ML22193A278
| ML22193A278 | |
| Person / Time | |
|---|---|
| Site: | SHINE Medical Technologies |
| Issue date: | 07/12/2022 |
| From: | Gavello M NRC/NRR/DANU/UNPL |
| To: | |
| Gavello M | |
| Shared Package | |
| ML22073A179 | List: |
| References | |
| Download: ML22193A278 (7) | |
Text
3.4.1 Design Criteria The NRC staff evaluated the sufficiency of the design criteria and design bases, as described in SHINE FSAR Section 3.1, using the guidance and acceptance criteria from Section 3.1, Design Criteria, of NUREG-1537, Parts 1 and 2.
The design criteria for the SHINE facility establish the engineering design criteria that provide reasonable assurance that the facility can be operated without undue risk to the health and safety of the public. The design bases identify the specific functions to be performed by an SSC, and the specific values or ranges of values chosen for controlling parameters as reference bounds for design. The design criteria for the SHINE facility were established in the preliminary safety analysis (PSAR) as required by 10 CFR 50.34(a)(3)(i). This subparagraph also required SHINE to provide the design bases and the relation of the design bases to the principal design criteria for the facility.
Subparagraph 50.34(b)(2) of 10 CFR, requires a description and analysis of the structures, systems, and components of the facility, with emphasis upon performance requirements, the bases, with technical justification therefor, upon which such requirements have been established, and the evaluations required to show that safety functions will be accomplished.
The description must be sufficient to permit understanding of the system designs and their relationship to safety evaluations. Subparagraph 50.34(b)(4) of 10 CFR, requires a final analysis and evaluation of the design and performance of SSCs with the objective stated in 10 CFR 50.34(a)(4) and considering any pertinent information developed since the submittal of the PSAR.
The NRC staffs analysis of the SHINE facility SSCs evaluated whether the design basis and design criteria for the SHINE systems and subsystems are met and if the FSAR describes how the principal design criteria for the facility are achieved.
SHINE includes the discussion on design criteria and design bases for SSCs in the applicable FSAR section describing those SSCs. For each SSC, FSAR Tables 3.1-1 Safety-Related Structures, Systems, and Components, and Table 3.1-2, Nonsafety-Related Structures, Systems, and Components identify the applicable FSAR section or sections that describe each SSC. Similarly, the NRC staff evaluation, as applicable to the specific design criteria and design basis, is included within the chapter of the SE where the staff evaluated those SSCs.
The discussion in this section of the NRC staffs evaluation discusses the acceptability of SHINEs chosen design criteria identified in Table 3.1-3, SHINE Design Criteria, and of the Nuclear Safety Classification, as described in SHINE FSAR Section 3.1, established by SHINE to ensure that the risk of events is highly unlikely or the consequences mitigated to acceptable levels.
SHINE Facility Design Criteria The SHINE design criteria emulate Appendix A to Part 50General Design Criteria for Nuclear Power Plants with the noted exception that they are adapted for a medical isotope production facility. Specifically, since SHINE uses low enriched uranium (LEU) in the form of a uranyl sulfate target solution that is irradiated in a subcritical assembly by neutrons produced by a fusion neutron source, many of the general design criteria (GDC) do not apply. Additionally, as discussed in Chapter 7, Instrumentation and Control Systems, of this SE, the application specific action items (ASAIs) specified in the NRC topical report on the highly integrated
protection system (HIPS) platform are intended for power reactor applications and therefore some of the ASAIs do not apply to the SHINE application of the HIPS platform for the target solution vessel reactivity protection system (TRPS) and engineered safety features actuation system (ESFAS).
SHINE lists 39 design criteria for the main production facility. The majority of the design criteria have specific application to individual SSCs within the IUs and RPF as listed in Table 3.1-1 and 3.1-2. SHINE further states that design criteria 1 through 8 from Table 3.1-3 are not specifically listed as applicable design criteria in Table 3.1-1 and 3.1-2 but are generally applicable to all SSCs.
Consistent with the guidance in NUREG-1537, the SHINE FSAR includes the following eight general design criterion:
Design Criterion 1- Quality standards and records.
SSCs) are designed, fabricated, erected, and tested to quality standards commensurate with the safety functions to be performed. Where generally recognized codes and standards are used, they are identified and evaluated to determine their applicability, adequacy, and sufficiency and are supplemented or modified as necessary to ensure a quality product in keeping with the required safety function.
A quality assurance program is established and implemented in order to provide adequate assurance that these SSCs satisfactorily perform their safety functions.
Appropriate records of the design, fabrication, erection and testing of safety-related SSCs are maintained by or under the control of SHINE throughout the life of the facility.
