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| issue date = 08/16/2007
| issue date = 08/16/2007
| title = Response to NEI Letter Dated July 16, 2007, Regarding Industry Proposal for FSAR Section 13.7, Fitness for Duty Program
| title = Response to NEI Letter Dated July 16, 2007, Regarding Industry Proposal for FSAR Section 13.7, Fitness for Duty Program
| author name = Reckley W D
| author name = Reckley W
| author affiliation = NRC/NRO/DNRL/NGIF
| author affiliation = NRC/NRO/DNRL/NGIF
| addressee name = Bell R J
| addressee name = Bell R
| addressee affiliation = Nuclear Energy Institute (NEI)
| addressee affiliation = Nuclear Energy Institute (NEI)
| docket =  
| docket =  
| license number =  
| license number =  
| contact person = reckley W D, NRO/DNRL/NRGA 415-1323
| contact person = reckley W, NRO/DNRL/NRGA 415-1323
| document type = Letter
| document type = Letter
| page count = 7
| page count = 7
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=Text=
=Text=
{{#Wiki_filter:August 16, 2007  
{{#Wiki_filter:August 16, 2007 Mr. Russell J. Bell, Director New Plant Licensing Nuclear Generation Division Nuclear Energy Institute 1776 I Street, NW, Suite 400 Washington, DC 20006-3708
 
Mr. Russell J. Bell, Director New Plant Licensing Nuclear Generation Division Nuclear Energy Institute 1776 I Street, NW, Suite 400 Washington, DC 20006-3708  


==Dear Mr. Bell:==
==Dear Mr. Bell:==


I am responding to your letter dated July 16, 2007, and to related comments from a public meeting held on August 9, 2007, concerning the nuclear industry's proposed approach to satisfy the requirement in 10 CFR 52.79(a)(44) that a combined license (COL) applicant describe its 10 CFR Part 26 Fitness for Duty (FFD) program in the COL application's Final Safety Analysis Report (FSAR).
I am responding to your letter dated July 16, 2007, and to related comments from a public meeting held on August 9, 2007, concerning the nuclear industrys proposed approach to satisfy the requirement in 10 CFR 52.79(a)(44) that a combined license (COL) applicant describe its 10 CFR Part 26 Fitness for Duty (FFD) program in the COL applications Final Safety Analysis Report (FSAR).
You propose in your letter that COL applicants use the following language in Section 13.7 of a COL application's FSAR:
You propose in your letter that COL applicants use the following language in Section 13.7 of a COL applications FSAR:
A Fitness for Duty (FFD) program is implemented and maintained to meet the requirements contained in 10 CFR Part 26. The FFD program complies with the FFD requirements contained in 10 CFR Part 26 at the new plant construction site during both the construction and operating phases of the nuclear unit. This program will be implemented at the new plant construction site prior to construction of safety- and security-related structures, systems, and components.  
A Fitness for Duty (FFD) program is implemented and maintained to meet the requirements contained in 10 CFR Part 26. The FFD program complies with the FFD requirements contained in 10 CFR Part 26 at the new plant construction site during both the construction and operating phases of the nuclear unit. This program will be implemented at the new plant construction site prior to construction of safety- and security-related structures, systems, and components.
You state that a COL applicants description of its FFD program can be very brief because the current Part 26 contains uniquely prescriptive FFD requirements for both the construction and operational phases. You also remark that the new Part 26 will be even more prescriptive, at least for the operational phase.
First, as the NRC staff noted at the August 9 public meeting: the new Part 26 is not yet in effect, and COL applicants are not required to address it until it goes into effect.
Nevertheless, the NRC agrees that the new Part 26 for the reactors operating phase will be very prescriptive and concludes that FSAR Section 13.7 language stating the applicants commitment to implement an FFD program that will comply with the new Part 26 for the reactors operating phase would satisfy the 10 CFR 52.79(a)(44) requirement.
For an applicants FFD program for construction under the new Part 26, the description requirement could be met by a reference to NEI 06-06, Rev. 1, Fitness for Duty Program Guidance for New Nuclear Power Plant Construction Sites; a reference to a regulatory guide if the NRC develops one; or a full description of the program. The Commission explained in SRM-SECY-04-0032, dated May 14, 2004, that a program is


