ML20184A086

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ML20184A086
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Issue date: 09/15/2020
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Office of Nuclear Material Safety and Safeguards Procedure Approval Reviewing the Non-Common Performance Indicator, Low-Level Radioactive Waste Disposal Program State Agreements (SA) Procedure SA-109 Issue Date: August XX, 2020 Review Date: August XX, 2025 Michael C. Layton Original Signed by Director, NMSS/MSST Michael C. Layton Date:

Lizette Roldan-Otero, Ph.D. Original Signed by Acting Branch Chief, NMSS/MSST/SALB Lizette Roldan-Otero Date:

Duncan White Original Signed by Procedure Contact, NMSS/MSST/SALB Duncan White Date:

David Crowley Original Signed by Chair, Organization of Agreement States David Crowley Date:

ML20184A085 NOTE Any changes to the procedure will be the responsibility of the NMSS Procedure Contact. Copies of NMSS procedures are available through the NRC Web site at https://scp.nrc.gov

SA-109: Reviewing the Non-Common Performance Indicator, Page: 1 of 14 Low-Level Radioactive Waste Disposal Program Issue Date:

Formatted: Header I. INTRODUCTION This document describes the procedure for conducting reviews of an Agreement State radiation control program (Agreement State Program) for the Non-Common Performance Indicator, Low-Level Radioactive Waste (LLRW) Disposal Program as specified in the U.S. Nuclear Regulatory Commission (NRC) Management Directive (MD) 5.6, Integrated Materials Performance Evaluation Program (IMPEP).

II. OBJECTIVES To determine that an Agreement States regulatory oversight of a LLRW Disposal Program is adequate to protect public health, safety, security, and the environment. Five sub-elements are reviewed: (1) Technical Staffing and Training; (2) Status of the LLRW Disposal Inspection Program; (3) Technical Quality of Inspections; (4) Technical Quality of Licensing Actions; and (5) Technical Quality of Incident and Allegation Activities. The review will confirm that the following objectives have been met:

A. That qualified and trained technical staff are available to license, regulate, inspect, and assess the operation and performance of the LLRW disposal facility.

The evaluation of staffing and training performance is reviewed according to State Agreements Procedure (SA) SA-103, Reviewing the Common Performance Indicator, Technical Staffing and Training; Inspection Manual Chapter (IMC) 1248, Formal Qualifications Program for Federal and State Material and Environmental Management Programs; and this procedure.

B. That the LLRW disposal facility is inspected at prescribed frequencies as stated in IMC 2401, Near-Surface Low-Level Radioactive Waste Disposal Facility Inspection Program, and to verify that statistical data on the status of the inspection program is maintained and can be retrieved, as generally assessed according to SA-101, Reviewing the Common Performance Indicator, Status of Materials Inspection Program, and this procedure.

C. That the technical quality of LLRW disposal inspections is adequate, as generally assessed according to SA-102, Reviewing the Common Performance Indicator, Technical Quality of Inspections, and this procedure.

D. That the technical quality of licensing actions is adequate, as generally assessed according to SA-104, Reviewing the Common Performance Indicator, Technical Quality of Licensing Actions, and this procedure.

E. That the response to incidents and allegations is adequate, as generally assessed according to SA-105, Reviewing the Common Performance Indicator, Technical Quality of Incident and Allegation Activities, and this procedure.

SA-109: Reviewing the Non-Common Performance Page: 2 of 13 Indicator, Low-Level Radioactive Waste Disposal Program Issue Date:

Formatted: Header III. BACKGROUND For the purposes of this procedure, the evaluation of the Agreement State Program for the regulation of a LLRW disposal facility is best accomplished by considering the facility at one of two phases: operations or closure. The operations phase would be those periods where the facility is undergoing pre-operations (e.g., initial licensing, construction), operations (e.g., waste receipt and disposal), through preparation for site closure. During this phase, the licensee (or operator) has an active presence at the site and the facility actively operates under a license and is subject to regulation by the Agreement State Program. The terms facility and site may be used interchangeably in this procedure.

The closure phase refers to the period when the facility has entered the post-closure period (see Title 10 of the Code of Federal Regulations (10 CFR) Part 61.29) and then the institutional control period. During these periods activities at the site are reduced and generally limited to observation, monitoring and maintenance and repair, first by the licensee (post-closure) and then the facility owner (institutional control). During the 5-year post-closure period (active maintenance period), the activities at the site are described by/ and specified in the licensees site closure plan.

IV. ROLES AND RESPONSIBILITIES A. IMPEP Review Team Leader (Team Leader)

1. In coordination with the IMPEP Program Manager, the Team Leader determines which team member is assigned lead review responsibility and assigns other team members to provide support, as necessary.
2. Assists in developing a plan to conduct further review or to identify root causes for any potential health, safety, security, or environmental protection issues identified by the review.
3. Communicates the teams findings to Agreement State Program management and ensures that the teams findings are in alignment with MD 5.6.
4. Determines, in coordination with NRC headquarters, if this performance indicator will be reviewed. This procedure allows for the option to not review a LLRW disposal facility that is in the closure phase provided there have been no changes or issues since the last IMPEP review that would impact safety. For example, a LLRW disposal facility that is in the closure phase and there have been no changes to releases to the environment, no problems with the engineered cap, and no incidents (e.g., fire, earthquake, etc.).

