october 3, 2012 ms. annette l. vietti-cook · october 3, 2012 ms. annette l. vietti-cook secretary...

PRM-72-7NUCLEAR ENERGY INSTITUTE

DOCKETED Anthony P. PietrangeloUSNRCOctoe 1SENIOR VICE PRESIDENT ANDO ctober 18, 2012 (2:27 p.m .)CHE NU LA OFI R

CHIEF NUCLEAR OFFICER

RULEMAKINGS ANDADJUDICATIONS STAFF

OFFICE OF THE SECRETARY

October 3, 2012

Ms. Annette L. Vietti-CookSecretaryAttn: Rulemaking and Adjudications Staff

U.S. Nuclear Regulatory Commission

Washington, DC 20555-0001

Subject: Petition to Amend 10 CFR Part 72, "Licensing Requirements for the Independent Storage

of Spent Nuclear Fuel, High-Level Radioactive Waste, and Reactor-Related Greater Than Class C

Waste"

Project Code: 689

Dear Ms. Vietti-Cook:

On behalf of its members and pursuant to 10 CFR 2.802, "Petition for Rulemaking," the Nuclear

Energy Institute (NEI) 1 submits the enclosed petition to amend 10 CFR Part 72, "Licensing

Requirements for the Independent Storage of Spent Nuclear Fuel, High-Level Radioactive Waste,

and Reactor-Related Greater Than Class C Waste." The purpose of this petition is to amend SubpartsC, F, L and K to add a new rule governing spent fuel storage cask Certificate of Compliance (CoC)

format and content, extend the applicability of the backfit rule to CoCs, and make other neededimprovements based on experience and risk insights gained since the regulations were developed in

the 1980s and modified in 1990 pursuant to the Nuclear Waste Policy Act.

NEI is the organization responsible for establishing unified nuclear industry policy on matters affecting the nuclear energy

industry, including the regulatory aspects of generic operational and technical issues. NEI's members include all entitieslicensed to operate commercial nuclear power plants in the United States, nuclear plant designers, majorarchitect/engineering firms, fuel fabrication facilities, nuclear material licensees, and other organizations and individualsinvolved in the nuclear energy industry.

1776 I Street, NW I Suite 400 I Washington, DC 1 20006-3708 I P: 202.739.8081 I F: 202.533.0182 I [email protected] I www.nei.org

6eci - 0S1 ->

Ms. Annette L. Vietti-CookOctober 3, 2012

We appreciate your attention to this matter. If you have any questions concerning this petition,please contact me or Rodney McCullum (202.739.8082; rxmdnei.org).

Sincerely,

P147 Af~~Anthony R. Pietrangelo

Attachment

c: The Honorable Allison M. Macfarlane, Chairman, NRCThe Honorable Kristine L. Svinicki, Commissioner, NRCThe Honorable William C. Ostendorff, Commissioner, NRCThe Honorable William D. Magwood, IV, Commissioner, NRCThe Honorable George Apostolakis, Commissioner, NRCMr. R. William Borchardt, EDO, NRCMs. Catherine Haney, NMSS, NRCMr. Mark D. Lombard, NMSS/DSFST, NRC

Before theUNITED STATES NUCLEAR REGULATORY COMMISSION

Rockville, Maryland

In the Matter of a ProposedRulemaking Regarding Amendmentof 10 CFR Part 72, "LicensingRequirements for the IndependentStorage of Spent Nuclear Fuel, High-Level Radioactive Waste, andReactor Related Greater than Class CWaste"

Docket No.

PETITION FOR RULEMAKING

This Petition for Rulemaking is submitted pursuant to 10 CFR 2.802, "Petition forRulemaking" by the Nuclear Energy Institute (NEI) on behalf of its members. NEIrequests that the U.S. Nuclear Regulatory Commission (NRC), following public noticeand opportunity for comment, amend 10 CFR Part 72 "Licensing Requirements for theIndependent Storage of Spent Nuclear Fuel, High-Level Radioactive Waste, and Reactor-Related Greater than Class C Waste" to refine existing requirements based on riskinsights and experience gained since the regulations were developed in the 1980's andmodified in 1990 pursuant to the Nuclear Waste Policy Act.

October 3, 2012 Page 1 of 41

NEI Petition to Amend 10 CFR Part 72

Table of Contents

1. Statement of Petitioner's Interest ...................................................................... 32. Background .................................................................................................. 3

2.1 Lessons Learned ......................................................................................... 3

2.2 Risk Informing the Regulatory Framework .................................................... 4

2.3 Holistic Perspective ..................................................................................... 52.4 On-Going Regulatory Framework Improvement Efforts ................................. 6

3. Proposed Amendments to 10 CFR Part 72 ......................................................... 73.1 Add New Rule for Certificate of Compliance Format and Content .................... 7

3.2 Revise the Backfit Rule to Apply to CoCs and CoC Holders ............................. 10

3.3 Delete the Requirement for the Review of the Cask SER .............................. 113.4 Clarify the Requirement for the Review of Programs and Plans Governed by OtherParts of the Regulations ................................................................................... 12

3.5 Revise the Requirement for Cask Marking .................................................. 12

3.6 Clarify the Applicability of the Criticality Monitoring Exemptions ..................... 124. Additional Regulatory Framework Improvements (not included in this Petition) ....... 13

5. Additional Conformance Information ............................................................... 16

6. Conclusion ................................................................................................... . . 16

Enclosure 1 - Rationale for Adding a New Rule for Certificate of Compliance Format andC o nte nt ................................................................................................................ 17Enclosure 2 - Rationale for Revising the Backfit Rule to Apply to CoCs and CoC Holders

..... . . . .........................•.I~ I........••.•.••.•...............................................................° 27

Enclosure 3 - Rationale for Deleting the Requirement for the Review of the Cask SER. 32

Enclosure 4 - Rationale for Clarifying the Requirement for the Review of Programs andPlans Governed by Other Parts of the Regulations ................................................ 34

Enclosure 5 - Rationale for Revising the Requirement for Cask Marking .................. 37

Enclosure 6 - Rationale for Clarifying the Applicability of Criticality MonitoringExem ptions ........................................................................................................... 39



1. Statement of Petitioner's Interest

NEI's members include entities licensed to operate commercial nuclear power plants inthe United States, nuclear plant designers, major architect/engineering firms, and otherorganizations and entities involved in the nuclear energy industry. These membersinclude certificate of compliance (CoC) holders, and licensees - under both the specificand general license provisions - regulated by the NRC through 10 CFR Part 72. NEI isresponsible for coordinating the combined efforts of licensees and CoC holders onmatters involving generic NRC regulatory policy issues, and generic operations andtechnical regulatory issues affecting the activities of NRC-licensed independent spentfuel storage installations (ISFSIs) and NRC-certified dry storage cask designs.

2. Background

The requested changes to 10 CFR Part 72 are based upon over 20 years of successfullyand safely implementing the regulations; acknowledge the need for a holistic approachto regulatory improvements, as well as the need to better risk inform the regulatoryframework;' and recognize on-going regulatory framework improvements.2 Afterextensive evaluation we determined that there was a subset of potential changes that:1) are essential to achieve needed improvements to regulatory efficiency andeffectiveness, 2) can only be achieved by amending the regulations, and 3) are notcurrently being pursued or considered by the NRC. The changes proposed in Section 3were determined to improve regulatory efficiency and effectiveness, and are thereforeincluded in this petition for rulemaking. The following discussion provides somebackground on the major driving forces for regulatory framework improvementsproposed in this petition.

2.1 Lessons Learned

The existing 10 CFR Part 72 regulations governing the storage of spent nuclear fuel atISFSIs were originally established based upon a combination of the philosophies used todevelop regulations governing the licensing of special nuclear material, 10 CFR Part 70,and transportation of radioactive materials, 10 CFR Part 71. Amendments to 10 CFRPart 72 have been made since the time of the original rule that have also incorporatedthe experience acquired through the regulation of nuclear reactors, 10 CFR Part 50. Theregulatory framework for the dry cask storage of spent fuel developed in this mannerbecause wide-spread use of dry cask storage simply was not anticipated, given the

I NRC Tasking Memorandum from G. Jaczko to B. Borchardt "Evaluating Options Proposed for aMore Holistic Risk-Informed, Performance-Based Regulatory Approach." June 14, 20112 SRM-COMSECY-10-0007



original expectation that used fuel would be loaded directly into a transportation cask forshipment to a repository or reprocessing facility and that storage space in spent fuelpools would be adequate up to that point.

While the current requirements ensure that dry cask storage can be accomplished safelyover long periods of time, much has been learned over the course of the safe loadingand storage of over 1,600 casks during the past 25 years. This experience indicatesthat there is a need for a more risk-informed, performance-based approach to theregulatory framework that takes into account the current maturity of the technology, inorder to improve efficiency and effectiveness.

2.2 Risk Informing the Regulatory Framework

In April 2012, the NRC Risk Management Task Force headed by NRC CommissionerGeorge Apostolakis, issued NUREG-2150 "A Proposed Risk Management RegulatoryFramework," encouraging the adoption of a more risk-informed approach to regulatingdry cask storage of spent nuclear fuel. Section 4.7 of this report acknowledges the needto expedite rule changes and updates to regulatory guidance for SNF storage based onrisk considerations. (Section 4.8 makes a similar recommendation for SNFtransportation.) The recommended Option B states:

This option would emphasize specific rule and guidance changes to the existingSNF storage regulatory approach to implement the Risk Management RegulatoryFramework contained in the proposed Commission Policy Statement developedto adopt this framework. It would also apply the proposed risk managementregulatory framework to the Commission-directed review of the paradigm ofspent fuel storage. This would include substantive outreach to interim SNFstorage stakeholders. It might involve forming a working group to determinewhere risk management might offer the greatest opportunities. Theseopportunities might include staff training on risk concepts, defense-in-depth(DID) and practical applications of risk methods (including development ofqualified risk assessment staff), development of guidance and tools to supportrisk-informing regulatory activities, and guidance and rule changes that mayresult from activities related to extended storage and transportation.

There is already a strong basis to undertake an effort to improve spent fuel storageregulations based on risk insights. In 2006, two dry cask storage probabilistic riskassessments (PRAs) were published, one by the Electric Power Research Institute andone by the NRC staff. The results of these studies were presented at the August 28,2006 meeting of NRC's Advisory Committee on Nuclear Waste (ACNW). Both reachedthe same conclusion - the risks of dry storage ranged from very low to extremely lowwith latent cancer fatality (LCF) risk calculated to be between 2.0 x 10-12 and 1.7 x 10-13per year. These risks, when considered in the context of the NRC Safety Goals, andcompared to the 2 x 10-6 LCF/yr public and lx 10-5 LCF/yr worker thresholds of negligiblerisk from NRC's framework for "Risk-Informed Decision-making for Nuclear Material andWaste Applications," Revision 1, indicate that there is substantial opportunity to improveregulatory efficiency by modifying requirements based upon risk insights. Thisconclusion should be recognized in regulatory improvement efforts.



In the case of dry cask storage of spent nuclear fuel (under 10 CFR Part 72), NRC'sexisting regulatory framework appears to be graded in an inverse manner from what therisk insights would suggest. The safety systems for storage casks are much lesscomplex, have lower probabilities of failure, and lower accident consequences thansafety systems for operating reactors. Nevertheless, the current regulatory frameworkhas established thresholds for regulatory intervention that call for a relatively high levelof detailed information to be subject to NRC review and approval. NRC's recentrecommendation to implement a proposed risk management regulatory frameworkthrough selected guidance and rule changes provides an excellent opportunity to accruesignificant benefits in dry cask storage and transportation regulation. We fully supportthis recommendation and within this petition identify several regulations that we believeshould be addressed in accordance with these recommendations, including specificproprosals for how how these regulations and supporting guidance should be updated.

