ML23333A446

Basis for Withdrawal of Regulatory Guides

ML23333A446
Person / Time
Issue date:	01/24/2024
From:	Leira Cuadrado Office of Nuclear Material Safety and Safeguards
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ML23333A443	List: ML23333A446 ML23333A448
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Download: ML23333A446 (3)

Text

1 Basis for Withdrawal of Regulatory Guides Regulatory Guide Numbers: 6.1, 6.2, 6.4, 6.5, 6.9, 10.2, 10.3, 10.4, 10.5, 10.6, 10.7, 10.8, 10.9 Division Titles:

Division 6, Products Division 10 General Office/Division/Branch:

NMSS/MSST/MSLB Technical Lead:

Leira Cuadrado

Subject:

Basis for Withdrawal (1)

What regulation(s) did the Regulatory Guides support?

The NRC staff has performed a review of the Regulatory Guides (RGs) in Division 6, Products, (RGs 6.1, 6.2, 6.4, 6.5, and 6.9), and in Division 10, General (RGs 10.2, 10.3, 10.4, 10.5, 10.6, 10.7, 10.8, and 10.9), and determined that they should be withdrawn. These RGs were originally published in the 1970s and 1980s and provided guidance for Title 10 of the Code of Federal Regulations (10 CFR), including 10 CFR Part 30, Rules of General Applicability to Domestic Licensing of Byproduct Material, 10 CFR Part 33, Specific Domestic Licenses of Broad Scope for Byproduct Material, 10 CFR Part 32, Specific Domestic Licenses to Manufacture or Transfer Certain Items Containing Byproduct Material, 10 CFR Part 34, Licenses for Industrial Radiography and Radiation Safety Requirements for Industrial Radiographic Operations, 10 CFR Part 35, Medical Use of Byproduct Material, 10 CFR Part 70 Domestic Licensing of Special Nuclear Material, 10 CFR Part 150 Exemptions and Continued Regulatory Authority in Agreement States and in Offshore Waters under Section 274, 10 CFR Part 20, Standards for Protection Against Radiation, 10 CFR Part 71, Packaging and Transportation of Radioactive Material, and 10 CFR Part 75, Safeguards on Nuclear MaterialImplementation of Safeguards Agreements Between the United States and the International Atomic Energy Agency.

The titles of these RGs are as follows:

1. RG 6.1, Leak Testing Radioactive Brachytherapy Sources

2. RG 6.2, Integrity and Test Specifications for Selected Brachytherapy Sources

3. RG 6.4, Verification of Containment Properties of Sealed Radioactive Sources

4. RG 6.5, General Safety Standard for Installations Using Nonmedical Sealed Gamma-Ray Sources

5. RG 6.9, Establishing Quality Assurance Programs for the Manufacture and Distribution of Sealed Sources and Devices Containing Byproduct Material

6. RG 10.2, Guidance to Academic Institutions Applying for Specific Byproduct Material Licenses of Limited Scope

7. RG 10.3, Guide for the Preparation of Applications for Special Nuclear Material Licenses for Less than Critical Mass Quantities

8. RG 10.4, Guide for the Preparation of Applications for Licenses to Process Source Material

9. RG 10.5, Applications for a Type A License of Broad Scope

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10. RG 10.6, Guide for the Preparation of Applications for an Industrial Radiography License

11. RG 10.7, Guide for the Preparation of Applications for Licenses for Laboratory and Industrial Use of Small Quantities of Byproduct Material

12. RG 10.8, Guide for the Preparation of Applications for Medical Use Programs

13. RG 10.9, Guide for the Preparation of Applications for Licenses for the Use of Self-Contained Dry Source-Storage Gamma Irradiators (2)

What was the purpose of the Regulatory Guides?

The Division 6 RGs (6.1, 6.2, 6.4, 6.5, and 6.9) provided guidance for leak testing radioactive brachytherapy sources, for integrity and test specifications for selected brachytherapy sources, for verification of containment properties of sealed radioactive sources, for safety standards for installations using nonmedical sealed gamma-ray sources, and for the establishment of quality assurance programs for manufacturing and distribution of sealed sources. The Division 10 RGs (10.2, 10.3, 10.4, 10.5, 10.6, 10.7, 10.8, and 10.9) provided guidance to licensees applying for specific byproduct material licenses of limited scope, licenses for the use of special nuclear material less than critical mass, licenses to process source material, type A licenses of broad scope, industrial radiography licenses, licenses for laboratory and industrial use of small quantities of byproduct material, for medical use programs, and for licenses for the use of self-contained dry source-storage gamma irradiators.

(3)

How were the Regulatory Guides used in regulatory activities, particularly licensing reviews and inspections?

Licensees were using these RGs for preparing applications for the possession and use of byproduct material.

(4)

Are these Regulatory Guides referenced in other technical or regulatory documents? What are the ripple effects on these documents if the RGs are withdrawn?

These RGs are not referenced in other documents. These RGs direct applicants to use the applicable Volume of NUREG-1556, Consolidated Guidance About Materials Licenses in preparing license applications for the use of byproduct material. No ripple effects are anticipated by withdrawing these RGs because the NUREG-1556 series has been the primary guidance document for the development of license applications for the use of byproduct material since the 1990s. If there is a legacy technical or regulatory guidance document referencing these RGs, the withdrawal notification will inform the applicants to use the NUREG-1556 series.

(5)

Why are these Regulatory Guides no longer needed (e.g., what is the rationale for withdrawing these Regulatory Guides instead of revising them)?

The NUREG-1556 series contains the latest guidance for applicants and licensees, and replaces the legacy guidance contained in these RGs, from the 1970s and 1980s. These RGs are no longer helpful to the staff or licensees because they do not include any staff positions and merely reference the NUREG-1556 series.

3 (6)

What guidance is available once the Regulatory Guides are withdrawn?

The NUREG-1556 series contains the guidance acceptable to NRC staff for developing license applications for the use of byproduct material.

(7)

Do other agencies rely upon these Regulatory Guides, e.g., the Agreement States, National Aeronautical and Space Administration, and Department of Energy?

The staff is unaware of any other agency that uses or relies on the guidance included in these RGs, that are proposed to be withdrawn.