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{{#Wiki_filter:UNITED NUCLEAR REGULATORY WASHINGTON, D.C. 20555"()001 December 5, 2012 Mr. Joseph H. Plona Senior Vice President and Chief Nuclear Officer Detroit Edison Company Fermi, Unit 2 6400 North Dixie Highway Newport, MI 48166 FERMI 2 -AUDIT OF THE LICENSEE'S MANAGEMENT OF REGULATORY COMMITMENTS (TAC NO. ME8996)  
{{#Wiki_filter:UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555"()001 December 5, 2012 Mr. Joseph H. Plona Senior Vice President and Chief Nuclear Officer Detroit Edison Company Fermi, Unit 2 6400 North Dixie Highway Newport, MI 48166
 
==SUBJECT:==
FERMI 2 - AUDIT OF THE LICENSEE'S MANAGEMENT OF REGULATORY COMMITMENTS (TAC NO. ME8996)


==Dear Mr. Plona:==
==Dear Mr. Plona:==
In Regulatory Issue Summary 2000-17, "Managing Regulatory Commitments Made by Power Reactor Licensees to the NRC Staff," dated September 21, 2000, the U.S. Nuclear Regulatory Commission (NRC) informed licensees that the Nuclear Energy Institute (NEI) document NEI 99-04, "Guidelines for Managing NRC Commitment Changes," contains acceptable guidance for controlling regulatory commitments and encouraged licensees to use the NEI guidance or similar administrative controls to ensure that regulatory commitments are implemented and that changes to the regulatory commitments are evaluated and, when appropriate, reported to the NRC. On May 27, 2003, the Office of Nuclear Reactor Regulation Office (NRR) Instruction LlC-105, "Managing Regulatory Commitments Made by Licensees to the NRC," was published.
 
LlC-105, which is publicly available electronica"y from the Agencywide Documents Access and Management Systems (ADAMS) Public Electronic Reading Room on the Internet at the NRC website (ADAMS Accession No. ML022750041) provides the NRC staff and its stakeholders with a common reference for handling regulatory commitments made by licensees for commercial nuclear reactors to the NRC staff. In accordance with LlC-105, the NRR staff has been instructed to perform an audit of licensees' commitment management programs (CMP) once every three years to determine whether the licensees' programs are consistent with the industry guidance in NEI 99-04, and whether regulatory commitments are being effectively implemented.
In Regulatory Issue Summary 2000-17, "Managing Regulatory Commitments Made by Power Reactor Licensees to the NRC Staff," dated September 21, 2000, the U.S. Nuclear Regulatory Commission (NRC) informed licensees that the Nuclear Energy Institute (NEI) document NEI 99-04, "Guidelines for Managing NRC Commitment Changes," contains acceptable guidance for controlling regulatory commitments and encouraged licensees to use the NEI guidance or similar administrative controls to ensure that regulatory commitments are implemented and that changes to the regulatory commitments are evaluated and, when appropriate, reported to the NRC.
An audit of Fermi 2 CMP was performed at the plant site during the period of July 31,2012 through August 3,2012. The NRC staff concludes, based on the audit, that (1) Fermi's program for managing Regulatory commitments is generally consistent with NEI 99-04, (2) Fermi 2 had implemented NRC commitments on a timely basis; (3) Fermi 2 has implemented an effective program to manage regulatory commitment changes, and (4) there were no misapplied commitments, Details of the audit are set forth in the enclosed audit report, J. Plona -However, as described in the enclosed audit report, there were additional observations made during the audit, which were discussed with the licensee during the exit meeting on August 3, 2012. The NRC staff appreciates the resources that were made available by your staff during the audit. If you have any questions, please have your staff contact me at (301) 415-8371.
On May 27, 2003, the Office of Nuclear Reactor Regulation Office (NRR) Instruction LlC-105, "Managing Regulatory Commitments Made by Licensees to the NRC," was published. LlC-105, which is publicly available electronica"y from the Agencywide Documents Access and Management Systems (ADAMS) Public Electronic Reading Room on the Internet at the NRC website (ADAMS Accession No. ML022750041) provides the NRC staff and its stakeholders with a common reference for handling regulatory commitments made by licensees for commercial nuclear reactors to the NRC staff.
Sincerely, Mahesh Chawla, Project Manager Plant Licensing Branch 111-1 Division of Operating Reactor Licensing Office of Nuclear Reactor Regulation Docket No. 50-341  
In accordance with LlC-105, the NRR staff has been instructed to perform an audit of licensees' commitment management programs (CMP) once every three years to determine whether the licensees' programs are consistent with the industry guidance in NEI 99-04, and whether regulatory commitments are being effectively implemented.
An audit of Fermi 2 CMP was performed at the plant site during the period of July 31,2012 through August 3,2012. The NRC staff concludes, based on the audit, that (1) Fermi's program for managing Regulatory commitments is generally consistent with NEI 99-04, (2) Fermi 2 had implemented NRC commitments on a timely basis; (3) Fermi 2 has implemented an effective program to manage regulatory commitment changes, and (4) there were no misapplied commitments, Details of the audit are set forth in the enclosed audit report,
 
J. Plona                                   - 2 However, as described in the enclosed audit report, there were additional observations made during the audit, which were discussed with the licensee during the exit meeting on August 3, 2012. The NRC staff appreciates the resources that were made available by your staff during the audit. If you have any questions, please have your staff contact me at (301) 415-8371.
Sincerely, Mahesh Chawla, Project Manager Plant Licensing Branch 111-1 Division of Operating Reactor Licensing Office of Nuclear Reactor Regulation Docket No. 50-341


==Enclosure:==
==Enclosure:==
Regulatory Commitments Audit Report cc w/encl: Distribution via ListServ
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555*0001 AUDIT REPORT BY THE OFFICE OF NUCLEAR REACTOR REGULATION REGULATORY COMMITMENTS MADE BY DETROIT EDISON COMPANY TO THE NUCLEAR REGULATORY COMMISSION FERMI 2 DOCKET NO. 50-341
==1.0      INTRODUCTION AND BACKGROUND==
In Regulatory Issue Summary 2000-17, "Managing Regulatory Commitments Made by Power Reactor Licensees to the NRC Staff," dated September 21,2000, the U.S. Nuclear Regulatory Commission (NRC) informed licensees that the Nuclear Energy Institute (NEI) document NEI 99-04, "Guidelines for Managing NRC Commitment Changes," contains acceptable guidance for controlling regulatory commitments and encouraged licensees to use the NEI guidance or similar administrative controls to ensure that regulatory commitments are implemented and that changes to the regulatory commitments are evaluated and, when appropriate, reported to the NRC.
On May 27,2003, the Office of Nuclear Reactor Regulation Office (NRR) Instruction LlC-105, "Managing Regulatory Commitments Made by Licensees to the NRC," was published. LlC-105, which is publicly available electronically from the Agencywide Documents Access and Management Systems (ADAMS) Public Electronic Reading Room on the Internet at the NRC website (Accession Number ML022750041), provides the NRC staff and its stakeholders with a common reference for handling regulatory commitments made by licensees for commercial nuclear reactors to the NRC staff.
In accordance with LlC-105, NRR staff has been instructed to perform an audit of licensees' commitment management programs (CMPs) once every three years to determine whether the licensees' programs are consistent with the industry guidance in NEI 99-04, and whether regulatory commitments are being effectively implemented.
NEI-99-04 defines a "regulatory commitment" as an explicit statement to take a specific action agreed to, or volunteered by a licensee, and submitted in writing on the docket to the NRC.
NRR guidance provided in LlC-105 directs the NRR Project Manager to audit the licensee's CMP by assessing the adequacy of the licensee's implementation of a sample of commitments made to the NRC in past licensing actions (amendments, reliefs, exemptions, etc.) and activities (bulletins, generic letters, etc.). LlC-105 provides a recommendation that a regulatory commitment management audit is to be performed every three years.
Enclosure
                                                    -2 The commitments will be controlled in accordance with the licensee's CMP in accordance with NEI99-04. Any change to the regulatory commitments is subject to licensee management approval and subject to the procedural controls established at the plant for commitment management in accordance with NEI 99-04, which include appropriate notification to the NRC.
In accordance with NEI 99-04, the NRC is informed of any regulatory commitment change that has safety or regulatory significance. The attached Table provides the list of commitments reviewed and the auditor's comments in the last column.
2.0      AUDIT PROCEDURE AND RESULTS An audit of the Fermi 2 CMP at the site during the period of July 31,2012, through August 3,2012. The Audit reviewed commitments made since the previous audit completed on October 23,2009. Thus this audit covers the period from October 23,2009 to July 30,2012.
The audit consisted of two major parts: (1) Review of Fermi 2's regulatory management program (2) Verification of the licensee's implementation of the commitments made to NRC that have been completed; and (3) verification of the licensee's program for managing changes to commitments made to NRC.
2.1      Verification of Licensee's Implementation of NRC Commitments The primary focus of this part of the audit is to confirm that the licensee has implemented those commitments made to the NRC as part of past licensing actions/activities. For commitments that had not yet been implemented, the NRC staff assessed whether the licensee managed regulatory commitments in an effective program for future implementation.
2.1.1    Audit Scope The audit focused on regulatory commitments (as defined above) made in writing to the NRC as a result of past licenSing actions (amendments, exemptions, reliefs, etc.) or licensing activities (response to bulletins, generic letters, etc.). Before the audit, the NRC staff searched the Official Agency Record system for licensee correspondence conveying commitments. During the last three years, the licensee did not make any new commitments. However, there were several old commitments which were modified or deleted, and therefore have been included in the audit. Some of the commitments made in Licensee Event Reports or in response to Notices of Violation were included in this audit since those were either changed or deleted even though these commitments are addressed under the NRC's inspection program.
The audit excluded certain types of commitments that are internal to licensee processes.
LlC-10Slimits the audit of commitments to those made (or those that should have been made) in writing to the NRC as a result of past licensing actions (amendments, reliefs exemptions, etc.)
or licensing activities (bulletins, generic letters, etc.). Accordingly, the audit excluded the following types of commitments:
(1)    Commitments made on the licensee's own initiative among internal organizational components.
                                                - 3 (2)    Commitments that pertain to milestones of licensing actions/activities (e.g.,
respond to an NRC request for additional information by a certain date).
Fulfillment of these commitments was indicated by the fact that the subject licensing action/activity was completed.
(3)    Commitments made as an internal reminder to take actions to comply with existing regulatory requirements such as regulations, Technical Specifications, and Updated Final Safety Analysis Reports. Fulfillment of these commitments was indicated by the licensee having taken timely action with the subject requirements.
The licensee provided the documentation to support the NRC staff's audit in each of the sample areas discussed above. The licensee's documentation included summary sheets providing the status of the commitment and appropriate backup documentation, as needed (I.e., plant procedures, examination records, and/or other plant documentation). The attached table summarizes the licensee's commitments that were audited by the NRC staff and the current status of the licensee's commitments.
2.1.2    Audit Results The licensee's commitments are tracked by the RACTS (Regulatory Action and Commitment Tracking System) process. as documented in the licensee's procedure MLS10. Revision 12. of the same name. The RACTS process uses a relatively old software technology. The software lacks productivity tools such as spell checking or grammar checking but appears to be able (1) to adequately record activities and (2) To provide an adequate method of linking together the specific documents, records and actions affected as a commitment evolves into full completion, partial completion (and the creation of successor RACTS). or "on-going closed status." RACTS uses an identifier (a 5-digit number), which is used in other documentation.
In general, the NRC staff found that the licensee's commitment tracking programs had captured the regulatory commitments that were identified by the NRC staff before the audit.
2.2      Verification of the Licensee's Program for Managing NRC Commitment Changes The NRC staff reviewed the licensee's process for managing commitment changes. The process is documented in procedure MLS 10, Revision 12. The analysis and implementation of the proposed changes are documented in Section 4.6 of the procedure and recorded on Forms MLS 10002 and MLS 10003. Section 4.6 of the procedure specifically refers to NEI 99-04. The forms were compared to similar forms in NEI 99-04, as were MLS10, Revision 12 change process flow charts. The NRC staff verified the consistency of both the forms and flow charts.
A note in MLS10, Revision 12, step 4.6.1 discusses enhancements, which are primarily to facilitate processing changes to older commitments to maintain record retention requirements and documenting changes to RACTS.
Use of the change process was observed during the examination of specific RACTS. The change process generally conformed to the guidance in NEI 99-04 and was effective in determining whether another codified change process (such as Title 10 of the Code of Federal Regulations (10 CFR) 50.59,10 CFR 50.54, or 10 CFR 50.71(e)), or a license amendment process was appropriate.


