ML22286A071

Harmonization of Transportation Safety Requirements with International Atomic Energy Agency Standards (Rin 3150-AJ85; NRC-2016-0179); Public Meeting Presentation

ML22286A071
Person / Time
Issue date:	10/25/2022
From:	Office of Nuclear Material Safety and Safeguards
To:
Firth J
References
NRC-2016-0179, RIN 3150-AJ85
Download: ML22286A071 (51)

Text

Public Meeting on Proposed Rule Harmonization of NRC Transportation Safety Requirements with IAEA Standards October 26, 2022 ADAMS Accession No.: ML22286A071

Purpose

• Provide information to facilitate stakeholders comments on the Harmonization of Transportation Safety Requirements with IAEA Standards (87 FR 55708) proposed rule and draft regulatory guidance (DG-7011, Standard Format and Content of Part 71 Applications for Approval of Packages for Radioactive Material (ML22223A085)

• The NRC is not collecting comments on the proposed rule and draft regulatory guidance during this meeting.

2

Agenda

• Welcome and Logistics

• Opening Remarks

• Background and Status

• Overview of the Proposed Rule and Draft Guidance

• Opportunities for Questions

• Resources for Preparing and Submitting Comments

• Next Steps

• Questions and Discussion 3

Logistics

• Audience members will be admitted as attendees with their microphones disabled

• During Questions and Discussion periods, please indicate your desire to speak by using the Raise Hand button in Teams (or by pressing *5 if participating by phone)

• Once your name has been called by the facilitator, you will need to unmute yourself (press *6 if you are on the phone)

• Chat feature is also enabled

• Presentation slides shown on the Microsoft Teams screen and in ADAMS at ML22286A071

• Phone attendees should email James.Firth@nrc.gov for attendance 4

Opening Remarks Tara Inverso Deputy Director Division of Rulemaking, Environmental, and Financial Support 5

Background and Status James Firth Project Manager Division of Rulemaking, Environmental, and Financial Support 6

Background on Harmonization and Compatibility with DOT Regulations

• The NRC periodically conducts rulemakings to harmonize the NRCs regulations with the IAEAs safety standards requirements and to maintain compatibility with the U.S. Department of Transportations (DOT) regulations.

• Issues Paper on Potential Revisions to Transportation Safety Requirements and Harmonization with International Atomic Energy Agency Transportation Requirements (81 FR 83171; November 21, 2016).

• Public meeting was held December 5-6, 2016.

• 14 issues documented in the paper.

7

Background on Harmonization and Compatibility with DOT Regulations

• Draft regulatory basis published for comment (84 FR 14898; April 12, 2019).

• 14 issues from the Issues Paper;

• Several NRC-identified changes, including clarifications to ensure compatibility with the DOT and changes to the compatibility categories for Agreement State regulations.

• 4 alternatives considered for each issue:

• Alternative 1take no action and maintain the status quo;

• Alternative 2issue generic communications and regulatory guidance;

• Alternative 3issue license-specific conditions and exemptions; and

• Alternative 4initiate a rulemaking action to revise 10 CFR Part 71.

• The alternatives were evaluated based on their viability to resolve the regulatory issues of concern and estimates of their costs and potential benefits.

• Public meeting was held April 30, 2019. Meeting summary: ML16343A661.

8

Status of Harmonization and Compatibility with DOT Regulations

• The NRC is proposing changes to Regulatory Guide 7.9 and has published draft regulatory guide 7011, Standard Format and Content of Part 71 Applications for Approval of Packages for Radioactive Material, for public comment.

• The proposed rule was published in the Federal Register on September 12, 2022 (87 FR 55708) with a 75-day comment period.

• The comment period ends November 28, 2022.

• The DOT published a related proposed rule on September 12, 2022 (87 FR 55743) with a 90-day public comment period.

