ML082910077: Difference between revisions

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| issue date = 01/08/2009
| issue date = 01/08/2009
| title = Final Safety Evaluation for Topical Report NEI 07-10, Generic Final Safety Analysis Review Template Guidance for Process Control Program, Revision 3 (TAC No. Q00159)
| title = Final Safety Evaluation for Topical Report NEI 07-10, Generic Final Safety Analysis Review Template Guidance for Process Control Program, Revision 3 (TAC No. Q00159)
| author name = Reckley W D
| author name = Reckley W
| author affiliation = NRC/NRO/DNRL
| author affiliation = NRC/NRO/DNRL
| addressee name = Bell R J
| addressee name = Bell R
| addressee affiliation = Nuclear Energy Institute (NEI)
| addressee affiliation = Nuclear Energy Institute (NEI)
| docket = PROJ0689
| docket = PROJ0689
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NEI-07-10 is organized into guidelines for responsibilities and administration of the program, approval process for quality assurance (QA) approved suppliers, waste types, solidification, dewatering, acceptability, waste characterization, waste classification, shipment manifests, and QA for the program itself. The safety evaluation (SE) follows the organization of the PCP.  
NEI-07-10 is organized into guidelines for responsibilities and administration of the program, approval process for quality assurance (QA) approved suppliers, waste types, solidification, dewatering, acceptability, waste characterization, waste classification, shipment manifests, and QA for the program itself. The safety evaluation (SE) follows the organization of the PCP.  


===3.1 Responsibilities===
3.1 Responsibilities and Administration The "Responsibilities" and "Administration" sections of NEI-07-10 describes the basic organizational responsibilities and controls over the administration of the program to assure that NRC guidance will be followed and requirements will be met. The program includes a commitment to develop procedures and practices to achieve the program objectives.
and Administration The "Responsibilities" and "Administration" sections of NEI-07-10 describes the basic organizational responsibilities and controls over the administration of the program to assure that NRC guidance will be followed and requirements will be met. The program includes a commitment to develop procedures and practices to achieve the program objectives.
NEI-07-10 does not specifically include a timeline for development of the complete program. The PCP does outline the procedures that will be developed, and which will be required to be developed and inspected after issuance of the license but prior to fuel load.
NEI-07-10 does not specifically include a timeline for development of the complete program. The PCP does outline the procedures that will be developed, and which will be required to be developed and inspected after issuance of the license but prior to fuel load.
Based on the staff's review of the "Responsibilities" and "Administration" sections of NEI-07-10 outlined above, the staff concludes that NEI-07-10 sufficiently describes, in terms of scope and level of detail, these aspects of the PCP to enable a reasonable assurance finding of    acceptability for issuance of a COL with verification of the PCP after completing the construction inspection program in implementing the plant-specific PCP under the requirements of a license condition.  
Based on the staff's review of the "Responsibilities" and "Administration" sections of NEI-07-10 outlined above, the staff concludes that NEI-07-10 sufficiently describes, in terms of scope and level of detail, these aspects of the PCP to enable a reasonable assurance finding of    acceptability for issuance of a COL with verification of the PCP after completing the construction inspection program in implementing the plant-specific PCP under the requirements of a license condition.  


===3.2 Approval===
3.2 Approval Process for (QA) Approved Suppliers, PCP Requirements for Vendor Processes and Services The "Approval Process for (QA) Approved Suppliers" and "PCP Requirements for Vendor Processes and Services" sections of NEI-07-10 indicate that suppliers will be evaluated and approved prior to providing related services, and vendor processes will ensure that processed materials will conform to waste class, form, and content stipulated by regulations and contract specifications. The PCP also requires that containers used for shipment offsite be designed and/or certified consistent with regulatory approvals such as certificates of compliance or design specifications. Vendor equipment used on site is required to meet design, construction, operation, and quality assurance provisions of NUREG-0800, SRP, BTP 11-3, "Design Guidance for Solid Radioactive Waste Management Systems Installed in Light-Water-Cooled Nuclear Power Reactor Plants," which includes provisions for collection of spilled materials (curbing/collection), connection of temporary and portable systems, corrosion prevention, leak and spill minimization, and prevention of cross-connection with, or contamination of,  non-radioactive systems.  
Process for (QA) Approved Suppliers, PCP Requirements for Vendor Processes and Services The "Approval Process for (QA) Approved Suppliers" and "PCP Requirements for Vendor Processes and Services" sections of NEI-07-10 indicate that suppliers will be evaluated and approved prior to providing related services, and vendor processes will ensure that processed materials will conform to waste class, form, and content stipulated by regulations and contract specifications. The PCP also requires that containers used for shipment offsite be designed and/or certified consistent with regulatory approvals such as certificates of compliance or design specifications. Vendor equipment used on site is required to meet design, construction, operation, and quality assurance provisions of NUREG-0800, SRP, BTP 11-3, "Design Guidance for Solid Radioactive Waste Management Systems Installed in Light-Water-Cooled Nuclear Power Reactor Plants," which includes provisions for collection of spilled materials (curbing/collection), connection of temporary and portable systems, corrosion prevention, leak and spill minimization, and prevention of cross-connection with, or contamination of,  non-radioactive systems.  