B. Reviewer

1. Coordinates with the Team Leader to determine which Program inspector(s) to accompany.

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Formatted: Header

2. Conducts inspector accompaniments (unless they are conducted by an alternate team member) before the on-site portion of the review.
3. Reviews each sub-element in accordance with this procedure.

3.4. Informs the Team Leader of their findings throughout the review.

4.5. Presents the results of the teams review to the Agreement State Program at the staff exit meeting.

5.6. Completes their portion of the IMPEP report for the LLRW Disposal Program performance indicator.

6.7. Attends the Management Review Board meeting and discusses the teams findings (this can be done either in-person or remotely).

V. GUIDANCE A. Scope

1. This procedure applies to the review of the LLRW Disposal Program. In particular, the procedure applies to activities involving licensing, management, operation, inspection, closure, and/or post-closure of radioactive waste disposal under NRCs 10 CFR Part 61 and/or equivalent Agreement State regulations.
2. The regulation of radioactive materials, waste disposal, and/or waste processing facilities that do not fall under the NRCs 10 CFR Part 61 and/or equivalent Agreement State regulations should be reviewed under the appropriate IMPEP common performance indicators. Radioactive waste processors are service provider licensees and are issued a 10 CFR Part 30 license.
3. The review of program elements (including regulations) required for compatibility are not within the scope of this indicator but are addressed under the non-common performance indicator, Legislation, Regulations and Other Program Elements.
4. The scope of the review of the LLRW Disposal Program should consider the phase(s) within the review period.
5. This procedure evaluates the Agreement States performance over the period since the last IMPEP review. This time frame is defined as the review period.
6. The review guidelines below are examples of evaluation elements and are not requirements.

SA-109: Reviewing the Non-Common Performance Page: 4 of 13 Indicator, Low-Level Radioactive Waste Disposal Program Issue Date:

Formatted: Header B. Preparation

1. Review MD 5.6, IMC 2401, and be knowledgeable of the applicable IMPEP SA procedures, the basic regulatory guides involving LLRW disposal siting, licensing, environmental impacts, performance assessment, waste characterization, and waste averaging. Review the list of reference documents located in Appendix A.the IMPEP Toolbox on the state communications portal Web site. These pertinent reference documents will be dependent on the LLRW disposal facility status.
2. Coordinate with the Team Leader, and the appropriate Agreement State personnel to accompany State inspectors during an inspection of the LLRW disposal facility before the on-site portion of the IMPEP review.
3. Request a copy of the current radioactive materials license, the last inspection report, a map of the LLRW disposal facility and disposal trenches, and related Agreement State procedures from the Agreement State Program prior to the on-site review.
4. Request the following documentation from the Team Leader prior to the on-site review:
a. Obtain a copy of the periodic meeting summaries for the review period to determine any new issues associated with the LLRW Disposal Program.
b. Obtain a copy of the last IMPEP report and identify any open issues or recommendations for this indicator.
5. Request a list of allegations referred to the State regarding the LLRW Disposal Program by the NRC from the Regional State Agreements Officer (RSAO) or the headquarters allegation team prior to the on-site review.
6. Obtain a list of incidents related to the LLRW Disposal Program. A list of incidents can be found in Nuclear Materials Event Database (NMED).
7. Review the responses generated by the Agreement State Program, relevant to LLRW disposal questions in the IMPEP questionnaire.

C. Evaluation Process

1. The reviewer should refer to Part III Evaluation Criteria, of MD 5.6 for specific evaluation criteria. As noted in MD 5.6, the criteria for a satisfactory program is as follows:
a. The LLRW Disposal Program meets the satisfactory finding for the common performance indicators, Technical Staffing and Training, Status of Materials Inspection Program, Technical Quality of Inspections, Technical Quality of Licensing Actions, and Technical Quality of Incident and Allegation Activities as described in Sections III.B.1, III.C.1, III.D.1, III.E.1, and III.F.1 of the handbook in MD 5.6.

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Formatted: Header

b. The LLRW disposal licensees are inspected at prescribed frequencies in accordance with IMC 2401 or compatible Agreement State procedure for a LLRW disposal facility. Any deviations from these schedules are coordinated and documented. IMC 2401 describes the specific radiological safety inspection program for near surface LLRW disposal facilities and defines specific inspection requirements.
c. Agreement State Program procedures are compatible with this procedure and are implemented and followed.
2. In applying the criteria, the reviewer(s) should consider the current phase of the life cycle of the LLRW disposal facility during the review period.
3. The reviewer should evaluate any open issues or recommendations for closure and/or modification.
4. The reviewer(s) will evaluate each sub-element for this non-common performance indicator as outlined in this procedure and the respective IMPEP performance indicator procedures (SA-101, SA-102, SA-103, SA-104, and SA-105).
5. Appendix B containsA list of examples to assist the reviewer in identifying less than satisfactory findings of program performance can be found in the IMPEP Toolbox on the state communications portal Web site.

D. Reviewer Actions by Sub-element During the Operations Phase The following describe reviewer actions in accordance with each sub-element for the evaluation of the Programs oversight of a LLRW disposal facility in the operations phase.