9

Proposed Rule and Related Documents

• Regulations.gov Docket: NRC-2016-0179

• https://www.regulations.gov/docket/NRC-2016-0179

• Proposed Rule

• Citation: 87 FR 55708 (September 12, 2022)

• https://www.govinfo.gov/content/pkg/FR-2022-09-12/pdf/2022-18520.pdf

• Supporting & Related Material

• Draft Regulatory Analysis (ML22209A039)

• Draft Environmental Assessment (ML22209A045)

• Draft Supporting Statement for Information Collections (ML22209A052) 10

Proposed Rule and Related Documents

• Correction notice

• Forthcoming

• Corrections and Changes

• Corrected information collection

• Changed the number of responses from 7.5 to 100 and the number of respondents from 6.5 to 99

• The overall burden does not change (rounded to a total of 1,377 hours0.00436 days <br />0.105 hours <br />6.233466e-4 weeks <br />1.434485e-4 months <br />)

• Comment period for the information collection extended until November 28, 2022

• Republished Draft Regulatory Analysis (correcting a publication error)

• Clarified the units for the mass limit (changed 140 g to 140 grams) 11

Proposed Rule and Related Documents

• Guidance Document

• Draft Regulatory Guide DG-7011, Standard Format and Content of Part 71 Applications for Approval of Packages for Radioactive Material (ML22223A085)

• Unofficial redline/strikeout comparison between DG-7011 and Regulatory Guide 7.9, (Revision 2), Standard Format and Content of Part 71 Applications for Approval of Packages for Radioactive Material (ML22280A061) 12

Overview of the Proposed Rule 13

Revision of Reduced External Pressure Test for Normal Conditions of Transport

• Summary:

• The NRC has decided not to pursue any changes to the reduced external pressure test requirement under § 71.73(c)(3)

• Additional information:

• The current 25 kPa (3.6 psia) would be retained 14 Where is this discussed in the FRN?

Section III.C. (Issue Number 2) (pages 55711-55712)

Which sections of the CFR would be amended?

None - no change What are the current and proposed compatibility categories?

No change

Deletion of the Low Specific Activity (LSA)-III Leaching Test

• Summary:

• The IAEA eliminated the LSA-III leaching test in SSR-6, 2018 Edition

• NRC proposes revising §§ 71.4, 71.77, and 71.100 to eliminate the LSA-III leaching test

• Additional information:

• Less burden on licensees with no decrease in safety 15 Where is this discussed in the FRN?

Section III.C. (Issue Number 6) (page 55713)

Which sections of the CFR would be amended?

10 CFR 71.4, 71.77, 71.100 What are the current and proposed compatibility categories?

Unchanged IAEA Harmonization Conform to DOT

Inclusion of New Definition for Surface Contaminated Object

• Summary:

• NRC proposes to add a definition of a third group of SCO (i.e., SCO-III) in § 71.4 that would align with the DOTs definition for SCO-III

• Additional information:

• Decommissioning activities can include transporting large radioactive objects

• Efficiencies are gained and burden is removed with the addition of the SCO-III definition 16 Where is this discussed in the FRN?

Section III.C. (Issue Number 7) (pages 55713 -55714)

Which sections of the CFR would be amended?

10 CFR 71.4 What are the current and proposed compatibility categories?

[B] [B]

IAEA Harmonization Conform to DOT

Revision of the Definition of Low Specific Activity

• Summary:

• NRC proposes to revise the definition of low specific activity in § 71.4

• Additional information:

• The change from excepted under § 71.15 to exempted under

§ 71.15 would align the definition with the section heading for § 71.15 17 Where is this discussed in the FRN?

Section III.C. (Issue Number 15.2) (page 55719)

Which sections of the CFR would be amended?

10 CFR 71.4 What are the current and proposed compatibility categories?

[B] [B]

NRC-Initiated

Revision of Tables Containing A1 and A2 Values and Exempt Material Activity and Consignment Limits

• Summary:

• NRC proposes revising 10 CFR 71, Appendix A, Tables A-1 and A-2

• Additional information:

• Seven radionuclides would be added

• Footnote c for Thorium-natural would be revised

• Alphabetical listing of radionuclides would be revised

• Would align with DOT 18 Where is this discussed in the FRN?

Section III.C. (Issue Number 15.3) (page 55719)

Which sections of the CFR would be amended?