Based on the staff's review of the "Approval Process for (QA) Approved Suppliers" and "PCP Requirements for Vendor Processes and Services" sections of NEI-07-10 outlined above, the staff concludes that NEI-07-10 sufficiently describes, in terms of scope and level of detail, these aspects of the PCP to enable a reasonable assurance finding of acceptability for issuance of a COL with verification of these program elements after completing the construction inspection program in implementing the plant-specific PCP under the requirements of a license condition.  
Based on the staff's review of the "Approval Process for (QA) Approved Suppliers" and "PCP Requirements for Vendor Processes and Services" sections of NEI-07-10 outlined above, the staff concludes that NEI-07-10 sufficiently describes, in terms of scope and level of detail, these aspects of the PCP to enable a reasonable assurance finding of acceptability for issuance of a COL with verification of these program elements after completing the construction inspection program in implementing the plant-specific PCP under the requirements of a license condition.
 
3.3 Waste Types The "Waste Types" section of NEI-07-10 describes in general terms the variety of waste types typically encountered from operations, and addresses categorization based on chemical and physical properties as required by NRC regulation. Stabilization of wastes is briefly addressed. Processing of the various waste types, and programs and processes to address waste types not specifically listed, are addressed throughout the PCP template.  
===3.3 Waste===
Types The "Waste Types" section of NEI-07-10 describes in general terms the variety of waste types typically encountered from operations, and addresses categorization based on chemical and physical properties as required by NRC regulation. Stabilization of wastes is briefly addressed. Processing of the various waste types, and programs and processes to address waste types not specifically listed, are addressed throughout the PCP template.  


Based on the staff's review of the "Waste Types" section of NEI-07-10 outlined above, the staff concludes that NEI-07-10 sufficiently describes, in terms of scope and level of detail, waste types sufficient to enable a reasonable assurance finding of acceptability for issuance of a COL with verification of these program elements after completing the construction inspection program in implementing the plant-specific PCP under the requirements of a license condition.
Based on the staff's review of the "Waste Types" section of NEI-07-10 outlined above, the staff concludes that NEI-07-10 sufficiently describes, in terms of scope and level of detail, waste types sufficient to enable a reasonable assurance finding of acceptability for issuance of a COL with verification of these program elements after completing the construction inspection program in implementing the plant-specific PCP under the requirements of a license condition.
3.4 PCP Solidification/Dewatering Process Descriptions The "PCP Solidification Process Description" and "PCP Dewatering Process Description" sections of NEI-07-10 addresses approved procedures for solidification and dewatering of liquid and wet solid wastes. Parameters relevant to determination of the appropriate process are addressed, such as chemical and physical forms, hazardous waste characterization, media, and    minimum acceptance criteria. Limitations on free standing liquids, slurried or other heterogeneous wastes containing liquids, and removal of interstitial liquids are also addressed.
3.4 PCP Solidification/Dewatering Process Descriptions The "PCP Solidification Process Description" and "PCP Dewatering Process Description" sections of NEI-07-10 addresses approved procedures for solidification and dewatering of liquid and wet solid wastes. Parameters relevant to determination of the appropriate process are addressed, such as chemical and physical forms, hazardous waste characterization, media, and    minimum acceptance criteria. Limitations on free standing liquids, slurried or other heterogeneous wastes containing liquids, and removal of interstitial liquids are also addressed.
Based on the staff's review of the "PCP Solidification Process Description" and "PCP Dewatering Process Description" sections of NEI-07-10 outlined above, the staff concludes that NEI-07-10 sufficiently describes, in terms of scope and level of detail, solidification and dewatering processes sufficient to make a reasonable assurance finding of acceptability for issuance of a COL with verification of these program elements after completing the construction inspection program in implementing the plant-specific PCP under the requirements of a license condition.  
Based on the staff's review of the "PCP Solidification Process Description" and "PCP Dewatering Process Description" sections of NEI-07-10 outlined above, the staff concludes that NEI-07-10 sufficiently describes, in terms of scope and level of detail, solidification and dewatering processes sufficient to make a reasonable assurance finding of acceptability for issuance of a COL with verification of these program elements after completing the construction inspection program in implementing the plant-specific PCP under the requirements of a license condition.
 