2.3 Holistic Perspective

This petition identifies, in Section 3, several desired changes in specific areas of theregulations that would improve regulatory efficiency and effectiveness. Although thispetition is narrowly-tailored and does not address all of the changes to 10 CFR Part 72that may be necessary or desirable, it does identify all of the changes that should bemade at this point in time. We note that future changes to regulations may benecessary, but are not ripe or are dependent upon successful implementation of theimprovements requested in this petition. Other improvements may not require changesto the regulations, but may be possible through new or revised guidance or NRCprocesses. Section 4 of this petition identifies these other potential improvements,describes their relationship to the changes requested in this petition, and explainswhether there are on-going efforts in these areas or whether they are recommended tobe phased in at a later time. Finally, a holistic perspective should not consider spentfuel storage casks in isolation, but should also include consideration of improvements tospent fuel transportation, 10 CFR Part 71, since many casks are licensed for bothstorage and transportation.

Improving the efficiency of nuclear safety regulations may seem counterintuitive duringa period in which additional NRC requirements are being promulgated in response to theFukushima Dai-ichi accident. However, in reality, one of the lessons learned from thisevent is that processes for removing spent nuclear fuel from reactor sites must becomemore efficient. This situation makes a compelling point about the need to assure thatspent fuel can be efficiently moved through a progression of steps that provideassurance of long term safety - i.e., from pools, to storage casks, to centralized storageor recycling facilities, and ultimately to a final repository. The current 10 CFR Part 71and 72 regulatory framework does not optimize this progression because it is notappropriately risk informed. Improving these regulations based on risk insights andperformance-based principles is not just a good idea, it is a must.

Amending an ISFSI license or spent fuel storage cask CoC (the latter involvingrulemaking) requires prior NRC approval. In many cases, changes of very low or nosafety-significance require such approval. This unnecessarily consumes valuable NRC,



licensee, and CoC holder resources with little or no safety benefit. The burdenassociated with obtaining NRC approval of such changes can cause licensees to delaydry cask loadings, which exacerbates the crowding of spent fuel pools and eventhreatens to interrupt reactor operations.

A holistic approach to improving the regulatory framework would encompass not onlythe regulations themselves, but also the guidance documents that help both NRC andindustry implement the regulations, along with the supporting technical bases for theregulations and guidance documents. Implementation of regulations, including thetechnical approach, should be consistent when similar regulations are established inmultiple areas (for example 50.59 and 72.48). A holistic approach would ensure thatmethods acceptable under one area (e.g. Part 50), would also be acceptable underanother area (e.g. Part 72).

2.4 On-Going Regulatory Framework Improvement Efforts

Currently, the NRC staff is performing a comprehensive review of the regulatoryframework for dry cask3 storage and transportation to identify improvements in itsefficiency and effectiveness that should be implemented in the near-term, as directed bythe Commission in the SRM-COMSECY-10-0007, "Project Plan for Regulatory ProgramReview to Support Extended Storage and Transportation of Spent Nuclear Fuel", datedDecember 6, 2010. The scope of this review includes the cask certification process,inspection program, and harmonization of Part 72 and Part 71 for dual purpose spentfuel storage casks and transportation packages.

Industry is actively participating in the NRC's efforts to implement the Commission'sdirective, having participated in public meetings held in March 2011', July 20115 andAugust 20126 on this topic, and submitted letters 7 outlining industry's perspectives.However, industry has identified rule changes in this petition that are fundamentallynecessary for meaningful and lasting improvement to the regulatory framework forindependent spent fuel storage facility licensing and cask certification, which are notcurrently encompassed in the NRC's efforts. In this regard, this petition for rulemakingcontributes to the achievement of the Commission's goals to implement near-termregulatory framework improvements as well as addressing the recommendations of the

3 Some improvements may also be relevant to wet (pool) Independent Spent Fuel StorageInstallations.4 Summary of March 28, 2011, Meeting (ML111150077)s Summary of July 16-17, 2011, Meeting (ML113000303)6 Summary of August 16-17, 2012, Meeting (ML12261A069)7 NEI Letter from M. Nichol to NRC T. Matula, "Industry Input on NRC Initiative to Enhance the10 CFR 71 and 72 Inspection Program", August 19, 2011; and NEI Letter from R. McCullum toNRC D. Weaver "NRC 2011 Spent Fuel Storage and Transportation Technical Exchange andRegulatory Conference" December 15, 2011



Risk Management Task Force 8. While this petition identifies improvements outside ofthose identified by the NRC, we nonetheless believe that these should be integrated intothe NRC's efforts as a foundational component of the improvement program called forby the Commission and recommended by the task force.

3. Proposed Amendments to 10 CFR Part 72

NEI is requesting, on behalf of the nuclear energy industry, that the regulations in 10CFR Part 72 be amended, consistent with the modified rule language described below.

The following sub-sections provide a summary of each proposed change, revised rulelanguage, and a reference to an Enclosure that provides a detailed rationale for therequested change.

3.1 Add New Rule for Certificate of Compliance Format and Content

NEI requests that 10 CFR Part 72 Subpart L be amended to provide specific criteria forthe format and content to be included in a spent fuel storage cask Certificate ofCompliance (CoC). We believe this is the single-most important near-term regulatoryimprovement that can be made, as it would provide the largest benefit to regulatoryclarity and stability by assuring that the level of detail in CoCs is consistent and risk-informed. This change is also necessary to realize the full benefit of ongoingimprovements to the guidance governing implementation of 10 CFR 72.48 and to theinspection program.

Defining CoC format and content, as well as selection criteria governing that content, isneeded in order to ensure consistency in the information contained in CoCs, but canonly be effective if included in the regulations. The additions related to the format willimprove ease of use and ensure that there is clarity with respect to the division ofresponsibilities between CoC holders and licensees in implementing the CoC, which willenhance compliance and NRC oversight. The additions related to the content willensure that there is clarity with respect to the appropriate details to be included in theCoC, which will improve efficiencies in licensing by focusing on the safety significantaspects of cask use. This will also reduce the number of unnecessary CoC amendmentsby eliminating the need for NRC review of less-safety-significant information that iscurrently included in many CoCs. That information would be re-located to the FSARwhere it would be reviewed pursuant to 10 CFR 72.48 to determine whether changesrequire prior NRC approval. Conforming rule changes are also requested to Subpart C toensure consistency between regulations governing the content of a site-specific ISFSIlicense and a CoC. Detailed rationale for this request is documented in Enclosure 1.

8 A Proposed Risk Management Regulatory Framework, U.S. NRC, NUREG-2150, April 2012; andUS NRC Memorandum from G. Jaczko to R. Borchardt "Evaluating Options Proposed for a MoreHolistic Risk-Informed, Performance-Based Regulatory Approach", June 14, 2012



To ensure that the full benefits of improved regulatory efficiency and effectivenessgained through the proposed rule changes are realized, accompanying implementationguidance must be developed. Consistent with the Commission's direction in SRM-SECY-11-0032, "Consideration of the Cumulative Effects of Regulation in the RulemakingProcess," if this petition is accepted, NEI commits to develop guidance, which we willsubmit for NRC endorsement in conjunction with the proposed rulemaking.

Proposed rule language for 10 CFR 72

Add a new section "10 CFR 72.237: Certificate of Compliance" with the following rulelanguage:

"(a) Each applicant for a CoC under the general license provision shall include in theapplication a proposed Certificate of Compliance that includes the Certified Design,Inspections Tests and Evaluations, and Technical Specifications in accordance with therequirements of this section. A summary statement of the bases or reasons for suchproposed specifications, other than those covering administrative controls, shall beincluded in the application, but shall not become part of the Certificate of Compliance.

(b) The Certificate of Compliance will include items in the following categories:

(1) Certified Design. Certified Design is implemented by the Certificate Holder andincludes:

(i) Technology. A concise description of the dry storage system for the purpose ofidentifying whether future modifications would be considered a significant deviation tothe type of technology or included components, or fundamental manner in which thecask system operates, such that modification to these could not be performed throughan amendment under 72.244.

(ii) Design Features. The design features that would have a significant effect on safety ifaltered or modified, such as materials of construction and geometric arrangement,would require an amendment under 72.244 in order to modify.

(2) Inspections, Tests, and Evaluations. Inspections, Tests, and Evaluations (ITE), andacceptance criteria, that are necessary and sufficient to provide reasonable assurancethat, if the ITE are performed and the acceptance criteria met, a cask has beenmanufactured and will operate in conformance with the certified design, and that thesafety functions of confinement, sub-criticality and shielding will be performed. Theentity responsible for implementing the ITE (i.e., Certificate Holder or Licensee) will beidentified. Documentation that the ITE and acceptance criteria are satisfied is notsubmitted for NRC review or approval, but shall be available for NRC inspection.

(3) Technical Specfications. Technical Specifications are implemented by the licenseeand will include the following:

(i) Limiting Conditions for Operation and Monitoring. Limiting conditions are the lowestfunctional capability or performance levels of equipment required for safe operation of



the ISFSI facility and cask. Functional and operating limits for a cask are limits on fuelhandling and storage conditions that are found to be necessary to protect the integrityof the stored fuel, to protect employees against occupational exposures and to guardagainst the uncontrolled release of radioactive materials. Monitoring instruments andlimiting control settings for casks are those related to fuel handling and storageconditions having significant safety functions. A technical specification limiting conditionfor operation of the ISFSI facility or cask must be established for each item meeting oneor more of the following criteria:

(A) Criterion 1. Installed instrumentation that is used to detect, and indicate a significantabnormal degradation of the cask confinement boundary;

(B) Criterion 2. An initial condition of a design basis accident that either assumes thefailure of or presents a challenge to the integrity of a fission product barrier;

(C) Criterion 3. A structure, system, or component which operating experience or riskconsiderations have been shown to be significant to public health and safety.

(ii) Surveillance Requirements. Surveillance requirements are those that confirm thelimiting conditions for operation and monitoring are met.

(iii) Approved Contents. Approved contents are the minimum set of parameters definingthe contents approved for storage in the certified design that would have a significanteffect on safety if altered or modified. Information in the Approved Contents section ofthe technical specifications must meet one or more of the following criteria:

(A) Criterion 1. The characteristic or parameter is identified in 10 CFR 72.236(a);

(B) Criterion 2. A characteristic or parameter for which verification is a necessarycondition to provide reasonable assurance that the cask safety functions of confinement,sub-criticality, and shielding will be performed;

(C) Criterion 3. A characteristic or parameter which operating experience or riskconsiderations have been shown to be significant to ensure public health and safety.

(iv) Administrative Controls. Administrative controls include the organization andmanagement of procedures, recordkeeping, review and audit, and reportingrequirements necessary to assure that the operations involved in the storage of spentfuel and reactor-related GTCC waste in an ISFSI are performed in a safe manner.

(c) A Certificate Holder is not required to propose to modify any Certificate ofCompliance approved before {DATE TBD}, to satisfy the requirements in paragraph (b)of this section but may choose to do so at any time."

