ML23156A426

PR-072 - 34FR59677 - Clarification and Addition of Flexibility

ML23156A426
Person / Time
Issue date:	11/03/1999
From:	Annette Vietti-Cook NRC/SECY
To:
References
PR-072, 64FR59677
Download: ML23156A426 (1)

Text

ADAMS Template: SECY-067 DOCUMENT DATE: 11/03/1999 TITLE: PR-072 - 64FR59677 - CLARIFICATION AND ADDITION OF FLEXIBILITY CASE

REFERENCE:

PR-072 64FR59677 KEYWORD: RULEMAKING COMMENTS Document Sensitivity: Non-sensitive - SUNSI Review Complete

Docket No.: PR-072 11/08/2000 FR Cite: 64FR59677 In the Matter of Clarification and Addition of Flexibility Comment Comment Docket Document Miscellaneous Accession Number Submitted by Representing Date Date Description Number 10/29/1999 10/26/1999 Federal Register Notice -

Proposed Rule James H. McCarthy Virginia Power 12/29/1999 12/17/1999 Manager, Nuclear Licensing and Operations Support 2 Jimmy D. Vandergrift Entergy Operations, Inc. 01/06/2000 01/05/2000 Director, Nuclear Safety 3 Lynnette Hendricks Nuclear Energy Institute 01/20/2000 01/18/2000 Director, Plant Support Nuclear Generation 4 James A. Hutton, Jr. PECO Energy Company 01/21/2000 01/13/2000 Director -.Licensing I

Docket No.: PR-072 11/08/2000 FR Cite: 64FR59677 In the Matter of Clarification and Addition of Flexibility Comment Comment Docket Document Miscellaneous Accession Number Submitted by Representing Date Date Description Number Rajiv S. Kundalkar Aorida Power & Light 01/24/2000 01/14/2000 Vice President - Nuclear Company Engineering 6 Jay E. Silberg, Esq. Private Fuel Storage, 01/27/2000 01/ 18/2000 L.L.C.

7 Brian Gutherman Holtec International 02/14/2000 02/11/2000 Licensing Manager 8 Gregg R. Overbeck Arizona Public Service 02/17/2000 01/28/2000 Sr. Vice President Company 08/17/2000 08/15/2000 Final Rule - Clarification and Addition of flexibility (Published at 65FR50606 on 08/21/2000.)

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Docket No.: PR-072 11/08/2000 FR Cite: 64FR59677 In the Matter of Clarification and Addition of Flexibility Comment Comment Docket Document Miscellaneou8 Accession Number Submitted by Representing Date Date Description Number 08/30/2000 08/29/2000 FRN-Final Rule; Correction 9 William F. Renz Virginia Power 10/04/2000 09/26/2000 ML003757994 Acting Manager 3

ET NUMBER 1w1.,oruuk Jechnica/ Center oseo 5000 Dominion Bou/ernrd Cl.P~ f R5 qCo71 Glen Allen, ""'""" 2106 September 26, 2000 GL 99-070A Secretary, U.S. Nuclear Regulatory Commission Washington, D.C. 20555-0001 Attn: Rulemaking and Adjudications Staff 10 CFR 72 Clarification and Addition of Flexibility, Final Rule

• VIRGINIA POWER The NRG issued a final rule, 10 CFR Part 72, Clarification and Addition of Flexibility, in the Federal Register (Vol. 65, No. 162) on August 21 , 2000. Virginia Power had commented on the proposed rule in a December 17, 1999 letter. Our comment pointed out an apparent discrepancy between what the NRG had previously stated in a November 12, 1998 letter to Virginia Power and what §72.180 requires concerning the applicability of

§73.51 to site specific licensees. The NRC's November 12, 1998 letter had stated that

§73.51 was not applicable to the North Anna or Surry ISFSls. 10 CFR 72.180 clearly states that §73.51 applies. We had previously discussed this concern with the NRG during an ISFSI status meeting on May 4, 1999.

The NRC's response to Comment A.1 in the Summary of Public Comments on the Proposed Rule stated that §73.51 does not apply to those ISFSls that are collocated at an operating reactor site, and that the physical protection measures for those ISFSls are implemented through §73.55. This appears to be a new requirement for ISFSls with a site specific license. It provides different security requirements for ISFSls based on the location of the facility and directly conflicts with license conditions for site specific licensees, the applicability section of §73.51, Subpart H of Part 72 (specifically §72.180),

as well as other comments in the supporting discussion for this final rule. The final rule appears to implement an unevaluated backfit for all site specific licensees that are collocated with an operating power reactor.

License conditions for both North Anna and Surry ISFSls require that Virginia Power comply with 10 CFR 72, Subpart H. 10 CFR 72.180 is part of Subpart H and was revised as part of the final rule issued in the May 15, 1998 Federal Register. This section currently states that "The licensee shall establish , maintain, and follow a detailed plan for physical protection as described in §73.51 of this chapter. " Therefore, the North Anna and Surry ISFSI license conditions require that the ISFSI security plans comply with 10 CFR 73.51. In addition , the Surry ISFSI SER dated May 1986 and the North Anna ISFSI SER dated June 30, 1998 state that the NRC found that Part 72 Subpart H was satisfied.

As stated in Subpart H of Part 72, the applicability section of §73.51, and the supporting discussion for the subject final rule, site specific licensees are required to comply with

§73.51 for physical security measures (not §73.55). 10 CFR 73.55 , "Requirements for physical protection of licensed activities in nuclear power reactors against radiological sabotage," applies to power reactors and is required to be followed by licensees storing spent fuel at an ISFSI under a Part 72 general license, with some specified exceptions ,

but is not applicable to site specific licensees as described in Part 72. In fact the new rule t ta

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adds §72.13(b) to specifically state that §72.180 (which requires security plans to be consistent with §73.51) applies to site specific licensees.

The proposed rule for §73.51 was issued in the Federal Register on August 15, 1995. The proposed rule stated that it would apply to licensees who stored spent fuel under a Part 72 specific license at an ISFSI , a monitored retrievable storage (MRS) installation or a nuclear power reactor that had permanently ceased reactor operations licensed pursuant to Part 50 . In contrast, the final rule for 10 CFR 73.51 deleted the applicability to nuclear power reactors .

The NRC's response to comment A.1 also stated the NRC's practice has been that a specific Part 72 licensee, who is also a Part 50 license holder does not have to comply with the security plan requirements of §73.51. This was based on a quote from the supporting discussion for the May 15, 1998 final rule that established §73.51. That quote was "The Commission notes that a licensee having a Part 50 license does not fall within the scope of the final rule [on §73.51] " This quote was incomplete and thereby misapplied and out of context.

The complete quote from the supporting discussion is "The Commission notes that a licensee having a Part 50 license does not fall within the scope of the final rule. The commission believes it is premature to bring these licensees under the provisions of the final rule because continued protection for spent fuel in storage pools at Part 50 sites is currently under study by the NRG." This quote is repeated again in the supporting discussion, then later shortened to the first sentence. Therefore , it contextually appears that "a licensee having a Part 50 license" is referring to Part 50 licensees that stored spent fuel in pools which were removed from the applicability of the rule during issuance of the final rule , and not Part 72 specific licensees. Part 72 specific licensees are licensed such that they could operate the ISFSI totally independent of Part 50 regardless of their location, wh ich makes the location of these facilities irrelevant.

Furthermore, the new rule appears to be inconsistent with Section Ill of the §73.51 supporting discussion (May 15, 1998), Summary of Specific Changes Made to the Proposed Rule as a Result of Public Comment. This section stated that it was an acceptable alternative to use the hardened alarm station sited at an adjacent operating power reactor instead of having a hardened alarm station within the protected area of the ISFSI. Therefore, it appeared that the rule applied to ISFSls sited adjacent to a power reactors.

Based on the NRC's discussion supporting the new rule that §73.51 does not apply to site specific licensees collocated with an operating power reacto r, and since §73.55 was not written to apply to site specific ISFSI licensees, there appears to be no requirements in Parts 72 or 73 that delineate specific physical security requi rements for site specific licensees collocated at an operating power reactor. The NRC's November 12, 1998 letter stated that the North Anna and Surry ISFSI security requirements were those contained in the NRC approved security plan , and that the staff was proposing rulemaking for clarification . It should be noted that this letter did not mention §73.55. The consequences

of this position is that the lack of regulatory requirements in Part 73 for site specific ISFSls collocated with an operating power reactors inhibits a licensees' ability to make changes to their security plan without prior NRC approval. 10 CFR 72.186 allows licensees to make such changes if the safeguards effectiveness is not decreased. Generic Letter 95-08 clarifies that a plan change does not "decrease the effectiveness" of the plan if the change does not decrease the ability of the physical protection system or organization as described in regulation . However, if the only basis for compliance is an approved ISFSI security plan, no change can be assessed for a reduction of effectiveness, since any change could constitute a reduction in effectiveness. Generically, the measure of the "decrease in the effectiveness" is directly tied to the compliance with regulation.

As we assess implementation of the final rule, we conclude that the physical security requirements for the ISFSls appear to have been significantly upgraded to those that are contained in §73.55 without the appropriate backfit analysis as required by §72.62. This rule change affects all site specific licensees that are collocated with an operating power reactor. We request that the NRC reevaluate the Part 72 final rule issued in the August 21, 2000 Federal Register. We believe that since §73.55 applies to operating power reactors , these requirements are not appropriate for a site specific ISFSI. We believe that the appropriate level of security for all site specific licensees is §73.51, as currently stated in the applicability section of §73.51 and our current Part 72 licenses. We specifically request that NRC reevaluate the new rule , and if the current position is maintained that the NRC perform the obligatory backfit analysis prior to enforcing this new rule.

If you need further information , please contact me.

Very truly yours, m F. Renz, Acting Manager Nuclear Licensing and Operations Support

7590--01-P '

Nuclear Regulatory Commission 10 CFR Part 72 *oo ~l" 30 Al :46 RIN 3150-AG15 Clarification and Addition of Flexibility; Correction A AGENCY: Nuclear Regulatory Commission.

ACTION: Final rule; correction.

SUMMARY

This document corrects a notice appearing in the Federal Register on August 21 , 2000 (65 FR 50606). This action is necessary to correct an erroneous Accession Number.

FOR FURTHER INFORMATION CONTACT: Anthony DiPalo, Office of Nuclear Material Safety and Safeguards, Washington, DC 20555-0001, telephone 301-415-6191 , e-mail ajd@nrc.gov.

SUPPLEMENTARY INFORMATION:

On page 50606, in .t he right column, in the third complete paragraph, in the last line, "ML003736106" is corrected to read "ML003701140".

Dated at Rockville, Maryland, this '2f} day of August 2000.

For the Nuclear Regulatory Commission.

David L. Meyer, Chief, Rules and Directives Branch, Division of Administrative Services, Office of Administration.

, ,~

( (ot./ F~ 59lo 77) or r'I

[7590-01-P]

• oo A r* 17 /; v *29 NUCLEAR REGULATORY COMMISSION ~

10 CFR Part 72 A RIN 3150-AG15 Clarification and Addition of Flexibility AGENCY: Nuclear Regulatory Commission.

ACTION: Final rule.

SUMMARY

The Nuclear Regulatory Commission (NRC) is amending its regulations on spent fuel storage to specify those sections of 10 CFR Part 72 that apply to general licensees, specific licensees , applicants for a specific license, certificate holders, and applicants for a certificate of compliance (CoC). These amendments are consistent with past NRC licensing

- practice to eliminate any ambiguity for these persons by clarifying which portions of Part 72 apply to their activities. The final rule eliminates the necessity for repetitive reviews of cask design issues in a licensing proceeding on applications for specific Part 72 licenses, where previously approved cask designs, or designs under Commission review, have been incorporated by reference into the application. Also, the final rule eliminates repetitive reviews in those cases where the site-specific licensing proceeding and a CoC review and certification (i.e., rulemaking) are proceeding in parallel. Lastly, t~is rule allows an applicant for a CoC to begin cask fabrication under an NRG-approved quality assurance (QA) program before the CoC is issued.

FOR FURTHER INFORMATION CONTACT: Anthony DiPalo, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone (301 ) 415-6191, e-mail AJD@nrc.gov.

SUPPLEMENTARY INFORMATION:

Background

The Commission's regulations at 10 CFR Part 72 were originally designed to provide specific licenses for the storage of spent nuclear fuel in an independent spent fuel storage installation (ISFSI) {45 FR 74693; November 12, 1980). In 1990, the Commission amended Part 72 to include a process for approving the design of spent fuel storage casks and issuing a CoC {Subpart L) and for granting a general license to reactor licensees (Subpart K) to use NRG-approved casks for the storage of spent nuclear fuel (55 FR 29181; July18, 1990).

Although the Commission intended that the requirements imposed in Subpart K for general licensees be used in addition to, rather than in lieu of, appropriate existing requirements, 4t ambiguity exists as to which Part 72 requirements, other than those in Subparts K and L, are applicable to general licensees and certificate holders, respectively.

In addition, the Commission has identified two aspects of Part 72 where it is desirable to reduce the regulatory burden and provide additional flexibility to applicants for a specific license or a CoC.

First, the Commission anticipates receipt of several applications for a specific license that will propose using storage cask designs previously approved by NRC under the provisions of Subpart L of Part 72 {i.e., cask designs that have been issued a CoC and are listed i~

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§ 72.214). Section 72.18, "Elimination of repetition," permits an applicant to incorporate by reference information contained in previous applications, statements, or reports filed with the NRC, including cask designs approved under Subpart L. Section 72.46 requires that in an application for a specific license under Part 72, the Commission shall issue or cause to be issued a notiCf' of proposed action and opportunity for a license hearing (i.e., ':1 licensing proceeding) in accordance with 10 CFR Part 2. Under current Part 72 regulations, the adequacy of the design of these previously approved casks could be at issue dufing a § 72.46 licensing proceeding for a specific license application (i.e., issues on the cask design which have been previously addressed by the Commission, including resolution of public comments, could be the subject of a licensing proceeding).

Second,§ 72.234(c), which was part of the 1990 amendments to Part 72, prohibits an applicant for a CoC from beginning fabrication of a spent fuel cask before the NRC issues a Coe for the cask design. However, an applicant for a specific license is currently allowed to begin fabrication of spent fuel storage casks before the license is issued. At the time the 1990 rule was proposed, a commenter suggested that a fabricator (i.e., applicant for a CoC) be allowed to take the risk of beginning fabrication before the receipt of the CoC. However, in the final rule, the Commission took the position, "[i]f a vendor has not received the certificate, then the vendor does not have the necessary approved specifications and may design ar,d fabricate casks to meet incorrect criteria" (55 FR 29185; July18, 1990).

Since 1990, the Commission has reviewed and approved several cask designs. These reviews and follow-up requests for additional inform~tion have established the NRC's expectation as to how its criteria for cask design and fabrication should be met. In January 1997, the NRC published NUREG-1536, "Standard Review Plan for Dry Cask Storage Systems," informing Coe applicants of its expectations in reviewing cask designs. Since then, 3

the Commission has granted several exemptions from§ 72.234(c) allowing applicants to begin fabrication before issuance of the CoC. Additional exemption requests from § 72.234(c) requirements are anticipated.

The Commission published a proposed rule in the Federal Register (64 FR 59677; November 3, 1999). The comment period ended January 18, 2000, and eight comment letters were received on the proposed rule. These comments and responses are discussed in the "Summary of Public Comments on the Proposed Rule" section.

Discussion Clarification:

This final rule eliminates the regulatory uncertainty that currently exists in Part 72 by adding a new section § 72.13 that specifies which Part 72 regulations apply to general J

licensees, specific licensees, applicants for a specific license, certificate holders, and applicants for a CoC. To aid users of Part 72 in understanding§ 72.13, the NRC has created a Table of Applicability for Part 72 regulations (Table}. For each section, paragraph, or subparagraph, the Table ide!1tifies whether the regulation applies to a general licensee, specific licensee, applicant for a specific license, certificate holder, and/or an applicant for a CoC. The Table is available for review in the NRC's Public Electronic Reading Room on the NRC's website (http://www.nrc.gov) under Accession Number ML003736106.

Flexibility:

First, the final rule eliminates the necessity for repetitious reviews of cask design issue~

during a § 72.48 licensing proceeding for issues the Commission has previously considered, or is considering, during the cask design review and certification process (i.e., rulemakingt The 4

Commission anticipates receipt of several applications, for specific ISFSI licenses, that will propose using storage cask designs either previously approved by the NRC under Subpart L or currently under consideration. Applicants for a specific license presently have the authority under § 72.18 to incorporate by reference into their application, information contained in previous applications, statements, or reports filed with the Commission, including information from the Safety Analysis Report on a cask design either previously approved or currently under review by the NRC for certification under the provisions of Subpart L. The Commission believes that both of these situation~ should be excluded from tj,e scope of a specific licensing proceeding. This is because the p~blic has the opportunity during the Subpart L approval process to comment on the adequacy of the cask design. Jhe opportunity of the public to comment on cask designs will not be affected by this rulemaking. However, design interface issues between the referenced cask design and specific site characteristics (~-9-,

meteorological, seismological, radiological, and hydrological), or changes to the cask's approved design, must be addressed by the applicant in its application and may be raised as potential issues in the licensing proceeding. Furthermore, the rights of the public to petition the Commission under §§ 2.206 and 2.802 to raise new safety issues on the adequacy of the cask design will not be adversely impacted by this rulemaking.

Second, the final rule permits an applicant for approval of a spent fuel storage cask design under Subpart L to begin fabrication of casks at its risk before the NRC has approved the cask design and issued the CoC. Currently, an applicant for a CoC is not permitted under

§ 72.234(c) to begin cask fabrication until after the CoC is issued. Applicants for a specific license, and their contractors, are currently allowed to begin fabrication of casks before the

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Commission issues their license. However, general licensees and their contractprs (Le, the certificate holder) are not allowed to begin fabrication before the CoC is issued. Co~s~quently, 5

this final_ rule eliminates NRC's disparate treatment between general and specific licensees.

The Commission and the staff have previously determined that exemptions from the fabrication prohibition in § 72.234(c) are authorized by law and do not endanger life or property, the common defense, or security and are otherwise in the public interest The Commission anticipates that additional cask designs will be submitted to the NRC for, approval and expects that these designs will be similar in nature to those cask designs that have already been approved. Absent this final rule, the Commission expects that additional exemption requests to permit fabrication would also be received. This final rulemaking eliminates the need for such exemption requests.

Additionally, the final rule revises the quality assurance regulations in Subpart G of Part 72 to require that an applicant for a CoC, who voluntarily wishes to begin cask fabrication, must conduct cask fabrication activities under an NRC-approved QA program. Currently, applicants for a CoC are required by§ 72.234(b) to conduct design; fabrication, testing, and maintenance activities under a QA program that meets the requirements of Subpart G. Prior NRC approval of the applicant's QA program is not required by§ 72.234(b). Hqwever,

§ 72.234(c) currently precludes cask fabrication until after the CoC is issued. The Commission believes the revised provision in the final rule is a conditional relaxation. to permit fabrication before the CoC is issued. ,,Because NRC staff would approve the applicant's QA program as part of issuance of a CoC, staff approval of the QA program before fabrication is a question of timing (i.e., w_hen the program is approved), rather than imposing a new requirement for approval of a program. The Comm'ission expects that any financial or scheduler risks associated with fabrication of casks before issuance of the CoC would be borne by the applicant. The Commission believes the final rule is not a backfrt because § 72.62 applies to licensees after the license is issued and does not apply to app!icants prior to issuance Qf the 6

licanse. The final rule requires that a cask for which fabrication was initiated before issuance of the CoC must contonn to the issued CoC before the cask may be used.

The final rule also requires an applicant for a specific license, who voluntarily wishes to begin fabrication of casks before the license is issued, to conduct fabrication under an NRC-approved QA program. Currently, an applicant for a specific license may begin cask fabrication before the license is issued. Additionally, the licensee is required by§ ,72.140(c) to obtain NRC approval of its QA program before spent fuel is loaded into the ISFSI. The Commission does not believe this final rule imposes a separate requirement on applicants for a specific license.

Rather, this rule requires different timing on when the NRC approves a QA program.

This final rule also revises § 72.140(d) to allow a licensee, applicant for a license, certificate holder, and applicant for a CoC to use an existing Part 50, 71, or 72 QA program that was previously approved by the NRC, in lieu of submitting a new QA program. The Commission expects that a new QA program or an existing Part 50 or Part 71 QA program used by these persons will comply with the requirements of Part 72, Subpart G.

As a result, the final rule requires both licensees and certificate holders to accomplish any fabrication activities under an NRC-approved QA program. The Commission be_lieves the final rule's increase in flexibility and change in timing of approval of a QA program is not a backfit.