Regulatory Commitments Audit Report cc w/encl: Distribution via ListServ UNITED NUCLEAR REGULATORY WASHINGTON, D.C. 20555*0001 AUDIT REPORT BY THE OFFICE OF NUCLEAR REACTOR REGULATION REGULATORY COMMITMENTS MADE BY DETROIT EDISON COMPANY TO THE NUCLEAR REGULATORY COMMISSION FERMI 2 DOCKET NO. 50-341
                                              -4 Therefore, the NRC staff concludes that the procedures and forms used by the licensee to manage commitments and their changes are appropriate and effective.
2.3      Review to Identify Misapplied Commitments The commitments reviewed for this audit were also evaluated to determine if they had been misapplied. A commitment is considered to be misapplied if the action comprising the commitment was relied on by the NRC staff in making a regulatory decision such as a finding of public health and safety in an NRC safety evaluation (SE) associated with a licensing action.
Reliance on an action to support a regulatory decision must be elevated from a regulatory commitment to a legal obligation (e.g., license condition, condition of a relief request, regulatory exemption limitation, or condition). A commitment is also considered to have been misapplied if the commitment involves actions that were safety significant (i.e., commitments used to ensure safety).
There were no misapplied commitments during the review period. Licensee proposed several Cyber Security Plan (CSP) implementation dates as regulatory commitments, but these commitments were not relied upon for the approval of this amendment as explained in 2.3.1.
2.3.1    Review of Safety Evaluation Reports for Licensing Actions since the Last Audit to Determine if They Are Properly Captured as Commitments or Obligations In addition to the commitments selected for the audit sample, all license amendment SEs, exemptions and relief request SEs that have been issued for Fermi 2 since the last audit were identified. These documents were evaluated to determine if they contained any misapplied commitments as described above.
The Fermi 2 Cyber Security Amendment No. 185 was issued on July 28, 2011. In the SE the staff stated that the licensee proposed several CSP implementation dates as regulatory commitments. However, the NRC did not regard the CSP milestone implementation dates as regulatory commitments that can be changed unilaterally by the licensee, particularly in light of the regulatory requirement of 10 CFR 73.54, which states that implementation of the licensee's cyber security program must be consistent with the approved schedule. In other words, NRC approval is required to make any changes to the implementation schedule.
2.3      Internal Audits of Regulatory Commitment Management MLS10, Revision 12, Step 3.6 contains a statement that "RACTS files are not auditable" followed by an explanation that the RACTS entries contain the minimum information to determine RACTS status and identify supporting information. The NRC staff asked the licensee if they had performed an internal audit on Regulatory Commitment Tracking. In response, the licensee provided an internal audit report NANL-12-0045, dated July 6,2012. This was a quick hit self assessment on Regulatory Commitment Tracking which was performed by the licensee during the time frame of May 21, 2012 through June 8, 2012. This report recognized the fact that RACTS database is an old system and is not very user friendly. Fermi 2 is planning to upgrade this system in 2015.


==1.0 INTRODUCTION==
                                                  -5 2.4    Audit Results The previous audit report issued on December 11, 2009 provided audit observations and suggestions in Section 2.4. In responding to the NRC comments, the licensee performed an internal audit and generated four CARDs (09-28740,28742,28788, and 28791) to address some of these issues, thereby improving the process of management of regulatory commitments at Fermi 2. However, there were some additional observations made during this audit, which are listed below:
2.4.1  Observations and Suggestions
: 1. The Fermi 2 commitment data base RACTS does not distinguish between the NRC regulatory commitments and the plant commitments. This is true for the plant procedures also. All commitments are designated as CM which is an abbreviation of a commitment. However, interviews with various plant personnel did demonstrate that the station personnel are well aware of the distinction between the external and internal commitments. The internal commitments are pre-fixed by letters in front of the number, such as DER or CARD. The NRC regulatory commitments are only numerical with no prefix letters.
: 2. The commitment tracking and documentation process is not easy to follow without getting help from the station personnel, thus making the process less transparent.
Therefore it is extremely difficult to establish the historical trail of a commitment, and the reason for its original creation, revision or deletion.
: 3. There is no set program to review and delete commitments which may be superseded due to various reasons such as change in technology or new NRC rules. It is left to the procedure writer to initiate the change and generate a document change request. Thus some of the old commitments get carried for many years until someone realizes that they are no longer necessary.
: 4. Due to prolonged delays in revision or deletion of old commitments as stated above, there is a potential that an older commitment maybe followed which may not be applicable due to change in technology or new rules. Although, no evidence of this was found, it is still recommended that the licensee act in a timely manner to manage their regulatory commitments.
: 5. In September 1985, through-wall cracks were discovered in two main steam turbine bypass lines at the Fermi 2 plant. Subsequently, all 30" diameter and all 24" diameter lines, up to the turbine pedestal wall, were replaced with a thicker wall pipe. In addition, piping vibration was analyzed and necessary pipe supports were redesigned as part of the corrective action taken. The root cause of the problem was determined to be acoustically induced flutter of the pipe wall.
In a letter to NRC dated November 7, 1986, the licensee provided final results of Hopper's analysis indicating that the main steam turbine bypass lines are acceptable if cumulative operation with bypass valve position between 30 percent and 45 percent opened does not exceed 100 days.