10 CFR 71, Appendix A, Tables A-1 and A-2 What are the current and proposed compatibility categories?

[B] [B]

IAEA Harmonization Conform to DOT

Revision of Fissile Exemptions

• Summary:

• NRC proposes to add two new fissile exemptions in § 71.15

• The fissile exemptions are similar to the new fissile exceptions in IAEA SSR-6

• Additional information:

• Would add an exemption for 3.5 grams 235U in uranium enriched up to 5.0 weight percent under § 71.15(a)

• Would add an exemption for up to 140 grams fissile material shipped exclusive use under § 71.15(g) 19 Where is this discussed in the FRN?

Section III.C. (Issue Number 1) (page 55711)

Which sections of the CFR would be amended?

10 CFR 71.15 What are the current and proposed compatibility categories?

[B] [B] and [--] [B]

IAEA Harmonization

Deletion of Type A Package Limitations in Fissile Material General Licenses

• Summary:

• NRC proposes revisions to the General Licenses in §§ 71.22 and 71.23 to allow the use of Type B packaging

• NRC proposes adding paragraphs (f), (g), and (h) to each requirement, containing requirements if Type B packaging is used

• Additional information:

• Some mass limits in current rule language are greater than Type A (e.g., plutonium and 233U)

• Mass limits would not change, but licensees would now be able to use General License with Type B packaging 20 Where is this discussed in the FRN?

Section III.C. (Issue Number 13) (pages 55717 - 55718)

Which sections of the CFR would be amended?

10 CFR 71.22 and 10 CFR 71.23 What are the current and proposed compatibility categories?

[B] [B] and [--] [B]

NRC-Initiated

Deletion of 233U Restriction in Fissile General License

• Summary:

• NRC proposes revising the General License in § 71.22 to modify the restriction on 233U for using lower mass limits in Table 71-1

• Current language in § 71.22(e)(5)(i) requires more restrictive mass limits if Uranium-233 is present in the package

• Proposed language would require more restrictive mass limits if 233U mass is more than 1% of 235U mass

• Additional information:

• New language is similar to existing restriction on plutonium mass in

§ 71.22(e)(5)(ii) 21 Where is this discussed in the FRN?

Section III.C. (Issue Number 14) (page 55718)

Which sections of the CFR would be amended?

10 CFR 71.22 What are the current and proposed compatibility categories?

[B] [B]

NRC-Initiated

Questions and Discussion 22

Type C Package Standards

• Summary:

• NRC proposes to not add Type C standards to 10 CFR Part 71 due to no existing or anticipated need for domestic transport

• Additional information:

• No anticipated need for domestic transport of Type C package based on comments received on the Regulatory Basis

• Type C packages can still be approved for international transport via DOT regulations 23 Where is this discussed in the FRN?

Section III.C.(Issue Number 3) (pages 55712)

Which sections of the CFR would be amended?

None What are the current and proposed compatibility categories?

N/A

Insolation

• Summary:

• Proposing to change the units for insolation in § 71.71(c)(1) to metric units (from g cal/cm2 to W/m2)

• Proposing to revise the test conditions in § 71.73(b) to include insolation as an initial condition to the tests for hypothetical accident conditions

• Additional information:

• Insolation is the amount of solar radiation reaching a given area 24 Where is this discussed in the FRN?

Section III.C. ((Issue Number 4) (pages 55712-55713)

Which sections of the CFR would be amended?

10 CFR 71.71(c)(1) and 10 CFR 71.73(b)

What are the current and proposed compatibility categories?

NRC NRC IAEA Harmonization

Inclusion of Definition for Radiation Level

• Summary:

• Would add the following definition to harmonize with IAEA definitions:

Radiation level means the radiation dose equivalent rate expressed in millisieverts per hour or mSv/h (millirems per hour or mrem/h)

• Additional information:

• No change in burden on licensees with no decrease in safety 25 Where is this discussed in the FRN?

Section III.C. (Issue Number 5) (page 55713)

Which sections of the CFR would be amended?

10 CFR 71.4 What are the current and proposed compatibility categories?

[--] [A]

IAEA Harmonization

Revision of Uranium Hexafluoride Package Requirements

• Summary:

• Would add uranium hexafluoride cylinder plug in § 71.55(g)

• Would require no contact between the cylinder plug and any other part of the packaging, other than at its original attachment point and that the cylinder plug remains leak tight

• Additional information:

• Ensures same requirement for the cylinder plug and valve 26 Where is this discussed in the FRN?

Section III.C. (Issue Number 8) (page 55714)

Which sections of the CFR would be amended?