The adequacy of the SHINE quality assurance program is reviewed and found acceptable in Section 12.9 of this SE. Additionally, inspections of records of some systems, (e.g., the TRPS and ESFAS) will evaluate adequate application of the program to the fabrication, erection and testing of the equipment (see Section 7.4.4.2.1 and 7.4.5.2.1 of this SE).
Design Criterion 2 - Natural phenomena hazards The facility structure supports and protects safety-related SSCs and is designed to withstand the effects of natural phenomena such as earthquakes, tornadoes, hurricanes, floods, tsunami, and seiches as necessary to prevent the loss of capability of safety-related SSCs to perform their safety functions.
Safety-related SSCs are designed to withstand the effects of earthquakes without loss of capability to perform their safety functions.
The NRC staff found SHINEs design for natural phenomena hazards acceptable in Section 2.4.3, 2.4.4, 2.4.5, 3.4.2, 3.4.3, and 3.4.4 of this SE. Also, the evaluation of the safety systems against the effects of natural phenomena is documented in Section 7.4.4.2.1 and 7.4.5.2.1.
FSAR Section 8a.4.1 and 8b.4.2, evaluate electrical system protections from lightning.
Criterion 3 - Fire protection
Safety-related SSCs are designed and located to minimize, consistent with other safety requirements, the probability and effect of fires and explosions.
Noncombustible and heat resistant materials are used wherever practical throughout the facility, particularly in locations such as confinement boundaries and the control room.
Fire detection and suppression systems of appropriate capacity and capability are provided and designed to minimize the adverse effects of fires on safety-related SSCs. Firefighting systems are designed to ensure that their rupture or inadvertent operation does not significantly impair the safety capability of these SSCs.
The NRC staff found SHINEs design for Fire protection acceptable in Section 2.4.2.3, 9a.4.3 and 9b.4.3 of this SE. The NRC staffs evaluation of fire protection for the safety systems is provided in Section 7.4.4.2.1 and 7.4.5.2.1. Additionally, combustible gas management is reviewed and accepted in Section 6a.4.2, 13a.4.9, 13a.5.1 and 13b.4.8 of this SE.
Criterion 4 - Environmental and dynamic effects Safety-related SSCs are designed to perform their functions with the environmental conditions associated with normal operation, maintenance, testing, and postulated accidents. These SSCs are appropriately protected against dynamic effects and from external events and conditions outside the facility.
The NRC staff finds SHINEs design for environmental and dynamic effects acceptable in Section 2.4.2 of this SE. The NRC staff also finds SHINEs protection system independence and equipment qualifications acceptable in Section 7.4.4.2.1 and 7.4.5.2.1. Additionally, credible facility-specific events related to operations and maintenance, including heavy load drop events, are found acceptable in Section 13a.4.12 of this SE. For the RPF, the NRC staff found SHINEs analyses for mishandling or malfunction of RPF equipment acceptable in Section 13b.4.6 of this SE.
Criterion 5 - Sharing of structures, systems, and components Safety-related SSCs are not shared between irradiation units unless it can be shown that such sharing will not significantly impair their ability to perform their safety functions.
The NRC staff considered the evaluation of the design and performance of the SSCs of the SHINE facility, including those SSCs shared by both the IF and RPF. The NRC staff found SHINEs design for sharing of SSCs, including the interface between the IF and RPF and common systems shared between these facilities is acceptable, as discussed in Section 1.4 of this SE. Additionally, the NRC staff note that all IUs share the ESFAS and the control room.
Also, three separate TPS, are shared by the eight IUs. However, as discussed in Section 7.4.4.2.1 and 7.4.5.2.1 of this SE, the NRC staff find that sharing of these systems does not impair the ability to perform the associated safety functions.
Criterion 6 - Control room A control room is provided from which actions can be taken to operate the irradiation units safely under normal conditions and to perform required operator actions under postulated accident conditions.
The NRC staff found SHINEs control room design acceptable in Section 7.4.9.1 of this SE.
Additionally, the operators role to perform required actions is reviewed and found acceptable in Section 7.4.9.2 of this SE. The adequacy of specific Controls and Displays are evaluated in Section 7.4.6 of this SE.
Criterion 7 - Chemical protection The design provides for adequate protection against chemical risks produced from licensed material, facility conditions that affect the safety of licensed material, and hazardous chemicals produced from licensed material.
