RIS 2013-01, Enclosure 1, Recently Issued FSME Generic Communication: Difference between revisions

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{{Adams
{{Adams
| number = ML12313A147
| number = ML13044A294
| issue date = 03/12/2013
| issue date = 03/12/2013
| title = Use of Aftermarket Sealed Sources in Devices Registered Under 10 CFR 32.210
| title = Enclosure 1, Recently Issued FSME Generic Communication
| author name = Dudes L A, Kokajko L E, McDermott B J
| author name = Dudes L A, Kokajko L E, McDermott B J
| author affiliation = NRC/FSME/DMSSA, NRC/NRO/DCIP, NRC/NRR/DPR
| author affiliation = NRC/FSME/DMSSA/LISD/RMSB, NRC/NRO/DCIP, NRC/NRR/DPR
| addressee name =  
| addressee name =  
| addressee affiliation =  
| addressee affiliation =  
| docket =  
| docket =  
| license number =  
| license number =  
| contact person = Janckovich, John 415-7904
| contact person = McIntosh A R
| document report number = RIS-13-001
| document report number = RIS-13-001
| package number = ML13044A257
| package number = ML13044A257
| document type = - No Document Type Applies
| document type = Graphics incl Charts and Tables
| page count = 7
| page count = 3
}}
}}
See also: [[followed by::RIS 2013-01]]
{{#Wiki_filter: List of Recently Issued Office of Federal and State Material and Environmental Management Programs Generic Communications Date GC No. Subject


=Text=
==Addressees==
{{#Wiki_filter:ML12313A147 UNITED STATES NUCLEAR REGULATORY COMMISSION OFFICE OF FEDERAL AND STATE MATERIALS AND ENVIRONMENTAL MANAGEMENT PROGRAMS OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS OFFICE OF NUCLEAR REACTOR REGULATION OFFICE OF NEW REACTORS WASHINGTON, March 12, 2013 NRC REGULATORY ISSUE SUMMARY 2013-01 USE OF AFTERMARKET SEALED SOURCES REGISTERED UNDER 10 CFR 32.210 ADDRESSEES All holders of and applicants for a possession and use of byproduct material license for the processing or manufacturing of items that contain byproduct material for commercial distribution under Title 10 of the Code of Federal Regulations (10 CFR) Part 30, "Rules of General Applicability to Domestic Licensing of Byproduct Material;" all holders of and applicants for a possession and use of byproduct material license for research and development under 10 CFR Part 30;" and all Radiation Control Program Directors and State Liaison Officer All holders of an operating license or construction permit for a nuclear power reactor under 10 CFR Part 50, "Domestic Licensing of Production and Utilization Facilities," that also hold a license under Part 3 All holders of and applicants for a power reactor early site permit, combined license, standard design certification, standard design approval, or manufacturing license under 10 CFR Part 52, "Licenses, Certifications, and Approvals for Nuclear Power Plants," that also hold a license under Part 3 INTENT The U.S. Nuclear Regulatory Commission (NRC) is issuing this regulatory issue summary (RIS) to provide guidance regarding the use, in devices, of replacement, also called "aftermarket," sealed sources that might be equivalent to original sources, but are not identified as such in the device registration certificat No specific action or written response is require BACKGROUND INFORMATION Users of sealed sources or devices (SSDs) containing byproduct material must obtain a specific license under 10 CFR 30.32, "Application for Specific Licenses." In the application for the license, in accordance with section 30.32(g), the applicant must identify the source or the device by manufacturer and model number as registered with the NRC under 10 CFR 32.210, "Registration of Product Information" or with an Agreement State under equivalent regulations, or provide the information identified in section 32.210(c). The registration, as conducted by the NRC, consists of issuance of a registration certificate which (a) confirms that the SSD design meets the regulatory requirements under 10 CFR 32.210, and (b) lists provisions of use for the RIS 2013-01 Page 2 of 6  produc Regarding devices, the provisions of the registration certificate identify the make and model of the source(s) which are authorized for use in the devic Sources, other than the makes and models listed in the device registration, are not authorized to be use Some source manufacturers produce sources that physically, chemically, and radiologically are either similar or identical to those produced by other source manufacturers; these sources could be considered equivalen Thus, it can be reasonably assumed that such sources could be substituted for one anothe However, if such a source were installed in a device, the device would not be in compliance with the registration certificat In addition, it must also be considered that in certain devices the source activity decays beyond its useful range and fresh source(s) must be installed so that the device could maintain its intended functio Consequently, the use of replacement or aftermarket sources must be addresse SUMMARY OF ISSUE In order to ensure that aftermarket sources may be safely used as replacements for the ones listed in the device registration under 10 CFR 30.32 and 10 CFR 32.210, two criteria must be met: (1) the equivalency of the physical, chemical, and radiological properties of the sources, and (2) the registration requirement This RIS provides assistance in addressing both of these issue . Equivalency of the physical, chemical, and radiological properties:
12/26/2012 IN-2012-23 Recent Radiography Events Resulting in Exposures Exceeding Regulatory Limits All holders of radiography licenses issued by the U.S. Nuclear Regulatory (NRC)
Commission under to Title 10 of the Code of Federal Regulations (10 CFR), Part 34, "Licenses for Industrial Radiography and Radiation Safety Requirements for Industrial Radiographic Operations;" NRC Master Material Licensees, Agreement State Radiation Control Program Directors and State Liaison Officer List of Recently Issued Office of Federal and State Material and Environmental Management Programs Generic Communications Date GC No. Subject


