ML22319A164

From kanterella
Jump to navigation Jump to search
Harmonization of Transportation Safety Requirements with International Atomic Energy Agency Standards; 11/15/22 Corar Meeting Presentation
ML22319A164
Person / Time
Issue date: 11/15/2022
From: James Firth, Bernie White
Division of Fuel Management, NRC/NMSS/DREFS
To:
References
RIN 3150-AJ85, NRC-2016-0179
Download: ML22319A164 (30)
v • d • e


Text

Harmonization of NRC Transportation Safety Requirements with IAEA Standards Council on Radionuclides and Radiopharmaceuticals, Inc.

Transportation Committee James Firth, Project Manager Bernard White, Senior Project Manager Division of Rulemaking, Environmental, and Financial Support Division of Fuel Management Office of Nuclear Material Safety and Safeguards Office of Nuclear Material Safety and Safeguards U.S. Nuclear Regulatory Commission U.S. Nuclear Regulatory Commission November 15, 2022 ADAMS Accession No.: ML22286A071

Rulemaking Process and Current Status

  • Proposed rule published in the Federal Register on September 12, 2022
  • 75-day comment period
  • Comment period closes on November 28, 2022
  • We are currently within the public comment period
  • Public comment period ends: November 28, 2022
  • Staff will respond to comments and develop a final rule
  • Final rule currently due to the We are here Commission: February 2024 2

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 U.S. Department of Transportation (DOT) published a related proposed rule on September 12, 2022 (87 FR 55743) with a 90-day public comment period.

3

Proposed Rule and Related Documents

  • Proposed Rule
  • Supporting & Related Material
  • Draft Supporting Statement for Information Collections (ML22209A052) 4

Proposed Rule and Related Documents

  • Correction notice
  • 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) 5

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) 6

International Atomic Energy Agency Harmonization

  • Fissile material exemptions
  • Revise insolation requirements for package evaluations
  • Include Evaluation of Aging Mechanisms and a
  • Revise units for insolation for normal conditions Maintenance Program of transport
  • Revise Transitional Arrangements*
  • Include insolation for Hypothetical Accident Conditions
  • Include Head Space for Liquid Expansion*
  • Include Definition for Radiation Level
  • Revise Tables Containing A1 and A2 Values and Exempt Material Activity and Consignment Limits*
  • Delete Low Specific Activity-III Leaching Test*
  • Changes to harmonize with U.S. Department of
  • Include New Definition for Surface Contaminated Transportation and International Atomic Energy Object* Agency Specific Safety Requirements (SSR) No. 6 7

Part 71: NRC-Initiated Changes

  • Biennial quality assurance reporting (§ 71.106)
  • Remove Type A limits from general license requirements (§§ 71.22, 71.23)
  • Revise the determination of the mass limits containing mixed quantities of fissile material when uranium-233 is present (§ 71.22)
  • Revise compatibility category designations for quality assurance requirements (Subpart H)
  • Remove duplicative reporting (§ 71.95)
  • Revise the definition of Low Specific Activity (LSA) Material (§ 71.4)
  • Remove references to irradiated reactor fuel in the advance notification requirements (§ 71.97) 8

Revision of Tables Containing Where is this discussed in the FRN?

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

A1 and A2 Values and Exempt Which sections of the CFR would be amended?

  • 10 CFR 71, Appendix A, Tables A-1 and A-2 Material Activity and Consignment What are the current and proposed compatibility categories?
  • [B] [B]

Limits

  • Summary:
  • 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 IAEA Harmonization Conform to DOT 9

Inclusion of Evaluation of Where is this discussed in the FRN?

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

Aging Mechanisms and a Which sections of the CFR would be amended?

Maintenance Program What are the current and proposed compatibility categories?

  • [--] NRC and NRC NRC
  • 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 IAEA Harmonization 10

Where is this discussed in the FRN?

Revision of Transitional

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

Which sections of the CFR would be amended?

Arrangements

  • 10 CFR 71.19 What are the current and proposed compatibility categories?
  • NRC NRC
  • 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 IAEA Harmonization Conform to DOT 11

Where is this discussed in the FRN?

Inclusion of Head Space for

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

Which sections of the CFR would be amended?