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Summary of Proposed Rule Amendments The changes to the sections discussed below were proposed when the rule was publish,ed for public comment on November 3, 1999, (64 FR 59677). These proposed changes were intended to: (1) eliminate the re,gulatory uncertainty that now exists in Part 72 and explicitly specify which regulations apply to general licensees, specific licensees, applicants for a specific license, certificate holders, and applicants for a CoC; (2) eliminate the necessity for repetitious reviews in a specific license hearing of cask design issues that the Commission previously considered during approval of the cask design; (3} permit an applicant for approval of a ,spent fuel storage cask design to begin cask fabrication, at its own risk, before the NRC has issued the CoC; and (4) require that NRC approval of the quality assurance program be obtained before. cask fabrication can commence.

Section 72.13 Applicability.

It was proposed that a new section be added to Part 72 to identify those sections of Part 72 that apply to specific licenses, general licenses, and Certificates of Compliance. No changes to the under1ying regulations would result from this amendment, as it is intended for 9 clarification only.

Section 72.46 Public hearings.

It was proposed that a new paragraph {e) be added to this section to indicate that the scope of any licensing proceeding for an application for a specific ISFSI license, shall not include any issues that were previously resolved by the Commission during the approval process of the design of a spent fuel storage cask when the application incorporates by reference information on the design of an NRC-approved *spent fuel storage cask. The 8

Commission considers rereview of cask design issues that have been previously resolved as an unnecessary regulatory burden on applicants causing unnecessary expenditure of staff and hearing board resources. For example, the cask's previously reviewed and approved thermal, criticality, and structural designs could not be raised as issues in a hearing. However, design interface issues between the approved cask design and specific site characteristics {e.g.,

meteorological, seismological, radiological, and hydrological) or changes to the cask's approved design must be addressed by the applicant in its application and may be raised as issues at a potential hearing.

The proposed provisions would not limit the scope of either the staff,s review of the application, or of a licensing proceeding, for new cask design issues that were not considered by the Commission during previous approval of the cask design. In addition, the rights of: the public to petition the Commission under§§ 2.206 or 2.802 to raise new safety issues on the adequacy of the cask design would not be affected by this proposed provision.

Section 72.86 Criminal penalties.

It was proposed that paragraph {b) of this section list those Part 72 regulations for which criminal sanctions may not be issued because the Commission considers these sections to be nonsubstantive regulations issued under the provisions of§ 161 (b), 0), or {o) of the Atomic Energy Act of 1954 (AEA). Substantive regulations are those regulations that create duties, obligations, conditions, restrictions, limitations, and prohibitions (see final rule on "Clarification of Statutory Authority for Purposes of Criminal Enforcemenf (57 FR 55062; November 24, 1992)). The Commission considers that the new§ 72.13 would not be a substantive regulation, issued under the provisions of§ 161(b), (i), or (o) ,of the.AEA.

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Therefore, proposed paragraph (b) of this section added§ 72.13 to indicate that willful violations of this new section would not be subject to criminal penalties.

Section 72.140 Quality assurance requirements.

It was proposed that paragraph (c)(1) be revised to add applicants for a specific license and applicants for a Coe. Paragraph (c)(2) would be revised to add the requirement that an applicant for a specific license shall obtain NRG approval of its QA program before beginning fabrication or testing of a spent fuel ~torage cask. Paragraph (c)(3) would-be revised to indicate that an applicant for a CoC shall obtain NRG approval of its QA program before beginning fabrication or testing of a spent fuel storage cask. These proposed revisions would result in consistent treatment of general !icensees, specific licensees, applicants for a specific license, certificate holders, and applicants for a CoC. These revisions would also ensure th?t the NRG has reviewed and approved a QA program before commencement of any fabrication or testing activities.

The proposed rule included a revised paragraph (d) to clarify the use of previously approved QA programs by a licensee, applicant for a license, certificate holder, and applicant for a CoC. The Commission expects these persons to notify the NRC of their intent to use a QA program previously approved by the NRC under the provisions of Parts 50, 71, or 72.

Section 72.234 Conditions of approval. ,

The proposed rule included a revised paragraph (c) that v.,ould permit an applicant for a CoC to begin fabrication of spent fuel storage casks (under an NRG-approved QA program), at the applicant's own risk, before the NRG issues the Coe. The proposed revision also requires that a cask fabricated before the CoC was issued conform to the issued Coe before sP._ent fuel

is loaded. Consequently, the Commission expects that any risks associated with fabrication (e.g., rewelding, reinspection, or even abandonment of the cask) would be borne by the applicant Requiring an applicant to confonn a fabricated cask to the issued CoC would not be subject to the backfit review provisions of§ 72.62.

Section 72.236 Specific requirements for spent fuel storage cask approval.

The introductory text in this section before paragraph (a) was proposed as a confonning change to§ 72.234(c) to indicate that all of the requirements in this section would apply to both certificate holders and applicants for a CoC.

Summary of Public Comments on the Proposed Rule The Commission received eight comment letters on the proposed rule. The commenters included five NRC licensees, one applicant for an NRC license, one NRC Part 72 certifi_cate holder, and the Nuclear Energy Institute (NEI) representing industry. All commenters favored the proposed rule, but with the addition of some changes.

Copies of the public comments are available for review in the NRC Public Document Room, 2120 L Street, NW (Lower Level), Washington, DC 20003-1527.

A review of the comments, not necessarily in the order received, and the Commission's responses follow.

A. Clarffication of Which Sections of Part 72 Apply to Specific Licensees, General Licensees, and Certificate Holders.

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Comment A.1: One commenter, a licensee, believes that § 72. ~ 80 should not apply to a specific licensee. The commenter noted that § 72.180 requires licensees to have a physical protection plan that meets the requirements of§ 73.51. The commenter also indicated that NRC staff had previously determined that the provisions of§ 73.51 were not applicable to site-specific licensees, as in the case of the North Anna or Surry ISFSls, who also possess a Part 50 reactor license. This clarification was documented in a letter from the NRC to Virginia Power, dated November 12, 1998.

Response: The NRC agrees with the commenter that § 73.51 does not apply to those ISFSls that are collocated at an operating reactor licensee's site. This is because adequate physical protection measures are implemented through § 73.55 requirements at operating nuclear power plant sites. However, for those ISFSls that are not collocated at a nuclear power plant site, NRC believes that the requirements of§ 73.51 apply. Therefore,§ 72.13 (b) indicates that § 72.180 applies to specific ISFSI licensees. Section 72.180 requires that an ISFSI licensee implement a physical protection plan as descf'ibed in § ?3.51.

Notwithstanding this response, the NRC agrees that the commenter has identified an area of the current regulations where further clarification is warranted. In a 1998 final rule, "Physical Protection for Spent Nuclear Fuel and High-Level Radioactive Waste/' the NRC revised § 72.180 to state, in part, "The licensee shall establish, maintain, and follow a detailed plan for physical protection as described in§ 73.51 of this chapter... " (63 FR 26955; May 15, 1998). The NRC also added a new§ 73.51 that stated, in part:

(a) Applicability. Notwithstanding the provisions of§§ 73.20, 73.50, or 73.67, the physical protection requirements of this section apply to each licensee that 12

stores spent nuclear fuel and high-level radioactive waste pursuant to paragraphs (a)(1)(i), (ii), and (2) of this section. This includes-(1) Spent nuclear fuel and high-level radioactive waste stored under a specific license issued pursuant to part 72 of this chapter:

(i) At an independent spent fuel storage installation (ISFSI) or ...

However, the NRC stated in the Statement of Consideration (SOC) for the May 15, 1998, final rule, Section 11.5, second comment, "The Commission notes that a licensee having a Part 50 license does not fall within the scope of the final rule [on§ 73.51]. ... (63 FR 26957). Based on M

the language of the SOC, the NRC's practice has been that a specific Part 72 licensee, who is also a Part 50 license holder, does not have to comply with the security plan requirements of

§ 73.51.

The NRC will consider revising§ 73.51 in a subsequent rulemaking to clarify that a ISFSI licensee, who is also a Part 50 reactor licensee, may follow the security plan requirements of either§ 73.51 or§ 73.55, Comment A.2: Three commenters - a licensee, NEI, and an applicant for a license -

believe that§ 72.214 should apply to general licenses. The commenters noted that Part 72 allows general licensees to store spent fuel in containers that are approved under the provisions of Part 72 and are listed under§ 72.214. The commenters believe that ambiguity would remain in Part 72 if § 72.13 does not reference that § 72.214 can be used by general licensees.

Response: The NRC agrees with the commenters that because a general licensee must choose a spent fuel storage cask design listed under§ 72.214, applying this section to 13

general licensees will reduce regulatory confusion. Therefore,§ 72.13(c) is revised in this final rule to include§ 72.214.

Comment A.3: Three commenters - a licensee, NEI, and an applicant for a license -

believe that § 72.240(a) should apply to general licenses. Section 72.240(a) allows the user of a cask design approved by the NRC to apply for reapproval CT.e., renewal) of a cask design, as an alternative to an application for renewal by the certificate holder. Therefo_re, the commenters believe that § 72.240(a) should also apply to general licenses and be listed in § 72.13(c).

Response: The NRC agrees with the commenters that a general licensee can currently apply for reapproval of a CoC under§ 72.240(a). Therefore,§ 72.13(c) is revised in this final rule to include § 72.240(a).

Comment A.4: One commenter, a licensee, believes that§§ 72.44(b)(1) and 72.50(a) should be revised to eliminate applicability of these sections to a general license.

Sections 72.44(b)(1) and 72.50(a) both require NRC consent in writing before a license is transferred, assigned, or in any manner disposed of, either voluntarily or involuntarily, directly or indirectly. Sections 72.44(b)(1) and 72.50(a) are inconsistent with§ 72.210. Section 72.210 provides for a general license to be issued to persons authorized to possess or operate nuclear power reactors under 10 CFR Part 50. It follows that if a transfer of the license to possess or operate a nuclear power reactor is approved under§ 50.80, the general license issued under § 72.210 is also transferred without additional action.

Response: The NRC disagrees with the commenter and believes that§§ 72.44(b)(1) and 72.50(a) apply to general and specific Part 72 licensees. A Part 72 general license_issued 14

to a "person" is a separate and legally distinct authority from a Part 50 reactor license, even if issued to the same "person." NRC believes confusion arises on this issue because possession of a Part 50 license is a required condition for automatic issuance of a Part 72 general license under§ 72.210. NRC also believes that licensees can reduce their regulatory burden by submitting a single application for NRC review and approval to transfer a Part 50 license and Part 72 general license to a new owner. While this application includes two legally separate regulatory actions, NRC will consolidate the reviews and approvals to reduce industry burden.

Comment A.5: One commenter, a licensee, believes that§§ 72.44(b)(2) and 72.60(a) should be revised to eliminate applicability of these sections to a general license.

Sections 72.44(b)(2) and 72.60(a) both state that a license is subject to amendment, revision, or modification by reason of amendments to the Atomic Energy Act of 1954 (AEA), as amended, or by reason, rules, or regulations, or orders issued in accordance with the Act or any amendment thereto. Sections 72.44(b)(2) and 72.60(a) are inconsistent with§ 72.210.

Section 72.210 issues a general license to persons authorized to possess or operate nuclear power reactors under Part 50. Section 50.54(e) contains a similar requirement to that of

§§ 72.44(b){2) and 72.60(a). A general license issued by § 72.21 O is subject to amendment, revision, or modification by reason of amendments to the AEA, as amended, or by reason, rules, or regulations through § 50.54(e).

Response: The NRG disagrees with the commenter and believes that§§ 72.44(b)(2) and 72.60(a) apply to general and specific Part 72 licensees. The NRG has the authority to modify, suspend, or revoke all, or part, of the general license being used by a Part 72 licensee to receive title to, own, or store power reactor spent fuel in an ISFSI. The NRC may order this action either as an enforcement sanction taken in response to a licensee's failure to corpply 15

/ with Part 72 regulations or because of passage of legislation that amends the AEA or the Nuclear Waste Policy Act of 1982 (i.e., the statutory bases for the Part 72 regulations).

Comment A.6: One commenter, a licensee, believes that§ 72.44(b)(3) should be revised to eliminate applicability of this section to a general license. Section 72.44(b)(3) requires:

\

"Upon request of the Commission, the licensee shall, at any time before expiration of the license, submit written statements, signed under oath or affirmation, if appropriate, to enable the Commission to determine whether or not the license shou_ld be modified, suspended, or revoked." Section 72.44(b)(3) is inconsistent with§ 72.210. Section 72.210 provides for a general license to be issued to persons authorized to possess or operate nuclear power reactors under Part 50. Section 50.54(f) contains a similar requirement to that of§ 72.44(b){3). It follows that a general license issued under§ 72.210 ,is subject to providing requested information through§ 50.54(f)_

Response: The NRC disagrees with the commenter and believes that§ 72.44(b)(3) currently applies to general and specific Part 72 licensees. The NRC has the authority under the AEA to require any licensee to submit written statements to the Commission to determine if e the license should be suspended, modified, or revoked. [See also Comments A.4 and A.5.]

Comment A.7: Two commenters, both licensees, bef.tave that§ 72.44(e) should be revised to eliminate applicability of this section to a generai license. Section 72.44(e) requires:

"The licensee shall make no change that would decrease the effectiveness of the physical security plan prepared pursuant to § 72.180 without the prior approval of the

/

Commission. A licensee desiring to make such a change shall submit an appliC<!tion for 16

an amendment to the license pursuant to § 72.56. A licensee may make changes to the physical security plan without prior Commission approval, provided that such changes do not decrease the effectiveness of the plan. The licensee shall furnish to the Commission a report containing a description of each change within 2 months after the change is made, and shall maintain records of changes to the plan made without prior Commission approval for a period of 3 years from the date of the change."

Sections 72.180 and 72.56 apply only to a specific license and do not apply to a general license. Therefore, applying§ 72.44(e) to a general license is inconsistent with the remaind~r of the proposed rule. Additionally,§ 72.44(e) is inconsistent with§ 72.212(b)(5) in Subpart K which invokes the requirements of§ 73.55 and the change control requirements of

§ 50.54(p).

Response: The NRC agrees with the commenters. As stated in the proposed rule (and as discussed in Comment A.1), § 72.180 applies only to Part 72 specific licensees. Because

§ 72.44(e) refers to changes to a physical security plan prepared pursuant to§ 72.180, this paragraph cannot apply to general licensees. Therefore,§ 72.13(c) is revised in this final rule

• to exciude § 72.44(e).

Comment A.8: One commenter, a licensee, believes that § 72.44(f) should be revised to eliminate applicability of this section to a general license. Section 72.44(f) requires, in part:

"A licensee shall follow and maintain in effect an emergency plan that is approved by the Commission." Section 72.44{f) is inconsistent with§ 72.212(b)(6} in Subpart K which requires:

"Review the reactor emergency plan, quality assurance program, training program, and radiation protection program to determine if their effectiveness is decreased and, if so, prepare the necessary changes and seek and obtain the necessary approvals." Section 50.54(q) 17

conta~ns the change control requirements for the emergency plan. Section 72. 13 should be revised to eliminate applicability of § 72.44(f) to a general license.

Response: The NRG disagrees with the commenter and believes that§ 72.44(f) applies to Part 72 general and specific licensees. As stated in the proposed rule, § 72.32(c) and (d) apply to both general and specific licensees. Specifically, § 72.32(c) permits a Part 72 licensee who is located on the site, or within the exclusion area, of a nudear power reactor to use an emergency plan that meets the requirements of§ 50.47 to satisfy the requirements of

§ 72.32. The emergency plan referred to in§ 72.212(b)(6) for a general licensee originates in

§ 50.47. Consequently, there is no inconsistency between§§ 72.32 anq 72.212. Additionally, similar to Comment A.4, changes to an emergency preparedness pl~n, that affects both a collocated ISFSI and a Part 50 reactor, can be made under a single submittal to reduce industry burden. NRG will consolidate its reviews and approvals of these changes to reduce industry burden.

Comment A.9: One commenter, a licensee, believes that§ 72.52(c) should be revised .

to eliminate applicability of this section to a general license. Section 72.52{c) states: "Any Creditor so secured may apply for transfer of the license covering spent fuel by filing an_

application for transfer of the license pursuant to § 72.S0(b). The ~ommission will act upon the application pursuant to§ 72.S0(c)." Section 72.50{b) and (c) are designated in§ 72.13 as applying only to a specific license and not applying to a general license. Therefore. applying

§ 72.52(c) to a general license is inconsistent with the remainder .._.,f the proposed rule.

Additionally, § 72.21 0 issues a general license to persons authorized 10 possess or operate nuclear power reactors under Part'50. If a transfer of the license ta possess or operate a nuclear power reactor is approved under Part 50, the general license issued by§ 72.21.9 is 18

also transferred without additional action. Section 72.13 should be revised to eliminate applicability of§ 72.52(c) to a general license.

Response: The NRC agrees with the commenter. As stated in the proposed rule,

§ 72.50{b) applies only to Part 72 specific licensees. Because§ 72.52(c) refers to a creditor applyjng for transfer of a license pursuant to§ 72.S0(b), applying § 72.52(c) to general licensees would be inconsistent with the remainder of the proposed rule. Therefore, § 72.13(c) is revised in this final rule to exclude § 72.52(c) .

• Comment A.10: One commenter, a licensee, believes that§ 72.54(f) through (m) should be revised to eliminate applicability of this section to a general license. Section 72.54(d) through (m) is designated as applying to a general license. Applying any of§ 72.54, "Expiration and termination of licenses and decommissioning of sites and separate buildings or outdoor areas," to a general license is inconsistent with existing Subpart K requirements in

§ -72.218, "Termination of licenses." Section 72.218 relies upon requirements contained in Part 50 which are adequate to ensure that spent fuel is disposed of properly and that decommissioning is completed so that the license cnay be terminated.

Response: The NRC agrees with the commenter. Section 72.218(a) requires that a general licensee shall notify the NRC of the licensee's program for management and removal of spent fuel in accordance with§ 50.54(bb). The timing of the notification required by

§ 50.54(bb} is different from that required by§ 72.54(d). Because a general licensee cannot be required to comply with two differing requirements on the same subject and § 72.218 is specifically directed to general licensees, the NRC agrees that§ 72.54(d) through (m) do not apply to a general licensee. Therefore,§ 72.13(c) is revised in this final rule to exclude

§ 72.54(d) through (m).

19

'i Comment A.11: One commenter, a licensee, believes that § 72.60(b) should be revised to eliminate applicability of this section to a general license. Section 72.60(b) enumerates reasons that a license may be modified, revoked, or suspended in whole, or in

' part. Section 72.60(b) is 'inconsistent with§ 72.210. Section 72.210 issues a general license to persons authorized to possess or operate nuclear power reactors under Part 50.

Section 50.100 requirements are similar to those of§ 72.60(b). Section 72.13 should be revised to eliminate applicability of§ 72.60(b) to a general license.

Response: The NRC disagrees with the commenter and believes that§ 72.60(b) applies to general and specific Part 72 licensees. The NRC has the authority under the AEA to modify, suspend, or revoke all, or part, of the general license being used by a Part 72 licensee to receive; transfer, or possess power reactor spent fuel. The purpose of this authority is the same as described in Comment A.5.

Comment A.12: One commenter, a licensee, believes that§ 72.60(c) should be revised to eliminate applicability of this section to a general license. Section 72.60(c) states, in part:

"Upon revocation of a license, the Commission may immediately cause the retaking of possession of all special nuclear material contained in spent fuel held by the licensee."

Section 72.60(c) is inconsistent with§ 72.210. Section 72.210 issues a general license to persons authorized to possess or operate nuclear power reactors under Part 50.

Section 50.101 requirements are similar to those of§ 72.60(c).

Response: The NRC di$agrees with the commenter and believes that§ 72.60(c) applies to general and specific Part 72 licensees. Associated with the NRC authority under the AEA to modify, suspend, or revoke all, or part, of the general license is the authority to order the recapture of any special nuclear material contained in spent fuel possessed by a ,ge_neral 20

licensee. The Commission may take such action in cases of extreme importance to the national defense and security or to the health and safety of the public. (See also Comments A.5 and A.11.)

Comment A.13: One commenter, a licensee, believes that§ 72.S0(f) should be revised to eliminate applicability of this section to a general license. Section 72.B0(f) states:

"If licensed activities are transferred or assigned in accordance with§ 72.44(b)(1), the licensee shall transfer the records required by§§ 20.2103(b)(4) and 72.30(d) to the new licensee and the new licensee will be responsible for maintaining these records until the license is terminated. D Section 72.B0(f) is inconsistent with § 72.210. Section 72.210 issues a general license to persons authorized to possess or operate nuclear power reactors under Part 50. If a transfer of the license to possess or operate a nuclear power reactor is approved under

§ 50.80, the general license issued by§ 72.210 is also transferred without additional action.

Section 50. 71 requires that records be retained until the facility license is terminated unless otherwise specified .

• Response: The NRC disagrees with the commenter and believes that§ 72.B0(f) applies to general and specific Part 72 licensees. As stated in the proposed rule (and as discussed in Comment A.4), §§ 72.44(b)(1) and 72.30(d) apply to both general and specific Part 72 licensees. Therefore, a general licensee can comply with the requirements to transfer required records to the new licensee.

