ML21350A190
| ML21350A190 | |
| Person / Time | |
|---|---|
| Site: | SHINE Medical Technologies |
| Issue date: | 12/16/2021 |
| From: | Jim Costedio SHINE Medical Technologies |
| To: | Document Control Desk, Office of Nuclear Reactor Regulation |
| References | |
| 2021-SMT-0184 | |
| Download: ML21350A190 (8) | |
Text
December 16, 2021 2021-SMT-0184 10 CFR 55.11 U.S. Nuclear Regulatory Commission ATTN: Document Control Desk Washington, DC 20555
References:
(1) U.S. Nuclear Regulatory Commission letter to SHINE Technologies, LLC, dated December 2, 2021, SHINE Medical Technologies, LLC - Issuance of Amendment No. 2 to Construction Permit No. CPMIF-001 for the SHINE Medical Isotope Production Facility Related to the Receipt and Possession of Certain Radioactive Materials (EPID No. L-2021-LLA-0104)
Request for Exemption from Licensed Operator Minimum Hours to Maintain Active Status and Minimum Hours to Restore Active Status SHINE Technologies, LLC (SHINE) is the holder of a Construction Permit (Reference 1), issued pursuant to 10 CFR Part 50, for the construction of a medical isotope production facility in Janesville, WI.
Pursuant to 10 CFR 55.11, SHINE hereby requests an exemption from the requirements of 10 CFR 55.53(e) and 10 CFR 55.53(f)(2) to modify the minimum number of hours required to actively perform the functions of an operator or senior operator, in order to maintain active status and restore active status. The requested exemption will allow SHINE to apply the same minimum hours required by 10 CFR 55.53(e) and 10 CFR 55.53(f)(2) for licensed operators of test and research reactors. provides the SHINE exemption request regarding the minimum hour requirements of 10 CFR 55.53(e) and 10 CFR 55.53(f)(2). The evaluation provided in Enclosure 1 identifies the specific requirements in the regulation for which an exemption is requested and concludes that the requested exemption is authorized by law, will not endanger life or property, and is in the public interest. SHINE requests the NRC incorporate approval of this exemption request into the safety evaluation report related to the SHINE operating license application.
If you have any questions, please contact Mr. Jeff Bartelme, Director of Licensing, at 608/210-1735.
3400 Innovation Ct.
- Janesville, WI 53546
- 877.512.6554
- info@shinemed.com
- www.SHINEtechnologies.com
Document Control Desk Page 2 I declare under the penalty of perjury that the foregoing is true and correct. Executed on December 16, 2021.
Very truly yours, James Costedio Vice President of Regulatory Affairs and Quality SHINE Technologies, LLC Docket No. 50-608 Enclosure cc: Project Manager, USNRC Supervisor, Radioactive Materials Program, Wisconsin Division of Public Health SHINE General Counsel
ENCLOSURE 1 SHINE TECHNOLOGIES, LLC REQUEST FOR EXEMPTION FROM LICENSED OPERATOR MINIMUM HOURS TO MAINTAIN ACTIVE STATUS AND MINIMUM HOURS TO RESTORE ACTIVE STATUS
Background
SHINE Technologies, LLC (SHINE) is the holder of a Construction Permit (Reference 1), issued pursuant to 10 CFR Part 50, for the construction of eight utilization facilities and one production facility designed for the production of medical radioisotopes.
10 CFR 55.53(e) and 10 CFR 55.53(f) provide the minimum hours required for an operator or senior operator to maintain active status and to restore active status, respectively.
10 CFR 55.53(e) states:
If a licensee has not been actively performing the functions of an operator or senior operator, the licensee may not resume activities authorized by a license issued under this part except as permitted by paragraph (f) of this section. To maintain active status, the licensee shall actively perform the functions of an operator or senior operator on a minimum of seven 8-hour or five 12-hour shifts per calendar quarter. For test and research reactors, the licensee shall actively perform the functions of an operator or senior operator for a minimum of four hours per calendar quarter.
10 CFR 55.53(f) states:
If paragraph (e) of this section is not met, before resumption of functions authorized by a license issued under this part, an authorized representative of the facility licensee shall certify the following:
(1) That the qualifications and status of the licensee are current and valid; and (2) That the licensee has completed a minimum of 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> of shift functions under the direction of an operator or senior operator as appropriate and in the position to which the individual will be assigned. The 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> must have included a complete tour of the plant and all required shift turnover procedures. For senior operators limited to fuel handling under paragraph (c) of this section, one shift must have been completed. For test and research reactors, a minimum of six hours must have been completed.
10 CFR 55.11 authorizes the NRC to grant exemptions from the requirements of its regulations as it determines are authorized by law and will not endanger life or property and are otherwise in the public interest.
The minimum number of hours required to maintain active status (i.e., 10 CFR 55.53(e)) and restore active status (i.e., 10 CFR 55.53(f)(2)), for operators and senior operators, was Page 1 of 6
promogulated via 52 FR 9453 (Reference 2). As described in Reference 2, the NRC applied special consideration to the smaller size and scope of test and research reactors in establishing the minimum hour requirements to maintain active status and restore active status for licensed operators of test and research reactors when compared to the minimum hour requirements for licensed operators of power reactors.
