ML25356A100

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Results of Periodic Review of Regulatory Guide 7.10, Revision 3, Establishing Quality Assurance Programs for Packaging Used in Transport of Radioactive Material
ML25356A100
Person / Time
Issue date: 01/26/2026
From: Mobasheran A
Division of Fuel Management, NRC/RES/DE
To:
Amir Mobasheran
Shared Package
ML25356A098 List:
References
RG 7.10, Rev 3
Download: ML25356A100 (0)


Text

Regulatory Guide Periodic Review Regulatory Guide Number:

7.10, Revision 3

Title:

Establishing Quality Assurance Programs for Packaging Used in Transport of Radioactive Material Office/division/branch:

NMSS/DFM/IOB Technical Lead:

Jeremy Tapp Staff Action Decided:

Revise

1.

What are the known technical or regulatory issues with the current version of the Regulatory Guide (RG)?

Regulatory Guide 7.10, Revision 3, Establishing Quality Assurance Programs for Packaging Used in Transport of Radioactive Material, issued in June 2015, provides guidance for an acceptable approach to prepare and submit Title 10 of the Code of Federal Regulations (10 CFR) Part 71 quality assurance program descriptions for U.S.

Nuclear Regulatory Commission (NRC) staff review. In addition to providing specific guidance for how to meet each of the eighteen quality criteria, it also references the endorsement of American National Standards Institute (ANSI) and the American Society of Mechanical Engineers (ASME), ANSI/ASME NQA-1-2008 and the NQA-1a-2009 Addenda, Quality Assurance Requirements for Nuclear Facility Applications. The endorsement of the NQA-1 standard has been updated per RG 1.28, Quality Assurance Program Criteria (Design and Construction), Revision 6, since the publication of this guide and should be updated to ensure reference to current standards as endorsed by the NRC. It has also been identified that guidance should be added regarding the timing of quality assurance program (QAP) submittals and those entities allowed to receive approval based on NRC regulations to ensure a clear understanding for future applicants. Lastly, guidance on audits performed by management needs to be clarified.

This is referring to regular management reviews as the audit requirements in 10 CFR Part 71 do not require management to perform audit activities. Overall, there are no significant technical or regulatory issues. Timing of submittals related to design of packages to clarify requirements based on recent industry questions.

2.

What is the impact on internal and external stakeholders of not updating the RG for the known issues, in terms of anticipated numbers of licensing and inspection activities over the next several years?

Since there are no significant technical or regulatory issues, use of the current version of RG 7.10 will have no known impact on internal or external stakeholders.

3.

What is an estimate of the level of effort needed to address identified issues in terms of full-time equivalent (FTE) and contractor resources?

NRC staff requires approximately 0.5 FTE to revise and update the RG. No contractor support is anticipated.

4.

Based on the answers to the questions above, what is the staff action for this guide (Reviewed with no issues identified, Reviewed with issues identified for future consideration, Revise, or Withdraw)?

Revise.

5.

Provide a conceptual plan and timeframe to address the issues identified during the review.

The staff plans to develop a draft guide by the end of the second quarter of Calendar Year (CY) 2026, and issue it for public comment by the fourth quarter of CY 2026.

NOTE:

This review was conducted in December 2025 and reflects the staffs plans as of that date. These plans are tentative and subject to change.