3.5 Acceptability The "Acceptability" section of NEI-07-10 describes in general terms the verification process to ensure that wastes are acceptable for disposal consistent with the requirements of the disposal facility and land disposal regulations. Verification procedures, compensatory action upon failure of solidification or dewatering processes, and mishaps or unsuccessful processes are briefly addressed.
===3.5 Acceptability===
The "Acceptability" section of NEI-07-10 describes in general terms the verification process to ensure that wastes are acceptable for disposal consistent with the requirements of the disposal facility and land disposal regulations. Verification procedures, compensatory action upon failure of solidification or dewatering processes, and mishaps or unsuccessful processes are briefly addressed.
The template provides for acceptability of materials for interim storage awaiting disposal through development of site-specific procedures, consistent with NRC guidance. The template does not require that radioactive materials be stored in containers suitable for transportation under Department of Transportation regulations, but does require that storage be according to procedures developed under the template and subject to site-specific NRC inspection and verification. With regard to storage, the template is consistent with NRC Generic Letter (GL) 81-038. Due to site-specific differences in availability of disposal capacities and variations in the need for storage capacity pending disposal, COL applicants will need to provide information on a case-by-case basis with respect to long-term management and storage of solid wastes using the guidance of RG 1.206 and SRP Section 11.4, Revision 3 (NUREG-0800).
The template provides for acceptability of materials for interim storage awaiting disposal through development of site-specific procedures, consistent with NRC guidance. The template does not require that radioactive materials be stored in containers suitable for transportation under Department of Transportation regulations, but does require that storage be according to procedures developed under the template and subject to site-specific NRC inspection and verification. With regard to storage, the template is consistent with NRC Generic Letter (GL) 81-038. Due to site-specific differences in availability of disposal capacities and variations in the need for storage capacity pending disposal, COL applicants will need to provide information on a case-by-case basis with respect to long-term management and storage of solid wastes using the guidance of RG 1.206 and SRP Section 11.4, Revision 3 (NUREG-0800).
Based on the staff's review of the "Acceptability" section of NEI-07-10 outlined above, the staff concludes that NEI-07-10 sufficiently describes, in terms of scope and level of detail, acceptability of process controls sufficient to enable a reasonable assurance finding of acceptability for issuance of a COL with verification of these program elements after completing the construction inspection program in implementing the plant-specific PCP under the requirements of a license condition.  
Based on the staff's review of the "Acceptability" section of NEI-07-10 outlined above, the staff concludes that NEI-07-10 sufficiently describes, in terms of scope and level of detail, acceptability of process controls sufficient to enable a reasonable assurance finding of acceptability for issuance of a COL with verification of these program elements after completing the construction inspection program in implementing the plant-specific PCP under the requirements of a license condition.  


===3.6 Waste===
3.6 Waste Characterization, Classification, and Manifests The "Waste Characterization, Classification, and Manifests" section of NEI-07-10 describes that waste classification will be implemented by site-specific procedures in accordance with  10 CFR 61.55, "Waste classification."  The section requires at least annual waste stream assessment through analysis (biannually for Class A waste) for radionuclide distribution and concentrations, and addresses non-gamma emitters, transuranics, and scaling factors. The section requires waste characteristics to be consistent with 10 CFR 61.56, "Waste characteristics."  The section also refers to identification of waste class as required by  10 CFR 61.57, "Labeling," and indicates that site shipping instructions be developed consistent with NUREG/BR-0204, "Instructions for Completing NRC's Uniform Low-Level Radioactive Waste Manifest", 10 CFR 20.2006, "Transfer for disposal and manifests", and 10 CFR Part 20,    Appendix G, "Requirements for Transfers of Low-Level Radioactive Waste Intended for Disposal at Licensed Land Disposal Facilities and Manifests."
Characterization, Classification, and Manifests The "Waste Characterization, Classification, and Manifests" section of NEI-07-10 describes that waste classification will be implemented by site-specific procedures in accordance with  10 CFR 61.55, "Waste classification."  The section requires at least annual waste stream assessment through analysis (biannually for Class A waste) for radionuclide distribution and concentrations, and addresses non-gamma emitters, transuranics, and scaling factors. The section requires waste characteristics to be consistent with 10 CFR 61.56, "Waste characteristics."  The section also refers to identification of waste class as required by  10 CFR 61.57, "Labeling," and indicates that site shipping instructions be developed consistent with NUREG/BR-0204, "Instructions for Completing NRC's Uniform Low-Level Radioactive Waste Manifest", 10 CFR 20.2006, "Transfer for disposal and manifests", and 10 CFR Part 20,    Appendix G, "Requirements for Transfers of Low-Level Radioactive Waste Intended for Disposal at Licensed Land Disposal Facilities and Manifests."
Based on the staff's review of the "Waste Characterization, Classification, and Manifests" section of NEI-07-10 outlined above, the staff concludes that NEI-07-10 sufficiently describes, in terms of scope and level of detail, acceptability of waste characterization, classification, and manifests, sufficient to make a reasonable assurance finding of acceptability for issuance of a COL with verification of these program elements after completing the construction inspection program in implementing the plant-specific PCP under the requirements of a license condition.  
Based on the staff's review of the "Waste Characterization, Classification, and Manifests" section of NEI-07-10 outlined above, the staff concludes that NEI-07-10 sufficiently describes, in terms of scope and level of detail, acceptability of waste characterization, classification, and manifests, sufficient to make a reasonable assurance finding of acceptability for issuance of a COL with verification of these program elements after completing the construction inspection program in implementing the plant-specific PCP under the requirements of a license condition.  