Conforming changes for proposed rule language for 10 CFR 72

Amend 10 CFR 72.13(c), to include the new 10 CFR 72.237 in the list of applicablesections for activities associated with a general license, as follows:



"...72.220, 72.237, and 72.240(a)."

Amend 10 CFR 72.238, to refer to the new 10 CFR 72.237, as follows:"The Certificate of Compliance format and content shall meet the requirements of 10CFR 72.237."

Amend 10 CFR 72.44(c)(2), to ensure consistent requirements for technicalspecifications for site-specific licenses and CoCs, as follows:

"A technical specification limiting condition for operation of the ISFSI or MRS 9 must beestablished for each item meeting one or more of the following criteria:

(i) Criterion 1. Installed instrumentation that is used to detect, and indicate a significantabnormal degradation of the cask confinement boundary;

(ii) Criterion 2. An initial condition of a design basis accident that either assumes thefailure of or presents a challenge to the integrity of a fission product barrier;

(iii) Criterion 3. A structure, system, or component which operating experience or riskconsiderations have been shown to be significant to public health and safety."

3.2 Revise the Backfit Rule to Apply to CoCs and CoC Holders

NEI requests that 10 CFR 72.62 be modified so that the backfitting protection providedby that section is applicable to CoCs and CoC holders, in addition to licenses andlicensees. This change would improve consistency between the way in which specificlicensees, CoC holders and general licensees are regulated, and would ensure thatchanges to CoCs are imposed only after an adequate justification has been developed.Detailed rationale for this request is documented in Enclosure 2.


Amend 10 CFR 72.62, to state:

"(a) As used in this section, backfitting means:

(1) The modification of or addition to a Certificate of Compliance issued pursuant toSubpart L of this Part; or

(2) The addition, elimination, or modification, after the license has been issued, of:

(i) Structures, systems, or components of an ISFSI or MRS, or

(ii) Procedures or organization required to operate an ISFSI or MRS.

9 MRS means a Monitored Retrivable Storage facility.



(b) The Commission will require backfitting of an ISFSI, MRS, or Certificate ofCompliance if it finds that such action is necessary to assure adequate protection tooccupational or public health and safety, or to bring the ISFSI, MRS, or Certificate ofCompliance into compliance with a license or the rules or orders of the Commission, orinto conformance with written commitments by a licensee or holder.

(c) The Commission may require the backfitting of an ISFSI, MRS, or Certificate ofCompliance if it finds:

(1) That there is a substantial increase in the overall protection of the occupational orpublic health and safety to be derived from the backfit, and

(2) That the direct and indirect costs of implementation for that ISFSI, MRS, orCertificate of Compliance are justified in view of this increased protection.

(d) The Commission may at any time require a holder of a license or Certificate ofCompliance to submit such information concerning the backfitting or the proposedbackfitting of an ISFSI, MRS, or Certificate of Compliance as it deems appropriate."

Conforming changes for proposed rule language for 10 CFR 72

Amend 10 CFR 72.13(d), as follows:"...72.45; 72.62; 72.84(a)..."

3.3 Delete the Requirement for the Review of the Cask SER

NEI requests that 10 CFR Part 72 Subpart K be amended to remove the requirement forgeneral licensees to perform a review of the NRC Safety Evaluation Report related to theCoC or amended CoC prior to use of the general license. This change would conformwith a previous NRC position1° and would eliminate an unnecessary requirement.Review of the SER is extraneous, as the SER will not contain any new requirements orcommitments that are not already contained in the CoC and FSAR. Detailed rationale forthis request is documented in Enclosure 3.


Amend 10 CFR 72.212 as follows:"(b)(6) Review the Safety Analysis Report referenced in the CoC or amended CoC andthp r i o F . . .S..,-, prior to use of the general license, to

determine whether or not the reactor site parameters, including analyses of earthquakeintensity and tornado missiles, are enveloped by the cask design bases considered inthese reports. The results of this review must be documented in the evaluation made inparagraph (b)(5) of this section."

10 64 Federal Register 53582, October 4, 1999



3.4 Clarify the Requirement for the Review of Programs and Plans Governed byOther Parts of the Regulations

NEI requests that 10 CFR Part 72 Subpart K be amended to clarify the requirement toreview various plans and programs that are governed by other regulations. This changewould remove ambiguity and duplication, and improve clarity by simply directing thegeneral licensee to the appropriate governing regulations for 10 CFR Part 50 programchange control. Detailed rationale for this request is documented in Enclosure 4.

Proposed rule language

Amend 10 CFR 72.212 as follows:"(b)(10) Review the reactor emergency plan, quality assurance program, trainingprogram, and radiation protection program, to determine if changes are required due touse of a specific cask their efeti'eness is dccrcacd and, if so, prepare make thenecessary changes and rs,,,, and 'btain the n...ssa.. apprzvals in accordance with theapplicable change control program."

3.5 Revise the Requirement for Cask Marking

NEI requests that 10 CFR Part 72 Subpart L be amended to remove the requirement tomark the empty weight on the storage cask. This change would remove a requirementthat serves no useful purpose. Detailed rationale for this request is documented inEnclosure 5.


Amend 10 CFR 72.236 as follows:"(k) The spent fuel storage cask must be conspicuously and durably marked with--(1) A model number; and(2) A unique identification number-,-and(3) An empty weight."

3.6 Clarify the Applicability of the Criticality Monitoring Exemptions

NEI requests that 10 CFR Part 72 Subpart F be amended to clarify that the applicabilityof the criticality monitoring exemption for dry storage areas includes all cask loading,preparation, onsite transport and storage operations governed by a Part 72 license. Thischange is consistent with NRC guidance, and with other parts of the regulations.Detailed rationale for this request is documented in Enclosure 6.


Amend 10 CFR 72.124 as follows:"(c) Criticality Monitoring. A criticality monitoring system shall be maintained in eacharea where special nuclear material is handled, used, or stored which will energizeclearly audible alarm signals if accidental criticality occurs. Underwater monitoring is notrequired when special nuclear material is handled or stored beneath water shielding.



Monitoring of dry storage areas where special nuclear material us pa.kaged in its stede..ifi•..a.ie. in a dry storage cask is being managed under a license issued under thissubpart is not required (this includes cask loading, preparation, onsite transport andstorage operation activities). "

4. Additional Regulatory Framework Improvements (not requested as part

of this Petition)

In addition to the Petition for Rulemaking submitted herewith, we believe there areother regulatory improvements that should also be considered, based upon over 20years of experience and risk insights that would achieve additional necessaryimprovements to the efficiency and effectiveness of the dry cask storage andtransportation regulatory framework. In many cases these other changes would providesynergies with the improvements requested in this petition. A brief discussion of theseother improvements is presented here, including on-going efforts and plans goingforward.

(1) Streamline Cask Certification Process - This improvement relates to therulemaking process currently required for the initial CoC and subsequentamendments to the CoC. Industry believes improvements to the certificationprocess are needed, and recognizes that the NRC also has on-going efforts toidentify improvements in this area. We initially investigated the potential foreliminating the rulemaking process for CoC amendments, but noted a PRM in2000 that made a similar request and was denied. After reviewing the historyof this prior attempt and experience since, we determined that elimination ofthe requirement to issue rulemaking for CoC amendments may not beadvisable. We would be interested in further discussing potentialimprovements to the certification process (e.g. concurrent rulemaking andstaff safety evaluations), and how these improvements could be implementedwithout the need to amend the regulations. We would also like to discuss thepossibility for other improvements, such as whether a new process could beestablished that allows non-substantive changes to be made withoutrulemaking, and whether it is feasible and desirable to have only one singleCoC amendment active.

(2) General License Process and Interface between Parts 50 and 72 -This improvement relates to improved clarity on the implementation of thegeneral license process and activities at the interface of Part 50 and Part 72requirements (e.g. cask loading, handling, and unloading activities performedin a Part 50 licensed facility). Industry believes that guidance, perhapsdeveloped by industry for NRC endorsement, in this area may be beneficial,and is interested in further discussion of this topic with the NRC.

(3) Implementation of 72.48 - This improvement relates to the industry-developed guidance with NRC endorsement, currently NEI 96-07, Appendix Bendorsed in Regulatory Guide 3.72. Industry submitted a comprehensiveupdate to the NEI Guidance for implementing the 10 CFR 72.48 regulatory



requirements for NRC endorsement in September 201211. This update willlead to improvements in program implementation and inspections, addressrecent changes in 10 CFR 72.212, and improve examples.

(4) Role of Cladding Integrity - This improvement relates to a potential futureregulatory framework that would place greater emphasis on the cask toperform the safety functions, and recast cladding integrity and fuelretrievability as defense-in-depth items that are not specifically required byregulation, wherein their role as defense-in-depth is appropriately definedbased upon risk insights. These improvements would maintain adequateprotection of public health and safety, while improving the regulatoryefficiency and effectiveness by focusing on what is safety significant. Theseimprovements have a potential impact on downstream used fuel managementactivities such as disposal and recycling. Therefore, DOE should be engagedin discussions on these potential improvements. Although implementation ofthis regulatory improvement could be implemented through rulemaking, it isnot included in this petition, since non-rulemaking options exist and the NRCstaff is preparing to address this topic through a Federal Register Notice in 4 th

quarter 2012.12

(5) Moderator Exclusion - This improvement relates to the capability of atransportation package containment boundary to prevent the intrusion ofmoderator, and the resulting credible configuration for criticality analyses.The Commission directed NRC staff to further investigate the use of burn-upcredit prior to reconsidering a rulemaking for moderator exclusion. 13 A recentrevision to ISG-8,14 (Revision 3) Burnup Credit in the Criticality SafetyAnalyses of PWR Spent Fuel in Transport and Storage Casks, has expandedthe capabilities for applying burn-up credit. Furthermore, there has beenexperience in implementing ISG-19, Moderator Exclusion Under HypotheticalAccident Conditions and Demonstrating Subcriticallty of Spent Fuel Under theRequirements of 10 CFR 71.55(e). To further build on these improvements,and as these activities may satisfy the pre-requisites communicated by theCommission, we are interested in discussing with the NRC the potential to re-initiate a rulemaking for moderator exclusion.

(6) Part 71 and Part 72 harmonization - This improvement would streamlinethe dual certification of casks for both storage and transportation. While thereare many potential benefits, there are also significant challenges inharmonizing these two regulations for spent fuel. One major challenge is thecurrent differences in technical approaches for these two regulations, whichneed to be resolved prior to pursuing harmonization of the regulations. Wewould like to continue discussing potential options for harmonization of Part71 and Part 72 for spent fuel with the NRC, but believe that a rulemaking topursue such improvements is pre-mature for the foreseeable future.

"NEI Letter from M. Nichol to NRC E. Benner "Submittal of NEI 12-04, Guidelines for 10 CFR72.48 Implementation, Revision 0, dated August 2012", September 10, 201212 NRC Staff statements at an August 16, 2012 NRC Workshop on Potential Enhancements to 10

CFR Part 71 and 10 CFR Part 7213 SRM-SECY-07-0185 "Moderator Exclusion in Transportation Packages"14 ISG means Interim Staff Guidance.



(7) Inspection Program - The NRC has an on-going effort to makeimprovements to the inspection program, and industry has provided input atpublic meetings and through formal correspondence. '5 We look forward tofurther progress in NRC's efforts and the opportunity for the industry toprovide additional input as appropriate. We recognize that rule changes thatplace more information under licensee control, as those proposed herein, anda highly effective inspection program that gives NRC confidence in the abilityof licensees and CoC holders to effectively carry out this responsibility are twoimprovement elements that go hand in hand.

