Attachment_J-8_-_2_of_4_NUREG-1757_Vol_1.pdf

DECOMMISSIONING PLANS: PROGRAM ORGANIZATION

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ACCEPTANCE CRITERIA

Information to be Submitted

The information supplied by the licensee should be sufficient to allow the staff to fully understand the types, volumes, and activities of mixed waste generated during decommissioning operations and the manner in which the licensee intends to manage and dispose of the wastes.

The staff’s review should verify that the following information is included in the mixed waste section of the facility DP:

a summary of the types of solid and liquid mixed waste that are expected to be generated during decommissioning operations;

a summary of the estimated volumes, in cubic feet, of each solid mixed waste type summarized under bullet 1 above and in liters for each liquid mixed waste;

a summary of the radionuclides (including the estimated activity of each radionuclide) in each type of mixed waste type summarized under bullet 1 above;

a summary of the estimated volumes of Class A, B, C and Greater-than-Class-C mixed waste that will be generated by decommissioning operations;

a description of how and where each of the mixed wastes summarized under bullet 1 above, will be stored onsite prior to shipment for disposal;

a description of how the each of the mixed wastes summarized under bullet 1 above, will be treated and packaged to meet disposal site acceptance criteria prior to shipment for disposal;

the name and location of the disposal facility that the licensee intends to use for each mixed waste type summarized under bullet 1 above;

a discussion of the requirements of all other regulatory agencies having jurisdiction over the mixed waste; and a demonstration that the licensee possesses the appropriate EPA or State permits to generate, store and/or treat the mixed wastes.

EVALUATION FINDINGS

Evaluation Criteria

The staff should verify that the information summarized under “Information to be Submitted,” above, is included in the licensee’s description of the liquid radioactive waste management program. The staff should verify that the licensee’s program for the management of mixed waste complies with NRC requirements at 10 CFR Part 20, Subpart K, 61.55, 61.56, 61.57 and 71.5.

The staff should make a qualitative assessment of the accuracy of the licensee’s descriptions of the types, volumes, and activities of mixed waste by comparing it to the information presented in the facility description, planned decommissioning activities, and radiological status portions of

NUREG - 1757, Vol. 1, Rev. 2 17-54 the DP. The staff should make a qualitative assessment of the licensee’s proposed methods to store mixed waste prior to disposal. The staff should verify that the waste disposal locations are appropriate for the mixed wastes generated during decommissioning by comparing the mixed waste generated by the decommissioning operations to publicly available information on the types of mixed wastes that are accepted by the disposal facility.

Note that the NRC staff is NOT responsible for ensuring that the licensee’s program complies with the requirements of 40 CFR 260–270 or the Department of Transportation regulations pertaining to the transportation of the hazardous component of the mixed waste. The staff should make a qualitative assessment of the acceptability of the licensee’s descriptions of the methods they will employ to comply with the requirements of other agencies with regulatory responsibility for the mixed waste.

Sample Evaluation Findings

None. The staff should combine the evaluation finding for the licensee’s description of mixed waste management programs with the findings for the remaining areas in this section of the guidance (see Section 17.5.1).

17.6 DECOMMISSIONING PLAN: QUALITY ASSURANCE PROGRAM

OVERVIEW

The staff should review the information supplied by the licensee to determine if the description of the quality assurance (QA) program is adequate to allow the staff to conclude that the licensee has adequate controls in place to support the decommissioning. Further, if the licensee effectively implements the QA program described, the data collected should be accurate and of sufficient quality to justify the conclusions drawn from the information. This information should include the following:

a description of the organization responsible for implementing the QA program;

a description of the QA program, including descriptions of the manner in which QA activities are controlled; a description of the manner in which QA program documents are controlled;

a description of how measuring and test equipment is controlled;

a description of how conditions adverse to quality are corrected; a description of the QA records that will be maintained; and a description of the audits and surveillances that are performed as part of the QA program.

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REVIEW PROCEDURES

Safety Evaluation

The material to be reviewed is informational in nature, and no specific detailed technical analysis is required. The staff should make a qualitative assessment as to whether the licensee’s QA program is adequate to ensure that accurate, high-quality information is developed to support the decommissioning of the facility.

17.6.1 ORGANIZATION

The purpose of the review of the QA organization is to verify that the licensee has an adequate organization, sound management philosophy, and the resources necessary to ensure that the information submitted to support the decommissioning is accurate and of sufficient quality to justify the conclusions drawn from the information.

ACCEPTANCE CRITERIA

Information to be Submitted

The staff should review the licensee’s description of its organizational structure to ensure that persons and organizations performing quality affecting activities have sufficient authority and freedom to identify quality problems, provide solutions, and verify that solutions have been implemented. The staff’s review should verify that the following information is included in the description of the QA program organization:

a description of the QA program management organization;

a description of the duties and responsibilities of each unit within the organization and how delegation of responsibilities is managed within the decommissioning program;

a description of how work performance is evaluated;

a description of the authority of each unit within the QA program; and an organization chart of the QA program organization.