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The PCP described in NEI-07-10 incorporates standards and guidance that allow an applicant to operate and maintain the facility, in a safe manner, during normal operation and anticipated operational occurrences. The PCP will be developed and maintained in compliance with the facility license and applicable regulations. The PCP calls for processes to be periodically evaluated and revised to reflect industry experience; to incorporate changes to the facility, procedures, regulations, and quality assurance requirements; and to support facility management in determining the overall program effectiveness as well as compliance with NRC regulations and state agency disposal site regulations. The template requires that the storage of waste pending disposal be developed under site-specific NRC review and verification by inspection, such as addressed in NRC GL 81-038. Due to site-specific differences in availability of disposal capacities and variations in the need for storage capacity pending disposal, applicants will need to provide information on a case-by-case basis with respect to long-term management and storage of solid wastes using the guidance of RG 1.206 and SRP Section 11.4, Revision 3 (NUREG-0800).
The PCP described in NEI-07-10 incorporates standards and guidance that allow an applicant to operate and maintain the facility, in a safe manner, during normal operation and anticipated operational occurrences. The PCP will be developed and maintained in compliance with the facility license and applicable regulations. The PCP calls for processes to be periodically evaluated and revised to reflect industry experience; to incorporate changes to the facility, procedures, regulations, and quality assurance requirements; and to support facility management in determining the overall program effectiveness as well as compliance with NRC regulations and state agency disposal site regulations. The template requires that the storage of waste pending disposal be developed under site-specific NRC review and verification by inspection, such as addressed in NRC GL 81-038. Due to site-specific differences in availability of disposal capacities and variations in the need for storage capacity pending disposal, applicants will need to provide information on a case-by-case basis with respect to long-term management and storage of solid wastes using the guidance of RG 1.206 and SRP Section 11.4, Revision 3 (NUREG-0800).
The final PCP prepared under a license condition will be further described in site and/or operating procedures as specified in the PCP template. Sufficient records will be maintained and kept available for NRC inspection during construction to verify adequacy of the program.
The final PCP prepared under a license condition will be further described in site and/or operating procedures as specified in the PCP template. Sufficient records will be maintained and kept available for NRC inspection during construction to verify adequacy of the program.
On the basis of its review, the staff concludes that NEI-07-10, "Generic FSAR Template Guidance for Process Control Program," Revision 3 adequately provides guidance for establishing the PCP. Accordingly, NRC staff concludes that NEI-07-10 Revision 3 complies with the applicable NRC regulations, guidance, and industry standards and can be utilized by applicants for COLAs.  
On the basis of its review, the staff concludes that NEI-07-10, "Generic FSAR Template Guidance for Process Control Program," Revision 3 adequately provides guidance for establishing the PCP. Accordingly, NRC staff concludes that NEI-07-10 Revision 3 complies with the applicable NRC regulations, guidance, and industry standards and can be utilized by applicants for COLAs.
: 5. REFERENCES 5.1 Bell, R. J., NEI, to the U.S. NRC, "Response to NRC April 28 Request for Additional Information on NEI 07-09 and May 6 Request for Additional Information on NEI 07-10,"
: 5. REFERENCES 5.1 Bell, R. J., NEI, to the U.S. NRC, "Response to NRC April 28 Request for Additional Information on NEI 07-09 and May 6 Request for Additional Information on NEI 07-10,"
May 30, 2008.
May 30, 2008.

Revision as of 05:50, 12 July 2019

Final Safety Evaluation for Topical Report NEI 07-10, Generic Final Safety Analysis Review Template Guidance for Process Control Program, Revision 3 (TAC No. Q00159)
ML082910077
Person / Time
Site: Nuclear Energy Institute
Issue date: 01/08/2009
From: William Reckley
NRC/NRO/DNRL
To: Bell R
Nuclear Energy Institute
Burrows, S A, NRO/DNRL/NRGA, 415-6086
References
TAC Q00159
Download: ML082910077 (15)
v • d • e


Text

January 8, 2009

Mr. Russell J. Bell, Director New Plant Licensing Nuclear Generation Division Nuclear Energy Institute 1776 I Street, NW, Suite 400 Washington, DC 20006-3708

SUBJECT:

FINAL SAFETY EVALUATION FOR TOPICAL REPORT NEI 07-10, "GENERIC FINAL SAFETY ANALYSIS REVIEW TEMPLATE GUIDANCE FOR PROCESS CONTROL PROGRAM," REVISION 3 (TAC NO. Q00159)

Dear Mr. Bell:

By letter dated September 27, 2007, the Nuclear Energy Institute (NEI) submitted for U.S. Nuclear Regulatory Commission (NRC) staff review it's proposed Topical Report, NEI 07-10, "Generic Final Safety Analysis Review Template Guidance for Process Control Program," Revision 0. Based on comments and input from NRC staff, NEI submitted Revision 1 of the Process Control Program (PCP) generic template on October 18, 2007 and Revision 2 on February 28, 2008.

In response to the NRC staff's May 6, 2008, request for additional information (RAI), NEI submitted NEI 07-10, Revision 3 on May 30, 2008.

Enclosed is the staff's safety evaluation (SE) which defines the basis for acceptance of NEI 07-10, Revision 3. The NRC staff finds that for combined license applications (COLAs),

NEI 07-10, Revision 3, provides an acceptable template for assuring that the administrative and operational controls for waste processing, process parameters, and surveillance requirements within the scope of the PCP will meet the requirements of Title 10 of the Code of Federal Regulations, Section 52.79.