(8) Interim Staff Guidance documents - In order to provide a stable andpredictable regulatory environment, much care and attention needs to beplaced on the process of establishing and maintaining the relevant NRCguidance, e.g., Regulatory Guides, and Standard Review Plans. In the currentimplementation of spent fuel storage and transportation regulations, manyregulations are interpreted through Interim Staff Guidance (ISG) (some inexistence for over 10 years), and the ISGs are expected to be used byapplicants, licensees, and CoC holders. However, an ISG is intended to be atemporary measure to modify NRC staff review guidance, and hence lacks thedurability and stability of a Regulatory Guide, which is intended to be used byIndustry. There are also several Standard Review Plans (SRPs) that areapplicable to dual-purpose casks (casks that are certified for storage andtransportation) - e.g., NUREG-1536, NUREG-1567, NUREG-1617, and NUREG-1927 - for which there is a significant amount of overlapping guidance, andwhich all in some way reference one or more common ISG(s). Some of theseSRPs have had the ISGs incorporated and some have not, further creatingconfusion. Multiple SRPs addressing the same review topics may be onereason the NRC desires to place ISGs as a centerpiece of the regulatoryframework, and the reason the ISGs persists indefinitely. Unfortunately, thisregulatory structure of establishing guidance and interpreting regulationsthrough ISGs, multiple overlapping SRPs, and the relatively few RegulatoryGuides presents a challenge for ensuring straight-forward application of theregulatory framework, and results in a decrease in regulatory clarity, efficiencyand effectiveness. Retiring existing ISGs and significantly limiting their futureuse through improvements to processes for configuration control, updating ofSRPs, and use of Regulatory Guides and other more appropriate regulatorytools, is an essential activity in a holistic approach. We look forward toworking with the NRC, and further communicating industry's thoughts, onachieving a more straight-forward regulatory framework by implementingimprovements to the organization of the network of guidance documents.

15 NRC Letter from A. Mohseni, et al. to D. Weaver, et al. "Licensing, Inspection and EnforcementPrograms Review for Storage and Transportation - Working Group Report," December 14, 2011



5. Additional Conformance Information

Environmental Impact Under NEPA'6This petition does not involve major Federal action significantly affecting the quality ofthe human environment. Therefore, an environmental impact statement is not required.Grant of the requested amendments to current regulations would not alter theenvironmental impact of the licensed activities described in the Final EnvironmentalImpact Statement for each facility, as prescribed in the National Environmental PolicyAct and 10 CFR Part 51.

In particular, the rule changes addressed in this petition would not significantly increasethe probability or consequences of an accident. Grant of the requested amendments tocurrent regulations would involve neither changes in the types or quantities ofradiological effluents that may be released offsite, nor a significant increase in public oroccupational radiation exposure since there would be no change to facility operationsthat could create a new or affect a previously analyzed accident or release path.

With regard to non-radiological impacts, the rule amendments addressed in this petitioninvolve neither changes to non-radiological plant effluents, nor changes in activities thatwould adversely affect the environment. Therefore, there are no significant non-radiological impacts associated with the petition.

Paperwork Reduction Act StatementThe proposed petition does not contain any new or amended information requirementsthat would be subject to the Paperwork Reduction Act.

Regulatory Backfit AnalysisThis petition does not involve any action constituting a backfit as addressed in 10 CFR72.62. In particular, the requested amendments to 10 CFR Part 72 would achieve thesame objective while reducing regulatory burden. Accordingly, as addressed in NUREG-1409, "Backfitting Guidelines," p. 2 (July 1990), they are not subject to the backfit rule.

6. Conclusion

Since the original implementation of 10 CFR Part 72 there have been a number ofdesired changes identified that would result in a clearer, more predictable, and moreeffective regulatory framework. The petition for proposed rulemaking has beendeveloped to achieve improvements based upon over 20 years of experiencesuccessfully and safely implementing the regulations, a holistic review of improving theregulatory framework, and greater application of risk information. This will result in amore efficient and effective NRC oversight of dry cask storage activities as well asimproved implementation of dry cask storage requirements by industry.

16 NEPA stands for National Environmental Policy Act of 1969.


NEI Petition to Amend 10 CFR Part 72ENCLOSURE 1 - Rationale for Adding a New Rule for Certificate of Compliance Format

and Content

Enclosure 1 - Rationale for Adding a New Rule for Certificate of

Compliance Format and Content

A. Requlatory background and need for change

The Commission's regulations in 10 CFR Part 72 were originally designed to provide forthe storage of spent nuclear fuel by specific licenses in an independent spent fuelstorage installation (ISFSI) (45 FR 74693; November 12, 1980). In 1990, theCommission amended Part 72 to provide for storage of used fuel at nuclear power plantsites without the need for additional site-specific Commission approval, as directed bythe Nuclear Waste Policy Act of 1982 (NWPA). The process adopted in the 1990rulemaking includes design approval of spent fuel storage casks through issuance of aCoC (Subpart L) and granting a general license to reactor licensees (Subpart K) to useNRC-approved casks for the storage of spent nuclear fuel (55 FR 29181; July 18, 1990).

Currently, the regulatory requirements for spent fuel storage cask approval andfabrication are contained in 10 CFR 72.236, and apply to the applicants and holders ofCoCs for spent fuel storage casks. However, these regulations do not provide specificrequirements for the CoC format and content. As a result, the content of existing CoCsand associated documents varies, with respect to both the type of information includedand the level of detail provided. Furthermore, many CoCs contain information that isnot clearly tied to the NRC's determination of reasonable assurance that adequateprotection of public health and safety is provided by the cask design, and may not beverifiable in the format specified in the CoC.

A similar issue for nuclear power plant operations was addressed by the NRC nearly twodecades ago in its policy statement entitled "NRC Policy Statement on TechnicalSpecifications Improvements for Nuclear Power Plants", 58 Fed. Reg. 39132 (July 22,1993). This policy statement established a specific set of objective criteria as guidancefor determining which requirements and operating restrictions should be included in theTS, namely those features that are of controlling importance to safety. Since issuance ofthe policy statement, regulatory reliability and clarity have been significantly improved,and the TS for power reactor operation have been standardized across the industry,resulting in valuable efficiencies for both the industry and the NRC.

The lack of clear requirements regarding the format and content of CoCs has resulted inuncertainty regarding NRC's expectations of CoC applicants, and difficulty implementingthe CoC terms, conditions, and specifications. In some cases applicants have beenrequested to include content that is not important to safety. Moreover, the lack ofclarity in this area has resulted in an inconsistent format, content, and level of detail, inthe CoC Terms and Conditions, Approved Contents, Technical Specification (TS), DesignFeatures, and the Final Safety Analysis Report (FSAR) associated with the caskscurrently certified by the NRC. For example, some cask CoC/TS include items that aremore appropriately controlled by the CoC holder or licensee under their respective



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Quality Assurance or 10 CFR 72.48 programs. (e.g., design details, fabricationrequirements, training requirements-including dry run exercises, codes and standards).Furthermore, TS for approved casks may include parameters that cannot be verified, orfabrication tests that go beyond the intent of providing controls for operation activitiesthat have potential impact on public health and safety.

B. Proposed Resolution

In order to achieve regulatory clarity and reliability in the NRC expectations regardingthe implementation of CoC regulatory requirements, and to achieve standardization inthe CoC format and content, the addition of a new section to the existing 10 CFR 72,Subpart L, is being proposed. The new proposed section would be 10 CFR 72.237,entitled "Certificate of Compliance format and content." This new subsection will alsoimprove clarity and consistency in determining whether content should be contained inthe CoC or in the Final Safety Analysis Report (FSAR). This will result in improvementsin regulatory efficiency in that it will reinforce the change-control hierarchy inherent inthe regulations. This ensures that the NRC reviews and approves the most safety-significant changes by including safety limits and design features, which if altered, wouldhave a significant effect on safety, in the CoC. Further this ensures that changes to theless safety significant information contained in the FSAR must be reviewed inaccordance with 10 CFR 72.48 in order to determine if they are permissible without priorNRC review and approval.

The proposed new rule, 10 CFR 72.237, "Certificate of Compliance format and content",would describe the structure of the CoC, and define the criteria for content of eachsection of the CoC, including the cask TS. This requires conforming changes to 10 CFR72.13 and 10 CFR 72.238, for clarity in the application of this new rule. This alsorequires conforming changes to 10 CFR 72.44 to ensure consistency, where appropriate,between the regulations for site-specific license technical specifications, and CoCtechnical specifications.

The proposed new rule includes, in section 10 CFR 72.237(b), the selection criteria fordetermining what information should be included in the cask CoC including the cask TS.The development of these criteria was informed by the NRC's 1993 Policy Statement onTechnical Specifications for 10 CFR Part 50 power reactors and the associated criteriacodified in 10 CFR 50.36(c)(2)(ii).

The cask FSAR and associated procedures contain more detailed information related tothe cask design, fabrication, materials, testing, inspection, operation, and safetyanalyses that is not contained in the CoC. This information would be subject to thechange control provisions in 10 CFR 72.48 process and inspection by NRC17. The cask

17 NRC is currently implementing Inspection Program Improvements, NRC Letter from A.Mohseni, et al. to D. Weaver, et al. "Licensing, Inspection and Enforcement Programs Review forStorage and Transportation - Working Group Report," December 14, 2011, which includeimprovements to the NRC oversight of activities related to 10 CFR 72.48.



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FSAR is prepared and updated by the CoC holder for the spent fuel storage cask, inaccordance with 10 CFR 72.248 requirements. The cask FSAR format is consistent withthe review areas identified in NUREG-1536 and includes the appropriate level of detail todemonstrate reasonable assurance of regulatory compliance and adequate protection ofpublic health and safety. This would include descriptions of the cask design features,fabrication, testing, inspection, and references to applicable industry codes andstandards. The FSAR also includes the cask fuel loading patterns. The general licenseecask loading activities would be undertaken in conformance with the fuel loadingpatterns specified by the CoC holder.

This proposal clarifies the change-control hierarchy, which requires prior NRC approvalfor changes to the most safety-significant documents (i.e., that information in, orappended to the CoC), while allowing the licensee to apply existing screening criteria(i.e., 10 C.F.R. 72.48) to determine whether prior agency approval is necessary forchanges to other, less safety-significant documents (e.g., FSAR). Reducing the numberof changes needing prior NRC approval will allow the NRC to more effectively deploy itsresources to address the growing scope of activities in the dry storage andtransportation field (such as extended storage, waste confidence and the potentialdevelopment of and transport of fuel to a consolidated storage facility).

Format of the Certificate of Compliance

The cask CoC would contain three sections: 1) Certified Design; 2) Inspections, Testsand Evaluations (ITEs); and 3) Technical Specifications (TS). This structure parallels themajor phases of activities, specifically cask design, fabrication, and operation. This alsoallows organization of content according to the entity responsible for complying with theCoC. Changes to the information contained in these sections would require prior NRCapproval. Finally, the format of the CoC is designed such that sections are mutuallyexclusive, and therefore avoids confusion as to where to place content that appears tofall within the scope of multiple sections. For example, although both the ITE and TSsections include inspections and tests, there is a distinct difference between the types oftests that fall within these sections. Tests that are performed to confirm cask fabricationclearly belong in the ITE, while tests that are performed during the use of the cask forloading or storage clearly belong in the TS.