AND BACKGROUND In Regulatory Issue Summary 2000-17, "Managing Regulatory Commitments Made by Power Reactor Licensees to the NRC Staff," dated September 21,2000, the U.S. Nuclear Regulatory Commission (NRC) informed licensees that the Nuclear Energy Institute (NEI) document NEI 99-04, "Guidelines for Managing NRC Commitment Changes," contains acceptable guidance for controlling regulatory commitments and encouraged licensees to use the NEI guidance or similar administrative controls to ensure that regulatory commitments are implemented and that changes to the regulatory commitments are evaluated and, when appropriate, reported to the NRC. On May 27,2003, the Office of Nuclear Reactor Regulation Office (NRR) Instruction LlC-105, "Managing Regulatory Commitments Made by Licensees to the NRC," was published.
                                                  -6 In a letter from Detroit Edison to NRC, dated February 20, 1987 (VP-NO-87 -0027), the licensee made the following commitment: "RACTS No. 87088: A record will be maintained for the cumulative operation time of the west bypass line while the bypass valve is opened between 30% and 45%:' There is no correspondence back from NRC to the licensee regarding approval or acknowledgement of this commitment.
LlC-105, which is publicly available electronically from the Agencywide Documents Access and Management Systems (ADAMS) Public Electronic Reading Room on the Internet at the NRC website (Accession Number ML022750041), provides the NRC staff and its stakeholders with a common reference for handling regulatory commitments made by licensees for commercial nuclear reactors to the NRC staff. In accordance with LlC-105, NRR staff has been instructed to perform an audit of licensees' commitment management programs (CMPs) once every three years to determine whether the licensees' programs are consistent with the industry guidance in NEI 99-04, and whether regulatory commitments are being effectively implemented.
NEI-99-04 defines a "regulatory commitment" as an explicit statement to take a specific action agreed to, or volunteered by a licensee, and submitted in writing on the docket to the NRC. NRR guidance provided in LlC-105 directs the NRR Project Manager to audit the licensee's CMP by assessing the adequacy of the licensee's implementation of a sample of commitments made to the NRC in past licensing actions (amendments, reliefs, exemptions, etc.) and activities (bulletins, generic letters, etc.). LlC-105 provides a recommendation that a regulatory commitment management audit is to be performed every three years. Enclosure 
-2 The commitments will be controlled in accordance with the licensee's CMP in accordance with NEI99-04.
Any change to the regulatory commitments is subject to licensee management approval and subject to the procedural controls established at the plant for commitment management in accordance with NEI 99-04, which include appropriate notification to the NRC. In accordance with NEI 99-04, the NRC is informed of any regulatory commitment change that has safety or regulatory significance.
The attached Table provides the list of commitments reviewed and the auditor's comments in the last column. AUDIT PROCEDURE AND RESULTS An audit of the Fermi 2 CMP at the site during the period of July 31,2012, through August 3,2012. The Audit reviewed commitments made since the previous audit completed on October 23,2009. Thus this audit covers the period from October 23,2009 to July 30,2012. The audit consisted of two major parts: (1) Review of Fermi 2's regulatory management program (2) Verification of the licensee's implementation of the commitments made to NRC that have been completed; and (3) verification of the licensee's program for managing changes to commitments made to NRC. Verification of Licensee's Implementation of NRC Commitments The primary focus of this part of the audit is to confirm that the licensee has implemented those commitments made to the NRC as part of past licensing actions/activities.
For commitments that had not yet been implemented, the NRC staff assessed whether the licensee managed regulatory commitments in an effective program for future implementation. Audit Scope The audit focused on regulatory commitments (as defined above) made in writing to the NRC as a result of past licenSing actions (amendments, exemptions, reliefs, etc.) or licensing activities (response to bulletins, generic letters, etc.). Before the audit, the NRC staff searched the Official Agency Record system for licensee correspondence conveying commitments.
During the last three years, the licensee did not make any new commitments.
However, there were several old commitments which were modified or deleted, and therefore have been included in the audit. Some of the commitments made in Licensee Event Reports or in response to Notices of Violation were included in this audit since those were either changed or deleted even though these commitments are addressed under the NRC's inspection program. The audit excluded certain types of commitments that are internal to licensee processes.
LlC-10Slimits the audit of commitments to those made (or those that should have been made) in writing to the NRC as a result of past licensing actions (amendments, reliefs exemptions, etc.) or licensing activities (bulletins, generic letters, etc.). Accordingly, the audit excluded the following types of commitments: Commitments made on the licensee's own initiative among internal organizational components. 
-Commitments that pertain to milestones of licensing actions/activities (e.g., respond to an NRC request for additional information by a certain date). Fulfillment of these commitments was indicated by the fact that the subject licensing action/activity was completed. Commitments made as an internal reminder to take actions to comply with existing regulatory requirements such as regulations, Technical Specifications, and Updated Final Safety Analysis Reports. Fulfillment of these commitments was indicated by the licensee having taken timely action with the subject requirements.
The licensee provided the documentation to support the NRC staff's audit in each of the sample areas discussed above. The licensee's documentation included summary sheets providing the status of the commitment and appropriate backup documentation, as needed (I.e., plant procedures, examination records, and/or other plant documentation).
The attached table summarizes the licensee's commitments that were audited by the NRC staff and the current status of the licensee's commitments. Audit Results The licensee's commitments are tracked by the RACTS (Regulatory Action and Commitment Tracking System) process. as documented in the licensee's procedure MLS10. Revision 12. of the same name. The RACTS process uses a relatively old software technology.
The software lacks productivity tools such as spell checking or grammar checking but appears to be able (1) to adequately record activities and (2) To provide an adequate method of linking together the specific documents, records and actions affected as a commitment evolves into full completion, partial completion (and the creation of successor RACTS). or "on-going closed status." RACTS uses an identifier (a 5-digit number), which is used in other documentation.
In general, the NRC staff found that the licensee's commitment tracking programs had captured the regulatory commitments that were identified by the NRC staff before the audit. Verification of the Licensee's Program for Managing NRC Commitment Changes The NRC staff reviewed the licensee's process for managing commitment changes. The process is documented in procedure MLS 10, Revision 12. The analysis and implementation of the proposed changes are documented in Section 4.6 of the procedure and recorded on Forms MLS 10002 and MLS 10003. Section 4.6 of the procedure specifically refers to NEI 99-04. The forms were compared to similar forms in NEI 99-04, as were MLS10, Revision 12 change process flow charts. The NRC staff verified the consistency of both the forms and flow charts. A note in MLS10, Revision 12, step 4.6.1 discusses enhancements, which are primarily to facilitate processing changes to older commitments to maintain record retention requirements and documenting changes to RACTS. Use of the change process was observed during the examination of specific RACTS. The change process generally conformed to the guidance in NEI 99-04 and was effective in determining whether another codified change process (such as Title 10 of the Code of Federal Regulations (10 CFR) 50.59,10 CFR 50.54, or 10 CFR 50.71(e)), or a license amendment process was appropriate. 
-4 Therefore, the NRC staff concludes that the procedures and forms used by the licensee to manage commitments and their changes are appropriate and effective. Review to Identify Misapplied Commitments The commitments reviewed for this audit were also evaluated to determine if they had been misapplied.
A commitment is considered to be misapplied if the action comprising the commitment was relied on by the NRC staff in making a regulatory decision such as a finding of public health and safety in an NRC safety evaluation (SE) associated with a licensing action. Reliance on an action to support a regulatory decision must be elevated from a regulatory commitment to a legal obligation (e.g., license condition, condition of a relief request, regulatory exemption limitation, or condition).
A commitment is also considered to have been misapplied if the commitment involves actions that were safety significant (i.e., commitments used to ensure safety). There were no misapplied commitments during the review period. Licensee proposed several Cyber Security Plan (CSP) implementation dates as regulatory commitments, but these commitments were not relied upon for the approval of this amendment as explained in 2.3.1. Review of Safety Evaluation Reports for Licensing Actions since the Last Audit to Determine if They Are Properly Captured as Commitments or Obligations In addition to the commitments selected for the audit sample, all license amendment SEs, exemptions and relief request SEs that have been issued for Fermi 2 since the last audit were identified.
These documents were evaluated to determine if they contained any misapplied commitments as described above. The Fermi 2 Cyber Security Amendment No. 185 was issued on July 28, 2011. In the SE the staff stated that the licensee proposed several CSP implementation dates as regulatory commitments.
However, the NRC did not regard the CSP milestone implementation dates as regulatory commitments that can be changed unilaterally by the licensee, particularly in light of the regulatory requirement of 10 CFR 73.54, which states that implementation of the licensee's cyber security program must be consistent with the approved schedule.
In other words, NRC approval is required to make any changes to the implementation schedule. Internal Audits of Regulatory Commitment Management MLS10, Revision 12, Step 3.6 contains a statement that "RACTS files are not auditable" followed by an explanation that the RACTS entries contain the minimum information to determine RACTS status and identify supporting information.
The NRC staff asked the licensee if they had performed an internal audit on Regulatory Commitment Tracking.
In response, the licensee provided an internal audit report NANL-12-0045, dated July 6,2012. This was a hit self assessment on Regulatory Commitment Tracking which was performed by the licensee during the time frame of May 21, 2012 through June 8, 2012. This report recognized the fact that RACTS database is an old system and is not very user friendly.
Fermi 2 is planning to upgrade this system in 2015. 
-5 2.4 Audit Results The previous audit report issued on December 11, 2009 provided audit observations and suggestions in Section 2.4. In responding to the NRC comments, the licensee performed an internal audit and generated four CARDs (09-28740,28742,28788, and 28791) to address some of these issues, thereby improving the process of management of regulatory commitments at Fermi 2. However, there were some additional observations made during this audit, which are listed below: 2.4.1 Observations and Suggestions The Fermi 2 commitment data base RACTS does not distinguish between the NRC regulatory commitments and the plant commitments.
This is true for the plant procedures also. All commitments are designated as CM which is an abbreviation of a commitment.
However, interviews with various plant personnel did demonstrate that the station personnel are well aware of the distinction between the external and internal commitments.
The internal commitments are pre-fixed by letters in front of the number, such as DER or CARD. The NRC regulatory commitments are only numerical with no prefix letters. The commitment tracking and documentation process is not easy to follow without getting help from the station personnel, thus making the process less transparent.
Therefore it is extremely difficult to establish the historical trail of a commitment, and the reason for its original creation, revision or deletion. There is no set program to review and delete commitments which may be superseded due to various reasons such as change in technology or new NRC rules. It is left to the procedure writer to initiate the change and generate a document change request. Thus some of the old commitments get carried for many years until someone realizes that they are no longer necessary. Due to prolonged delays in revision or deletion of old commitments as stated above, there is a potential that an older commitment maybe followed which may not be applicable due to change in technology or new rules. Although, no evidence of this was found, it is still recommended that the licensee act in a timely manner to manage their regulatory commitments. In September 1985, through-wall cracks were discovered in two main steam turbine bypass lines at the Fermi 2 plant. Subsequently, all 30" diameter and all 24" diameter lines, up to the turbine pedestal wall, were replaced with a thicker wall pipe. In addition, piping vibration was analyzed and necessary pipe supports were redesigned as part of the corrective action taken. The root cause of the problem was determined to be acoustically induced flutter of the pipe wall. In a letter to NRC dated November 7, 1986, the licensee provided final results of Hopper's analysis indicating that the main steam turbine bypass lines are acceptable if cumulative operation with bypass valve position between 30 percent and 45 percent opened does not exceed 100 days. 
-6 In a letter from Detroit Edison to NRC, dated February 20, 1987 (VP-NO-87  
-0027), the licensee made the following commitment: "RACTS No. 87088: A record will be maintained for the cumulative operation time of the west bypass line while the bypass valve is opened between 30% and 45%:' There is no correspondence back from NRC to the licensee regarding approval or acknowledgement of this commitment.
In a recent letter to NRC, the licensee deleted this commitment, since recording and reporting of the cumulative hours of operation with bypass valves open, is done by a plant computer, under another commitment (RACTS 20028). This mode of operation is limited to 100 days for the life of the plant. The licensee reports this on an annual basis and the current value is 42.91 days per Detroit Edison letter No. NRC-12-0025, dated April 26, 2012 (ADAMS Accession No. ML12118A147).
In a recent letter to NRC, the licensee deleted this commitment, since recording and reporting of the cumulative hours of operation with bypass valves open, is done by a plant computer, under another commitment (RACTS 20028). This mode of operation is limited to 100 days for the life of the plant. The licensee reports this on an annual basis and the current value is 42.91 days per Detroit Edison letter No. NRC-12-0025, dated April 26, 2012 (ADAMS Accession No. ML12118A147).
In February 20, 1987 letter, the licensee also stated that if the cumulative operating time of the west bypass line with bypass valve opened between 30 percent and 45 percent exceeds 80 days, a reassessment of the line condition will be made and appropriate actions will be taken. However, the part regarding reassessment has never been made into a commitment.
In February 20, 1987 letter, the licensee also stated that if the cumulative operating time of the west bypass line with bypass valve opened between 30 percent and 45 percent exceeds 80 days, a reassessment of the line condition will be made and appropriate actions will be taken. However, the part regarding reassessment has never been made into a commitment. This is critical since the licensee at present does not have an alternate plan if the limit of 100 days were to be exceeded. This is also important since the licensee has future plans for the license renewal of Fermi 2.
This is critical since the licensee at present does not have an alternate plan if the limit of 100 days were to be exceeded.
The licensee stated that Fermi 2 has this item on their list as an issue, which will be addressed during their application for the license renewal. This issue has been brought to the attention of Fermi 2 resident inspectors, NRR man~gement and staff and the management of Division of License Renewal, and is expected to be identified as a Time-Limited Aging Analysis for the purpose of license renewal under Part 54.
This is also important since the licensee has future plans for the license renewal of Fermi 2. The licensee stated that Fermi 2 has this item on their list as an issue, which will be addressed during their application for the license renewal. This issue has been brought to the attention of Fermi 2 resident inspectors, NRR and staff and the management of Division of License Renewal, and is expected to be identified as a Time-Limited Aging Analysis for the purpose of license renewal under Part 54.  
 
