SA 100 Implementation of Integrated Materials Performance Evaluation Program (IMPEP)

Office of Nuclear Material Safety and Safeguards

Procedure Approval

Implementation of the Integrated Materials Performance Evaluation Program (IMPEP),

Interim State Agreements (SA) Procedure SA-100

Issue Date:

Review Date:

Michael C. Layton, Director

Director, NMSS/MSST Date:

Paul Michalak, Branch Chief

Branch Chief, NMSS/MSST/SALPB Date:

Lizette Roldán-Otero, Ph.D.

Procedure Contact, NMSS/MSST/SALPB Date:

ML

NOTE

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

I. INTRODUCTION

A. This document describes the procedures for conducting the Integrated Materials Performance Evaluation Program (IMPEP) reviews including scheduling, staffing, and reporting the results of reviews of the Agreement State and U.S. Nuclear Regulatory Commission (NRC) radiation control programs.

B. It is the policy of the NRC to evaluate the Agreement State and NRC radiation control programs in an integrated manner using common and non-common performance indicators, as specified in Management Directive (MD) 5.6, Integrated Materials Performance Evaluation Program (IMPEP).

II. OBJECTIVES

A. To provide the guidelines that will be followed by IMPEP teams when preparing, conducting, and reporting results of IMPEP reviews of the NRC or Agreement State radiation control programs.

B. To provide guidelines for coordination of IMPEP, including facilitating consistency among regulatory programs by interchange of ideas between State and Federal regulators.

III. BACKGROUND

The authority for review of Agreement States is contained in Section 274j(1) of the Atomic Energy Act (AEA) of 1954, as amended. The NRC has programmatic responsibility to periodically review the actions of both the NRC and the Agreement States to comply with the requirements of the AEA. While this authority is reserved to the NRC, the current review process, IMPEP, is conducted with Agreement State staff participation under the National Materials Program¹. The IMPEP process employs a team of NRC and Agreement State staff to assess radiation control programs of both the NRC and Agreement States.

IV. ROLES AND RESPONSIBILITIES

The Office of Nuclear Material Safety and Safeguards (NMSS) is the lead office responsible for the implementation of IMPEP. The Division of Materials Safety, Security, State, and Tribal Programs (MSST), within NMSS, has the responsibility for the oversight and management of IMPEP.

A. Management Review Board (MRB):

Provides a senior-level review of the IMPEP team’s findings and recommendations, and issues the final findings to the radiation control program.

Roles and responsibilities of the MRB and the guidelines to be followed by the MRB are contained in NMSS Procedure SA-106, The Management Review Board.

B. Director, MSST:

1. Establishes a schedule and develops a detailed review regimen for conducting IMPEP reviews of the NRC and Agreement State programs.

2. Provides staffing support and training for review teams.

3. Participates on MRBs when delegated by the Director of NMSS.

4. Monitors the IMPEP process; evaluates and develops IMPEP policy, criteria, and methodology; and assesses the uniformity and adequacy of the implementation of the program.

5. Prepares proposed final IMPEP reports for the NRC or Agreement State program IMPEP review for consideration by the MRB.

6. Prepares the final IMPEP report for review and signature by the MRB Chair.

7. Coordinates with the Organization of Agreement States to provide appropriate representatives for IMPEP reviews and MRB meetings.

8. Ensures all personnel acting as IMPEP team members or team leaders achieve and maintain qualifications.

C. State Agreement and Liaison Programs Branch (SALPB) Chief

1. Assigns an IMPEP Project Manager;

2. Approves IMPEP team leader assignments, or assigns a designee to perform this duty;

3. Reviews and provides feedback on all versions of IMPEP reports to the IMPEP team leader and IMPEP Project Manager

4. Signs out the draft IMPEP report to the NRC or the Agreement State program;

5. Signs out the proposed final IMPEP report to the MRB; and

6. Attends MRB meetings.

D. IMPEP Project Manager:

1. Acts as the lead staff for the day-to-day management and oversight of the IMPEP reviews, including tracking the status of reports, maintaining statistical information, interfacing with the Organization of Agreement States (OAS) for Agreement State participants, coordinating NRC staff assignments for IMPEP reviews, and coordinating MRB meetings per NMSS Procedure SA-106;

2. Develops the annual IMPEP review schedule and assigns team members;

3. For non-common indicators, coordinates with the proposed team leader and the RSAO, to determine if the performance indicator needs to be reviewed, as applicable.

4. Reviews and provides feedback on all versions of IMPEP reports to both the IMPEP team leader, SALPB Chief, and MSST management;

5. Schedules IMPEP mid-week debrief meetings;

6. Develops and provides annual IMPEP Team Leader and Team Member Training; and

7. Prepares the annual report to the Commission which includes a discussion of the radiation control programs’ performance, IMPEP status, trending analysis, and other relevant information.

E. IMPEP Team Leader:

1. Coordinates and conducts assigned IMPEP reviews;

2. Coordinates onsite review logistics including hotel reservations, transportation to and from the hotel and the program office for the IMPEP team;

3. Coordinates pre-IMPEP and pre-MRB conference calls with the IMPEP Team;

4. Assures and verifies that team members have all the documentation needed to complete their respective indicator(s);

5. Coordinates the IMPEP inspection accompaniments or is actively involved in the selection and planning of inspection accompaniments with the team member assigned the task;

6. Briefs the radiation control programs’ management undergoing the IMPEP review, on inspection accompaniment outcomes;

7. Designates an IMPEP team member to act as the principal reviewer for each applicable performance indicator;

8. Provides the teams findings to senior level management at the exit meeting and ensures the team’s findings are in alignment with MD 5.6;