1. Technical Staffing and Training (see SA-103)

The reviewer(s) should ensure that all technical staff involved in the LLRW Disposal Program have completed training in accordance with Appendix E of IMC 1248.

a. Based on the LLRW disposal facility activities, the reviewer(s) should ensure there are staff (or access to staff in other divisions/, departments/,

agencies, or towith consultants) available with expertise, as needed, in materials licensing and/or inspection; health physics and radiation protection; radioactive materials transportation and inspection; civil (geotechnical) and mechanical engineering; geology/ or geochemistry, surface water and ground water hydrology; chemical safety; and environmental science. The reviewer should conduct interviews with staff to evaluate qualifications and potential needs.

b. The reviewer(s) should ensure the LLRW Disposal Program has a plan and schedule for development and implementation of a training program for the staff. The reviewer(s) should ensure records of staff training and

SA-109: Reviewing the Non-Common Performance Page: 6 of 13 Indicator, Low-Level Radioactive Waste Disposal Program Issue Date:

Formatted: Header qualification records include refresher training (e.g., radiation protection, transportation, treatment, storage, and disposal of radioactive waste, as well as environmental monitoring aspects).

c. The reviewer(s) should ensure technical staff, conducting performance assessment reviews, receive training in risk and performance assessment, and are made aware of NUREG-2175, Guidance for Conducting Technical Analyses for 10 CFR Part 61 and NUREG-1573, A Performance Assessment Methodology for Low-Level Radioactive Waste Disposal Facilities: Recommendations of NRC's Performance Assessment Working Group. The reviewer(s) should ensure technical staff are aware of NRCs risk informed performance-based approaches and probabilistic risk assessment methods. The Agreement State Program may utilize other divisions/, departments/, agencies, or with consultants for performing this work.
2. Status of the LLRW Disposal Inspection Program (see SA-101)
a. Inspections may include the following:
  • site security and site boundaries;
  • inspection of trenches and disposal cells;
  • waste shipments;
  • waste manifest;
  • waste characteristics and volumes;
  • shipment vehicle surveys and records;
  • release surveys for equipment, structures, and vehicles;
  • waste packages; marking, labeling, and placarding;
  • emergency response information; general shipping inspections for compliance with regulatory requirements by Department of Transportation (DOT), NRC, and/or Agreement State;
  • personnel exposures and dosimetry (e.g., internal, bioassay, and external dosimetry);
  • personnel qualifications and training;
  • air monitoring surveys;
  • radiological surveys;
  • surface water and ground water monitoring;
  • emergency response plans and drills;
  • waste receipt, treatment, storage, and disposal operations;

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  • instrument calibrations and check sources;
  • radiological posting;
  • respiratory protections;
  • As Low As is Reasonably Achievable (ALARA) records; and
  • records of incidents and allegations.
b. The reviewer(s) should:
i. Evaluate inspections and assess the adequacy and frequency needed for safety, security, and to demonstrate compliance with regulatory requirements and license conditions.

ii. Use inspection data provided by the Agreement State Program from the IMPEP questionnaire and information provided during the onsite review. The Agreement State Program should not be penalized for failing to meet internally developed inspection schedules that are more restrictive/ or stringent than those specified in IMC 2401.

iii. Evaluate inspections in comparison to IMC 2401 and note any missed, late, or overdue inspections during the IMPEP review period. In this regard, the reviewer(s) should review the license, license conditions and amendments, and current LLRW disposal activities.

2. Technical Quality of LLRW Disposal Inspections (see SA-102)
a. The reviewer(s) performs inspector accompaniments of a representative number of the States LLRW inspectors. The reviewer(s) can record their observations of the accompaniment using Appendix C,the Inspector Accompaniment Summary Sheet which can be found in the IMPEP Toolbox on the state communications portal Web site.
b. The reviewer(s) should:
i. Address the completeness of the inspections to cover LLRW disposal activities outlined in IMC 2401 including timeliness and follow-up on inspection findings.

ii. Review inspection documentation and interview inspectors to gain an understanding of the risk significance of radiological hazards at an LLRW disposal facility.

iii. Determine whether inspection findings, including violations, are communicated to the licensee in accordance with Agreement State procedures.

SA-109: Reviewing the Non-Common Performance Page: 8 of 13 Indicator, Low-Level Radioactive Waste Disposal Program Issue Date:

Formatted: Header iv. Ensure that inspections focus on radiological safety aspects, implementation of safety procedures, potential effluent releases to the environment, public and workers exposure, and release surveys for equipment, structures, and vehicles.

v. Ensure the inspections address the quality and adequacy of environmental monitoring data (e.g., air, soil, surface-water, and/or ground water) and evaluation of data, if applicable, for potential radionuclide releases above threshold limits has been properly addressed.

vi. Review inspection data regarding the quality and performance of liners and covers placed at the LLRW disposal facility, to ensure compliance with the required standards. Not all facilities may utilize liners and covers.

vii. Review inspection records for waste shipments, to ensure that radiological and, physical/, and chemical characteristics of the waste are consistent with license requirements and NRCs and DOTs regulations and guidance.

viii. Interview staff to ensure there are radiological monitoring and surveys of any potential on-site/ and off-site residual contamination.

3. Technical Quality of Licensing Actions (see SA-104)

During the operations phase, the pre-licensing/ and construction activities may require a review of licensing actions regarding site selection, site performance assessment, disposal cell designs, establishment of license conditions and technical specifications of liners and engineering barriers.