In order to determine the equivalency of the physical, chemical, and radiological properties of aftermarket sources, an SSD safety evaluation similar to that conducted for the registration of all products under 10 CFR 32.210 is require The NRC staff conducts the SSD safety evaluations in accordance with the guidance in NUREG-1556, Vol. 3, "Consolidated Guidance about Materials Licenses: Applications for Sealed Source and Device Evaluation and Registration."
==Addressees==
12/25/2012 IN-2012-22 Counterfeit, Fraudulent, SuspectItem (CFSI) Training Offerings All holders of and applicants for: a specific source material license under Title 10 of the Code of Federal Regulations (10 CFR) Part 40, "Domestic Licensing of Source Material"; a power reactor early site permit, combined license, standard design certification, standard design approval, or manufacturing license under 10 CFR Part 52, "Licenses, Certifications, and Approvals for Nuclear Power Plants;" a fuel cycle facility license or a special nuclear material license authorizing the possession, use, or transport of formula quantities of strategic special nuclear material under 10 CFR Part 70, "Domestic Licensing of Special Nuclear Material; " a transportation package certificate of compliance or for a specific approval for transport of radioactive material shipping containers under 10 CFR Part 71, "Packaging and Transportation of Radioactive Material;"
an independent spent fuel storage installation license or a certificate of compliance under 10 CFR Part 72, "Licensing Requirements for the Independent Storage of Spent Nuclear Fuel, High-Level Radioactive Waste and Reactor- Related Greater Than Class C Waste;" a gaseous diffusion plant certificate of compliance or an approved compliance plan under 10 CFR Part 76, "Certification of Gaseous Diffusion Plants." All contractors and vendors that supply basic components to U.S. Nuclear Regulatory Commission (NRC) licensee All holders of an operating license, research and test reactor operating license, or construction permit for a nuclear power reactor under 10 CFR Part 50, "Domestic Licensing of Production and Utilization Facilities," including those who have permanently ceased operations and have certified that fuel has been permanently removed from the reactor vesse All Agreement State Program Directors and State Liaison Officer List of Recently Issued Office of Federal and State Material and Environmental Management Programs Generic Communications Date GC No. Subject