10 CFR 71.55(g)(1)

What are the current and proposed compatibility categories?

NRC NRC IAEA Harmonization

Inclusion of Evaluation of Aging Mechanisms and a Maintenance Program

• Summary:

• Would add a requirement in § 71.35(d) for the application for package approval to include a description of the package maintenance program

• Would revise § 71.43(d) to include the evaluation of the effects of aging

• Additional information:

• IAEA added requirement for applications for package approval include a maintenance program and evaluation of the effects of aging

• No burden on NRC certificate holders since applications for NRC package approval already include both 27 Where is this discussed in the FRN?

Section III.C. (Issue Number 9) (pages 55714-55715)

Which sections of the CFR would be amended?

10 CFR 71.35(d) 10 CFR 71.43(d)

What are the current and proposed compatibility categories?

[--] NRC and NRC NRC IAEA Harmonization

Revision of Transitional Arrangements

• Summary:

• Phase out older packages without a -85 or -96 in the package identification number

• Limit use of packages with a -96 in the package identification number to those whose fabrication has been completed by December 31, 2028

• Limit fabrication of special form sources

• Additional information:

• Proposing to revise § 71.19 to allow existing packages be recertified to show compliance with the revised regulations and remove restrictions on package use and fabrication 28 Where is this discussed in the FRN?

Section III.C. (Issue Number 10) (pages 55715-55716)

Which sections of the CFR would be amended?

10 CFR 71.19 What are the current and proposed compatibility categories?

NRC NRC IAEA Harmonization Conform to DOT

Inclusion of Head Space for Liquid Expansion

• Summary:

• Would add a design requirement in § 71.43(i) for packages containing liquids to ensure adequate space for liquid expansion during evaluation of the normal conditions of transport and hypothetical accident conditions

• Additional information:

• Ensure consistency with § 71.87(d) 29 Where is this discussed in the FRN?

Section III.C. (Issue Number 11) (pages 55716-55717)

Which sections of the CFR would be amended?

10 CFR 71.43(i)

What are the current and proposed compatibility categories?

[--] NRC Conform to DOT IAEA Harmonization

Deletion of Duplicative Reporting Requirements

• Summary:

• Proposes to remove reporting requirement in § 71.95(a)(3), which is duplicative of paragraph (b)

• Additional information:

• None 30 Where is this discussed in the FRN?

Section III.C. (Issue Number 15.1) (page 55719)

Which sections of the CFR would be amended?

10 CFR 71.95(a)(3)

What are the current and proposed compatibility categories?

D [--]

NRC-Initiated

Deletion of References to Irradiated Reactor Fuel in Part 71 Advance Notification Requirements

• Summary:

• Would remove references to irradiated reactor fuel in the advance notification requirements in § 71.97

• Additional information:

• Advance notice requirements for irradiated reactor fuel are located in 10 CFR Part 73

• References to irradiated reactor fuel were not removed from § 71.97 when the notifications for small quantities of irradiated reactor fuel were moved to § 73.35 31 Where is this discussed in the FRN?

Section III.C. (Issue Number 15.1) (page 55720)

Which sections of the CFR would be amended?

10 CFR 71.97 What are the current and proposed compatibility categories?

B B NRC-Initiated

Questions and Discussion 32

Quality Assurance Program (QAP) Biennial Report Issue

• Summary:

• Clarification of requirements for biennial reports for QAP changes

• Additional information:

• Proposed change modifies language in § 71.106 to clarify that biennia reports are required even when no changes have been made to an NRC-approved QAP in the previous 24-month period

• Consistent with 10 CFR 50 reporting requirements [§§ 50.54(a)(3) and 50.71(e)(2)]

• Would match guidance currently provided in RG 7.10

• Would remove regulatory uncertainty 33 Where is this discussed in the FRN?

Section III.C. (Issue Number 12) (pages 55717)

Which sections of the CFR would be amended?

