this email.
In accordance with Title 10 of the Code of Federal Regulations (10 CFR) 2.390 of the NRCs Rules of Practice, a copy of this correspondence will be made available electronically for public inspection in the NRC Public Document Room or from the NRC's Agencywide Documents Access and Management System (ADAMS), accessible from the NRC Web site at https://www.nrc.gov/reading-rm/adams.html.
Best regards,
Frank Tran Health Physicist/License Reviewer NRC Region III/Division of Nuclear Materials Safety Phone: 630-829-9623 Fax: 630-515-1078 Email: Frank.Tran@nrc.gov