However, in cases where the aftermarket source has been issued a registration certificate, the SSD safety evaluation can be limited to confirming the following: * The NRC or an Agreement State has conducted a safety evaluation of the aftermarket source, which is listed in a registration certificat * The registration certificate of the aftermarket source must state which other sources the aftermarket source can be substituted fo * The aftermarket source has been prototype tested to meet or exceed the performance classification (e.g., standards classification, such as ANSI N43.6 or ISO2919) of the original source in the device as registere * The aftermarket source geometry and manufacturing tolerances are compatible with the source holder configuration in the devic * The materials of the aftermarket source design, such as encapsulation, and the methods of construction are equivalent to the original sourc * The aftermarket source activity is within the design specifications of the devic RIS 2013-01 Page 3 of 6  * The aftermarket source has been designed, tested, and manufactured by a licensed manufacturer with a quality assurance program which the NRC or an Agreement State found acceptabl . Compliance with registration requirements: Under the regulations, five alternative pathways may be followed to authorize the use of aftermarket source Each of these pathways is delineated belo Note that Pathway (a) is the preferred pathway, because this course of action is most closely related to the original device registratio (a) Amendment of the Existing Device Registration: The aftermarket source manufacturer may contact and request that the device manufacturer add the aftermarket source to the device registratio The device manufacturer could accomplish this by requesting, from its respective regulatory authority (the NRC or Agreement State), an amendment of the device registration to list additional sources including the aftermarket sourc The use of the aftermarket source then will be authorized in accordance with the provisions of 10 CFR 32.210 and can be licensed on the basis of 10 CFR 30.32(g)(1) or equivalent Agreement State regulation This course of action provides for a broad-based approach to the issue because the amended device registration would be applicable for all licensees in all NRC and Agreement State (b) Issuance of a New Device Registration: The aftermarket source manufacturer may seek through its regulatory authority a new evaluation of the device with the use of its aftermarket sourc To accomplish this, the aftermarket source manufacturer would have to meet the criteria in 10 CFR 32.210, providing sufficient information such that the regulator could perform the requisite safety analysis and evaluatio Following satisfactory completion of that evaluation, a new registration certificate would be issued to the aftermarket source manufacturer approving use of that source in that devic Fees associated with the registration are specified in 10 CFR 170.31,
==Addressees==
"Schedule of Fees for Materials Licenses and Other Regulatory Services, including Inspections, and Import and Export Licenses," and 10 CFR 171.16, "Annual Fees: Materials Licenses, Holders of Certificate of Compliance, Holders of Sealed Source and Device Registrations, Holders of Quality Assurance Program Approvals, and Government Agencies Licensed by the NRC." This course of action provides for a broad-based approach for the issue because the new device registration will be applicable for all licensees in all NRC and Agreement State (c) Device "Custom" Registration: The device user may apply to the NRC for a "custom" registration certificate of the device to incorporate the aftermarket source as an authorized sourc Such a custom registration certificate is issued under 10 CFR 30.32(g)(1). Guidance on the custom registration process is provided in NUREG-1556, Vol. 3, referenced above (i.e., Section 5.2 in Rev. 1). The NRC staff should consider the equivalency and suitability of the aftermarket source by using the principles for equivalency described abov In addition, the custom device with the aftermarket source also must be properly labeled in accordance with the requirements in 10 CFR 32.21 Fees associated with custom registration are specified in 10 CFR 170.31.9D and 10 CFR 171.16.9 This course of action authorizes the use of the aftermarket source for one licensee only; the process must be repeated for each device user or license RIS 2013-01 Page 4 of 6    (d) License Amendment (License Condition): The device user may request from its regulatory authority the amendment of its license to add a license condition to its license which authorizes the use of the aftermarket replacement source in the devic This approach must comply with the provisions of 10 CFR 30.32(g)(2). In the request for license amendment, the device user must provide, for the aftermarket source, information identified in 10 CFR 32.21 The device user may obtain such information from the manufacturer of the aftermarket sourc The licensee must retain the documentation, as required under 10 CFR 30.51, "Records," such as the application documents and installation information (e.g., date of installation; name, address, license number of the installer) as records related to the aftermarket sourc The NRC staff should consider the equivalency and suitability of the aftermarket source by using the principles for equivalency described abov Regarding labeling, the original label must stay on the device because it is registered under its original registration