Comment A.14: One commenter, a certificate holder, believes that§ 72.62 should be revised to apply to certificate holders. Section 72.62 provides specific criteria to be met if the Commission is to require the backfitting of changes to structures, systems. and compon~nts of 21

an ISFSI or changes to the procedures or organization required to operate an ISFSI.

Section 72.13' excludes the applicability of§ 72.62 to certificate holders. The commenter believes that without backfit protection, certificate holders .are subject to new requirements that may provide little safety benefit or are excessively costly to implement.

Response: The NRC believes this comment is beyond the scope of the proposed rule.

As discussed in Comr11ent A.1, § 72.13 only clarified which sections of Part 72 apply to specific licensees, general licensees, and certificate holders; it did not change the current scope or intent of these individual sections. The current language in § 72.62 only refers to Part 72 licensees 0.e., specific and general licensees). Consequently, revising§ 72.13 to indicate that

§ 72.62 applies to certificate holders would also require adding certificate holders to the language of§ 72.62.

Comment A.15: One commenter, a licensee, believes that§ 72.44(d) should not apply to general licensees. Section 72.44(d) states in part, "[e]ach license authorizing in the receipt, handling, and storage of spent fuel or high-level radioactive.waste under this part must include technical specifications ... " The commenter believes that the technical specifications are a component of a Part 72 ISFSI specific license or a Part 72 CoC; however, they are not part of a Part 72 ISFSI general license. The commenter noted that in issuing the general license provisions in Subpart K (55 FR 29181; July 18, 1990), the NRC did not require submission of an application to receive a general license. Therefore, technical specifications, that are to be submitted as part of a license application, cannot be part of a general ticense.

Response: The NRC agrees with the commenter. The Part 72, Subpart K general license is issued in accordance with the provisions of§ 72.210. Section 72.210 does not contain any technical specifications; however, "license conditions" for this general licens~ are 22

contained in§ 72.212. Specifically, § 72.212(b)(7) states, in part, "[t)he licensee shall comply with the tenns and conditions of the certificate.* The CoC for a cask design contains technical specifications for its use. Consequently, a general licensee is required to comply with the CoC's technical specifications associated with the cask design it is using, rather than submitting separate technical specifications under§ 72.44(d). Therefore,§ 72.13(c) is revised in the final rule to exclude § 72.44(d).

• Comment A.16: One commenter, a licensee, believes that§ 72.192 should not apply to general licensees. Section 72.192 states that, "[t]he applicant for a license under this part shall establish a program for training, proficiency testing, and certification of ISFSI or MRS personnel. This program must be submitted to the Commission for approval with the license application." The commenter noted that§ 72.S(a) indicates that a general license is effective without the filing of an application to the Commission [emphasis original]. Therefore, the commenter believes that applying§ 72.192 to a general license creates conflicting regulations.

Response: The NRC agrees with the commenter that a general licensee is not required

\

to submit an application. Consequently, a* general licensee would not have to submit a training program for NRG approval "with the license application." Therefore,§ 72.13(c) is revised in the final rule to exclude § 72.192.

B. Eliminate Repetitive Reviews of Cask Design Issues in Licensing Proceedings on Applications for Specific Part 72 Licenses Which Reference NRG-Approved Quality Assurance Programs Before Issuance of a CoC.

23

COMMENT 8.1: Three commenters, a licensee, NEI, and an applicant for a license, support avoiding repetitive reviews of cask design issues in a Part 72 specific license hearing where the previously-approved cask design has been incorporated by reference into the application. However, the commenters believe that this aspect of the proposed rulemaking should be clarified. The commenters indicated that, as written,§ 72.46(e) could be read to i

preclude repetitive reviews only where the CoC had already been issued (i.e., "cask design issues previously addressed by the Commission when it issued the CoCH) [emphasis original].

The commenters indicated that there will be cases where the site-specific license proceeding and the Coe review are proceeding in parallel. Because the site-specific license cannot be issued until the CoC for the design referenced in the site-specific application has also been issued, there are no safety issues involved with eliminating repetitive cask design reviews in the site-specific licensing proceeding. These safety issues can still be raised in the CoC review process. Those issues need not be repetitively reviewed and resolved in the parallel site-specific licensing proceeding. The commenters believe that allowing .those issues to be raised in both of these proceedings would create the specter of inconsistent results as well as duplicative and wasteful use of resources by the NRC staff and applicants. The commenters also stated that, u[t]he NRC's CoC review will encompass all safety issues which the Commission, in its expert judgment, determines are needed to adequately protect public health and safety."

The commente~ argued that UD]t is a basic principle of administrative law that an agency's choice to proceed by rulemaking or by case specific adjudication is within the agency's discretion." Furthermore, u[d]eferring consideration of issues from site-specific

~icensing] proceedings to a generic proceeding [i.e., rulemaking] is well established in NRC and judicial case law. This is the case even when the generic proceedings are still in prs,gress.

24

Commission decisions have long held that 'licensing boards should not accept in individual license proceedings contentions which are (or are about to become) the subject of general rulemaking by the Commission."' Therefore, the commenters concluded that "[ijogic, NRC pre~ent, and federal case law all suggest that cask design issues should not be reviewed in site-specific proceedings whether the Coe is issued prior to, during, or &fter the site-specific

~icensing] proceeding.*

Response: The NRC agrees with the commenters that NRC precedent and Federal

• case law identified by the commenter support the position that cask design issues should not be reviewed in a site-specific licensing proceeding whether the CoC is issued before, during, or after the site-specific licensing proceeding. The NRC agrees that cask design issues can be adequately raised by the public in the context of the Part 72 rulemaking process approving the design and that the NRC staff can still adequately review, evaluate, and disposition any such issues during this process. As stated in the proposed rule, the opportunity of the public to comment on cask designs will not be affected by this rulemaking. However, design interface issues between the referenced cask design and specific site characteristics {e.g.,

• meteorological, seismological, radiological, and hydrological), or changes to the cask's approved design, must be addressed by the applicant in its application and may be raised as potential issues at a licensing proceeding. Therefore, in the final rule, § 72.46(e) has been I,

revised to read as suggested by the commenter.

Finally, the NRC agrees with the commenters that if an applicant chooses to incorporate by reference in its application for a specific license a cask design that has not yet been approved by the NRC, then the NRC will not issue the specific Hcense to the applicant-assuming that all other NRC review and approval actions have been completed- until after 25

the referenced cask design has been added to the list of approved cask designs contained§ 72.214.

Comment 8.2: Three commenters, a licensee, NEI, and an applicant for a license, I

while agreeing with the proposed§ 72.46(e) also indicated that the NRC should clarify in the Statements of Consideration for the final rule the process for requesting changes to an approved cask design. The commenters believe that if a cask design issue was, in fact, not addressed in connection with the issuance of the CoC, the proper mechanism to raise that cask design issue after the CoC was issued would be to file either a request for action with the Commission pursuant to § 2.206, or a petition to amend the rule adopting the CoC pursuant to

§ 2.802. Alternatively, an attempt to raise a cask design issue involving a cask which had 1

received a CoC, in a site-specific proceeding, could be made subject to§ 2.758, which establishes the process for handling challenges to the NRC regulations in individual licensing proceedings.

Response: The NRC agrees with the commenters that for a cask design currently under NRC review, individuals who wish to raise issues on the cask design may do so during the review process or by commenting on the cask design when the proposed rule to approve the

• design is published for public comment in the Federal Register. After a cask design is approved by rulemaking, individuals who wish to raise new issues should do so via the petition provision contained in either§ 2.206 or§ 2.802. Finally, the NRC also agrees that individuals may challenge NRC regulations in an individual licensing proceeding under the provisions of

§ 2.758.

C. Permitting CoC Applicants to Begin Fabrication Under an NRG-approved QA Program Before Issuance of the Coe.

26

COMMENT: Two commenters, NEI and an appli~nt for a license, supported allowing applicants for a CoC to begin cask fabrication before issuance of a CoC, if fabrication is done under an NRG-approved quality assurance program. The commenters believe that the practice of fabrication in advance of issuance of a CoC results in no increase in risk to the public, because an applicant cannot load casks that do not conform to the issued Coe. The commenters further recognized that this practice places the applicant at economic risk if the CoC contains changes not considered at the time the cask was fabricated.

RESPONSE: No response required.

Summary of Final Amendments to the Proposed Rule In§ 72.13, paragraphs (a), (b), and (d) remain unchanged from the proposed rule amendments. Paragraph (c) is changed to incorporate§§ 72.214, 72.240(a) and to exclude

§§ 72.44(d) and (e), 72.52(c}, 72.54(d) through (m), and 72.192, and is revised to read as follows:

• (c) The following sections apply to activities associated with a general license: §§ 72.1; 72.2(a}(1), (b), (c), and (e); 72.3 through 72.6(c)(1); 72.7 through 72.13(a} and (c); 72.30(c) and (d); 72.32(c) and (d); 72.44(b) and (f); 72.48; 72.S0(a); 72.52(a), {b), (d), and (e); 72.60; 72.62; 72.72 through 72.80(f); 72.82 through 72.86; 72.104; 72.106, 72.122; 72.124; 72.126; 72.140 through 72.176; 72.190; 72.194; 72.210 through 72.220. and 72.240(a).

In § 72.46, paragraph (e) is revised to read as follows:

(e) If an application for (or an amendment to) a specific license issued under this part incorporates by reference information on the design of a spent fuel storage cask for which 27

NRC approval pursuant to subpart L of this part has been issued or is b:3ing sought, the scope of any public hearing held to consider the application will not include any cask design issues.

Sections 72.86, 72.140, 72.234, and 72.236, remain unchanged from the proposed rule amendments.

Criminal Penalties For the purposes of Section 223 of the Atomic Energy Act (AEA), the Commission is issuing the final rule to amend 10 CFR 72.140, 72.234, and 72.236 under one or more of Sections 161b, 161i, or 1610 of the AEA. Willful violations of the rule would be subject to criminal enforcement.

Agreement State Compatibility Under the "Policy Statement on Adequacy and Compatibility of Agreement State Programs" approved by the Commission on June 30, 1997, and published in the Federal Register on September 3, 1997 (62 FR 46517), this final rule is classified as Category NRC.

Compatibility is not required for Category NRC regulations. The NRC program elements in this category are those that relate directly to areas of regulation reserved to the NRC by the AEA or the provisions of Title 10 of the Code of Federal Regulations.

28

Voluntary Consensus Standards The National Technology Transfer Act of 1995 (Pub. L 104-113) requires that Federal agencies use technical standards that are developed or adopted by voluntary consensus standards bodies unless the use of such a standard is inconsistent with applicable law or otherwise impractical. The NRG is amending its regulations on spent fuel storage in those sections of 10 CFR Part 72 that apply to general licensees, specific licensees, applicants for a specific license, certificate holders, and applicants for a certificate. This final rule eliminates the necessity for repetitious Part 72 specific licensing proceeding reviews of cask design issues that the Commission previously considered, or is considering, and resolved during approval of the cask design.

• This final rule also allows an applicant for a CoC to begin cask fabrication at its risk before the CoC is issued. This action does not constitute the establishment of a standard that establishes generally applicable requirements.

Environmental Impact: Categorical Exclusion

• The NRC has determined that this final rule is the type of action described in the categorical exclusion in 10 CFR 51.22(c)(2) and (3). This action represents amendments to the regulations which are corrective or of a minor or nonpolicy nature and do not substantially modify the existing regulations. Therefore, neither an environmental impact statement nor an environmental assessment has been prepared for this final rule.

29

Paperwork Reduction Act Statement This final rule would decrease the burden on licensees by eliminating the requirement to request an exemption to begin cask design before a license is issued, and by allowing all licensees and CoC holders to reference previously~approved QA programs. The public burden reduction for this information collection would average 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> per exemption request However, because no burden has previously been approved for exemption requests and no licensees are expected to reference previously approved QA programs in the foreseeable Mure, no burden reduction can be taken for this rulemakmg. Existing requirements were approved by the Office of Management and Budget, approval number 3150-0132.

Public Protection Notification If a means used to impose an information collection does not display a currently valid 0MB control number, the NRC may not conduct or sponsor, and a person is not required to

• respond to, the information collection.

30

Regulatory Analysis Statement of the Problem and Objective:

The Commission's regulations at 10 CFR Part 72 were originally designed to provide specific licenses for the storage of spent nuclear fuel in ISFSls (45 FR 74693; November 12, 1980). In 1990, the Commission amended Part 72 to include a process for approving the design of spent fuel storage casks and issuance of a CoC (Subpart L); and for granting a

• general license to reactor licensees (Subpart K) to use NRC-approved casks for storage of spent nuclear fuel (55 FR 29181; July 17, 1990). Although the Commission intended that the requirements imposed in Subpart K for general licensees be used in addition to, rather than in lieu of, appropriate existing requirements, ambiguity exists as to which of the Part 72 requirements, other than those in Subpart K, are applicable to general licensees and certificate holders, r:espectively. This final rule will resolve that ambiguity.

In addition, the Commission has identified two aspects of Part 72 where it would be desirable to reduce the regulatory burden for applicants, NRC staff, and hearing boards and to .

afford additional flexibility to applicants for a specific license or CoC.

First, this final rule will eliminate the necessity for repetitious reviews of cask design issues in a Part 72 specific licensing proceeding (§ 72.46), where the previously-approved cask design has been incorporated by reference into the application. In addition, repetitive reviews will also be eliminated in those cases where the site-specific licensing proceeding and CoC review are proceeding in parallel. The Commission anticipates receipt of several applications, for specific ISFSI licenses, that will propose using storage cask designs previously approved by the NRC. Applicants for a specific license presently have the authority under§ 72.18 to incorporate by reference into their application, information contained in_

31

previous applications, statements, or reports filed with the Commission, including information from the Safety Analysis Report for a cask design previously approved by the NRC under the provisions of Subpart L. The Commission believes previously-reviewed cask design issues should be excluded from the scope of a license proceeding. This is because the public had the right to question the adequacy of the cask design, during the approval process under Subpart L. The right of the public to comment on cask designs would not be affected by this rulemaking. For new cask design issues, this rulemaking would not limit the scope of the staff's review of the application or 9f license hearings. For example, a cask's previously-reviewed and-approved thermal, criticality, and structural designs could not be raised as issues in a hearing. However, design interface issues between the approved cask design and specific site characteristics (e.g., meteorological, seismological, radiological, and hydrological) or changes to the cask's approved design must be addressed by the applicant in its application and may be raised as issues at a potential hearing. In addition, for the situation previously

• mentioned, where the CoC review is proceeding in parallel with the site-specific license -

proceeding, there is no safety issue involved with eliminating repetitive cask design reviews, since the site-specific license cannot be issued until the CoC for the design referenced in the site-specific application has also been issued. Allowing those issues to be raised in both the licensing proceeding and CoC review process could create the specter of inconsistent results as well as duplicative and wasteful use of resources by the NRC staff and applicants.

Furthermore, the NRC's CoC review will encompass all safety issues which the Commission determines are needed to adequately protect public health and safety. Deferring consideration of these issues from site-specific proceedings to a generic proceeding is well established in NRC precedent and Federal case law which suggests that cask design issues should not be 32

reviewed in site-specific proceedings regardless whether the CoC is issued before, during, or after the site-specific licensing proceeding.

The NRC notes that, for a cask design currently under NRC review, individuals who wish to raise issues on the cask design may do so during the review process or by commenting on the cask design when the proposed rule to approve the:: design is published for public comment in the Federal Register. After a cask design is approved by rulemaking, individuals who wish to raise new issues should do so via the petition provision contained in either§§ 2.206 or 2.802. Individuals who wish to challenge NRC regulations in an individual licensing proceeding can do so under the provisions of § 2. 758.

Second, the final rule permits an applicant for approval of a spent fuel storage cask design under Subpart L to begin fabrication of casks before the NRC has approved the cask design and issued the CoC. Currently, an applicant for a CoC is not permitted under

§ 72.234(c) to begin cask fabrication until after the CoC is issued. Applicants for a specific license, and their contractors, are currently allowed to begin fabrication of casks before the Commission issues their license. However, general licensees and their contractors (i.e, the ti certificate holder) are not allowed to begin fabrication before the CoC is issued. Consequently, this final rule would eliminate NRC's disparate treatment betyveen general and specific licensees. _The Commission and the staff have previously determined that exemptions from the fabrication prohibition are authorized by law and do not endanger life or property, the common defense or security, and are otherwise in the public interest The Commission anticipates that additional cask designs will be submitted to the NRC for approval and expects that these designs will be similar in nature to those cask designs that have already been approved. Jhe Commission also expects that exemption requests to permit fabrication would 33.

also be received. Therefore, this rulemaking would eliminate the need for such exemption requests.

This final rule also revises the QA regulations in Subpart G of Part 72 to require that an applicant for a CoC, who voluntarily wishes to begin cask fabrication before issuance of the cask CoC, m1...st conduct cask fabrication under an NRG-approved QA program. Currently, applicants for a CoC are required by§ 72.234(b) to conduct design, fabrication, testing, and maintenance activities under a QA program that meets the requirements of Subpart G. Prior NRC approval of the applicant's QA program is not required by§ 72.234(b). However,

§ 72.234(c) precludes cask fabrication until after the Coe is issued. The Commission believes this final rule is a conditional relaxation to permit fabrication before the CoC is issued.

Because NRC staff would approve the applicant's QA program as part of the issuance of a CoC, staff approval of the QA program before fabrication is a question of timing (i.e., when the program is approved, as opposed to imposing a new requirement for approval of a program).

The Commission *expects that any financial or schedule risks associated with fabrication of casks before issuance of the CoC would be borne by the applicant The Commission believes that the final rule is not a backfit because § 72.62 applies to licensees after the license is issued and does not apply to applicants before issuance of the license or CoC. This rule requires that a cask, for which fabrication was initiated before issuance of the CoC, must conform to the issued CoC before it may be used.

This final rule also requires an applicant for a specific license, who voluntarily wishes to begin fabrication of casks before the license is issued, to conduct fabricati<;>n under an NRC-approved QA program. Currently, an applicant for a specific license is required by§ 72.140(c) to obtain NRC approval of its QA program before spent fuel is loaded into the ISFSI. The 34

Commission does not believe this final rule will impose a separate requirement, rather it would require different timing on when the QA program is approved.

This final rule also revises§ 72.140(d) to allow a licensee, applicant for a license, certificate holder, and applicant for a Coe to use an existing Part 50, 71, or 72 QA program that was previously approved by the NRC.

As a result of this final rule, both licensees and certificate holders are required to accomplish any fabrication activities under an NRC.approved QA program. The Commission believes this final rule's increase in flexibility and change in timing of approval of a QA program are not a backfit.

_The Commission expects that any risks associated with fabrication (e.g., rewelding, reinspection, or even abandonment of the cask} would be borne by the applicant. In particular, the NRC will require that a cask fabricated before the CoC was issued conform with the issued CoC before spent fuel is loaded in the cask. Requiring an applicant to conform a fabricated cask to the issued CoC would not be subject to the backfit review provisions of § 72.62.

Identification and Analysis of Alternative Approaches to the Problem:

• Option 1 - Conduct a rulemaking that would address the regulatory problems as described above.

First, this final rulemaking specifies the sections in Part 72 that apply to genenl licensees, specific licensees, applicants for a specific license, certificate holders, and applicants for a CoC. This eliminates the need to resolve, on a case-by-case basis, 35

s questions on which Part 72 sections are applicable to those activities. The final rule is administrative in nature and, other than the cost of rulemaking, would have no impact Second, this rulemaking reduces the regulatory burden on applicants, staff, and hearing board resources relating to any § 72.46 licensing proceedings involving cask design issues associated with an application for a specific license, where the cask design has been previously approved by the NRC or is currently under review.

Elimination of the need for repetitious reviews of cask design issues and licensing hearings on these same cask design issues together would save 1.0 FTE of applicant effort and 0.1 FTE of staff effort for each specific license application received. NRC expects to review two applications in 2000, three applications in 2001, and four applications each in 2002 and 2003. While applicants for a license are currently allowed to incorporate by reference information on cask design information, this rulemaking reduces applicant burden associated with providing additional information on the cask design and responding to licensing board contentions on issues which have been previously reviewed and resolved.

Third, this rulemaking also provides increased flexibility to applicants for a CoC by allowing them to begin cask fabrication, before the CoC is issued. This rulemaking reduces the burden on applicants for a Coe associated with submission of requests for exemption from§ 72.234(c). Certificate holders have requested these exemptions to take advantage of favorable business conditions o.e., they want to begin fabrication of casks as soon as possible to meet their contract obligations). Elimination of the '1eed for submission and rev.iew of exemption requests from the cask fabrication requirement of§ 72.234(c) will save 0.1 FTE of applicant effort and 0.1 FTE of staff effort, for each exemption request not received, Without this action, NRC expects that two requ~sts 36

for exemption from § 72.234(c) will be received each year in 2000 and beyond. This rulemaking also eliminates the disparate treatment of general and specific licensees under Part 72, with respect to fabrication of spent fuel storage casks. This rulemaking also reduces staff burden associated with review of such exemption requests.