EVALUATION FINDINGS

Evaluation Criteria

The staff should verify that the information summarized under “Information to be Submitted,” above, is included in the licensee’s description of the QA program. The staff should verify that the organization or individual responsible for submitting the license application exercises and retains the responsibility for the establishment and execution of the overall program. The staff

NUREG - 1757, Vol. 1, Rev. 2 17-56 should verify that major delegations of work are fully described and that in each case, organizational responsibilities and methods for control of the work by the applicant are described, including how responsibility for delegated work is to be retained and exercised. The staff should verify that the licensee and its prime contractors describe how responsibility is exercised for the overall QA program and that the extent of management responsibility and authority are addressed. The staff should verify that policies regarding the implementation of the QA program are documented and made mandatory.

The staff should verify that the licensee and its contractors will evaluate the performance of work delegated to other organizations, including audits/surveillances of the contractor’s QA programs and audits/surveillances of subcontractors, consultants, and vendors furnishing equipment or services to the applicant or its contractors. The frequency and method of this evaluation should be specified.

The staff should verify that the licensee and prime contractors identify a management position that retains overall authority and responsibility for the QA program (normally, this position is filled by the QA Manager). The staff should verify that the QA Manager position is at the same or a higher organization level than the position of the highest line manager directly responsible for performing activities affecting quality (such as engineering, procurement, construction, and operation) and is sufficiently independent from cost and schedule restraints (this does not mean that the QA position must report outside of the project or program). The staff should verify that the authority and duties of persons and organizations performing functions related to meeting the performance objectives are clearly established and delineated in writing, including both the performing functions of attaining the requisite quality of work (quality achieving) and the assurance functions of verifying the attainment of quality (quality assuring). The staff should verify that designated QA personnel, sufficiently free from direct pressures resulting from cost and schedule, have the responsibility, delineated in writing, to stop unsatisfactory work and control further processing or delivery of nonconforming material.

The staff should verify that persons and organizations performing quality assurance functions have sufficient authority and organizational freedom (1) to identify quality problems, (2) to initiate, recommend, or provide solutions through designated channels, and (3) to verify implementation of solutions. The staff should verify that persons and organizations with the above authority are identified and a description of how those actions are carried out is provided.

The staff should verify that provisions are established for the resolution of disputes involving quality arising from a difference of opinion between QA personnel and other department personnel. The staff should verify that the position description ensures that the individual directly responsible for the definition, direction, and effectiveness of the overall QA program has sufficient authority to implement responsibilities effectively. This position is to be sufficiently free from cost and schedule responsibilities.

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The staff should verify that the person responsible for the onsite QA program is identified by position and has the appropriate organizational position, responsibilities, and authority to exercise proper control over the QA program.

The staff should verify that organization charts clearly identify all the onsite and offsite organizational elements that function under the cognizance of the QA program.

17.6.2 QUALITY ASSURANCE PROGRAM

The purpose of the review of the QA program is to verify that the licensee’s QA program and activities affecting quality will be controlled by written policies, procedures and instruction, which, if effectively implemented, should ensure that the information submitted to support the decommissioning is accurate and of sufficient quality to justify the conclusions drawn from the information.

ACCEPTANCE CRITERIA

Information to be Submitted

The staff should review the licensee’s QA program to determine if activities affecting quality will be conducted in accordance with written policies, procedures, and instructions, and that activities affecting quality are accomplished by suitably trained and qualified individuals. The staff should review the licensee’s QA program to ensure that quality affecting activities are prescribed by documented procedures, drawings, or instructions. The staff should verify that the following information is included in the description of the QA program:

a commitment that activities affecting the quality of site decommissioning will be subject to the applicable controls of the QA program and activities covered by the QA program are identified on program defining documents;

a brief summary of the company’s corporate QA policies;

a description of provisions to ensure that technical and quality assurance procedures required to implement the QA program are consistent with regulatory, licensing, and QA program requirements and are properly documented and controlled;

a description of the management reviews, including the documentation of concurrence in these quality-affecting procedures;

a description of the quality-affecting procedural controls of the principal contractors, including documentation of the acceptance of the controls before the initiation of activities affected by the program;

a description of how NRC will be notified of changes (a) for review and acceptance in the accepted description of the QA program as presented or referenced in the DP before implementation and (b) in organizational elements within 30 days after the announcement of

NUREG - 1757, Vol. 1, Rev. 2 17-58 the changes (note that editorial changes or personnel reassignments of a nonsubstantive nature do not require NRC notification);

a description is provided of how management (above or outside the QA organization) regularly assesses the scope, status, adequacy, and compliance of the QA program;

a description of the instruction provided to personnel responsible for performing activities affecting quality pertaining to the purpose, scope, and implementation of the quality-related manuals, instructions, and procedures;

a description of the training and qualifications of personnel verifying activities affecting quality in the principles, techniques, and requirements of the activity being performed;

for formal training and qualification programs, documentation includes attendees, date of attendance, and the objectives and content of the program;

a description of the self-assessment program to confirm that activities affecting quality comply with the QA program;

a commitment that persons performing self-assessment activities are not to have direct responsibilities in the area they are assessing;

a description of the organizational responsibilities for ensuring that activities affecting quality are (a) prescribed by documented instructions, procedures, and drawings; and

(b) accomplished through implementation of these documents; and a description of the procedures to ensure that instructions, procedures, and drawings include quantitative acceptance criteria (such as those pertaining to dimensions, tolerances, and operating limits) and qualitative acceptance criteria (such as workmanship samples) for determining that important activities have been satisfactorily performed.