The pre-operational activities may require examination of Agreement State licensing actions regarding each component of the LLRW disposal facility.

These components may include engineering systems and planned disposal operations or processes. The operations phase may require modifications of license conditions, expansion of LLRW disposal activities, mitigation measures, site security, modification of cell design, and financial assurance.

The following specific review guidelines may apply to the LLRW Disposal Program reviews.

a. The reviewer(s) should:
i. Evaluate a sample of licensing actions (e.g., site performance assessments, renewals, amendments) that are representative based on the number and type of actions performed during the review period. As practical, a cross-section of as many different technical reviewers and types of actions should be included.

ii. Ensure that selected licensing actions have been reviewed for technical correctness and quality, including adequacy, accuracy, completeness, clarity, specificity, and consistency.

SA-109: Reviewing the Non-Common Performance Page: 9 of 13 Indicator, Low-Level Radioactive Waste Disposal Program Issue Date:

Formatted: Header iii. Ensure that when the Agreement State examines the licensees technical documents, the Agreement State provides a technical basis supporting their licensing decision and actions specifically any risk-significant decisions related to health and safety. The basis for licensing actions should be documented.

iv. Ensure that selected licensing actions conform to applicable regulations and license conditions, based on regulatory guidance, checklists, and policy memoranda, to ensure consistency with current accepted practice and standards.

v. Determine whether NRC guidance is used or if the Agreement State has developed their own guidance to perform licensing reviews. If the Agreement State developed their own guidance, the reviewer(s) should evaluate the guidance for technical adequacy and compatibility with NRC procedures.

vi. Review records that document deficiencies in licensee supporting information, including risk-significant errors, omissions, or missing information. Such records include letters, file notes of a telephone conversation, and other documents.

vii. Determine that licensing actions are issued/ and signed under by an authorized official in accordance with the Agreement State procedure.

viii. Verify the justifications of the technical licensing review whereby the Agreement State Program granted an exception, exemption, variance, or waiver from an applicable rule, regulatory guide, or industry standard.

ix. Determine how the Agreement State Program ensured adequate financial assurance has been maintained for site closure in accordance with regulatory requirements and applicable guidance.

This includes ensuring that the closure fund has the necessary funds or has reasonable assurance of obtaining the necessary funds, or a combination of the two to cover the estimated costs of conducting all licensed activities over the planned operating life of the project, including costs of construction and disposal (See Subpart E of 10 CFR Part 61).

x. If the reviewer identifies a performance issue regarding one or more aspects of the technical review of licensing action(s), then the number of licensing actions reviewed should be increased. The reviewer will determine the root cause and extent of the issue and identify if the issue represents a programmatic weakness. The finding, if any, should be documented in the report.

SA-109: Reviewing the Non-Common Performance Page: 10 of 13 Indicator, Low-Level Radioactive Waste Disposal Program Issue Date:

Formatted: Header

4. Technical Quality of Incident and Allegation Activities (see SA-105)
a. The reviewer(s) should:
i. Coordinate with the RSAO and the headquarters allegation team to obtain a listing of the LLRW disposal concerns and allegations the NRC referred to the Agreement State Program.

ii. Review the Agreement State Programs incident and allegation procedures.

iii. Examine a representative number of incidents and allegations files from the entire review period. All reportable incidents and allegations should be reviewed, if possible.

iv. Focus on: (a) risk-significant aspects; (b) discernment of root causes; (c) confidentiality and protection of allegers identity; (d) conformance to the Programs procedures, (e) follow-up actions for closure of allegations, and (f) follow-up actions for incidents.

v. Review LLRW disposal facility event records entered in the Nuclear Material Events Database (NMED). The reviewer(s) should verify whether event actions and notifications are conducted as specified in SA-300, Reporting Material Events.

E. Reviewer Actions During the Closure Phase The term closure is typically used to encompass LLRW disposal activities that must be carried out to allow issuance of a license amendment for the disposal-site closure. The LLRW disposal-site closure is followed by a period of post-closure (observation and maintenance) then institutional control for observation of performance, environmental monitoring program at the disposal site, periodic surveillance, and minor custodial care. The post-closure period, typically five years (see 10 CFR Part 61.29), is followed by an institutional control period of up to 100 years (see 10 CFR Part 61.7(b)(4) and 10 CFR Part 61.59(b)). The licensee develops a site closure plan for review and approval by the Agreement State Program.

1. The reviewer will evaluate the five sub-elements as noted above in Section D but will tailor the review to closure phase activities.
2. The reviewer(s) should include the following:
i. Focus on the review of the site-closure plan approved by the Agreement State and implementation activities associated with any portion of the plan and should also be familiar with closure phase inspection procedures listed in IMC 2401 during the closure/ and post-closure periods.