You state that a COL applicant's description of its FFD program can be very brief because the current Part 26 "contains uniquely prescriptive FFD requirements for both the construction and operational phases."  You also remark that the new Part 26 "will be even more prescriptive, at least for the operational phase."
Bell                                          considered fully described when the program is clearly and sufficiently described in terms of the scope and level of detail to allow a reasonable assurance finding of acceptability. Required programs should always be described at a functional level and at an increased level of detail where implementation choices could materially and negatively affect the program effectiveness and acceptability.
If an applicant references NEI 06-06 while that document is being reviewed by the Commission for endorsement, then the applicant should indicate that NEI 06-06 is under review by the Commission and reference the NRCs Agencywide Documents Access and Management System (ADAMS) accession number of NEI 06-06. All applicants referencing a generic document such as NEI 06-06 should provide, as appropriate, additional site-specific information. Near-term applicants also need to be aware of the risks of using NEI 06-06. They should ensure that NEI 06-06 provides a full program description because they will be relying on an industry document that has not been reviewed yet by the NRC. Essentially, such applicants will be in the same position as an applicant using its own program description. Also, if the NRC does not endorse NEI 06-06, applications will have to be amended to provide the full description of the applicants FFD program for construction. If NEI 06-06 is endorsed by the NRC and the endorsed version differs from the version referenced in the COL application, applicants will need to amend their applications to reflect the revised document. In addition, if the NRC endorses NEI 06-06, the NRC will need to write a safety evaluation on the FFD program description provided in the COL application before issuing a license.
Regarding the current Part 26, the NRC has determined that the proposed language for FSAR Section 13.7 would not meet the requirement of 10 CFR 52.79(a)(44) under the current Part 26 because the current Part 26 is not as prescriptive as the new Part 26 is expected to be. Applicants could meet the requirements of 10 CFR 52.79(a)(44) for the current Part 26 with a full description of: (1) an existing FFD program at the same site as the proposed reactor(s); (2) an existing FFD program used by a licensee within the same corporate family as the applicant; or (3) the following 10 points:
(1)  How the FFD program personnel responsibilities will be assigned by the licensee and implemented within the licensees organizational units; (2) The estimated number of persons to be assigned to implement the FFD program; (3) The general educational and experience requirements for positions or classes of positions necessary to implement the FFD program; (4) FFD program equipment maintenance and calibration procedures; (5) Quality assurance procedures for operations and maintenance of FFD program equipment; (6) Training of supervisors, escorts, and FFD program personnel; (7) Random drug and alcohol testing rates; (8) The drugs the licensee will test for and the cutoff level for each of these drugs; (9) The alcohol testing cutoff level; and (10) Procedures for establishing which substances the licensee will test for, other than the substances required by 10 CFR Part 26 A fourth option for meeting the requirements of 10 CFR 52.79(a)(44) for the current Part 26 exists. Compliance with the provisions of the December 2006 version of the new Part 26 (ADAMS Accession No. ML062550263) would satisfy most requirements in the current Part 26. Thus, an applicant could submit the text of the new Part 26, minus the


First, as the NRC staff noted at the August 9 public meeting:  the new Part 26 is not yet in effect, and COL applicants are not required to address it until it goes into effect. Nevertheless, the NRC agrees that the new Part 26 for the reactor's operating phase will be very prescriptive and concludes that FSAR Section 13.7 language stating the applicant's commitment to implement an FFD program that will comply with the new  Part 26 for the reactor's operating phase would satisfy the 10 CFR 52.79(a)(44) requirement. 
Bell                                         few provisions that conflict with the current Part 26 (e.g., the use of oral fluids for initial alcohol testing), and describe how the applicant would meet those provisions of the current rule that would not be satisfied by compliance with the new rule.
 
Notwithstanding the option chosen by the applicant, the program description must include implementation milestones (e.g., the FFD program for the reactors operational phase will be implemented before the receipt of special nuclear material in the form of fuel assemblies).
For an applicant's FFD program for construction under the new Part 26, the description requirement could be met by a reference to NEI 06-06, Rev. 1, "Fitness for Duty Program Guidance for New Nuclear Power Plant Construction Sites;" a reference to a regulatory guide if the NRC develops one; or a full description of the program. The Commission explained in SRM-SECY-04-0032, dated May 14, 2004, that a program is Bell considered "fully described" when "the program is clearly and sufficiently described in terms of the scope and level of detail to allow a reasonable assurance finding of acceptability. Required programs should always be described at a functional level and at an increased level of detail where implementation choices could materially and negatively affect the program effectiveness and acceptability."
To comply with the current Part 26 requirements for an entity performing NRC-authorized construction, this entity must comply with the current Part 26 requirements for an operating licensee. Therefore, an applicants FFD program description under the current Part 26 should be the same for a reactors construction and operating phases.
 
During the August 9, 2007, public meeting, the industry asked whether a COL applicant could request an exemption from the requirement of 10 CFR 52.79(a)(44) to describe the applicants FFD program under the current Part 26. The NRCs response is that the NRC would have to consider any exemption request and the basis for the request in accordance with the applicable standards in the NRCs regulations.
If an applicant references NEI 06-06 while that document is being reviewed by the Commission for endorsement, then the applicant should indicate that NEI 06-06 is under review by the Commission and reference the NRC's Agencywide Documents Access and Management System (ADAMS) accession number of NEI 06-06. All applicants referencing a generic document such as NEI 06-06 should provide, as appropriate, additional site-specific information. Near-term applicants also need to be aware of the risks of using NEI 06-06. They should ensure that NEI 06-06 provides a full program description because they will be relying on an industry document that has not been reviewed yet by the NRC. Essentially, such applicants will be in the same position as an applicant using its own program description. Also, if the NRC does not endorse  NEI 06-06, applications will have to be amended to provide the full description of the applicant's FFD program for construction. If NEI 06-06 is endorsed by the NRC and the endorsed version differs from the version referenced in the COL application, applicants will need to amend their applications to reflect the revised document. In addition, if the NRC endorses NEI 06-06, the NRC will need to write a safety evaluation on the FFD program description provided in the COL application before issuing a license. 
One commenter at the public meeting mentioned that the NRC had previously informed the industry that COL applicants could seek exemptions from the requirement to fully describe FFD programs under the current Part 26. The NRC believes that in past public meetings, stakeholders and NRC staff discussed the possibility of an applicant seeking an exemption from the current Part 26 while requesting NRC authority to conduct certain activities under a limited work authorization pursuant to the current 10 CFR 50.10(e).
 