==3.0      CONCLUSION==


==3.0 CONCLUSION==
The NRC staff concludes that, based on the above audit, (1) the licensee had implemented, and is tracking for future implementation regulatory commitments; and (2) the licensee has implemented an effective program to manage regulatory commitment changes.
The implications of processing safety-related regulatory commitments in a process not subject to internal audit needs further study.
4.0     LICENSEE PERSONNEL CONTACTED FOR THIS AUDIT A. I. Hassoun Joseph M. Pendergast Norman Gerow Marc A. Brooks Michael Williams Paul Roelant Principal Contributor: M. Chawla Date: December 5, 2012


The NRC staff concludes that, based on the above audit, (1) the licensee had implemented, and is tracking for future implementation regulatory commitments; and (2) the licensee has implemented an effective program to manage regulatory commitment changes. The implications of processing safety-related regulatory commitments in a process not subject to internal audit needs further study. 4.0 LICENSEE PERSONNEL CONTACTED FOR THIS AUDIT A. I. Hassoun Joseph M. Pendergast Norman Gerow Marc A. Brooks Michael Williams Paul Roelant Principal Contributor:
ATTACHMENT
M. Chawla Date: December 5, 2012 ATTACHMENT  


==SUMMARY==
==SUMMARY==
OF AUDIT RESULTS REGULATORY COMMITMENT AUDIT PERFORMED JULY 31 -AUGUST 3.2012 FERMI Audited Fermi-2 Regulatory Commitments Subject to Audit Item No. Licensee's Commitment Tracking No. RACTS Commitment Date Licensee's Submittal Description of the Commitment Implementation Status 1 87088 02/20/1987 0027, Confirm that a record is maintained for the cumulative operation of the west main steam turbine bypass lines while the bypass valve is open between 30% and 45%. Deleted. Recording is now done by a plant computer instead of using the original plant chart recorder.
OF AUDIT RESULTS REGULATORY COMMITMENT AUDIT PERFORMED JULY 31 - AUGUST 3.2012 FERMI 2
Cumulative hours of operation are reported annually to the NRC per RACTS No. 20028. 2 20028 11/07/86 VP-86-0154 Submit the Main Steam Bypass Line Report per VP-86-0154.
 
This report can be submitted concurrently with the Annual Occupational Radiation Exposure Report, Annual Safety Relief Valve Challenge report, or Emergency Core Cooling System Cooling Performance Evaluation Model changes or errors Report. Open 3 94092 03/11/1994 IR 93-022 Changes were made to the work control and protective tagging process to ensure that proper plant conditions and protective tagging for the total work package are established before the Nuclear Shift Supervisor releases a work package. *Deleted. This commitment is no longer necessary because of a revision in the TaggingMfork Control Process from tagging the entire work package to tagging individual tasks within the work package. This revised process ensures that each task is properly tagged prior to the task being released for work to commence.
Audited Fermi-2 Regulatory Commitments Subject to Audit Licensee's   Commitment Licensee's       Description of the Commitment       Implementation Status Item Commitment Date            Submittal No.
Attachment Item No. Licensee's Commitment Tracking No. RACTS Commitment Date Licensee's Submittal Description of the Commitment Implementation Status 4 03394 07/13/1984 EF2-69210 Contracts for Non-Destructive Examination (NDE) require that personnel be qualified in accordance with IEB 83-02. This commitment is no longer necessary because the qualifications have been replaced by ASME Section XI, Appendix VIII requirements.
Tracking No.
5 88411 08/05/1988 0191 Contracts for NDE will require demonstrations of qualifications as per the Electric Power Research Institute guidelines.
RACTS 1 87088       02/20/1987   VP-NO-87    Confirm that a record is maintained   Deleted. Recording is now done by a 0027,        for the cumulative operation of the  plant computer instead of using the west main steam turbine bypass       original plant chart recorder.
This commitment is no longer necessary because the qualifications have been replaced by ASME Section XI, Appendix VIII requirements.
lines while the bypass valve is open Cumulative hours of operation are between 30% and 45%.                 reported annually to the NRC per RACTS No. 20028.
6 07797 03/14/1986 NP-86-0116 Corrective Action was to revise all Emergency Diesel Generator (EDG) operating procedures, which require slow starting, to slow start the engine at approximately 550 Revolutions Per Minute (RPM) instead of 400 RPM. This commitment is no longer necessary because EDG speed control system was replaced and does not allow the option to set the engine speed below 550 RPM. 7 20107 07/07/2003 0010 Develop access authorization status categories.
2 20028       11/07/86     VP-86-0154   Submit the Main Steam Bypass Line     Open Report per VP-86-0154. This report can be submitted concurrently with the Annual Occupational Radiation Exposure Report, Annual Safety Relief Valve Challenge report, or Emergency Core Cooling System Cooling Performance Evaluation Model changes or errors Report.
This commitment is no longer necessary because NEI 03-01 as endorsed by NRC has been implemented at Fermi 2. NEI 03-01 replaced this commitment.
3 94092       03/11/1994   IR 93-022   Changes were made to the work         Deleted. This commitment is no longer
I 8 20108 01/07/2003 0010 Verify the true identity of applications for unescorted access. This commitment is no longer necessary because NEI 03-01 as endorsed by NRC has been implemented at Fermi 2. NEI 03-01 replaced this commitment.
* control and protective tagging        necessary because of a revision in the process to ensure that proper plant  TaggingMfork Control Process from conditions and protective tagging for tagging the entire work package to the total work package are            tagging individual tasks within the work established before the Nuclear Shift  package. This revised process ensures Supervisor releases a work          that each task is properly tagged prior to package.                              the task being released for work to commence.
9 20109 01/07/2003 0010 Per NRC Order for access authorization issued on January 7, 2003, Nuclear Security will revise implementing procedures to further identity the types of records and references that may be used to satisfy these requirements.
Attachment
This commitment is no longer necessary because NEI 03-01 as endorsed by NRC has been implemented at Fermi 2. NEI 03-01 replaced this commitment. .
 