EVALUATION FINDINGS

Evaluation Criteria

The staff should verify that the information summarized under “Information to be Submitted,” above, is included in the description of the QA program. Licensees are encouraged to submit the information in electronic format.

17.6.3 DOCUMENT CONTROL

The purpose of the review of the licensee’s description of how QA program documents are issued and amended is to ensure that adequate control is exercised over the development, issuance and revision of the documents.

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ACCEPTANCE CRITERIA

Regulatory Requirements

10 CFR 30.36(g)(4)(ii), 40.42(g)(4)(ii),40.28(b)(3), 70.22(f), 70.38(g)(4)(ii), and 72.54(g)(6)

Information to be Submitted

The information supplied by the licensee should be sufficient to allow the staff to understand how the licensee will develop, issue and revise documents associated with the QA program. The staff’s review should verify that the following information is included in the description of the QA document control program:

a summary of the types of QA documents included in the program; and a description of how the licensee develops, issues, revises and retires QA documents.

EVALUATION FINDINGS

Evaluation Criteria

The staff should verify that the information summarized under “Information to be Submitted,” above, is included in the licensee’s description of the QA document control program. The staff should verify that the scope of the document control program is described, and the types of controlled documents are identified. As a minimum, controlled documents include quality assurance, quality control manuals, quality-affecting procedures, and technical reports. The staff should verify that procedures for the review, approval, and issuance of documents and changes will be established and described to ensure technical adequacy and inclusion of appropriate quality requirements before implementation. The staff should verify that procedures will be established to ensure that changes to documents are reviewed and approved by the same organizations as those that performed the initial review and approval or by other qualified responsible organizations delegated by the applicant. The staff should verify that procedures will be established to ensure that documents are available at the location where the activity will be performed prior to commencing work. The staff should verify that procedures will be established to ensure that obsolete or superseded documents are removed and replaced by applicable revisions in work areas in a timely manner. Licensees are encouraged to submit the information in electronic format.

17.6.4 CONTROL OF MEASURING AND TEST EQUIPMENT

The purpose of the review of the description of the test and measurement equipment calibration program is to verify that the licensee has a program to ensure that equipment used to support decommissioning activities is properly controlled, calibrated, and maintained.

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ACCEPTANCE CRITERIA

Regulatory Requirements

10 CFR 30.36(g)(4)(ii), 40.42(g)(4)(ii), 40.28(b)(3), 70.22(f), 70.38(g)(4)(ii), and 72.54(g)(6)

Information to be Submitted

The information supplied by the licensee should be sufficient to allow the staff to fully understand the methods and procedures that the licensee will use to ensure that only accurate and calibrated test and measurement equipment will be used during the decommissioning project.

The staff’s review should verify that the following information is included in the description of the test and measurement equipment QA program:

a summary of the test and measurement equipment used in the program;

a description of how and at what frequency the equipment will be calibrated;

a description of the daily calibration checks that will be performed on each piece of test or measurement equipment; and a description of the documentation that will be maintained to demonstrate that only properly calibrated and maintained equipment was used during the decommissioning.

EVALUATION FINDINGS

Evaluation Criteria

The staff should verify that the information summarized under “Information to be Submitted,” above, is included in the licensee’s description of the test and measurement equipment program.

The staff should verify that the scope of the program for the control of measuring and test equipment is described and the types of equipment to be controlled are established. The staff should verify that QA and other organizations’ responsibilities are described for establishing, implementing, and ensuring effectiveness of the calibration and adjustment program. The staff should verify that procedures will be established for calibration (technique and frequency), maintenance, and control of the measuring and test equipment. The staff should also verify that the review of and documented concurrence in these procedures are described, and the organization responsible for these functions is identified. The staff should further verify that measuring and test equipment are identified and traceable to the calibration test data. The staff should verify that measuring and test equipment will be labeled or tagged or “otherwise controlled” to indicate due date of the next calibration. The method to “otherwise control” equipment should be described. The staff should verify that measuring and test equipment will be calibrated at specified intervals on the basis of the required accuracy, purpose, degree of usage, stability characteristics, and other conditions affecting the measurement.

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17.6.5 CORRECTIVE ACTION

The staff should review the licensee’s QA program to ensure that measures have been established to assure that conditions adverse to quality are promptly identified and corrected.