The NRC is not aware of any previous public discussions concerning COL applicants seeking exemptions from the current Part 26.
Regarding the current Part 26, the NRC has determined that the proposed language for FSAR Section 13.7 would not meet the requirement of 10 CFR 52.79(a)(44) under the current Part 26 because the current Part 26 is not as prescriptive as the new Part 26 is expected to be. Applicants could meet the requirements of 10 CFR 52.79(a)(44) for the current Part 26 with a full description of:  (1) an existing FFD program at the same site as the proposed reactor(s); (2) an existing FFD program used by a licensee within the same corporate family as the applicant; or (3) the following 10 points:
The NRC looks forward to continuing to work with the industry and stakeholders to further develop guidance for COL applicants.
(1) How the FFD program personnel responsibilities will be assigned by the licensee and implemented within the licensee's organizational units; (2) The estimated number of persons to be assigned to implement the FFD program; (3) The general educational and experience requirements for positions or classes of positions necessary to implement the FFD program; (4) FFD program equipment maintenance and calibration procedures; (5) Quality assurance procedures for operations and maintenance of FFD program equipment; (6) Training of supervisors, escorts, and FFD program personnel; (7) Random drug and alcohol testing rates; (8) The drugs the licensee will test for and the cutoff level for each of these drugs; (9) The alcohol testing cutoff level; and (10) Procedures for establishing which substances the licensee will test for, other than the substances required by 10 CFR Part 26 A fourth option for meeting the requirements of 10 CFR 52.79(a)(44) for the current  Part 26 exists. Compliance with the provisions of the December 2006 version of the new Part 26 (ADAMS Accession No. ML062550263) would satisfy most requirements in the current Part 26. Thus, an applicant could submit the text of the new Part 26, minus the Bell few provisions that conflict with the current Part 26 (e.g., the use of oral fluids for initial alcohol testing), and describe how the applicant would meet those provisions of the current rule that would not be satisfied by compliance with the new rule.
Sincerely,
Notwithstanding the option chosen by the applicant, the program description must include implementation milestones (e.g., the FFD program for the reactor's operational phase will be implemented before the receipt of special nuclear material in the form of fuel assemblies).
                                              /RA/
To comply with the current Part 26 requirements for an entity performing NRC-authorized construction, this entity must comply with the current Part 26 requirements for an operating licensee. Therefore, an applicant's FFD program description under the current Part 26 should be the same for a reactor's construction and operating phases.
William D. Reckley, Branch Chief Guidance, Rulemaking and Advanced Reactor Branch Division of New Reactor Licensing Office of New Reactors cc:      see attached list
During the August 9, 2007, public meeting, the industry asked whether a COL applicant could request an exemption from the requirement of 10 CFR 52.79(a)(44) to describe the applicant's FFD program under the current Part 26. The NRC's response is that the NRC would have to consider any exemption request and the basis for the request in accordance with the applicable standards in the NRC's regulations.
One commenter at the public meeting mentioned that the NRC had previously informed the industry that COL applicants could seek exemptions from the requirement to fully describe FFD programs under the current Part 26. The NRC believes that in past public meetings, stakeholders and NRC staff discussed the possibility of an applicant seeking an exemption from the current Part 26 while requesting NRC authority to conduct certain activities under a limited work authorization pursuant to the current 10 CFR 50.10(e). The NRC is not aware of any previous public discussions concerning COL applicants seeking exemptions from the current Part 26.


Bell                                        few provisions that conflict with the current Part 26 (e.g., the use of oral fluids for initial alcohol testing), and describe how the applicant would meet those provisions of the current rule that would not be satisfied by compliance with the new rule.
Notwithstanding the option chosen by the applicant, the program description must include implementation milestones (e.g., the FFD program for the reactors operational phase will be implemented before the receipt of special nuclear material in the form of fuel assemblies).
To comply with the current Part 26 requirements for an entity performing NRC-authorized construction, this entity must comply with the current Part 26 requirements for an operating licensee. Therefore, an applicants FFD program description under the current Part 26 should be the same for a reactors construction and operating phases.
During the August 9, 2007, public meeting, the industry asked whether a COL applicant could request an exemption from the requirement of 10 CFR 52.79(a)(44) to describe the applicants FFD program under the current Part 26. The NRCs response is that the NRC would have to consider any exemption request and the basis for the request in accordance with the applicable standards in the NRCs regulations.
One commenter at the public meeting mentioned that the NRC had previously informed the industry that COL applicants could seek exemptions from the requirement to fully describe FFD programs under the current Part 26. The NRC believes that in past public meetings, stakeholders and NRC staff discussed the possibility of an applicant seeking an exemption from the current Part 26 while requesting NRC authority to conduct certain activities under a limited work authorization pursuant to the current 10 CFR 50.10(e).
The NRC is not aware of any previous public discussions concerning COL applicants seeking exemptions from the current Part 26.
The NRC looks forward to continuing to work with the industry and stakeholders to further develop guidance for COL applicants.
The NRC looks forward to continuing to work with the industry and stakeholders to further develop guidance for COL applicants.
Sincerely,         /RA/ William D. Reckley, Branch Chief Guidance, Rulemaking and Advanced     Reactor Branch Division of New Reactor Licensing Office of New Reactors cc: see attached list  
Sincerely,
                                              /RA/
William D. Reckley, Branch Chief Guidance, Rulemaking and Advanced Reactor Branch Division of New Reactor Licensing Office of New Reactors cc:     see attached list Distribution:
WReckley                GWest                TMcCune        HBenowitz RidsOgcMailCenter        RidsNroDnrlNgif Accession Number: ML072270296 OFFICE      BC:NSIR/DSO/DDSP/LP        OGC                        BC:NRO/DNRL/NRCA NAME        GWest                      HBenowitz                  WReckley DATE        08/20/2007                  08/16/2007                08/16/2007 OFFICIAL RECORD COPY