Specifically, the proposed 10 CFR 72.237(b) requires that the applicant propose a CoCthat contains the following sections:(1) Section A: Certified Design (implementation by CoC holder)Subsection 1: Define the technologySubsection 2: Define the design features

(2) Section B: Inspections, Tests, and EvaluationsSubsection 1 (implementation by CoC holder)Subsection 2 (implementation by licensee)

(3) Section C: Technical Specifications (implementation by licensee)Subsection 1: Use and Application



and Content

Subsection 2: Approved Contents

Subsection 3.0: Limiting Condition for Operation and Surveillance RequirementApplicability

Subsection 3.1: Limiting Conditions for Operation and Surveillance Requirements

Subsection 4.0: Administrative Controls

The general licensee is responsible for compliance with the cask TS LCOs, SRs,Administrative Controls programs and Approved Contents.

The cask FSAR and CoC holder or licensee procedures should contain all the otherinformation related to the cask design, testing, inspection, operation, and safetyanalyses that is not included in the CoC. Changes to this information would begoverned by 10 CFR 72.48.

The proposed 10 CFR 72.237(b) section also codifies the criteria for determining thecontent of the cask Certificate of Compliance (CoC) including the cask TechnicalSpecifications (TS). The development of these criteria was informed by the NRC's 1993Policy Statement on Technical Specifications for 10 CFR Part 50 power reactors and theassociated criteria codified in 10 CFR 50.36(c)(2)(ii).

Content, and Associated Criteria, of the Cask Certificate of Compliance

The proposed 10 CFR 72.237(b) codifies the content, and associated criteria fordetermining the content, of the cask CoC. The proposed content and rule language areconsistent, where applicable, with the requirements in 10 CFR 72.44 that define thecontent for site-specific ISFSI technical specification. Additionally, the proposed rulelanguage includes criteria for determining what is to be included as content to the CoC,including the cask Technical Specifications (TS), by analogy with 10 CFR 50.36regulations for operating reactors. This concept of criteria for the content does notcurrently exist in 72.44, which is a current deficiency in that regulation. The criteriaproposed herein are developed in consideration of incorporation into both the new72.237, and the existing 72.44. It is also the single most important part of the proposedrulemaking to achieve consistency.

The development of selection criteria for spent fuel cask CoCs is based on the NRC's1993 "Final Policy Statement on Technical Specification Improvements for Nuclear PowerReactors", which established a specific set of objective criteria as guidance fordetermining which regulatory requirements and operating restrictions should be includedin the TS. Although the Policy Statement is specific to nuclear power plant operation,the guiding principle regarding the purpose of TS articulated in the Policy Statementseems equally applicable here. In this regard, the Policy Statement states:

The purpose of the Technical Specifications is to impose those conditions orlimitations upon ... operation necessary to obviate the possibility of an



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abnormal situation or event giving rise to an immediate threat to the publichealth and safety by identifying those features that are of controlling importanceto safety and establishing on them certain conditions of operation which cannotbe changed without prior Commission approval. 18

The NRC codified the selection criteria for power reactor TS limiting conditions foroperation (LCOs), in 10 CFR 50.36(c)(2)(ii). In addition, the 10 CFR Part 50 ImprovedTechnical Specification (ITS) effort resulted in the publication of the respective NUREGswith re-formatted TS and Bases for each NSSS design (e.g., NUREG-1431, etc.). The 10CFR 50.36(c)(2)(ii) selection criteria and the NUREG guidance are used to develop theTS in the ITS format, depending on the operating reactor design at a particular site.The Policy Statement also describes an evaluation process whereby requirements thatdo not meet these criteria can be identified and controlled through mechanisms otherthan TS. That process is governed by the NRC regulations in 10 CFR 50.59 foroperating reactor licenses, corresponding to 10 CFR 72.48 for 10 CFR Part 72 licensesand CoC holders.

The 10 CFR Part 50 ITS program is the model for the scope of the proposed rulemaking(i.e., the cask CoC/TS format and content) because of the common focus on the safetyanalysis and public health and safety that determines what type of information shouldbe subject to the most stringent level of change control. The same criteria are alsoadapted and applied to 10 CFR Part 72 specific licenses and TS, which result inconforming changes to 10 CFR 72.44.

The 10 CFR Part 72 CoC content selection criteria described below were developed usingthe framework for operating reactors, modified as appropriate to account for differencesbetween spent fuel casks and operating reactors. The use of the terms related to"safety" in the selection criteria is important. These terms are intended to encompassonly those requirements that, if complied with correctly, will ensure that public healthand safety is protected, e.g., by preventing a criticality event or significant radiologicalrelease to the public.

Application of the new rule to create a Standardized CoC would be facilitated through aguidance document developed by industry and submitted for NRC endorsement (a draftwill be available to accompany the proposed rule if this petition is granted). In therespective guidance, the CoC content would be shown with brackets indicating wheretechnology-specific information should be inserted in the actual CoC, similar to the 10CFR Part 50 ITS NUREGs (e.g., NUREG-1431, etc.), which are used to develop the site-specific ITS for operating reactors.

While the 10 CFR Part 50 model is used as a starting point, there are two overarchingthemes that distinguish spent fuel cask operation from power reactor operation. Thesethemes were considered in developing the cask CoC selection criteria to ensure both

18 58 Federal Register 39136 (July 22, 1993).



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NRC's and industry's resources are appropriately focused on safety significant issues.These themes are:

* The much lower relative risk to public health and safety of spent fuel caskoperation compared to operating a reactor, as shown in both NRC's and EPRI'sprobabilistic risk assessments of dry cask storage and actual experience. Latentcancer fatality (LCF) risk was calculated to be between 2.0 x 10-12 and 1.7 x 1013

per year which is orders of magnitude lower than the thresholds of negligible riskof 2 x 10-6 LCF/yr. for the public and 1 x 10-5 LCF/yr. for workers (from NRC'sframework for "Risk-Informed Decision-making for Nuclear Material and WasteApplications", Revision 1, February 2008).

* The passive design of spent fuel storage casks. Active cooling for storage casksis prohibited by regulation, 10 CFR 72.236(f). Thus, no active failure modesneed to be considered in ensuring the cask can perform its safety functions.

Certified Design CriteriaInformation in the Certified Design section of the CoC must meet one or more of thefollowing criteria:

1. A concise description of the type of technology (e.g., bare fuel cask or canister,above ground or below grade, etc.); the licensed components (e.g., canister,storage cask or module, transfer cask, etc.); and the fundamental manner inwhich the cask system operates (e.g., vertical or horizontal orientation,ventilated or unventilated, etc.)

2. Cask design features critical to performing cask safety functions (e.g., fuel cellpitch, number of fuel assemblies, neutron absorber B-10 areal density, canisterdecay heat, inert environment)

The intent of the descriptive items is to have the CoC holder provide the appropriateamount of detail about the cask system and components to define the storagetechnology and the scope of the CoC as it relates to the ability of the system to protectpublic health and safety. The descriptive information forms the basis upon which futuredesign changes can clearly be classified as an amendment to an existing CoC (seeCriteria 2 above), or would require a new CoC (see Criteria 1 above).

Design features should include only those design elements that are safety significant,such that prior NRC approval of changes is necessary (versus allowing changes to thesefeatures to be under CoC holder or licensee control, pursuant to 10 CFR 72.48).

Inspections, Tests, and Evaluations CriteriaInformation in the Inspection, Tests, and Evaluations (ITE) section of the CoC mustmeet one or more of the following criteria:

1. Inspections and tests that are critical to ensuring the cask is capable ofperforming the safety functions and, are required to confirm that a cask hasbeen fabricated in compliance with the certified cask design features critical to



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performing safety functions (Certifled Design Criteria 2 above).

2. Site-specific evaluations that are critical to ensuring the cask safety functions willbe performed for the specific site conditions.

The scope of the inspections and tests is limited to those that take place duringcomponent fabrication or during final sealing operations at the power plant after fuelloading. The inspections/tests should be established based on the cask safety functionsof maintaining subcriticality and confinement, and should include the acceptance criteriathe cask must satisfy during the inspection/test, to demonstrate the as-fabricated caskcomplies with the certified design. Description of inspections and tests are only to be ata high level, e.g., confinement boundary test, with the stated acceptance criteria.Detailed description of the cask inspections and tests are to be provided in the caskFSAR, for example, the FSAR would describe that a helium leak rate test is performed tofulfill the ITE required confinement boundary test. The FSAR will also describe manyfabrication inspections and tests that will not be included in the CoC's ITE section (i.e.,very few fabrication inspections and tests will be in the CoC's ITE section, because mostwill be related to the QA and Test programs and are more appropriately addressed inthe FSAR). Inspections and tests required during storage operations to protect publichealth and safety would be included, as appropriate, in the technical specifications.

The scope of the site-specific evaluations includes those evaluations necessary toconfirm that the generic cask design used at that particular site will ensure that the caskwill perform the safety functions of maintaining subcriticality and confinement. This isintended to address evaluations for which a generic evaluation was not part of the casklicensing basis (e.g., a comparison of a site-specific value to a generic design value, or acomplete new analysis). It does not include those licensee evaluations already requiredby a specific regulation, such as storage pad design (per 10 CFR 72.212(b)(5)(ii)) andconfirmation that the reactor site parameters are bounded by the generic cask designdescribed in the cask FSAR (per 10 CFR 72.212(b)(6)). Descriptions of evaluations areonly to be at a high level, e.g., seismic analysis, with the stated acceptance criteria.Detailed description of the evaluations are to be provided in the cask FSAR, for example,the FSAR would describe a method, reference a Regulatory Guide or Topical Report, orindicate that the licensee's method approved under 10 CFR Part 50 be used forperforming the evaluation. The FSAR will also describe many evaluations that will notbe included in the CoC's ITE section (i.e., very few evaluations will be in the CoC's ITEsection).

Finally, the organization responsible for performing the ITE should be identified in theCoC's ITE section. For example, most, if not all, fabrication related inspections and testswill likely be performed by the CoC holder, while the site specific evaluations will likelybe performed by the licensee. In areas where either entity could perform the ITE, itshould be identified as such.

Technical Specifications (TS) CriteriaSection 1.0, Use and Application: No selection criteria required.



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This section contains definitions developed by the CoC holder, and standard rules forinterpreting and using the cask TS.

Section 2.0, Approved Contents: Information in the Approved Contents Section of the TS

must meet one or more of the following criteria:

1. The characteristic or parameter is identified in 10 CFR 72.236(a);

2. The characteristic or parameter is critical to ensure the cask will perform itssafety functions;

3. A characteristic or parameter for which operating experience or riskconsiderations has shown to be significant to ensuring public health and safety(e.g., Small changes to the characteristic or parameter can produce a significantimpact on criticality control, shielding, or confinement).

Section 3.0, Limiting Condition for Operation and Surveillance Requirement Applicability:No selection criteria required.

Section 3.1, Limiting Conditions for Operation and Surveillance Requirements. LimitingConditions for Operation (LCOs) are the lowest functional capability or performancelevels of equipment required for safe operation of the ISFSI facility or cask. A technicalspecification LCO for operation of the ISFSI facility or cask must be established for eachitem meeting one or more of the following criteria:

1. Installed instrumentation that is used to detect, and indicate a significantabnormal degradation of the cask confinement boundary (e.g., bolted lid barefuel cask helium pressure monitoring system);

2. An initial condition of a design basis accident that either assumes the failure of orpresents a challenge to the integrity of a fission product barrier (e.g., caskcooling flow paths, fuel decay heat, helium backfill pressure, cask cavity dryness,etc.);

3. A structure, system, or component which operating experience or riskconsiderations have been shown to be significant to public health and safety.