9. Develops the draft IMPEP report and accompanying transmittal correspondence for IMPEP Project Manager review in accordance with the schedule outlined in this procedure;

10. Completes the IMPEP report in accordance with MD 5.6, and this procedure; and

11. Participates in the MRB meeting for the IMPEP review either in person, or remotely.

F. IMPEP Team Member:

1. Completes the review of assigned indicator(s) and writes corresponding section(s) of the IMPEP report;

2. Informs the team leader daily on the status of his/her indicator during the on-site review or during inspection accompaniments;

3. Supports other team members to review indicators as needed;

4. Conducts the review of all assigned indicators in accordance with the applicable NMSS procedures;

5. Briefs the team leader of inspection accompaniment outcomes, if assigned inspection accompaniments;

6. Brief’s program staff on their assigned indicator findings during the staff exit; and

7. Participates in the MRB meeting for the IMPEP review either in person, or remotely.

V. GUIDANCE

A. Types of Reviews and Meetings

1. IMPEP Reviews:

1. Normally, IMPEP reviews are scheduled every four years; however, these reviews may be extended to five years if the radiation control program has had two consecutive IMPEP reviews with all indicators found satisfactory (subject to MRB approval);

2. The interval between IMPEP reviews of a radiation control program may be shortened due to performance weaknesses and at the direction of the MRB, based on the review team’s recommendation, or other information obtained during the MRB meeting;

3. Separate trips to perform specific parts of an IMPEP review are permitted and may be advantageous to the radiation control program. Examples are accompaniments of inspectors and visits to specific licensed facilities. Such activities, however, should be completed prior to the IMPEP review exit meeting.

2. Follow-up IMPEP Reviews

A follow-up IMPEP review is a limited evaluation specific to findings from a previous IMPEP review and is conducted before the next routine IMPEP review. The purpose of the follow-up IMPEP review is to evaluate a radiation control program’s response to recommendations, and to re-evaluate indicator(s) found less than satisfactory.

Specific guidance on conducting follow-up reviews is contained in NMSS Procedure SA-119, Follow-up IMPEP Reviews.

3. Special IMPEP Review

A special review is a review that is performed during an IMPEP cycle. The purpose of the review is to address a specific circumstance or challenge facing a radiation control program.

A Special IMPEP review should be conducted by an individual qualified to review the IMPEP performance indicator and independent of the radiation control program. Under a Special IMPEP review, an indicator(s) may be fully or partially reviewed.

a. A Special IMPEP review may be scheduled if:

i. A radiation control program is experiencing serious weaknesses because of the loss of key staff, funding issues, or other acute problem(s) having a major impact upon the program;

ii. An Agreement State implements a change (or changes) to its regulations or operating procedures which introduces a conflict of compatibility, or purports to impose its regulatory authority on persons subject to NRC authority;

iii. NRC staff learns of special problems with a licensee or group of licensees or of an event requiring special attention; or

iv. The MRB directs the evaluation of progress in areas needing improvement identified on a routine or follow-up IMPEP.

b. A Special IMPEP review for a radiation control program may be scheduled upon request by the NRC or by an Agreement State when specific circumstances indicate the need for such a review.

3. A Special IMPEP review may be scheduled as directed by the MRB for observations made during IMPEP reviews and periodic meetings.

4. Periodic Meetings

Periodic meetings of the NRC and Agreement State radiation control programs which are typically scheduled at the mid-point between routine IMPEP reviews, are held to ensure that the NRC and the Agreement States remain knowledgeable of their respective programs and to plan for future IMPEP reviews. The meeting also provides an open forum for discussions about a program’s status and performance. The interval may be adjusted at the direction of the MRB Chair, based on the IMPEP review team’s recommendation or other information obtained during the MRB meeting or review period.

Specific guidance on conducting periodic meetings is contained in NMSS Procedure SA-116, Periodic Meetings Between IMPEP Reviews.

5. Orientation Meetings for New Agreement States

The purpose of the orientation meeting for new Agreement States is to gain an understanding of the State’s program status when evaluated against the IMPEP criteria, and to identify any concerns or issues during the initial implementation of

the Agreement prior to the first IMPEP review. The meeting is held approximately 9 months after the signing of the Agreement and about 9 months prior to the first IMPEP review.

a. Specific guidance on conducting an orientation meeting with a new Agreement State is contained in NMSS Procedure SA-118, Orientation Meetings for New Agreement States.

b. The first IMPEP review of a new Agreement State should be held approximately 18 months after the effective date of the Agreement.

B. Annual IMPEP Schedule

1. Each year, the IMPEP Project Manager will initiate the development of the

12-month review schedule for the upcoming fiscal year.

2. MSST will distribute the proposed schedule to the other NMSS Divisions, the NRC Regions, and the Agreement States for their review and comments. Following receipt of comments, the schedule will be finalized and copies will be distributed to the other NMSS Divisions, the NRC Regions, and the Agreement States.

3. Final schedules are subject to change as circumstances require.

C. Assignment of Personnel for IMPEP Reviews

1. The IMPEP Project Manager proposes assignments for team leaders, and NRC and Agreement State team members for the upcoming fiscal year. All assignments are subject to the team members’ management’s approval to ensure their availability and time commitment for the entire review schedule.

2. Review assignments are subject to change based on team member availability, need, and special circumstances.

3. Assignment of staff to specific performance indicators will be performed in accordance with the qualifications established in NMSS Procedure SA-111, Formal Qualifications for Integrated Materials Performance Evaluation Program (IMPEP) Team Members and Team Leaders.

4. IMPEP Review Teams

1. For Agreement States, the review team will be comprised of at least three members: a team leader from another Region or NMSS, a Regional State Agreement Officer (RSAO), and at least one Agreement State representative.