Item No. Licensee's Commitment Tracking No. RACTS Commitment Date Licensee's Submittal Description of the Commitment Implementation Status Procedures will be revised to include the elements delineated in the guidance contained in the order. 10 20110 01/07/2003 0010 Per NRC Order on Access Authorizations for updated unescorted access verify employment/unemployment history. This commitment is no longer necessary because NEI 03-01 as endorsed by NRC has been implemented at Fermi 2. NEI 03-01 replaced this commitment.
2 Licensee's   Commitment Licensee's Description of the Commitment           Implementation Status Item Commitment Date        Submittal No.
11 20111 01/07/2003 0010 Per NRC Order for access authorization issued on January 7, 2003, it is required for initial and updated unescorted access applications to undergo professionally accepted and standardized psychological evaluations.
Tracking No.
This commitment is no longer necessary because NEI 03-01 as endorsed by NRC has been implemented at Fermi 2. NEI 03-01 replaced this commitment.
RACTS 4 03394       07/13/1984 EF2-69210 Contracts for Non-Destructive           This commitment is no longer necessary Examination (NDE) require that           because the qualifications have been personnel be qualified in accordance     replaced by ASME Section XI, Appendix with IEB 83-02.                          VIII requirements.
12 20112 01/07/2003 0010 Per NRC Order for access authorization issued on January 7, 2003, to ensure inquiries for reinstatements are conducted, DECO will apply the provisions delineated in section 1.2.0 of the This commitment is no longer necessary because NEI 03-01 as endorsed by NRC has been implemented at Fermi 2. NEI 03-01 replaced this commitment.
5 88411       08/05/1988 NRC-88    Contracts for NDE will require           This commitment is no longer necessary 0191      demonstrations of qualifications as      because the qualifications have been per the Electric Power Research          replaced by ASME Section XI, Appendix Institute guidelines.                    VIII requirements.
guidance contained in the order for reinstatement of unescorted access authorization.
6 07797       03/14/1986 NP-86-0116 Corrective Action was to revise all     This commitment is no longer necessary Emergency Diesel Generator (EDG)         because EDG speed control system operating procedures, which require     was replaced and does not allow the slow starting, to slow start the        option to set the engine speed below engine at approximately 550             550 RPM.
13 20122 01/07/2003 0010 Per NRC Order for access authorization issued on January 7, 2003, personnel information management requirements will be This commitment is no longer necessary because NEI 03-01 as endorsed by NRC has been implemented at Fermi 2. NEI 03-01 replaced this commitment.
Revolutions Per Minute (RPM) instead of 400 RPM.
Item No. Licensee's Commitment Tracking No. RACTS Commitment Date Licensee's Submittal Description of the Commitment Implementation Status developed.
7 20107       07/07/2003 NRC-03    Develop access authorization status     This commitment is no longer necessary 0010      categories.                              because NEI 03-01 as endorsed by NRC has been implemented at Fermi 2.
Revise procedures to add additional guidance contained in the order for the protection, transmission, storage and access of the information obtained during a background investigation.
NEI 03-01 replaced this commitment. I 8 20108       01/07/2003 NRC-03    Verify the true identity of applications This commitment is no longer necessary 0010      for unescorted access.                  because NEI 03-01 as endorsed by NRC has been implemented at Fermi 2.
14 88383 07/25/1988 IR 88-012 Unresolved Item 88-012-07:
NEI 03-01 replaced this commitment.
Overtime for Technical Group This commitment is no longer necessary because the activity has been eliminated by the Code of Federal Regulations 10 CFR 26. 15 91241 08/16/1991 IR 91-015 Unresolved Item 91-015-06:
9 20109       01/07/2003 NRC-03    Per NRC Order for access                 This commitment is no longer necessary 0010      authorization issued on January 7,       because NEI 03-01 as endorsed by 2003, Nuclear Security will revise       NRC has been implemented at Fermi 2.
Violation of Technical Specification Overtime Limits. On approximately 390 occasions, Technical Specification required overtime limits were exceeded without appropriate management approval.
implementing procedures to further       NEI 03-01 replaced this commitment.
The deviations, which happened throughout the outage, occurred in numerous onsite departments.
identity the types of records and references that may be used to satisfy these requirements.                                                    .
 
3 Licensee's   Commitment Licensee's Description of the Commitment         Implementation Status Item Commitment Date        Submittal No.
Tracking No.
RACTS Procedures will be revised to include the elements delineated in the guidance contained in the order.
10 20110       01/07/2003 NRC-03    Per NRC Order on Access               This commitment is no longer necessary 0010      Authorizations for updated            because NEI 03-01 as endorsed by unescorted access verify              NRC has been implemented at Fermi 2.
employment/unemployment history.      NEI 03-01 replaced this commitment.
11 20111       01/07/2003 NRC-03    Per NRC Order for access             This commitment is no longer necessary 0010      authorization issued on January 7,   because NEI 03-01 as endorsed by 2003, it is required for initial and NRC has been implemented at Fermi 2.
updated unescorted access             NEI 03-01 replaced this commitment.
applications to undergo professionally accepted and standardized psychological evaluations.
12 20112        01/07/2003 NRC-03    Per NRC Order for access              This commitment is no longer necessary 0010      authorization issued on January 7,    because NEI 03-01 as endorsed by 2003, to ensure inquiries for        NRC has been implemented at Fermi 2.
reinstatements are conducted,        NEI 03-01 replaced this commitment.
DECO will apply the provisions delineated in section 1.2.0 of the guidance contained in the order for reinstatement of unescorted access authorization.
13 20122       01/07/2003 NRC-03    Per NRC Order for access             This commitment is no longer necessary 0010      authorization issued on January 7,   because NEI 03-01 as endorsed by 2003, personnel information          NRC has been implemented at Fermi 2.
management requirements will be      NEI 03-01 replaced this commitment.
 
4 Licensee's   Commitment Licensee's Description of the Commitment         Implementation Status Item Commitment Date        Submittal No.
Tracking No.
RACTS developed. Revise procedures to add additional guidance contained in the order for the protection, transmission, storage and access of the information obtained during a background investigation.
14 88383       07/25/1988 IR 88-012 Unresolved Item 88-012-07:             This commitment is no longer necessary Overtime for Technical Group          because the activity has been eliminated by the Code of Federal Regulations 10 CFR 26.
15 91241       08/16/1991 IR 91-015 Unresolved Item 91-015-06:             This commitment is no longer necessary Violation of Technical Specification   because the activity has been Overtime Limits. On approximately     eliminated by the Code of Federal 390 occasions, Technical               Regulations 10 CFR 26.
Specification required overtime limits were exceeded without appropriate management approval. The deviations, which happened throughout the outage, occurred in numerous onsite departments.
Quality Assurance (QA) initiated the subject Deviation Event Report (DER) to track resolution of the issue which the Plant Manager assigned to himself for follow up. At the end of the inspection period, Corrective Actions were under development to preclude repetition.
Quality Assurance (QA) initiated the subject Deviation Event Report (DER) to track resolution of the issue which the Plant Manager assigned to himself for follow up. At the end of the inspection period, Corrective Actions were under development to preclude repetition.
This commitment is no longer necessary because the activity has been eliminated by the Code of Federal Regulations 10 CFR 26.
 
Item No. Licensee's Commitment Tracking No. RACTS Commitment Date Licensee's Submittal Description of the Commitment Implementation Status i 16 93029 01/15/1993 0137 Reply to Notice of Violation 01, "Ineffective Corrective Actions for Overtime Violations" FIP-AD4-03 will be revised to contain additional guidance to track overtime, to define shift turnover and to define work periods. Emphasis will be placed on the process for submitting and approving staffing deviation forms. Overtime restrictions will be limited to those situations defined in Technical Specification Section 6.2.2.F. This commitment is no longer necessary because the activity has been eliminated by the Code of Federal Regulations 10 CFR 26.
5 Licensee's   Commitment Licensee's Description of the Commitment         Implementation Status Item Commitment Date        Submittal No.
J. Plona -2 However, as described in the enclosed audit report, there were additional observations made during the audit. which were discussed with the licensee during the exit meeting on August 3. 2012. The NRC staff appreciates the resources that were made available by your staff during the audit. If you have any questions, please have your staff contact me at (301) 415-8371.
Tracking No.
Sincerely, IRAJ Mahesh Chawla, Project Manager Plant Licensing Branch 111-1 Division of Operating Reactor Licensing Office of Nuclear Reactor Regulation Docket No. 50-341  
RACTS                                                                                                          i 16 93029       01/15/1993 NRC-92    Reply to Notice of Violation 92-017  This commitment is no longer necessary 0137      01, "Ineffective Corrective Actions   because the activity has been for Overtime Violations" FIP-AD4-03   eliminated by the Code of Federal will be revised to contain additional Regulations 10 CFR 26.
guidance to track overtime, to define shift turnover and to define work periods. Emphasis will be placed on the process for submitting and approving staffing deviation forms.
Overtime restrictions will be limited to those situations defined in Technical Specification Section 6.2.2.F.
 
