ML22131A269

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Shine OL SER Chapter 12.13 with No Open Items
ML22131A269
Person / Time
Site: SHINE Medical Technologies
Issue date: 05/11/2022
From: Gavello M
NRC/NRR/DANU/UNPL
To:
Gavello M
Shared Package
ML22073A179 List:
References
Download: ML22131A269 (16)
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12.4.13 Material Control and Accounting Plan The NRC staff evaluated the sufficiency of the SHINE material control and accounting (MC&A) plan, as described in SHINE FSAR Section 12.13, Material Control and Accounting Plan and as submitted by letter dated January 27, 2022 (ADAMS Accession No. ML22027A670 - cover letter only), using the guidance and acceptance criteria from Section 12.13, Material Control and Accounting Plan, in the ISG Augmenting NUREG-1537, Parts 1 and 2 (ADAMS Accession Nos. ML12156A069 and ML12156A075, respectively).

Under 10 CFR 70.22(b), applicants for a license to possess special nuclear material (SNM) or to possess and use at any one time and location SNM in a quantity exceeding one effective kilogram must submit, as part of its application for a license, a full description of its program for control and accounting of special nuclear material that will be in its possession under license to show how compliance with the requirements of 10 CFR 74.31, 74.33, 74.41, or 74.51, as applicable, will be accomplished. Of those requirements, 10 CFR 74.31 will not apply because SHINE will be a production and utilization facility licensed pursuant to parts 50 or 70 and will not possess more than one effective kilogram of special nuclear material (SNM) of low strategic significance; 10 CFR 74.33 will not apply because SHINE will not be authorized to possess equipment capable of enriching uranium or to operate an enrichment facility; 10 CFR 74.51 will not apply because SHINE will not be authorized to possess five or more formula kilograms of strategic special nuclear material. SHINE will, however, be authorized to possess moderate strategic significance. Therefore, to comply with 10 CFR 70.22(b), the applicants plan must show how compliance with the requirements of 10 CFR 74.41 will be accomplished.

Accordingly, the MC&A Plan for SHINE describes how the applicants program for the control and accounting of SNM meets the performance objectives of 10 CFR 74.41(a) and the system features and capabilities requirements of 10 CFR 74.41(c).

As an initial matter, SHINE has not yet submitted its application for a license to possess SNM and to possess and use at any one time and location SNM in a quantity exceeding one effective kilogram, meaning 10 CFR 70.22(b) does not currently apply to SHINE. The NRC staff, however, understands that SHINE intends to submit a 10 CFR Part 70 license. As the NRC staff understands it, if the NRC staff approves both SHINEs 10 CFR Parts 50 and 70 licenses, SHINE intends to combine the two licenses in accordance with 10 CFR 50.31. Given this, and the fact that SHINE has submitted its MC&A plan as part of its 10 CFR Part 50 license, the NRC staff is reviewing it against the relevant regulatory requirements.

Chapter 1 - Introduction Chapter 1, Introduction, of the MC&A Plan contains the purpose and scope of the plan, facility description, process description, and a description of the forms of SNM to be processed at the SHINE facility. The information provided in this chapter is supplemental and administrative in nature. The NRC staff finds the information provided in Chapter 1 to be acceptable because it adequately describes the facility processes and the SNM processed at the facility in sufficient detail for the staff to review the rest of the plan.

Chapter 2 - General Performance Objectives Under 10 CFR 74.41(a) applications shall establish, implement and maintain a Commission-approved material control and accounting system that will achieve four performance objectives:

(1) maintain accurate, current, and reliable information on, and confirm, the quantities and locations of SNM in the licensees possession; (2) conduct investigations and resolve any 1

anomalies indicating a possible loss of SNM; (3) permit rapid determination of whether an actual loss of a significant quantity of SNM has occurred as the phrase significant quantity is defined in 10 CFR 74.41(a)(3)(i)-(ii); and generate information to aid in the investigation and recovery of missing SNM in the event of an actual loss.

The applicant addresses the general performance objectives throughout the submitted MC&A Plan. An overview of the basis for the SHINE MC&A program is described in Chapter 2, General Performance Objectives. Chapter 4, Measurements, and Chapter 5, Measurement Control System, describe the measurement program and controls that ensure SNM quantities are accurate, current, and reliable. Chapter 7, Physical Inventory Program, describes the inventory program that confirms the quantities and presence of all SNM at the facility. Chapter 8, Item Control Program, describes controls in place to ensure current knowledge on SNM in items. Chapter 13, Resolving Indications of Loss, Theft, Diversion or Misuse of Special Nuclear Material, describes how the applicant will investigate and resolve indications of loss, theft, diversion, or misuse of SNM. Chapter 14, Aiding Investigation and Recovery of Missing Special Nuclear Material, describes the applicants program for aiding the investigation and recovery of missing SNM. Chapter 15, Recordkeeping, describes how the applicant establishes and maintains records that demonstrate how the general performance objectives and system capabilities are met.

The NRC staff reviewed the applicants strategy for meeting the general performance objectives as provided in the application. This review is discussed throughout this SER. On the basis of that review, the NRC staff has determined that the applicants overall MC&A program includes processes and procedures to ensure accurate, current, and reliable information on all SNM; to confirm the presence of SNM; to investigate and resolve anomalies; to permit rapid determination of whether a significant loss of SNM has occurred; and to generate information to aid in the investigation and recovery of missing SNM. The NRC staff found the applicants program for meeting the overall general performance objectives includes the appropriate components to meet the requirements in 10 CFR 74.41(a) and is, therefore, acceptable.

Chapter 3 - Management Structure Under 10 CFR 74.43(a) and (b)(1)-(4), licensees subject to 10 CFR 74.41 must implement internal controls laid out in 10 CFR 74.43(b)(1)-(4) that relate to management structure. The management structure requirements are meant to separate the performance of key MC&A functions from each other to incorporate checks and balances that increase MC&A system reliability and make the theft or diversion of SNM less likely. These functions are then overseen by a single individual as specified by 10 CFR 74.43(b)(2). This separation at the performance level is also meant to free MC&A management personnel from conflicts of interest with other major functions, such as production, and ensure independence of action and objectiveness of decisions. An effective management structure also relies on the adequate review, approval, and use of written MC&A procedures, and the training and qualification of personnel in key positions to maintain a high level of safeguards awareness.