Section 4.0, Administrative Controls: No selection criteria required.Includes programs for the activities requiring written procedures, cask transportevaluation, TS Bases control, etc. The CoC holder would determine the programsrequired and the level of description for program content that needs to reside in theCoC.

Impact on Current CoCs and backfit analysis

Section 10 CFR 72.237(c) is proposed to ensure clarity that the intent of the proposedrule is only for future CoC applications and amendments. Therefore, there is no intent



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to retroactively apply this to existing or previously approved CoCs, and thus no backfit.The "grandfather" date should be determined based upon when the final rule goes intoeffect, and should be sufficiently delayed, for example 6 months, such that applicationsfor a new CoC or amended CoC would have sufficient time to incorporate the newrequirements.

Guidance for Standardized CoC

Guidance will be needed to ensure the full benefit of improvements provided by theaddition of this new rule, specifically, defining a model for Standardized CoC, similar towhat has been done for the 10 CFR Part 50 Standardized Technical Specification. Webelieve that guidance developed by industry and submitted for NRC endorsement is themost effective approach. We will develop draft guidance for Standardized CoCs, basedupon the proposed rule language, and will submit it to the NRC so that it can be issuedconcurrent with a proposed rule.

It is acknowledged that NUREG-1745 "Standard Format and Content for TechnicalSpecifications for 10 CFR Part 72 Certificates of Compliance" currently exists, but that ithas not been widely adopted since its inception. The reason for the lack of success withthis guidance is that it was developed without due consideration and incorporation ofindustry's perspectives. Due consideration of industry's perspectives is essentialbecause industry will ultimately be responsible for implementing and conforming to theCoC and technical specifications.

NUREG-1536 (i.e., "Standard Review Plan for Spent Fuel Dry Storage Systems at aGeneral License Facility'", may also need to be revised accordingly, to reflect theproposed rule changes.

C. Alternatives to Rulemaking considered

In addition to the proposed rulemaking, several other options were considered andevaluated based upon their merits and deficiencies. The options included:

1. Revision to NUREG-1745 - A revision to NUREG-1745, which currentlydescribes a generic format for the CoC was considered, as this is currently beingconsidered by the NRC. This option has the advantage of potentially requiringthe least amount of time and resources to complete, and it could be updated toinclude the proposed format and content, including criteria, included in thispetition. However, there are two major deficiencies in this approach: 1) It lacksthe ability to provide regulatory stability. Since guidance does not establishrequirements, there would be no assurance that the CoC format and content,including criteria, would be adopted by all applicants, nor does it prevent NRCstaff from inserting details in the CoC beyond what is in NUREG-1745, as hasbeen experienced. Furthermore, guidance would not assure long-termconsistency in the same manner as a regulation. 2) The current version ofNUREG-1745 has not fully considered industry's perspectives on Standardization.Such consideration is important to assuring wide-spread adoption (the primarysuccess metric for standardization). This would also be inconsistent with the



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approach under 10 CFR Part 50, where industry developed StandardizedTechnical Specifications for NRC endorsement and wide spread adoption wasachieved.

2. New Industry Guidance (only) - Development of industry guidance (withoutestablishing a new rule) was considered, as the need for guidance wasdetermined to be necessary even with establishment of a new rule. This optionhas the advantage of requiring fewer resources and time to complete, and itcould include the proposed format and content, including criteria, included in thispetition. While it would avoid the second deficiency in Alternative #1, it wouldstill have the first deficiency of that alternative, in that it lacks the ability toprovide regulatory stability. Since guidance does not establish requirements,there would be no assurance that the CoC format and content, including criteria,would be adopted by all applicants, nor does it prevent NRC staff from insertingdetails in the CoC beyond what is in the guidance, as has been experienced.Furthermore, guidance would not assure long-term consistency in the samemanner as a regulation.

3. No Action - Although considered, this alternative has no merits, other thanavoiding the investment in time and resources necessary to improve theregulatory framework. However, the need for regulatory improvement is sogreat that this alternative is considered non-viable.

The proposed rulemaking is the only option that would provide consistency, reliability,and clarity in the regulatory process for review and approval of CoC applications andamendment requests by focusing the process on issues important to public health andsafety. The resources and time required to pursue the recommended rule change arefar outweighed by the resource savings that the new rule would provide. Theinvestment of time and resources would be returned several times over in thesubsequent reduction in time and resources in the future on the numerous CoCapplications and amendments, and more efficient oversight and implementation of theCoC. The proposed rulemaking is the option most consistent with the NRC's regulatoryprinciple on "Efficiency" which states: "Regulatory activities should be consistent withthe degree of risk reduction they achieve. Where several effective alternatives areavailable, the option which minimizes the use of resources should be adopted.Regulatory decisions should be made without undue delay."


NEI Petition to Amend 10 CFR Part 72ENCLOSURE 2 - Rationale for Revising the Backfit Rule to apply to CoCs and CoC

Holders

Enclosure 2 - Rationale for Revising the Backfit Rule to Apply to CoCs and

COC Holders


Currently, the NRC backfitting rule contained in 10 CFR 72.62 is applicable to generaland specific licensees, but not CoC holders. Specifically, the language of 72.62 refersonly to "license." Further, 10 CFR 72.13 "Applicability" - which identifies the sections ofPart 72 that apply to activities associated with a specific license, a general license, or acertificate of compliance - indicates that the backfitting provisions of 72.62 apply toactivities associated with specific and general licenses, but not activities associated withCertificates of Compliance (CoC).

10 CFR 72.62 defines "backfitting" as the addition, elimination, or modification of thestructures, systems, components of an ISFSI or Monitored Retrievable Storage facility(MRS), or the procedures or organization required to operate an ISFSI or MRS, afterissuance of the license for either facility. With certain exceptions, the rule appropriatelylimits such "addition, elimination, or modification" to situations where the Commissionfinds that the proposed change will yield a substantial increase in the overall protectionof public health and safety and is cost-justified. In this way, the rule serves animportant safety function by recognizing that both agency and industry resources arefinite and that these resources must be focused on regulatory activities that will yield themost substantial safety benefits.

The industry believes that the same regulatory requirements regarding backfitting ineffect for general and specific license holders should apply to CoC holders. A CoCdescribes the design and conditions for use of dry storage casks, which represent theprimary structures, systems, and components of a nuclear power plant ISFSI. Thus,while not imposed directly on the licensee, changes to a CoC could directly affect thestructures, systems, components (SSC) and procedures necessary to operate an ISFSI.The backfitting implications of such changes are most effectively and efficientlyaddressed during review and development of the new or amended position to beimposed on the CoC holder, rather than waiting until the position has been finalized andis imposed on the licensee using a certified cask. If the safety benefits of the new oramended position are not appropriately understood and documented pursuant to thebackfit rule, it should not be imposed on the CoC holder. It makes little sense to allowimposition of such a position on the CoC holder, but then to decide that it cannot beimposed on the licensee using a certified cask because it cannot meet the requirementsof the backfitting rule that apply to the ISFSI.

In addition, although CoC holders may not operate "nuclear facilities" licensed by theNRC, they invest significant time and resources to obtain approval of a cask design fromthe agency. The same principals of fundamental fairness that underlie application of thebackfitting rule to licensees require application of the rule to CoC holders. As the NRC's



Holders

General Counsel has clarified, "the Backfit Rule does not protect the expectations offuture applicants (including licensees seeking NRC permission to conduct licensedactivities in a manner different than what the NRC previously approved) regarding theregulatory requirements that they must meet to obtain NRC approval."1 9 But unlikeapplicants, CoC holders have already obtained NRC approval in the form of the CoC andare entitled to rely on that approval, unless a change is appropriately justified throughapplication of the backfitting rule. Thus, the interests of CoC holders are analogous tothose of licensees, and notably different from those of applicants. In this vein, it is alsonotable that the backfitting rule contained in 10 CFR 50.109 seems to recognize similarinterests, as that rule appropriately applies to modifications of or additions to designapprovals and manufacturing licenses, as well as SSCs and procedures required tooperate a production or utilization facility.

Similarly, the backfitting rule should apply to CoC holders that request amendments toexisting CoCs in the same way that it applies to licensees requesting such amendments.As stated in the NRC General Counsel's July 2010 letter to NEI:

If a licensee voluntarily seeks to change its licensing basis (i.e., the change isinitiated by the licensee to take advantage of a voluntary alternative afforded inthe NRC's regulations, such as the adoption of NFPA 805 under 10 CFR 50.48(c),and is not compelled by a new or amended regulation), then the NRC maycondition its approval of the proposed change upon a licensee agreement toadopt new or revised guidance. Such action will not be deemed to be backfittingif.- (i) the new or revised guidance relates directly to the licensee's voluntaryrequest; and (ii) the specific subject matter of the new or revised guidance is anessential consideration in the NRC staffs determination of the acceptability of thelicensee's voluntary request.20

Although this interpretation allows imposition of new or revised guidance uponapplicants for voluntary license amendments, 21 in order to avoid application of thebackfitting rule the subject matter of the new or revised guidance must relate directlytothe licensee's voluntary request (i.e., the amendment request), and be essentialto theNRC staff's acceptability determination (i.e., decision to approve or deny the amendmentrequest). As discussed above, the CoC holder requesting an amendment and NRC staffreviewing the request are best positioned to address the backfitting implications

19 Letter from Stephen G. Burns (General Counsel, NRC) to Ellen C. Ginsberg (General Counsel,

NEI), dated July 14, 2010.

20 Id., at pg. 2, FN2 (emphasis added).

21 With respect to volition, the General Counsel's letter recognizes that there are situations - such

as recommendations to adopt new guidance followed by issuance of information requests under50.54(f) that require licensees to explain whether the licensee intends to adopt the staff'srecommendations - that are implicitly coercive and would require a backfit analysis. See id, atpg. 1.



Holders

associated with approval of CoC amendments. Application of the backfitting rule toamendment requests submitted by CoC holders will serve to focus both applicants andthe NRC on safety significant issues that are directly and essentially related to review ofthe application in question.

From a policy standpoint, adoption of industry's position is also consistent with theNRC's Principles of Good Regulation, which stress development and maintenance of aclear, consistent, and reliable regulatory framework. Specifically, with respect toreliability, the Principles state: "Once established, regulation should be perceived to bereliable and not unjustifiably in a state of transition. Regulatory actions should alwaysbe fully consistent with written regulations and should be promptly, fairly, and decisivelyadministered so as to lend stability to the nuclear operational and planning processes."The Principles of Good Regulation are no less applicable or relevant to CoC holders thanthey are to licensees. In fact, CoC holders have equivalent programs to licensees, e.g.QA and corrective action, and are regulated similar to licensees in that they are subjectto inspections and enforcement.