certificate, but the device would require an additional label to indicate that the original source has been replaced with an aftermarket sourc The additional label should indicate that a replacement source has been installed, and list such information as the make, model, serial number, and activity level of the replacement source as well as the date of installatio The NRC review schedule for granting a license condition depends on the complexity of the technical and safety issues involved, and may be longer than customar This course of action will authorize the use of the aftermarket source for one licensee only, and must be repeated for each device user or license (e) Broad Scope License Use: In cases where the aftermarket manufacturer, holding a license under 10 CFR Part 30, wishes to distribute the replacement sources to broad scope licensees; i.e., entities licensed under 10 CFR Part 33, "Specific Domestic Licenses of Broad Scope for Byproduct Material," the broad scope licensee may approve the use of aftermarket sources for its own use under the conditions of its license provided that the following conditions are met: (i) the licensee's radiation safety committee approved such a use, (ii) the chemical and physical form of the byproduct material in the aftermarket source is in compliance with that specified in the license, and (iii) the activity of the aftermarket source does not exceed the quantities specified in the licens Approval of the use of aftermarket sources by the radiation safety committee applies only to the broad scope licensee's own device BACKFIT DISCUSSION This RIS requires no action or written respons Any action on the part of addressees in accordance with the guidance contained in this RIS is strictly voluntary and, therefore, is not a backfit under any requiremen Consequently, the staff did not perform a backfit analysi FEDERAL REGISTER NOTIFICATION A notice of opportunity for public comment on this RIS was not published in the Federal Register because it is informational and does not represent a departure from current regulatory requirement RIS 2013-01 Page 5 of 6  CONGRESSIONAL REVIEW ACT The NRC has determined that this RIS is not a rule as designated by the Congressional Review Act (5 U.S.C. 801-808) and, therefore, is not subject to the Ac PAPERWORK REDUCTION ACT STATEMENT This RIS references information collection requirements that are subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). These information collections were approved by the Office of Management and Budget (OMB), approval number 3150-000 PUBLIC PROTECTION NOTIFICATION The NRC may not conduct or sponsor, and a person is not required to respond to, a request for information or an information collection requirement unless the requesting document displays a currently valid OMB control numbe RIS 2013-01 Page 6 of 6  CONTACT This regulatory issue summary requires neither specific action nor written respons If you have any questions about this summary, please contact the technical contact listed below or the appropriate regional offic R/A R/A Lawrence E. Kokajko, Director Brian J. McDermott, Director Division of Policy and Rulemaking Division of Materials Safety Office of Nuclear Reactor Regulation and State Agreements Office of Federal and State Materials and Environmental Management Programs R/A Laura A. Dudes, Director Division of Construction, Inspection, and Operational Programs Office of New Reactors
03/20/2012 RIS-2012-04 Notice of Revision to the Criteria for Identifying Materials Licensees for Discussion at the Agency Action Review Meeting All U.S.Nuclear Regulatory Commission materials licensees (including fuel cycle facilities and master material licensees),
Agreement State Radiation Control Program Directors, and State Liaison Officers. 01/17/2012 RIS-2012-01 Availability of Safety Culture Policy Statement All U.S. Nuclear Regulatory Commission licensees, certificate holders, permit holders, authorization holders, holders of quality assurance program approvals, vendors and suppliers of safety-related components, and applicants subject to NRC authority. All Agreement State Radiation Control Program Directors, State Liaison Officers, and other interested stakeholders. 09/29/2011 RIS-2011-11 Regarding Long-Term Surveillance Charge for Conventional or Heap Leach Uranium Recovery Facilities Licensed Under 10 CFR Part 40 All holders of operating licenses for conventional or heap leach uranium recovery facilities; holders of licenses for conventional or heap leach uranium recovery facilities in decommissioning; companies that have submitted applications to construct new conventional or heap leach uranium recovery facilities or letters of intent to submit such applications; UMTRCA Title II sites; Agreement State Radiation Control Program Directors, and State Liaison Officers 08/31/2011 RIS-2011-10 Informing Licensees About the NRC's Public Web Site for Significant Enforcement Actions When Evaluating Individuals for Employment All U.S. Nuclear Regulatory Commission licensees, certificate holders, permit holders, applicants, Agreement State Radiation Control Program Directors, State Liaison Officers, and other interested stakeholders. Note: This list contains the six most recently issued generic communications, issued by the Office of Federal and State Materials and Environmental Management Programs (FSME). A full listing of all generic communications may be viewed at the NRC public website at the following address: http://www.nrc.gov/reading-rm/doc-collections/gen-comm/index.html
}}