2. For NRC, the review team will be comprised of at least nine members: a team leader, NRC staff from another Region or NMSS, and at least half of the team Agreement State representatives.

c. The exact size and composition of the review team will be a function of the size and activities of the program being evaluated. The IMPEP Project Manager will provide additional guidance on the composition of each specific IMPEP review team. IMPEP team members should be independent of the program being reviewed. IMPEP team leaders should not lead consecutive IMPEP reviews for the same program.

5. Special Circumstances during IMPEP Reviews

Staff assignments may be made because of known or potential weaknesses in certain aspects of a program. In such cases, a staff member with specialized training or experience in the appropriate field may be assigned to assist. Alternatively, technical assistance from other NRC offices or Agreement States may be provided. In all cases, the qualifications detailed in SA-111 shall be followed.

6. Agreement State Personnel

Agreement State participation is coordinated between NMSS and the Organization of Agreement States (OAS).

Specific guidance on Agreement State participants in IMPEP is contained in NMSS Procedure SA-120, Agreement State Participation as IMPEP Team Members.

D. Scheduling IMPEP Reviews

1. The team leader should contact the appropriate management level at the Agreement State (usually the Program Director) or the NRC to set the date for the program review per the designated schedule. This scheduling should be completed as soon as possible on the issuance of the annual IMPEP schedule, but at a minimum of 120 days before the review. Team leaders are encouraged to make early contact with the Agreement State or the NRC to "block out" the review dates with the understanding that details, such as inspector accompaniments, site visits, etc., will be established later. The team leader should indicate the time frame of the MRB meeting based on the established review dates. The MRB meeting should be held no later than 90 days after the exit meeting.

2. Team leaders are encouraged to utilize the RSAO assigned to the Agreement State when coordinating the IMPEP reviews.

3. Inspector accompaniments or visits to State licensed facilities should be scheduled following the guidance in NMSS procedure SA-102, Reviewing the Common Performance Indicator, Technical Quality of Inspections (TQI).

1. The team leader, principal reviewer for TQI, or other assigned team member should coordinate with the radiation control program prior to the onsite review to perform accompaniments of the NRC or Agreement State inspectors.

2. The reviewer should select a risk-informed sample of the radiation control program’s pending inspection activities for observation. The focus should be on high priority (Priority 1, 2, and 3) and all initial inspections.

3. All NRC or Agreement State materials inspectors are candidates for inspector accompaniments. Priority should be given to newly qualified inspectors when planning and selecting the inspection accompaniments.

4. IMPEP inspector accompaniments are performance-based evaluations of inspector effectiveness. The reviewer should ensure that risk-significant safety and security issues, i.e., those that have the potential to cause an overexposure, or loss of risk-significant radioactive material (RSRM); and/or the unintended or unauthorized use of radioactive material are addressed during the accompaniment. Feedback should be given to the inspector at the conclusion of each accompaniment.

5. If the reviewer identifies a weakness in the performance of the inspector, the reviewer should address the weakness with the inspector at the end of the accompaniment. Additional inspector accompaniments may be necessary to better understand performance weaknesses.

6. Significant safety and/or security issues should be addressed with the inspector prior to the exit meeting to allow the issue to be resolved during the inspection accompaniment.

7. The team leader should be debriefed on every inspection accompaniment before the team member debriefs the radiation control program management. The team leader should be present during the team member’s final debrief to the radiation control program management.

E. Scheduling Letter and Review Questionnaire for IMPEP reviews

1. At least 120 days prior to a routine review, the team leader should send, electronically, the current IMPEP questionnaire to the Agreement State or NRC Region along with correspondence requesting that the completed questionnaire be returned at least two weeks before the on‑site review. The most recent version of the scheduling correspondence and the IMPEP questionnaire (as approved by the Office of Management and Budget) can be found at https://scp.nrc.gov/impeptoolbox/impepquestionnaire.pdf. No printed copies of the questionnaire will be mailed.

2. For Agreement States, the questionnaire will include questions involving all the common performance indicators, and the non-common performance indicator, Compatibility Requirements, and any of the additional areas where the Agreement State has regulatory jurisdiction [i.e., Sealed Source and Device (SS&D) Evaluation Program, Low-Level Radioactive Waste (LLRW) Disposal Program, or Uranium Recovery (UR) Program].

3. For NRC, the questionnaire will include questions involving all the common performance indicators, and the non-common performance indicators, SS&D, LLRW Program, and Uranium Recovery Program, as appropriate.

F. Preparation for IMPEP Reviews

1. Prior to the on-site review, the team leader and team members should review the following documents to identify existing or potential problems, so these issues can be fully discussed and reviewed:

1. The response to the questionnaire;

2. The most recent and past IMPEP report(s) (including special or follow-up reviews) and the Agreement State’s or NRC response to the report. (Note: the minutes for the applicable MRB meeting should also be reviewed for any changes/comments directed by the MRB that were not reflected in the final IMPEP report);

3. A printout of incidents from the Nuclear Material Events Database (NMED) for the specific Agreement State or NRC dating back to the previous review;

4. For Agreement States, a printout of the State’s regulation status from the State Regulations Status Data Sheet maintained by MSST;

5. For Agreement States and NRC, periodic meeting summaries for all meetings held since the previous IMPEP review. (Note: the minutes for the applicable Special MRB meeting should also be reviewed for any changes/comments directed by the MRB that were not reflected in the summary report);

6. For Agreement States monitoring or heightened oversight call summaries, if applicable, for all meetings since the previous IMPEP review;

7. For Agreement States, a printout or listing of all allegations referred to the State by the NRC should be obtained from the RSAO and the NMSS allegation coordinator dating back to the previous IMPEP review; and

8. Other documents or files relating to Agreement State or NRC activities, such as preliminary notices of incidents, abnormal occurrence reports, technical assistance requests and responses, and pending requests for information.