Because a certificate holder is currently required by§ 72.140(c)(3) to obtain NRC approval of its QA program before commencing fabrication, and the staff is currently required to review and approve these programs, no increase in applicant burden or staff resources will occur with respect to the final change to § 72.140(c)(3). However, the timing of the staff review and approval of the QA program would change.

The impact of this option consists primarily of a reduction in regulatory burden on an applicant for a specific license, a reduction in regulatory burden and increa.se in regulatory flexibility for an applicant for a cask design, and a reduction in the expenditure of NRC resources involved in reviewing applications for a specific license, supporting license hearings, and reviewing .requests for exemption from § 72.234(c).

This option will result in the expenditure of NRC resources to conduct this rulemaking.

• Option 2- No action.

The benefit of the no action alternative is that NRC resources will be conserved because no rulemaking will be conducted. The impact of this alternative is that the regulatory problems de~cribed above would not be addressed. Instead, applicant and staff resources will continue to be expended on repetitious reviews of previously-approved cask designs, conducting licensing hearings on previously-approved cask 37

design issues, and processing requests for exemption from§ 72.234(c), to allow fabrication of casks.

Estimation and Evaluation of Values and Impacts:

The clarification of which Part 72 sections apply ,to specific licensees, applicants for a

• specific license, general licensees, certificate holders, and applicants for a CoC alone will have no impact other than the cost of rulemaking, because this action is administrative in nature.

The elimination of repetitious reviews of cask design issues in a Part 72 specific license proceeding (§ 72.46) and parallel CoC reviews will save 1.0 FTE of applicant effort and 0.1 FTE of staff effort for each license application received. NRC expects to review two applications in 2000, three applications in 2001, and four applications each in 2002 and 2003.

The elimination of the need for submission and review of exemption requests from the cask fabrication requirement of§ 72.234(c) will save 0.1 FTE of applicant effort and 0.1 FTE of staff effort, for each exemption request not received. Wrthout this action, NRC expects that two requests for exemption from§ 72.234(c) will be received each year in 2000 and beyond.

Presentation of Results:

The recommended action is to adopt the first option because it will set forth a clear regulatory base f_or Part 72 general licensees, specific licensees, applicants for a specific license, certificate holders, and applicants for a CoC.

The recommended action will eliminate the need for repetitious licensing proceeding adjudication of cask design issues that the Commission has previously reviewed in approving the cask design, or is currently reviewing, when an applicant for a specific license has incorporated by reference a cask design that has been approved, or is under review, by_ the 38

Commission under the provisions of Subpart L. This is because the public has the right to question the adequacy of the cask design during the approval process under Subpart L. The right of the public to comment on cask designs will not be affected by this rulemaking. This final rule also eliminates repetitive reviews in those cases where the site-specific licensing proceeding and CoC review are proceeding in parallel. In addition, the rights of the public to*

petition the Commission under§§ 2.206 and 2.802 to raise new safety issues on the adequacy of the cask design would not be affected by this rulemaking. The Commission considers rereview of cask design issues which have been previously evaluated and dispositioned as an unnecessary regulatory burden on applicants and an unnecessary expenditure of staff and hearing board resources. For example, the cask's previously-reviewed and -approved thermal, criticality, and structural designs could not be raised as issues in a hearing. However, design interface issues between the approved cask design and specific site characteristics (e.g.,

meteorological, seismological, radiological, and hydrological) or changes to the cask's approved design must be addressed by the applicant in its application and may be raised as issues at a potential hearing. Therefore, this action has no safety impact.

- The recommended action will permit an applicant for approval of a spent fuel storage cask design under Subpart L to begin fabrication of casks before the NRC has approved the cask design and issued the CoC. Currently, an applicant for a CoC is not permitted under

§ 72.234(c) to begin cask fabrication until after the CoC is issued. Applicants for a specific license, and their contractors, are currently allowed to begin fabrication of casks before the Commission issues their license. However, general licensees and their contractors (i.e, the certificate holder) are not allowed to begin fabrication before the CoC is issued. Consequently, this final rule will eliminate NRC's disparate treatment between general and specific licensees.

In addition to allowing an applicant for a CoC to begin fabrication of a cask before issu~nce of 39

the CoC, comments would be requested on the need for a general licensee to also begin fabrication of a cask before the Coe is issued. The Commission and the, staff have previously determined that exemptions from the fabrication prohibition are authorized by law and do not endanger life or property, the common defense or security, and are otherwise in the public interest. The Commission anticipates that additional cask designs will be submitted to the NRC for approval and expects that these designs will be similar in nature to those cask designs that have already been approved. The Commission also expects that exemption requests to permit fabrication will also be received. Therefore, this rulemaking will eliminate the need for such exemption requests.

This final rule is revising the QA regulations in Subpart G of Part ~2 to require that an applicant for a CoC, who voluntarily wishes to begin cask fabrication, must conduct cask fabrication under an NRG-approved QA program. Currently, applicants for a CoC are required by§ 72.234(b) to conduct design, fabrication, testing, and maintenance activities under a QA program that meets the requirements of Subpart G. Prior NRC approval of the applicant's QA program is not required by§ 72.234(b). However,§ 72.234(c) precludes cask fabrication until _

after the CoC is issued. The Commission believes this final rule is a conditional relaxation to 9 permit fabrication before the CoC is issued. Because NRC staff will approve the applicant's QA program as part of issuance of a CoC, staff approval of the QA program before fabrication is a question of timing (i.e., when the program is approved. as opposed to imposing a new requirement for approval of a program). The Commission expects that any financial or scheduler risks associated with fabrication of casks before issuance of the CoC will be borne by the applicant. The Commission believes that the final rule is not a backfit because § 72.62 applies to licensees after the license is issued and does not apply to applicants before

\

40

issuance of the license or CoC. This rule requires that a cask, for which fabrication was initiated before issuance of the CoC, must conform to the issued CoC before it may be used.

This final rule requires an applicant for a specific license, who voluntarily wishes to begin fabrication of casks before the license is issued, to conduct fabrication under an NRG-approved QA program. Currently, an applicant for a specific license is ,*equired by§ 72.140(c) to obtain NRG approval of its QA program before spent fuel is loaded into the ISFSI. The Commission does not believe this final rule will impose a separate requirement, rather it will require different timing on when the QA program is approved.

This final rule also revises§ 72.140(d) to allow a licensee, applicant for a license, certificate holder, and applicant for a Coe to use an existing Part 50, 71, or 72 QA program that was previously approved by the NRG. In addition, the C9mmission expects that any existing QA program which is used by these persons, in lieu of submitting a new Part 72 QA program, will fully comply with the requirements of Part 72, Subpart G.

As a result of this final rule, both licensees and certificate holders are required to conduct any fabrication activities under an NRG-approved QA program. The Commission

- believes this final rule's increase in flexibility and change in timing of approval of a QA program is not a back.fit.

The Commission expects that any risks associated with fabrication (e.g., rewelding, reinspection, or even abandonment of the cask) will be borne by the applicant. In particular, the NRC will require that a cask fabricated before the CoC was issued conform with the issued Coe. Requiring an applicant to conform a fabricated cask to the issued Coe will not be subject to the backfit review provisions of § 72.62.

The total cost of this rulemaking to the NRC is estimated at 1.9 FTE. The total savings to the NRG for this rulemaking is estimated at 1.3 FTE over a 4-year period (2000 thro~gh 41

2003). The total savings to applicants is estimated at 13.0 FTE over a 4-year period.

Therefore, this action is considered to be cost beneficial to applicants and will improve the efficiency and effectiveness of the NRG. Consequently, the Commission believes public confidence in the safe storage of spent fuel at independent spent fuel storage installations will not be adversely affected by this rulemaking.

Decision Rationale:

The rationale is to proceed with this final rulemaking. This rulemak.ing will save both staff and applicant resources as discussed above.

The clarification of the provisions of Part 72 and their application to general licensees, specific licensees, applicants for a specific license, certificate holders, and applicants for a CoC is administrative in nature and has no safety impacts.

The elimination of the need for repetitious license hearings on cask design issues, that the NRG has previously reviewed, or is currently reviewing, and approved in an application for a ~oC, induding those instances where the site-specific licensing proceeding and Coe review .

are proceeding in parallel, will have no safety impacts. The public's right to comment on cask 9 design issues, through the Subpart L cask approval process, will remain unchanged.

The flexibility to begin cask fabrication before the NRG issues the CoC, when combined with the requ!rement that cask fabrication must be performed unde/an NRG-approved QA program, will have no safety impacts.

42

Regulatory Flexibility Certification As required by the Regulatory Flexibility Act (5 U.S.C. 605(b)), the Commission certifies that this final rule will not have a significant economic impact on a substantial number of small entities. This final rule clearly specifies which sections of Part 72 apply to general licensees, specific licensees, applicants for a specific license, certificate holders, and applicants for a certificate and allows these persons to determine which Part 72 regulations apply to their activity. This clarification eliminates the ambiguity that now exists. This final rule also eliminates repetitious licensing proceeding reviews of cask design issues, that were under review, or previously reviewed and approved by the NRC, when the applicant for a specific license incorporates by reference information on a cask design that was previously approved, or under review, by the NRC. Finally, this final rule allows applicants for a CoC to begin fabrication of a cask design before the NRC has issued a CoC. Applicants desiring to begin fabrication shall use an NRC-approval QA program. The requirement to obtain NRC approval of the applicant's QA program is not considered an additional burden. An applicant who has

- been issued a CoC, and is then considered a certificate holder, is currently required by

§ 72.140(c)(3) to obtain NRC approval of its QA program before fabrication or testing is commenced; consequently, no actual increase in burden occurs. Similarly, an applicant for a specific license is currently required by§ 72.140(c)(2) to obtain NRC approval of its QA program before receipt of spent fuel or high-level waste; consequently, no actual increase in burden occurs. This final rule does not impose any additional obligations on entities that mav fall within the definition of "small entities* as set forth in Section 601 (6) of the Regulatory Flexibility Act; or within the definition of "small business* as found in Section 3 of the Small 43

Business Act, 15 U.S.C. 632; or within the size standards adopted by the NRC on April 11,1985 (60 FR 18344).

Small Business Regulatory Enforcement Fairness Act In accordance with the Small Business Regulatory Enforcement Fairness Act of 1996, the NRC has determined that this action is not "a major" rule and has verified this determination with the Office of Information and Regulatory Affairs, Office of Management and Budget Backfit Analysis The NRC has determined that the back.fit rule, § 72.62, does not apply to this final rule.

Because these amendments do not involve any provisions that would impose back.fits as defined in§ 72.62(a}, a back.fit analysis is not required.

List of Subjects in 10 CFR Part 72 Criminal penalties, Manpower training programs, Nuclear materials, Occupational safety and health, Reporting and recordkeeping requirements, Security measures, Spent fuel.

For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974, as amended, and 5 U.S.C. 552 and 553, the NRC is adopting the following amendments to 10 CFR ~ar!_ 72.

44

PART 72 - LICENSING REQUIREMENTS FOR THE INDEPENDENT STORAGE OF SPENT NUCLEAR FUEL AND HIGH-LEVEL RADIOACTIVE WASTE

1. The authority citation for Part 72 continues to read as follows:

AUTHORITY: Secs. 51, 53, 57, 62, 63, 65, 69, 81, 161, 182, 183, 184, 186, 187, 189, 68 Stat. 929, 930, 932, 934, 935, 948, 953, 954, 955, as amended, sec. 234, 83 Stat. 444, as amended(42U.S.C. 2071, 2073,2077, 2092, 2093, 2095, 2099, 2111, 2201,2232,2233, 2234, 2236, 2237, 2238, 2282); sec. 274, Pub. L.86-373, 73 Stal 688, as amended (42 U.S.C. 2021); sec. 201, as amended, 202, 206, 88 Stal 1242, as amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846); Pub. L.95-601, sec. 10, 92 Stal 2951 as amended by Pub. L. 102-486, sec. 7902, 106 Stat. 3123 (42 U.S.C. 5851); sec. 102, Pub. L.91-190, 83 Stat. 853* (42 U.S.C. 4332); Secs. 131, 132, 133, 135, 137, 141, Pub. L.97-425, 96 Stal 2229, 2230, 2232, 2241, sec. 148, Pub. L. 100-203, 101 Stat. 1330-235 (42 U.S.C. 10151, 10152, 10153, 10155, 10157, 10161, 10168).

Section 72.44(9) also issued under secs. 142(b) and 148(c), (d), Pub. L 100-203, 101

• 9 Stat 1330-232, 1330-236 (42 U.S.C. 10162(b), 10168(c}, (d)). Section 72.46 also issued under sec. 189, 68 Stat. 955 (42 U.S.C. 2239); sec. 134, Pub. L.97-425, 96 Stat 2230 (42 U.S.C. 10154). Section 72.96(d) also issued under sec. 145(g), Pub. L. 100-203, 101 Stat.

1330-235 (42 U.S.C. 10165(9)). Subpart J also issued under secs. 2(2), 2(15), 2(19): 117(a),

141(h), Pub. L 97-425, 96 Stat. 2202, 2203, 2204, 2222, 2224 (42 U.S.C. 10101, 10137(a),

10161(h)). Subparts Kand L a.-e also issued under sec. 133, 98 Stat. 2230 (42 U.S.C. 10153) and sec. 218(a), 96 Stat. 2252 (42 U.S.C. 10198).

45

2. Section 72. 13 is added to Subpart A to read as follows:

§ 72.13 Applicability.

{a) This section identifies those sections, under this part, that apply to the activities associated with a specific license, a general license, or a certificate of compliance.

{b) The following sections apply to activities associated with a specific license: §§ 72.1; 72.2(a) through (e); 72.3 through 72.13(b}; 72.16 through 72.34; 72.40 through 72.6.2; 72.70 through 72.86; 72.90 through 72.108; 72.120 through 72.130; 72.140 through 72.176; 72.180 through 72.186; 72.190 through 72.194; *and 72.200 through 72.206.

(c) The following sections apply to activities associated with a general license:

§§ 72.1; 72.2(a)(1), (b}, (c), and (e); 72.3 through 72.6(c){1); 72.7 through 72.13(a) and (c);

72.30(c) and (d); 72.32(c) and (d); 72.44(b) and (f); 72.48; 72.S0(a); 72.52(a), (b), (d), and (e};

• 72.60; 72.62; 72.72 through 72.80(f); 72.82 through 72.86; 72.104; 72.106; 72.122; 72.124;

\

72.126; 72.140 through 72.176; 72.190; 72.194; 72.210 through 72.220, and 72.240(a).

(d) The following sections apply to activities associated with a certificate of compliance: .

§§ 72.1; 72.2(e) and (f); 72.3; 72.4; 72.5; 72.7; 72.9 through 72.13(a) and (d); 72.48; 72.84(a); 4lt 72.86; 72.124; 72.140 through 72.176; 72.214; and 72.230 through 72.248.

46

3. In§ 72.46, paragraph (e) is added to read as follows:

§ 72.46 Public hearings.

(e) If an application for (or an amendment to) a specific license issued under this part incorporates by reference information on the design of a spent fuel storage cask for which NRC approval pursuant to subpart L of this part has been issued or is being sought, the scope of any public hearing held to consider the application will not include any cask design issues.

4. In§ 72.86, paragraph (b} is revised to read as follows:

§ 72.86 Criminal penalties.

(b) The regulations in Part 72 that are not issued under sections 161b, 161i, or 1610 for the purposes of section 223 are as follows:§§ 72.1, 72.2, 72.3, 72.4, 72.5, 72.7, 72.8, 72.9,

- 72.13, 72.16, 72.18, 72.20, 72.22, 72.24, 72.26, 72.28, 72.32, 72.34, 72.40, 72.46, 72.56, 72.58, 72.60, 72.62, 72.84, 72.86, 72.90, 72.96, 72.108, 72.120, 72.122, 72.124, 72.126, 72.128, 72.130, 72.182, 72.194, 72.200, 72.202, 72.204, 72.206, 72.210, 72.214, 72.220, 72.230, 72.238, and 72.240.

47

5. In§ 72.140, paragraphs (c) and (d) are revised to read as follows:

§ 72.140 Quality assurance requiremen~.

(c) Approval of program:

(1) Each licensee, applicant for a license, certificate holder, or applicant for a CoC shall file a description of its quality assurance program, including a discussion of which requirements of this subpart are applicable and how they will be satisfied, in accordance with § 72.4.

(2) Each licensee shall obtain Commission approval of its quality assurance program prior to receipt of spent fuel at the ISFSI or spent fuel and high-level radioactive waste at the MRS. Each licensee or applicant for a specific license shall obtain Commission approval of its quality assurance program before commencin'g fabrication or testing of a spent fuel storage cask.

(3) Each certificate holder or applicant for a CoC shall obtain Commission approval of .

its quality assurance program before commencing fabrication or testing of a spent fuel storage cask.

(d) Previously-approved programs. A quality assurance program previously approved by the Commission as satisfying the requirements of Appendix B to part 50 of this chapter, subpart H to part 71 of this chapter, or subpart G to this part Wlil be accepted as satisfying the requirements of paragraph (b) of this section, except that a licensee, applicant for a license, certificate holder, and applicant for a CoC who is using an Appendix B or subpart H quality assurance program shall also meet the recordkeeping requirements of§ 72.174. In filing the description of the quality assurance program required by paragraph (c) of this section, ~ach 48

t licensee, applicant for a license, certificate holder, and applicant for a CoC shall notify the NRC, in accordance with § 72.4, of its intent to apply its previously-approved quality assurance program to ISFSI activities or spent fuel storage cask activities. The notification shall identify the previously-approved quality assurance program by date of submittal to the Commission, docket number, and date of Commission approval.

6. In§ 72.234, paragraph (c) is revised to read as follows:

§ 72.234 Conditions of approval.

(c) An applicant for a Coe may begin fabrication of spent fuel storage casks before the Commission issues a CoC for the cask; however, applicants who begin fabrication of casks without a Coe do so at their own risk. A cask fabricated before the CoC is issued shall be made to conform to the issued CoC before being placed in service or before spent fuel is loaded.

49

7. Section 72.236 is amended by revising the introductory text to read as follows:

§ 72.236 Specific requirements for spent fuel storage cask approval and fabrication.

The certificate holder and applicant for a CoC shall ensure that the requirements of this section are met.

Dated at Rockville, Maryland, ~is 1-:::d::'.b day of ~ I 2000.

For the Nuclear Regulatory Commission.

~V Annette L.

=-~

Vietti~Cook, Secretary of the Commission.

50

011 .

DJ Gregg R. Overbeck Mail Station 7602 Palo Verde Nuclear Senior Vice President TEL (623) 393-5148 P.O. Box 52034 Generating Station Nuclear FAX (623) 393-6077 "Q(f ho~A4 !j507p.~~f, 8 1-02-04399-GRO/SABl-!jAM January 28, 2000 '" I Secretary Au, U.S. Nuclear Regulatory Commission Washington, DC 20555-0001 ATTN : Rulemakings and Adjudications Staff CKET BER Pn~Fn RlJL JJJ..

Dear Sirs:

(~~FR -f'i-"11- 1)

Subject:

Palo Verde Nuclear Generating Station (PVNGS)

Units 1, 2, and 3 Docket Nos. STN 50-528/529/530 Comment on Proposed Rule - 10 CFR Part 72: Clarification and Addition of Flexibility Enclosed are comments from Arizona Public Service Company (APS) on the proposed rule changes to 10 CFR Part 72 for spent fuel storage published in the November 3, 1999 Federal Register (64 FR 59677) .

No comm itments are being made to the NRC by this letter.

If you have any questions, please contact Scott A. Bauer at (623) 393-5978.

Sincerely, G RO/SAB/GAM Enclosure cc: E. W. Merschoff M. B. Fields J . H. Moorman

AK1NGS & ADJUDICATIONS STAFF 1FFICE OF THE SECRETARY

'1!: THE COMMISSIO Document Statisti~

, mark Date f 00 --

1es Received _ _ _ _ _ __

d'I Copies Reproduced _ _ _ __

c.:pecial Distribution._ _ _ _ _ __

COMMENTS ON 10 CFR Part 72 PROPOSED RULE:

CLARIFICATION AND ADDITION OF FLEXIBILITY The NRC published, and requested comments on, proposed rule changes to 10 CFR Part 72 for spent fuel storage in the November 3, 1999 Federal Register (64 FR 59677).

The NRC states in the Federal Register notice that the Commission intended that the requirements imposed in Subpart K for general licensees for an independent spent fuel storage installation (ISFSI) be used in addition to, rather than in lieu of, appropriate existing requirements in Part 72. The proposed Section 72.13 identifies Part 72 sections that would be the "appropriate existing requirements" for activities associated with a general license for an ISFSI. However, some of these requirements were written for the ISFSI specific license, and their application to a general license is not clear or is inconsistent with Subpart K requirements. The following comments contain examples.