ACCEPTANCE CRITERIA

Regulatory Requirements

10 CFR 30.36(g)(4)(ii), 40.42(g)(4)(ii),40.28(b)(3), 70.22(f), 70.38(g)(4)(ii), and 72.54(g)(6)

Information to be Submitted

The information supplied by the licensee should be sufficient to allow the staff to determine whether adequate procedures and controls are in place to identify and correct conditions that will adversely affect quality. The staff’s review should verify that the following information is included in the description of the corrective action program portion of the QA program:

a description of the corrective action procedures for the facility, including a description of how the corrective action is determined to be adequate; and a description of the documentation maintained for each corrective action and any follow-up activities by the QA organization, after the corrective action is implemented.

EVALUATION FINDINGS

Evaluation Criteria

NRC staff should verify that the information summarized under “Information to be Submitted,” above, is included in the licensee’s description of the corrective action. The staff should verify that procedures will be established for a corrective action program and that the QA organization reviews and documents concurrence in the procedures. The staff should verify that corrective action will be documented and initiated following the determination of a condition adverse to quality (such as nonconformance, failure, malfunction, deficiency, deviation, and defective material and equipment) to preclude recurrence. The staff should verify that the QA organization will be included in the concurrence chain regarding the adequacy of the corrective action. The staff should verify that follow-up action will be taken by the QA organization to verify the proper implementation of corrective action and to close out the corrective action in a timely manner. The staff should verify that significant conditions adverse to quality, the cause of the conditions, and the corrective action taken to preclude repetition will be documented and reported to immediate management and upper levels of management for review and assessment.

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17.6.6 QUALITY ASSURANCE RECORDS

The purpose of the review of the QA records program is to verify that the licensee has procedures and facilities in place to adequately maintain and store the QA program records.

ACCEPTANCE CRITERIA

Regulatory Requirements

10 CFR 30.36(g)(4)(ii), 40.42(g)(4)(ii),40.28(b)(3), 70.22(f), 70.38(g)(4)(ii), and 72.54(g)(6)

Information to be Submitted

The information supplied by the licensee should be sufficient to allow the staff to fully understand the types of procedures that will be in place to manage the QA program records. The staff should verify that the following information is included in the description of the QA records program:

a description of the manner in which the QA records will be managed;

a description of the responsibilities of the QA organization as well as all other units involved in the decommissioning to implement and maintain QA records; and a description of the QA records storage facility.

EVALUATION FINDINGS

Evaluation Criteria

The staff should verify that the information summarized under “Information to be Submitted,” above, is included in the licensee’s description of the QA records program. The staff should verify that the QA records program is described, and includes results of reviews, inspections, tests, audits, and material analyses; monitoring records of work performance; and records on the qualification of personnel, procedures, and equipment. The staff should verify that QA and other organizations are identified and their responsibilities are described for the definition and implementation of activities related to QA records. The staff should verify that suitable facilities for the storage of records are described and satisfy the requirements of ANSI/ASME NQA–1.

Alternatives to the fire protection rating provisions are acceptable if record storage facilities conform to National Fire Protection Association Standard NFPA 232, Class 1, for permanent records and if the 2-hour fire-rating requirement contained in proposed ANSI N45.2.9 is met by the applicant in any one of the following three ways: (1) a 2-hour-rated vault meeting NFPA 232, (2) 2-hour-rated file containers meeting NFPA 232 (Class B), or (3) a 2-hour-rated fire resistant file room meeting NFPA 232.

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17.6.7 AUDITS AND SURVEILLANCE

The purpose of the staff’s review of the licensee’s description of audits and surveillances is to ensure that the licensee has a comprehensive system of audits planned to verify compliance with all aspects of the QA program, and to determine the effectiveness of the QA program.

ACCEPTANCE CRITERIA

Regulatory Requirements

10 CFR 30.36(g)(4)(ii), 40.42(g)(4)(ii),40.28(b)(3), 70.22(f), 70.38(g)(4)(ii), and 72.54(g)(6)

Information Criteria

The information supplied by the licensee’s should be sufficient to allow the staff to determine if the audit and surveillance program is adequate to ensure that a comprehensive system of audits planned to verify compliance with all aspects of the QA program is in place to determine the effectiveness of the QA program. The following information should be included in the description of the audit program:

a description of the audit program, including the procedures for conducting the audits or surveillances;

a description of the records and documentation generated during the audits and the manner in which the documents are managed;

a description of all followup activities associated with audits or surveillances; and a description of the trending/tracking that will be performed on the results of audits and surveillances.

EVALUATION FINDINGS

Evaluation Criteria

The staff should verify that the information summarized under “Information to be Submitted,” above, is included in the licensee’s description of the audits program for the facility. The staff should verify that audits and surveillances will be performed in accordance with pre-established written procedures or checklists and conducted by trained personnel not having direct responsibilities for the achievement of quality in the areas being audited. The staff should verify that audit and surveillance results will be documented and then reviewed with management having responsibility in the area audited. The staff should verify that provisions exist such that appropriate follow-up corrective action to audit and surveillance reports will be undertaken by responsible management and that auditing organizations schedule and conduct appropriate follow-up to assure that the corrective action is effectively accomplished. The staff should

NUREG - 1757, Vol. 1, Rev. 2 17-64 verify that both technical and QA programmatic audits and surveillances will be performed to provide a comprehensive independent verification and evaluation of procedures and activities affecting quality. The staff should verify that audits and surveillances objectively assess the effectiveness and proper implementation of the QA program and address the technical adequacy of the activities being conducted. The staff should verify that provisions will be provided such that audits and surveillances are required to be performed in all areas where the requirements of the QA program are applicable. The staff should verify that audit and surveillance deficiency data are analyzed and trended. The staff should verify that reports that indicating quality trends and the effectiveness of the QA programs will be given to management for review, assessment, corrective action, and follow up.

