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

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 withd rawn. These RGs were originally published in the 1970s and 1980s and provided guidance for Titl e 10 of the Code of Federal Regulations (10 CFR), including 10 CFR Part 30, Rules of General Applicab ility to Domestic Licensing of Byproduct Material, 10 CFR Part 33, Specific Dom estic Licenses of Broad Scope for Byproduct Material, 10 CFR Part 32, Specific Domestic Lic enses to Manufacture or Transfer Certain Items Containing Byproduct Material, 10 CFR P art 34, Licenses for Industrial Radiography and Radiation Safety Requirements for Industrial Ra diographic Operations, 10 CFR Part 35, Medical Use of Byproduct Material, 10 CFR Part 7 0 Domestic Licensing of Special Nuclear Material, 10 CFR Part 150 Exemptions and Cont inued 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 T ransportation of Radioactive Material, and 10 CFR Part 75, Safeguards on Nuclear Material Implementation of Safeguards Agreements Between the United States and the Interna tional 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 Brach ytherapy Sources

3. RG 6.4, Verification of Containment Properties of Sealed Rad ioactive Sources

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

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

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

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

8. RG 10.4, Guide for the Preparation of Applications for Licen ses 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 I ndustrial Radiography License

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

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

13. RG 10.9, Guide for the Preparation of Applications for Lice nses 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 guida nce for leak testing radioactive brachytherapy sources, for integrity and test specifications fo r selected brachytherapy sources, for verification of containment properties of sealed radioactiv e sources, for safety standards for installations using nonmedical sealed gamma-ray sources, and fo r 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 g uidance 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 ma terial, 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 activitie s, particularly licensing reviews and inspections?

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

(4) Are these Regulatory Guides referenced in other technical o r 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 dire ct applicants to use the applicable Volume of NUREG-1556, Consolidated Guidance About M aterials Licenses in preparing license applications for the use of byproduct materia l. 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 us e of byproduct material since the 1990s. If there is a legacy technical or regulatory guidance do cument referencing these RGs, the withdrawal notification will inform the applicants to use t he NUREG-1556 series.

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

The NUREG-1556 series contains the latest guidance for applican ts and licensees, and replaces the legacy guidance contained in these RGs, from the 1 970s 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.

2 (6) What guidance is available once the Regulatory Guides are w ithdrawn?

The NUREG-1556 series contains the guidance acceptable to NRC s taff 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.

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