The NRC staff found SHINEs evaluation involving hazardous materials or activities on the SHINE site and in the vicinity of the SHINE site acceptable in Section 2.4.2.3 of this SE. SHINE evaluated onsite toxic chemicals in SHINE FSAR Section 13b.3, Analyses of Accidents with Hazardous Chemicals and SHINE FSAR Table 13b.3-2, Hazardous Chemical Source Terms and Concentration Levels. The NRC staff found SHINEs evaluation for adequate protection against chemical risks acceptable in Section 13b.4.9 of this SE.
Criterion 8 - Emergency capability The design provides emergency capability to maintain control of:
- 1) licensed material and hazardous chemicals produced from licensed material;
- 2) evacuation of on-site personnel; and
- 3) on-site emergency facilities and services that facilitate the use of available off-site services.
The NRC staff evaluated SHINE document EMG-01-01, Revision 1, Emergency Plan (ADAMS Accession No. ML22027A666) to assess the sufficiency of SHINEs emergency capability. The NRC staff found SHINEs design for emergency capability acceptable in Section 12.4.7 of this SE.
The remaining 31 SHINE design criteria are specifically assigned to systems and subsystems as detailed in FSAR Tables 3.1-1 and 3.1-2. The NRC staff evaluation of these specific design criteria are provided in the corresponding section of this SE.
SHINE Facility Nuclear Safety Criteria To demonstrate that the principal design criteria are adequate, SHINE states in FSAR Section 3.1 that acceptable risk is achieved by ensuring that all postulated events are highly unlikely or by reducing the consequences to less than the SHINE safety criteria. The SHINE safety criteria are listed below followed by the NRC staffs evaluation of the acceptability as constraints to meet NRC regulations and ensure public health and safety.
- SHINE Safety Criterion: An acute worker dose of five rem or greater total effective dose equivalent (TEDE).
A dose of 5 rem TEDE is the regulatory occupational dose limit for adults under 10 CFR 20.1201, Occupational dose limits for adults. It is also the basis for the derived annual limit on intake (ALI) for the amount of radioactive material taken into the body of an adult worker by inhalation or ingestion in a year. ALI is the smaller value of intake of a given radionuclide in a
year by the reference man that would result in a committed effective dose equivalent of 5 rem.
SHINE defines the control room operator, as the worker receptor for calculating radiological consequences.
- SHINE Safety Criterion: An acute dose of 1 rem or greater TEDE to any individual located outside the owner-controlled area.
As discussed in Section 13a.4.1 of this SE, no radiological accident dose criterion is set forth in Title 10 CFR or in applicable guidance to assess the risk to public health and safety and control room operators for non-power production or utilization facilities. As a matter of comparison, the NRC staff, has used the public dose limits of 10 CFR Part 20, Standards for Protection Against Radiation, as the accident dose criteria to license non-power production or utilization facilities.
The NRC staff stated that it deems the public dose limit of 0.1 rem (0.001 Sv) TEDE as unduly restrictive to be applied as accident dose criteria for NPUFs, not subject to 10 CFR Part 100, Reactor Site Criteria. The NRC staff finds SHINEs accident dose criterion to be acceptable based on the early phase protective action guidelines (PAG) established by the Environmental Protection Agency (EPA) and the NRCs proposed accident dose criterion of 1 rem TEDE to provide reasonable assurance of adequate protection of the public from unnecessary exposure to radiation. The maximum hypothetical accident, which results in a maximum public dose of 727 mrem is reviewed and found acceptable in Section 13.5.4.7 of this SE.
- SHINE Safety Criterion: An intake of 30 milligrams or greater of uranium in a soluble form by any individual located outside the owner-controlled area.
As discussed in Section 13a.4.2 of this SE, the SHINE safety criteria include the high consequence limit on soluble uranium intake. The NRC staff notes that 10 CFR 70.61(c) doesnt include a soluble uranium intake limit for intermediate consequences; the limit is in 10 CFR 70.61(b), which means an event leading to an intake in excess of 30 milligrams or greater of uranium would be a high consequence event. However, with SHINEs approach of reducing the likelihood of both high and intermediate consequence events to highly unlikely, the NRC staff finds SHINEs use of the soluble uranium intake limit of 30 milligram or greater of uranium to be acceptable. The NRC staff finds that the high consequence limits align with those specified in 10 CFR 70.61(b).
- SHINE Safety Criterion: An acute chemical exposure to an individual from licensed material or hazardous chemicals produced from licensed material that could lead to irreversible or other serious, long-lasting health effects to a worker or could cause mild transient health effects to any individual located outside the owner-controlled area.