Comment 1 Section 72.44(d), under license conditions, is one of the existing Part 72 sections identified in proposed 72.13 as applying to a general licensee. 72.44(d) states:

"Each license authorizing the receipt, handling, and storage of spent fuel or high-level radioactive waste under this part must include technical specifications that, in addition to stating the limits on the release of radioactive materials for compliance with limits of part 20 of this chapter and the "as low as is reasonably achievable" objectives for effluents, require that:

(1) Operating procedures for control of effluents be established and followed ,

and equipment in the radioactive waste treatment systems be maintained and used, to meet the requirements of 72.104; (2) An environmental monitoring program be established to ensure compliance with the technical specifications for effluents; and (3) An annual report be submitted to the Commission in accordance with Sec.

72.4, specifying the quantity of each of the principal radionuclides released to the environment in liquid and in gaseous effluents during the previous 12 months of operation and such other information as may be required by the Commission to estimate maximum potential radiation dose commitment to the public resulting from effluent releases. On the basis of this report and any additional information that the Commission may obtain from the licensee or others, the Commission may from time to time require the licensee to take such action as the Commission deems appropriate. The report must be submitted within 60 days after the end of the 12-month monitoring period.

The "technical specifications" are a component of a Part 50 reactor operating license, a Part 72 ISFSI specific license, and a Part 72 Cask Certificate of Compliance (CoC).

However, a Part 72 ISFSI general license would not have technical specifications as a component of the license. The original Subpart K proposed rule that established general license requirements was published in the May 5, 1989 Federal Register (54 1

FR 19379), and the final rule was published in the July 18, 1990, Federal Register (55 FR 29181 ). According to the NRC discussion with the proposed Subpart K rule and the statements of consideration with the final rule, the NRC did not intend for general licensees to submit an application for a license that would include technical specifications. With this proposed rule, does the NRC intend that the cask technical specifications (written by and held by the cask vendor) would meet the requirements of 10 CFR 72.44(d) for general licensees? If so, 72.44(d) should be clarified to state that, for a general license, the required technical specifications would be those included with the cask Certificate of Compliance and would not be included with the general license.

Requiring a general licensee to "include technical specifications" in their license is not clear and is subject to various interpretations.

Comment 2 Section 72.44(e), under license conditions is one of the existing Part 72 sections

• identified in proposed 72.13 as applying to a general licensee. 72.44(e) states:

"The licensee shall make no change that would decrease the effectiveness of the physical security plan prepared pursuant to 72.180 without the prior approval of the Commission. A licensee desiring to make such a change shall submit an application for an amendment to the license pursuant to 72.56. A licensee may make changes to the physical security plan without prior Commission approval, provided that such changes do not decrease the effectiveness of the plan. The licensee shall furnish to the Commission a report containing a description of each change within two months after the change is made, and shall maintain records of changes to the plan made without prior Commission approval for a period of 3 years from the date of the change."

Security requirements for a general licensee are specified in 10 CFR 72.212(4) under

• Subpart K. A general licensee would not prepare a security plan pursuant to 72.180 because 72.180 is not in the proposed 72.13 tor applicability to general licensees.

Further, a general licensee would not submit an application tor an amendment pursuant to 72.56, since that section is not in the proposed 72.13 tor general licensees. The general licensee would incorporate the ISFSI security requirements into their 73.55 security plan. Requiring 72.44(e) to be applicable to general licensees appears inconsistent with the existing general license requirements in Subpart K.

2

Comment 3 Section 72.192, operator training and certification program , is one of the existing Part 72 sections identified in proposed 72.13 as applying to a general licensee. Section 72.192 states that:

"The applicant for a license under this part shall establish a program for training, proficiency testing, and certification of ISFSI or MRS personnel. This program must be submitted to the Commission for approval with the license application."

However, this requirement is not consistent with other requirements for a general license. Section 72.6(a) states that a general license is effective without the filing of an application to the commission. Therefore, application of this section to a general license creates conflicting regulations. A general licensee does not submit a license application. Further, in the Statements of Consideration (SoC) published in the July 18, 1990, Federal Register for the creation of Subpart K to Part 72 for general license requirements (55 FR 29181 ), the NRC response to comment no. 19 identifies what a current reactor licensee would have to do to obtain a general license. Submitting a program for training, proficiency testing, and certification of independent spent fuel storage installation (ISFSI) personnel for NRC approval is not identified as a requ irement.

The proposed Subpart K rule for general license requirements was published in the May 5, 1989 Federal Register (54 FR 19379). The NRC discussion with the proposed rule states that reactor licensees would have to review their training program using procedures in 50.59 and modify it as necessary to cover the activities related to spent fuel storage under the general license. Nowhere in the NRC discussion of the proposed Subpart K rule is it suggested that the Commission intended for general licensees to obtain prior NRC approval of their program for training, proficiency testing, and certification of ISFSI personnel. This proposal should be clarified for application to

• a general license.

3

(j) t Holtec Center, 555 Lincoln Drive West, Marlton, NJ 08053 Telephone (856) 797-0900 HOLTEC r r_n rr '1 4 P

-'?, : (J Fax (856) 797 -0909 I NTERNAT I ONAL

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B~8VERNIGHT MAIL February 11, 2000 Secretary U.S. Nuclear Regulatory Commission Washington, DC 20555-0001 Attention: Rulemakings and Adjudications Staff

Subject:

10 CFR Part 72, Clarifications and Addition of Flexibility Comments on Proposed Rulemaking

Reference:

Federal Register, Volume 64, No. 212, Page 59677

Dear Sir:

Holtec International has reviewed the subject proposed rulemaking and offers the following comment for consideration by the Nuclear Regulatory Commission.

10 CFR 72.62 provides specific criteria to be met if the Commission is to require the backfitting of changes to structures, systems, and components of an ISFSI or MRS or changes to the procedures or organization required to operate an ISFSI or MRS. The above-referenced proposed rulemaking, at Section 72.13, excludes applicability of 10 CFR 72.62 to certificate holders. As a Part 72 certificate holder, Holtec International believes strongly that Section 72.62 should also apply to certificate holders.

Without backfit protection, certificate holders are subject to new requirements which may provide little safety benefit or are excessively costly to implement. As an example, 10 CFR 72.104 was revised in October, 1998 to change the methodology used to calculate normal and off-normal radiation doses due to effluents from spent fuel storage casks. The intent of this rule change was simply to conform the methodology and dose acceptance criteria in Section 72.104 to be consistent with other parts of the regulations. However, the revised rule contained no language excluding existing certificate holders from having to revise their confinement analyses to incorporate the new methodology. Compliance with this new requirement would require the expenditure of significant man-hours of analytical time and a revision to the Safety Analysis Report with little or no safety benefit.

U.S. NUCLEAA REGULA uH~ vUMIVII;,, ION RULEMAKINGS &AOJUOlrltllONS STAFF FACE 0FMIECRETARY OF THE COMMISSION Document Smtistlcs ostmark Date c:2 CopiesRecet.,ed

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Holtec Center, 555 Lincoln Drive W est, Marlton, NJ 08053 Telephone (856) 797-0900 HOLTE C Fax (856) 797-0909 INTERNATIONAL U.S. Nuclear Regulatory Commission AITN: Document Control Desk Document ID 5014366 Page 2 of2 As such, proposed Section 72.13(d) should be amended to include Section 72.62 to the list of sections applicable to activities associated with a certificate of compliance.

Please feel free to contact me at (856) 797-0900, extension 668 if you require additional information.

Sincerely, Brian Gutherman, P .E.

Licensing Manager Document ID: 5014366

DOCKET UMBER PROPOSED RllE. 7C:Z.

ShawPittman 16¥F,R 5 '/b11)

A Law Partnership Including Professional Corporations JAY E. SILBERG 202.663 .8063 jay.silberg@shawpittman.com

• oo J!\N 2, P3 :Q4 January 18, 2000 A

Secretary U.S. Nuclear Regulatory Commission Washington, D.C. 20555-0001 Attention: Rulemakings and Adjudications Staff

Dear Sirs:

Re: Proposed Rulemaking, 10 CFR Part 72 "Clarification and Addition of Flexibility" 64 Fed. Reg. 59677 (1999)

On November 2, 1999, the Nuclear Regulatory Commission (NRC) published in the Federal Register proposed amendments to 10 C.F.R. Part 72. 64 Fed. Reg. 59677 (1999). The proposed amendments would clarify those sections of Part 72 which apply to activities associated with general licenses, specific licenses, and Certificates of Compliance (CoC). The proposed amendments would also allow CoC applicants to begin cask fabrication under an NRC-approved quality assurance program prior to issuance of the CoC. Finally, the proposed amendments would eliminate repetitive reviews of cask design issues in hearings on applications for specific Part 72 licenses which reference NRC-approved cask designs.

On behalf of Private Fuel Storage, L.L.C. (PFS), we are pleased to submit the following comments. PFS is the applicant for a specific license under 10 C.F .R. Part 72 to construct and operate an independent spent fuel storage installation on the Skull Valley Indian Reservation in Tooele County, Utah. PFS ' application currently references two spent fuel storage cask designs for which applications had been filed for CoC's pursuant to Subpart L of Part 72, the HI-STORM 100 cask system designed by Holtec International and the TranStor Storage Cask System of BNFL Fuel Solutions Corporation.

PFS welcomes the attention which the Commission continues to give to the Part 72 process. The generic licensing approach reflected in Part 72 provides an important mechanism for the NRC to carry out its radiological health and safety responsibilities in an efficient and effective manner.

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ShawPittman Secretary U.S. Nuclear Regulatory Commission January 18, 2000 Page2 PFS supports the proposed amendment adding § 72.13 so as to resolve the ambiguity as to which provisions of Part 72 apply to specific licenses, which apply to general licenses, and which apply to CoC's. We would, however, suggest that the list of sections applicable to general licensees be amended to include 10 C.F.R. §§ 72.214 and 72.240(a). PFS also supports the proposed amendments to§§ 72.140 and 72.234, which would permit CoC applicants to begin fabrication of spent fuel storage casks, under an NRC-approved quality assurance plan, prior to issuance of the CoC.

With respect to the third aspect of the proposed rulemaking, PFS supports avoiding repetitive reviews of cask design issues in those Part 72 specific license hearings involving cask designs which are the subject of CoC's. We believe, however, that this aspect of the proposed rulemaking should be clarified in two respects. First, the proposed language should be revised so that it clearly applies to cask designs which are in the CoC review process, as well as those that have already received a CoC. Second, the proposed amendment should also make clear that site-specific hearings are not the appropriate forum to seek to raise cask design issues which an intervenor claims were not considered in the CoC review process. These clarifications will assure that repetitive reviews will in fact be avoided and that the savings ofNRC Staff and applicant resources estimated by the NRC (~ 64 Fed. Reg. at 59683) will in fact be achieved.

The CoC process was created to provide a means for evaluating and approving the

• designs for spent fuel storage casks that would be more efficient, expeditious and economic than a site-specific licensing of the cask design each time its use was proposed.

By providing for a single review of the cask design, with the opportunity for public participation in the review process, culminating in the issuance of a formal rule approving the design, the NRC has been able to achieve the benefits of generic consideration, while avoiding the inefficiencies ofrepetitive evaluations in case-by-case adjudications. The Commission has successfully adopted similar generic approval mechanisms in other areas as well - Part 71 (transportation casks and packages); Part 52 (standard design certifications), Part 51 (license renewal environmental reviews,§ 51.53(c); need for power,§ 51.36(b); waste confidence,§ 51.23; nuclear fuel cycle impacts,§§ 51.51 and 51.52). These types of generic approvals have received explicit approval by the courts.

~.~.Baltimore Gas and Electric Co. v. Natural Resources Defense Council, 462 U.S.

82 (1983); Union of Concerned Scientists v. AEC, 499 F.2d 1069 (D.C. Cir. 1974);

Nuclear Information Resource Service v. NRC, 969 F.2d 1169 (D.C. Cir. 1992). It is a basic principle of administrative law that an agency's choice to proceed by rulemaking or

ShawPittman Secretary U.S. Nuclear Regulatory Commission January 18, 2000 Page 3 by case-specific adjudication is within the agency's discretion. Mobil Oil Exploration &

Production Southwest, Inc. v. United Distribution Cos., 498 U.S. 211,228 (1991);

Heckler v. Campbell, 461 U.S. 458,467 (1983); NLRB v. Bell Aerospace Co., 416 U.S.

267,294 (1974); FPC v. Texaco, Inc., 377 U.S. 33, 44 (1964). That principle has been specifically applied to the Commission. Kelley v. Selin, 42 F.3d 1501, 1511 (6 th Cir.),

~ denied 515 U.S. 1159 (1995); Morningside Renewal Council v. AEC, 482 F.2d 234, 239 (2d Cir. 1973), ~- denied, 417 U.S. 951 (1974); Ecolog_v Action v. ABC, 492 F.2d 998 (2d Cir. 1974).

The first requested clarification is to make sure that repetitive cask design issue reviews are avoided in those site-specific licensing cases where the CoC review is still underway. As written, proposed§ 72.46(e) could be read to preclude repetitive reviews only where the CoC had already been issued ("cask design issues previously addressed by the Commission when it ~ the Certificate of Compliance"). There will be cases where the site-specific licensing proceeding and the CoC review are proceeding in parallel. Since the site-specific license cannot be issued until the CoC for the design referenced in the site-specific application has also been issued, there is no safety issue involved with eliminating repetitive cask design reviews in the site-specific hearing.

Such safety issues can still be raised in the CoC proceeding and will be resolved in that proceeding. Those issues need not be repetitively reviewed and resolved in the parallel site-specific proceeding. Allowing those issues to be raised in both proceedings would create the specter of inconsistent results as well as duplicative and wasteful use of resources by the NRC Staff and applicants.

Deferring consideration of issues from site-specific proceedings to generic proceeding is well established in NRC and judicial case law. This is the case even when the generic proceedings are still in progress. Commission decisions have long held that "licensing boards should not accept in individual license proceedings contentions which are (or are about to become) the subject of general rulemaking by the Commission."

Potomac Electric Power Co. (Douglas Point Nuclear Generating Station, Units 1 and 2),

ALAB-218, 9 A.E.C. 79, 85 (1974); accord Duke Power Co. (Catawba Nuclear Station, Units 1 & 2), ALAB-813, 22 N.R.C. 59, 85-86 (1985); ~ alsQ Private Fuel Storage, L.L.C. (Independent Spent Fuel Storage Installation), LBP-98-7, 47 N.R.C. 142, 179 (1998). The Commission has recently reaffirmed this rule oflaw. Duke Ener~ Corp.

(Oconee Nuclear Station, Units 1, 2 and 3), CLI-99-11 , 49 N.R.C. 328,345 (1999).

ShawPittman Secretary U.S. Nuclear Regulatory Commission January 18, 2000 Page4 The courts have taken the same position. Union of Concerned Scientists v. AEC),

499 F.2d at 1081 (no due process violation for excluding regulatory challenge from administrative proceedings where a rulemaking proceeding is underway). Columbia Broadcasting Coalition v. FCC, 505 F.2d 320, 325 (D.C. Cir. 1974) (during pendency of rulemaking, agency may refuse to consider issue in individual case unless specific abuse shown). It would make no sense, and would be wholly counter-productive to the aims expressed by the Commission in the proposed rulemaking, to allow the redundant review in a site-specific proceeding of cask design issues which are within the scope of the CoC proceeding, merely because the CoC proceeding happened not to be completed prior to the site-specific proceeding. Logic, NRC precedent, and federal case law all suggest that cask design issues should not be reviewed in site-specific proceedings whether the CoC is issued prior to, during, or after the site-specific licensing proceeding.

The second aspect of proposed § 72.46( e) which requires clarification concerns the possibility that the proposed rule could be read to exclude from site-specific proceedings only those generic cask design issues which were explicitly addressed in the CoC proceeding. The NRC's CoC review will encompass all safety issues which the Commission in its expert judgment determines are needed to adequately protect the public health and safety. Members of the public are entitled to raise in the CoC process any questions that they may have with respect to the cask design and the NRC will address those concerns in the course of the review or in the rulemaking process that follows. What would be inefficient and inappropriate would be for an intervenor in a site-specific licensing process to be able to raise a cask design issue, claiming that it should be litigated in the site-specific proceeding because the NRC allegedly did not address (or did not adequately address) the issue in the CoC proceeding. If a cask design issue was, in fact, not addressed in connection with the issuance of the CoC, the proper mechanism to raise that issue after the CoC is issued would be by filing a request for action pursuant to 10 C.F .R. § 2.206, or a petition to amend the rule adopting the CoC pursuant to 10 C.F.R. § 2.802. Alternatively, an attempt to raise in a site-specific proceeding a cask design issue involving a cask which had received a CoC, could be made subject to 10 C.F.R. § 2.758, which establishes the process for handling challenges to NRC regulations in individual licensing proceedings. Regardless of which procedural route is used, the final rule and its accompanying statement of considerations should make clear that cask design issues involving casks which are the subject of issued or pending CoC's should not be litigated in site-specific proceedings. It would make no sense, and would be inconsistent with the prior NRC precedent described above, to allow

ShawPittman Secretary U.S. Nuclear Regulatory Commission January 18, 2000 Page 5 assertions that an NRC generic decision was incomplete or inadequate to be raised and litigated in a site-specific hearing. Unless this is made clear, the rule as proposed may open a loophole which can significantly undermine the valuable policies underlying the proposed rule.

To accomplish both of these clarifications, we recommend that the proposed 10 C.F.R. § 72.46(e) be revised to read as follows:

• "( e) If an application for (or an amendment to) a specific license issued under this part incorporates by reference information on the design of a spent fuel storage cask for which NRC approval pursuant to Subpart L of this part has been issued or is being sought, the scope of any public hearing held to consider the application will not include any cask design issues."

The statement of considerations accompanying the final rule would make clear (as made clear in connection with the proposed rule, 64 Fed. Reg. 59678) that design interface issues between the cask design and site specific characteristics (e.g., meteorological, seismological, radiological, and hydrological) may be raised as issues at a site-specific hearing.

Thank you for the opportunity to provide these comments. If you have any comments or questions, we would be happy to discuss these with you.

Very truly yours, 880822

Florida Power & Light Company, P. 0. Box 14000, Juno Beach, FL 33408-0420 IC , l I

JAN 1 4 2000

• oo JAN 24 P4 G' gooo-015 Ms. Annette Vietti-Cook 0

Secretary I U.S. Nuclear Regulatory Commission AD,1 Washington, D.C. 20555-0001 Attn: Rulemakings and Adjudications Staff 1 0CKET NUMBER Re: Florida Power & Light Company Comments OPOSED AULE.=,.=.~i;;p;c;:::t\.

Notice of Proposed Rulemaking -10 CFR Part 72 Clarification and Addition of Flexibility RIN 3150-AG15, 64 Fed. Reg. 59677 (Nov. 3, 1999)

Dear Ms. Vietti-Cook:

• Florida Power & Light Company (FPL), the owner and operator of the St. Lucie Nuclear Plant, Units 1 and 2, and the Turkey Point Nuclear Plant, Units 3 and 4, hereby submits the following comments in support of the above-referenced notice of proposed rulemaking. In summary, the clarifications and flexibility proposed by the Commission will streamline the licensing process for independent spent fuel storage installations without any decrease in the level of protection of the public health and safety.

FPL suggests one change to the proposed rule. As proposed, the rule (1 0 CFR 72.46(e)) would eliminate consideration of storage cask designs from any public hearing held to consider an application for a site specific Part 72 license in cases where a certificate of compliance has been issued for the storage cask incorporated by reference in the application. The rationale for the proposed change is that storage cask designs that are included in Subpart L to Part 72 have already been the subject of public comment as part of the rulemaking conducted to review and approve that cask design.

This is deemed acceptable because the public has already had a chance to meaningfully participate, by rulemaking, in the approval process for spent fuel storage casks.

In this regard , FPL suggests that the exclusion from the scope of the public hearing on a site specific Part 72 license in 10 CFR 72.46(e) should also extend to storage casks for which applications for a certificate of compliance have been filed with the Commission at the time the request for hearing is filed. The rationale stated by the Commission applies equally to this situation. The public will have an opportunity for meaningful participation in the rulemaking process for the referenced storage cask, regardless of whether the NRC's review of that application is pending or final at the time of the publicJhearing on the Part 72 license application. ' '

We appreciate the opportunity to comment on the proposed changes to 10 CFR Part 72.

Sincerely yours, V _.._ I \~ s..

~Js. Kundalkar Vice President Nuclear Engineering ml ? 3 11100 an FPL Group company

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• oo JAN Zi P2 :50 Wayne, PA 19087-5691 January 13, 2000 Secretary U.S. Nuclear Regulatory Commission Attn: Rulemakings and Adjudications Staff Washington, DC 20555-0001

Subject:

Comments Concerning Proposed Rule 10CFR72, "Clarification and Addition of Flexibility" (64FR59677, dated November 3, 1999)

Dear Sir/Madam:

This letter is being submitted in response to the NRC's request for comments concerning Proposed Rule 10CFR72, "Clarification and Addition of Flexibility," which was published in the Federal Register (i.e., 64FR59677, dated November 3, 1999).

