Comment on Draft Revision to NMSS Procedure SA-100, Implementation of the Integrated Materials Performance Evaluation Program (I

Office of Nuclear Material Safety and Safeguards State

Procedure Approval

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

Issue Date:

Review Date:

Daniel S. Collins, Director Signature:

Division of Material Safety, State, Tribal

and Rulemaking Programs Date:

Paul Michalak, Branch Chief Signature:

Agreement State Program Branch Chief

Division of Material Safety, State, Tribal

and Rulemaking Programs Date:

Lizette Roldán-Otero, Ph.D., Procedure Contact Signature:

Agreement State Program Branch

Division of Material Safety, State, Tribal

and Rulemaking Programs Date:

ML17037C941

NOTE

Any changes to the procedure will be the responsibility of the Procedure Contact. Copies of the procedures are available through the NRC Website.

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 U.S. Nuclear Regulatory Commission (NRC) and Agreement State radioactive materials programs.

B. It is the policy of the NRC to evaluate the NRC and Agreement State radioactive materials 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 NRC Headquarters, NRC Regional, or Agreement State radioactive materials programs (materials program).

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), as amended. The NRC has programmatic responsibility to periodically review the actions of the Agreement States to comply with the requirements of the AEA to continue to maintain adequate and compatible programs. 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 materials programs.

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 Material Safety, State, Tribal and Rulemaking Programs (MSTR), 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 materials 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, MSTR:

Attends IMPEP review exit meetings or designates an individual such as the Deputy Director, MSTR; Regional Division Director, DNMS; or Regional Deputy Division Director, DNMS to attend.

C. Agreement State Programs Branch (ASPB) Chief

1. Assigns an IMPEP Project Manager;

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

3. Attends IMPEP review exit meetings as designated by the Director, MSTR;

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

5. Signs out the draft IMPEP report to the NRC regional, NRC headquarters or the Agreement State program; and

6. Signs out the proposed final IMPEP report to the MRB.

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 review schedule;

3. Reviews and provides feedback on all versions of IMPEP reports to both the IMPEP team leader, ASPB Chief, and MSTR management;

4. Develops and provides annual IMPEP Team Member Training; and

5. Prepares the annual report to the Commission which includes a discussion of materials program 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 reservation, 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. Determines the scope of the review for the applicable non-common indicators using appropriate NMSS Procedures as guidance;

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

7. Briefs materials program management on inspection accompaniment outcomes;

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

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

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

11. Participates in the MRB meeting for the IMPEP review either in person, by video conference, or by teleconference.

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 member 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; and

6. Participates in the MRB meeting for the IMPEP review either in person, by video conference, or by teleconference.

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 materials program has had two consecutive IMPEP reviews with all indicators found satisfactory (subject to MRB approval);

2. The interval between IMPEP reviews of a materials 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 materials 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. Followup IMPEP Reviews

A followup 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 followup IMPEP review is to evaluate a materials program’s response to recommendations, and to re-evaluate indicator(s) found “unsatisfactory.”

Specific guidance on conducting followup reviews is contained in NMSS Procedure SA-119, Followup IMPEP Reviews.

3. Special Reviews

A special review is a focused review under IMPEP that is performed due to unforeseen circumstances that occur during an IMPEP cycle. The purpose of the special review is to address the specific circumstance or challenge facing a materials program.

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

a. A special review may be scheduled if:

i. A materials program is experiencing serious weaknesses because of the loss of key staff, loss of operating funds, 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 followup IMPEP.

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

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

4. Periodic Meetings

The periodic meeting was created to help the NRC and the Agreement States remain knowledgeable of the respective programs and to plan for future IMPEP reviews. The purpose of the periodic meeting is to provide an open forum for interactive discussions of a materials program status and performance.

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. MSTR 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-100, Formal Qualifications for Integrated Materials Performance Evaluation Program (IMPEP) Team Members and Team Leaders.

4. Routine IMPEP Reviews

1. For Agreement States, the review team will usually consist of at least three members: a team leader from another Region or NMSS, a Regional State Agreement Officer (RSAO) not assigned to that Agreement State, and at least one Agreement State representative.

2. For NRC Regions, the review team will usually consist of at least four members: a team leader from another Region or NMSS, an NRC staff from another Region or NMSS, and two 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.

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. Personnel From Agreement States

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 NRC Region 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.

2. Team leaders are encouraged to make early contact with the Agreement State or NRC Region 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.

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

4. 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 materials 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 materials program’s pending inspection activities for observation. The focus should be on safety and security significant 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 significant safety and security issues 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 materials program management. The team leader should be present during the team members final debrief to the materials 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 Program].

3. For NRC, the questionnaire will include questions involving all the common performance indicators, and the non-common performance indicators, Sealed Source and Device Evaluation Program, Low Level Radioactive Waste Program, and Uranium Recovery Program licensing, 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 followup reviews) and the Agreement State’s or NRC Region’s 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 Region 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 MSTR;

5. For Agreement States and NRC Regions, 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 State or NRC Regional 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 materials 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.