Furthermore, in October 2011 the Commission provided direction to the NRC staff on theconsideration of the cumulative effects of the agency's regulatory activities.22 TheCommission also directed the staff to provide its response to Executive Order 13579(July 11, 2011), which states, in part: "To the extent permitted by law, [regulatory]decisions should be made only after consideration of their costs and benefits (bothquantitative and qualitative)." More recently, the Office of Management and Budgetissued a memorandum to the heads of executive departments and agencies addressingthe cumulative effects of regulation. 23 This memorandum states:

Consistent with Executive Order 13563, and to the extent permitted by law,agencies should take active steps to take account of the cumulative effects ofnew and existing rules and to identify opportunities to harmonize and streamlinemultiple rules. The goals of this effort should be to simplify requirements on thepublic and private sectors; to ensure against unjustified, redundant, or excessiverequirements; and ultimately to increase the net benefits of regulations.

NEI believes that, when properly implemented, the backfitting rule plays an importantrole in both assessing cumulative effects of the NRC's regulatory actions and respondingto Executive Order 13579. Specifically, if the rule were applied broadly and theexceptions construed reasonably, then the cost-justified, substantial increase analysisrequired by 10 CFR § 72.62 would give the NRC, licensees, and CoC holders a solidanalytical basis to assess the burdens and benefits associated with individual regulatoryactions. The cost-justified, substantial increase analyses accompanying these individual

22 "Staff Requirements - SECY-11-0032 - Consideration of the Cumulative Effects of Regulation in

the Rulemaking Process," Oct. 11, 2011.

23 "Memorandum for the Heads of Executive Departments and Agencies: Cumulative Effects ofRegulations," Office of Management and Budget, March 20, 2012.



Holders

regulatory actions could then be used to examine the aggregate or cumulative effects ofimposing multiple regulatory actions, either simultaneously or in series. Without athorough understanding of the agency's individual regulatory actions, which could beenhanced by the logical application of the backfitting rule to CoC holders, assessing theaggregate or cumulative effects of these individual actions becomes more difficult.


Amend 10 CFR Part 72 to make the backfitting provisions of 10 C.F.R. 72.62 applicableto Certificates of Compliance (CoC) and CoC holders, in addition to ISFSI's and MRS'sand holders of general and specific licenses. This proposed rule change affects 10 CFR72.62 and 10 CFR 72.13 (conforming change).

The proposed rulemaking would extend the applicability of the backfitting rule to CoCsand the CoC holders, thereby amending 10 CFR 72.62 and 10 CFR 72.13 accordingly.New or amended NRC staff positions should not be imposed on a CoC or CoC holder,unless the NRC official communicating that position has first ascertained whether thenew or changed position is a backfit. When a staff proposed position is identified as abackfit, the staff should determine expeditiously whether the backfit is needed to ensureadequate protection of the public health and safety, or to comply with Commission rulesor orders, the CoC itself, or written CoC holder commitments. Positions identified asCoC backfits that do not fall into one of these exceptions, should be imposed on CoCsand CoC holders only after documentation of a determination indicating that there is asubstantial increase in the overall protection of the public health and safety, or thecommon defense and security, and that the direct and indirect costs of implementationare outweighed by the increased protection.

The industry believes that the proposed rulemaking to amend 10 CFR 72.62, withconforming change to 10 CFR 72.13, will ensure that the regulatory frameworkapplicable to the dry storage of used fuel is clear, consistent, and reliable; and maintainsan appropriate focus on safety-significant matters.

C. Alternatives to Rulemakinq considered

In addition to the proposed rulemaking, other options were considered and evaluated.There is no available regulatory alternative to the backfitting rule. Therefore, only the"no action" option was identified.

1. No Action - Although considered, this alternative has no merits, other thanavoiding the investment in time and resources necessary to improve theregulatory framework. However, due to the substantial benefit resulting fromthis regulatory improvement, this alternative is considered non-viable. Also, theopportunity to combine this rule change along with other significantimprovements allows it to be achieved with minimal resources.

The proposed change is necessary to ensure a consistent, clear and reliable regulatoryframework regarding spent fuel dry storage. The proposed amendments will make the



Holders

NRC process for review, approval, inspection and enforcement of dry cask storageactivities more effective by focusing the NRC staff, licensees, and CoC holders on issuesthat are most relevant to protecting public health and safety.


NEI Petition to Amend 10 CFR Part 72ENCLOSURE 3 - Rationale for Deleting the Requirement for the Review of the Cask SER

Enclosure 3 - Rationale for Deleting the Requirement for the Review of

the Cask SER

A. Requlatorv background and need for change

Currently, 10 CFR 72.212 "Conditions of general license issued under § 72.210", requiresgeneral licensees to perform a compliance evaluation of the Safety Analysis Report(SAR), referenced in the Certificate of Compliance (CoC), or the amended CoC, and therelated NRC Safety Evaluation Report (SER), prior to use of the general license, todetermine if the site-specific parameters are enveloped by the cask design basescontained in these reports.

Review of the SER is extraneous, as the SER will not contain any new requirements orcommitments that are not already contained in the CoC and FSAR. Thus, review of theSER requires additional time and resources without providing any safety or compliancebenefit.


Amend 10 CFR 72.212(b)(6) to remove the requirement for the general licensee toperform the NRC SER compliance evaluation.

The proposed rule change would remove the requirement for the NRC SER compliancereview, since the review of the cask SAR referenced in the CoC or amended CoC, wouldencompass the evaluation of the site-specific parameters versus the cask design basesinformation. This approach is supported by the NRC Statements of Consideration (SOC)contained in the 10 CFR Part 72 Rulemaking dated October 4, 1999 (64FR 53582),which states the following (emphasis added):

This rule adds new § 72.248 to part 72 and this section addresses this issue byrequiring a certificate holder to submit a final safety analysis report (FSAR) afterissuance of the CoC. This rule also describes the process for periodic updates ofthe FSAR. Section 72.248, paragraphs (a)(1) and (a)(2) state, in part:

Each certificate holder shall submit an original FSAR to the Commissionwithin 90 days after the spent fuel storage cask design has beenapproved pursuant to § 72.238. This original FSAR shall be based on thesafety analysis report submitted with the application and reflect anychanges and applicant commitments developed during the cask designreview process. The original FSAR shall be updated to reflect any changesto requirements contained in the issued Certificate of Compliance (CoC).


NEI Petition to Amend 10 CFR Part 72ENCLOSURE 3 - Rationale for Deleting the Requirement for the Review of the Cask SER

The Commission agrees with the petitioner 24 that the FSAR should befully conformed (i.e., consistent) with the operating limits contained inthe CoC, because the FSAR contains the design information the staff usedto make its safety finding and to approve the dry storage cask design foruse. The Commission disagrees with the petitioner's request that theFSAR be conformed to the NRC SER for the dry storage cask design, andthat the FSAR be submitted to the NRC before approval of the caskdesign (i.e., issuance of the CoC). The NRC SER contains staffconclusions on the adequacy of the cask design, not applicantcommitments to the NRC on the cask design. Therefore, theCommission believes it is not necessary to conform the FSAR to theissued NRC SER before the CoC can be issued.

Therefore, the proposed rule change would eliminate the need for duplicate reviews andduplicate evaluation reports, while maintaining the requirement for the general licenseeto ensure the activities related to spent fuel dry storage are performed in accordancewith the conditions described in the CoC SAR.


In addition to the proposed rulemaking, other options were considered and evaluated.Only the "no action" option was identified, as no non-rulemaking option would addressthe issue.

1. No Action - Although considered, this alternative has no merits, other thanavoiding the investment in time and resources necessary to improve theregulatory framework. However, the need for regulatory improvement issufficiently significant that this alternative is considered undesirable. Also, theopportunity to combine this rule change along with other significantimprovements allows it to be achieved with minimal resources.

The proposed change is necessary in order to be consistent with NRC's Principles ofGood Regulation. The principle on "Reliability" states: "Once established, regulationshould be perceived to be reliable and not unjustifiably in a state of transition.Regulatory actions should always be fully consistent with written regulations and shouldbe promptly, fairly, and decisively administered so as to lend stability to the nuclearoperational and planning processes."

24 As stated in 64 FR 53604, Section 0.2: A PRM was received and noticed in 61 FR 24249, whichrequested changes to Part 72 to require conformance with the NRC's Safety Evaluation Report,among other changes.


NEI Petition to Amend 10 CFR Part 72ENCLOSURE 4 - Rationale for Clarifying the Requirement for Review of Programs and

Plans Governed by Other Parts of the Regulations

Enclosure 4 - Rationale for Clarifying the Requirement for Review of

Programs and Plans Governed by Other Parts of the Regulations


Currently, 10 CFR 72.212(b)(10) requires that general licensees perform a review of theemergency plan (EP), quality assurance program (QAP), training program, and radiationprotection program (RP), to determine if their effectiveness is decreased and, if so,prepare the necessary changes and seek and obtain the necessary approvals.

As currently written, the rule may be interpreted as imposing change controlrequirements for these programs that are different than the existing change controlrequirements already provided in 10 C.F.R. Part 50. For example, requiring NRC reviewand approval for general licensees' evaluations of the training program or the RP, whichis contrary to the provisions of 10 CFR 50.54 (e.g., training program and radiationprotection program are not included in the programs listed under 10 CFR 50.54,"Conditions of licenses').


Amend 10 CFR 72.212(b)(10) to clarify the regulatory requirements for the generallicensee to review the emergency plan, quality assurance program, training program,and radiation protection program in order to determine if there are any changes, andmake the necessary changes in accordance with the applicable change control program.

The proposed rule change would maintain the requirement for the general licensee toperform the necessary reviews and prepare written evaluations. It would only clarify thefact that, if there are any required changes to the subject programs, these changesshould be processed in accordance with the applicable change control program (e.g.,QAP changes are addressed by 10 CFR 50.54(a), EP changes are addressed by 10 CFR50.54(q), etc.).

The proposed amendment would make 10 CFR Part 72 consistent with the regulatoryrequirements provided in 10 CFR Part 50, "Domestic Licensing of Production andUtilization Facilities" and would remove the ambiguity in the existing 10 CFR72.212(b)(10).

NUREG-1536, "Standard Review Plan for Spent Fuel Dry Storage Systems at a GeneralLicense Facility," contains the NRC guidance for reviewing applications for a Certificateof Compliance (CoC) of a dry storage system (DSS) for use at a general license facility.Sections 6.5.4.3 and 11.5.3.1 address the radiological protection program evaluationsperformed by general licensees and specify that the NRC review and approval is notrequired. An excerpt from 11.5.3.1 is provided below (6.5.4.3 is substantially similar):




[A] general licensee must perform a written evaluation to demonstrate that therequirements of 72.104 are met. An evaluation similar to that for a site-specificISFSI should be performed. The licensee may use information provided in thecask SAR as well as site-specific information to perform the evaluation.Evaluations performed by the general ISFSI licensee are not submitted to NRCfor approval; however, they are subject to NRC inspection and should berecorded and maintained by the general licensee.The general licensee should establish measures in the radiological protectionprogram, environmental monitoring program, and/or operating procedures toidentify and re-evaluate potential increases in exposure to the real individuals.Compliance with the dose limits in 10 CFR 72.104 will be verified by theenvironmental monitoring program with direct radiation measurements and/oreffluent measurements, as appropriate.

The general licensee radiological protection program has to comply with the regulatoryrequirements of 10 CFR 72.104 for normal and off-normal conditions, and 10 CFR72.106 for accident conditions. Also, the general licensee has to comply with 10 CFRPart 20 requirements for occupational radiation exposure. These written evaluationsperformed by the general licensee to demonstrate compliance with 10 CFR 72.212, aresubject to the NRC inspection and enforcement program, but the evaluations themselvesshould not be submitted for NRC approval. In fact, the NRC does not desire to reviewand approve these type evaluations, as discussed in NUREG-1536, and the requirementis extraneous. Therefore, the proposed rule change would not preclude the generallicensee from performing the necessary reviews and preparing written evaluations. Itwill only clarify which programs require NRC review and approval (e.g., NRC review andapproval of changes to the reactor Emergency Plan or the Quality Assurance Program isrequired, if the licensee evaluation determines that the use of the cask results in adecreased effectiveness of those programs).