Bell few provisions that conflict with the current Part 26 (e.g., the use of oral fluids for initial alcohol testing), and describe how the applicant would meet those provisions of the current rule that would not be satisfied by compliance with the new rule.
Combination Mailing List:
Notwithstanding the option chosen by the applicant, the program description must include implementation milestones (e.g., the FFD program for the reactor's operational phase will be implemented before the receipt of special nuclear material in the form of fuel assemblies).
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To comply with the current Part 26 requirements for an entity performing NRC-authorized construction, this entity must comply with the current Part 26 requirements for an operating licensee. Therefore, an applicant's FFD program description under the current Part 26 should be the same for a reactor's construction and operating phases.
Mr. Laurence Parme                          Mr. Charles Brinkman Manager, GT-MHR Safety & Licensing          Westinghouse Electric Co.
During the August 9, 2007, public meeting, the industry asked whether a COL applicant could request an exemption from the requirement of 10 CFR 52.79(a)(44) to describe the applicant's FFD program under the current Part 26. The NRC's response is that the NRC would have to consider any exemption request and the basis for the request in accordance with the applicable standards in the NRC's regulations.
General Atomics Company                    Washington Operations P.O. Box 85608                              12300 Twinbrook Pkwy., Suite 330 San Diego, CA 92186-5608                    Rockville, MD 20852 Mr. David Lochbaum, Nuclear Safety Engineer Mr. Joseph D. Hegner Union of Concerned Scientists              Lead Engineer - Licensing 1707 H Street, NW, Suite 600                Dominion Generation Washington, DC 20006-3919                  Early Site Permitting Project 5000 Dominion Boulevard Mr. Paul Gunter                            Glen Allen, VA 23060 Nuclear Information & Resource Service 1424 16th Street, NW, Suite 404            Mr. Edward L. Quinn Washington, DC 20036                        Longenecker and Associates Utility Operations Division Mr. James Riccio                            23292 Pompeii Drive Greenpeace                                  Dana Point, CA 92629 702 H Street, NW, Suite 300 Washington, DC 20001                        Mr. Paul Leventhal Nuclear Control Institute Mr. Adrian Heymer                          1000 Connecticut Avenue NW Nuclear Energy Institute                    Suite 410 Suite 400                                  Washington, DC 20036 1776 I Street, NW Washington, DC 20006-3708                  Mr. Jay M. Gutierrez Morgan, Lewis & Bockius, LLP Mr. George Alan Zinke                      1111 Pennsylvania Avenue, NW Project Manager                            Washington, DC 20004 Nuclear Business Development Entergy Nuclear                            Mr. W. Edward Cummins M-ECH-683                                  AP600 and AP1000 Projects 1340 Echelon Parkway                        Westinghouse Electric Company Jackson, MS 39213                          P.O. Box 355 Pittsburgh, PA 15230-0355 Ms. Marilyn Kray Vice President, Special Projects            Mr. Gary Wright, Manager Exelon Generation                          Office of Nuclear Facility Safety 200 Exelon Way, KSA3-E                      Illinois Department of Nuclear Safety Kennett Square, PA 19348                    1035 Outer Park Drive Springfield, IL 62704
One commenter at the public meeting mentioned that the NRC had previously informed the industry that COL applicants could seek exemptions from the requirement to fully describe FFD programs under the current Part 26. The NRC believes that in past public meetings, stakeholders and NRC staff discussed the possibility of an applicant seeking an exemption from the current Part 26 while requesting NRC authority to conduct certain activities under a limited work authorization pursuant to the current 10 CFR 50.10(e). The NRC is not aware of any previous public discussions concerning COL applicants seeking exemptions from the current Part 26.
 
The NRC looks forward to continuing to work with the industry and stakeholders to further develop guidance for COL applicants.
Sincerely,       /RA/ William D. Reckley, Branch Chief Guidance, Rulemaking and Advanced    Reactor Branch Division of New Reactor Licensing Office of New Reactors cc: see attached list Distribution
: WReckley  GWest  TMcCune HBenowitz RidsOgcMailCenter RidsNroDnrlNgif