The NRC is proposing to amend its regulations on spent fuel storage to specify those sections of 10 CFR Part 72 that apply to general licensees, specific licensees, applicants for a specific license, certificate holders, and applicants for a certificate.

PECO Energy appreciates the opportunity to comment on this proposed rule. We believe that the proposed rule provides for increased clarity and minimizes ambiguity as to which portions of Part 72 apply to the various activities. However, the proposed rule would apply portions of Part 72 to the general licensee which are inconsistent with existing requirements in Subpart K of Part 72 .

• Specific comments on the Proposed Rule are provided in Attachment 1.

If you have any questions, please do not hesitate to contact us.

Very truly yours ,

James A . Hutton, Jr.

Director - Licensing Attachment

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ATTACHMENT 1

Attachment 1 Page 1 of 3 The Proposed Rule adds Section 72.13 to identify the sections of 10CFR72 that apply to the activities associated with a specific license, a general license, or a certificate of compliance .

The following changes are necessary to eliminate inconsistencies:

1. 72.44(b) and 72 .50(a) are designated as applying to a general license. 72.44(b)(1) and 72.50(a) both require consent in writing prior to a license being transferred , assigned, or in any manner disposed of, either voluntarily or involuntarily, directly or indirectly. 72.44(b)(1) and 72.50(a) are inconsistent with 72.210. 72.210 issues a general license to persons authorized to possess or operate nuclear power reactors under 10CFR50. It follows that if a transfer of the license to possess or operate a nuclear power reactor is approved under 10CFR50.80, the general license issued by 72.210 is also transferred without additional action. Section 72.13 should be revised to eliminate applicability of 72.44(b)(1) and 72 .50(a) to a general license.

2. 72.44(b) and 72.60 are designated as applying to a general license. 72.44(b)(2) and 72 .60(a) both state that a license is subject to amendment, revision, or modification by reason of amendments to the Atomic Energy Act of 1954, as amended, or by reason, rules or regulations. 72.44(b)(2) and 72.60(a) are inconsistent with 72.210. 72.210 issues a general license to persons authorized to possess or operate nuclear power reactors under 10CFR50. 10CFR50.54(e) contains a similar requirement to that of 72.44(b)(2) and 72.60(a). It follows that a general license issued by 72.210 is subject to amendment, revision, or modification by reason of amendments to the Atomic Energy Act of 1954, as amended, or by reason , rules or regulations through 10CFR50.54(e). Section 72.13 should be revised to eliminate applicability of 72.44(b)(2) and 72.60(a) to a general license.

3. 72.44(b) is designated as applying to a general license. 72.44(b)(3) requires , "Upon request of the Commission , the licensee shall, at any time before expiration of the license, submit written statements, signed under oath or affirmation if appropriate, to enable the Commission to determine whether or not the license should be modified , suspended, or revoked. 72.44(b)(3) is inconsistent with 72.210. 72.210 issues a general license to persons authorized to possess or operate nuclear power reactors under 10CFR50.

10CFR50.54(f) contains a similar requirement to that of 72.44(b)(3). It follows that a general license issued by 72.210 is subject to providing requested information through 10CFR50.54(f). Section 72.13 should be revised to eliminate applicability of 72.44(b)(3) to a general license.

4. 72.44(e) is designated as applying to a general license. 72.44(e) requires , "The licensee shall make no change that would decrease the effectiveness of the physical security plan prepared pursuant to 72.180 without the prior approval of the Commission. A licensee desiring to make such a change shall submit an application for an amendment to the license pursuant to 72.56. A licensee may make changes to the physical security plan without prior Commission approval, provided that such changes do not decrease the effectiveness of the plan. The licensee shall furnish to the Commission a report containing a description of each change within two months after the change is made, and shall maintain records of changes to the plan made without prior Commission approval for a period of 3 years from the date of the change." 72.180 and 72.56 are designated as applying only to a specific license and not applying to a general license. Therefore,

Attachment 1 Page 2 of 3 applying 72.44(e) to a general license is inconsistent with the remainder of the Proposed Rule. Additionally 72.44(e) is inconsistent with 72.212(b)(5) in Subpart K which invokes the requirements of 10CFR73.55 and the change control requirements of 10CFR50.54(p).

Section 72.13 should be revised to eliminate applicability of 72.44(e) to a general license.

5. 72.44(f) is designated as applying to a general license. 72.44(f) requires in part, "A licensee shall follow and maintain in effect an emergency plan that is approved by the Commission." 72.44(f) is inconsistent with 72.212(b)(6) in Subpart K which requires, "Review the reactor emergency plan, quality assurance program, training program, and radiation protection program to determine if their effectiveness is decreased and, if so, prepare the necessary changes and seek and obtain the necessary approvals."

10CFR50.54(q) contains the change control requirements for the emergency plan. Section 72.13 should be revised to eliminate applicability of 72.44(f) to a general license.

6. 72.52 is designated as applying to a general license. 72.52(c) states, "Any Creditor so secured may apply for transfer of the license covering spent fuel by filing an application for transfer of the license pursuant to 72 .50(b). The Commission will act upon the application pursuant to 72.50(c)." 72.50 (b) and (c) are designated as applying only to a specific license and not applying to a general license. Therefore, applying 72.52(c) to a general license is inconsistent with the remainder of the Proposed Rule. Additionally, 72.210 issues a general license to persons authorized to possess or operate nuclear power reactors under 10CFR50. It follows that if a transfer of the license to possess or operate a nuclear power reactor is approved under 10CFR50, the general license issued by 72.210 is also transferred without additional action. Section 72.13 should be revised to eliminate applicability of 72.52(c) to a general license.

7. 72.54(d) through (m) is designated as applying to a general license. Applying any of 72.54, "Expiration and termination of licenses and decommissioning of sites and separate buildings or outdoor areas, " to a general license is inconsistent with existing Subpart K requirements in 72.218, Termination of licenses." 72.218 relies upon requirements contained in 10CFRS0 which are adequate to ensure that spent fuel is disposed of properly and that decommissioning is completed so that the license may be terminated.

Section 72.13 should be revised to eliminate applicability of 72.54(d) through (m) to a general license.

8. 72.60 is designated as applying to a general license. 72.60(b) enumerates reasons that a license may be modified, revoked, or suspended in whole or in part. 72.60(b) is inconsistent with 72.210. 72.210 issues a general license to persons authorized to possess or operate nuclear power reactors under 10CFR50. 10CFR50.100 requirements are similar to those of 72.60(b). Section 72.1 3 should be revised to eliminate applicability of 72.60(b) to a general license.

9. 72.60 is designated as applying to a general license. 72.60(c) states in part, "Upon revocation of a license, the Commission may immediately cause the retaking of possession of all special nuclear material contained in spent fuel held by the licensee."

72 .60(c) is inconsistent with 72.210. 72.210 issues a general license to persons authorized to possess or operate nuclear power reactors under 10CFR50. 10CFR50.101

Attachment 1 Page 3 of 3 requirements are similar to those of 72.60(c). Section 72.13 should be revised to eliminate applicability of 72.60(c) to a general license.

10. 72.B0(f) is designated as applying to a general license. 72.B0(f) states, "If licensed activities are transferred or assigned in accordance with 72.44(b)(1 ), the licensee shall transfer the records required by 20.2103(b)(4) and 72.30(d) to the new licensee and the new licensee will be responsible for maintaining these records until the license is terminated." 72.B0(f) is inconsistent with 72.2 10. 72.210 issues a general license to persons authorized to possess or operate nuclear power reactors under 10CFRS0. It follows that if a transfer of the license to possess or operate a nuclear power reactor is approved under 10CFR50.80, the general license issued by 72.210 is also transferred without additional action. 10CFR50.71 requires that records be retained until the facility license is terminated unless otherwise specified. Section 72.13 should be revised to eliminate applicability of 72.B0(f) to a general license .

I 0,) L, 1,-1, I '

u- 'I NUCLE AR ENERGY INSTITUTE

• oo JAN 20 A9 :QS r\ Lynnette Hendricks V I DIRECTOR, PLANT SUPPORT NUCLEAR GENERATION January 18, 2000 DOCKET NUMBER Secretary P OP SEO FUJI E ~

Attention: Rulemakings and Adjudications Staff ( 6 'IF.

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U.S. Nuclear Regulatory Commission Washington, DC 20555-0002

Subject:

10 CFR Part 72 Proposed Rule: Clarification and Addition of Flexibility November 3, 1999 (64 Fed. Reg. 59677) Request for Comments On behalf of the nuclear energy industry, the Nuclear Energy Institute is pleased to provide comments on the NRC's proposed revisions to 10 CFR Part 72 , Clarification and Addition of Flexibility, published November 3, .1999 (64 Fed. Reg. 59677).

We commend the staff for initiating this rulemaking to (1) permit Certificate of Compliance (CoC) applicants to begin fabrication under an NRC-approved quality assurance program prior to issuance of the CoC; (2) eliminate repetitive review of container designs issues, and, (3) eliminate the ambiguity in 10CFR 72 regarding the applicability of each section to site-specific licensees, general licensees, and certificate holders.

Based on our review, we have the following comments for th e staffs consideration.

1. Fabrication Under an NRC-Approved Quality Assurance Program Prior to Issuance of a COC Industry fully supports the proposed amendment to permit CoC applicants to fabricate spent fuel containers prior to CoC issuance. This flexibility will greatly assist operating plants as they prepare to store fuel in containers where spent fuel pools are running out of space, and will assist permanently shut down plants to empty and decommission their spent fuel pools. This amendment would provide more consistency in that NRC's existing regulatory program already permits specific applicants to fabricate containers under a NRC-approved quality program prior to CoC issuance.

~cknowfedaed by can1 ... ....... -- - -.,,..

1776 I STREET NW SUITE 400 WASHINGTON, DC 20006-3708 PHONE 202 739 8000 FAX 202 785 4019 www nei org

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Secretary January 18, 2000 Page 2 The practice of fabrication in advance of issuance of a CoC results in no increase in risk to the public because the applicant cannot load containers that do not conform to the CoC. It is recognized that this practice places the applicant at economic risk if the CoC contains changes not considered at the time the container was fabricated.

2. Exclusion of Container Design Issues from Specific Part 72 License Hearings The industry fully supports the NRC proposal to exclude container design issues from specific Part 72 license hearings. This revision could have the considerable benefits of eliminating repetitive reviews of container design issues whereby the issue would otherwise be considered in the context of a generic rulemaking to approve a container and then be reconsidered in a specific Part 72 hearing.

Two clarifications are needed. First, a clarification is needed to assure that repetitive reviews will in fact be avoided and that the savings of NRC staff and applicant resources estimated by the NRC (see 64 Fed. Reg. at 59683) will in fact be achieved. Second, a clarification is needed to ensure the NRC rules provide a clear statement of where and how issues are to be considered so that issues are directed to the most appropriate process. This clear statement of destination will avoid "orphaning issues.

The first clarification is that the proposed language be revised so that it clearly applies to container designs, which are in the CoC review process, or will be in the review process as well as those that have already received a CoC. The current wording appears to only consider for exclusion froni the specific license hearing those "cask designs issues previously a ddressed by the Commission when it issued the Certificate of Compliance." The practice of deferring issues brought up in individual license proceedings to generic rulemakings provides the added benefits of a broader review in the context of wider input from the different perspectives of multiple users of the generic provision. The Commission and the courts have widely upheld this practice.

From a practical perspective it is not logical to permit redundant review of issues in a specific license hearing merely because the process for the preferred review in the broader generic context has not yet been completed. Further we can envision a specific Part 72 license application that would not be limited to specific container designs but would be open ended to account for additional or new or improved designs for which generic rulemaking to determine compliance with NRC's pre-established acceptance criteria have not yet been initiated.

For containers that have not yet received CoCs, NRC can meet the stipulation in the proposed rule for addressing the interface issues between containers and the site by using the general acceptance criteria for the design issues.

Secretary January 18, 2000 Page 3 For example, all NRC approved containers must meet certain criteria to demonstrate that they are acceptable for high seismic areas. Containers not specifically certified to high seismic capability in accordance with NRC approved methodology and acceptance criteria could not be deployed at a site with high seismic characteristics. Ample opportunities are provided in the generic rulemaking for the CoC to comment on NRC's finding that the container meets NRC criteria for withstanding high seismic events. And the specific Part 72 hearing provides ample opportunities to provide input on the seismic activity expected at that site.

The second clarification needed for the proposed amendment is a clear statement in the rule that site-specific hearings are not the appropriate forum to raise container design issues, which are purported to be new, or beyond the scope of NRC's

• consideration of those issues in the generic rulemaking. To avoid the misimpression that these issues are being "orphaned" the preamble to the final rule should stipulate where and how those issues might be raised. For example, if a cask design issue was not adequately addressed in connection with issuance of the CoC, that issue should be raised in accordance with specific processes in NRC's regulations which were crafted to provide discipline to such reviews.

Specifically, Parts 2.206 and 2.802 delineate the processes whereby the Commission determines whether the public or proceedings are served by initiating new proceedings to amend the Commission's rules. Further, Part 2. 758 delineates the process whereby the presiding officer of a hearing may determine that the application of the Commission rules or regulations would not serve the purpose for which the rule or regulation was adopted.

3. Ambiguities Regarding the Applicability of Part 72 Requirements Two clarifications are needed to eliminate the ambiguity in 10 CFR Part 72 regarding the applicability of each section to site-specific licensees, general licensees, and certificate holders.

The first clarification applies to proposed section 10CFR72.13, which lists those sections in Part, 72 that apply to general licensees. Part 72 allows general licensees to store spent fuel in containers approved under the provisions of Part 72. The containers approved for use by general licensees are listed in 10CFR72.214.

Proposed 10CFR72.13 does not include 10CFR72.214. We believe that ambiguity would remain in Part 72 if 10CFR 72.13 does not reference the section listing containers that can be utilized by general licensees:

Secretary January 18, 2000 Page4 The second clarification also addresses 10CFR 72.13. Section 10CFR72.240(a) allows the user of a container approved by the NRC to apply for a container model re-approval as an alternative to application by the certificate holder. Since general licensees are the cask users, we believe 10CFR72.240 should also be listed in 10CFR72.13 as applicable to general licensees.

We appreciate the opportunity to comment on revisions to 10 CFR Part 72 "Clarification and Addition of Flexibility." If you have any questions please contact me at (202) 739-8110 or by e-mail (lxh@nei.org), or Alan Nelson at (202) 739-8110 or by e-mail (apn@nei.org).

Sincerely,

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Lynnette Hendricks

( Page 11 l/

Entergy Operations, Inc.

1448 S.R. 333 Russellville, AR 72801

• oo JA -6 P2 :35 Tel 501 858-5000 CJ January 5, 2000 AC.

Secretary DOCKET NUMBER U.S. Nuclear Regulatory Commission PROPO ,.. 1/L Washington, DC 20555-0002 (b'lrf<.5'!"77)

Attention: Rulemakings and Adjudications Staff

Subject:

Comments on Proposed Rule: Clarification and Addition ofFlexibilityRIN 3150-AG15 Entergy Operations at Arkansas Nuclear One (ANO) has reviewed the proposed rulemaking to provide clarification to IOCFR72. We commend the Staff for initiating this rulemaking to eliminate the ambiguity currently inherent in 10CFR72 pertaining to the applicability of each section to site-specific licensees, general licensees, and certificate holders. As a general licensee, we have been subject to varied and shifting opinions and the applicability of various sections of 10CFR72 since 1994, two years prior to our first cask loading.

Based on our review, we have the following comments for the Staffs consideration.

I. IOCFR72.212(a)(2) allows general licensees to store spent fuel in casks approved under the provisions of Part 72. The casks approved for use by general licensees are listed in

• 10CFR72.214. The sections of Part 72 currently proposed in 10CFR72.13 to apply to general licensees do not include 10CFR72.214. We believe that ambiguity would remain in Part 72 if the list of casks that general licensees can utilize are contained in a section of Part 72 that is listed (in IOCFR72.13) as not applicable to general licensees.

2. IOCFR72.240(a) allows the user of a cask approved by the NRC to apply for a cask model re-approval as an alternative to application by the certificate holder. Since general licensees are the cask users, we believe IOCFR72.240 should also be listed in 10CFR72.13 as applicable to general licensees.

Sincerely, Jimmy D. Vandergrift Director, Nuclear Safety

.... 1- .. ,1..1.1uLAI UHY CO Ml:SSI J EMAKING & ADJUOICATIONS STAFF OFFICE OF THE SECRETARY OF THE COMMISSiON

i Page 11 From: Carol Gallagher To: Adria Byrdsong, Anthony DiPalo Date: Thu, Jan 6, 2000 9:42 AM

Subject:

Comment on Clarifications Rule Adria/Tony, Attached is a comment on the Clarifications Rule that I received via the rulemaking website on 1/5/00.

The commenter is:

Jimmy D. Vandergrift Entergy Operations, Inc.

1448 S.R. 333 Russellville, AR 72801

11111~/Jruok Technical Center 5000 Dominion Boulevard Glen Allen, Virginia 23060 December 17, 1999 GL 99-070

• 99 OEr 29 A9 :26 Secretary, U.S. Nuclear Regulato~ *Commission Washington , D.C. 20555-0001 AD..... ..

Attn : Rulemaking and Adjudications Staff VIRGINIA POWER

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10 CFR 72.13 Applicability of Part 72 Virginia Power appreciates the opportunity to comment on the NRC's proposed rule, 10 CFR Part 72 Clarification and Addition of Flexibility, that was published in the Federal Register (Vol. 64, No. 212) on November 3, 1999, pages 59677 through 59684. While Virginia Power concurs with the proposed changes that will remove inconsistencies and streamline the licensing process for an applicant for a Certificate of Compliance, we have identified an apparent inconsistency in the section of the proposed rule that specifies which sections of Part 72 apply to holders of site specific licenses.

The proposed rule states in §72.13(b) that §72.180 applies to activities associated with a specific license. This would appear to require clarification as it is not consistent with a previously docketed NRC interpretation . §72.180 requires licensees to have a physical protection plan that meets the requirements of §73.51 . However, the NRC staff has determined that the provisions of §73.51 are not applicable to site specific licenses, as in the case of the North Anna or Surry ISFSls. This formal interpretation was documented in a letter to Virginia Power dated

• November 12, 1998. Therefore, we conclude that §72.180 can not be referenced as applicable to site specific licenses.

If the subject rule is adopted as proposed, it would appear to conflict with the NRC's previous determination for site specific licenses and would , in effect, endorse the applicability of §73.51 to site specific licenses.

If you need further information, please contact me at 804-273-2699 .

Respectfully,

/ 4 ~cCarthy, Manager Nuclear Licensing and Operat ons Support

U 24 1000 -

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0.S.NUCLEAA Htuv.... .,,1 1,,1Mlb~1U fl.lEMAKINGS&ADJ NS STAFF OfRCE 0Fll4E Sl!CRETA Y OF THE COMMISSION Document statlalllcr osbnartc oate I;;./,117 L.

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DOCKET UMBER PROPOSED RULE .PR 1:z 0 C,J.TL:-1 U( 1[7590-01-P]

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• 99 OC1 29 P2 :24 NUCLEAR REGULATORY COMMISSION 10 CFR Part 72 RIN 31 50-AG1 5 Clarification and Addition of Flexibility AGENCY: Nuclear Regulatory Commission.

ACTION: Proposed rule.

SUMMARY

The Nuclear Regulatory Commission (N RC) is proposing to amend its regulations on spent fuel storage to specify those sections of 10 CFR Part 72 that apply to general licensees, specific licensees, applicants for a specific license, certificate holders, and applicants for a certificate. The proposed amendment is* consistent with past NRC staff licensing practice and would eliminate any ambiguity for these persons by clarifying which portions of Part 72 apply to their activities.* This proposed rule would eliminate the necessity for repetitious Part 72 specific license hearing reviews of cask design issues that the Commission previously considered and resolved during approval of the cask design. This proposed rule would also allow an applicant for a Certificate of Compliance (CoC) to begin cask fabrication under an NRG-approved quality assurance (QA) program before the CoC is issued.

~~ I B; ,;:J /JO tJ DATES: Submit comments by (tnsei:t Elate 75 Ela¥& after pt1blieation date~. Comments received after this date will be considered if it is practical to do so, but the Commission is able to ensure consideration only for comments received on or before this date.

ADDRESSES: Comments may be sent by mail to the Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemakings and Adjudications Staff.

Hand deliver comments to: 11555 Rockville Pike, Rockville, Maryland, between 7:30 am and 4: 15 pm on Federal workdays.

You may also provide comments via the NRC's interactive rulemaking web site through the NRC home page (http://www.nrc.gov). This site provides the availability to upload comments as files (any format), if your web browser supports that function. For information about the interactive rulemaking site, contact Ms. Carol Gallagher (301) 415-5905; e-mail CAG@nrc.gov.