Chapter 3, Management Structure, of the applicants MC&A Plan describes the management structure, including the facility organization, MC&A organization, procedures, and training and qualifications. Section 3.2, Facility Organization, and Section 3.3, MC&A Organization, describe the various facility organizations as they relate to MC&A and discuss the responsibilities of the MC&A functions, including accounting, measurement, control, and custodianship. Chapter 3 discusses the overall responsibility for MC&A, independence from manufacturing responsibilities, and separation of key responsibilities, which ensures that the 2

individual with overall responsibility for the MC&A program will function with independence of action and objectiveness of decisions. Section 3.3.5, MC&A Procedures, provides information related to the adequate review, approval, and use of written procedures which cover all aspects of the MC&A program. MC&A procedures are listed in Appendix 16.4 of the MC&A Plan.

Section 3.4, Training and Qualification Requirements, describes MC&A training for the general employee, training and qualification for employees with specific MC&A tasks, and minimum qualifications for positions with significant MC&A responsibilities. The applicant states that personnel who work in key positions involving MC&A are trained to maintain a high level of safeguards awareness.

The NRC staff finds that the applicants plan for management structure for the SHINE facility provided in Chapter 3 of the MC&A Plan incorporates clear overall responsibility for MC&A functions, independence from production and manufacturing, separation of key responsibilities, and overall responsibility for MC&A vested in a single individual at a level sufficient to assure independence of action and objectiveness of decisions to meet the requirements in 10 CFR 74.43(b)(1)-(2). The applicants plan for review, approval and use of written procedures, and assurance that personnel who work in key positions are trained to a high level of safeguards awareness meets the requirements of 10 CFR 74.43(b)(3)-(4). Therefore, the NRC staff finds the applicants plan for these internal controls acceptable.

Chapter 4 - Measurements Under 10 CFR 74.45(b), licensees must establish, maintain, and use a program for the measurement of all SNM (both element and fissile isotope) received, produced, transferred between internal control areas, on inventory, or shipped, discarded, or otherwise removed from inventory, with certain exceptions. Licensees must develop and follow approved written procedures related to reference standards, measurement system calibrations, performing measurements, obtaining samples, performing laboratory analyses, and recording, reviewing, and reporting measurements.

Chapter 4, Measurements, of the applicants MC&A Plan describes the SHINE SNM measurement program. Systems are in place for quantifying the mass of all SNM received, shipped, discarded, and listed in the physical inventory. Section 4.1, Measurement Points, lists the items/containers that will be on site and the measurements to be taken. Section 4.2, Measurement Systems, describes the various measurement systems used at the facility, including analytical measurements, sampling, mass measurements, volume, and nondestructive assay measurements. Section 4.4, Measurement Procedures, states that approved, written procedures are used for all accountability measurement methods, including sampling.

Approved written procedures are also used for control and reference standards and for calibrating measurement systems. As described in Chapter 5, Measurement Control Systems, SHINE will use approved written procedures on calibration methods, use of control standards, and replicate samples.

The NRC staff finds that the applicants plan for the measurement program provided in Chapter 4 and Chapter 5 of the MC&A Plan includes sufficient detail regarding the measurement points and measurement systems that will be used at the facility, and the program for the development and use of written procedures for all aspects of its measurement program, to meet the requirements in 10 CFR 74.45(b) and is, therefore, acceptable.

Chapter 5 - Measurement Control System 3

Under 10 CFR 74.45(c)(1) through (11), licensees must ensure that measurement systems used to establish SNM accountability quantities are controlled by a formal measurement control program that ensures measurement quality is maintained and measurement uncertainty values are estimated. Chapter 5, Measurement Control System, of the applicants MC&A Plan describes the measurement control program.

Under 10 CFR 74.45(c)(1) licensees must assign responsibility for planning, developing, coordinating, and administering a measurement control program to an individual who has no direct responsibility for performing measurements or for SNM processing or handling, and who holds a position at an organizational level which permits independence of action and has adequate authority to obtain all the information required to monitor and evaluate measurement quality.

In Section 5.1, Organization and Management, and Chapter 3 (as discussed above) of the MC&A Plan, the applicant provides a description of the organization and management of the measurement control program, which includes personnel from the MC&A organization that are responsible for the oversight and implementation of the program, as well as the personnel outside of the MC&A organization that are responsible for performing measurement control activities. The applicant states that the MC&A Manager is responsible for implementing the overall MC&A program, including planning and coordination, and for administering the measurement control program. The applicant states that oversight of the measurement control program is provided by the MC&A organization, which is independent of the organizations that perform measurements and measurement control activities.

The NRC staff finds that the organization and management of the measurement control program for the SHINE facility provided in Section 5.1 and Chapter 3 of the MC&A Plan are sufficiently independent from performing measurements or SNM processing and handling to meet the measurement control requirement of 10 CFR 74.45(c)(1) and is, therefore, acceptable.

Under 10 CFR 74.45(c)(2) licensees must ensure that any contractor who performs MC&A measurement services conforms with the applicable measurement control requirements in 10 CFR 74.45(c)(5), (6), (7), (10), and (11), and that conformance includes reporting of sufficient measurement control data to allow the licensee to calculate the associated measurement uncertainties.

In Section 5.1, Organization and Management, of the applicants MC&A Plan the applicant states that outside contractors and offsite laboratories used to provide measurement services for SHINE are reviewed to ensure measurement control systems are in place and adequate to meet the requirements of 10 CFR 74.45(c)(2). The applicant also states that the outside contractor program is audited annually. Additionally, the applicant states in Section 10.5, Assessment of Outside Contractor, of the MC&A Plan that the outside contractor or laboratorys measurement services will be assessed as part of the independent assessment of the SHINE MC&A program, as described in Chapter 10 of the plan.

