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UNITED STATES NUCLEAR REGULATORY COMMISSION REGION III 2443 WARRENVILLE RD. SUITE 210 LISLE, IL 60532-4352 | |||
February 2, 2024 | |||
William Peters, Ph.D. | |||
Radiation Safety Officer Niowave, Inc. | |||
1012 N. Walnut St. | |||
Lansing, MI 48906 | |||
==SUBJECT:== | |||
AMENDMENT NO. 05 TO RADIOACTIVE MATERIALS LICENSE FOR NIOWAVE, INC., NRC LICENSE NO. 21-35144-04 | |||
==Dear Dr. Peters:== | |||
Enclosed is Amendment No. 05 to your U.S. Nuclear Regulatory Commission (NRC) Materials License No. 21-35144-04 in accordance with your request dated November 17, 2023. | |||
Specifically, you requested an increase in the quantity of radium-226 and strontium-90 and their progeny, adding new users, and changes for the ventilation system and decommissioning financial assurance. The updated decommissioning financial assurance will be reviewed under Mail Control No. 624947. Your request is available electronically from the Agencywide Documents Access and Management System (ADA MS) at Accession No. ML23324A446 (non-public). | |||
Please note that, we did not increase the quantity for radium-226 and strontium-90 and their progeny. Based on 10 CFR 30.33(a)(1) and the licensing guidance in NUREG-1556 Series, the radioactive material and use should be commensurate with your needs for the principal licensed activities. 10 CFR 30.38 requires the applicant/licensee to provide the grounds for the amendment. We determined that your grounds for the request was inadequate. Specifically, you did not provide sufficient evidence to support your request. For the information, the current possession limit for those radionuclides authorized in your license are already significantly higher comparing to other large radionuclide drug manufacturers or distributors; the NRC does not consider acquiring and storing radioactive mate rial a principal activity; and the NRC policy is to limit the radioactive material at a licensed faci lity to a minimum to protect health and minimize danger to life or property. | |||
Additionally, we did not add the proposed users for all listed licensed materials per your request. | |||
We are aware that your company has never acquired licensed material listed in Item 6.A. and its associated radionuclides listed in Items 6.B. th rough 6.AI. Based on discussions with the NRC, your company stated that it will not use those materials and will submit a license amendment | |||
The enclosed document contains sensitive security-related information. | |||
When separated from this cover letter this letter is uncontrolled. | |||
Official Use Only - Security-Related Information Official Use Only - Security-Related Information | |||
W. Peters | |||
request to delete them from the license. Therefore, we did not add new users for the licensed materials above. | |||
Please review the enclosed document carefully and be sure that you understand all conditions. | |||
If there are any errors or questions, please notify the U.S. NRC Region III office at (630) 829-9887 so that we may provide appropriate corrections and answers. | |||
An environmental assessment for this action is not required because this action is categorically excluded under Title 10 of the Code of Federal Regulations (CFR) Section 51.22(c). | |||
You will be periodically inspected by NRC. Failur e to conduct your program in accordance with NRC regulations, license conditions, and representa tions made in your license application and supplemental correspondence with NRC will result in enforcement action against you. This could include issuance of a notice of violatio n; or imposition of a civil penalty; or an Order suspending, modifying, or revoking your licens e as specified in the NRC Enforcement Policy. | |||
Since serious consequences to employees and the public can result from failure to comply with NRC requirements, prompt and vigorous enforcement action will be taken when dealing with licensees who do not achieve the necessary meticulous attention to detail and the high standard of compliance that NRC expects of its licensees. | |||
The NRCs Safety Culture Policy Statement became effective in June 2011. While a policy statement and not a regulation, it sets forth the agencys expectations for individuals and organizations to establish and maintain a positive safety culture. You can access the policy statement and supporting material that may benefit your organization on NRCs safety culture Web site at https://www.nrc.gov/about-nrc/regulator y/enforcement/safety-culture.html. We strongly encourage you to review this material and adapt it to your particular needs in order to develop and maintain a positive safety culture as you engage in NRC-regulated activities. | |||
NRCs Regulatory Issue Summary (RIS) RIS 2005- 31 provides criteria to identify security related sensitive information and guidance for handling and marking of such documents. This ensures that potentially sensitive information is not made publicly available through NRCs ADAMS, the NRCs electronic document system. Pursuant to NRCs RIS 2005-31 and in accordance with 10 CFR 2.390 of the NRCs Rules of Practice and Procedure, the enclosed license document is exempt from public disc losure because its disclosure to unauthorized individuals could present a security vulnerability. The RIS may be located on the NRCs Generic Communications Web page under Regulatory Issue Summaries at https://www.nrc.gov/reading-rm/doc-collections/gen-comm/ , and the link for frequently asked questions regarding protection of security-related sensitive information may be located at https://www.nrc.gov/reading-rm/sensitive-info/faq.html . | |||
Official Use Only - Security-Related Information Official Use Only - Security-Related Information | |||
W. Peters | |||
A copy of this letter will be available electron ically for public inspection in the NRC Public Document Room or from the NRCs ADAMS, accessible from the NRC Web site at https://www.nrc.gov/reading-rm/adams.html . | |||
Sincerely, Digitally signed by FRANK TRAN FRANK TRAN Date: 2024.02.02 08:35:41 -06'00' Frank P. D. Tran Senior Health Physicist Materials Licensing Branch | |||
Docket No.: 070-07031 License No.: 21-35144-04 Docket No.: 070-07031 | |||
==Enclosure:== | |||
Amendment No. 05 to NRC License No. 21-35144-04 | |||
Official Use Only - Security-Related Information}} | |||
Revision as of 05:21, 3 September 2024
| ML24033A166 | |
| Person / Time | |
|---|---|
| Site: | 07007031 |
| Issue date: | 02/02/2024 |
| From: | Frank Tran NRC/RGN-III |
| To: | Peters W Niowave |
| References | |
| 637976 | |
| Download: ML24033A166 (3) | |
Text
Official Use Only - Security-Related Information
UNITED STATES NUCLEAR REGULATORY COMMISSION REGION III 2443 WARRENVILLE RD. SUITE 210 LISLE, IL 60532-4352
February 2, 2024
William Peters, Ph.D.