SA-109: Reviewing the Non-Common Performance Page: 11 of 13 Indicator, Low-Level Radioactive Waste Disposal Program Issue Date:

Formatted: Header ii. Evaluate conformance with applicable regulations under 10 CFR Part 20 (Standards for Protection against Radiation) and 10 CFR Part 61 (Licensing Requirements for Land Disposal of Radioactive Waste) during the site-closure/ and post-closure periods. Conformance with license conditions and applicable regulations to these phases (e.g., 10 CFR Part 61.26 through 61.31 or Agreement State compatible regulations) must be evaluated.

iii. Evaluate the Agreement State Program inspections during the closure phase to ensure that the licensee has implemented all elements of the closure plan and the Agreement State has approved initiation of the post-closure observation and maintenance.

iv. Determine if the Agreement State Program examined monitoring and observational data collected by the licensee during the closure and post-closure phases. The reviewer(s) should assess if the licensee compared the data to the performance assessment and site stability analysis results generated during earlier phases of facility operation. If the data did not agree with the analysis, the reviewer(s) should determine if modifications were made to the analysis or facility design, or if the differences were determined to be insignificant to public health and safety.

v. Review the closure and post-closure period licensing actions.

These licensing actions may involve on-site, buffer zone, and off-site environmental monitoring activities, mitigation and clean-up measures, and financial assurance and institutional control issues.

vi. Review the following activities, as applicable during the institutional control phase:

  • LLRW disposal-site record keeping;
  • review of site safety and security;
  • review of environmental monitoring data and records and follow-up, as appropriate based on trend analysis;
  • review of site repair and maintenance activities and records;
  • review of financial assurance records; and
  • activities pertaining to license transfer, termination, and institutional controls.

SA-109: Reviewing the Non-Common Performance Page: 12 of 13 Indicator, Low-Level Radioactive Waste Disposal Program Issue Date:

Formatted: Header F. Discussion of Findings with the Radiation Control Program

1. The IMPEP team should follow the guidance in SA-100, for discussions of technical findings with inspectors, supervisors, and management. If performance issues are identified by the reviewer(s) that lead to programmatic weaknesses, the reviewer(s) should seek to identify the root cause(s) of the issues which can be used as the basis for developing recommendations for corrective actions. SA-100, Appendix D contains criteria regarding the development of recommendations by the IMPEP team.
2. The reviewer(s) will provide one overall rating for this indicator. In terms of general guidance for the IMPEP review team, a finding of "satisfactory" should be considered when none or only a few or small number of the cases or areas reviewed involve performance issues/deficiencies (e.g., inspection, licensing, staffing, etc.); an "unsatisfactory" finding should be considered when a majority or a large number of cases or areas reviewed involve performance issues/deficiencies, especially if they are chronic, programmatic, and/or of high-risk significance; and a finding of "satisfactory, but needs improvement" should be considered when more than a few or a small number of the cases or areas reviewed involve performance issues/deficiencies in high-risk-significant regulatory areas, but not to such an extent that the finding would be considered unsatisfactory.

I. APPENDICES Appendix A - Specific Reference Material List Appendix B - Examples of Less than Satisfactory Findings of a Program Performance Appendix C - Inspector Accompaniment Summary Sheet II. APPENDICES VI. REFERENCES Management Directives (MD) available at https://scp.nrc.gov NMED is available at https://nmed.inl.gov/

NMSS SA Procedures available at https://scp.nrc.gov NRC Allegation Manual at https://www.nrc.gov/docs/ML1700/ML17003A227.pdf NRC Inspection Manual Chapters available at https://www.nrc.gov/reading-rm/doc-collections/insp-manual/manual-chapter/

NRC Inspection Procedures available at https://www.nrc.gov/reading-rm/doc-collections/insp-manual/inspection-procedure/

Title 10 Code of Federal Regulations available at https://www.nrc.gov/reading-rm/doc-collections/cfr/

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Formatted: Header IMPEP Toolbox (e.g., specific material reference list, examples of a less than satisfactory program, and inspector accompaniment summary sheet) available at https://scp.nrc.gov/impeptools.html

SA-109: Reviewing the Non-Common Performance Page: 14 of 13 Indicator, Low-Level Radioactive Waste Disposal Program Issue Date:

Formatted: Header VI.VII. ADAMS REFERENCE DOCUMENTS For knowledge management purposes, all previous revisions of this procedure, as well as associated correspondence with stakeholders that have been entered into NRCs Agencywide Documents Access and Management System (ADAMS) are listed below.

No. Date Document Title/Description Accession Number 1 7/2/2004 STP-04-047, Opportunity for Comments on Draft of ML041880157 Two New IMPEP Procedures Regarding Review of Uranium Recovery Programs and Low-Level Waste Programs 2 6/20/05 STP Procedures SA-109, Reviewing the ML061640294 Non- Common Performance Indicator, Low-Level Radioactive Waste Disposal Program (Redline/Strikeout Version) 3 6/20/05 Summary of Comments on SA-109 ML061640301 4 5/16/06 STP Procedures SA-109, Reviewing the ML061640290 Non- Common Performance Indicator, Low-Level Radioactive Waste Disposal Program 5 6/30/05 STP-05-050, Final STP Procedure SA-109 ML051810484 6 7/14/09 NMSS-09-051, Opportunity to Comment on ML091330602 Draft Revisions to SA-108 and SA-109 7 7/14/09 NMSS Procedure SA-109 Draft Revision ML091330114 8 1/22/10 Procedure SA-109, Reviewing the Non- ML092740597 Common Performance Indicator, Low-Level Radioactive Waste Disposal P

9 12/18/19 NMSS Procedure SA-109 Draft Revision ML19316A954 10 7/1/2020 Resolution of Comments ML20188A165 11 8/4/2020 Final NMSS Procedure SA-109 ML20184A085