The NRC staff finds that the applicants plan for evaluating and reviewing contractors who provide MC&A measurement services for SHINE provided in Sections 5.1 and 10.5 of the MC&A Plan is sufficiently comprehensive to meet the measurement control requirement in 10 CFR 74.45(c)(2) and is, therefore, acceptable.

Under 10 CFR 74.45(c)(3) licensees must identify potential sources of sampling error and ensure that samples are representative by performing process sampling tests using well 4

characterized materials to establish or verify the applicability of utilized procedures for sampling SNM and for maintaining sample integrity during transport and storage. Licensees are also required to conduct sampling tests whenever a new sampling procedure or technique is used, or new sampling equipment is installed; a sampling procedure, technique, or equipment is modified; or sample containers, sample transport methods or sample storage conditions are modified.

In Section 4.2.5, Sampling Systems, of the applicants MC&A Plan, the applicant describes the potential sources of sampling error and the performance of sampling tests to ensure solutions are homogeneous and samples are representative. The applicant states that sampling tests are also performed when modifications are made to sampling a sampling system, a new sampling procedure is used, a sampling technique is modified, sample containers are modified, or sample storage is modified.

The NRC staff finds that the applicants plan for sampling tests provided in Section 4.2.5 of the MC&A Plan includes sufficient descriptions of possible sampling errors, sampling tests, and when sampling tests would be used to allow the NRC staff to determine the program meets the measurement control requirement in 10 CFR 74.45(c)(3) and is, therefore, acceptable.

Under 10 CFR 74.45(c)(4) licensees must establish and maintain a measurement control program so that for each inventory period the standard of error for the inventory difference (SEID) is less than 0.125 percent of the active inventory, and assure that any MC&A measurements performed under contract are controlled so that the licensee can satisfy this requirement.

In Chapter 5, Measurement Control System, of the applicants MC&A Plan, and in Section 6.2.2, Estimating the Standard Error of the Inventory Difference, the applicant states that measurement uncertainty is controlled so that the SEID, based on all measurement contributions, is less than 0.125 percent of the active inventory. Chapter 5 also states that the same measurement control requirements must be met for outside contractors or offsite laboratories providing accountability measurement services, and that these outside organization measurement programs are subject to review before use and by annual audits.

The NRC staff finds that the applicants plan for establishing and maintaining a measurement control program provided in Chapters 5 and 6 of the MC&A Plan presents sufficient explanation of its approach for controlling measurement uncertainty to allow the NRC staff to determine the program meets the measurement control requirement in 10 CFR 74.45(c)(4) and is, therefore, acceptable.

Under 10 CFR 74.45(c)(5) licensees must generate current data on the performance of each measurement system used during each material balance period in order to establish measured values and uncertainties, including bias, variance components for calibration, sampling, and replicate measurements.

In Section 3.3.2, Nuclear Material Measurement Responsibilities, of the applicants MC&A Plan, the applicant states that the measurement control program coordinator has responsibility for oversight of MC&A measurements and implementation of the measurement control program.

Chapter 5 describes the activities involved in monitoring measurement systems, including calibrations; use of control standards to ensure systems are in control and to estimate bias; and the use of replicate samples and measurements to estimate sampling uncertainties and random errors. Section 5.1, Organization and Management, states that the MC&A Organization is 5

responsible for analyzing measurement control data and evaluating measurement performance.

Section 5.1 also states that Operations, Radiation Protection, and the Laboratories are responsible for performing control measurements and providing the control measurement results to the MC&A organization. In Chapter 6, Statistics, the applicant describes the statistical methods used to determine measurement uncertainties and to identify biases.

The NRC staff finds that the applicants plan for generating and monitoring current measurement control data provided in Chapters 3, 5, and 6 of the MC&A Plan includes sufficient details on estimating and controlling bias and measurement uncertainties through calibration, sampling, and replicates to allow the NRC staff to determine the program meets the measurement control requirement in 10 CFR 74.45(c)(5) and is, therefore, acceptable.

Under 10 CFR 74.45(c)(6) licensees must use standards on an ongoing basis for the calibration and control of all measurement systems used for SNM accountability. Additionally, 10 CFR 74.45(c)(6) requires licensees ensure that:

  • Calibrations are repeated whenever any significant change occurs in a measurement system or when program data indicate a need for recalibration;
  • Calibrations and control standard measurements are based on standards whose assigned values are traceable to certified reference standards or certified standard reference materials; and
  • Control standards are representative of the process material or items being measured by the measurement system in question.

In Section 5.2, Calibrations, of the MC&A Plan, the applicant describes the use of calibration standards and methods for laboratory instruments, scales and balances, and tanks and other vessels. The applicant states that calibrations are repeated when a significant change to a measurement system occurs and when control standard measurements fail to meet acceptance criteria. In Chapter 5, Measurement Control System, and Section 4.2, Measurement Systems, of the MC&A Plan, the applicant states that calibration standards are traceable to nationally recognized standards.

In Section 5.3, Control Standards, of the MC&A Plan, the applicant describes the use of control standards to ensure measurement systems are in control. The applicant states that control standard measurements are used to verify the performance of each measurement system that is not point-calibrated, and the control standards are traceable to nationally recognized standards. The licensee also states that control standards are representative of the process material being measured.

The NRC staff found that the applicants plan for the use of calibration and control standards provided in Sections 5.2 and 5.3 of the MC&A Plan sufficiently utilizes these standards to meet the measurement control requirements in 10 CFR 74.45(c)(6) and is, therefore, acceptable.

Under 10 CFR 74.45(c)(7) licensees must conduct control measurements to provide current data for the determination of random error behavior. The program must also, on a predetermined schedule, include the following, as appropriate:

  • Replicate analyses of individual samples;
  • Analysis of replicate process samples;
  • Replicate volume measurements of bulk process batches; 6
  • Replicate weight measurements of process items and bulk batches, or alternatively, the use of data generated from the replicate weighings of control standard weights as derived from the control standard program; and
  • Replicate nondestructive assay (NDA) measurements of individual process containers or items, or alternatively, the use of data generated from the replicate measurements of NDA control standards as derived from the control standard program.