Accession Number:  ML072270296 OFFICE BC:NSIR/DSO/DDSP/LP OGC BC:NRO/DNRL/NRGA NAME GWest HBenowitz WReckley DATE 08/20/2007 08/16/2007 08/16/2007 OFFICIAL RECORD COPY Combination Mailing List
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Mr. Laurence Parme      Mr. Charles Brinkman Manager, GT-MHR Safety & Licensing  Westinghouse Electric Co. General Atomics Company    Washington Operations P.O. Box 85608      12300 Twinbrook Pkwy., Suite 330  San Diego, CA 92186-5608    Rockville, MD 20852 Mr. David Lochbaum, Nuclear Safety Engineer Mr. Joseph D. Hegner  Union of Concerned Scientists    Lead Engineer - Licensing 1707 H Street, NW, Suite 600    Dominion Generation  Washington, DC 20006-3919    Early Site Permitting Project        5000 Dominion Boulevard  Mr. Paul Gunter    Glen Allen, VA 23060  Nuclear Information & Resource Service 1424 16th Street, NW, Suite 404    Mr. Edward L. Quinn  Washington, DC 20036    Longenecker and Associates Utility Operations Division  Mr. James Riccio      23292 Pompeii Drive  Greenpeace      Dana Point, CA 92629  702 H Street, NW, Suite 300         Washington, DC 20001    Mr. Paul Leventhal Nuclear Control Institute  Mr. Adrian Heymer      1000 Connecticut Avenue NW Nuclear Energy Institute     Suite 410  Suite 400     Washington, DC 20036  1776 I Street, NW Washington, DC 20006-3708   Mr. Jay M. Gutierrez        Morgan, Lewis & Bockius, LLP  Mr. George Alan Zinke    1111 Pennsylvania Avenue, NW  Project Manager    Washington, DC 20004 Nuclear Business Development Entergy Nuclear    Mr. W. Edward Cummins  M-ECH-683      AP600 and AP1000 Projects  1340 Echelon Parkway    Westinghouse Electric Company Jackson, MS 39213    P.O. Box 355        Pittsburgh, PA 15230-0355 Ms. Marilyn Kray  Vice President, Special Projects  Mr. Gary Wright, Manager  Exelon Generation    Office of Nuclear Facility Safety  200 Exelon Way, KSA3-E    Illinois Department of Nuclear Safety  Kennett Square, PA 19348    1035 Outer Park Drive        Springfield, IL 62704 
Mr. Brendan Hoffman                      Ms. Vanessa E. Quinn, Chief Research Associate on Nuclear Energy    Radiological Emergency Public Citizens Critical Mass Energy and Preparedness Branch Environmental Program                    Nuclear and Chemical Preparedness 215 Pennsylvania Avenue, SE              and Protection Division Washington, DC 20003                    Department of Homeland Security 1800 South Bell Street, Room 837 Mr. Lionel Batty                        Crystal City-Arlington, VA 22202 Nuclear Business Team Graftech                                Mr. Ron Simard 12300 Snow Road                          6170 Masters Club Drive Parma, OH 44130                          Suwanee, GA 30024 Mr. Ian M. Grant                        Ms. Sandra Sloan Canadian Nuclear Safety Commission      Areva NP, Inc.
280 Slater Street, Station B            3315 Old Forest Road P.O. Box 1046                            P.O. Box 10935 Ottawa, Ontario                          Lynchburg, VA 24506-0935 K1P 5S9 Ms. Anne W. Cottingham Mr. Glenn H. Archinoff                  Assistant General Counsel AECL Technologies                        Nuclear Energy Institute 481 North Frederick Avenue              1776 I Street, NW, Suite 400 Suite 405                                Washington, DC 20006 Gaithersburg, MD 20877 Mr. David Repka Mr. Ed Wallace, General Manager          Winston & Strawn LLP Projects                                1700 K Street, NW PBMR Pty LTD                            Washington, DC 20006-3817 PO Box 9396 Centurion 0046                          Mr. Robert E. Sweeney Republic of South Africa                IBEX ESI 4641 Montgomery Avenue Mr. Dobie McArthur                      Suite 350 Director, Washington Operations         Bethesda, MD 20814 General Atomics 1899 Pennsylvania Avenue, NW, Suite 300 Mr. Eugene S. Grecheck Washington, DC 20006                    Vice President Nuclear Support Services Mr. Russell Bell                        Dominion Energy, Inc Director                                5000 Dominion Blvd.
Nuclear Energy Institute                 Glen Allen, VA 23060 Suite 400 1776 I Street, NW Washington, DC 20006-3708


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Mr. Brendan Hoffman    Ms. Vanessa E. Quinn, Chief  Research Associate on Nuclear Energy  Radiological Emergency Public Citizens Critical Mass Energy and    Preparedness Branch Environmental Program    Nuclear and Chemical Preparedness 215 Pennsylvania Avenue, SE      and Protection Division  Washington, DC 20003    Department of Homeland Security        1800 South Bell Street, Room 837  Mr. Lionel Batty      Crystal City-Arlington, VA 22202 Nuclear Business Team        Graftech      Mr. Ron Simard  12300 Snow Road    6170 Masters Club Drive  Parma, OH 44130    Suwanee, GA 30024 Mr. Ian M. Grant      Ms. Sandra Sloan  Canadian Nuclear Safety Commission  Areva NP, Inc.
E-Mail:
280 Slater Street, Station B    3315 Old Forest Road  P.O. Box 1046      P.O. Box 10935  Ottawa, Ontario      Lynchburg, VA 24506-0935 K1P 5S9        Ms. Anne W. Cottingham Mr. Glenn H. Archinoff    Assistant General Counsel  AECL Technologies      Nuclear Energy Institute    481 North Frederick Avenue    1776 I Street, NW, Suite 400  Suite 405      Washington, DC 20006  Gaithersburg, MD 20877 Mr. David Repka  Mr. Ed Wallace, General Manager    Winston & Strawn LLP  Projects      1700 K Street, NW  PBMR Pty LTD      Washington, DC 20006-3817  PO Box 9396 Centurion 0046      Mr. Robert E. Sweeney Republic of South Africa    IBEX ESI        4641 Montgomery Avenue  Mr. Dobie McArthur  Suite 350 Director, Washington Operations    Bethesda, MD 20814 General Atomics      1899 Pennsylvania Avenue, NW, Suite 300  Mr. Eugene S. Grecheck  Washington, DC 20006    Vice President        Nuclear Support Services  Mr. Russell Bell    Dominion Energy, Inc Director      5000 Dominion Blvd. Nuclear Energy Institute    Glen Allen, VA 23060 Suite 400        1776 I Street, NW      Washington, DC 20006-3708 Combination List
tom.miller@hq.doe.gov tom.miller@ nuclear.energy.gov mark.beaumont@wsms.com sfrantz@morganlewis.com ksutton@morganlewis.com jgutierrez@morganlewis.com sandra.sloan@areva.com mwetterhahn@winston.com gcesare@enercon.com whorin@winston.com erg-xl@cox.net steven.hucik@ge.com david.hinds@ge.com chris.maslak@ge.com mgiles@entergy.com patriciaL.campbell@ge.com bob.brown@ge.com jim@ncwarn.org pshastings@duke-energy.com ronald.hagen@eia.doe.gov murawski@newsobserver.com Cary.Fleming@constellation.com tansel.selekler@nuclear.energy.gov tansel.selekler@hq.doe.gov trsmith@winston.com James.Beard@gene.ge.com george.stramback@gene.ge.com david.lewis@pillsburylaw.com paul.gaukler@pillsburylaw.com john.o'neill@pillsburylaw.com matias.travieso-diaz@pillsburylaw.com maria.webb@pillsburylaw.com roberta.swain@ge.com cee@nei.org}}
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E-Mail: tom.miller@hq.doe.gov tom.miller@ nuclear.energy.gov mark.beaumont@wsms.com sfrantz@morganlewis.com ksutton@morganlewis.com jgutierrez@morganlewis.com sandra.sloan@areva.com mwetterhahn@winston.com gcesare@enercon.com whorin@winston.com erg-xl@cox.net steven.hucik@ge.com david.hinds@ge.com chris.maslak@ge.com mgiles@entergy.com patriciaL.campbell@ge.com bob.brown@ge.com jim@ncwarn.org pshastings@duke-energy.com ronald.hagen@eia.doe.gov murawski@newsobserver.com Cary.Fleming@constellation.com tansel.selekler@nuclear.energy.gov tansel.selekler@hq.doe.gov trsmith@winston.com James.Beard@gene.ge.com george.stramback@gene.ge.com david.lewis@pillsburylaw.com paul.gaukler@pillsburylaw.com john.o'neill@pillsburylaw.com matias.travieso-diaz@pillsburylaw.com maria.webb@pillsburylaw.com roberta.swain@ge.com cee@nei.org}}