Radiation Safety Officer Niowave, Inc.
1012 N. Walnut St.
Lansing, MI 48906
SUBJECT:
AMENDMENT NO. 05 TO RADIOACTIVE MATERIALS LICENSE FOR NIOWAVE, INC., NRC LICENSE NO. 21-35144-04
Dear Dr. Peters:
Enclosed is Amendment No. 05 to your U.S. Nuclear Regulatory Commission (NRC) Materials License No. 21-35144-04 in accordance with your request dated November 17, 2023.
Specifically, you requested an increase in the quantity of radium-226 and strontium-90 and their progeny, adding new users, and changes for the ventilation system and decommissioning financial assurance. The updated decommissioning financial assurance will be reviewed under Mail Control No. 624947. Your request is available electronically from the Agencywide Documents Access and Management System (ADA MS) at Accession No. ML23324A446 (non-public).
Please note that, we did not increase the quantity for radium-226 and strontium-90 and their progeny. Based on 10 CFR 30.33(a)(1) and the licensing guidance in NUREG-1556 Series, the radioactive material and use should be commensurate with your needs for the principal licensed activities. 10 CFR 30.38 requires the applicant/licensee to provide the grounds for the amendment. We determined that your grounds for the request was inadequate. Specifically, you did not provide sufficient evidence to support your request. For the information, the current possession limit for those radionuclides authorized in your license are already significantly higher comparing to other large radionuclide drug manufacturers or distributors; the NRC does not consider acquiring and storing radioactive mate rial a principal activity; and the NRC policy is to limit the radioactive material at a licensed faci lity to a minimum to protect health and minimize danger to life or property.
Additionally, we did not add the proposed users for all listed licensed materials per your request.
We are aware that your company has never acquired licensed material listed in Item 6.A. and its associated radionuclides listed in Items 6.B. th rough 6.AI. Based on discussions with the NRC, your company stated that it will not use those materials and will submit a license amendment
The enclosed document contains sensitive security-related information.
When separated from this cover letter this letter is uncontrolled.
Official Use Only - Security-Related Information Official Use Only - Security-Related Information
W. Peters
request to delete them from the license. Therefore, we did not add new users for the licensed materials above.
Please review the enclosed document carefully and be sure that you understand all conditions.
If there are any errors or questions, please notify the U.S. NRC Region III office at (630) 829-9887 so that we may provide appropriate corrections and answers.
An environmental assessment for this action is not required because this action is categorically excluded under Title 10 of the Code of Federal Regulations (CFR) Section 51.22(c).
You will be periodically inspected by NRC. Failur e to conduct your program in accordance with NRC regulations, license conditions, and representa tions made in your license application and supplemental correspondence with NRC will result in enforcement action against you. This could include issuance of a notice of violatio n; or imposition of a civil penalty; or an Order suspending, modifying, or revoking your licens e as specified in the NRC Enforcement Policy.
Since serious consequences to employees and the public can result from failure to comply with NRC requirements, prompt and vigorous enforcement action will be taken when dealing with licensees who do not achieve the necessary meticulous attention to detail and the high standard of compliance that NRC expects of its licensees.
The NRCs Safety Culture Policy Statement became effective in June 2011. While a policy statement and not a regulation, it sets forth the agencys expectations for individuals and organizations to establish and maintain a positive safety culture. You can access the policy statement and supporting material that may benefit your organization on NRCs safety culture Web site at https://www.nrc.gov/about-nrc/regulator y/enforcement/safety-culture.html. We strongly encourage you to review this material and adapt it to your particular needs in order to develop and maintain a positive safety culture as you engage in NRC-regulated activities.
NRCs Regulatory Issue Summary (RIS) RIS 2005- 31 provides criteria to identify security related sensitive information and guidance for handling and marking of such documents. This ensures that potentially sensitive information is not made publicly available through NRCs ADAMS, the NRCs electronic document system. Pursuant to NRCs RIS 2005-31 and in accordance with 10 CFR 2.390 of the NRCs Rules of Practice and Procedure, the enclosed license document is exempt from public disc losure because its disclosure to unauthorized individuals could present a security vulnerability. The RIS may be located on the NRCs Generic Communications Web page under Regulatory Issue Summaries at https://www.nrc.gov/reading-rm/doc-collections/gen-comm/ , and the link for frequently asked questions regarding protection of security-related sensitive information may be located at https://www.nrc.gov/reading-rm/sensitive-info/faq.html .
Official Use Only - Security-Related Information Official Use Only - Security-Related Information
W. Peters
A copy of this letter will be available electron ically for public inspection in the NRC Public Document Room or from the NRCs ADAMS, accessible from the NRC Web site at https://www.nrc.gov/reading-rm/adams.html .
Sincerely, Digitally signed by FRANK TRAN FRANK TRAN Date: 2024.02.02 08:35:41 -06'00' Frank P. D. Tran Senior Health Physicist Materials Licensing Branch
Docket No.: 070-07031 License No.: 21-35144-04 Docket No.: 070-07031
Enclosure:
Amendment No. 05 to NRC License No. 21-35144-04
Official Use Only - Security-Related Information