In Section 5.4, Replicate Measurements, of the MC&A Plan, the applicant describes the replicate measurement program used to determine random error behavior. The applicant discusses the use of duplicate or replicate samples to estimate combined analytical plus sampling error. The applicant states that for mass measurements, replicate measurements are taken of control standards. The applicant states that NDA replicates are not taken due to the low quantity of SNM in waste measured by NDA. The applicant also states that volume replicates are not taken since the replicates would not be independent of each other and would therefore not be statistically appropriate.

The NRC staff finds that the applicants plan for the replicate program to determine random error behavior provided in Section 5.4 of the MC&A Plan includes sufficient description of its approach to conducting control measurements, including limitations due to small quantities of SNM in some material areas, to allow the NRC staff to determine the program meets the measurement control requirement in 10 CFR 74.45(c)(7) and is, therefore, acceptable.

Under 10 CFR 74.45(c)(8) licensees must use all measurements and measurement controls generated during the current material balance period for the estimation of the SEID. Under 10 CFR 74.45(c)(9) licensees must evaluate with appropriate statistical methods all measurement system data generated pursuant to 10 CFR 74.45(c)(5) to determine significant contributors to the measurement uncertainties associated with inventory differences and shipper-receiver differences so that if SEID exceeds specified limits established in 10 CFR 74.45(c)(4), the cause of the excessive SEID can be identified for corrective action with respect to controlling the standard error within applicable limits.

In Section 6.2.2, Estimating the Standard Error of the Inventory Difference, of the applicants MC&A Plan, the applicant describes the approach used to determine the various components of the SEID. The applicant states that the SEID takes into account all measurement error contributions to the components of the inventory difference, and that measurement uncertainty is controlled so that SEID does not exceed 0.125% of active inventory. Determination of the measurement errors, both random and systematic, are described in Section 6.1.2, Estimating Random Uncertainty, and Section 6.1.3, Estimating Systematic Uncertainty. In Section 6.1, Determination of Measurement Uncertainties, of the MC&A Plan, the applicant states that measurement uncertainties are estimated using measurement control data (control standards and replicates) as described in Chapter 5 of the Plan. The applicant states that established statistical techniques are used to analyze measurement data to provide random and systematic error variances in the measurement method. In Section 7.7, SEID Limit and Response Actions, the applicant states that if a calculated SEID exceeds the limit of 0.125% of active inventory, an investigation will be initiated to determine which measurement systems(s) were the source of the excessive SEID.

The NRC staff finds that the applicants plan for the use of measurements and measurement controls to estimate SEID along with its plan for the use of appropriate statistical methods to evaluate all measurements and measurement controls in estimating the SEID in Chapters 5, 6, and 7 of the MC&A Plan includes appropriate data and calculations to meet the measurement 7

control requirements in 10 CFR 74.45(c)(8) and (9), including calculating SEID and identifying the cause of excessive SEID for corrective action, and is, therefore, acceptable.

Under 10 CFR 74.45(c)(10) licensees must establish and maintain a statistical control system, including control charts, formal statistical procedures, and control limits (established at the 0.05 and 0.001 significance levels or their equivalent) designed to monitor the quality of each measurement device or system. Under10 CFR 74.45(c)(11) licensees must promptly investigate and take any appropriate corrective action whenever a control datum exceeds an 0.05 control limit, and whenever a control datum exceeds an 0.001 control limit, the measurement system that generated the datum shall immediately be placed out-of-service with respect to MC&A measurements until the deficiency has been corrected and the system brought back into control within the 0.05 control limits.

In Section 5.5, Control Limits, of the applicants MC&A Plan, the applicant states that control limits are established at the 0.05 (warning limit) and 0.001 (alarm limit) significance levels, and statistical analyses are performed to evaluate a measurement systems performance, including the use of control charts. The applicant describes the response activities when control limits are exceeded, including remeasurements when the warning limits are exceeded and removal of the measurement system from service when the control standard result is out-of-control (exceeds the alarm limit). The applicant states that the system will not be returned to service until the measurement system has been returned to statistical control. The applicant states in Section 3.3.2, Nuclear Material Measurement Responsibilities, of the MC&A Plan that the measurement control coordinator monitors control standard results from measurement systems to ensure that no accountability values were established using an out-of-control system. In Section 5.1, Organization and Management, the applicant states that all facility procedures that address measurement include a section on measurement control, if applicable, and are subject to approval by the MC&A Manager.

The NRC staff finds that the applicants plan to establish and maintain a statistical control system to monitor the quality of each measurement system provided in Sections 3.3.2, 5.1, and 5.5 of the MC&A Plan includes procedures, control charts, and the appropriate calculations, alarm levels, and alarm responses to meet the measurement control requirements in 10 CFR 74.45(c)(10) and (11) and is, therefore, acceptable.

Chapter 6 - Statistics Proper use of statistics is important to ensure that the regulatory requirements in 10 CFR 74.43, Internal Controls, Inventory, and Records, and 10 CFR 74.45, Measurements and Measurement Control, are met. An effective statistical program will ensure measurement uncertainties are estimated and propagated; the inventory difference (ID) and SEID are properly determined; and bias corrections are appropriately estimated and applied.

Chapter 6, Statistics, of the applicants MC&A Plan describes the use of statistics in the MC&A program. The chapter describes how both random and systematic measurement uncertainties are determined and the sources of the uncertainties. Calculation of the ID and SEID are described in Section 6.2, Determination of Inventory Statistics. The applicant describes the calculation of the active inventory (used in evaluating the SEID) and states that common items are appropriately removed from the active inventory equation. Section 6.3, Bias Corrections, describes how the applicant corrects for bias and states that significant biases are corrected in each measurement value or as a total in the inventory difference equation.

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The NRC staff found the applicants statistical programs include the appropriate consideration of uncertainties and use of calculations and meet the system capabilities requirements in 10 CFR 74.43 and 10 CFR 74.45. Therefore, the applicants statistical programs are acceptable.