2. If repetitive problems or weaknesses were identified during the previous review or other interactions, the review team should review any additional documents that may help determine possible root causes of the repetitive problems or weaknesses.

3. Prior to the on-site review, the team leader should contact the radiation control program management and request that a meeting room or other suitable location(s) be available for the team as a base of operations over the course of the on-site review.

4. Prior to the onsite review, the team leader should request information from the program as to the type of files (paper/electronic) that the team will encounter during their case work review; and any associated training, passwords, etc. that will be necessary to access the files. For NRC and applicable Agreement States, the Web-Based Licensing (WBL) system may be used to review case files.

1. The team leader should contact the NRC to make arrangements for the reviewing of electronic files by an Agreement State team member.

5. One week prior to the on-site portion of the IMPEP review, the team leader and IMPEP Project Manager will host a teleconference with the review team to coordinate final arrangements and to discuss any emerging issues. Emerging issues may include additional areas requiring review, additional specific guidance, and/or specific correspondence that may be beneficial to review prior to the on-site review.

6. The time, location, and participants of the exit meeting should be finalized, if possible.

7. Appendix A of this procedure contains a checklist for the team leader to assist in preparation for the IMPEP review.

G. Entrance Meeting

1. During the entrance meeting for the on-site portion of the IMPEP review, the team leader should present the purpose and the scope of the review, introduce the team members and their respective areas of review, and describe the general timeline and sequence of activities.

2. The team leader should request introductions to radiation control program management and staff.

3. Information which was requested but not previously furnished by the radiation control program should be obtained.

4. Additional meetings (such as daily meetings with radiation control program management or additional exit meetings) should be discussed.

5. Accompaniments of inspectors and visits to licensed facilities conducted prior to the on-site review should be mentioned.

6. The team leader should be prepared to discuss items of current interest to Agreement States or the NRC. This could include new information such as changes in NRC licensing and inspection procedures, proposed changes to NRC organization and administration, new regulations affecting the Agreement State programs, new training programs, changes or innovations by the Agreement State, etc.

H. IMPEP Review – On-Site Portion

1. Specific guidance for reviewing the common performance indicators is contained in NMSS Procedures SA-101 through 105. (See Section VII of this procedure, References).

2. Specific guidance for reviewing the non-common performance indicators is contained in NMSS Procedures SA-107 through SA-110. (See Section VII of this procedure, References).

3. Questions regarding information provided in the response to the IMPEP Questionnaire should be discussed and corrections should be made, if necessary.

4. Periodic meeting reports, previous review reports, and questionnaire responses should be used to focus the review on any potential program weaknesses.

a. The review team should evaluate any follow-up actions taken and the current status of any previously identified program weaknesses during the on‑site review.

b. The status of open recommendations from previous IMPEP reviews should be evaluated for closure/modification.

5. The review team should have access to all the information necessary to document and evaluate the NRC Region's or Agreement State's performance relative to each applicable performance indicator. However, team members should not retain or remove any documents containing sensitive information from the facility.

6. Upon direction of the MRB Chair or NMSS management, the review team may need to obtain additional or more detailed information. Such a request may be specific to the program being reviewed or may be generic, as appropriate.

7. Identification of Weaknesses

1. Individual team members should discuss casework weaknesses with the license reviewer or inspector whenever possible; and the team leader if it is determined that these weaknesses are programmatic in nature.

2. The team leader should discuss any programmatic weaknesses with the radiation control program management as they are identified, ideally on a daily basis during the on-site review.

3. In the discussions with radiation control program management, the team leader and review team should seek to identify and understand the root cause(s) of the programmatic weaknesses. This can serve as the basis for developing recommendations for corrective actions. Criteria and Examples of Recommendations can be found in Appendix D of this procedure.

4. The review team should determine the indicator areas under which each programmatic weakness falls and determine whether the weakness is a significant problem.

5. The review team may also identify areas under a specific indicator area that the review team believes could enhance the radiation control program. These discussions should be documented in the IMPEP report.

6. When a finding relates to potential risk-significant health and safety, or security issues (such as an omission of a critical element of a safety plan for a facility), the issue should be brought to the attention of the program immediately and dealt with as soon as possible. The IMPEP report should indicate how the matter is being addressed.

7. The review team may also identify shortcomings or weaknesses in the NRC’s oversight program. These issues should be documented in the IMPEP report.

8. For programs where the agreement only includes non-common indicators (e.g., uranium recovery, low level radioactive waste disposal program).

1. Review each sub-element independently as a common performance indicator and attribute a rating to each indicator.

2. Specific guidance for reviewing the non-common performance indicators is contained in NMSS Procedures SA-109 and SA-110. (See Section VII, references)

3. Legislation, Regulation, and Other Program Elements will be evaluated as a non-common indicator as specified in NMSS Procedure SA-107.

4. Overall adequacy and compatibility will be determined in accordance with the rating attributed to each sub-element as described in MD 5.6.

9. If the conduct of a team member is disruptive to the review, the team leader is to bring this matter to the attention of the IMPEP Project Manager, SALPB Chief or MSST management immediately.

I. Third Party Attendance in IMPEP Reviews

1. Reviews of Agreement States are meetings between fellow regulators conducted in compliance with Sec. 274j(1) of the Atomic Energy Act, as amended. From time to time, members of the public or media may learn of a review and ask to attend all or parts of a review. These requests should be referred to Agreement State management since the review activities (other than field activities) take place in State offices.

