RIS 2005-21, Clarification of the Reporting Requirements in 10 CFR 20.2201: Difference between revisions

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| issue date = 11/14/2005
| issue date = 11/14/2005
| title = Clarification of the Reporting Requirements in 10 CFR 20.2201
| title = Clarification of the Reporting Requirements in 10 CFR 20.2201
| author name = Case M J, Miller C L
| author name = Case M, Miller C
| author affiliation = NRC/NMSS/IMNS, NRC/NRR/ADRO/DIRS
| author affiliation = NRC/NMSS/IMNS, NRC/NRR/ADRO/DIRS
| addressee name =  
| addressee name =  
Line 9: Line 9:
| docket =  
| docket =  
| license number =  
| license number =  
| contact person = DeCicco J E, NMSS/IMNS, 415-7833
| contact person = DeCicco J, NMSS/IMNS, 415-7833
| document report number = RIS-05-021
| document report number = RIS-05-021
| document type = NRC Regulatory Issue Summary
| document type = NRC Regulatory Issue Summary
| page count = 9
| page count = 9
}}
}}
{{#Wiki_filter:UNITED STATESNUCLEAR REGULATORY COMMISSIONOFFICE OF NUCLEAR REACTOR REGULATIONOFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDSWASHINGTON, DC 20555-0001November 14, 2005NRC REGULATORY ISSUE SUMMARY 2005-21CLARIFICATION OF THE REPORTING REQUIREMENTS IN 10 CFR 20.2201
{{#Wiki_filter:UNITED STATES
                            NUCLEAR REGULATORY COMMISSION
                        OFFICE OF NUCLEAR REACTOR REGULATION
                OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS
                                WASHINGTON, DC 20555-0001 November 14, 2005 NRC REGULATORY ISSUE SUMMARY 2005-21 CLARIFICATION OF THE REPORTING REQUIREMENTS IN
                                        10 CFR 20.2201  


==ADDRESSEES==
==ADDRESSEES==
All U.S. Nuclear Regulatory Commission (NRC) licensees and Part 76 certificate holdersauthorized to possess licensed material.
All U.S. Nuclear Regulatory Commission (NRC) licensees and Part 76 certificate holders authorized to possess licensed material.


==INTENT==
==INTENT==
NRC is issuing this regulatory issue summary (RIS) to clarify the reporting requirementsregarding lost, stolen, or missing licensed material in 10 CFR 20.2201. This RIS does not transmit any new requirements or new staff positions. No specific action or written response is required.
NRC is issuing this regulatory issue summary (RIS) to clarify the reporting requirements regarding lost, stolen, or missing licensed material in 10 CFR 20.2201. This RIS does not transmit any new requirements or new staff positions. No specific action or written response is required.


==BACKGROUND==
==BACKGROUND==
There has been an increased interest in ensuring the security of NRC-licensed material duringthe last several years. In addition, every radiation protection program, to be both efficient and effective, requires accountability of its licensed material. For these reasons the reporting requirements for lost, stolen, or missing sources as specified in 10 CFR 20.2201 are being clarified.
There has been an increased interest in ensuring the security of NRC-licensed material during the last several years. In addition, every radiation protection program, to be both efficient and effective, requires accountability of its licensed material. For these reasons the reporting requirements for lost, stolen, or missing sources as specified in 10 CFR 20.2201 are being clarified.