Chapter 7 - Physical Inventory Program The regulations in 10 CFR 74.43(c)(1) through (8) describe licensee requirements related to inventory control and physical inventories. Chapter 7, Physical Inventory Program, of the MC&A Plan describes the physical inventory program for the SHINE facility.

Under 10 CFR 74.43(c)(1) licensees must provide unique identification for each item on inventory and maintain inventory records showing the identity, location, and quantity of SNM for these items.

In Section 7.1, General Description, of the MC&A Plan, the applicant provides a general description of the physical inventory. The applicant states that a book inventory list includes all SNM items that records indicate should be present, and that the list indicates the current status of all items. Section 8.3, Item Identity Controls, indicates that all SNM containers have a unique identity that cannot be altered. Section 15.1, Description of Records, of the MC&A Plan describes the Item History Form, which is the primary record used to account for SNM.

The form includes item identity, current location, and quantity of SNM.

The NRC staff finds that the item identity controls used for item control and inventory control, as provided in Sections 7.1, 8.3, and 15.1 of the MC&A Plan, will include the item identity, location, and quantity to meet the inventory control requirement in 10 CFR 74.43(c)(1) and are, therefore, acceptable.

Under 10 CFR 74.43(c)(2) licensees must document all transfers of SNM between designated internal control areas within the licensees site.

In Section 3.6, Material Control Boundaries, of the applicants MC&A Plan, the applicant describes the internal control areas to be used to facilitate control of SNM. The applicant states that records are prepared to document movement of SNM between the areas. In Section 3.3.4, Nuclear Material Custodians, of the MC&A Plan, the applicant states that the nuclear material custodians are responsible for assuring that transfers of SNM out of the area to which they are assigned have been approved and ensuring that all activities involving SNM are documented.

In Section 15.1, Description of Records, of the MC&A Plan, the applicant describes the primary forms used to document history and movement of SNM items. The Item History Form follows the item, including location, from receipt and throughout its existence. The SNM Transfer Form records relocation of items.

The NRC staff finds that the transfer documentation controls used for item control and inventory control, as provided in Sections 3.6, 3.3.4, and 15.1 of the MC&A Plan, including assigning transfer control responsibilities to Nuclear Material Custodians, provide for documentation of all transfers of SNM to meet the inventory control requirement in 10 CFR 74.43(c)(2) and are, therefore, acceptable.

Under 10 CFR 74.43(c)(3) licensees must maintain and follow procedures for tamper-safing of containers or vaults containing SNM, if tamper-safe seals are to be used for assuring the validity of prior measurements. The procedures must include control of access to, and distribution of, unused seals and to records showing the date and time of seal application.

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The applicants tamper-safing program is described in Chapter 11, Tamper-Safing, of the MC&A Plan. The NRC staffs review of the applicants tamper-safing program can be found in Chapter 11 - Tamper-Safing, of this SER Section.

Under 10 CFR 74.43(c)(4) licensees must maintain and follow procedures for confirming the validity of prior measurements associated with unencapsulated and unsealed items on ending inventory.

In Section 11.1, Characteristics of Tamper-Safing Devices, of the applicants MC&A Plan, the applicant states that tamper-indicating devices (TIDs) are used on containers of SNM to ensure that no tampering has occurred with the contents. The applicant states that TIDs are used on containers of SNM that are stored on site and when they are in transit. In Section 8.4, Storage Controls, of the MC&A Plan, the applicant describes storage of SNM items and states that the containers are tamper-safed. In Section 7.3, Typical Inventory Composition, of the MC&A Plan, the applicant states that any SNM items that were measured prior to the inventory-taking are not re-measured if a TID was applied and the TID remains intact. In addition, any SNM included in the inventory that has not previously been measured is measured for the inventory.

In Section 7.5, Conducting Physical Inventories, of the MC&A Plan, the applicant states that during inventory-taking, the TID integrity and identification number are confirmed, and that any discrepancies that are identified during the inventory are investigated and resolved.

The NRC staff finds that the applicants program for confirmation of the validity of prior measurements used for item control and inventory control, as provided in Sections 11.1, 8.4, 7.3, and 7.5 of the MC&A Plan, includes the appropriate use of TIDs to meet the inventory control requirement in 10 CFR 74.43(c)(4) and is, therefore, acceptable.

Under 10 CFR 74.43(c)(5) licensees must maintain and follow physical inventory procedures to ensure the requirements in 10 CFR 74.43(c)(5)(i) through (vi) are met. Under 10 CFR 74.43(c)(6) licensees must conduct physical inventories according to written instructions which meet the requirements in 10 CFR 74.43(c)(6)(i) through (iv).

Concerning the inventory procedure requirements in 10 CFR 74.43(c)(5), Section 7.1, General Description, of the applicants MC&A Plan states that all aspects of the applicants physical inventory program are contained in the MC&A procedure, Physical Inventory Taking. Chapter 7 of the applicants MC&A Plan describes the physical inventory program, including the general description, organization, procedures, inventory composition, and conduct of the inventory. In Sections 7.3, Typical Inventory Composition, and 7.5, Conducting Physical Inventories, of the MC&A Plan, the applicant states that any SNM not previously measured is measured for inventory, and that every item is accounted for and no item is counted more than once by using controlled inventory tags. Cutoff procedures for transfers and processing, and for records and reports, are established as described in Sections 7.3 and 7.5. As stated in Section 7.3, any SNM not previously measured is measured for the inventory, and the measurements are completed as soon as possible after the inventory listing. In Section 7.5, the applicant states that following the physical inventory, the book and inventory records are reconciled with, and adjusted to, the results of the physical inventory for each internal control area.

Concerning the inventory written instructions requirements in 10 CFR 74.43(c)(6), Section 7.5 of the MC&A Plan states that detailed inventory instructions are issued prior to the start of each inventory and are approved by the MC&A manager. Section 7.5 also states that licensee staff with inventory responsibilities are named in the instructions and trained to perform their 10

inventory activities. The applicant states that the instructions include a timeline of activities including cutoff times for SNM movement and processing, steps taken to clean out processing equipment, and the timing and performance of various inventory steps. In Section 7.3, the applicant states that SNM items measured prior to inventory are not remeasured if a tamper-indicating device (TID) was applied at the time of measurement and if inspection of the item indicates the contents are intact. If there is evidence of tampering, the contents will be remeasured. The inventory instructions identify specific points where measurements should be made and detail any deviation from normal inventory procedures.