Technical Contact: John P. Jankovich, DMSSA/FSME (301) 415-7904 E-mail: john.jankovich@nrc.gov Note: NRC generic communications may be found on the NRC public Web site, http://www.nrc.gov, under NRC Library/Document Collection RIS 2013-01 Page 6 of 6  CONTACT This regulatory issue summary requires neither specific action nor written respons If you have any questions about this summary, please contact the technical contact listed below or the appropriate regional offic R/A R/A Lawrence E. Kokajko, Director Brian J. McDermott, Director Division of Policy and Rulemaking Division of Materials Safety Office of Nuclear Reactor Regulation and State Agreements Office of Federal and State Materials and Environmental Management Programs R/A Laura A. Dudes, Director Division of Construction, Inspection, and Operational Programs Office of New Reactors
{{RIS-Nav}}
 
Technical Contact: John P. Jankovich, DMSSA/FSME (301) 415-7904 E-mail: john.jankovich@nrc.gov Note: NRC generic communications may be found on the NRC public Web site, http://www.nrc.gov, under NRC Library/Document Collection ADAMS Accession Number: ML12313A147  *via e-mail  TAC MF0415 Office DMSSA/LB Tech Editor* FSME* RI* RIII* RIV* Name JJankovich JDougherty AMcIntosh MFerdas PJPelke JWhitten Date 02/06/13 12/13/12 12/04/12 12/04/12 12/03/12 12/04/12 Office DMSSA/LB/BC NMSS/FCSS/CDMB/BC* OE* NRR/PMDA* OIS* D/DORL* Name MKotzalas (LBolling for) PSilva (MBartlett for)NHilton (LSreenivas for)LHill TDonnell (KBenney for)MEvans Date 02/06/13 12/27/12 01/04/13 12/28/12 01/07/13 01/10/13 Office NMSS/SFST/D* OGC* PGCB/LA PGCB/PM PGCB/BC D/DCIP Name MLombard SChidakel CHawes TAlexion DPelton LDudes Date 01/11/13 02/05/13 02/07/13 02/07/13 02/11/13 02/19/13 Office DD/DPR D/DPR DD/DMSSA D/DMSSA Name SBahadur LKokajko PHenderson BMcDermott Date 02/28/13 02/28/13 03/8/13 03/12/2013 / / / / OFFICIAL RECORD COPY
}}

Revision as of 14:11, 8 March 2018

Enclosure 1, Recently Issued FSME Generic Communication
ML13044A294
Person / Time
Site: 03039281
Issue date: 03/12/2013
From: Dudes L A, Kokajko L E, McDermott B J
NRC/FSME/DMSSA/LISD/RMSB, Division of Construction Inspection and Operational Programs, Division of Policy and Rulemaking
To:
McIntosh A R
Shared Package
ML13044A257 List:
References
RIS-13-001
Preceding documents:
Download: ML13044A294 (3)
v • d • e


List of Recently Issued Office of Federal and State Material and Environmental Management Programs Generic Communications Date GC No. Subject

Addressees

12/26/2012 IN-2012-23 Recent Radiography Events Resulting in Exposures Exceeding Regulatory Limits All holders of radiography licenses issued by the U.S. Nuclear Regulatory (NRC)