==SUMMARY OF ISSUE==
==SUMMARY OF ISSUE==
Section 20.2201 mandates that each licensee report, by telephone, its discovery of any lost,stolen, or missing licensed material, including sources. The regulations require, in 10 CFR
Section 20.2201 mandates that each licensee report, by telephone, its discovery of any lost, stolen, or missing licensed material, including sources. The regulations require, in 10 CFR
20.2201(a)(1)(I), an immediate report by telephone if the material in question is equal to or greater than 1000 times the quantity specified in Appendix C to 10 CFR Part 20, under such circumstances that an exposure could result to persons in unrestricted areas. In accordance with 10 CFR 20.2201(a)(1)(ii), each licensee shall report by telephone, within 30 days after the occurrence of any lost, stolen, or missing licensed material becomes known to the licensee, licensed material that is greater than 10 times the quantity specified in Appendix C to Part 20, ML052700314 RIS  2005-21 that is still missing at the time. A written report is required by 10 CFR 20.2201(b), within 30days of either telephone call; the information required in the written report is described in 10
20.2201(a)(1)(I), an immediate report by telephone if the material in question is equal to or greater than 1000 times the quantity specified in Appendix C to 10 CFR Part 20, under such circumstances that an exposure could result to persons in unrestricted areas. In accordance with 10 CFR 20.2201(a)(1)(ii), each licensee shall report by telephone, within 30 days after the occurrence of any lost, stolen, or missing licensed material becomes known to the licensee, licensed material that is greater than 10 times the quantity specified in Appendix C to Part 20,
CFR 20.2201(b)(1)(I) - (vi). Subsequent to the written report, 10 CFR 20.2201(d) requires the licensee to report any additional substantive information on the loss or theft of the licensed material within 30 days after the licensee learns of such information.This RIS clarifies the term immediately in the context of reporting the occurrence of lost, stolen,or missing licensed material, how the term exposure could result is used, and the licensee'sresponsibility to inform the NRC of the recovery of lost or stolen licensed material.The NRC staff has reviewed the reporting requirements for 10 CFR 20.2201 and has includedclarifications for the following requirements: 10 CFR 20.2201, Reports of theft or loss of licensed material (a) Telephone reports.(1) Each licensee shall report by telephone as follows:
that is still missing at the time. A written report is required by 10 CFR 20.2201(b), within 30
(i) Immediately after its occurrence becomes known to the licensee, a lost, stolen, ormissing licensed material in an aggregate quantity equal to or greater than 1000 times the quantity specified in Appendix C, to Part 20, under such circumstances that it appears to the licensee that an exposure could result to persons in unrestricted areas.10 CFR 30.50(a), 40.60(a), and 70.50(a) indicate NRC reporting requirements for anevent that involves exposure to byproduct, source, and special nuclear material, respectively, in excess of applicable limits. These paragraphs require an immediate report, and each licensee shall notify NRC as soon as possible, but not later than 4 hours, after the discovery of an event that prevents immediate protective actions necessary to avoid exposures to radiation or radioactive materials that could exceed regulatory limits, or releases of licensed materials that could exceed regulatory limits (events may include fires, explosions, toxic gas releases, etc.). Therefore, for the immediate reporting requirements of 10 CFR 20.2201, NRC desires notification within 4hours after the occurrence becomes known to the licensee of any lost, stolen, ormissing licensed material, including sources.In the context above, the phrase "exposure could result" connotes having the possibilityto result in exposure to a person, and a licensee would be required to report unlessexposure to a person was not possible.(ii) Within 30 days after the occurrence of any lost, stolen, or missing licensed materialbecomes known to the licensee, all licensed material in a quantity greater than 10 times the quantity specified in Appendix C to Part 20, that is still missing at this time.10 CFR 30.9(a), 40.9(a), and 70.9(a) require that information provided to the Commission by a licensee shall be complete and accurate in all material respects.
days of either telephone call; the information required in the written report is described in 10
CFR 20.2201(b)(1)(I) - (vi). Subsequent to the written report, 10 CFR 20.2201(d) requires the licensee to report any additional substantive information on the loss or theft of the licensed material within 30 days after the licensee learns of such information.
 
This RIS clarifies the term immediately in the context of reporting the occurrence of lost, stolen, or missing licensed material, how the term exposure could result is used, and the licensees responsibility to inform the NRC of the recovery of lost or stolen licensed material.
 
The NRC staff has reviewed the reporting requirements for 10 CFR 20.2201 and has included clarifications for the following requirements:
10 CFR 20.2201, Reports of theft or loss of licensed material (a) Telephone reports.
 