2. If the public or media is permitted by an Agreement State to attend, the NRC position is that they may observe and may offer comments or questions at the conclusion of the review team’s summary presentation. In some cases, the review team may arrange for a separate meeting with public or media representatives to answer any questions they may have. The review team should state that the findings of the IMPEP review are preliminary, and that the MRB will deliberate the findings in a public meeting. Questions regarding the IMPEP and MRB processes can be referred to the IMPEP Project Manager.

3. In all cases where public or media representatives request attendance at, or are allowed to attend reviews, promptly inform the SALPB Chief and the appropriate Public Affairs Officer.

4. Reviews of the NRC program are considered internal management reviews. As such, reviews are not subject to requirements for public notice, nor are they normally accessible to public attendance.

J. Summarizing IMPEP Review Findings

1. For the evaluation criteria for each performance indicator and overall program findings, refer to MD 5.6 and NMSS Procedures SA-101 through SA-105 and SA-107 through SA-110. Team members should familiarize themselves with the overall performance criteria determination for their performance indicator prior to the IMPEP review. Team members evaluating a given performance indicator will provide their findings to the team leader and team members with their overall performance criteria determination, in accordance with MD 5.6.

2. The impact of issues in one performance indicator could have a negative impact on performance in other indicators. As a general matter, a performance deficiency, and associated root causes, should be assigned to only the most appropriate indicator and not counted against multiple indicators.

3. The primary decision for the determination of each performance indicator finding is the responsibility of the team member qualified to perform the evaluation. Team members will present their findings and final evaluation to the team leader and other IMPEP team members. During this presentation, the team will have an opportunity to ask questions regarding the findings. The purpose of the presentation is to ensure the team member has a clear understanding of the findings, can articulate the findings in a clear and concise manner, and that the determination of the finding is in accordance with MD 5.6. In addition, it is an opportunity to prepare for MRB inquiries regarding the performance indicator.

4. 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. Specific guidance and examples pertaining to each finding can be found in the applicable NMSS SA procedures for each indicator.

5. The overall performance findings for adequacy and compatibility of the radiation control program should be determined through team consensus. In reaching this consensus there should be an open collaborative environment where each team member can ask questions, express differing views, and where ultimately the team can agree on a decision that all members can support.

6. In the event that the team cannot reach a consensus, the report should reflect any difference of opinion to ensure the MRB is aware of the issue. The team lead should consult with the IMPEP Program Manager as to a path forward. Refer to MD 10.159, NRC Differing Professional Opinion Process.

7. The team leader should hold debriefs regarding the results of the program review at both staff and management levels for Agreement States and the NRC.

8. It is NRC management's practice to attend IMPEP review exit meetings for radiation control programs. NRC management should be briefed prior to the exit meeting on the preliminary findings of the review.

9. Comments (i.e., remarks or observations) are intended to be constructive and to promote improvements. Comments made during meetings, particularly on weaknesses, should be made in programmatic terms and should not, to the extent possible, reflect on individual performance.

10. The team leader is responsible for assuring that ample time is provided for: (1) radiation control program staff to express their reactions to the comments, and (2) full discussion of the findings with staff and management. Any disagreements with the comments should be acknowledged by the team leader.

11. On-going discussions should be at the working staff level during the on-site review period. It may be advantageous to hold a summary discussion with the entire materials staff at the conclusion of the review.

a. The discussions should be in sufficient detail to ensure the inspector or the license reviewer and immediate supervisors are aware of each specific weakness, the reason it was considered a weakness, and the corrective action needed.

2. Actions by the staff which are considered to be meritorious should be discussed.

2. Good practices identified by the review team should be noted and documented in the report. Previous examples of a “Good Practice” can be found on the IMPEP toolbox: https://scp.nrc.gov/impeptools.html

12. The first level of discussion with radiation control program management should be with the Director, Radiation Control Program or the NRC Director, MSST, and supervisors.

a. The review team should discuss the comments and recommendations for each indicator and whether or not each finding is significant. These discussions should be limited to the weaknesses and their corrective actions.

b. Items or areas considered meritorious should be emphasized.

c. The review team should identify the recommendations that will be made to the senior managers’², or designee, at the scheduled exit meeting.

2. If one or more significant issues exist with respect to the performance indicators, the Director should be informed that improvements in these areas are critical and that recommendations will be made to the MRB. The MRB Chair will make the final decision on program adequacy and compatibility.

12. The final level of discussion should be with the senior managers.

a. The summary discussion with the senior manager should normally be confined to those items expected to be included in the formal review report. The discussion should be sufficient to explain that other comments relating to the technical aspects of the program were discussed with the Director during the review meeting and were resolved. If requested, the team leader or individual team members should be prepared to cover these findings in the discussion. See Appendix B of this procedure for on-site summary discussion guidance.

2. Any meritorious aspects, such as good practices should be noted.

2. If significant issues exist in one or more performance indicator, the team leader should inform the senior manager that the need for improvement in these areas is critical and that recommendations to the MRB will reflect this fact.

2. The team leader should state during the summary meeting that all findings are preliminary until deliberated by the MRB and approved by the MRB Chair, and that formal recommendations will be provided in the final report. In all cases, the team leader should inform the senior manager that the MRB Chair makes the final decision on program adequacy and compatibility.

2. If one or more significant issues are found, a summary meeting or discussion should be held with the senior manager rather than with his or her designee, if possible.

K. Draft and Proposed Final Reports

1. The team leader is responsible for preparing the draft report following an IMPEP review.

2. The review team members should complete assigned sections of the draft report and submit them to the team leader according to the timeline established by the team leader, but no later than seven calendar days after the last day of the review.

1. The casework evaluated may be incorporated to the report as an appendix, when the team recommends a finding of satisfactory, but needs improvement for one or more indicators.

2. The casework evaluated must be incorporated into the report as an appendix, when the team recommends a finding of unsatisfactory for an indicator.