J. Plona                                   -2 ~
However, as described in the enclosed audit report, there were additional observations made during the audit. which were discussed with the licensee during the exit meeting on August 3.
2012. The NRC staff appreciates the resources that were made available by your staff during the audit. If you have any questions, please have your staff contact me at (301) 415-8371.
Sincerely, IRAJ Mahesh Chawla, Project Manager Plant Licensing Branch 111-1 Division of Operating Reactor Licensing Office of Nuclear Reactor Regulation Docket No. 50-341


==Enclosure:==
==Enclosure:==
Regulatory Commitments Audit Report cc w/encl: Distribution via ListServ DISTRIBUTION:
Regulatory Commitments Audit Report cc w/encl: Distribution via ListServ DISTRIBUTION:
PUBLIC RidsNrrDlrRapb Resource LPLlII-1 RtF RidsNrrDlrRasb Resource RidsNrrPM Fermi2 RidsNrrDlrRarb Resource RidsNrrLABTully RidsOgcRp RidsNrrDorlLpl3-1 RidsRgn3MailCenter RidsAcrsAcnw_MailCTR RidsNrrDorlDpr ML NRR/LPL3-1/PM NRR/LPL3-1/LA NRR/LPL3-1/BC MChawla BTuily RCarlson 12/03/12 12 12/05/12 OFFICIAL RECORD COpy}}
PUBLIC                                 RidsNrrDlrRapb Resource LPLlII-1 RtF                           RidsNrrDlrRasb Resource RidsNrrPM Fermi2                       RidsNrrDlrRarb Resource RidsNrrLABTully RidsOgcRp RidsNrrDorlLpl3-1 RidsRgn3MailCenter RidsAcrsAcnw_MailCTR RidsNrrDorlDpr ML12324A273 NRR/LPL3-1/PM           NRR/LPL3-1/LA           NRR/LPL3-1/BC MChawla                 BTuily                   RCarlson Ir-----~-----------------
12/03/12                       12               12/05/12 OFFICIAL RECORD COpy}}

Latest revision as of 19:55, 11 November 2019

Audit of the Licensee'S Manangment of Regulatory Commitments
ML12324A273
Person / Time
Site: Fermi DTE Energy icon.png
Issue date: 12/05/2012
From: Mahesh Chawla
Plant Licensing Branch III
To: Plona J
Detroit Edison, Co
Chawla, Mac
References
TAC ME8996
Download: ML12324A273 (15)
v • d • e


Text

UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555"()001 December 5, 2012 Mr. Joseph H. Plona Senior Vice President and Chief Nuclear Officer Detroit Edison Company Fermi, Unit 2 6400 North Dixie Highway Newport, MI 48166

SUBJECT:

FERMI 2 - AUDIT OF THE LICENSEE'S MANAGEMENT OF REGULATORY COMMITMENTS (TAC NO. ME8996)

Dear Mr. Plona:

In Regulatory Issue Summary 2000-17, "Managing Regulatory Commitments Made by Power Reactor Licensees to the NRC Staff," dated September 21, 2000, the U.S. Nuclear Regulatory Commission (NRC) informed licensees that the Nuclear Energy Institute (NEI) document NEI 99-04, "Guidelines for Managing NRC Commitment Changes," contains acceptable guidance for controlling regulatory commitments and encouraged licensees to use the NEI guidance or similar administrative controls to ensure that regulatory commitments are implemented and that changes to the regulatory commitments are evaluated and, when appropriate, reported to the NRC.

On May 27, 2003, the Office of Nuclear Reactor Regulation Office (NRR) Instruction LlC-105, "Managing Regulatory Commitments Made by Licensees to the NRC," was published. LlC-105, which is publicly available electronica"y from the Agencywide Documents Access and Management Systems (ADAMS) Public Electronic Reading Room on the Internet at the NRC website (ADAMS Accession No. ML022750041) provides the NRC staff and its stakeholders with a common reference for handling regulatory commitments made by licensees for commercial nuclear reactors to the NRC staff.

In accordance with LlC-105, the NRR staff has been instructed to perform an audit of licensees' commitment management programs (CMP) once every three years to determine whether the licensees' programs are consistent with the industry guidance in NEI 99-04, and whether regulatory commitments are being effectively implemented.

An audit of Fermi 2 CMP was performed at the plant site during the period of July 31,2012 through August 3,2012. The NRC staff concludes, based on the audit, that (1) Fermi's program for managing Regulatory commitments is generally consistent with NEI 99-04, (2) Fermi 2 had implemented NRC commitments on a timely basis; (3) Fermi 2 has implemented an effective program to manage regulatory commitment changes, and (4) there were no misapplied commitments, Details of the audit are set forth in the enclosed audit report,

J. Plona - 2 However, as described in the enclosed audit report, there were additional observations made during the audit, which were discussed with the licensee during the exit meeting on August 3, 2012. The NRC staff appreciates the resources that were made available by your staff during the audit. If you have any questions, please have your staff contact me at (301) 415-8371.

Sincerely, Mahesh Chawla, Project Manager Plant Licensing Branch 111-1 Division of Operating Reactor Licensing Office of Nuclear Reactor Regulation Docket No. 50-341

Enclosure:

Regulatory Commitments Audit Report cc w/encl: Distribution via ListServ

UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555*0001 AUDIT REPORT BY THE OFFICE OF NUCLEAR REACTOR REGULATION REGULATORY COMMITMENTS MADE BY DETROIT EDISON COMPANY TO THE NUCLEAR REGULATORY COMMISSION FERMI 2 DOCKET NO. 50-341

1.0 INTRODUCTION AND BACKGROUND

In Regulatory Issue Summary 2000-17, "Managing Regulatory Commitments Made by Power Reactor Licensees to the NRC Staff," dated September 21,2000, the U.S. Nuclear Regulatory Commission (NRC) informed licensees that the Nuclear Energy Institute (NEI) document NEI 99-04, "Guidelines for Managing NRC Commitment Changes," contains acceptable guidance for controlling regulatory commitments and encouraged licensees to use the NEI guidance or similar administrative controls to ensure that regulatory commitments are implemented and that changes to the regulatory commitments are evaluated and, when appropriate, reported to the NRC.

On May 27,2003, the Office of Nuclear Reactor Regulation Office (NRR) Instruction LlC-105, "Managing Regulatory Commitments Made by Licensees to the NRC," was published. LlC-105, which is publicly available electronically from the Agencywide Documents Access and Management Systems (ADAMS) Public Electronic Reading Room on the Internet at the NRC website (Accession Number ML022750041), provides the NRC staff and its stakeholders with a common reference for handling regulatory commitments made by licensees for commercial nuclear reactors to the NRC staff.

In accordance with LlC-105, NRR staff has been instructed to perform an audit of licensees' commitment management programs (CMPs) once every three years to determine whether the licensees' programs are consistent with the industry guidance in NEI 99-04, and whether regulatory commitments are being effectively implemented.

NEI-99-04 defines a "regulatory commitment" as an explicit statement to take a specific action agreed to, or volunteered by a licensee, and submitted in writing on the docket to the NRC.

NRR guidance provided in LlC-105 directs the NRR Project Manager to audit the licensee's CMP by assessing the adequacy of the licensee's implementation of a sample of commitments made to the NRC in past licensing actions (amendments, reliefs, exemptions, etc.) and activities (bulletins, generic letters, etc.). LlC-105 provides a recommendation that a regulatory commitment management audit is to be performed every three years.

Enclosure

-2 The commitments will be controlled in accordance with the licensee's CMP in accordance with NEI99-04. Any change to the regulatory commitments is subject to licensee management approval and subject to the procedural controls established at the plant for commitment management in accordance with NEI 99-04, which include appropriate notification to the NRC.

In accordance with NEI 99-04, the NRC is informed of any regulatory commitment change that has safety or regulatory significance. The attached Table provides the list of commitments reviewed and the auditor's comments in the last column.

2.0 AUDIT PROCEDURE AND RESULTS An audit of the Fermi 2 CMP at the site during the period of July 31,2012, through August 3,2012. The Audit reviewed commitments made since the previous audit completed on October 23,2009. Thus this audit covers the period from October 23,2009 to July 30,2012.

The audit consisted of two major parts: (1) Review of Fermi 2's regulatory management program (2) Verification of the licensee's implementation of the commitments made to NRC that have been completed; and (3) verification of the licensee's program for managing changes to commitments made to NRC.