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 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 materials program management and staff.

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

4. Additional meetings (such as daily meetings with materials 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 NRC Regions. 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, references)

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

6. Upon direction of the MRB 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 materials program management as they are identified, ideally on a daily basis during the on-site review.

3. In the discussions with materials 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.

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 materials program. These discussions should be documented in the IMPEP report.

6. When a finding relates to potentially significant health and safety 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. When the conduct of a team member is disruptive to the review, the team leader is to bring this matter to the attention of the ASPB Branch Chief and MSTR 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. In such cases, the final decision in an Agreement State is up to 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 ASPB Branch Chief and the Regional Public Affairs Officer.

4. Reviews of the NRC Regions 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 primary decision for the determination of each performance indicator 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 for the performance indicator.

3. The overall performance of the materials 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.

4. 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.

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

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

7. 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 reflect on individual performance, to the extent possible.

8. The team leader is responsible for assuring that ample time is provided for materials program staff to express their reactions to the comments. Any disagreements with the comments should be acknowledged by the team leader. However, priority shall be given to assuring adequate time is left for full discussion of the findings with staff and management. In such cases, MSTR management should be consulted.

9. 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.

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

10. The first level of discussion with materials program management should be with the Director, Radiation Control Program or the NRC Director, Division of Nuclear Materials Safety, 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.

d. 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, which will make the final decision on program adequacy and compatibility.

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

a. The summary discussion with the senior manager or RA 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 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.

3. The team leader should state during the summary meeting that all findings are preliminary until agreed upon by the MRB, 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 makes the final decision on program adequacy and/or 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.

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 ASPB Branch 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 materials program within 32 calendar days of the last day of the review with concurrence from all team members. 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 materials 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 materials 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 contains a comment resolution table template.

9. The IMPEP Project Manager or designee will coordinate the scheduling of MRB meetings for materials programs reviews in consultation with the team leader. A copy of the materials 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 74-90 days from the last day of the IMPEP review 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 materials 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 via video teleconference.

Otherwise, the team member should call in for the meeting to present their performance indicator.

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

M. Issuance of Final Reports and Follow-up Actions

1. The ASPB 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 for the Deputy Executive Director for Materials, Waste, Research, State, Tribal, Compliance, Administration, and Human Capital Programs’ signature.

2. 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.

4. 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

VII. REFERENCES

1. NRC Management Directive 5.6, Integrated Materials Performance Evaluation Program (IMPEP).

2. NRC Management Directive 5.10, Formal Qualifications for Integrated Materials Performance Evaluation Program (IMPEP) Team Members.

3. NRC Management Directive 10.158, NRC Non-Concurrence Process

4. NRC Management Directive 10.159 NRC Differing Professional Opinion Program

5. NMSS Procedure SA-101, Reviewing the Common Performance Indicator, Status of Materials Inspection Program.

6. NMSS Procedure SA-102, Reviewing the Common Performance Indicator, Technical Quality of Inspections.

7. NMSS Procedure SA-103, Reviewing the Common Performance Indicator, Technical Staffing and Training.

8. NMSS Procedure SA-104, Reviewing the Common Performance Indicator, Technical Quality of Licensing Actions.

9. NMSS Procedure SA-105, Reviewing Common Performance Indicator, Response to Incidents and Allegations.

10. NMSS Procedure SA-106, The Management Review Board.

11. NMSS Procedure SA-107, Reviewing Non-Common Performance Indicator, Compatibility Requirements.

12. NMSS Procedure SA-108, Reviewing the Non-Common Performance Indicator, Sealed Source and Device Evaluation Program.

13. NMSS Procedure SA-109, Reviewing the Non-Common Performance Indicator, Low-Level Radioactive Waste Disposal Program.

14. NMSS Procedure SA-110, Reviewing the Non-Common Performance Indicator, Uranium Recovery Program.

15. NMSS Procedure SA-116, Periodic Meetings Between IMPEP Reviews.

16. NMSS Procedure SA-118, Orientation Meeting for New Agreement States.

17. NMSS Procedure SA-119, Followup IMPEP Reviews.

18. NMSS Procedure SA-120, Agreement State Participation as IMPEP Team Members.

19. IMPEP Toolbox - http://www.hsrd.ornl.gov/nrc/impeptools.shtm

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

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

__Status of State’s regulations from MSTR’s 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 review team and I want to thank you and your staff for your cooperation and patience during our review.

• The review 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 30 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.

• Upon receipt of your comments, the NRC will schedule the MRB meeting to discuss the team’s findings and recommendations within 2-3 weeks. 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 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 104 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 review 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 review 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 review team [agrees/disagrees] with the comment. Explain why the team agrees/disagrees.

1 The National Materials Program is defined as the broad collective framework within which both the NRC and the Agreement States function in carrying out their respective radiation safety regulatory programs.

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