Latest revision as of 04:30, 23 November 2019

Response to NEI Letter Dated July 16, 2007, Regarding Industry Proposal for FSAR Section 13.7, Fitness for Duty Program
ML072270296
Person / Time
Issue date: 08/16/2007
From: William Reckley
NRC/NRO/DNRL/NGIF
To: Bell R
Nuclear Energy Institute
reckley W, NRO/DNRL/NRGA 415-1323
References
Download: ML072270296 (7)
v • d • e


Text

August 16, 2007 Mr. Russell J. Bell, Director New Plant Licensing Nuclear Generation Division Nuclear Energy Institute 1776 I Street, NW, Suite 400 Washington, DC 20006-3708

Dear Mr. Bell:

I am responding to your letter dated July 16, 2007, and to related comments from a public meeting held on August 9, 2007, concerning the nuclear industrys proposed approach to satisfy the requirement in 10 CFR 52.79(a)(44) that a combined license (COL) applicant describe its 10 CFR Part 26 Fitness for Duty (FFD) program in the COL applications Final Safety Analysis Report (FSAR).

You propose in your letter that COL applicants use the following language in Section 13.7 of a COL applications FSAR:

A Fitness for Duty (FFD) program is implemented and maintained to meet the requirements contained in 10 CFR Part 26. The FFD program complies with the FFD requirements contained in 10 CFR Part 26 at the new plant construction site during both the construction and operating phases of the nuclear unit. This program will be implemented at the new plant construction site prior to construction of safety- and security-related structures, systems, and components.

You state that a COL applicants description of its FFD program can be very brief because the current Part 26 contains uniquely prescriptive FFD requirements for both the construction and operational phases. You also remark that the new Part 26 will be even more prescriptive, at least for the operational phase.

First, as the NRC staff noted at the August 9 public meeting: the new Part 26 is not yet in effect, and COL applicants are not required to address it until it goes into effect.

Nevertheless, the NRC agrees that the new Part 26 for the reactors operating phase will be very prescriptive and concludes that FSAR Section 13.7 language stating the applicants commitment to implement an FFD program that will comply with the new Part 26 for the reactors operating phase would satisfy the 10 CFR 52.79(a)(44) requirement.

For an applicants FFD program for construction under the new Part 26, the description requirement could be met by a reference to NEI 06-06, Rev. 1, Fitness for Duty Program Guidance for New Nuclear Power Plant Construction Sites; a reference to a regulatory guide if the NRC develops one; or a full description of the program. The Commission explained in SRM-SECY-04-0032, dated May 14, 2004, that a program is

Bell considered fully described when the program is clearly and sufficiently described in terms of the scope and level of detail to allow a reasonable assurance finding of acceptability. Required programs should always be described at a functional level and at an increased level of detail where implementation choices could materially and negatively affect the program effectiveness and acceptability.

If an applicant references NEI 06-06 while that document is being reviewed by the Commission for endorsement, then the applicant should indicate that NEI 06-06 is under review by the Commission and reference the NRCs Agencywide Documents Access and Management System (ADAMS) accession number of NEI 06-06. All applicants referencing a generic document such as NEI 06-06 should provide, as appropriate, additional site-specific information. Near-term applicants also need to be aware of the risks of using NEI 06-06. They should ensure that NEI 06-06 provides a full program description because they will be relying on an industry document that has not been reviewed yet by the NRC. Essentially, such applicants will be in the same position as an applicant using its own program description. Also, if the NRC does not endorse NEI 06-06, applications will have to be amended to provide the full description of the applicants FFD program for construction. If NEI 06-06 is endorsed by the NRC and the endorsed version differs from the version referenced in the COL application, applicants will need to amend their applications to reflect the revised document. In addition, if the NRC endorses NEI 06-06, the NRC will need to write a safety evaluation on the FFD program description provided in the COL application before issuing a license.