10 CFR 71.106 What are the current and proposed compatibility categories?

C B NRC-Initiated

Revision to Agreement State Compatibility Categories

• Summary:

• Regulations that contain QAP review criteria would be revised from Compatibility Category C to Compatibility Category B so Agreement States can approve, inspect, and enforce their licensees QAPs

• Reporting requirements in § 71.95 would change from Compatibility Category D to Compatibility Category C, so State licensees would report to:

• NRC for instances of package defects or a reduction in effectiveness

• State regulator for instances where the CoC was not followed in making a shipment

• Additional information:

• §§71.109, 71.111, 71.113, 71.115, 71.117, 71.119, 71.121, 71.123, and 71.125 would be revised from Compatibility Category NRC to Compatibility Category B

• § 71.95 would be revised from Compatibility Category D to Compatibility Category C 34 NRC-Initiated Where is this discussed in the FRN?

Section III.C.(Issue Number 15.4) (pages 55719-55720)

Which sections of the CFR would be amended?

N/A What are the current and proposed compatibility categories?

C B, §§71.109, 71.111, 71.113, 71.115, 71.117, 71.119, 71.121, 71.123, and 71.125 D C, §§71.95

Compatibility Categories A and B Compatibility Category A

• Basic radiation protection standards and scientific terms and definitions that are necessary to understand radiation protection concepts.

• Should be essentially identical to those of the NRC to provide uniformity in the regulation of agreement material on a nationwide basis.

Compatibility Category B

• Activities that cross jurisdictional boundaries.

• Need to be adopted in an essentially identical manner in order to ensure uniformity of a regulation on a national basis.

35 Where is this discussed in the FRN?

Section XV. (pages 55725-55727)

Which sections of the CFR would be amended?

N/A What are the current and proposed compatibility categories?

See Compatibility Table

Compatibility Category C Compatibility Category C

• Program elements that are important for an Agreement State to have in order to avoid conflict, duplication, gaps, or other conditions that would jeopardize an orderly pattern in the regulation of agreement material on a nationwide basis.

• Agreement State program elements must embody the essential objectives of these NRC program elements.

• May be more restrictive than the NRC program elements provided that the essential objective is met, and the State requirements do not jeopardize an orderly pattern of regulation of agreement material on a nationwide basis.

36 Where is this discussed in the FRN?

Section XV. (pages 55725-55727)

Which sections of the CFR would be amended?

N/A What are the current and proposed compatibility categories?

See Compatibility Table

Compatibility Category D Compatibility Category D

• Program elements that do not meet any of the criteria of Compatibility Categories A, B, or C, or have a particular health and safety role.

• Do not need to be adopted by Agreement States for purposes of compatibility.

• An Agreement State may adopt and implement these program elements that fall within its jurisdiction.

• If adopted, the program element should be adopted in a manner such that:

• They are comparable with those of the NRC,

• They do not preclude, or effectively preclude a practice in the national interest without adequate protection of public health and safety, security, or environmental basis related to radiation protection, and

• They do not preclude, or effectively preclude the ability of the NRC to evaluate the effectiveness of the Agreement State program with respect to the protection of public health and safety.

37 Where is this discussed in the FRN?

Section XV. (pages 55725-55727)

Which sections of the CFR would be amended?

N/A What are the current and proposed compatibility categories?

See Compatibility Table

Compatibility Categories NRC and H&S Compatibility Category NRC

• Program elements that address areas of regulation that cannot be discontinued when a State enters into an Agreement with the NRC pursuant to the AEA or provisions of Title 10 of the Code of Federal Regulations (CFR).

• The NRC maintains regulatory authority over these program elements.

• Agreement States must not adopt these NRC program elements.

Compatibility Category H&S

• Program elements that embody the basic health and safety aspects of the NRCs program elements because of particular health and safety considerations.

• Must be adopted by Agreement States.

• Not required for compatibility.

38 Where is this discussed in the FRN?

Section XV. (pages 55725-55727)

Which sections of the CFR would be amended?

N/A What are the current and proposed compatibility categories?

See Compatibility Table

Compatibility Table: Compatibility Categories and Changes Where is this discussed in the FRN?

Section XV. (pages 55726-55727)

Which sections of the CFR would be amended?

N/A What are the current and proposed compatibility categories?

See Compatibility Table 39

Draft Regulatory Guide

• Draft Regulatory Guide DG-7011, Standard Format and Content of Part 71 Applications for Approval of Packages for Radioactive Material (ML22223A085)

• Added detail on air transport requirements in structural and thermal chapters

• Moved information on materials evaluations to Chapter 7

• Added Chapter 10 on Quality Assurance

• Unofficial Redline/Strikeout Version of draft guidance (ML22280A061) 40 Where is this discussed in the FRN?