The NRC staff finds that the inventory procedures and instructions used for inventory control, as described in Sections 7.1, 7.3, and 7.5 of the MC&A Plan, sufficiently address the inventory control requirements in 10 CFR 74.43(c)(5) and (6) and are, therefore, acceptable.

Under 10 CFR 74.43(c)(7) licensees must conduct physical inventories of all SNM possessed at intervals not to exceed nine calendar months. Under 10 CFR 74.43(c)(8) licensees must, within 60 calendar days after the start of the physical inventory required by 10 CFR 74.43(c)(7),

calculate, for the material balance period terminated by the physical inventory, the ID and associated SEID for both element and isotope; reconcile and adjust the book record of quantity of element and isotope, as appropriate, to the results of the physical inventory; and investigate and report to the Director, Office of Nuclear Material Safety and Safeguards, any occurrence where the ID or the SEID exceed limits specified in 10 CFR 74.43(c)(8)(iii) and include a statement of the probable reasons for the excessive inventory difference and the corrective actions taken or planned. The regulations in 10 CFR 74.13, Material status reports, require, in part, licensees to submit material balance reports and physical inventory listings for each physical inventory performed within sixty calendar days of the beginning of the physical inventory. The regulations in10 CFR 74.17(b), Special nuclear material physical inventory summary report, require, in part, licensees to report the results of each physical inventory using NRC Form 327, Special Nuclear Material (SNM) and Source Material (SM) Physical Inventory Summary Report, not later than 60 calendar days from the start of each physical inventory required by § 74.43(c)(7).

In Chapter 7, Physical Inventory Program, of the applicants MC&A Plan the applicant provides a description of the physical inventory program for the SHINE facility. In Section 7.1, General Description, the applicant states that a physical inventory of all SNM at the facility is conducted at intervals not to exceed 9 calendar months, and that differences between the accounting records and the physical inventory are investigated and reconciled. Details of the physical inventory process, including reconciliation activities to align the accounting records and the physical inventory, are provided in Section 7.5, Conducting Physical Inventories.

In Section 7.1 of the MC&A Plan, the applicant states that material status reports and physical inventory listings, and the inventory summary report (NRC Form 327) are submitted within 60 days of the start of the physical inventory. Calculation of the ID and the associated SEID are described in Section 6.2, Determination of Inventory Statistics, of the MC&A Plan. In Section 7.6, Inventory Limits and Response Actions, the applicant describes calculation of the ID limits and response actions when the ID exceeds the limits specified in 10 CFR 74.43(c)(8)(iii),

including reporting to the NRC. In Section 7.7, SEID Limit and Response Actions, the applicant states that if the SEID exceeds its 10 CFR 74.43(c)(8)(iii) control limit an investigation will be conducted and the NRC will be notified. Finally, as stated in Chapter 7, calculation of ID and SEID; relevant reconciliation activities; and investigation and reporting of SEID and ID exceeding relevant limits will be completed within 60 calendar days after the start of each physical inventory.

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The NRC staff finds that the applicants plan for conducting inventories and reporting results of the inventories, as provided in Chapter 7 and Section 6.2 of the MC&A Plan, includes sufficient explanation of how and when it will conduct inventories and the associated reporting to allow the NRC staff to determine the program meets the inventory control requirements in 10 CFR 74.43(c)(7) and (8), 10 CFR 74.13, and 10 CFR 74.17, and is, therefore, acceptable.

Chapter 8 - Item Control Program Under 10 CFR 74.43(b)(5) licensees must establish, document, and maintain an item control program to protect against and detect unauthorized and unrecorded removal of items, or of material from items. This includes providing current knowledge of SNM items with respect to identity, element and isotope content, and stored location. Further, 10 CFR 74.43(b) exempts certain items from the requirements of 10 CFR 74.42(b)(5). An item, as defined in 10 CFR 74.4, Definitions, means any discrete quantity or container of SNM or source material, not undergoing processing, having a unique identity and also having an assigned element and isotope quantity.

Chapter 8, Item Control Program, of the applicants MC&A Plan describes the item control program. The organizational responsibilities for the item control program are provided in Section 8.1, Organization, as well as Sections 3.3.1, 3.3.3, and 3.3.4 of the management structure chapter. A general description of the item control program is provided in Section 8.2, General Description, which states that the item control program is designed to provide current knowledge of items and ensures detection of unauthorized or unrecorded removal of SNM.

Chapter 8 also describes item identity and storage controls, which ensures that items have unique identities and are protected during storage, and item monitoring procedures, which confirms that items are stored and identified as indicated in the records. Section 8.6, Investigation and Resolution of Item Discrepancies, states the type of discrepancies identified by item monitoring tests and that all discrepancies are investigated and resolved. Other sections of the MC&A Plan discuss activities that support item control. Sections 9.1, Receiving Procedures, and 9.5, Shipments, discuss controls for receipts and shipments to ensure that they are properly tracked and controlled. Chapter 11, Tamper-Safing, discusses tamper-safing, which ensures the integrity of the contents of items. Chapter 12, Designation of Material Balance Areas, Item Control Areas, and Custodians, discusses the designation of material balance areas and custodians to facilitate SNM control. Chapter 15, Recordkeeping, discusses recordkeeping, including the use of two forms: the item history form to track an item throughout its existence and the SNM transfer form to document relocations of SNM.

The NRC staff finds that the applicants program for item control for the SHINE facility, as provided in Chapters 8, 9, 11, 12, and 15 of the MC&A Plan, adequately describes how the program provides current knowledge of, protects, and detects missing SNM items to allow the NRC staff to determine the program meets the item control requirements in 10 CFR 74.43(b)(5) as modified by the 10 CFR 74.43(b)(6) exemption, and is, therefore, acceptable.