Our acceptance applies only to material provided in NEI 07-10, Revision 3. We do not intend to repeat our review of the acceptable material described in the NEI 07-10, Revision 3. When the NEI 07-10, Revision 3 appears as a reference in COLAs, our review will ensure that the material presented applies to the specific application involved. Licensing requests that deviate from NEI 07-10, Revision 3, will be subject to a plant-specific or site-specific review in accordance with applicable review standards.

In accordance with the guidance provided on the NRC website, we request that NEI publish the accepted version of NEI 07-10, Revision 3 within 3 months of receipt of this letter. The accepted version should incorporate this letter and the enclosed SE after the title page. The accepted version should also contain historical review information, including NRC RAIs and your responses. The accepted versions shall include a "-A" (designating accepted) following the report identification symbol.

If future changes to the NRC's regulatory requirements affect the acceptability of NEI 07-10, Revision 3, NEI will be expected to revise NEI 07-10 appropriately, or justify its continued applicability for subsequent referencing.

If you have any questions, please contact Sheryl A. Burrows at (301) 415-6086 or via email at Sheryl.Burrows@nrc.gov. Sincerely, /RA/ William D. Reckley, Chief Rulemaking, Guidance, and Advanced Reactor Branch Division of New Reactor Licensing Office of New Reactors Project No. 689

Enclosure:

Safety Evaluation cc w/encl: See next page

ML082910077 NRO-002 OFFICE DNRL/NRGA:PM DNRL/NRGA:LADCIP/CHPB:BCOGC DNRL/NRGA:BCNAME SBurrows RRobinson TFrye* MSpencer WReckley DATE 10/17/2008 10/17/2008 9/30/2008 01/ 08/2009 NLO 01/08/2009 Enclosure SAFETY EVALUATION FINAL SAFETY EVALUATION FOR THE NUCLEAR ENERGY INSTITUTE'S TECHNICAL REPORT NEI 07-10, "GENERIC FINAL SAFETY ANALYSIS REVIEW TEMPLATE GUIDANCE FOR PROCESS CONTROL PROGRAM," REVISION 3 (TAC NO. Q00159)

1.0 BACKGROUND

On September 27, 2007, the Nuclear Energy Institute (NEI) submitted for U.S. Nuclear Regulatory Commission (NRC) staff review its proposed Topical Report, NEI 07-10, "Generic Final Safety Analysis Report Template Guidance for Process Control Program" Revision 0 [Agencywide Documents Access Management System (ADAMS) accession no. ML072740309]. NEI-07-10 was developed by the NEI to assist in expediting NRC review and approval of combined licenses (COLs). Based on comments and input distributed at a series of public meetings in the intervening period, NEI submitted Revision 1 of the Process Control Program (PCP) template on October 18, 2007 [ADAMS accession no. ML072840029] and Revision 2 on February 28, 2008 [ADAMS accession no. ML080640463]. The staff determined that additional information was necessary to complete its review, and on April 1, 2008, an email of a request for additional information (RAI) was transmitted to NEI staff, with follow-up letter dated May 6, 2008 [ADAMS accession no. ML080940250]. On May 31, 2008, the NEI formally responded to the RAI by submission of Revision 3 of the Technical Report [ADAMS accession no. ML081720166]. The Technical Report provides a generic PCP description for use with combined license applications (COLAs). NEI-07-10 is not applicable to the review and issuance of construction permits or operating licenses under Title of the Code of Federal Regulations , Part 50 (10 CFR Part 50).

2.0 REGULATORY EVALUATION

The NRC staff verified that NEI-07-10, Revision 3 complies with the following regulations, regulatory guidance, and NUREGs:

  • 10 CFR Part 50, "Domestic licensing of production and utilization facilities."
  • 10 CFR Part 52, "Licenses, certifications, and approvals for nuclear power plants; Subpart A, Subpart B, Subpart C."
  • 10 CFR Part 61, "Licensing requirements for land disposal of radioactive waste."
  • Regulatory Guide (RG) 1.143, "Design Guidance for Radioactive Waste Management Systems, Structures, and Components Installed in Light-Water-Cooled Nuclear Power Plants."
  • NUREG-0800, Standard Review Plan (SRP), Section 11.4, Revision 3, "Solid Waste Management System."
  • NUREG-0800, SRP, Branch Technical Position (BTP) 11-3, Revision 3, "Design Guidance for Solid Radioactive Waste Management Systems Installed in Light-Water-Cooled Nuclear Power Reactor Plants."

3.0 TECHNICAL EVALUATION

The staff's review concentrated on the proposed PCP as one element of the Process and Effluent Monitoring and Sampling Program. The staff also reviewed the template to ensure that the generic PCP addressed those items pertaining to the Process and Effluent Monitoring and Sampling Program, and proposed milestones were included under the requirements of Section 13.4 of the final safety analysis review (FSAR). In evaluating the adequacy of the program, the staff followed the guidance of the SRP (NUREG-0800), Section 11.4, "Solid Waste Management System."