17.7 RESTRICTED USE

17.7.1 OVERVIEW

NRC staff should review the information supplied by the licensee to determine if the description of the activities undertaken by the licensee is adequate to allow the staff to conclude that the licensee has complied with the requirements of 10 CFR 20.1403 for those licensees who intend to request termination of their radioactive materials licenses using the restricted use provisions of 10 CFR Part 20, Subpart E.

If the licensee is requesting license termination under restricted use in 10 CFR 20.1403, this information should include: a demonstration that the licensee qualifies for license termination under 10 CFR 20.1403(a); a description of the institutional controls the licensee has instituted or plans to institute at the site; a description of the activities undertaken by the licensee to obtain advice from the public on the proposed institutional controls and the results of these activities; a demonstration that the potential doses from residual radioactive material at the site will not exceed the limits in 10 CFR 20.1403 and are ALARA; and a description of the amount and mechanism for financial assurance required under 10 CFR 20.1403(c).

The LTR established a system of controls to sustain protection at restricted use or alternate criteria sites. This approach is described in Appendix M. The total system includes the following six elements: (1) legally enforceable institutional controls; (2) engineered barriers; (3) monitoring and maintenance; (4) independent third party oversight; (5) sufficient funding; and

(6) maximum limits on dose (i.e., “dose caps”) if institutional controls fail. While elements 1, 3, 4, 5, and 6 are required by the LTR, element 2 (engineered barriers) is not required but could be used to mitigate adverse processes (e.g., infiltration or erosion) so that the dose criteria of the LTR can be met (see Section 3.5 of Volume 2 of this NUREG report). The licensee should describe how it proposes to apply the total system approach to its specific site.

The licensee should describe how it has used the risk-informed graded approach (described in Appendix M of this Volume and Section 3.5 of Volume 2 of this NUREG report) to select the appropriate institutional controls and engineered barriers for decommissioning under restricted use or alternate criteria, so that restrictions and engineered barriers are most effectively targeted

17-65 NUREG - 1757, Vol. 1, Rev. 2 and are based on duration and magnitude of the hazard. This approach is flexible and uses risk insights from dose assessments to tailor site-specific restrictions and engineered barriers that would prevent potential disruptive land uses or natural processes important to compliance with the dose criteria. Appendix M also describes how institutional controls combine with other elements, such as engineered barriers, to form a total system to sustain protection.

If a licensee cannot establish acceptable institutional controls or independent third party arrangements, the licensee may propose one of the two new options involving NRC: an NRC long-term control (LTC) license or an NRC legal agreement and restrictive covenant (LA/RC).

Both of these options are described in Appendix M of this Volume and are summarized below.

These options are new types of legally enforceable and durable institutional controls established by Commission policy (see SECY-03-0069). These options are not for the purpose of storage of radioactive materials; they are to serve as an institutional control mechanism for restricted use decommissioning. These options should not be considered a guaranteed option for decommissioning, but would be used as a last resort for those sites that could not decommission to unrestricted use levels and could not arrange for other institutional controls. Therefore, these options should not encourage or lead to the proliferation of restricted use sites. In addition, for both of these options, all the restricted use requirements of the LTR must be met, to ensure protection of the public health and safety. Furthermore, NRC is taking measures to prevent future decommissioning problem sites (including reducing the number of future restricted use sites) by considering changes to financial assurance requirements and licensee operations, as described in SECY-03-0069 and RIS-2004-08.

The LTC license option is a possession-only license that would be used to satisfy the LTR requirement for legally enforceable and durable (if needed) institutional controls. The conditions of the LTC license would require the licensee to maintain restrictions on site use and any necessary monitoring, maintenance, and reporting. NRC would use inspections and enforcement, if needed, to assure that the licensee’s controls and other activities are effective.

The LA/RC option is a combination of a legal agreement and restrictive covenant that provides a legally enforceable and durable institutional control, with the NRC having an oversight role.

Under the LA/RC option, the current licensee or site owner and NRC enter into a legal agreement on the restrictions and controls needed for license termination under restricted conditions. The legal agreement includes using a restrictive covenant, which outlines the restrictions on site use and any necessary maintenance, monitoring, or reporting. In accordance with the legal agreement, the licensee or site owner is required to record the restrictive covenant with the appropriate recordation body in the jurisdiction where the site is located, before the site is released under restricted conditions.

It is noted that the LA/RC option has not been implemented by the NRC or legally tested, and NRC’s ability to enforce the LA/RC depends on the laws of the jurisdiction where the site is located. Therefore, the licensee must demonstrate that the LA/RC is a legally enforceable institutional control in the jurisdiction where the site is located.