SHINE FSAR Section 13a2, states that SHINE safety analysis (SSA) applies a methodology based on NUREG-1520, to identify and evaluate credible accident scenarios, including hazardous chemical accidents. The NRC staff evaluated the SSA using the guidance and acceptance criteria from the ISG augmenting NUREG-1537, Part 2, which endorses the use of integrated safety analysis methodologies as described in 10 CFR Part 70, Domestic Licensing of Special Nuclear Material and NUREG-1520, Standard Review Plan for Fuel Cycle Facilities License Applications. As discussed in Section 13a.4.2 of this SE, the NRC staff finds SHINEs analysis of radiological consequences as well as chemical consequences for chemical hazards directly associated with NRC licensed radioactive material acceptable.
- SHINE Safety Criterion: Criticality where fissionable material is used, handled, or stored (with the exception of the target solution vessel).
SHINE analyzes inadvertent nuclear criticality in the RPF in FSAR Section 13b.1.2.5. SHINE stated that nuclear criticality safety is achieved through the use of preventative controls throughout the RPF, which reduces the likelihood of a criticality accident to highly unlikely. The
NRC staff reviewed and found SHINEs analysis of inadvertent nuclear criticality in the RPF acceptable in Section 6b.4.3 of this SE.
- SHINE Safety Criterion: Loss of capability to reach safe shutdown conditions.
SHINE defines safe shutdown in Section 1.3. Definitions, of the SHINE technical specifications (TSs) as:
Safe Shutdown: An IU is in a Safe Shutdown condition if the following performance criteria are achieved and maintained:
A. Target solution is not present:
No target solution is present in the IU AND TSV fill valves are closed.
OR B. Target solution is present:
Target solution is drained from the TSV AND Hydrogen is controlled:
Nitrogen purge system (N2PS) is Operable OR Target solution hydrogen generation rates are below those requiring preventive controls.
The NRC staff evaluated the specified conditions identified by SHINE for safe shutdown. If target solution is not present within the IU, the IU is stated to be in Mode 0, as defined in Table 1.3, IU Modes of Operation, in the SHINE TSs. The additional requirement that the fill valves be closed helps ensure that the IU is in a safe shutdown condition. Alternately, the facility is considered to be in safe shutdown, if target solution is present (but not present in the TSV) and hydrogen is controlled. This implies that the IU is in either Mode 3 (shutdown/post-irradiation) or Mode 4 (transfer to RPF). Although the hydrogen generation rate of the irradiated target solution is minimized by stopping irradiation activities, hydrogen generation continues in facility tanks containing irradiated target solution or radioactive liquid waste via radiolysis generated by radioactive decay. Control of hydrogen minimizes the risk of reaching a flammable concentration and is assured by either operating the N2PS or when hydrogen generation rates are below levels of concern. The draining of the target solution to the TSV dump tank results in safe shutdown since the target solution is drained to the favorable geometry TSV dump tank. The NRC staff evaluated the subcritical assembly and phenomena that are expected to impact the changes in target solution composition in Section 4a.4.2 and in Section13a4.1 of the this SE and finds that the target solution design and its interface with the pressure boundary offers reasonable assurance that the health and safety of the public can be assured during normal operation and that the SHINE safe shutdown safety criterion ensures that the facility is designed to automatically shut down the irradiation process, place the target solution into a safe condition, and stabilize accident conditions without immediate operator actions.
Review Findings for Design Criteria The NRC staff reviewed the descriptions and discussions of SHINEs design criteria, as described in SHINE FSAR Section 3.1, as supplemented, against the applicable regulatory requirements and using appropriate regulatory guidance and acceptance criteria. Based on its review of the information in the FSAR, the NRC staff determined that:
- SHINE specified design criteria for each SSC that is assumed in the FSAR to perform an operational or safety function.
- SHINE design criteria include references, where appropriate, to applicable up-to-date standards, guides, and codes. The descriptions of the design are included in the section of the FSAR that corresponds to the specific SSC and generally include the following:
- Design for the complete range of normal expected operating conditions.
- Design to cope with anticipated transients and potential accidents, as discussed in Chapter 13, Accident analysis of the FSAR.
- Design redundancy, so that any single failure of any active component will not prevent safe shutdown or result in an unsafe condition.
- Design to facilitate inspection, testing, and maintenance.
- Design provisions to avoid or mitigate fires, explosions, and potential man-made or natural conditions
- Quality standards commensurate with the safety function and the potential risks.
- Analysis and designs for meteorological, hydrological, and seismic effects (See SE Section 3.2, 3.3, and 3.4)
- Design bases necessary to ensure the availability and operability of required SSCs.
Based on the above determinations, the NRC staff finds that the descriptions and discussions of SHINEs design criteria are sufficient and meet the applicable regulatory requirements and guidance and acceptance criteria for the issuance of an operating license.