To satisfy Section 13.4 of each FSAR application, Operational Program Procedures under NEI 07-10 are to be developed, but will not necessarily all be implemented, prior to fuel load. Under the requirements of a license condition, a COL holder is required to make available to the NRC a plant-specific PCP. The plant-specific PCP developed under the requirements of the license condition will be verified by the NRC through inspection and shall replace and supersede the generic NEI 07-10 Template. Accordingly, NEI 07-10 fulfills licensing requirements starting with the submission of a COLA, and ending with the fulfillment of the license condition specifying the availability of and verification by the NRC of a plant-specific PCP prior to fuel load. Finally, in accordance with SECY 05-0197, the implementation of operational programs identified in NEI 07-10 does not necessitate inspections, tests, analyses, and acceptance criteria (ITAAC) in a design certification (DC) or COLA.

NEI-07-10 is organized into guidelines for responsibilities and administration of the program, approval process for quality assurance (QA) approved suppliers, waste types, solidification, dewatering, acceptability, waste characterization, waste classification, shipment manifests, and QA for the program itself. The safety evaluation (SE) follows the organization of the PCP.

3.1 Responsibilities and Administration The "Responsibilities" and "Administration" sections of NEI-07-10 describes the basic organizational responsibilities and controls over the administration of the program to assure that NRC guidance will be followed and requirements will be met. The program includes a commitment to develop procedures and practices to achieve the program objectives.

NEI-07-10 does not specifically include a timeline for development of the complete program. The PCP does outline the procedures that will be developed, and which will be required to be developed and inspected after issuance of the license but prior to fuel load.

Based on the staff's review of the "Responsibilities" and "Administration" sections of NEI-07-10 outlined above, the staff concludes that NEI-07-10 sufficiently describes, in terms of scope and level of detail, these aspects of the PCP to enable a reasonable assurance finding of acceptability for issuance of a COL with verification of the PCP after completing the construction inspection program in implementing the plant-specific PCP under the requirements of a license condition.

3.2 Approval Process for (QA) Approved Suppliers, PCP Requirements for Vendor Processes and Services The "Approval Process for (QA) Approved Suppliers" and "PCP Requirements for Vendor Processes and Services" sections of NEI-07-10 indicate that suppliers will be evaluated and approved prior to providing related services, and vendor processes will ensure that processed materials will conform to waste class, form, and content stipulated by regulations and contract specifications. The PCP also requires that containers used for shipment offsite be designed and/or certified consistent with regulatory approvals such as certificates of compliance or design specifications. Vendor equipment used on site is required to meet design, construction, operation, and quality assurance provisions of NUREG-0800, SRP, BTP 11-3, "Design Guidance for Solid Radioactive Waste Management Systems Installed in Light-Water-Cooled Nuclear Power Reactor Plants," which includes provisions for collection of spilled materials (curbing/collection), connection of temporary and portable systems, corrosion prevention, leak and spill minimization, and prevention of cross-connection with, or contamination of, non-radioactive systems.

Based on the staff's review of the "Approval Process for (QA) Approved Suppliers" and "PCP Requirements for Vendor Processes and Services" sections of NEI-07-10 outlined above, the staff concludes that NEI-07-10 sufficiently describes, in terms of scope and level of detail, these aspects of the PCP to enable a reasonable assurance finding of acceptability for issuance of a COL with verification of these program elements after completing the construction inspection program in implementing the plant-specific PCP under the requirements of a license condition.

3.3 Waste Types The "Waste Types" section of NEI-07-10 describes in general terms the variety of waste types typically encountered from operations, and addresses categorization based on chemical and physical properties as required by NRC regulation. Stabilization of wastes is briefly addressed. Processing of the various waste types, and programs and processes to address waste types not specifically listed, are addressed throughout the PCP template.

Based on the staff's review of the "Waste Types" section of NEI-07-10 outlined above, the staff concludes that NEI-07-10 sufficiently describes, in terms of scope and level of detail, waste types sufficient to enable a reasonable assurance finding of acceptability for issuance of a COL with verification of these program elements after completing the construction inspection program in implementing the plant-specific PCP under the requirements of a license condition.

3.4 PCP Solidification/Dewatering Process Descriptions The "PCP Solidification Process Description" and "PCP Dewatering Process Description" sections of NEI-07-10 addresses approved procedures for solidification and dewatering of liquid and wet solid wastes. Parameters relevant to determination of the appropriate process are addressed, such as chemical and physical forms, hazardous waste characterization, media, and minimum acceptance criteria. Limitations on free standing liquids, slurried or other heterogeneous wastes containing liquids, and removal of interstitial liquids are also addressed.

Based on the staff's review of the "PCP Solidification Process Description" and "PCP Dewatering Process Description" sections of NEI-07-10 outlined above, the staff concludes that NEI-07-10 sufficiently describes, in terms of scope and level of detail, solidification and dewatering processes sufficient to make a reasonable assurance finding of acceptability for issuance of a COL with verification of these program elements after completing the construction inspection program in implementing the plant-specific PCP under the requirements of a license condition.