The NRC has previously acknowledged the similarity of the SHINE facility and test and research reactor facilities for regulatory determinations, and the same acknowledgement should be applied in addressing the requirements of 10 CFR 55.53(e) and 10 CFR 55.53(f)(2). Section 1.5 of NUREG-2189, Safety Evaluation Report Related to SHINE Medical Technologies, Inc.
Construction Permit Application for a Medical Radioisotope Production Facility (Reference 3),
discusses a number of safety considerations for the SHINE facility which are similar to test and research reactors, such as:
Provisions for removal of fission heat during operation.
Consideration of decay heat generation after shutdown.
Reactivity feedback mechanisms.
Control of fission gas release during operation and subsequent gas management engineering safety features.
Control of radiolytic decomposition of water and generated oxygen and hydrogen gases.
Control of fission product inventory buildup.
Accident scenarios, such as loss of coolant, reactivity additions, and release of fission products.
The SHINE facility is of smaller size and scope than power reactor facilities. The thermal power level of the SHINE irradiation units (IUs) (i.e., 125 kilowatts [kW]) is comparable to that of research reactors. The smaller comparable size of the SHINE facility is also demonstrated by the SHINE source term, which is expected to be several orders of magnitude lower than that of a power reactor. The smaller scope of SHINE facility operations is demonstrated by operator responsibilities; there are no postulated accident sequences that credit operator action to mitigate the consequences of the event after initiation of the event.
As described above, and consistent with the NRCs special considerations described in 52 FR 9453, the smaller size and scope of the SHINE facility, when compared to a power reactor, warrants application of the same minimum hour requirements of 10 CFR 55.53(e) and 10 CFR 55.53(f)(2) applicable to licensed operators of test and research reactors to the operators and senior operators at the SHINE facility.
Additionally, application of the same minimum hour requirements for licensed operators of test and research reactors to the operators and senior operators at the SHINE facility is consistent with the following NRC application guidance applicable to the SHINE facility:
Section 12.10 of NUREG-1537, Part 1, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors, Format and Content, (Reference 4) states, in part:
To maintain active status, 10 CFR 55.53(e) requires that each licensed reactor operator or senior reactor operator actively perform the functions of a reactor operator or senior reactor operator for a minimum of 4 hours4.62963e-5 days <br />0.00111 hours <br />6.613757e-6 weeks <br />1.522e-6 months <br /> each calendar quarter. For senior reactor operators, direct supervision of these operations may Page 2 of 6
be considered equivalent to actual performance. If this requirement is not met, the license becomes inactive; before reactivation of the license, the licensee should verify that the qualifications and status of the operator are current, and the operator should perform 6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br /> of licensed activities in the position that is being recertified under the direction of a licensed operator or senior reactor operator as appropriate.
Section 12.10 of NUREG-1537, Part 2, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors Standard Review Plan and Acceptance Criteria, (Reference 5), states, in part:
The applicant should discuss the requirements for operators to maintain active status. At a minimum, operators should actively perform the functions of a reactor operator or senior reactor operator for 4 hours4.62963e-5 days <br />0.00111 hours <br />6.613757e-6 weeks <br />1.522e-6 months <br /> per calendar quarter.
Section 12.10 of the Final Interim Staff Guidance (ISG) Augmenting NUREG-1537, Part 1, Guidelines for Preparing and Reviewing Applications for Licensing Non-Power Reactors: Format and Content, for Licensing Radioisotope Production Facilities and Aqueous Homogeneous Reactors (Reference 6), states, in part:
NUREG-1537 is applicable to a non-power reactor facility without requiring changes in this ISG.
and, ANSI/ANS 15.4-2007 may contain additional guidance on training and qualification of personnel applicable to production facilities.
Section 12.10 of the Final Interim Staff Guidance (ISG) Augmenting NUREG-1537, Part 2, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors: Standard Review Plan and Acceptance Criteria, for Licensing Radioisotope Production Facilities and Aqueous Homogeneous Reactors (Reference 7) states, in part:
The current wording of this section in NUREG-1537 is applicable to a non-power reactor and radioisotope production facility without requiring changes in this ISG.
and, ANSI/ANS-15.4-2007 may contain additional guidance on training and qualification of personnel applicable to production facilities.
Page 3 of 6
Section 6.5 of American National Standards Institute/American Nuclear Society (ANSI/ANS) 15.4-2007, Selection and Training of Personnel for Research Reactors (Reference 8) states:
Licensed personnel who have not actively performed the functions of an operator or senior operator for a minimum of four hours per calendar quarter shall perform a minimum of six hours of licensed functions under the direction of a qualified individual holding the same or higher-level license prior to being reinstated.
The SHINE Licensed Operator Continuing Training Program, OPS-01-03 (Reference 9) currently specifies a minimum number of hours required to maintain active status and restore active status which are consistent with the 10 CFR 55.53(e) and 10 CFR 55.53(f)(2) requirements for test and research reactors and consistent with the exemption requested herein.