3. Comments regarding evaluated casework that will appear in the report’s appendix should be factual, concise, and concentrate on casework deficiencies and their root cause(s).

3. The team leader is responsible for integrating the information from the team members and developing a draft report to be shared with the review team for their comments.

4. After receiving comments from the review team, the team leader is responsible for submitting both the draft report and transmittal correspondence to the IMPEP Project Manager and the SALPB Chief for review and comment within 18 calendar days of the last day of the review.

5. The draft report and transmittal correspondence should be transmitted to the radiation control program within 45 calendar days of the last day of the review with concurrence from the team leader. A copy of the draft report should also be sent to the RSAO assigned to that Agreement State.

6. If the team did not reach a consensus and a team member declines to concur on the draft report, that team member needs to refer to MD 10.158 and follow the non-concurrence process within 18 calendar days. If the team member is from an Agreement State, the team leader should contact the IMPEP Project Manager for guidance.

7. The radiation control program will be requested to review the draft report and address any factual errors or misstatements within four weeks from receipt of the draft report.

8. Upon review of the radiation control program’s response, the team leader will be responsible for making any appropriate corrections. If the comments are extensive, a separate comment resolution document should be prepared by the team leader for submittal to the MRB. Appendix C of this procedure contains a comment resolution table template.

9. The IMPEP Project Manager or designee will coordinate the scheduling of MRB meetings for radiation control programs reviews in consultation with the team leader. A copy of the radiation control program’s comments on the draft report will accompany the proposed final report presented to the MRB.

L. MRB Meeting

MRB meetings are to be conducted approximately between 90-105 days from the last day of the IMPEP review, including follow-up and focused IMPEP reviews, in order to achieve the timeliness goals. The NRC has a timeliness metric of issuing the final report within 30 days of the MRB meeting.

If the radiation control program has significant issues identified in one or more performance indicators, the team leader and the team member for the performance indicator presenting the issues should attend the MRB in person, if possible. Team members should make all reasonable attempts to attend the meeting remotely via Skype or video. Otherwise, the team member should call in for the meeting to present their performance indicator.

The Chair of the MRB will make the final determination regarding the overall assessment of the NRC or Agreement State's program as an outcome of an IMPEP review and the MRB’s deliberations. If the radiation control program disagrees with the MRB Chair’s decision to continue or enter a period of monitoring or heightened

oversight, the radiation control program may appeal that decision to the Executive Director of Operations (EDO) within seven calendar days of the issuance of the final MRB report.

Specific guidance on conducting MRB meetings, additional guidance on the proposed final report, and the appeals process is contained in NMSS Procedure SA-106.

M. Issuance of Final Reports and Follow-up Actions

1. The SALPB Chief and the IMPEP Project Manager, in consultation with the team leader, will be responsible for preparation of the final review report and transmittal correspondence to the Deputy Executive Director for Materials, Waste, Research, State, Tribal, Compliance, Administration, and Human Capital Programs’ for signature.

2. Program responses to recommendations made in the IMPEP report will be evaluated by the IMPEP Project Manager or designee and the team leader in consultation with the review team.

3. An acknowledgment letter shall be prepared by the IMPEP Project Manager or designee within 30 days after receipt of the response to recommendations.

VI. APPENDICES

Appendix A – Checklist for the Team Leaders to Assist in Preparation for IMPEP Reviews

Appendix B – On-Site Summary Discussion Guidance

Appendix C – Comment Resolution Table Template

Appendix D – Criteria and Examples of Recommendations

VII. REFERENCES

1. IMPEP Toolbox - https://scp.nrc.gov/impeptools.html

2. Management Directives (MD) available at https://scp.nrc.gov.

3. NMSS SA Procedures available at https://scp.nrc.gov.

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 the NRC’s Agencywide Document Access Management System (ADAMS) are listed below.

No	Date	Document Title/Description	Accession Number
1	1/28/00	SP-00-008, Draft OSP Procedure SA-100, Implementation of IMPEP	ML003680423
2	7/11/00	STP Procedure SA-100, Implementation of IMPEP	ML011230502
3	7/25/00	Summary of Comments on SA-100	ML011230545
4	8/8/06	STP-06-070, Opportunity to Comment on Draft Revisions to STP Procedure SA-100	ML062210006
5	8/8/06	Draft STP Procedure SA-100	ML062210010
6	12/19/06	Summary of Comments on SA-100	ML070370201
7	2/1/07	STP Procedure SA-100	ML070360578
8	XX/XX/19	NMSS Procedure, SA-100

Appendix A

Sample Checklist for the Team Leaders to

Assist in Preparation for the IMPEP Review

• Contact team members and determine their availability for projected IMPEP review target dates.

• Assign indicators to team members.

• Contact State or Region and establish dates for IMPEP review no later than 120 days before a review schedule target.

• Make hotel reservations for team and NRC management attending exit.

• Ensure that Inspector Accompaniments are completed by appropriate team member before on-site review.

• Send Questionnaire at least 60 days prior to on-site portion

__Received completed Questionnaire at least 2 weeks prior to the review

• Request and arrange location(s) for the team at State or Regional offices during the on-site portion of the IMPEP review.

• Assemble and send the following information to the appropriate team members as soon as it is available:

__Response to the IMPEP Questionnaire

__Electronic links for the past IMPEP review

__NMED print out of incidents for specific State or Region

__Appropriate correspondence

__Electronic links, if appropriate, or copies of State’s current regulations from RSAO

__State Regulation Status (SRS) Sheet

__All periodic meeting summaries or mid-cycle review reports since last IMPEP

__All allegations referred to the Agreement State by the NRC (contact RSAO and

NMSS allegation coordinator)

__Other______________________________

• Conduct Pre-Review Teleconference with team and IMPEP Project Manager.