3.5 Acceptability The "Acceptability" section of NEI-07-10 describes in general terms the verification process to ensure that wastes are acceptable for disposal consistent with the requirements of the disposal facility and land disposal regulations. Verification procedures, compensatory action upon failure of solidification or dewatering processes, and mishaps or unsuccessful processes are briefly addressed.

The template provides for acceptability of materials for interim storage awaiting disposal through development of site-specific procedures, consistent with NRC guidance. The template does not require that radioactive materials be stored in containers suitable for transportation under Department of Transportation regulations, but does require that storage be according to procedures developed under the template and subject to site-specific NRC inspection and verification. With regard to storage, the template is consistent with NRC Generic Letter (GL) 81-038. Due to site-specific differences in availability of disposal capacities and variations in the need for storage capacity pending disposal, COL applicants will need to provide information on a case-by-case basis with respect to long-term management and storage of solid wastes using the guidance of RG 1.206 and SRP Section 11.4, Revision 3 (NUREG-0800).

Based on the staff's review of the "Acceptability" section of NEI-07-10 outlined above, the staff concludes that NEI-07-10 sufficiently describes, in terms of scope and level of detail, acceptability of process controls sufficient to enable a reasonable assurance finding of acceptability for issuance of a COL with verification of these program elements after completing the construction inspection program in implementing the plant-specific PCP under the requirements of a license condition.

3.6 Waste Characterization, Classification, and Manifests The "Waste Characterization, Classification, and Manifests" section of NEI-07-10 describes that waste classification will be implemented by site-specific procedures in accordance with 10 CFR 61.55, "Waste classification." The section requires at least annual waste stream assessment through analysis (biannually for Class A waste) for radionuclide distribution and concentrations, and addresses non-gamma emitters, transuranics, and scaling factors. The section requires waste characteristics to be consistent with 10 CFR 61.56, "Waste characteristics." The section also refers to identification of waste class as required by 10 CFR 61.57, "Labeling," and indicates that site shipping instructions be developed consistent with NUREG/BR-0204, "Instructions for Completing NRC's Uniform Low-Level Radioactive Waste Manifest", 10 CFR 20.2006, "Transfer for disposal and manifests", and 10 CFR Part 20, Appendix G, "Requirements for Transfers of Low-Level Radioactive Waste Intended for Disposal at Licensed Land Disposal Facilities and Manifests."

Based on the staff's review of the "Waste Characterization, Classification, and Manifests" section of NEI-07-10 outlined above, the staff concludes that NEI-07-10 sufficiently describes, in terms of scope and level of detail, acceptability of waste characterization, classification, and manifests, sufficient to make a reasonable assurance finding of acceptability for issuance of a COL with verification of these program elements after completing the construction inspection program in implementing the plant-specific PCP under the requirements of a license condition.

3.7 QA Programs The "QA Programs" section of NEI-07-10 indicates that site procedures will be implemented consistent with RG 1.143, "Design Guidance for Radioactive Waste Management Systems, Structures, and Components Installed in Light-Water-Cooled Nuclear Power Plants" and/or American National Standards Institute 55.6, "Liquid Radioactive Waste Processing Systems for Pressurized Water Reactor Plants."

Based on the staff's review of the "QA Programs" section of NEI-07-10 outlined above, the staff concludes that NEI-07-10 sufficiently describes, in terms of scope and level of detail, acceptability of QA programs, sufficient to enable a reasonable assurance finding of acceptability for issuance of a COL, with verification of these program elements after completing the construction inspection program in implementing the plant-specific PCP under the requirements of a license condition.

3.8. NRC Post Combined License Activities Before the implementation of a plant specific PCP, the NRC staff will inspect the elements of the PCP in accordance with the NRC Construction Inspection Program as outlined in the NRC Inspection Manual Chapter 2504. The objectives of these inspections are to determine the readiness of the PCP program in performing its intended objectives. The inspection will confirm that solid waste management systems (SWMS) equipment, administrative programs, and operational procedures implementing the functional elements of the PCP are consistent with the DC, supplemental information or departures described in the COL; regulatory requirements of 10 CFR Part 20, 10 CFR Part 61, 10 CFR Part 71, 49 CFR Parts 171-180; GL 89-01; NUREG-1301 for PWR Plants or NUREG-1302 for BWR plants and NUREG-0133 for either plant; RGs 1.21 and 1.33, and applicable NRC and industry guidance, as listed in NEI 07-10.

The NRC inspection will confirm that the COL holder has successfully completed all applicable ITAACs for those portions of the liquid waste management systems (LWMS) and SWMS used to process solid and wet wastes under the PCP. The ITAACs are described in DCD Tier 1 of DCs and Section 14.3 of the FSAR of COL applications. The staff will confirm whether the COL holder has addressed all relevant ITAACs for liquid and solid waste processing systems, including confirming their descriptions, functional arrangements, and operating characteristics. The ITAACs, once performed by the COL holder and meeting their respective acceptance criteria, provide reasonable assurance that a plant that incorporates the features described in its DC, and operates in accordance with the DC and PCP, will meet the provisions of NRC regulations.