2.1 Verification of Licensee's Implementation of NRC Commitments The primary focus of this part of the audit is to confirm that the licensee has implemented those commitments made to the NRC as part of past licensing actions/activities. For commitments that had not yet been implemented, the NRC staff assessed whether the licensee managed regulatory commitments in an effective program for future implementation.

2.1.1 Audit Scope The audit focused on regulatory commitments (as defined above) made in writing to the NRC as a result of past licenSing actions (amendments, exemptions, reliefs, etc.) or licensing activities (response to bulletins, generic letters, etc.). Before the audit, the NRC staff searched the Official Agency Record system for licensee correspondence conveying commitments. During the last three years, the licensee did not make any new commitments. However, there were several old commitments which were modified or deleted, and therefore have been included in the audit. Some of the commitments made in Licensee Event Reports or in response to Notices of Violation were included in this audit since those were either changed or deleted even though these commitments are addressed under the NRC's inspection program.

The audit excluded certain types of commitments that are internal to licensee processes.

LlC-10Slimits the audit of commitments to those made (or those that should have been made) in writing to the NRC as a result of past licensing actions (amendments, reliefs exemptions, etc.)

or licensing activities (bulletins, generic letters, etc.). Accordingly, the audit excluded the following types of commitments:

(1) Commitments made on the licensee's own initiative among internal organizational components.

- 3 (2) Commitments that pertain to milestones of licensing actions/activities (e.g.,

respond to an NRC request for additional information by a certain date).

Fulfillment of these commitments was indicated by the fact that the subject licensing action/activity was completed.

(3) Commitments made as an internal reminder to take actions to comply with existing regulatory requirements such as regulations, Technical Specifications, and Updated Final Safety Analysis Reports. Fulfillment of these commitments was indicated by the licensee having taken timely action with the subject requirements.

The licensee provided the documentation to support the NRC staff's audit in each of the sample areas discussed above. The licensee's documentation included summary sheets providing the status of the commitment and appropriate backup documentation, as needed (I.e., plant procedures, examination records, and/or other plant documentation). The attached table summarizes the licensee's commitments that were audited by the NRC staff and the current status of the licensee's commitments.

2.1.2 Audit Results The licensee's commitments are tracked by the RACTS (Regulatory Action and Commitment Tracking System) process. as documented in the licensee's procedure MLS10. Revision 12. of the same name. The RACTS process uses a relatively old software technology. The software lacks productivity tools such as spell checking or grammar checking but appears to be able (1) to adequately record activities and (2) To provide an adequate method of linking together the specific documents, records and actions affected as a commitment evolves into full completion, partial completion (and the creation of successor RACTS). or "on-going closed status." RACTS uses an identifier (a 5-digit number), which is used in other documentation.

In general, the NRC staff found that the licensee's commitment tracking programs had captured the regulatory commitments that were identified by the NRC staff before the audit.

2.2 Verification of the Licensee's Program for Managing NRC Commitment Changes The NRC staff reviewed the licensee's process for managing commitment changes. The process is documented in procedure MLS 10, Revision 12. The analysis and implementation of the proposed changes are documented in Section 4.6 of the procedure and recorded on Forms MLS 10002 and MLS 10003. Section 4.6 of the procedure specifically refers to NEI 99-04. The forms were compared to similar forms in NEI 99-04, as were MLS10, Revision 12 change process flow charts. The NRC staff verified the consistency of both the forms and flow charts.

A note in MLS10, Revision 12, step 4.6.1 discusses enhancements, which are primarily to facilitate processing changes to older commitments to maintain record retention requirements and documenting changes to RACTS.

Use of the change process was observed during the examination of specific RACTS. The change process generally conformed to the guidance in NEI 99-04 and was effective in determining whether another codified change process (such as Title 10 of the Code of Federal Regulations (10 CFR) 50.59,10 CFR 50.54, or 10 CFR 50.71(e)), or a license amendment process was appropriate.

-4 Therefore, the NRC staff concludes that the procedures and forms used by the licensee to manage commitments and their changes are appropriate and effective.

2.3 Review to Identify Misapplied Commitments The commitments reviewed for this audit were also evaluated to determine if they had been misapplied. A commitment is considered to be misapplied if the action comprising the commitment was relied on by the NRC staff in making a regulatory decision such as a finding of public health and safety in an NRC safety evaluation (SE) associated with a licensing action.

Reliance on an action to support a regulatory decision must be elevated from a regulatory commitment to a legal obligation (e.g., license condition, condition of a relief request, regulatory exemption limitation, or condition). A commitment is also considered to have been misapplied if the commitment involves actions that were safety significant (i.e., commitments used to ensure safety).

There were no misapplied commitments during the review period. Licensee proposed several Cyber Security Plan (CSP) implementation dates as regulatory commitments, but these commitments were not relied upon for the approval of this amendment as explained in 2.3.1.

2.3.1 Review of Safety Evaluation Reports for Licensing Actions since the Last Audit to Determine if They Are Properly Captured as Commitments or Obligations In addition to the commitments selected for the audit sample, all license amendment SEs, exemptions and relief request SEs that have been issued for Fermi 2 since the last audit were identified. These documents were evaluated to determine if they contained any misapplied commitments as described above.

The Fermi 2 Cyber Security Amendment No. 185 was issued on July 28, 2011. In the SE the staff stated that the licensee proposed several CSP implementation dates as regulatory commitments. However, the NRC did not regard the CSP milestone implementation dates as regulatory commitments that can be changed unilaterally by the licensee, particularly in light of the regulatory requirement of 10 CFR 73.54, which states that implementation of the licensee's cyber security program must be consistent with the approved schedule. In other words, NRC approval is required to make any changes to the implementation schedule.

2.3 Internal Audits of Regulatory Commitment Management MLS10, Revision 12, Step 3.6 contains a statement that "RACTS files are not auditable" followed by an explanation that the RACTS entries contain the minimum information to determine RACTS status and identify supporting information. The NRC staff asked the licensee if they had performed an internal audit on Regulatory Commitment Tracking. In response, the licensee provided an internal audit report NANL-12-0045, dated July 6,2012. This was a quick hit self assessment on Regulatory Commitment Tracking which was performed by the licensee during the time frame of May 21, 2012 through June 8, 2012. This report recognized the fact that RACTS database is an old system and is not very user friendly. Fermi 2 is planning to upgrade this system in 2015.

-5 2.4 Audit Results The previous audit report issued on December 11, 2009 provided audit observations and suggestions in Section 2.4. In responding to the NRC comments, the licensee performed an internal audit and generated four CARDs (09-28740,28742,28788, and 28791) to address some of these issues, thereby improving the process of management of regulatory commitments at Fermi 2. However, there were some additional observations made during this audit, which are listed below:

2.4.1 Observations and Suggestions

1. The Fermi 2 commitment data base RACTS does not distinguish between the NRC regulatory commitments and the plant commitments. This is true for the plant procedures also. All commitments are designated as CM which is an abbreviation of a commitment. However, interviews with various plant personnel did demonstrate that the station personnel are well aware of the distinction between the external and internal commitments. The internal commitments are pre-fixed by letters in front of the number, such as DER or CARD. The NRC regulatory commitments are only numerical with no prefix letters.
2. The commitment tracking and documentation process is not easy to follow without getting help from the station personnel, thus making the process less transparent.

Therefore it is extremely difficult to establish the historical trail of a commitment, and the reason for its original creation, revision or deletion.

3. There is no set program to review and delete commitments which may be superseded due to various reasons such as change in technology or new NRC rules. It is left to the procedure writer to initiate the change and generate a document change request. Thus some of the old commitments get carried for many years until someone realizes that they are no longer necessary.
4. Due to prolonged delays in revision or deletion of old commitments as stated above, there is a potential that an older commitment maybe followed which may not be applicable due to change in technology or new rules. Although, no evidence of this was found, it is still recommended that the licensee act in a timely manner to manage their regulatory commitments.
5. In September 1985, through-wall cracks were discovered in two main steam turbine bypass lines at the Fermi 2 plant. Subsequently, all 30" diameter and all 24" diameter lines, up to the turbine pedestal wall, were replaced with a thicker wall pipe. In addition, piping vibration was analyzed and necessary pipe supports were redesigned as part of the corrective action taken. The root cause of the problem was determined to be acoustically induced flutter of the pipe wall.

In a letter to NRC dated November 7, 1986, the licensee provided final results of Hopper's analysis indicating that the main steam turbine bypass lines are acceptable if cumulative operation with bypass valve position between 30 percent and 45 percent opened does not exceed 100 days.

-6 In a letter from Detroit Edison to NRC, dated February 20, 1987 (VP-NO-87 -0027), the licensee made the following commitment: "RACTS No. 87088: A record will be maintained for the cumulative operation time of the west bypass line while the bypass valve is opened between 30% and 45%:' There is no correspondence back from NRC to the licensee regarding approval or acknowledgement of this commitment.

In a recent letter to NRC, the licensee deleted this commitment, since recording and reporting of the cumulative hours of operation with bypass valves open, is done by a plant computer, under another commitment (RACTS 20028). This mode of operation is limited to 100 days for the life of the plant. The licensee reports this on an annual basis and the current value is 42.91 days per Detroit Edison letter No. NRC-12-0025, dated April 26, 2012 (ADAMS Accession No. ML12118A147).