Regarding the current Part 26, the NRC has determined that the proposed language for FSAR Section 13.7 would not meet the requirement of 10 CFR 52.79(a)(44) under the current Part 26 because the current Part 26 is not as prescriptive as the new Part 26 is expected to be. Applicants could meet the requirements of 10 CFR 52.79(a)(44) for the current Part 26 with a full description of: (1) an existing FFD program at the same site as the proposed reactor(s); (2) an existing FFD program used by a licensee within the same corporate family as the applicant; or (3) the following 10 points:

(1) How the FFD program personnel responsibilities will be assigned by the licensee and implemented within the licensees organizational units; (2) The estimated number of persons to be assigned to implement the FFD program; (3) The general educational and experience requirements for positions or classes of positions necessary to implement the FFD program; (4) FFD program equipment maintenance and calibration procedures; (5) Quality assurance procedures for operations and maintenance of FFD program equipment; (6) Training of supervisors, escorts, and FFD program personnel; (7) Random drug and alcohol testing rates; (8) The drugs the licensee will test for and the cutoff level for each of these drugs; (9) The alcohol testing cutoff level; and (10) Procedures for establishing which substances the licensee will test for, other than the substances required by 10 CFR Part 26 A fourth option for meeting the requirements of 10 CFR 52.79(a)(44) for the current Part 26 exists. Compliance with the provisions of the December 2006 version of the new Part 26 (ADAMS Accession No. ML062550263) would satisfy most requirements in the current Part 26. Thus, an applicant could submit the text of the new Part 26, minus the

Bell few provisions that conflict with the current Part 26 (e.g., the use of oral fluids for initial alcohol testing), and describe how the applicant would meet those provisions of the current rule that would not be satisfied by compliance with the new rule.

Notwithstanding the option chosen by the applicant, the program description must include implementation milestones (e.g., the FFD program for the reactors operational phase will be implemented before the receipt of special nuclear material in the form of fuel assemblies).

To comply with the current Part 26 requirements for an entity performing NRC-authorized construction, this entity must comply with the current Part 26 requirements for an operating licensee. Therefore, an applicants FFD program description under the current Part 26 should be the same for a reactors construction and operating phases.

During the August 9, 2007, public meeting, the industry asked whether a COL applicant could request an exemption from the requirement of 10 CFR 52.79(a)(44) to describe the applicants FFD program under the current Part 26. The NRCs response is that the NRC would have to consider any exemption request and the basis for the request in accordance with the applicable standards in the NRCs regulations.

One commenter at the public meeting mentioned that the NRC had previously informed the industry that COL applicants could seek exemptions from the requirement to fully describe FFD programs under the current Part 26. The NRC believes that in past public meetings, stakeholders and NRC staff discussed the possibility of an applicant seeking an exemption from the current Part 26 while requesting NRC authority to conduct certain activities under a limited work authorization pursuant to the current 10 CFR 50.10(e).

The NRC is not aware of any previous public discussions concerning COL applicants seeking exemptions from the current Part 26.

The NRC looks forward to continuing to work with the industry and stakeholders to further develop guidance for COL applicants.

Sincerely,

/RA/

William D. Reckley, Branch Chief Guidance, Rulemaking and Advanced Reactor Branch Division of New Reactor Licensing Office of New Reactors cc: see attached list

Bell few provisions that conflict with the current Part 26 (e.g., the use of oral fluids for initial alcohol testing), and describe how the applicant would meet those provisions of the current rule that would not be satisfied by compliance with the new rule.

Notwithstanding the option chosen by the applicant, the program description must include implementation milestones (e.g., the FFD program for the reactors operational phase will be implemented before the receipt of special nuclear material in the form of fuel assemblies).

To comply with the current Part 26 requirements for an entity performing NRC-authorized construction, this entity must comply with the current Part 26 requirements for an operating licensee. Therefore, an applicants FFD program description under the current Part 26 should be the same for a reactors construction and operating phases.

During the August 9, 2007, public meeting, the industry asked whether a COL applicant could request an exemption from the requirement of 10 CFR 52.79(a)(44) to describe the applicants FFD program under the current Part 26. The NRCs response is that the NRC would have to consider any exemption request and the basis for the request in accordance with the applicable standards in the NRCs regulations.

One commenter at the public meeting mentioned that the NRC had previously informed the industry that COL applicants could seek exemptions from the requirement to fully describe FFD programs under the current Part 26. The NRC believes that in past public meetings, stakeholders and NRC staff discussed the possibility of an applicant seeking an exemption from the current Part 26 while requesting NRC authority to conduct certain activities under a limited work authorization pursuant to the current 10 CFR 50.10(e).

The NRC is not aware of any previous public discussions concerning COL applicants seeking exemptions from the current Part 26.

The NRC looks forward to continuing to work with the industry and stakeholders to further develop guidance for COL applicants.

Sincerely,

/RA/

William D. Reckley, Branch Chief Guidance, Rulemaking and Advanced Reactor Branch Division of New Reactor Licensing Office of New Reactors cc: see attached list Distribution:

WReckley GWest TMcCune HBenowitz RidsOgcMailCenter RidsNroDnrlNgif Accession Number: ML072270296 OFFICE BC:NSIR/DSO/DDSP/LP OGC BC:NRO/DNRL/NRCA NAME GWest HBenowitz WReckley DATE 08/20/2007 08/16/2007 08/16/2007 OFFICIAL RECORD COPY

Combination Mailing List:

cc: (page 1)

Mr. Laurence Parme Mr. Charles Brinkman Manager, GT-MHR Safety & Licensing Westinghouse Electric Co.