The amended rule will ensure consistency in regulatory requirements for the licenseewho performs activities under either a 10 CFR Part 50 facility operating license, or a 10CFR Part 72 general license.



1. No Action - Although considered, this alternative has no merits, other thanavoiding the investment in time and resources necessary to improve theregulatory framework. However, the need for regulatory improvement issufficiently significant that this alternative is considered undesirable. Also, theopportunity to combine this rule change along with other significantimprovements allows it to be achieved with minimal resources.




The proposed change is necessary to achieve consistency with NRC's Principles of GoodRegulation. The principle on "Clarity" states: "Regulations should be coherent, logical,and practical. There should be a clear nexus between regulations and agency goals andobjectives whether explicitly or implicitly stated. Agency positions should be readilyunderstood and easily applied."


NEI Petition to Amend 10 CFR Part 72ENCLOSURE 5 - Rationale for Revising the Requirement for Cask Marking

Enclosure 5 - Rationale for Revising the Requirement for Cask Marking

A. Regulatory background and need for change

Currently 10 CFR 72.236 (k) stipulates the requirements for conspicuously and durablymarking the storage cask. The following three items are required: 1) model number, 2)unique identification number, and 3) empty weight. Only these first two items, modelnumber and unique identification number, are included in 10 CFR 72.234(d)(2), whichstipulates requirements for the information that must be included for each spent fuelstorage cask fabricated under the Certificate of Compliance (CoC).

The required model number and unique identification number ensure that the cask canbe properly identified, and traced back to its QA records, which include information onthe design and contents. Since cask weight would be included in the QA controlledrecords, which are maintained for the life of the cask, there is no need to include thisinformation for the purposes of identification or configuration control.

It is also important to ensure that the cask markings are minimized as much as possible,such that if detailed information is variable or could possibly change in the future,permanent markings on the cask will not need to be changed. Changing permanentmarkings on the cask are problematic since this would require significant repair work,evaluation to verify the cask maintains conformance with the CoC, and worker dose ifthe cask contains used fuel. The most efficient and effective regulatory approach forcask configuration control is to have the minimum markings that ensure the individualcask can be traced to the QA controlled records containing the most accurateinformation for that cask.

Knowing the maximum fully-loaded cask weight is important for ensuring adequatecrane capacity for lifting and handling the cask prior to loading; however, marking thisinformation on the cask is not essential since the records containing the information arereadily available. These records will necessarily be reviewed in advance of anyanticipated lifting or handling activities in order to verify the crane capacity is sufficient.Once the cask is loaded, there then is no further practical value to knowing oridentifying the empty weight, since the cask "system," which refers to the canister in theoverpack, will not be without fuel until it is unloaded at a repository, recycling, or someother transfer facility. Therefore, retaining the empty cask weight is unnecessary, asthe cask system empty weight is associated with a configuration that will never occur.

The requirement to mark the empty weight on each cask results in increased time andcost for cask fabrication activities. It does not improve or otherwise provide anyincrease to the protection of public health and safety. However, it does create thepotential to result in additional work dose or increased resources, if the cask weightmarking needs to be changed.


NEI Petition to Amend 10 CFR Part 72ENCLOSURE 5 - Rationale for Revising the Requirement for Cask Marking


Amend 10 CFR 72.236 to remove the requirement for the cask "empty weight" (i.e.,delete 10 CFR 72.236(k)(3)).

The proposed rule change would remove this from the regulations, since it serves nopractical purpose and it provides no benefit to the adequate protection of public healthand safety. Therefore, the proposed rule change clarifies the intent of the regulation toprovide a means to identify an individual cask and trace it back to its QA records, whilemaintaining the focus of 10 CFR 72.236 on items of safety significance.

NUREG-1536, "Standard Review Plan for Spent Fuel Dry Storage Systems at a GeneralLicense Facility", sections 10.5 and 10.6 mention the cask empty weight and should berevised accordingly, after the proposed amended rule becomes effective, to ensureconsistency.


In addition to the proposed rulemaking, other options were considered and evaluated.

1. Modify Marking from "empty weight" to "maximum loaded weight" -The benefit of this alternative is that it would continue to ensure that there is aweight stamped on the cask, which could be readily observed, and would notrely on having a document package accompany the cask. Whereas "emptyweight" provides no useful information, "maximum loaded weight" does conveythe load requirements of a handling crane. Although a benefit would be thereduced reliance on institutional controls to ensure a document packageaccompanies the cask, the potential for a loss of institutional controls is remote.Therefore, there is not a need to have a weight stamped on the cask, andreliance on the accompanying document package is appropriate.

2. No Action - The merits of this alternative is that it would avoid the demand ontime and resources necessary to improve a regulatory requirement that wouldonly provide minor benefits. However, given that this change can be combinedalong with other significant improvements, allowing it to be achieved withminimal resources, this alternative was rejected.

The proposed change is necessary to achieve consistency with NRC's Principles of GoodRegulation. The principle on "Clarity" states: "Regulations should be coherent, logical,and practical. There should be a clear nexus between regulations and agency goals andobjectives whether explicitly or implicitly stated. Agency positions should be readilyunderstood and easily applied."


NEI Petition to Amend 10 CFR Part 72ENCLOSURE 6 - Rationale for Clarifying the Applicability of Criticality Monitoring

Exemptions

Enclosure 6 - Rationale for Clarifying the Applicability of CriticalityMonitoring Exemptions

A. Regulatory background and need for change

10 CFR Part 72, "Licensing Requirements for the Independent Storage of Spent NuclearFuel, High-Level Radioactive Waste, and Reactor-Related Greater than Class C Waste,"contains the regulatory requirements for the design, fabrication, testing and operation ofthe dry cask storage of spent nuclear fuel. As discussed in the Statements ofConsideration (SOC) contained in the 10 CFR Part 72 Rulemaking dated July 18, 1990(55 FR 29181), maintaining subcriticality of spent nuclear fuel stored in dry casks isensured by the 10 CFR 72.236(c) criterion, which states: "The spent fuel storage caskmust be designed and fabricated so that the spent fuel is maintained in a subcriticalcondition under credible conditions." Findings by the NRC concerning safety of the caskdesign are based on the analyses described in the cask Safety Analysis Report (SAR)submitted to the NRC by the cask vendor, including criticality analyses. Cask fabricationactivities are performed under an NRC-approved Quality Assurance Program, which issubject to the NRC inspection and enforcement policy.

NUREG-1536, "Standard Review Plan for Spent Fuel Dry Storage Systems at a GeneralLicense Facility", contains the NRC guidance for the NRC reviewers to ensure the spentfuel storage cask is designed and fabricated to maintain subcriticality under all crediblescenarios, and states the following:

The criticality review and evaluation ensures that spent nuclear fuel (SNF)to be placed into the dry storage system (DSS) remains subcritical undernormal, off-normal, and accident conditions involving handling,packaging, transfer, and storage. The criticality review is designed tofulfill the strategic outcome of no inadvertent criticality events, part of thestrategic goal of safety described in the agency's strategic plan (NUREG-1614)." Furthermore, section 7.5.4.2 states: "Because of the importanceand complexity of the criticality evaluation, independent calculationsshould be performed to ensure that the most reactive conditions havebeen addressed, the reported ke is conservative and the applicant hasappropriately modeled the storage cask geometry and materials.

NUREG-1536 Section 7.1.5, "Criticality Design Criteria and Features (HIGH Priority),"addresses the key elements of spent fuel cask criticality reviews:

The criticality design of the cask relies on the general dimensions of thecask components and the spacing of the fuel assemblies. The criticalitydesign also often relies on neutron poisons. These may be in the form offixed poisons in the basket structure, which may be used together withflux traps, and/or soluble poisons in the water of the SNF pool. During



Exemptions

loading and unloading operations, NRC staff accepts the use of boratedwater as a means of criticality control if the applicant specifies a minimumboron content and strict controls are established to ensure that theminimum required boron concentration is maintained.

Therefore, the NRC review is focused on the bounding criticality analysis, whichencompasses the most reactive set of conditions during cask loading, preparation, onsitetransport, and storage operation activities. This is consistent with the existing NRCregulations in 10 CFR 70.24(d), which permit 10 CFR Part 50 licensees to credit thecriticality analysis for fuel storage performed pursuant to 10 CFR 50.68(b), in lieu ofproviding criticality monitoring.

Industry's current compliance approach is to provide temporary criticality monitoringfrom the time the cask or canister is removed from the spent fuel pool until the cask orcanister is drained, dried, inerted, and sealed. This approach is based on NRC's 2000letter25 of interpretation to a CoC holder pertaining to this regulation. However, thistemporary criticality monitoring is being performed at a time when the contents of thecanister are in a less-reactive state than they were when they were located in the spentfuel pool, fully moderated with water. The cask/canister is analyzed for criticality underthe most reactive conditions as part of cask certification licensing. Therefore, nocriticality monitoring should be required as long as the cask/canister is being managedin accordance with its approved licensing and design basis as described in the Cask CoCor ISFSI license and their respective FSARs.


Amend 10 CFR 72.124, "Criteria for nuclear criticality safety", to modify 10 CFR72.124(c), to reflect that criticality monitoring does not apply to spent fuel dry storage,including cask loading, preparation, onsite transport, and storage operation.

Currently, 10 CFR 72.124(c) states that "monitoring of dry storage areas where specialnuclear material is packaged in its stored configuration under a license issued under thissubpart is not required."

The proposed rulemaking would modify this regulation to specify that criticalitymonitoring does not apply to special nuclear material in a dry storage cask beingmanaged under a license granted pursuant to Part 72, with "managed" defined as caskloading, preparation, onsite transport and storage operation. Therefore, the proposedrule change to modify 10 CFR 72.124(c), would clarify the regulations without modifyingthe intent.

25 ML003737252



Exemptions



1. No Action - The merits of this alternative is that it would avoid the demand ontime and resources necessary to improve a regulatory requirement that wouldonly provide minor benefits. However, given that this change can be combinedalong with other significant improvements, allowing it to be achieved withminimal resources, this alternative was rejected.

This change is necessary to achieve consistency with NRC's Principles of GoodRegulation. The principle on "Efficiency" states: "Where several effective alternativesare available, the option which minimizes the use of resources should be adopted."


Rulemaking Comments

From:Sent:To:Cc:Subject:

Attachments:

Vietti-Cook, AnnetteWednesday, October 03, 2012 5:28 PMRulemaking CommentsNgbea, EvangelineFW: Petition to Amend 10 CFR Part 72, "Licensing Requirements for the Independent Storageof Spent Nuclear Fuel, High-Level Radioactive Waste, and Reactor-Related Greater ThanClass C Waste"Petition to Amend 10 CFR Part 72, "Licensing Requirements for the Independent Storage ofSpent Nuclear Fuel, High-Level Radioactive Waste, and Reactor-Related Greater Than ClassC Waste"

1

october 3, 2012 ms. annette l. vietti-cook · october 3, 2012 ms. annette l. vietti-cook secretary...

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