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If complex monitoring or maintenance activities are needed at a restricted use site, the LTC license could be an appropriate institutional control option (compared to the LA/RC). Under the LTC license option, NRC would need to review and approve the transfer of site ownership (including determining whether the new owner had the technical capability or means to conduct any complex monitoring or maintenance activities), as the new owner(s) would become the LTC licensee to provide the necessary controls outlined in the LTC license. Complex monitoring or maintenance activities could include maintenance of an engineered barrier or groundwater or radiological monitoring activities, which require the site owner to have necessary knowledge, expertise, or technical abilities to carry out these activities and comply with all provisions of the LTC license. If the restrictions on site use or monitoring and reporting activities are simpler, the LA/RC may be an appropriate institutional control option. Simpler restrictions or activities related to the restrictions could include the site owner responding to an annual NRC inquiry as to how the site is being used or allowing the NRC to conduct a periodic inspection of the site.

Figure 17.1 illustrates the process for selecting appropriate institutional controls (including institutional control options involving NRC) for restricted use or alternate criteria decommissioning. Refer to Section 17.8 of this volume for guidance on decommissioning using the alternate criteria provisions in 10 CFR 20.1404. The steps in this process are described below.

1. Determine if the site is a lower or higher risk site, based on the following criteria. (See also Table M.1 and Section M.2 of this volume.)

Lower risk sites (legally enforceable institutional controls):

Shorter hazard duration: shorter dose persistence or shorter radionuclide half-life (less than 100 years).

Lower hazard level: calculated dose is less than 1.0 mSv/y (100 mrem/y) assuming institutional controls are not in place.

Higher risk sites (legally enforceable and durable institutional controls):

Longer hazard duration: longer dose persistence or longer radionuclide half-life (more than 100 years).

Higher hazard level: calculated dose is 1.0–5.0 mSv/y (100–500 mrem/y) assuming institutional controls are not in place.

2. For lower risk sites, determine if legally enforceable institutional controls and independent third party arrangements can be established.

Yes: Licensee can arrange for appropriate legally enforceable institutional controls and independent third party arrangements. The licensee must comply with all LTR requirements in 10 CFR 20.1403 or 10 CFR 20.1404, for license termination under restricted conditions or alternate criteria, respectively.

No: Licensee should document that it could not arrange for legally enforceable institutional controls or independent third party arrangmements and may go to step 4

17-67 NUREG - 1757, Vol. 1, Rev. 2 to select institutional control options involving NRC. The institutional control options involving NRC, which provide legally enforceable and durable institutional controls, may be used, even though durable controls are not necessary for lower risk sites.

3. For higher risk sites, determine if legally enforceable and durable institutional controls, via government (Agency other than NRC) ownership or control, and independent third party arrangements can be established.

Yes: Licensee can arrange for legally enforceable and durable institutional controls and independent third party arrangements. The licensee must comply with all LTR requirements in 10 CFR 20.1403 or 10 CFR 20.1404, for license termination under restricted conditions or alternate criteria, respectively.

No: Licensee should submit a letter from Federal, State, or local government declining to take ownership or control responsibility and may go to step 4 to select institutional control options involving NRC.

4. Determine the appropriate NRC option for providing an institutional control.

LTC license option could be used if:

— Substantial restrictions, monitoring, or maintenance require special expertise (e.g., groundwater monitoring or maintaining an engineered barrier); or

— Maintaining single ownership of a site with both restricted use and unrestricted use areas is desirable to sustain future ownership to ensure long-term protection of public health and safety.

LA/RC option could be used if:

— Current licensee or formerly licensed site owner demonstrates that the LA/RC option would be effective and legally enforceable by NRC in the jurisdiction where the site is located; and

— Restrictions, monitoring, or maintenance activities are simple and do not require special expertise (e.g., annual letter certifying restrictions are in place, fence repair, or sign replacement).

Both the LTC license and LA/RC institutional control options provide legally enforceable and durable (if needed) institutional controls. The licensee must comply with all LTR requirements in 10 CFR 20.1403 or 10 CFR 20.1404, for license termination under restricted conditions or alternate criteria, respectively.

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Demonstrate LTR compliance in the DP: After the above steps are completed and an institutional control option is selected, the licensee would incorporate the option into its DP and demonstrate compliance with all other applicable LTR requirements in 10 CFR 20.1403 or 10 CFR 20.1404, for license termination under restricted conditions or alternate criteria, respectively.

Before preparation and submittal of the DP to NRC, licensees are encouraged to contact NRC or the appropriate Agreement State authority to discuss the selection of appropriate institutional controls (including institutional control options involving NRC) for restricted use or alternate criteria decommissioning.

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LOWER OR

HIGHER RISK

SITE?

LEGALLY

ENFORCEABLE AND

DURABLE

INSTITUTIONAL

CONTROLS

ABLE

TO ESTABLISH

LEGALLY

ENFORCEABLE

INSTITUTIONAL

CONTROLS?