Commission under to Title 10 of the Code of Federal Regulations (10 CFR), Part 34, "Licenses for Industrial Radiography and Radiation Safety Requirements for Industrial Radiographic Operations;" NRC Master Material Licensees, Agreement State Radiation Control Program Directors and State Liaison Officer List of Recently Issued Office of Federal and State Material and Environmental Management Programs Generic Communications Date GC No. Subject

Addressees

12/25/2012 IN-2012-22 Counterfeit, Fraudulent, SuspectItem (CFSI) Training Offerings All holders of and applicants for: a specific source material license under Title 10 of the Code of Federal Regulations (10 CFR) Part 40, "Domestic Licensing of Source Material"; a power reactor early site permit, combined license, standard design certification, standard design approval, or manufacturing license under 10 CFR Part 52, "Licenses, Certifications, and Approvals for Nuclear Power Plants;" a fuel cycle facility license or a special nuclear material license authorizing the possession, use, or transport of formula quantities of strategic special nuclear material under 10 CFR Part 70, "Domestic Licensing of Special Nuclear Material; " a transportation package certificate of compliance or for a specific approval for transport of radioactive material shipping containers under 10 CFR Part 71, "Packaging and Transportation of Radioactive Material;"

an independent spent fuel storage installation license or a certificate of compliance under 10 CFR Part 72, "Licensing Requirements for the Independent Storage of Spent Nuclear Fuel, High-Level Radioactive Waste and Reactor- Related Greater Than Class C Waste;" a gaseous diffusion plant certificate of compliance or an approved compliance plan under 10 CFR Part 76, "Certification of Gaseous Diffusion Plants." All contractors and vendors that supply basic components to U.S. Nuclear Regulatory Commission (NRC) licensee All holders of an operating license, research and test reactor operating license, or construction permit for a nuclear power reactor under 10 CFR Part 50, "Domestic Licensing of Production and Utilization Facilities," including those who have permanently ceased operations and have certified that fuel has been permanently removed from the reactor vesse All Agreement State Program Directors and State Liaison Officer List of Recently Issued Office of Federal and State Material and Environmental Management Programs Generic Communications Date GC No. Subject

Addressees

03/20/2012 RIS-2012-04 Notice of Revision to the Criteria for Identifying Materials Licensees for Discussion at the Agency Action Review Meeting All U.S.Nuclear Regulatory Commission materials licensees (including fuel cycle facilities and master material licensees),

Agreement State Radiation Control Program Directors, and State Liaison Officers. 01/17/2012 RIS-2012-01 Availability of Safety Culture Policy Statement All U.S. Nuclear Regulatory Commission licensees, certificate holders, permit holders, authorization holders, holders of quality assurance program approvals, vendors and suppliers of safety-related components, and applicants subject to NRC authority. All Agreement State Radiation Control Program Directors, State Liaison Officers, and other interested stakeholders. 09/29/2011 RIS-2011-11 Regarding Long-Term Surveillance Charge for Conventional or Heap Leach Uranium Recovery Facilities Licensed Under 10 CFR Part 40 All holders of operating licenses for conventional or heap leach uranium recovery facilities; holders of licenses for conventional or heap leach uranium recovery facilities in decommissioning; companies that have submitted applications to construct new conventional or heap leach uranium recovery facilities or letters of intent to submit such applications; UMTRCA Title II sites; Agreement State Radiation Control Program Directors, and State Liaison Officers 08/31/2011 RIS-2011-10 Informing Licensees About the NRC's Public Web Site for Significant Enforcement Actions When Evaluating Individuals for Employment All U.S. Nuclear Regulatory Commission licensees, certificate holders, permit holders, applicants, Agreement State Radiation Control Program Directors, State Liaison Officers, and other interested stakeholders. Note: This list contains the six most recently issued generic communications, issued by the Office of Federal and State Materials and Environmental Management Programs (FSME). A full listing of all generic communications may be viewed at the NRC public website at the following address: http://www.nrc.gov/reading-rm/doc-collections/gen-comm/index.html


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