Chapter 9 - Receiving and Shipping Program Under 10 CFR 74.43 (b)(7) licensees must conduct and document shipper-receiver comparisons for all SNM receiptson both an individual batch basis and total shipment basis and ensure that any shipper-receiver difference (SRD) that is statistically significant and exceeds twice the estimated standard deviation of the difference estimator and 200 grams of plutonium or U-233, or 300 grams of U-235 is investigated and resolved.

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Chapter 9, Receiving and Shipping Program, of the applicants MC&A Plan describes the conduct of shipper-receiver comparisons. Chapter 9 describes receiving procedures and how the receivers values are determined. Section 9.3, Evaluation of Shipper-Receiver Differences, discusses the statistical evaluation of SRDs, including how the combined standard error is determined, and the criteria for finding an SRD significant. Investigation and resolution of significant SRDs is described in Section 9.4, Resolution of Significant Shipper-Receiver Differences, including steps taken to investigate a significant SRD and possible causes. The applicants program states that any SRD that is statistically significant and exceeds twice the estimated standard deviation of the difference estimator and 300 grams of U-235, for both total receipt and individual containers, is investigated and resolved. In Section 15.1, Description of Records, the applicant states that MC&A records include records related to the calculation of SRDs.

The NRC staff finds that the applicants program for conducting shipper-receiver comparisons for the SHINE facility, as provided in Chapter 9 of the MC&A Plan, adequately addresses the calculation of SRD and resulting actions to meet the shipper-receiver requirement in 10 CFR 74.43(b)(7) and is, therefore, acceptable.

Chapter 10 - Assessment and Review of the MC&A Program Under 10 CFR 74.43(b)(8) licensees are required to perform independent assessments of the MC&A program at least every 18 months. This assessment, must assess the performance of the MC&A program, review its effectiveness, and document managements action on prior assessment recommendations and identified deficiencies. The assessment must also include a review and evaluation of any contractor who performs SNM accountability measurements for the licensee.

Chapter 10, Assessment and Review of the MC&A Program, of the applicants MC&A Plan describes the assessment and review of the MC&A program. Chapter 10 describes the makeup and responsibilities of the assessment team, a comprehensive list of the areas to be reviewed, details of the review process, including timing of the review and distribution of the report, and the review and response to the report findings. The applicant states that the assessment evaluates the performance and overall effectiveness of the MC&A program every 18 months, and documents management action on prior assessment recommendations and deficiencies.

The applicant also states that the assessment includes an evaluation of any contractor who performs SNM accountability measurements for the licensee.

The NRC staff finds that the applicants program for independent assessment of the MC&A program for the SHINE facility, as provided in Chapter 10 of the MC&A Plan, sufficiently describes its approach to allow the staff to determine that the assessment meets the assessment program requirement in 10 CFR 74.43(b)(8) and is, therefore, acceptable.

Chapter 11 - Tamper-Safing Under 10 CFR 74.43(c)(3) licensees must maintain and follow procedures for tamper-safing of containers or vaults containing SNM, if tamper-safe seals are to be used for assuring the validity of prior measurements. The procedures must include control of access to, and distribution of, unused seals to records showing the date and time of seal application.

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Chapter 11, Tamper-Safing, of the applicants MC&A Plan describes the tamper-safing program. The applicant describes the types of TIDs used at the facility and the testing of the TIDs to ensure that removal would be detected. The plan further describes TID control and usage, inventory of unused and unissued TIDs, the proper application of TIDs, and training of authorized users in the application and destruction of TIDs. Chapter 11 also describes the records that are prepared to document TID activities. The applicants tamper-safing program ensures that procedures are maintained and followed for tamper-safing, and includes control of access to, and distribution of, unused seals and to records showing the date and time of seal application.

The NRC staff finds that the applicants tamper-safing program for the SHINE facility, as provided in Chapter 11 of the MC&A Plan, adequately describes its use of TIDs to allow the staff to determine the program meets the tamper-safing requirement in 10 CFR 74.43(c)(3) and is, therefore, acceptable.

Chapter 12 - Designation of Material Balance Areas, Item Control Areas, and Custodians As discussed above, because of the material SHINE expects to possess, it is governed by 10 CFR 74.41, 10 CFR 74.43, or 10 CFR 74.45. These regulations do not require material balance areas (MBAs), item control areas, and the designation of custodians. However, regulations related to measurements in 10 CFR 74.45(b) and to inventory in 10 CFR 74.43(c) do refer to internal control areas, and licensees do use internal control areas (ICAs) in some form to facilitate control of SNM.

Chapter 12, Designation of Material Balance Areas, Item Control Areas, and Custodians, of the applicants MC&A Plan describes the designation of material control boundaries and custodians. Due to the size of the facility, only one MBA is designated. However, to facilitate control, localize losses, and aid in the resolution of MC&A anomalies, the one MBA is divided into five ICAs. Chapter 3, Management Structure, of the MC&A Plan contains additional information on ICAs and custodial responsibilities. The ICAs are characterized by the form of material and by the physical location of the material. The MC&A Plan also states that custodial responsibility is assigned to one individual for each ICA.

As noted above, the applicant is not required to identify material balance areas, item control areas, or designate custodians. That said, nothing in the regulations prevents the applicant from going beyond the regulatory requirements. The NRC staff has reviewed this chapter of the MC&A plan and finds that the applicants plan for designation of MBAs, item control areas, and custodians for the SHINE facility, as provided in Chapter 12 and Chapter 3 of the MC&A Plan, does not contravene any regulatory requirements.

Chapter 13 - Resolving Indications of Loss, Theft, Diversion, or Misuse of Special Nuclear Material Under the general performance objectives in 10 CFR 74.41(a)(2) and (3) licensees should be able to promptly conduct investigations and resolve anomalies indicating a possible loss of SNM, and rapidly determine whether an actual loss of a significant quantity of SNM, as defined in 10 CFR 74.41(a)(3)(i)-(ii), has occurred.