4.0 CONCLUSION

Construction Health Physics Branch (CHPB) staff used the acceptance criteria of SRP Section 11.4, "Solid Waste Management System," and BTP 11-3, "Design Guidance for Solid Radioactive Waste Management Systems Installed in Light-Water-Cooled Nuclear Power Reactor Plants," as the basis for evaluating the acceptability of NEI-07-10, "Generic FSAR Template Guidance for Process Control Program," Revision 3. The CHPB staff has determined that NEI-07-10 Revision 3 is consistent with the requirements, guidance, and industry standards for a PCP as outlined in Section 2.0 of this evaluation with verification of the program after completing the construction inspection program in implementing the plant-specific PCP under the requirements of a license condition. Any processing, storage, or handling of wastes offsite are required to be consistent with onsite controls, and are to be addressed by applicants as site-specific information.

The PCP described in NEI-07-10 incorporates standards and guidance that allow an applicant to operate and maintain the facility, in a safe manner, during normal operation and anticipated operational occurrences. The PCP will be developed and maintained in compliance with the facility license and applicable regulations. The PCP calls for processes to be periodically evaluated and revised to reflect industry experience; to incorporate changes to the facility, procedures, regulations, and quality assurance requirements; and to support facility management in determining the overall program effectiveness as well as compliance with NRC regulations and state agency disposal site regulations. The template requires that the storage of waste pending disposal be developed under site-specific NRC review and verification by inspection, such as addressed in NRC GL 81-038. Due to site-specific differences in availability of disposal capacities and variations in the need for storage capacity pending disposal, applicants will need to provide information on a case-by-case basis with respect to long-term management and storage of solid wastes using the guidance of RG 1.206 and SRP Section 11.4, Revision 3 (NUREG-0800).

The final PCP prepared under a license condition will be further described in site and/or operating procedures as specified in the PCP template. Sufficient records will be maintained and kept available for NRC inspection during construction to verify adequacy of the program.

On the basis of its review, the staff concludes that NEI-07-10, "Generic FSAR Template Guidance for Process Control Program," Revision 3 adequately provides guidance for establishing the PCP. Accordingly, NRC staff concludes that NEI-07-10 Revision 3 complies with the applicable NRC regulations, guidance, and industry standards and can be utilized by applicants for COLAs.

5. REFERENCES 5.1 Bell, R. J., NEI, to the U.S. NRC, "Response to NRC April 28 Request for Additional Information on NEI 07-09 and May 6 Request for Additional Information on NEI 07-10,"

May 30, 2008.

5.2 NUREG-0800, SRP, Section 11.4, Revision 3, "Solid Waste Management System," March 2007.

5.3 NUREG-0800, SRP, BTP 11-3, Revision 3, "Design Guidance for Solid Radioactive Waste Management Systems Installed in Light-Water-Cooled Nuclear Power Reactor Plants," March 2007.

5.4 RG 1.206, "Combined License Applications for Nuclear Power Plants (LWR Edition)" Section C.I.11, "Radioactive Waste Management," June 2007.

DCWG - Combined (All) (Revised 12/15/2008) cc: Mr. Glenn H. Archinoff Director AECL Technologies Division of Compliance & Inspection 481 North Frederick Avenue Bureau of Radiation Control Suite 405 Texas Department of State Health Services Gaithersburg, MD 20877 1100 West 49th Street Austin, TX 78756-3189 Mr. Ray Aycock Field Supervisor Mr. Eugene S. Grecheck U.S. Fish and Wildlife Service Vice President Mississippi Ecological Services Office Nuclear Support Services 6578 Dogwood View Parkway Dominion Energy, Inc.

Jackson, MS 39213 5000 Dominion Blvd.

Glen Allen, VA 23060 Mr. Richard L. Baker Bechtel Power Corporation Mr. Jay M. Gutierrez 5275 Westview Drive Morgan, Lewis & Bockius, LLP Frederick, MD 21703-8306 111 Pennsylvania Avenue, NW Washington, DC 20004 Scott Bond Callaway Plant Ms. Sophie Gutner P.O. Box 620 P.O. Box 4646 Fulton, MO 65251 Glen Allen, VA 23058 Ms. Michele Boyd Mr. Brian Hastings Legislative Director Public Utility Commission Energy Program William B. Travis Building Public Citizens Critical Mass Energy P.O. Box 13326 and Environmental Program 1701 Noth Congress Avenue 215 Pennsylvania Avenue, SE Austin, TX 78701-3326 Washington, DC 20003 Mr. Tim E. Herrmann Ms. Cindy Brizes Vice President, Nuclear Engineering U.S. Department of Energy AmerenUE P.O. Box A P.O. Box 620 Aiken, SC 29802 Fulton, MO 65251 Mr. Barton Z. Cowan, Esquire Mr. Ronald Kinney Eckert Seamans Cherin & Mellott, LLC South Carolina DHEC 600 Grant Street, 44th Floor 2600 Bull Street Pittsburgh, PA 15219 Columbia, SC 29201 DCWG - Combined (All)

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