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Category:Regulatory Guidance
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10/18-19/2022 ACRS Public Meeting - Predecisional - Documents to Support Part 53- DRO-ISG-2023-03 Development of Scalable Human Factors Engineering Review Plans
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Draft Interim Staff Guidance COL-ISG-030 Advanced Reactor Application-Environmental Considerations for Advanced Nuclear Reactor Applications That Reference the Generic Environmental Impact Statement (NUREG-2249)
Information Notice 2021-02, Recent Issues Associated with Monitoring Occupational Exposure to Radiation from Licensed and Unlicensed Radiation Sources2021-08-0404 August 2021
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Yttrium-90 Microsphere Brachytherapy Sources and Devices Therasphere and SIR-Spheres Licensing Guidance
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Information Notice 2020-01, Increased Electronic Equipment Issues After Electrostatic Cleaning2020-09-0808 September 2020
Increased Electronic Equipment Issues After Electrostatic Cleaning
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Document 3 - Supplemental Guidance for NUREG-1556, Volume 14, Revision 1, Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Well Logging, Tracer, and Field Flood Study Licenses
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Document 2 - Supplemental Guidance for NUREG-1556, Volume 6, Revision 1, Consolidated Guidance About Materials Licenses: Program-Specific Guidance About 10 CFR Part 36 Irradiator Licenses
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Document 1 - Supplemental Guidance for NUREG-1556, Volume 2, Revision 1, Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Industrial Radiography Licenses
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Information Notice 2019-12, Recent Reported Medical Events Involving the Administration of Yttrium-90 Microspheres for Therapeutic Medical Procedure2019-12-31031 December 2019
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Patient Skin Contamination Events Associated with I-131 Metaiodobenzylguanidine During Neuroblastoma Treatments
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Information Notice 2012-15, Use of Enclosures to Mitigate Leakage From Joints That Use A-286 Bolts2012-08-0909 August 2012
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Information Notice 2009-28, Summary of Fitness for Duty Program Performance Reports for Calendar Year 20082009-11-24024 November 2009
Summary of Fitness for Duty Program Performance Reports for Calendar Year 2008
Information Notice 2007-40, Inadequate Implementation of 10 CFR Part 21 Requirements by Vendors Who Supply Basic Components to Nuclear Power Plant Licensees2007-12-21021 December 2007
Inadequate Implementation of 10 CFR Part 21 Requirements by Vendors Who Supply Basic Components to Nuclear Power Plant Licensees
Information Notice 2004-14, Use of Less Then Optimal Bounding Assumptions in Criticality Safety Analysis at Fuel Cycle Facilities2004-07-19019 July 2004
Use of Less Then Optimal Bounding Assumptions in Criticality Safety Analysis at Fuel Cycle Facilities
Information Notice 2004-14, Use of Less Then Optimal Bounding Assumptions In Criticality Safety Analysis at Fuel Cycle Facilities2004-07-19019 July 2004
Use of Less Then Optimal Bounding Assumptions In Criticality Safety Analysis at Fuel Cycle Facilities
Information Notice 2003-22, Heightened Awareness for Patients Containing Detectable Amounts of Radiation from Medical Administrations2003-12-0909 December 2003
Heightened Awareness for Patients Containing Detectable Amounts of Radiation from Medical Administrations
Information Notice 2002-24, Potential Problems with Heat Collectors on Fire Protection Sprinklers2002-07-19019 July 2002
Potential Problems with Heat Collectors on Fire Protection Sprinklers
Information Notice 2001-03, Incident Reporting Requirements for Radiography Licensees2001-04-0606 April 2001
Incident Reporting Requirements for Radiography Licensees
Information Notice 2000-19, Implementation of Human Use Research Protocols Involving U.S. Nuclear Regulatory Commission Regulated Materials2000-12-0505 December 2000
Implementation of Human Use Research Protocols Involving U.S. Nuclear Regulatory Commission Regulated Materials
Information Notice 1999-16, Federal Bureau of Investigation'S Nuclear Site Security Program1999-05-28028 May 1999
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Information Notice 1998-10, Probable Misadministrations Occurring During Intravascular Brachytherapy with Novoste Beta-cath System1998-03-0909 March 1998
Probable Misadministrations Occurring During Intravascular Brachytherapy with Novoste Beta-cath System
Information Notice 1998-09, Collapse of an Isocam II, Dual-Headed Nuclear Medicine Gamma Camera1998-03-0505 March 1998
Collapse of an Isocam II, Dual-Headed Nuclear Medicine Gamma Camera
Information Notice 1997-58, Mechanical Integrity of In-SITU Leach Injection Wells & Piping1997-07-31031 July 1997
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Leak Testing of Packaging Used in Transport of Radioactive Material
Information Notice 1997-55, Calculation of Surface Activity for Contaminated Equipment & Materials1997-07-23023 July 1997
Calculation of Surface Activity for Contaminated Equipment & Materials
Information Notice 1994-23, Guidance to Hazardous, Radioactive and Mixed Waste Generators on the Elements of a Waste Minimization Program1994-03-25025 March 1994
Guidance to Hazardous, Radioactive and Mixed Waste Generators on the Elements of a Waste Minimization Program
Information Notice 1994-21, Regulatory Requirements When No Operations Are Being Performed1994-03-18018 March 1994
Regulatory Requirements When No Operations Are Being Performed
Information Notice 1993-69, Radiography Events at Operating Power Reactors1993-09-0202 September 1993
Radiography Events at Operating Power Reactors
Information Notice 1993-36, Notifications, Reports, and Records of Misadministrations1993-05-0707 May 1993
Notifications, Reports, and Records of Misadministrations
Information Notice 1993-04, Investigation and Reporting of Misadministrations by the Radiation Safety Officer1993-01-0707 January 1993
Investigation and Reporting of Misadministrations by the Radiation Safety Officer
2024-06-18
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Text
Regulatory Guide Number: 6.6, Revision 0
Title:
Acceptance Sampling Procedures for Exempted and Generally Licensed Items Containing Byproduct Material Office/Division/Branch: NMSS/MSTR/MSLB Technical Lead: Richard Struckmeyer
SUBJECT:
Basis for Withdrawal
- 1. What regulation(s) did the Regulatory Guide support?