Appendix B

On-Site Summary Discussion Guidance

IMPEP TEAM AREAS OF RESPONSIBILITY

[LIST TEAM MEMBERS] [AS APPROPRIATE]

_________________, Team Leader

_________________, Technical Staffing and Training

_________________, Status of Materials Inspection Program

_________________, Technical Quality of Inspections

_________________, Technical Quality of Licensing Actions

_________________, Technical Quality of Incident and

Allegation Activities

_________________, Compatibility Requirements

_________________, Sealed Source and Device Evaluation

Program

_________________, Low-Level Radioactive Waste Disposal

Program

_________________, Uranium Recovery Program

NRC Management Attending, ____________________________________________________

OPENING REMARKS - Team Leader Guidance

NRC management will present a short synopsis of IMPEP and introduce the team.

Team Leader should cover the following points:

• The team and I want to thank you and your staff for your cooperation and patience during our review.

• The team will be recommending to the Management Review Board (MRB) that the Program be found [ADEQUATE; ADEQUATE, BUT NEEDS IMPROVEMENT; OR INADEQUATE; AND COMPATIBLE OR NOT COMPATIBLE].

• At this time, I will ask each of the team members to briefly summarize their results for the indicators that they reviewed. I want to emphasize that these ratings are preliminary and may be changed as the report is written. If a rating does get altered, I will inform you of the change before the draft report is issued.

COMMON PERFORMANCE INDICATORS

TECHNICAL STAFFING AND TRAINING - Principal Reviewer Guidance

• The team will recommend to the MRB that the Program be found [SATISFACTORY; SATISFACTORY, BUT NEEDS IMPROVEMENT; OR UNSATISFACTORY] with respect to the indicator, Technical Staffing and Training.

• The criteria for [SATISFACTORY; SATISFACTORY, BUT NEEDS IMPROVEMENT; OR UNSATISFACTORY] finding, include: [EVALUATION CRITERIA FROM MD 5.6, PART III]

• The team looked at the Program’s response to the IMPEP questionnaire relative to this indicator, interviewed program management and staff, and considered any possible backlogs in licensing or compliance actions.

• [SPECIFIC RECOMMENDATIONS, IF ANY]

• [SPECIFIC GOOD PRACTICES, IF ANY]

STATUS OF MATERIALS INSPECTION PROGRAM - Principal Reviewer Guidance

• The team will recommend to the MRB that the Program be found [SATISFACTORY; SATISFACTORY, BUT NEEDS IMPROVEMENT; OR UNSATISFACTORY] with respect to the indicator, Status of Materials Inspection Program.

• The criteria for [SATISFACTORY; SATISFACTORY, BUT NEEDS IMPROVEMENT; OR UNSATISFACTORY] finding, include: [EVALUATION CRITERIA FROM MD 5.6, PART III]

• The team focused on five factors in reviewing this indicator: inspection frequency, overdue inspections, initial inspection of new licenses, the timely dispatch of inspection findings to licensees, and the performance of reciprocity inspections. The team looked at the computer generated reports of inspection tracking, as well as [NUMBER] individual license files.

• [SPECIFIC RECOMMENDATIONS, IF ANY]

• [SPECIFIC GOOD PRACTICES, IF ANY]

TECHNICAL QUALITY OF INSPECTIONS - Principal Reviewer Guidance

• The team will recommend to the MRB that the Program be found [SATISFACTORY; SATISFACTORY, BUT NEEDS IMPROVEMENT; OR UNSATISFACTORY] with respect to the indicator, Technical Quality of Inspections.

• The criteria for [SATISFACTORY; SATISFACTORY, BUT NEEDS IMPROVEMENT; OR UNSATISFACTORY] finding, include: [EVALUATION CRITERIA FROM MD 5.6, PART III]

• The team looked at [NUMBER] inspections reports conducted during the review period, for all of the Program's materials inspectors and covered a sampling of the higher priority categories of license types as follows: [LIST TYPES OF LICENSES]. [NUMBER] inspectors were accompanied. The team also reviewed the laboratory facilities and equipment available to the program.

• [SPECIFIC RECOMMENDATIONS, IF ANY]

• [SPECIFIC GOOD PRACTICES, IF ANY]

TECHNICAL QUALITY OF LICENSING ACTIONS - Principal Reviewer Guidance

• The team will recommend to the MRB that the Program be found [SATISFACTORY; SATISFACTORY, BUT NEEDS IMPROVEMENT; OR UNSATISFACTORY] with respect to the indicator, Technical Quality of Licensing Actions.

• The criteria for [SATISFACTORY; SATISFACTORY, BUT NEEDS IMPROVEMENT; OR UNSATISFACTORY] finding, include: [EVALUATION CRITERIA FROM MD 5.6, PART III]

• The team looked at [NUMBER] licenses, which included [LIST TYPE OF LICENSING ACTIONS SUCH AS NEW, RENEWAL, AMENDMENTS, AND TERMINATIONS.] The work of [NUMBER] license reviewers was included in the sampling covering the following types of licenses: [LIST TYPE OF LICENSE REVIEWED].

• [SPECIFIC RECOMMENDATIONS, IF ANY]

• [SPECIFIC GOOD PRACTICES, IF ANY]

TECHNICAL QUALITY OF INCIDENT AND ALLEGATION ACTIVITIES - Principal Reviewer Guidance

• The team will recommend to the MRB that the Program be found [SATISFACTORY; SATISFACTORY, BUT NEEDS IMPROVEMENT; OR UNSATISFACTORY] with respect to the indicator, Technical Quality of Incident and Allegation Activities.