Liquid Expansion

What are the current and proposed compatibility categories?

  • [--] NRC
  • 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)

IAEA Harmonization Conform to DOT 12

Where is this discussed in the FRN?

Deletion of Duplicative

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

Which sections of the CFR would be amended?

Reporting Requirements

What are the current and proposed compatibility categories?

  • D [--]
  • Summary:
  • Proposes to remove reporting requirement in § 71.95(a)(3), which is duplicative of paragraph (b)
  • Additional information:
  • None NRC-Initiated 13

Where is this discussed in the FRN?

Quality Assurance Program

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

Which sections of the CFR would be amended?

(QAP) Biennial Report Issue

  • 10 CFR 71.106 What are the current and proposed compatibility categories?
  • CB
  • 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 NRC-Initiated 14

Where is this discussed in the FRN?

Revision to Agreement State

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

Which sections of the CFR would be amended?

Compatibility Categories

  • N/A What are the current and proposed compatibility categories?
  • NRC B, §§ 71.109, 71.111, 71.113, 71.115, 71.117, 71.119, 71.121, 71.123, and 71.125
  • D C, §§ 71.95
  • Summary:
  • Regulations that contain QAP review criteria would be revised from Compatibility Category NRC 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 NRC-Initiated 15

Where is this discussed in the FRN?

  • Section XVII (pages 55727-55728)

Draft Regulatory Guide Which sections of the CFR would be amended?

  • N/A What are the current and proposed compatibility categories?
  • N/A
  • 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) 16

Where is this discussed in the FRN?

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

IV. Specific Request for Comment: IX. Cumulative Effects of Regulation:

1. IAEA Changes in SSR-6 (2018 Edition) Not in the Scope 1. Does the proposed rules effective date provide sufficient of This Proposed Rule time to implement the new proposed requirements?
2. Removing Tables A-1 Through A-4 in Appendix A to 10 2. If current or projected cumulative effects of regulation CFR Part 71 challenges exist, what should be done to address this situation?
3. Merits of Requiring a Biennial Report for No Changes to a Quality Assurance Program 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.

17

Questions and Discussion 18

Contacts:

James Firth Bernard White James.Firth@nrc.gov Bernard.White@nrc.gov 301-415-6628 301-415-6577 19

Acronyms CFR Code of Federal Regulations RG regulatory guide CoC Certificate of Compliance SSR Specific Safety Requirements DG Draft regulatory guide DOT U.S. Department of Transportation FAQs Frequently Asked Questions FR Federal Register H&S Health and safety IAEA International Atomic Energy Agency LSA Low Specific Activity NRC U.S. Nuclear Regulatory Commission QAP Quality Assurance Program 20

=

Background===

Compatibility Where is this discussed in the FRN?

Compatibility Categories A

  • Section XV. (pages 55725-55727)

Which sections of the CFR would be amended?

and B

  • N/A What are the current and proposed compatibility categories?
  • See Compatibility Table 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.

23

Where is this discussed in the FRN?

  • Section XV. (pages 55725-55727)

Compatibility Category C Which sections of the CFR would be amended?

  • N/A What are the current and proposed compatibility categories?
  • See Compatibility Table 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.

24

Where is this discussed in the FRN?

  • Section XV. (pages 55725-55727)

Compatibility Category D Which sections of the CFR would be amended?

  • N/A What are the current and proposed compatibility categories?
  • See Compatibility Table 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.

25

Where is this discussed in the FRN?

Compatibility Categories NRC

  • Section XV. (pages 55725-55727)

Which sections of the CFR would be amended?

and H&S

  • N/A What are the current and proposed compatibility categories?
  • See Compatibility Table 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 Atomic Energy Act 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.

26

Compatibility Table: Compatibility Where is this discussed in the FRN?

  • Section XV. (pages 55726-55727)

Which sections of the CFR would be amended?

Categories and Changes

  • N/A What are the current and proposed compatibility categories?
  • See Compatibility Table 27

Resources for Preparing and Submitting Comments 28

Commenters Checklist on Regulations.gov

  • 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 29

Submitting a comment

  • 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 30

Retrieved from "https://kanterella.com/w/index.php?title=ML22319A164&oldid=3522028"