Certain documents related to this rulemaking, including comments received, the regulatory analysis, and a Table of Applicability, may be examined at the NRC Public Document Room, 2120 L Street NW. (Lower Level), Washington, DC. These same documents also may be viewed and downloaded electronically via the interactive rulemaking website established by NRC for this rulemaking.

FOR FURTHER INFORMATION CONTACT: Anthony DiPalo, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone (301) 415-6191, or e-mail at AJD@nrc.gov.

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SUPPLEMENTARY INFORMATION:

Background

The Commission's regulations at 10 CFR Part 72 were originally designed to provide specific licenses for the storage of spent nuclear fuel In an i,ndependent spent fuel storage

\

installation (ISFSI) (45 FR 74693; November 12, 1980). In 1990, the Commission amended Part 72 to include a process for approving the design of spent fuel storage casks and issuing a CoC (Subpart L) and for granting a general license to reactor licensees (Subpart K) to use NRC*

approved casks for the storage of spent nuclear fuel (55 FR 29181; August 17, 1990). Although the Commission intended that the requirements imposed in Subpart K for general licensees be

• used in addition to, rather than in lieu of, appropriate existing requirements, ambiguity exists as to which Part 72 requirements, other than those in Subpart K, are applicable to general licensees.

In addition, the Commission has identified two aspects of Part 72 where it would be desirable to reduce the regulatory burden and provide additional flexibility to applicants for a specific license or for a Coe.

First, the staff anticipates that the Commission may receive several applications for J

specific licenses for ISFSl's that will propose using storage cask designs previously approved by NRC under the provisions of Subpart L of Part 72 (i.e., cask designs that have been issued a CoC and are listed in§ 72.214). Section 72.18, MElimination of repetition,* permits an applicant to incorporate by reference information contained in previous applications, statements, or reports filed with the NRC, including cask designs approved under Subpart L. Section 72.46 requires that in an application for a license under Part 72, the Commission shall issue or cause to be issued a notice of proposed action and opportunity for a license hearing in accordance with 10 CFR Part 2. Under current Part 72 regulations, the adequacy of the design of these 3

previously approved casks could be at issue durirrg a § 72.46 license hearing for a specific license application ~.e., Issues on the cask design which have been previously addressed by the Commission, including resolution of public comments, that could be the subject of license hearings}.

Second,§ 72.234(c}, which was part of the 1990 ~mendments to Part 72, prohibits an applicant for a Coe from beginr:1ing fabrication of a spent fuel cask before the NRC issues a CoC for the cask design. However, an applicant for a specific license is currently allowed to begin fabrication of spent fuel storage casks before the license is .issued. At the time the 1990 rule was proposed, a commenter suggested that a fabricator (i.e. applicant for a CoC) be allowed to take the risk of beginning fabrication before the receipt of the CoC. However, the Commission took the position, *riJf a vendor has not received the certificate, then the vendor does not have the necessary approved specifications and may design and fabricate casks to meet incorrect criteria,* ( 55 FR 29185; August 17, 1990).

Since 1990, the Commission has reviewed and approved several cask designs. These reviews and follow-up requests for additional information have established. the NRC's expectation as to how its criteria'for cask design and fabrication should be met. In January 1997, the NRC published NUREG-1536, "Standard Review Plan for Dry Cask Storage Systems,* informing CoC applicants of its expectations in reviewing cask designs. Since then, the Commission has granted six exemptions from§ 72.234(c) allowing applicants to begin fabrication prior to issuance of the CoC. One exemption request is currently under review by NRC. Additional exemption requests frof!! § 72.234(c) requirements are anticipated.

4

Discussion Clarification:

This proposed rulemaking would eliminate the regulatory uncertainty that now exists in Part 72 by adding a new section § 72.13 which specifies which Part 72 regulations apply to general licensees, specific licensees, applicants for a specific license, certificate holders, and applicants for a Coe.

Flexibility:

First, this proposed rule would eliminate the necessity for repetitious § 72.46 specific license hearing board reviews of cask design issues that the Commission has previously considered during approval of the cask design. The Commission anticipates receipt of several applications, for specific ISFSI licenses, that will propose using storage cask designs previously approved by the NRC. Applicants for a specific license presently have the authority under

§ 72.18 to incorporate by reference into their application, information contained in previous applications, statements, or reports filed with the Commission, including information from the Safety Analysis Report on a cask design previously approved by the NRC under the provisions of Subpart L. The Commission believes previously reviewed cask design issues should be excluded from the scope of a license hearing. This is because the public had the right during the Subpart L approval process to comment on the adequacy of the cask design. The right of

.the public to comment on cask designs would not be affected by this rulemaking. For new cask design issues, this rulemaking would not limit the scope of staffs review of the application or of license hearings. For example, a cask's previously reviewed and approved thermal, criticality, and structural designs could not be raised as issues in a licensing hearing. However, design interface issues between the approved cask design and specific site characteristics (e.g.,

5

meteorological, seismological, radiological, and hydrclogical) or changes to the cask's approved design may be raised as issues at a potential hearing. Furthermore, the rights of the public to petition the Commission under § 2.206 to raise new safety issues on the adequacy of the cask design would not be affected by this rulemaking.

Second, the proposed rule would permit an applicant for approval of a spent fuel storage cask design under Subpart L to begin fabrication of casks before the NRC has approved the cask desig,n and issued the Coe. Currently, an applicant for a Coe is not permitted under

§ 72.234(c) to begin cask fabrication until after the CoC is issued. Applicants for a specific license, and their contractors, are currently allowed to begin fabrication of casks before the Commission issues their license. However, general licensees and their contractors (Le, the certificate holder) are not allowed to begin fabrication before the CoC is issued. Consequently, this proposed rule would eliminate NRC's disparate treatment between general and specific licensees. In addition to allowing an applicant for a CoC to begin fabrication of a cask, comments would be requested on the need for a general licensee to also begin fabrication of a cask before issuance of the Coe. The Commission and the staff have previously determined that exemptions from th~ fabrication prohibition are authorized by law and do not endanger life or property, the common defense, or security and are otherwise in the public interest. The Commission anticipates that additional cask designs will be submitted to the NRC for approval and expects that these designs will be similar in nature to those cask designs that have already been approved. The Commission also expects that exemption requests to permit fabrication would also be received. This rulemaking would eliminate the need for such exemption requests.

This proposed rule would revise the quality assurance regulations in Subpart G of Part 72 to require that an applicant for a CoC, who voluntarily wishes to begin cask fabrication, must conduct cask fabrication under an NRC-approved QA program. Currently, applicants for a CoC 6

are required by§ 72.234(b) to conduct design, fabrication, testing, and maintenance activities under a QA program that meet the requirements of Subpart G. Prior NRC approval of the applicant's QA program is not required by§' 72.234(b). However, § 72.234(c) precludes cask fabrication until after the Coe is issued. The Commission believes this proposed rule is a conditional relaxation to permit fabrication before the CoC is issued. Since NRC staff would approve the applicant's QA program as part of issuance of a CoC, staff approval of the QA program prior to fabrication is a question of timing (e.g., when the program is approved, as opposed to imposing a new requirement for approval of a program). The Commission expects that any financial or scheduler risks associated with fabrication of casks prior to issuance of the CoC would be borne by the applicant. The Commission believes that the proposed rule is~not a backfit because§ 72.62 applies to licensees after the license is issued and does not apply to applicants prior to issuance of the license or CoC. This rule would require that a cask for which fabrication was initiated before issuance of the Coe must'conform to the issued CoC before it may be used.

This proposed rule would also require an applicant for a specific license, who voluntarily wishes to begin fabrication of casks before the license is issued, to conduct fabrication under an NRG-approved QA program. Currently, an applicant for a specific license is required by

§ 72.140(c) to obtain NRC approval of its QA program before spent fuel is loaded into the ISFSI.

The Commission does not believe this proposed ,rule would impose a separate requirement, rather it would require different timing on when the QA program is approved.

This proposed rule would also revise§ 72.140(d) to allow a licensee, applicant for a license, certificate holder, and applicant for a CoC to use an existing Part 50, 71, or 72 QA program that was previously approved by the NRC.

7

As a result of this proposed rule, both licensees and certificate holders will be required to accomplish any fabrication activities under an NRC--approved QA program. The Commission believes this proposed rule's increase in flexibility and change in timing of approval of a QA program is not a backfrt.

In addition to an applicant's fabrication of a cask design prior to issuance of the CoC, the Commission is requesting comments on the need for a general licensee to also begin fabrication of a cask design, before the cask design is approved and the CoC is issued.

Section by Section Discussion of Proposed Amendments This proposed rule would make several amendment changes to Part 72 which are characterized as follows. This proposed rule would eliminate the regulatory uncertainty that now exists in Part 72 and explicitly specifies which regulations apply to general licensees, specific licensees, and certificate holders. The proposed rule would eliminate the necessity for repetitious reviews in a specific license hearing of cask design issues that the Commission previously considered during approval of the cask design. The proposed rule would permit an applicant for approval of a spent fuel storage cask design to.begin cask fabrication, at its own risk, before the NRC has issued the Coe. The proposed rule would require that NRC approval of the quality assurance program be obtained before cask fabrication can commence.

§ 72 .13 Applicability.

This new section identifies those sections of Part 72 that apply to specific licenses, general licenses, and Certificates of Compliance. No changes to the underlying regulations would result from this amendment, it is intended for clarification only.

8

§ 72.46 Public hearings.

A new paragraph (e) would be added to this section to Indicate that the scope of any license hearing, for an application for an ISFSI license, shall not include any issues that were previously resolved by the Commission during the approval process of the design of a spent fuel storage cask, when the application incorporates by reference, information on the design of an NRG-approved spent fuel storage cask. The Commission considers rereview of cask design issues, which have been previously resolved as an unnecessary regulatory burden on applicants causing unnecessary expenditure of staff and hearing board resources. For example, the cask's previously reviewed and approved thermal, criticality, and structural designs could not be raised as issues in a hearing. However, design interface issues between the.

approved cask design and specific site characteristics (e.g., meteorological, seismological, radiological, and hydrological) or changes to the cask's approved design may be raised as issues at a potential hearing.

This proposed rulemaking would not limit the scope of staff's review of the application or of license het![ings, for new cask design issues that were not considered by the Commissi9n during previous approval of the* cask design. In addition, the rights of the public to petition the

• Commission under§ 2.206 to raise new safety issues on the adequacy of the cask design would not be affected by this rulemaking.

§ 72.86 Criminal penalties.

Paragraph (b) of this section lists those Part 72 regulations for which criminal sanctions may not be issued, because the Commission considers these sections to be non-substantive regulations issued under the provisions of§ 161 {b), (i), or (o) of the Atomic Energy Act of 1954 (AEA).

9

Substantive regulations are those regulation~ tr.at create duties, obligations, conditions, restrictions, limitations, and prohibitions (see final rule on "Clarification of Statutory Authori!}' for Purposes of Criminal Enforcement* (57 FR 55062; November 24, 1992)). The Commission considers that the new § 72.13 would not be a substantive regulation, issued under the provisions of§ 161 (b}, {i), or (o) of the AEA Therefore, paragraph {b) of this section WOL!ld be revised to add § 72.13 to indicate that willful violations of this new section would not be subject to criminal penalties.

§ 72.140 Quality assurance requirements.

Paragraph (c)(1) would be revised to add applicants for a specific license and applicants for a Coe. Paragraph (c)(2) would be revised to add the requirement that an applicant for a specific license shall obtain NRC-approval of its QA program before beginning fabrication or testing of a spent fuel storage cask. Paragraph (c)(3) would be revised to indicate that an applicant for a Coe shall obtain NRC:.approval of its QA program requirement before beginning fabrication or testing of a spent fuel storage cask. These revisions would result in consistent

• treatment of general licensees, specific licensees, applicants for a specific license, certificate holders, and applicants for a CoC. These revisions would also ensure that the NRC has reviewed and approved a QA program before commencement of any fabrication or testing activities.

Paragraph (d) would be revised to clarify the use of previously approved QA programs by a licensee, applicant for a license, certificate holder, and applicant for a CoC. The Commission expects these persons to notify the NRC of their intent to use a QA program previously approved by the NRC under the provisions of Parts 50, 71, or 72.

§ 72.234 Conditions of approval.

Paragraph (c) of this section would be revised to permit an applicant for a Coe to begin I

fabrication of spent fuel storage casks (under an NRC-approved QA program), at the applicant's own risk, before the NRC issues the CoC. The Commission expects that any risks associa~ed with fabrication (e.g., rewelding, reinspection, or even abandonment of the cask) would be borne by the applicant. The NRC would also require that a cask fabricated before the Coe was issued conform to the issued CoC before spent fuel is loaded. Requiring an applicant to conform a fabricated cask to the issued Coe would not be subject to the backfit review provisions of§ 72.62 .

• § 72.236 Specific requirements for spent fuel storage cask approval.

The introductory text in this section before paragraph (a) would be revised as a

\

conforming change to§ 72.234(c) to indicate that all of the requirements in this secti9n apply to both certificate holders and applicants for a CoC.

Criminal Penalties .r For the purposes of Section 223 of the Atomic Energy Act (AEA), the Commissior'!~s issuing t~e proposed rule to amend 10 CFR 72.140, 72.234, and 72.236 under one or more of

• Sections 161b, 161i, or 1610 of the AEA. Willful violations of the rule would be subject to criminal enforcement.

Agreement State Compatibility Under the "Policy Statement on Adequacy and Compatibility of Agreement State Programs" approved by the Commission on June 30, 1997, and published in the Federal 1

Register on September 3, 1997 (62 FR 46517), this proposed rule is classified as Category NRC. Compatibility is not required for Category NRC regulations. The NRC program elements 11

in this category are those that relate directly to ar~as of regulation reserved to the NRC by the AEA or the provisions of Title 1O of the Code of Federal Regulations.

Plain Language The Presidential Memorandum dated June 1, 1998, entitled, aPlain Language in Govemment*Writing," directed that the government's writing be in plain language. The NRC requests comments on this proposed rule specifically with respect to the clarity and effectiveness of the language used. Comments should be sent to the address listed under the heading "ADDRESSESb above.

Voluntary Consensus Standards The National Technology Transfer Act of 1995, (Pub. L. 104-113), requires that Federal agencies use technical standards that are developed or adopted by voluntary consensus standards bodies unless the use of such a standard is inconsistent with applicable law or otherwise impractical. The NRC is proposing to amend its regulations on spent fuel storage in those sections of 10 CFR Part 72 that apply to general licensees, specific licensee.s, applicants for a specific license, certificate holders, and applicants for a certificate. This proposed rule would eliminate the necessity for repetitious Part 72 specific license hearing reviews of cask design issues that the Commission previously considered and resolved during approval of the f

cask design. This proposed rule would also allow an applicant for a Certificate of Compliance (CoC) to begin cask fabrication before the CoC is issued. This action does not constitLJte the establishment of a standard that establishes generally applicable requirements.

Environmental Impact: Categorical Exclusion The NRC has determined that this proposed rule is the type of action described in the categorical exclusion in 10 CFR 51.22(c)(2) and (3). This action represents amendments to the regulations which are corrective or of a minor *Or nonpolicy nature and do not substantially 12

modify the existing regulations. Therefore, neither .an environmental impact statement nor an environmental assessment has been prepared for this proposed rule.

Paperwork Reduction Act Statement This proposed rule would decrease the burden on licensees by eliminating the requirement to request an exemption to begin cask design before a license is issued, and by allowing all licensees and Coe holders to reference previously approved QA programs. The public burden reduction for this information collection would average 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> per exemption request. However, because no burden has previously been approved for exemption requests and no licensees are expected to reference previously approved QA programs in the foreseeable future, no burden reduction can be taken for this rulemaking. Existing requirements were approved by the Office of Management and Budget, approval number 3150-0132.

Public Protection Notification If a means used to impose an information collection does not display a currently valid 0MB control number, the NRC may not conduct or sponsor, and a person is not. required to respond to, the information collection.

Regulatory Analysis Statement of the Problem and Objective:

The Commission's regulations at 10 CFR Part 72 were originally designed to provide specific licenses for the storage of spent nuclear fuel in independent spent fuel storage installations (ISFSls) {45 FR 74693; November 12, 1980). In 1990, the Commission amended Part 72 to include a process for approving the dE?sign of spent fuel storage casks and issuance of a Coe (Subpart L); and for granting a general license to reactor licensees {Subpart K) to use NRC-approved casks for storage of spent nuclear fuel (55 FR 29181; August 17, 1990).

Although the Commission intended that the requirements imposed in Subpart K for general 13

licensees be used in addition to, rather than in lieu of, appropriate existing requirements, ambiguity exists as to which of the Part 72 requirements, other than those in Subpart K, are applicable to general licensees. This rulemaking would resolve that ambiguity.

In addition, the Commission has identified two aspects of Part 72 where it would be desirable to reduce the regulatory burden for applicants, NRC staff, and hearing boards and to afford additional flexibility to applicants for a CoC:

First, this proposed rule would eliminate the necessity for. repetitious reviews, during a Part 72 specific license hearing (§ 72.46), of cask design issues that the Commission has previously considered during approval of the cask design. The Commission anticipates receipt of several applications, far specific ISFSI licenses, that will propose using storage cask designs previously approved by the NRC. Applicants for a specific license presently have the authority under § 72.18 to incorporate by reference into their application, information contained in previous applications, statements, or reports filed with the Commission, including information from the Safety Analysis Report for a cask design previously approved by the NRC under the provisions of Subpart L. The Commission believes previously reviewed cask design issues should be excluded from the scope of a license hearing. This is because the public had the right to question the adequacy of the cask design, during the approval process under Subpart L. The right of the public to comment on cask designs would not be affected by thi$ rulemaking. For new cask design issues, this rulemaking would not limit the scope of staff's review of the application or of license hearings. For example, a cask's previously reviewed and approved thermal, criticality, and strµctural designs could not be raised as issues in a hearing. However, design interface issues between the approved cask design and specific site characteristics (e.g.,

meteorological, seismological, radiological, and hydrological) or changes to the cask's approved design may be raised as issues at a potential hearing. In addition, the rights of the public to 14

\..

petition the Commission under § 2.206 to raise new safety issues on the adequacy of the cask design would not be affected by this rulemaklng.

Second, the proposed rule would permit an applicant for approval of a spent fuel storage cask design under Subpart L to begin fabrication of casks before the NRC has approved the cask.design and issued the Coe. Currently, an applicant for a CoC is not permitted under

§ 72.234(c) to begin cask fabrication until after the CoC is issued. Applicants for a specific license, and their contractors, are currently allowed to begin fabrication of casks before the Commission issues their license. However, general licensees and their contractors (i.e, the certificate holder) are not allowed to begin fabrication before the CoC is issued. Consequently, this proposed rule would eliminate NRC's disparate treatment between general and speciijc licensees. In addition to allowing an applicant for a CoC to begin fabrication of a ,cask prior to issuance of the CoC, comments would be requested on the need for a general licensee to also begin fabrication of a cask before the CoC is issued. The Commission and the staff have previously determined that exemptions from the fabrication prohibition are autho~zed by law and do not endanger life or property, the common defense, or security and are otherwise in the public Interest. The Commission anticipates that additional cask designs will be submitted to the NRC for approval and expects that these designs will be similar in nature to those cask designs that have already been approved. The Commission also expects that exemption requests to permit fabrication would also be received. Therefore, this rulemaking would eliminate the need for such exemption requests.

This proposed rule would revise the quality assurance regulations in Subpart G of Part 72 to require that an applicant for a CoC, who voluntarily wishes to begin cask fabrication, must conduct cask fabrication under an NRG-approved QA program. Currently, applicants for a Coe are required by§ 72.234(b) to conduct design, fabrication, testing, and maintenance 15

activities *under a QA program that meets the requirements of Subpart G. Prior NRC approval of the applicant's QA program is not required by§ 72.234(b). However,§ 72.234(c) precludes I

cask fabrication until after the CoC is issued. The Commission believes this proposed rule is a conditional relaxation to permit fabrication before the Coe is issued. Since NRC staff would approve the applicant's QA program as part of issuance of a Coe, staff approval of the QA program prior,to fabrication is a question of timing (E!-9-,.when the program is approved, as opposed to imposing a new requirement for approval of a program). The Commission expects that any financial ofscheduler risks associated with fabrication of casks prior to issuance of the CoC would be borne by the applicant. The Commission believes that the proposed rule is not a backfit because§ 72.62 applies to licensees after the license is issued and does not apply to applil:::ants prior to issuance of the license or Coe.' This rule would require that a cask for which' fabrication was initiated before issuance of the CoC must conform to the issued CoC before it may be used.

I This proposed rule would also require an applicant for a specific license, who voluntarily wishes to begin fabrication of casks before the license is issued, to conduct fabrication und~r an NRG-approved QA program. Currently, an applicant for a specific license is required by

§ 72.140(c) to obtain NRC approval of its QA program before spent fuel is loaded into the ISFSI.