Specific Exemption Request In accordance with 10 CFR 55.11, SHINE requests NRC approval of an exemption from the minimum hour requirements of 10 CFR 55.53(e) and 10 CFR 55.53(f)(2) applicable to licensed operators of power reactors and the SHINE facility. SHINE proposes to apply the same minimum hour requirements of 10 CFR 55.53(e) and 10 CFR 55.53(f)(2) applicable to licensed operators of test and research reactors to the operators and senior operators at the SHINE facility, as follows:
To maintain active status, the licensee shall actively perform the functions of an operator or senior operator for a minimum of four hours per calendar quarter.
To restore active status, the licensee shall complete a minimum of 6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br /> of shift functions under the direction of an operator or senior operator as appropriate and in the position to which the individual will be assigned.
The Requested Exemption is Authorized by Law The NRC has the authority under the Atomic Energy Act to grant exemptions from its regulations if doing so would not violate the requirements of law. No law exists that precludes the activities covered by this exemption request. The provisions of 10 CFR 55.53(e) and 10 CFR 55.53(f)(2) were adopted at the discretion of the Commission consistent with its statutory authority. No statute required the NRC to adopt the specific provisions from which SHINE seeks an exemption. The NRC may determine that alternative means are adequate to provide reasonable assurance of safety.
The Requested Exemption Will Not Endanger Life or Property In adopting the minimum hour requirements of 10 CFR 55.53(e) and 10 CFR 55.53(f)(2) for test and research reactors (Reference 2), the NRC acknowledged that the minimum hour requirements of power reactors were not appropriate for facilities of smaller size and scope.
Similar to test and research reactors, applying the 10 CFR 55.53(e) and 10 CFR 55.53(f)(2) requirements for licensed operators of power reactors is not appropriate for licensed operators of the SHINE facility. The intent of the subject regulations is to ensure that operators and senior operators maintain active status by actively performing the functions of an operator or senior Page 4 of 6
operator. Implementation of the same minimum hours requirements of 10 CFR 55.53(e) and 10 CFR 55.53(f)(2) for test and research reactors by SHINE will meet the intent of the subject regulations, and will not endanger life, property, or the common defense and security.
The Requested Exemption is in the Public Interest NRC approval of the requested exemption is in the public interest because it will allow SHINE to implement operator and senior operator active status requirements in a cost-efficient manner.
Efficient operation of the SHINE facility supports the establishment of a domestically produced commercial supply of molybdenum-99, which is in the interest of public health. NRC denial of the requested exemption is not in the public interest because it will result in increased cost, inefficient operation, and the associated economic losses, all without any safety benefit.
Therefore, granting the requested exemption is in the public interest.
Conclusion Applying the same minimum hours requirements applicable to licensed operators of test and research reactors to operators and senior operators of the SHINE facility is consistent with the intent of the final rule promulgated via 52 FR 9453 (Reference 2). The requested exemption is authorized by law, will not endanger life or property, and is in the public interest. Since the provisions of 10 CFR 55.11 are satisfied, the requested exemption should be granted. SHINE requests the NRC incorporate approval of this exemption request into the safety evaluation report related to the SHINE operating license application.
References
- 1. U.S. Nuclear Regulatory Commission letter to SHINE Technologies, LLC, dated December 2, 2021, SHINE Medical Technologies, LLC - Issuance of Amendment No. 2 to Construction Permit No. CPMIF-001 for the SHINE Medical Isotope Production Facility Related to the Receipt and Possession of Certain Radioactive Materials (EPID No. L-2021-LLA-0104) (ML21320A224)
- 2. U.S. Nuclear Regulatory Commission, Operators Licenses and Conforming Amendments Final Rule, Federal Register, Vol. 52, No. 57, March 25, 1987, pp. 9453-9469
- 3. U.S. Nuclear Regulatory Commission, NUREG-2189, Safety Evaluation Report Related to SHINE Medical Technologies, Inc. Construction Permit Application for a Medical Radioisotope Production Facility Docket Number 50-608, dated August 2016
- 4. U.S. Nuclear Regulatory Commission, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors, Format and Content, NUREG-1537, Part 1, February 1996
- 5. U.S. Nuclear Regulatory Commission, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors, Standard Review Plan and Acceptance Criteria, NUREG-1537, Part 2, February 1996
- 6. U.S. Nuclear Regulatory Commission, Interim Staff Guidance Augmenting NUREG-1537, Part 1, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Page 5 of 6
Reactors: Format and Content, for Licensing Radioisotope Production Facilities and Aqueous Homogeneous Reactors, October 2012
- 7. U.S. Nuclear Regulatory Commission, Interim Staff Guidance Augmenting NUREG-1537, Part 2, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors: Standard Review Plan and Acceptance Criteria, for Licensing Radioisotope Production Facilities and Aqueous Homogeneous Reactors, October 2012
- 8. American National Standards Institute/American Nuclear Society, Selection and Training of Personnel for Research Reactors, ANSI/ANS 15.4-2007, 2007