In February 20, 1987 letter, the licensee also stated that if the cumulative operating time of the west bypass line with bypass valve opened between 30 percent and 45 percent exceeds 80 days, a reassessment of the line condition will be made and appropriate actions will be taken. However, the part regarding reassessment has never been made into a commitment. This is critical since the licensee at present does not have an alternate plan if the limit of 100 days were to be exceeded. This is also important since the licensee has future plans for the license renewal of Fermi 2.

The licensee stated that Fermi 2 has this item on their list as an issue, which will be addressed during their application for the license renewal. This issue has been brought to the attention of Fermi 2 resident inspectors, NRR man~gement and staff and the management of Division of License Renewal, and is expected to be identified as a Time-Limited Aging Analysis for the purpose of license renewal under Part 54.

3.0 CONCLUSION

The NRC staff concludes that, based on the above audit, (1) the licensee had implemented, and is tracking for future implementation regulatory commitments; and (2) the licensee has implemented an effective program to manage regulatory commitment changes.

The implications of processing safety-related regulatory commitments in a process not subject to internal audit needs further study.

4.0 LICENSEE PERSONNEL CONTACTED FOR THIS AUDIT A. I. Hassoun Joseph M. Pendergast Norman Gerow Marc A. Brooks Michael Williams Paul Roelant Principal Contributor: M. Chawla Date: December 5, 2012

ATTACHMENT

SUMMARY

OF AUDIT RESULTS REGULATORY COMMITMENT AUDIT PERFORMED JULY 31 - AUGUST 3.2012 FERMI 2

Audited Fermi-2 Regulatory Commitments Subject to Audit Licensee's Commitment Licensee's Description of the Commitment Implementation Status Item Commitment Date Submittal No.

Tracking No.

RACTS 1 87088 02/20/1987 VP-NO-87 Confirm that a record is maintained Deleted. Recording is now done by a 0027, for the cumulative operation of the plant computer instead of using the west main steam turbine bypass original plant chart recorder.

lines while the bypass valve is open Cumulative hours of operation are between 30% and 45%. reported annually to the NRC per RACTS No. 20028.

2 20028 11/07/86 VP-86-0154 Submit the Main Steam Bypass Line Open Report per VP-86-0154. This report can be submitted concurrently with the Annual Occupational Radiation Exposure Report, Annual Safety Relief Valve Challenge report, or Emergency Core Cooling System Cooling Performance Evaluation Model changes or errors Report.

3 94092 03/11/1994 IR 93-022 Changes were made to the work Deleted. This commitment is no longer

  • control and protective tagging necessary because of a revision in the process to ensure that proper plant TaggingMfork Control Process from conditions and protective tagging for tagging the entire work package to the total work package are tagging individual tasks within the work established before the Nuclear Shift package. This revised process ensures Supervisor releases a work that each task is properly tagged prior to package. the task being released for work to commence.

Attachment

2 Licensee's Commitment Licensee's Description of the Commitment Implementation Status Item Commitment Date Submittal No.

Tracking No.

RACTS 4 03394 07/13/1984 EF2-69210 Contracts for Non-Destructive This commitment is no longer necessary Examination (NDE) require that because the qualifications have been personnel be qualified in accordance replaced by ASME Section XI, Appendix with IEB 83-02. VIII requirements.

5 88411 08/05/1988 NRC-88 Contracts for NDE will require This commitment is no longer necessary 0191 demonstrations of qualifications as because the qualifications have been per the Electric Power Research replaced by ASME Section XI, Appendix Institute guidelines. VIII requirements.

6 07797 03/14/1986 NP-86-0116 Corrective Action was to revise all This commitment is no longer necessary Emergency Diesel Generator (EDG) because EDG speed control system operating procedures, which require was replaced and does not allow the slow starting, to slow start the option to set the engine speed below engine at approximately 550 550 RPM.

Revolutions Per Minute (RPM) instead of 400 RPM.

7 20107 07/07/2003 NRC-03 Develop access authorization status This commitment is no longer necessary 0010 categories. because NEI 03-01 as endorsed by NRC has been implemented at Fermi 2.

NEI 03-01 replaced this commitment. I 8 20108 01/07/2003 NRC-03 Verify the true identity of applications This commitment is no longer necessary 0010 for unescorted access. because NEI 03-01 as endorsed by NRC has been implemented at Fermi 2.

NEI 03-01 replaced this commitment.

9 20109 01/07/2003 NRC-03 Per NRC Order for access This commitment is no longer necessary 0010 authorization issued on January 7, because NEI 03-01 as endorsed by 2003, Nuclear Security will revise NRC has been implemented at Fermi 2.

implementing procedures to further NEI 03-01 replaced this commitment.

identity the types of records and references that may be used to satisfy these requirements. .

3 Licensee's Commitment Licensee's Description of the Commitment Implementation Status Item Commitment Date Submittal No.

Tracking No.

RACTS Procedures will be revised to include the elements delineated in the guidance contained in the order.

10 20110 01/07/2003 NRC-03 Per NRC Order on Access This commitment is no longer necessary 0010 Authorizations for updated because NEI 03-01 as endorsed by unescorted access verify NRC has been implemented at Fermi 2.

employment/unemployment history. NEI 03-01 replaced this commitment.

11 20111 01/07/2003 NRC-03 Per NRC Order for access This commitment is no longer necessary 0010 authorization issued on January 7, because NEI 03-01 as endorsed by 2003, it is required for initial and NRC has been implemented at Fermi 2.

updated unescorted access NEI 03-01 replaced this commitment.

applications to undergo professionally accepted and standardized psychological evaluations.

12 20112 01/07/2003 NRC-03 Per NRC Order for access This commitment is no longer necessary 0010 authorization issued on January 7, because NEI 03-01 as endorsed by 2003, to ensure inquiries for NRC has been implemented at Fermi 2.

reinstatements are conducted, NEI 03-01 replaced this commitment.

DECO will apply the provisions delineated in section 1.2.0 of the guidance contained in the order for reinstatement of unescorted access authorization.

13 20122 01/07/2003 NRC-03 Per NRC Order for access This commitment is no longer necessary 0010 authorization issued on January 7, because NEI 03-01 as endorsed by 2003, personnel information NRC has been implemented at Fermi 2.

management requirements will be NEI 03-01 replaced this commitment.

4 Licensee's Commitment Licensee's Description of the Commitment Implementation Status Item Commitment Date Submittal No.

Tracking No.

RACTS developed. Revise procedures to add additional guidance contained in the order for the protection, transmission, storage and access of the information obtained during a background investigation.

14 88383 07/25/1988 IR 88-012 Unresolved Item 88-012-07: This commitment is no longer necessary Overtime for Technical Group because the activity has been eliminated by the Code of Federal Regulations 10 CFR 26.

15 91241 08/16/1991 IR 91-015 Unresolved Item 91-015-06: This commitment is no longer necessary Violation of Technical Specification because the activity has been Overtime Limits. On approximately eliminated by the Code of Federal 390 occasions, Technical Regulations 10 CFR 26.

Specification required overtime limits were exceeded without appropriate management approval. The deviations, which happened throughout the outage, occurred in numerous onsite departments.

Quality Assurance (QA) initiated the subject Deviation Event Report (DER) to track resolution of the issue which the Plant Manager assigned to himself for follow up. At the end of the inspection period, Corrective Actions were under development to preclude repetition.

5 Licensee's Commitment Licensee's Description of the Commitment Implementation Status Item Commitment Date Submittal No.

Tracking No.

RACTS i 16 93029 01/15/1993 NRC-92 Reply to Notice of Violation 92-017 This commitment is no longer necessary 0137 01, "Ineffective Corrective Actions because the activity has been for Overtime Violations" FIP-AD4-03 eliminated by the Code of Federal will be revised to contain additional Regulations 10 CFR 26.

guidance to track overtime, to define shift turnover and to define work periods. Emphasis will be placed on the process for submitting and approving staffing deviation forms.

Overtime restrictions will be limited to those situations defined in Technical Specification Section 6.2.2.F.

J. Plona -2 ~

However, as described in the enclosed audit report, there were additional observations made during the audit. which were discussed with the licensee during the exit meeting on August 3.

2012. The NRC staff appreciates the resources that were made available by your staff during the audit. If you have any questions, please have your staff contact me at (301) 415-8371.

Sincerely, IRAJ Mahesh Chawla, Project Manager Plant Licensing Branch 111-1 Division of Operating Reactor Licensing Office of Nuclear Reactor Regulation Docket No. 50-341

Enclosure:

Regulatory Commitments Audit Report cc w/encl: Distribution via ListServ DISTRIBUTION:

PUBLIC RidsNrrDlrRapb Resource LPLlII-1 RtF RidsNrrDlrRasb Resource RidsNrrPM Fermi2 RidsNrrDlrRarb Resource RidsNrrLABTully RidsOgcRp RidsNrrDorlLpl3-1 RidsRgn3MailCenter RidsAcrsAcnw_MailCTR RidsNrrDorlDpr ML12324A273 NRR/LPL3-1/PM NRR/LPL3-1/LA NRR/LPL3-1/BC MChawla BTuily RCarlson Ir-----~-----------------

12/03/12 12 12/05/12 OFFICIAL RECORD COpy

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