LEGALLY

ENFORCEABLE

AND DURABLE

INSTITUTIONAL

CONTROLS *

INSTITUTIONAL

CONTROLS

INVOLVING NRC

WHICH NRC

OPTION FOR

INSTITUTIONAL

CONTROLS?

LONG-TERM

CONTROL

LICENSE *

LEGAL

AGREEMENT /

RESTRICTIVE

COVENANT *

LOW HIGH

YES

NO

YES

NO

ABLE

TO ESTABLISH

LEGALLY

ENFORCEABLE AND

DURABLE

INSTITUTIONAL

CONTROLS?

LEGALLY

ENFORCEABLE

INSTITUTIONAL

CONTROLS

LEGALLY

ENFORCEABLE

INSTITUTIONAL

CONTROLS *

* The licensee must comply with all LTR requirements in 10 CFR

20.1403 or 10 CFR 20.1404, for license termination under restricted conditions or alternate criteria, respectively.

decom-10_Fig17-1.ppt 08302006

LOWER OR

HIGHER RISK

SITE?

LEGALLY

ENFORCEABLE AND

DURABLE

INSTITUTIONAL

CONTROLS

ABLE

TO ESTABLISH

LEGALLY

ENFORCEABLE

INSTITUTIONAL

CONTROLS?

LEGALLY

ENFORCEABLE

AND DURABLE

INSTITUTIONAL

CONTROLS *

INSTITUTIONAL

CONTROLS

INVOLVING NRC

WHICH NRC

OPTION FOR

INSTITUTIONAL

CONTROLS?

LONG-TERM

CONTROL

LICENSE *

LEGAL

AGREEMENT /

RESTRICTIVE

COVENANT *

LOW HIGH

YES

NO

YES

NO

ABLE

TO ESTABLISH

LEGALLY

ENFORCEABLE AND

DURABLE

INSTITUTIONAL

CONTROLS?

LEGALLY

ENFORCEABLE

INSTITUTIONAL

CONTROLS

LEGALLY

ENFORCEABLE

INSTITUTIONAL

CONTROLS *

LOWER OR

HIGHER RISK

SITE?

LEGALLY

ENFORCEABLE AND

DURABLE

INSTITUTIONAL

CONTROLS

ABLE

TO ESTABLISH

LEGALLY

ENFORCEABLE

INSTITUTIONAL

CONTROLS?

LEGALLY

ENFORCEABLE

AND DURABLE

INSTITUTIONAL

CONTROLS *

INSTITUTIONAL

CONTROLS

INVOLVING NRC

WHICH NRC

OPTION FOR

INSTITUTIONAL

CONTROLS?

LONG-TERM

CONTROL

LICENSE *

LEGAL

AGREEMENT /

RESTRICTIVE

COVENANT *

LOW HIGH

YES

NO

YES

NO

ABLE

TO ESTABLISH

LEGALLY

ENFORCEABLE AND

DURABLE

INSTITUTIONAL

CONTROLS?

LEGALLY

ENFORCEABLE

INSTITUTIONAL

CONTROLS

LEGALLY

ENFORCEABLE

INSTITUTIONAL

CONTROLS *

* The licensee must comply with all LTR requirements in 10 CFR

20.1403 or 10 CFR 20.1404, for license termination under restricted conditions or alternate criteria, respectively.

Figure 17.1 Process for Selecting Institutional Controls.

NUREG - 1757, Vol. 1, Rev. 2 17-70

17.7.2 INITIAL ELIGIBILITY DEMONSTRATION

The purpose of the review of the licensee’s demonstration that it is initially eligible to further evaluate release of the site, under the provisions of 10 CFR 20.1403, is to verify that the licensee has demonstrated that further reductions in residual radioactivity at the site to meet the unrestricted release criteria in 10 CFR 20.1402 would: (1) result in net public or environmental harm; or (2) are not being undertaken because the residual radioactivity levels are ALARA.

ACCEPTANCE CRITERIA: INFORMATION TO BE SUBMITTED

The information supplied by the licensee should be sufficient to allow the staff to fully understand how the licensee has concluded that reducing radioactivity to the unrestricted use levels in 10 CFR 20.1402 would result in net public or environmental harm or are not being undertaken because the residual radioactivity levels are ALARA. The staff’s review should verify that the following information is included in the licensee’s demonstration that it is eligible for requesting license termination under the provisions of 10 CFR 20.1403:

A demonstration that the benefits of dose reduction are less than the cost of doses, injuries, and fatalities (see Volume 2 of this NUREG series); or

A demonstration that the proposed residual radioactivity levels at the site are ALARA.

EVALUATION FINDINGS: EVALUATION CRITERIA

If the licensee has concluded that further reductions in residual radioactivity levels would result in net public or environmental harm, the staff should verify that the licensee has accurately calculated the benefits versus costs of further remediation using the guidance in Chapter 6 and Appendix N of Volume 2 of this NUREG series. In considering the net public and environmental harm, a licensee’s evaluation should consider the radiological and nonradiological impacts of decommissioning on a person that may be impacted, as well as the potential impact on ecological systems from decommissioning activities. (See Section B.3.2 of the “Statements of Consideration” for the License Termination Rule, 62 FR 39069.)