Section XVII (pages 55727-55728)

Which sections of the CFR would be amended?

N/A What are the current and proposed compatibility categories?

N/A

Questions and Discussion 41

Requests for Comments IV. Specific Request for Comment:

1.

IAEA Changes in SSR-6 (2018 Edition) Not in the Scope of This Proposed Rule 2.

Removing Tables A-1 Through A-4 in Appendix A to 10 CFR Part 71 3.

Merits of Requiring a Biennial Report for No Changes to a Quality Assurance Program IX. Cumulative Effects of Regulation:

1.

Does the proposed rules effective date provide sufficient time to implement the new proposed requirements?

2.

If current or projected cumulative effects of regulation challenges exist, what should be done to address this situation?

3.

Do other regulatory actions (from the NRC or other agency) influence the implementation of the proposed rules requirements?

4.

Are there unintended consequences? Does the proposed rule create conditions that would be contrary to the proposed rules purpose and objectives? If so, what are the unintended consequences, and how should they be addressed?

5.

Please comment on the NRCs cost and benefit estimates in the regulatory analysis that supports this proposed rule.

42 Where is this discussed in the FRN?

Section IV, Specific Request for Comment, (pages 55720-55722),Section IX,Cumulative Effects of Regulation, (page 55724)

Regulatory Analysis

• Summary:

• The proposed rule represents the best option that could address all the issues and could result in net savings of $3,354,982 in averted costs to the industry licensees and Certificate of Compliance holders.

• Estimated licensee savings: $5,929,424.

• Estimated Certificate of Compliance holder costs: ($2,574,442).

• Net cost to Agreement States: ($2,408,083) to implement the rule and revise procedures.

Implementation costs for the Agreement States: ($2,242,429).

Marginal operational cost for the Agreement States: ($165,654).

43 Where is this discussed in the FRN?

Section VI, Regulatory Flexibility Certification, and Section VII, Regulatory Flexibility Act, (pages 55723-55724)

Draft Environmental Assessment and Proposed (Draft) Finding of No Significant Impact

• Summary:

• Alternatives considered:

• Proposed action: rulemaking to amend Part 71

• No action alternative: do not amend Part 71

• Impacts:

• No significant environmental impacts from the proposed action 44 Where is this discussed in the FRN?

Section XI, Environmental Assessment and Proposed Finding of No Significant Environmental Impact, (pages 55724)

Resources for Preparing and Submitting Comments 45

Commenters Checklist on Regulations.gov 46

• Available from Regulations.gov at:

https://downloads.regulations.gov/F S-2018-0053-0007/content.pdf

• This information is also available from the page for submitting comments on the proposed rule:

https://www.regulations.gov/comme nton/NRC-2016-0179-0072

Submitting a comment 47

• Frequently Asked Questions (FAQs) on commenting are available at:

https://www.regulations.gov/faq

• Ways You Can Submit Comments:

• Regulations.gov: comment form for the proposed rule on docket NRC-2016-0179 or

• Email: Rulemaking.Comments@nrc.gov or

• Mail: Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, ATTN:

Rulemakings and Adjudications Staff

Next Steps

• Public comment period ends: November 28, 2022

• Staff will respond to comments and develop a final rule

• Final rule currently due to the Commission: February 2024 48

Questions and Discussion 49

Contacts:

James Firth James.Firth@nrc.gov 301-415-6628 Bernard White Bernard.White@nrc.gov 301-415-6577 50

Acronyms ADAMS Agencywide Documents Access and Management System CER Cumulative effects of regulation CFR Code of Federal Regulations CoC Certificate of Compliance DG Draft regulatory guide DOT U.S. Department of Transportation FAQs Frequently Asked Questions FR Federal Register FRN Federal Register notice H&S Health and safety IAEA International Atomic Energy Agency LSA Low Specific Activity NRC U.S. Nuclear Regulatory Commission QAP Quality Assurance Program QR Quick response RG regulatory guide SCO Surface Contaminated Object SSR Specific Safety Requirements 51