Chapter 13, Resolving Indications of Loss, Theft, Diversion, or Misuse of Special Nuclear Material, of the applicants MC&A Plan describes the resolution program. The applicant describes methods and procedures for identifying indicators and the actions taken when an 14

alarm occurs. Chapter 13 provides a list of the types of indicators investigated, describes the information needed for an investigation, and describes the steps taken in the investigation and resolution process. The applicant describes the criteria for determining that an indicator is resolved, the timing of the investigation, and notifications to the NRC. Chapter 13 of the MC&A Plan also describes response actions for unresolved indicators, including escalating the response actions and the level of management involved, and conducting a possible cleanout inventory. Section 13.2, System and Procedures for Investigating and Resolving Loss Indicators, states the time allowed for resolution, and states that if the indicator is true or the applicant is unable to determine it is not true, notification is made to the NRC in accordance with 10 CFR 74.11, Reports of Loss or Theft or Attempted Theft or Unauthorized Production of Special Nuclear Material. Section 13.4, Documentation Requirements, of the MC&A Plan states the documentation required for the investigation and resolution of an indicator.

The NRC staff found that the applicants resolution program for the SHINE facility, as provided in Chapter 13 of the MC&A Plan, adequately describes its criteria and process for resolving indications to allow the staff to determine the program meets the resolution program requirements in 10 CFR 74.41(a)(2) and (3), and 10 CFR 74.11, and is, therefore, acceptable.

Chapter 14 - Aiding Investigation and Recovery of Missing Special Nuclear Material The general performance objective in 10 CFR 74.41(a)(4) requires licensees to generate information to aid in the investigation and recover of missing SNM in the event of an actual loss.

Chapter 14, Aiding Investigation and Recovery of Missing Special Nuclear Material, of the applicants MC&A Plan describes the program for aiding investigation and recovery of missing SNM. The applicant describes the types of information available to aid in the investigation and recovery, lists the sources of information indicating that a loss or theft may have occurred, and lists additional information that may be useful in resolving indications of missing SNM. In Chapter 14 the applicant states that records are prepared and maintained for all activities and are available to the NRC and any other government investigators to assist in any investigation relating to actual or suspected missing material.

The NRC staff found that the applicants program for providing information to aid in the investigation and recovery of missing SNM, as provided in Chapter 14 of the MC&A Plan, is sufficiently complete to meet the investigational aid requirement in 10 CFR 74.41(a)(4) and is, therefore, acceptable.

Chapter 15 - Recordkeeping Under 10 CFR 74.43(d)(5) licensees must establish and maintain records that demonstrate that the general performance objectives of 10 CFR 74.41(a)(1) through (4) and the system capabilities of 10 CFR 74.43(b) and (c) and 10 CFR 74.45(b) and (c) have been met. Further, in accordance with 10 CFR 74.43(d)(5), licensees must retain these records for a minimum of 3 years (or longer if specifically required by 10 CFR 74.19(b), 10 CFR Part 75, Safeguards on Nuclear MaterialImplementation of US/IAEA Agreement, or by a specific license condition).

Additionally, under 10 CFR 74.43(d)(1)-(3) licensees must maintain records documenting the following information:

  • Receipt, shipment, disposal, and current inventory associated with all possessed SNM;
  • Quantities of SNM added to and removed from process; and
  • Shipper-receiver evaluations associated with SNM receipts.

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Under 10 CFR 74.43(d)(4) licensees must retain records pertaining to the receipt and disposal of SNM until the Commission terminates the license. In addition to meeting the recordkeeping requirements of 10 CFR 74.43(d), the licensees MC&A system must, in accordance with 10 CFR 74.41(c)(1) and (2), incorporate checks and balances that are sufficient to detect falsification of data and reports that could conceal diversion of SNM by: (1) a single individual, including an employee in any position; or (2) collusion between two individuals, one or both of whom have authorized access to SNM.

Chapter 15, Recordkeeping, of the applicants MC&A Plan describes the recordkeeping program. The applicant lists the records, forms, reports, and procedures that are considered to be MC&A records, lists records generated by other facility organizations which are necessary for MC&A, and describes retention periods for the records. The applicant states that MC&A records, forms, reports, and procedures are to be retained for a minimum of 3 years or longer if specifically required by 10 CFR Part 75, and that records pertaining to receipt and disposal of SNM are retained until the NRC terminates the license. Chapter 15 describes the program and controls for ensuring an accurate and reliable record system, including: access to records; storage controls; redundancy of records; controls to protect computerized records; and checks and balances to detect destruction or falsification of records, such as signature by two individuals. In addition, Sections 3.3, MC&A Organization, 3.5, MC&A Program Description, and 3.7, Commitments and Acceptance Criteria, of the plan describe the MC&A program and organizational elements that ensure checks and balances are in place to detect falsification of data and reports that could conceal diversion of SNM.

The NRC staff found that the applicants recordkeeping program, as provided in Chapter 15 and Chapter 3 of the MC&A Plan, includes the appropriate records, retention periods, and checks and balances to meet the recordkeeping requirements in 10 CFR 74.43(d) and 10 CFR 74.41(c)(1) and (2) and is, therefore, acceptable.

Chapter 16 - Appendix Chapter 16 contains supplemental information including: site layout; production facility layout; organization chart; list of MC&A procedures; list of MC&A forms; item history form; and SNM transfer form. This section is administrative in nature. Therefore, the NRC staff found that the information provided in Chapter 16 to be acceptable.

Conclusion The purpose of NRC staffs evaluation was to determine if the MC&A Plan satisfies the applicable requirements of 10 CFR Part 74 and is consistent with the applicable guidance discussed in this SER. The staff concludes that the MC&A Plan is acceptable and contains appropriate and necessary commitments to meet applicable MC&A requirements as stipulated in 10 CFR 74, thereby providing reasonable assurance that the licensee will adequately control and account for the SNM in its possession during the term of the license.

The revised MC&A Plan (Revision 4), submitted by letter dated January 27, 2022, describes acceptable methods for achieving the general performance objectives in 10 CFR 74.41(a) and the system features and capabilities requirements of 10 CFR 74.43 and 10 CFR 74.45. Therefore, the NRC staff finds the SHINE MC&A Plan acceptable.

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