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Formatted: Header Appendix A SPECIFIC REFERENCE MATERIAL LIST General IMPEP related documents:

1. NMSS Procedure SA-100, Implementation of the Integrated Materials Performance Evaluation Program (IMPEP)
2. NMSS Procedure SA-101, Reviewing the Common Performance Indicator, Status of Materials Inspection Program
3. NMSS Procedure SA-102, Reviewing the Common Performance Indicator, Technical Quality of Inspections
4. NMSS Procedure SA-103, Reviewing the Common Performance Indicator, Technical Staffing and Training
5. NMSS Procedure SA-104, Reviewing the Common Performance Indicator, Technical Quality of Licensing Actions
6. NMSS Procedure SA-105, Reviewing the Common Performance Indicator, Technical Quality of Incident and Allegation Activities
7. NMSS Procedure SA-111, Formal Qualifications for Integrated Materials Performance Evaluation Program (IMPEP) Team Members and Team Leaders
8. NMSS Procedure SA-300, Reporting Material Events
9. NMSS Procedure SA-400, Management of AllegationsManagement Directive 5.6, Integrated Materials Performance Evaluation Program (IMPEP)
10. NRC Management Directive 8.8, Management of Allegations Documents for both operations and closure phases of a LLRW disposal facility:
1. NRC Inspection Manual, Inspection Manual Chapter (IMC) 1248, Qualification Programs for Federal and State Materials and Environmental Management Programs
2. NRC Inspection Manual, Inspection Manual Chapter (IMC) 2401, Near-Surface Low-Level Radioactive Waste Disposal Facility Inspection Program (Issue date: 11/27/01)
3. NRC Regulatory Guide 4.15, Quality Assurance for Radiological Monitoring Programs (Inception through Normal Operations to License Termination) - Effluent Streams and the Environment
4. NRC Regulatory Guide 4.18, Standard Format and Content of Environmental Reports for Near Surface Disposal of Radioactive Waste
5. NRC NUREG-0945, Final Environmental Impact Statement on 10 CFR Part 61:

Licensing Requirements for Land Disposal of Radioactive Waste A-1

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6. NRC NUREG-1200, Standard Review Plan for the Review of a License Application for a Low-Level Radioactive Waste Disposal Facility
7. NRC NUREG-1573, A Performance Assessment Methodology for Low-Level Radioactive Waste Disposal Facilities: Recommendations of NRC's Performance Assessment Working Group
8. NRC NUREG-2175, Guidance for Conducting Technical Analyses for 10 CFR Part 61
9. Low-Level Radioactive Waste Disposal Information on the NRC Web site https://www.nrc.gov/waste/llw-disposal.html includes, but is not limited to the following documents:
i. Branch Technical Position on Concentration Averaging and Encapsulation, dated February 2015, (ADAMS Accession Nos.: ML12254B065, ML12326A611, and ML16096A278) ii. Interim Guidance on Blending of Low-Level Radioactive Waste, dated March 17, 2011 (ML110480850) iii. Branch Technical Position on Waste Form, Rev.1, dated January 24, 1991 (ML033630746)

Documents specifically for the operations phase for the LLRW disposal facility:

1. NRC Regulatory Guide 4.19, Guidance for Selecting Sites for Near Surface Disposal of Low-Level Radioactive Waste
2. NUREG-1199, Rev 2, Standard Format and Content of a License Application for a Low-Level Radioactive Waste Disposal Facility, January 1991
3. NUREG-1300, Environmental Standard Review Plan for the Review of a License Application for a Low-Level Radioactive Waste Disposal Facility, April 1987
4. NRC NUREG/CR-6567, Low-Level Radioactive Waste Classification, Characterization, and Assessment: Waste Streams and Neutron-Activated Metals Documents specifically for the closure phase of a LLRW disposal facility:
1. NUREG-1388, Environmental Monitoring of Low-Level Radioactive Waste Disposal Facility, December 1989
2. Site Closure Plan for the LLRW disposal facility
3. 10 CFR Part 61.28 Contents of Application for Closure A-2

SA-109: Reviewing the Non-Common Performance Page: 17 of 13 Indicator, Low-Level Radioactive Waste Disposal Program Issue Date:

Formatted: Header Appendix B EXAMPLES OF LESS THAN SATISFACTORY FINDINGS OF A PROGRAM PERFORMANCE The effectiveness of a program is assessed through the evaluation of the criteria listed in Section III, Evaluation Criteria, of MD 5.6. These criteria are NOT intended to be exhaustive but provide a starting point for the IMPEP review team to evaluate this indicator. The review team should also take into consideration other relevant mitigating factors that may have an impact on the programs performance under this performance indicator. The review team should consider a less than satisfactory finding when the identified performance issue(s) is/are programmatic in nature, and not isolated to one aspect, case, individual, etc. as applicable.

This list is not all inclusive and will be maintained and updated in the IMPEP Toolbox on the state communications portal website: https://scp.nrc.gov.

The IMPEP Team should take a holistic approach when reviewing these examples and take into consideration the impact on health, safety, and security. There would have to be multiple examples of impact on health, safety, and/or security to result in a less than satisfactory rating.

For this non-common performance indicator, the team will provide one overall finding.