If the licensee has concluded that further reductions in residual radioactivity levels are not required because they are ALARA, the staff should verify that the licensee has considered all of the applicable benefits and costs of further reduction of residual radioactivity and accurately calculated the benefits and costs using the methodology described in Chapter 6 and Appendix N of Volume 2 of this NUREG series.

17.7.3 INSTITUTIONAL CONTROLS AND ENGINEERED BARRIERS

The purpose of the review of the description of the institutional controls and engineered barriers the licensee has provided for the site is to determine if the licensee has made provisions for

17-71 NUREG - 1757, Vol. 1, Rev. 2 legally enforceable institutional controls that will limit the dose to the average member of the critical group to less than 0.25 mSv/y (25 mrem/y).

ACCEPTANCE CRITERIA: INFORMATION TO BE SUBMITTED

The information supplied by the licensee should be sufficient to allow the staff to fully understand what institutional controls and engineered barriers the licensee plans to use or has provided for the site and the manner in which these institutional controls will limit doses to the average member of the critical group to 0.25 mSv/y (25 mrem/y).

In the NRC’s view, engineered barriers are distinct and separate from institutional controls (NRC 2002). Used in the general sense, an engineered barrier could be one of a broad range of barriers with varying degrees of durability, robustness, and isolation capability. Generally, engineered barriers are passive, man-made structures or devices intended to enhance a facility's ability to meet the dose criteria in the LTR. Engineered barriers are usually designed to inhibit water from contacting waste, limit releases of radionuclides (e.g., through groundwater, biointrusion, erosion), or to mitigate doses for inadvertent intruders. Institutional controls are used to limit inadvertent intruder access to, and/or use of, the site to ensure that the exposure from the residual radioactivity does not exceed the established criteria. Institutional controls include legal mechanisms (e.g., land use restrictions) and may include, but are not limited to, physical controls (e.g., signs, markers, landscaping, and fences) to control access to the site and minimize disturbances to engineered barriers.

NRC reviewers and licensees should refer to Section 3.5 of Volume 2 of this NUREG series for guidance on engineered barriers. Section 3.5 provides guidance on the engineered barrier analysis process, including analysis of: (a) contribution of engineered barriers towards compliance, with institutional controls in place, including monitoring and maintenance; and

(b) contribution of engineered barriers toward compliance, assuming loss of institutional controls (including monitoring and maintenance) and degradation of barriers. The guidance also discusses the main elements that support the assessment of engineered barrier performance, including: (a) design and functionality of engineered barriers, including interactive effects (both positive and negative) from the implementation of multiple barriers; (b) technical basis for design and functionality of engineered barriers; (c) degradation mechanisms and sensitivity analysis; (d) uncertainty in design and functionality of engineered barriers; (e) suitability of numerical models; (f) model support; and (g) quality assurance.

The licensee should summarize the total system of controls used to provide protection and include a general description of each system element and how it contributes to protection.

Elements might include institutional controls, engineered barriers, monitoring and maintenance;

independent third party oversight; trust fund; and maximum limits on dose (i.e., “dose caps”) assuming institutional controls fail. Refer to Appendix M of this Volume, which describes this total system approach and apply the approach for the specific site. The staff’s review should verify that the following information is included in the description of institutional controls that the licensee plans to use or has provided for the site:

NUREG - 1757, Vol. 1, Rev. 2 17-72

Area and Type of Institutional Controls

Area and description of the general type of institutional controls and the basis for selection, using NRC’s risk-informed graded approach in Appendix M of this Volume. Using this approach, determine if the restricted area of the site is a lower or higher risk area and the general type of institutional controls that are needed. Consider both hazard duration, based on the dose persistance and the half-life of radionuclides, as well as hazard level [i.e., less than or greater than 1.0 mSv/y (100 mrem/y)] based on dose assessments assuming controls are no longer in effect. For a simpler site, the complete area of the current site would be restricted use. For a more complex site, this approach might result in identifying unrestricted use areas where no institutional controls are required, and restricted use areas using either legally enforceable institutional controls or durable and legally enforceable institutional controls.

A demonstration that the size of the restricted use area has been minimized. The staff considers that minimizing the size of the restricted use area would contribute to demonstrating ALARA for sites that are considering subdividing the site into unrestricted and restricted use portions. It would also result in a smaller area to control, which may make access limitations like fencing and surveillance simpler and thus more effective.

When determining what portion of the site needs to be restricted (or how a site could be subdivided between restricted and unrestricted portions), the licensee should consider and balance the goal of minimizing the restricted area of the site (and minimizing burdens associated with restricted use) with defining the area that will ensure long-term protection.

Risk insights from dose assessments (extent of residual radioactivity and how it migrates/travels through the environment) will help determine what areas need to be monitored and the location and size of the restricted area.

For a licensee considering an LTC license that has both restricted and…