**NRC INSPECTION MANUAL**	NMSS/DFM

INSPECTION PROCEDURE 60857

REVIEW OF 10 CFR 72.48 EVALUATIONS

Effective Date:  01/01/2021

PROGRAM APPLICABILITY:  2690

60857-01	INSPECTION OBJECTIVE

01.01	Review and assess the effectiveness of licensee/certificate holder’s performance of 10 CFR 72.48 evaluations and ensure that the required license or certificate of compliance (CoC) amendments have been obtained.

01.02 - Conduct a review of the licensee’s/certificate holder’s 10 CFR 72.48 biennial summary report to determine if there is a need for additional review. 

60857-02	INSPECTION REQUIREMENTS

02.01	Selection of 10 CFR 72.48 Evaluations.  Review 10 CFR 72.48 evaluations that were completed since the last ISFSI inspection.  As part of this review, the inspector shall also consider for review any ISFSI-related 10 CFR 50.59, “Changes, Test, and Experiments,” evaluations completed since the last ISFSI inspection.  The 10 CFR 72.48 evaluations reviewed shall be of such complexity that the change affects either the license basis or the 10 CFR 72.3 Design Basis.  Emphasis must be given to evaluations based upon their safety significance, risk significance, and complexity.  The inspectors shall use the guidance of Inspection Manual Chapter (IMC) 2690, “Inspection Program for Storage of Spent Reactor Fuel and Reactor Related Greater than Class C Waste at Independent Spent Fuel Storage Installations and for 10 CFR Part 71 Transportation Packagings,” Appendix E, “Guidance for Risk-Informed Review of 72.48 Evaluations,” as applicable, in selecting risk-informed 10 CFR 72.48 evaluations to review.  

02.02	10 CFR 72.48 Screenings.  Review changes, tests, and experiments (CTEs) that were screened out by the licensee/certificate holder as not requiring performance of 10 CFR 72.48 or 10 CFR 50.59 (ISFSI-related) evaluations.  Emphasis shall be given to items aligning to Priority 1 in IMC 2690 Appendix E.

02.03	10 CFR 72.48 Evaluation Review.  For inspection of evaluations performed in accordance with 10 CFR 72.48 (and 10 CFR 50.59 ISFSI-related), and CTEs, or methodology changes that the licensee/certificate holder determined did not require 10 CFR 72.48 or 10 CFR 50.59 evaluations, ensure the following attributes are met: 

a. Verify that when CTEs were implemented, evaluations were performed in accordance with 10 CFR 72.48.  Verify that the licensee/certificate holder had appropriately concluded that the CTE can be accomplished without obtaining a license amendment. 

b. Verify that safety issues related to the CTEs have been resolved. 

c. For the CTEs that were determined to not need an evaluation (screened out), verify that the licensee’s/certificate holder’s conclusions were correct and consistent with 10 CFR 72.48. 

02.04	10 CFR 72.48 Biennial Report.  10 CFR 72.48(d)(2) requires the licensee/certificate holder to submit a summary report at intervals not to exceed 24 months that contain a brief description of any CTEs, including a summary evaluation of each.  The 10 CFR 72.48 biennial summary reports shall be reviewed for both headquarters and region led inspections to support inspection preparation activities.

60857-03	INSPECTION GUIDANCE

General Guidance 

This IP should be used to provide inspector guidance in performing reviews of 10 CFR 72.48 evaluations when directed to do so by the procedures under IMC 2690.  The totality of items selected for inspection should, when possible, address the five safety focus areas described in IMC 2691, “Technical Basis for the Independent Spent Fuel Storage Installation Inspection Program,” Section 04.05.

The regulations in Title 10 of the *Code of Federal Regulations* (10 CFR) Part 72, “Licensing Requirements for the Independent Storage of Spent Nuclear Fuel and High-Level Radioactive Waste,” Section 72.48, “Changes, tests and experiments,” contain requirements for the process by which licensees (specific and general) and certificate holders may make changes, under certain conditions, to their facility’s independent spent fuel storage installation (ISFSI), spent fuel storage cask designs, and procedures, as described in the final safety analysis report (FSAR), as updated, without prior U.S. Nuclear Regulatory Commission (NRC) approval.

As part of the review of the licensee/certificate holder’s implementation of 10 CFR 72.48 requirements, the inspectors should ensure that the licensee or certificate holder’s program has sufficient controls to perform 10 CFR 72.48 screenings and evaluations appropriately.  A licensee/certificate holder’s 10 CFR 72.48 program should include the following aspects: 

a. Assessing and documenting whether 10 CFR 72.48 applies,

b. Assessing and documenting whether a change to the facility can be made

	without requiring a license amendment, or a CoC amendment, 

c. Provisions for the exchange between licensees and certificate holders of records of changes in accordance with 10 CFR 72.48(d)(6)(i)-(iii),

d. Ensuring that complete and up-to-date design information necessary for preparing adequate 10 CFR 72.48 screenings and evaluations is available to personnel that prepare those documents, and

e. Ensuring that the personnel that prepare, review, and approve 10 CFR 72.48 screenings and evaluations are trained and qualified, consistent with 10 CFR 72.144(d) and the licensee/certificate holder’s NRC-approved quality assurance program.