A finding of "satisfactory, but needs improvement" should be considered when more than a few or a small number of the cases or areas reviewed involve performance issues/deficiencies in high risk-significant regulatory areas, but not to such an extent that the finding would be considered unsatisfactory.

The following are examples of review findings that resulted (or could result) in a program being found satisfactory, but needs improvement for this indicator:

Performance Indicator (subelement) issues:

Technical Staffing and Training

  • There were vacancies in the Program which resulted in a backlog of inspections.

Inspections were frequently completed late. Program management has not prioritized the inspection backlog based on health and safety risk significance.

  • More than a few inspectors and license reviewers have not completed the required training in accordance with IMC 1248 which has adversely affected the quality and timeliness of licensing actions and inspections.

Status of the Materials Inspection Program

  • There have been more than a few missed or overdue inspections over the review period.

The Program was aware of what inspections were conducted overdue and identified actions but did not document or implement actions to conduct inspections at the required frequencies.

B-1

SA-109: Reviewing the Non-Common Performance Page: 18 of 13 Indicator, Low-Level Radioactive Waste Disposal Program Issue Date:

Formatted: Header Technical Quality of Inspections

  • Management (or designated senior staff) did not perform accompaniments for more than a few of the inspectors during the review period. During the review team accompaniments, the Program inspectors missed some health and safety issues.
  • For more than a few inspections conducted by the Program, the review team identified that inspectors either did not use appropriate survey instrumentation or was not in calibration. As a result, Program inspectors could not perform independent measurements of licensee activities.

Technical Quality of Licensing Actions

  • The review team found that the Program failed to conduct necessary analyses in all areas to ensure that the performance assessment used appropriate input values and to ensure that the sensitivity to certain key input values was identified.
  • There was no independent assessment made by the Program for the technical basis provided by the licensee for more than a few licensing actions. There was an appearance that the license reviewer accepted the licensees analysis without adequate review and there was no documentation of an independent review. The review team identified technical issues with the licensees technical basis document.

Technical Quality of Incident and Allegation Activities

  • For more than a few cases, the Program did not conduct an inspection for incidents that could have resulted in releases or doses in excess of regulatory limits, but instead the Program evaluated the incident in the office and delayed an on-site review.
  • For more than a few cases, the review team identified that handling of allegations was not treated consistently across the Program. The Programs policy only allowed the submission of written allegations and not oral allegations and missed identifying potential health and safety concerns.

Consideration should be given to a finding of unsatisfactory when a review demonstrates the presence of one or more of the following conditions:

Performance Indicator (subelement) issues:

Technical Staffing and Training

  • There were ongoing vacancies in the Program which resulted in a chronic backlog of inspections. Most inspections were completed late. Program management has not prioritized the backlog based on health and safety risk significance.
  • Most inspectors and license reviewers have not completed the required training in accordance with IMC 1248 which has adversely affected the quality and timeliness of licensing actions and inspections.

B-2

SA-109: Reviewing the Non-Common Performance Page: 19 of 13 Indicator, Low-Level Radioactive Waste Disposal Program Issue Date:

Formatted: Header Status of the Materials Inspection Program

  • Most required inspections have been missed or overdue for the review period. The Program was aware of what inspections were conducted overdue and identified actions but did not document or implement actions to conduct inspections at the required frequencies.

Technical Quality of Inspections

  • Management (or designated senior staff) did not perform accompaniments for most of the inspectors during the review period. During the review team accompaniments, the Program inspectors missed several health, safety, and security issues.
  • For most inspections conducted by the Program, the review team identified that inspectors either did not use appropriate survey instrumentation or the instrumentation was not in calibration. As a result, Program inspectors could not perform independent measurements of licensee activities.

Technical Quality of Licensing Actions

  • The review team found that the Program failed to conduct necessary analyses in all areas to ensure that the performance assessment used appropriate input values and to ensure that the sensitivity to certain key input values was identified.
  • There was no independent assessment made by the Program for the technical basis provided by the licensee for more than a few licensing actions. There was an appearance that the license reviewer accepted the licensees analysis without adequate review and there was no documentation of an independent review. The review team identified technical issues with the licensees technical basis document.

Technical Quality of Incident and Allegation Activities

  • For most cases, the Program did not conduct an inspection for incidents that could have resulted in releases or doses in excess of regulatory limits, but instead the Program evaluated the incident in the office and delayed an on-site review.
  • For most cases, the review team identified that handling of allegations was not treated consistently across the Program. The Program did not take oral allegations and missed identifying potential health and safety concerns.

B-3

SA-109: Reviewing the Non-Common Performance Page: 20 of 13 Indicator, Low-Level Radioactive Waste Disposal Program Issue Date:

Formatted: Header Appendix C INSPECTOR ACCOMPANIMENT

SUMMARY

SHEET A/S: Reviewer: Accompaniment No.