The Commission does not believe this proposed rule would impose a separate requirement, rather it would require different timing on when the QA program is approved.

This proposed rule would also revise§ 72.140(d) to allow a licensee, applicant for a license, certificate holder, and applicant for a Coe to use an existing Part 5_0, 71, or 72 QA program that was previously approved by the NRC.

As a result of this proposed rule both licensees and certificate holders will be required to a~complish any fabrication activities under an NRG-approved QA program. The Commission 16

believes this proposed rule's Increase in flexibility and change in timing of approval of a QA program is not a backfrt.

The Commission expects that any risks associated with fabrication (e.g., rewelding, reinspection, or even abandonment of the cask) would be borne by the applicant. In particular, the staff would require that a cask, which was fabricated before the CoC was issued, must conform with the issued CoC. Requiring an applicant to conform a fabricated cask to the issued Coe would not be subject to the backfit review provisions of§ 72.62.

Identification and Preliminary Analysis of Alternative Approaches to the Problem:

• Option 1 - Conduct a rulemaking that would address the ,regulatory problems as

• described above.

First, this proposed rulemaking would specify the sections in Part ?2 that apply to general licensees, specific licensees, and certificate holders. This would eliminate the need to resolve on a case-by-case basis questions on which Part 72 sections are applicable to those activities. The proposed rule is administrative in nature and other than 'the cost of rulemaking, would have no impact.

Second, this rulemaking would reduce the regulatory burden on applicants, staff, and hearing board resources relating to any § 72.46 license hearings involving cask design issues associated with an application for a specific license, where the cask design has been previously approved by the NRC. Elimination of the need for repetitious reviews of cask design issues and licensing hearings on these same cask design issues together would save 1.0 FTE of applicant effort and 1.0 FTE of staff effort for each license application received. NRC expects to receive three applications in 1999 and six applications each year in 2000 and 2001. While applicants for a license are currently allowed to incorporate by reference information on cask design information, this 17

rulemaking would reduce applicant burden a.::;-sociated with pr'?viding additional information on the cask design and responding to hearing board contentions on issues which have been previously reviewed.

Third, this rulemaking would also proviqe increased flexibility to applicants for a Coe by allowing them to begin cask fabrication, before the Coe is issued. This rulemaking would reduce the burden on applicants for a Coe associated with submission of requests for exemption from§ 72.234(c). Certificate holders have requested these exemptions to take advantage of favorable business conditions (i.e., they want to begin fabrication of casks a soon as possible to meet their contract obligations). Elimination of the need for submission and review of exemption requests from the cask fabrication requirement of§ 72.234(c) would save 0.1 FTE of applicant effort and 0.1 FTE of staff effort, for each exemption request not received. Without this action, NRC expects that two requests for exemption from§ 72.234(c) would be received each year in 1999 and beyond. This rulemaking would also eliminate the disparate treatment of general and r

specific licensees under Part 72, with respect to fabrication of spent fuel storage casks.

This rulemaking would also reduce staff burden associated with review of such exemption requests. Because a certificate holder is currently required by~ 72.140(c)(3) to obtain NRC approval of its QA program before commencing fabrication, and the staff is currently required to review and approve such programs, no increase in applicant burden or staff resources would occur with respect to the proposed change to

§ 72.140(c)(3). However, the timing of the staff review and approval of the QA program would change.

The impact of this option consists primarily of a reduction in regulatory burden on an applicant for a specific license, a reduction in regulatory burden and increase in 18

regulatory flexibility for an applicant for a cask design, and a reduction in the expenditure of NRC resources involved in reviewing applications for a specific license, supporting license hearings, and reviewing requests for exemption from§ 72.234(c). This option would result in the expenditure of NRC resources to conduct this rulemak.ing.

• Option 2- No action .

The benefit of the no action alternative is that NRC resources will be conserved because no rulemak.ing would be conducted. The impact of this alternative would be that the regulatory problems described above would not be addressed. Instead, applicant and staff resources will continue to be expended on repetitious reviews of previously

• approved cask designs, conducting licensing hearings on previously approved cask*

design issues, and processing requests for exemption from§ 72.234{c), to allow fabrication of casks.

Estimation and Evaluation of Values and Impacts:

The clarification of which Part 72 sections apply to specific licensees, applicants for a specific license, general licensees, certificate holders, and applicants for a Coe alone would_

have no impacts other than the cost of rulemak.ing, because this action is administrative in

• nature.

The elimination of the need for repetitious reviews of cask design issues, that were previously reviewed by the NRC, and elimination of licensing hearings on these same cask design issues together would save 1.0 FTE of applicant effort and 1.0 FTE of staff effort for each license application received. NRC expects to receive three applications in 1999 and six applications each year in 2000 and 2001.

The elimination of the need for submission and review of exemption requests from the

~sk fabrication requirement of§ 72.234{c) would save 0.1 FTE of applicant effort and 0.1 FTE 19

of staff effort, for each exemption request not receiived. Without this action, NRC expects that two requests for exemption from§ 72.234(c) would be received each year in_ 1999 and beyond.

Presentation of Results:

The recommended action is to adopt the first option because it will set forth a clear regulatory base for Part 72 general licensees, specific licensees, applicants for a specific license, certificate holders, and applicants for a Coe.

The recommended action would eliminate the need for repetitious license hearing adjudication of cask design issues that the Commission has previously reviewed in approving the cask design, when an applicant for a specific license has incorporated by reference a cask design tnat has been approved by the Com*mission under the provisions of Subpart L. This is because the public had the right to question the adequacy of the cask design during the approval process under Subpart L. The right of the public to comment on cask designs would not be affected by this rulemaking. This rulemaking would not limit the scope of staff's review of the application or license hearings for issues which were not considered by the Commission during previous approval of the cask design. In addition, the rights of the public to petition the Commission under § 2.206 to raise new safety issues on the adequacy of the cask design would not be affected by this rulemaking. The Commission considers rereview of cask design issues which have been previously evaluated and dispositioned as an unnecessary regulatory burden on appliqants and an-unnecessary expenditure of staff and hearing board resources. For example, the cask's previously reviewed and approved thermal, criticality, and structural designs could not be raised as issues in a hearing. However, design interface issues between the approved cask design and specific site characteristics (e.g., meteorological, seismological, radiological, and hydrological) or changes to the cask's approved design may be raised as issues at a potential hearing. Therefore, this action has no safety impact.

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The recommended action would permit an applicant for approyal of a spent fuel storage cask design under Subpart L to begin fabrication of casks before the NRC has approved the cask design and issued the CoC. Currently, an applicant for a CoC is not permitted under

§ 72.234(c) to begin cask fabrication until after the Coe is issued. Applicants for a specific license, and their contractors, are currently allowed to begin fabrication of casks before the Commission issues their license. However, general licensees and their contractors (i.e, the certificate holder) are not allowed to begin fabrication before the CoC is issued. Consequently, this proposed rule would eliminate NRC's disparate treatment between general and specific licensees. In addition to allowing an applicant for a Coe to begin fabrication of a cask prior to issuance of the CoC, comments would be requested on the need for a general licensee to also begin fabrication of a cask before the Coe is issued. The Commission and the staff have previously determined that exemptions from the fabrication prohibition are authorized by law and do not endanger life or property, the common defense, or security and are otherwise in the public interest. The Commission anticipates that additional cask designs will t;,e s.ubmitted to the NRC for approval and expects that these designs will be similar in nature to those cask de$igns that have already been approved. The Commission also expects that exemption requests to permit fabrication would also be received. Therefore, this rulemaking would eliminate the need for such exemption requests.

This proposed rule would revise the quality assurance regulations in Subpart G of Part 72 to require that an applicant for a CoC, who voluntarily wishes to begin cask fabrication, must conduct cask fabrication under an NRG-approved QA program. Currently, applicants for a CoC are required by§ 72.234(b) to conduct design, fabrication, testing, and maintenance activities under a QA program that meet the requirements of Subpart G. Prior NRC approval of the applicant's QA program Is not required by§ 72.234(b). However,§ 72.234(c) precludes cask 21

fabrication until after the CoC is Issued. The Commis3ion believes this proposed rule Is a conditional relaxation to permit fabrication before the Coe is issued. Since NRC staff would approve the applicant's QA program as part of issuance of a Coe, staff approval of the QA program prior to fabrication is a question of timing (e.g., when the program Is approved, as opposed to imposing a new requirement for approval of a program). The Commission expects that any financial or scheduler risks associated with fabrication of casks prior to issuance of the CoC would be borne by the applicant. The Commission believes that the proposed rule is not a ,

backfit because § 72.62 applies to licensees after the license is issued and does not apply to applicants prior to issuance of the license or Coe. This rule would require that a cask for which fabrication was initiated before issuance of the Coe must conform to the issued CoC before it may be used.

This proposed rule would also require an applicant for a specific license, who voluntarily wishes to begin fabrication of casks before the license is issued, to conduct fabrication under an NRC-approved QA program. Currently, an applicant for a specific license is required by

§ 72.140(c} to obtain NRC approval of its QA program before spent fuel is loaded into the ISFSI.

The Commission does not believe this proposed rule would impose a separate requirement, rather it would require different timing on when the QA program is approved.

This proposed rule would also revise§ 72.140(d) to allow a licensee, applicant for a

\

license, certificate holder, and applicant for a Coe to use an existing Part 50, 71, or 72 QA program that was previously approved by the NRC.

As a result of this proposed rule, both licensees and certificate holders will be required to conduct any fabrication activities under an NRC-approved QA program. The Commission believes this proposed rule's increase in flexibility and change in timing of approval of a QA program is not a backfrt. Therefore, these actions have no safety impact.

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The Commission expects that any risks associated with fabrication (e.g., rewelding, reinspectlon, or even abandonment of the cask) would be borne by the applicant. In particular, the staff would require that a cask, which was fabricated before the Coe was issued, must conform with the issued CoC. Requiring an applicant to conform a fabricated cask to the issued CQC would not be subject to the backfit review provisions of§ 72.62.

The total cost of this rulemaking to the NRC is estimated at 1.9 FTE. The total savings to the NRC for this rule making is estimated at 16.5 FTE over a 3-year period ( 1999 through 2001 ).

The total savings to applicants is estimated at 15.0 FTE over the same 3-year period.

Therefore, this action would be considered cost beneficial to both NRC and applicants, would

• reduce the burden on applicants, and would improve the efficiency and effectiveness of the NRC. Consequently, the Commission believes public confidence in the safe storage of spent fuel at independent spent fuel storage installations would not be adversely affected by this rulemaking.

Decision Rationale:

The rationale is to proceed with this proposed rulemaking implementing the Commission' approved rulemaking plan. This rulemaking would save both staff and applicant resources as

• discussed above.

The clarification of the provisions of Part 72 and their application to general licensees, specific licensees, applicants for a specific license, certificate holders, and applicants for a Coe is administrative in nature and would have no safety impacts.

The elimination of the need for repetitious license hearings on cask design issues, that the NRC has previously reviewed and approved, in..,an application for a specific license would have no safety impacts. The public's right to comment on cask design issues, through the Subpart L cask approval process, will remain unchanged.

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The flexibility to begin fabrication cask fabrication before the NRC issues the CoC, when combined with the requirement that cask fabrication must be performed under an NRC-approved QA program, would have no safety impacts.

Regulatory Flexibility Certification As required by the Regulatory Flexibility Act (5 U.S.C. 605(b)), the Commission certifies that this proposed rule, if adopted, would not have a significant economic impact on a substantial number of small entities. This proposed rule would clearly specify which sections of Part 72 apply to general licensees, specific licensees, applicants for a specific license, certificate holders, and applicants for a certificate and allow these persons to determine which Part 72 regulations apply to their activity. This clarification will eliminate the ambiguity that now exists. This proposed rule would also eliminate the need for repetitious license-hearing reviews of cask design issues, that were previously reviewed and approved by the NRC, when the applicant for a specific license incorporates by reference information on a cask design that was previously approved by the NRC. Finally, this proposed rule would allow applicants for a CoC to begin fabrication of a cask design before the NRC has issued a CoC. Applicants desiring to begin fabrication shall use an NRC-approval QA program. .The requirement to obtain NRC-approval of the applicant's QA program is not considered an additional burden. An applicant who has been issued a Coe, and is then considered a certificate holder, is currently required by§ 72.140(c)(2) to obtain NRC-approval before fabrication or testing is commenced; consequently, no actual increase in burden occurs. Similarly, an applicant for a license is currently required to obtain NRC-approval prior to receipt of spent fuel or high-level waste; consequently, no actual increase in burden occurs. This proposed rule does not impose any additional obligations on entities that may fall within the definition of "small entities" as set forth in Section 601 (6) of the Regulatory Flexibility Act; or within the definition of "small business" as 24

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found in Section 3 of the Small Business Act, 15 U.S.C. 632; or within the size standards adopted by the NRC on April 11, 1985 (60 FR 18344).

Backfrt Analysis The NRC has determined that the backfrt rule, § 72.62, does not apply to this proposed rule. Because these amendments would not involve any provisions that would impose backfits as defined in § 72.62(a), a backfit analysis is not required.

List of Subjects in 10 CFR Part 72 Criminal penalties, Manpower training programs, Nuclear materials, Occupational safety and health, Reporting and recordkeeping requirements, Security measures, Spent fuel.

For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974, as amended, and 5 U.S.C. 553t the NRC is proposing to adopt the following amendments to 10 CFR Part 72.

PART 72 - LICENSING REQUIREMENTS FOR THE INDEPENDENT STORAGE_

OF SPENT NUCLEAR FUEL AND HIGH-LEVEL RADIOACTIVE WASTE

1. The authority citation for Part 72 continues to read as follows:

AUTHORITY: Secs. 51, 53, 57, 62, 63, 65, 69, 81, 161, 182, 183, 184, 186, 187, 189, 68 Stat. 929, 930, 932, 934, 935, 948, 953, 954, 955, as amended, sec. 234, 83 Stat. 444, as amended{42U.S.C.2071,2073,2077,2092,2093,2095,2099,2111,2201,2232,2233, 2234, 2236, 2237, 2238, 2282); sec. 274, Pub. L.86-373, 73 Stat. 688, as amended (42 U.S.C. 2021);

sec. 201, as amended, 202,206, 88 Stat. 1242, as amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846); Pub. L.95-601, sec. 10, 92 Stat. 2951 as amended by Pub. L. 102-486, sec. 7902, 25

106 Stat. 3123 (42 U.S.C. 5851); sec. 102, Pub. L. 91-*i90, 83 Stat. 853 (42 U.S.C. 4332); Secs. 131, 132, 133, 135, 137, 141, Pub. L.97-425, 96 Stat. 2229, 2230, 2232, 2241, sec. 148, Pub.

L. 100-203, 101 Stat. 1330-235 (42 U.S.C. 10151, 10152, 10153, 10155, 10157, 10161, 10168).

I Section 72.44(g) also issued under secs. 142(b) and 148(c), (d), Pub. L. 100-203, 101 Stat. 1330-232, 1330-236 (42 U.S.C. 10162(b), 10168(c), (d)). Section 72.46 also issued under sec. 189, 68 Stat. 955 (42 U.S.C. 2239); sec. 134, Pub. L.97-425, 96 Stat. 2230 (42 U.S.C.

10154). Section 72.96{d) also issued under sec. 145(g), Pub. L. 100-203, 1Q1 Stat. 1330-235 (42 U.S.C. 10165(g)}. Subpart J also issued under secs. 2(2), 2(15), 2(19), 117(a), 141(h), Pub.

L.97-425, 96 Stat. 2202, 2203, 2204, 2222, 2224 (42 U.S.C. 10101, 10137(a), 10161(h)).

Subparts Kand Lare also issued under sec. 133, 98 Stat. 2230 (42 U.S.C. 10153) and sec. 218(a), 96 Stat. 2252 (42 U.S.C. 10198).

2. Section 72.13 is added to read as follows:

§ 72.13 Appllcabillty.

(a) This section identifies those sections, under this part, that apply to the activities associated with a specific license, a general license, or a certificate of compliance.

(b) The following sections apply to activities associated with a specific license: §§ 72.1; 72.2(a) through (e); 72.3 through 72.13(b); 72.16 through 72.34; 72.40 through 72.62; 72.70 through 72.86; 72.90 through 72.108; 72.120 through 72.130; 72.140 through 72.176; 72.180 through 72.186; 72.190 through 72.194; and 72.200 through 72.206.

(c) The following sections apply to activities associated with a general license: §§ 72.1; 72.2(a)(1), (b), (c), and (e); 72.3 through 72.6(c)(1); 72.7 through 72.13(a) and (c); 72.30(c) and

(~); 72.32(c) and 72.32(d); 72.44(b), (d), (e), and (f); 72.48; 72.S0(a); 72.52; 72.54(d) through 26

\,

(m); 72.60; 72.62; 72.72 through 72.S0(f); 72.82 through 72.86; 72.104; 72.106; 72.122; 72.124; 72.126; 72.140 through 72.176; 72.190 through 72.194; 72.210; 72.212; and 72.216 through 72.220.

(d) The following sections apply to activities associated with a certificate of compliance:

")

§§ 72.1; 72.2(e) and (f); 72.3; 72.4; 72.5; 72.7; 72.9through 72.13(a) and {d); 72.48; 72.84(a);

72.86; 72.124; 72.140 through 72.176; 72.214; and 72.230 through 72.248.

3. In § 72.46, paragraph (e) is added to read as follows:

§ 72.46 Public hearings.

(e) If an application for (or an amendment to) a specific license issued under this part incorporates by reference information on the design of an NRC-approved spent fuel storage cask, the scope of any public hearing held to consider t~e application will not include any cask design issues previously addressed by the Commission when it issued a Certificate of Compliance under subpart L of this part.

4. In§ 72.86, paragraph (b) is revised to read as follows:

§ 72.86 Crimlnal penalties.

(b) The regulations in Part 72 that are not issued under sections 161b, 161i, or 1610 for the purposes of section 223 are as follows: §§ 72.1, 72.2, 72.3, 72.4, 72.5, 72. 7, 72.8, 72.9, 72.13, 72.16, 72.18, 72.20, 72.22, 72.2( 72.26, 72.28, 72.32, 72.34, 72.40, 72.46, 72.56, 72.58, 27

72.60, 72.62, 72.84, 72.86, 72.90, 72.96, 72.108, 7_2.120,.72.122, 72.124, 72.126, 72.128, 72.130, 72.182, 72.194, 72.200, 72.202, 72.204, 72.206, 72.210, 72.214, 72.220, 72.230, 72.238, and 72.240.

5. In§ 72.140, paragraphs (c) and (d) are revised to read as follo~s;

§ 72.140 Quality assurance requirements.

(c) Approval of program:

(1) Each licensee, applicant for a license, certificate holder, or applicant for a CoC shall file a description of its quality assurance program, including a discussion of which requirements of this subpart are applicable and how they will be satisfied, in accordance with § 72.4.

(2) Each licensee shall obtain Commission approval of its quality assurance program prior to receipt_ of spent fuel at the ISFSI or spent fuel and high-level radioactive waste at the MRS. Each licensee or applicant for a specific license shall obtain Commission approval of its quality assurance program prior to commencing fabrication or testing of a spent fuel storage cask.

(3) Each *certificate holder or applicant for a CoC shall obtain Commission approval of its quality assurance program prior to commencing fabrication or testing of a spent fuel storage cask.

(d) Previously approved programs. A quality assurance program previously approved by the Commission as satisfying the requirements of Appendix B to part 50 of this chapter, subpart H to part 71 of this chapter, or subpart G to this part will be accepted as satisfying the requirements of paragraph (b) of this section, except that a licensee, applicant for a license, 28

certificate holder, and applicant for a CoC who is using an Appendix B or subpart H quality assurance program shall also meet the recordkeeplng requirements of§ 72.174. In filing th1e description of the quality assurance program required by paragraph (c) of this section, each licensee, applicant for a license, certificate holder, and applicant for a Coe shall notify the NRC, in accordance with § 72.4, of its intent to apply its previously approved quality assurance program to ISFSI activities or spent fuel storage cask activities. The notificat\on shall identify the previously approved quality assurance program by date of submittal to the Commission, docket number, and date of Commission approval.

6. In§ 72.234, paragraph (c) is revised to read as follows:

§ 72.234 Conditions of approval.

(c) An applicant for a CoC may begin fabrication of spent fuel storage casks before the Commission issues a Coe for the cask; however, applicants who begin fabrication of casks without a Coe do so at their own risk. A cask fabricated before the Coe is issued shall be: made to conform to the issued Coe prior to being placed in service or prior to spent fuel being loaded.

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7. Section 72.236 is revised to read as follows:

§ 72.236 Specific requirements for spent fuel storage cask approval.

The certificate holder and applicant for a CoC shall ensure that the requirements of this section are met.

Dated at Rockville, Maryland, this ol.(e day of 06\:p~ , 1999.

For the Nuclear Regulatory Commission.

Annette L. Vietti-Cook, Secretary of the Commission.

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