• The criteria for [SATISFACTORY; SATISFACTORY, BUT NEEDS IMPROVEMENT; OR UNSATISFACTORY] finding, include: [EVALUATION CRITERIA FROM MD 5.6, PART III]

• The team looked at the Program's actions responding to [NUMBER] incidents and [NUMBER] allegations, reviewed the incidents reported for [PROGRAM] in the ”Nuclear Material Events Database (NMED)” against those identified by the Program, and reviewed the casework and license files, as appropriate, for these files.

• [SPECIFIC RECOMMENDATIONS, IF ANY]

• [SPECIFIC GOOD PRACTICES, IF ANY]

NON-COMMON PERFORMANCE INDICATORS (AS APPLICABLE)

• The team will recommend to the MRB that the Program be found [SATISFACTORY; SATISFACTORY, BUT NEEDS IMPROVEMENT; OR UNSATISFACTORY] with respect to the indicator, [Compatibility Requirements, Sealed Source and Device (SS&D) Evaluation Program, Low-Level Radioactive Waste (LLRW) Disposal Program, or Uranium Recovery Program].

• The criteria for [SATISFACTORY; SATISFACTORY, BUT NEEDS IMPROVEMENT; OR UNSATISFACTORY] finding, include: [EVALUATION CRITERIA FROM MD 5.6, PART III]

• The team looked at [LIST].

• [SPECIFIC RECOMMENDATIONS, IF ANY]

• [SPECIFIC GOOD PRACTICES, IF ANY]

REPEAT, AS NECESSARY, FOR ALL APPLICABLE NON-COMMON PERFORMANCE INDICATORS

SUMMARY GUIDANCE - Team Leader

• In summary, the team will be recommending to the MRB that the Program be found [SUMMARIZE FINDINGS FOR SPECIFIC PERFORMANCE INDICATORS- NUMBER OF SATISFACTORY; NUMBER OF SATISFACTORY, BUT NEEDS IMPROVEMENT; AND NUMBER OF UNSATISFACTORY]. The team will be recommending to the MRB that the Program be found [ADEQUATE; ADEQUATE, BUT NEEDS IMPROVEMENT; OR INADEQUATE; AND COMPATIBLE OR NOT COMPATIBLE] with NRC’s program.

• The draft IMPEP report containing the team’s findings and recommendations will be completed in approximately 45 days and provided to you for factual review and comment. We ask that you review the report and provide comments to the NRC within four weeks.

• The MRB meeting to discuss the team’s findings and recommendations has been scheduled for DATE.

• The proposed final IMPEP report addressing your comments will be provided to you and the MRB in advance of the meeting.

• You or your representative will be invited to attend the meeting. NRC will provide travel for one representative, yet you may send as many as you wish. NRC also has means for video (e.g., Skype) and/or teleconferencing if either of those mediums is preferred.

• The final report will feature the findings and recommendations as decided upon by the MRB, based on recommendations of the IMPEP team, any additional information provided by the Program, and the deliberations within the board. The NRC’s goal is to issue the final report within 120 days of the on-site review.

• We welcome any comments you may have on the review of your Program or on the IMPEP process in general.

• Again, I want to thank you and your staff for their cooperation and assistance this week. It has been a pleasure working with you and your staff.

Appendix C

YYYY STATE IMPEP

Comment Resolution for letter dated [MONTH] [DAY], [YEAR] from STATE regarding the [MONTH] [DAY], YEAR, draft IMPEP report

[STATE] Comment 1

Report Section

Write comment as presented by the Agreement State

NRC Response

The team [agrees/disagrees] with the comment. Explain why the team agrees/disagrees.

[STATE] Comment 2

Report Section

Write comment as presented by the Agreement State.

NRC Response

The team [agrees/disagrees] with the comment. Explain why the team agrees/disagrees.

[STATE] Comment 3

Report Section

Write comment as presented by the Agreement State.

NRC Response

The team [agrees/disagrees] with the comment. Explain why the team agrees/disagrees.

Appendix D

Criteria and Examples of Recommendations

When the team identifies performance deficiencies that have resulted in a programmatic weakness, the team should seek to identify the root cause of the issue and consider providing recommendations for corrective actions based on the root cause. Recommendations should relate directly to program performance, be constructive, promote improvement, focus on the root cause of the weakness, and should be performance based. The team should consult with program management to ensure that the goal of the recommendation, as written, is understood and implementable.

The following examples are recommendations approved by the MRB in previous IMPEP reports. The purpose of the examples is to assist in the development of recommendations by the IMPEP team:

• The team recommends that the [radiation control program] create a formal training qualification program equivalent to Inspection Manual Chapter 1248 and apply it to new staff and staff currently going through the qualification process.

• The team recommends that the [radiation control program] revise its licensing procedures to include the essential objectives of the NRC’s Pre-Licensing guidance, that the revised guidance be applied to all new applications and transfers of control, and provide its staff with training on the revised procedures.

• The team recommends that the [radiation control program] establish and implement a system to track incident and allegation investigations to ensure timeliness, proper documentation, appropriate follow up, and closure.

• The team recommends that the [radiation control program] formalize the SS&D procedures for: the review of applications; the proper use of checklists; handling of proprietary information; full control of records; incorporating regulations and policies as legally binding requirements; and the requirement for signatures by two qualified reviewers.

• The team recommends that the uranium recovery program provide written results of team inspections and site visits to all licensees within 45 days of the completion of the inspection in accordance with IMC 610.

1 The National Materials Program is defined as the broad collective effort within which both the NRC and Agreement States function in carrying out their respective regulatory programs for agreement material. Agreement Material is defined in Section V. of MD 5.6.

2 Senior Manager: For the radiation control program, the senior manager is the government executive who receives the final IMPEP report.