Regulatory Guide (RG) 6.6, Acceptance Sampling Procedures for Exempted and Generally Licensed Items Containing Byproduct Material, was published in June 1974, to provide guidance to comply with the requirements in Title 10 of the Code of Federal Regulations (10 CFR) 32.110, Acceptance Sampling Procedures Under Certain Specific Licenses.
- 2. What was the purpose of the Regulatory Guide?
The information in RG 6.6 describes sampling procedures intended to limit the risk of products with excessively poor conformance to specifications from reaching the public.
- 3. How was the Regulatory Guide used?
This RG describes specific procedures concerning acceptance sampling plans that could be used by applicants and licensees, as well as the NRC staff, in license applications and inspection activities.
- 4. Why is the Regulatory Guide no longer needed?
RG 6.6 describes a prescriptive methodology for determining whether a product should be accepted or rejected based on statistical sampling methods. In 2012, the NRC amended its regulations in 10 CFR Part 32, "Specific Domestic Licenses to Manufacture or Transfer Certain Items Containing Byproduct Material," to delete 10 CFR Part 32.110 (77 FR 43673; July 25, 2012), so that it was no longer required. As stated in the Federal Register (77 FR 43673; July 25, 2012), [t]he Commission determined that the requirements for manufacturers or initial distributors of exempt and generally licensed products were in some cases overly prescriptive, particularly in the areas of prototype testing and acceptance sampling/quality control (QC) procedures. Such a prescriptive approach is easy to implement and regulate, but is relatively inflexible. This rule is intended to focus the regulations on performance, rather than procedures. The regulations retain general requirements and provide general standards by which performance may be judged, rather than specifying detailed procedures that must be followed. Thus, the NRC decided to allow acceptance sampling to be performance-based, rather than specifying procedural details.
The staff believes that there was limited use of the guidance in RG 6.6 since its publication in 1974. The acceptance sampling procedures and tables included in the guide became obsolete since licensees can now easily use widely available computer software to determine their own acceptance sampling procedures. This allows licensees to select procedures that would best monitor their manufacturing processes to provide sufficient evidence that the appropriate components are capable of performing their intended functions.
- 5. What guidance is available once the Regulatory Guide is withdrawn?
Specific guidance is not needed since the NRC made the decision to amend its regulations in 2012 to use a more performance-based approach.
- 6. Is the Regulatory Guide referenced in other documents and what are the ripple effects on these documents if it is withdrawn?
No reference to Regulatory Guide 6.6 is found in various NRC documents that discuss topics of this or a similar nature such as the materials Inspection Manuals and Procedures, NUREGs, and Regulatory Guides. In particular, this includes the NRC Inspection Manual Chapter 2800, Materials Inspection Program, all volumes of the NUREG-1556 series, Consolidated Guidance about Materials Licensees, NUREG-1717, Systematic Radiological Assessment of Exemptions for Source and Byproduct Materials, NUREG/CR-5883, Health Risk Assessment of Irradiated Topaz, and Regulatory Guides in Division 6, "Products" (it should be noted that NUREG-1556, Volume 12 lists a series of RGs including RG 6.6; however, it is not mentioned in the text.)
Some licensees may have included this guidance in their licensing basis. Although a RG is withdrawn, current licensees may continue to use it, and withdrawal does not affect any existing licenses or agreements. Withdrawal means that the guide should not be used for future NRC licensing activities.
- 7. What is the basis for believing that no guidance similar to that in the Regulatory Guide will ever be needed?
In 2012 the Commission determined that the requirements for manufacturers or initial distributors of exempt and generally licensed products were in some cases overly prescriptive. As a result, the NRC regulations in 10 CFR Part 32, "Specific Domestic Licenses to Manufacture or Transfer Certain Items Containing Byproduct Material," were amended to remove 10 CFR Part 32.110 (77 FR 43673; July 25, 2012). The rulemaking focused the regulations on performance rather than procedures. Therefore, the guidance in RG 6.6 was not needed. The staff does not intend to require prescriptive guidance in the future.
- 8. Will generic guidance still be needed?
Generic prescriptive guidance will not be needed since the staff now requires a performance-based approach.
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- 9. What is the rationale for withdrawing this Regulatory Guide instead of revising it?
The guidance contained in RG 6.6 is no longer needed to meet an NRC regulation since 10 CFR Part 32.110 was deleted from the regulations (77 FR 43673; July 25, 2012) and the RG will not be used for future license applications. Although a RG is withdrawn, current licensees may continue to use it, and withdrawal does not affect any existing licenses or agreements. Withdrawal means that the guide should not be used for future NRC licensing activities. However, if a licensee has committed to such guidance the NRC inspectors will continue to review their commitment for compliance.
- 10. Do other agencies rely upon the Regulatory Guide, e.g., the Agreement States, National Aeronautical and Space Administration, Department of Energy?
The staff is unaware of any other agency or an Agreement State that uses or relies on this guidance.
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