General Atomics Company Washington Operations P.O. Box 85608 12300 Twinbrook Pkwy., Suite 330 San Diego, CA 92186-5608 Rockville, MD 20852 Mr. David Lochbaum, Nuclear Safety Engineer Mr. Joseph D. Hegner Union of Concerned Scientists Lead Engineer - Licensing 1707 H Street, NW, Suite 600 Dominion Generation Washington, DC 20006-3919 Early Site Permitting Project 5000 Dominion Boulevard Mr. Paul Gunter Glen Allen, VA 23060 Nuclear Information & Resource Service 1424 16th Street, NW, Suite 404 Mr. Edward L. Quinn Washington, DC 20036 Longenecker and Associates Utility Operations Division Mr. James Riccio 23292 Pompeii Drive Greenpeace Dana Point, CA 92629 702 H Street, NW, Suite 300 Washington, DC 20001 Mr. Paul Leventhal Nuclear Control Institute Mr. Adrian Heymer 1000 Connecticut Avenue NW Nuclear Energy Institute Suite 410 Suite 400 Washington, DC 20036 1776 I Street, NW Washington, DC 20006-3708 Mr. Jay M. Gutierrez Morgan, Lewis & Bockius, LLP Mr. George Alan Zinke 1111 Pennsylvania Avenue, NW Project Manager Washington, DC 20004 Nuclear Business Development Entergy Nuclear Mr. W. Edward Cummins M-ECH-683 AP600 and AP1000 Projects 1340 Echelon Parkway Westinghouse Electric Company Jackson, MS 39213 P.O. Box 355 Pittsburgh, PA 15230-0355 Ms. Marilyn Kray Vice President, Special Projects Mr. Gary Wright, Manager Exelon Generation Office of Nuclear Facility Safety 200 Exelon Way, KSA3-E Illinois Department of Nuclear Safety Kennett Square, PA 19348 1035 Outer Park Drive Springfield, IL 62704

Combination Mailing List:

cc: (page 2)

Mr. Brendan Hoffman Ms. Vanessa E. Quinn, Chief Research Associate on Nuclear Energy Radiological Emergency Public Citizens Critical Mass Energy and Preparedness Branch Environmental Program Nuclear and Chemical Preparedness 215 Pennsylvania Avenue, SE and Protection Division Washington, DC 20003 Department of Homeland Security 1800 South Bell Street, Room 837 Mr. Lionel Batty Crystal City-Arlington, VA 22202 Nuclear Business Team Graftech Mr. Ron Simard 12300 Snow Road 6170 Masters Club Drive Parma, OH 44130 Suwanee, GA 30024 Mr. Ian M. Grant Ms. Sandra Sloan Canadian Nuclear Safety Commission Areva NP, Inc.

280 Slater Street, Station B 3315 Old Forest Road P.O. Box 1046 P.O. Box 10935 Ottawa, Ontario Lynchburg, VA 24506-0935 K1P 5S9 Ms. Anne W. Cottingham Mr. Glenn H. Archinoff Assistant General Counsel AECL Technologies Nuclear Energy Institute 481 North Frederick Avenue 1776 I Street, NW, Suite 400 Suite 405 Washington, DC 20006 Gaithersburg, MD 20877 Mr. David Repka Mr. Ed Wallace, General Manager Winston & Strawn LLP Projects 1700 K Street, NW PBMR Pty LTD Washington, DC 20006-3817 PO Box 9396 Centurion 0046 Mr. Robert E. Sweeney Republic of South Africa IBEX ESI 4641 Montgomery Avenue Mr. Dobie McArthur Suite 350 Director, Washington Operations Bethesda, MD 20814 General Atomics 1899 Pennsylvania Avenue, NW, Suite 300 Mr. Eugene S. Grecheck Washington, DC 20006 Vice President Nuclear Support Services Mr. Russell Bell Dominion Energy, Inc Director 5000 Dominion Blvd.

Nuclear Energy Institute Glen Allen, VA 23060 Suite 400 1776 I Street, NW Washington, DC 20006-3708

Combination List:

cc: (page 3)

E-Mail:

tom.miller@hq.doe.gov tom.miller@ nuclear.energy.gov mark.beaumont@wsms.com sfrantz@morganlewis.com ksutton@morganlewis.com jgutierrez@morganlewis.com sandra.sloan@areva.com mwetterhahn@winston.com gcesare@enercon.com whorin@winston.com erg-xl@cox.net steven.hucik@ge.com david.hinds@ge.com chris.maslak@ge.com mgiles@entergy.com patriciaL.campbell@ge.com bob.brown@ge.com jim@ncwarn.org pshastings@duke-energy.com ronald.hagen@eia.doe.gov murawski@newsobserver.com Cary.Fleming@constellation.com tansel.selekler@nuclear.energy.gov tansel.selekler@hq.doe.gov trsmith@winston.com James.Beard@gene.ge.com george.stramback@gene.ge.com david.lewis@pillsburylaw.com paul.gaukler@pillsburylaw.com john.o'neill@pillsburylaw.com matias.travieso-diaz@pillsburylaw.com maria.webb@pillsburylaw.com roberta.swain@ge.com cee@nei.org

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