Specific Guidance.

03.01	Selection of 10 CFR 72.48 Evaluations.  Emphasis should be given to evaluations based upon their safety significance, risk significance, and complexity.  The inspectors should use the guidance of IMC 2690, Appendix E, in selecting risk-informed 10 CFR 72.48 evaluations.

The inspectors should review evaluations performed in accordance with 10 CFR 72.48, and CTEs performed since the last inspection that the licensee/certificate holder determined did not require 10 CFR 72.48 evaluations.  Substantial changes performed since the last inspection should be reviewed.  Consideration should also be given to degraded and non-conforming conditions.  In addition, for general licensees, the inspectors should review a list of CoC holder-performed 10 CFR 72.48 CTEs and confirm that an adoption of the change did not affect the site-specific procedures and/or 10 CFR 72.212, “Conditions of general license issued under § 72.210” evaluation and, therefore, would require that the change be evaluated through the 10 CFR 72.48 process.

Since lists of changes provided by the licensee/certificate holder will not necessarily indicate the complexity and scope of a change, several changes should be reviewed prior to the inspection.  This is best accomplished by first choosing documents from the list provided by the licensee/certificate holder and then requesting the actual documentation for the changes.  An initial review of these changes prior to the inspection should result in a smaller final list to review.

03.02 10 CFR 72.48 Screenings.  Inspection guidance included in Section 03.01.

03.03	10 CFR 72.48 Evaluation Review.  Regulatory Guide (RG) 3.72, “Guidance for implementation of 10 CFR 72.48, “Changes, Tests, and Experiments,” Revision 1, endorses Nuclear Energy Institute (NEI) document NEI 12-04, “Guidelines for 10 CFR 72.48 Implementation,” Revision 2, dated September 2018.  The NRC found that NEI 12-04 provides methods that are acceptable to the NRC staff for complying with the provisions of 10 CFR 72.48. 

The inspectors should refer to NEI 12-04 for guidance in completing this inspection.  The inspectors should verify the licensee/certificate holder has appropriately concluded, as applicable, that the CTE can be accomplished without obtaining a license or CoC amendment.

For reviews of ISFSI-related 10 CFR 50.59 evaluations, the inspectors should refer to NEI 96-07, Rev. 1 in completing the review.  The guidance in NEI 96-07, Rev. 1 was endorsed by the NRC in RG 1.187, “Guidance for Implementation of 10 CFR 50.59, Changes, Tests, and Experiments,” Revision 1.  It should be noted that for changes that affect both the 10 CFR 50 reactor facility and the 10 CFR 72 ISFSI facility or dry storage system design, both a 50.59 and 72.48 screening/evaluation may be required.

03.04	10 CFR 72.48 Biennial Report.  The review of the 10 CFR 72.48 biennial summary report to support inspection preparation activities should be completed using the guidance contained in IMC 2690 Appendix E to prioritize the selection of 10 CFR 72.48 evaluations for detailed review.  In addition, the inspectors may use the guidance in Section 03.03 above when reviewing the information provided in the 10 CFR 72.48 biennial summary report.

60857-04	INSPECTION RESOURCES

This is a reference IP that will normally be used to provide inspector guidance in performing reviews of 10 CFR 72.48 evaluations when directed to do so in IPs under IMC 2690.  Inspection hours should be charged to the IP used for the inspection in progress.

60857-05	REFERENCES

Regulatory Guide 1.187, “Guidance for Implementation of 10 CFR 50.59, Changes, Tests, and Experiments,” Revision 1

Regulatory Guide 3.72, “Guidance for Implementation of 10 CFR 72.48, “Changes, Tests, and Experiments,” Revision 1.

NEI 12-04, “Guidelines for 10 CFR 72.48 Implementation,” Revision 2.

NEI 96-07, “Guidelines for 10 CFR 50.59 Implementation,” Revision 1

NUREG/CR-6407, “Classification of Transportation Packaging and Dry Spent Fuel Storage System Components According to Importance to Safety,” February 1996.

IMC 2690, “Inspection Program for Storage of Spent Reactor Fuel and Reactor Related Greater Than Class C Waste at Independent Spent Fuel Storage Installations and for 10 CFR Part 71 Transportation Packagings”

IMC 2691, “Technical Basis for the Independent Spent Fuel Storage Installation Inspection Program”

END

Issue Date: XX/X/XX		60857

Issue Date:  10/20/20	2	60857

Attachment 1:  Revision History Page for IP 60857

Issue Date:  10/20/20	Att1-1	60857