PRELIMINARY DISCUSSION WITH INSPECTOR DONE

1. Explain the reviewers role in the inspection
2. Discuss introducing reviewer to licensee and explaining his/her role in inspection
3. Explain methods to be used in evaluating inspectors performance and providing feedback GENERAL INFORMATION:

LRW Disposal Facility: License #:

Phase: Operations Closure Priority:

Periods: Pre-Licensing Construction Pre-operations Operations Closure Post-closure Institutional Control Period Location(s) Inspected:

Inspection Dates: Inspector:

Inspection Type:

Unannounced Announced Activities Inspected Procedure Used:

PERFORMANCE COMMENTS AND INSPECTION FINDINGS

SA-109: Reviewing the Non-Common Performance Page: 21 of 13 Indicator, Low-Level Radioactive Waste Disposal Program Issue Date:

Formatted: Header C-1

SA-109: Reviewing the Non-Common Performance Page: 22 of 13 Indicator, Low-Level Radioactive Waste Disposal Program Issue Date:

Formatted: Header ITEM OK or COMMENTS/QUESTIONS N/A INSPECTORS PREPARATION Adequate review of license, tie-down conditions, compliance history, & NMED search Inspection procedure(s), guidance, plan or field form (including last inspection record/report)

Appropriate radiation detection and measurement instruments for activities inspected Calibrated Instrument response check, if appropriate Supplemental materials:

Identification Regulations Forms Dosimetry OPENING Entrance briefing conducted at appropriate level Explanation of inspection purpose, scope, method Inquired about any incidents, overexposures, worker injuries, equipment failure, etc.

Inquired about what activities are occurring at the LLRW disposal facility C-2

SA-109: Reviewing the Non-Common Performance Page: 23 of 13 Indicator, Low-Level Radioactive Waste Disposal Program Issue Date:

Formatted: Header ITEM OK or COMMENTS/QUESTIONS N/A INSPECTION Use of appropriate inspection form or checklist "Walk through" of licensee facility Observation of licensee performance, licensee operations, licensed activities in progress Independent and/or confirmatory measurements performed including validation of public dose limits Facilities checked for proper posting, Waste checked for proper labeling/marking Site security and site boundaries verified Restricted area and facility perimeter fence integrity Guard force or licensee personnel maintaining security Workers checked for proper dosimetry Interviews and discussions conducted with:

Licensee personnel /

radworkers Ancillary workers Adherence to ALARA evaluated Inspection conducted in sufficient scope & depth C-3

SA-109: Reviewing the Non-Common Performance Page: 24 of 13 Indicator, Low-Level Radioactive Waste Disposal Program Issue Date:

Formatted: Header ITEM OK or COMMENTS/QUESTIONS N/A Verification of corrections to:

previous violations open or unresolved items Review of management oversight of licensed activities C-4

SA-109: Reviewing the Non-Common Performance Page: 25 of 13 Indicator, Low-Level Radioactive Waste Disposal Program Issue Date:

Formatted: Header ITEM OK or COMMENTS/QUESTIONS N/A Document the specific activity(ies) the inspector reviewed:

C-5

SA-109: Reviewing the Non-Common Performance Page: 26 of 13 Indicator, Low-Level Radioactive Waste Disposal Program Issue Date:

Formatted: Header ITEM OK or COMMENTS/QUESTIONS N/A Inspectors should review select records to supplement the performance-based inspection, as appropriate. For example:

receipt & transfer of material internal (safety & security) audits radiation safety committee meeting minutes qualification and training of personnel; refresher training authorized users incidents and allegations instrument calibration radiological surveys &

monitoring personnel dosimetry, bioassay, declarations of pregnancy operating & emergency procedures utilization logs leak tests sealed source inventory vehicle surveys equipment & maintenance release of air & sewer effluents environmental sampling &

monitoring waste management, storage &

disposal hazmat refresher training transportation of materials (waste manifests) any new licensee procedure C-6

SA-109: Reviewing the Non-Common Performance Page: 27 of 13 Indicator, Low-Level Radioactive Waste Disposal Program Issue Date:

Formatted: Header ITEM OK or COMMENTS/QUESTIONS N/A INSPECTORS PROFESSIONALISM Use of proper health physics techniques (self monitoring, time, distance, shielding, use of survey instrument, etc.)

Accurate evaluation of radiation safety Knowledge of health physics &

regulations Appropriate appearance for license type, including proper use of PPE and safety equipment as appropriate Skill in wording questions Suitable rapport with management and workers CLOSING Preparation for exit meeting; assembly of supporting material Exit conducted at appropriate management level Violations fully explained; license condition or regulation cited Recommendations clearly distinguished from violations, as applicable Impending enforcement actions explained Licensee advised of expected response and need for corrective actions C-7

SA-109: Reviewing the Non-Common Performance Page: 28 of 13 Indicator, Low-Level Radioactive Waste Disposal Program Issue Date:

Formatted: Header

SUMMARY

OF EVALUATION The purposes of the inspector accompaniment(s) are to: (a) observe the status of LLRW disposal facility safety and security, (b) observe the inspector to ensure the inspector is familiar with the inspection process and procedures, (c) evaluate the adequacy of inspection tools and equipment used, (d) evaluate the completeness of the on-site inspection, and examine inspection reports, inspection records, and findings. If an onsite inspector is stationed at the facility, the reviewer(s) may observe this inspector as part of the inspector accompaniments.

1. Inspectors performance Satisfactory Needs Improvement
2. Performance comments:
3. Specific areas of improvement:
4. The inspector might benefit from additional training in:

(Specify type of training, e.g., formal course, mentoring, on-the-job, webinar, etc.)

5. Evaluation discussed with inspector at the end of the inspection on:

6 Evaluation discussed with Team Leader on:

7. Evaluation discussed during conference call with inspectors supervisor /

management and Team Leader on:

C-8

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