(1) Each licensee shall report by telephone as follows:
    (i) Immediately after its occurrence becomes known to the licensee, a lost, stolen, or missing licensed material in an aggregate quantity equal to or greater than 1000 times the quantity specified in Appendix C, to Part 20, under such circumstances that it appears to the licensee that an exposure could result to persons in unrestricted areas.
 
10 CFR 30.50(a), 40.60(a), and 70.50(a) indicate NRC reporting requirements for an event that involves exposure to byproduct, source, and special nuclear material, respectively, in excess of applicable limits. These paragraphs require an immediate report, and each licensee shall notify NRC as soon as possible, but not later than 4 hours, after the discovery of an event that prevents immediate protective actions necessary to avoid exposures to radiation or radioactive materials that could exceed regulatory limits, or releases of licensed materials that could exceed regulatory limits (events may include fires, explosions, toxic gas releases, etc.). Therefore, for the immediate reporting requirements of 10 CFR 20.2201, NRC desires notification within 4 hours after the occurrence becomes known to the licensee of any lost, stolen, or missing licensed material, including sources.
 
In the context above, the phrase "exposure could result connotes having the possibility to result in exposure to a person, and a licensee would be required to report unless exposure to a person was not possible.
 
(ii) Within 30 days after the occurrence of any lost, stolen, or missing licensed material becomes known to the licensee, all licensed material in a quantity greater than 10 times the quantity specified in Appendix C to Part 20, that is still missing at this time.
 
10 CFR 30.9(a), 40.9(a), and 70.9(a) require that information provided to the Commission by a licensee shall be complete and accurate in all material respects.


Thus, when licensed material is recovered that has been reported under 10 CFR
Thus, when licensed material is recovered that has been reported under 10 CFR
20.2201 as lost, stolen, or missing, the licensee must notify the NRC of the recovery. NRC desires that licensees make a telephone report within 4 hours regarding therecovery of any lost, stolen, or missing licensed material that is equal to or greater than Category II levels. Category II material and level are defined in the International Atomic Energy Agency, "Code of Conduct on the Safety and Security of Radioactive Sources"
        20.2201 as lost, stolen, or missing, the licensee must notify the NRC of the recovery. NRC desires that licensees make a telephone report within 4 hours regarding the recovery of any lost, stolen, or missing licensed material that is equal to or greater than Category II levels. Category II material and level are defined in the International Atomic Energy Agency, Code of Conduct on the Safety and Security of Radioactive Sources
2004, and in the NRC proposed rule for the National Source Tracking of Sealed Sources  
        2004, and in the NRC proposed rule for the National Source Tracking of Sealed Sources
(70 FR 43646; July 28, 2005). Below is a table that provides the thresholds for Category II material and level:RadionuclideQuantity ofConcern (TBq)Quantity ofConcern (Ci )Am-2410.616 Am-241/Be0.616 Cf-2520.25.4 Cm-2440.514Co-600.38.1 Cs-137127Gd-15310270Ir-192 0.822Pm-14740011,000Pu-2380.616 Pu-239/Be0.616 Se-75254 Sr-90 (Y-90)10270 Tm-1702005,400 Yb-169381                                                                                                                (b) Written reports. (1) Each licensee required to make a report under paragraph (a) of this section shall, within30 days after making the telephone report, make a written report setting forth the information contained in 10 CFR 20.2201(b)(1)(i) through (vi). (c) A duplicate report is not required, under paragraph (b), if the licensee is also required tosubmit a report pursuant to paragraphs 10 CFR 30.55(c); 40.64(c); 50.72; 50.73; 70.52;
        (70 FR 43646; July 28, 2005). Below is a table that provides the thresholds for Category II material and level:
73.27(b); 73.67(e)(3)(vii); 73.67(g)(3)(iii); 73.71; or 150.19(c), of chapter 1 of the regulations. (d) Subsequent to filing the written report, the licensee shall also report any additionalsubstantive information on the loss or theft, within 30 days after the licensee learns of such information.The above paraphrases most of 10 CFR 20.2201, and additional information was cited to helpclarify what is meant by the terms immediately and exposure could result. Consult theregulations for the full text.This clarification of the requirements from 10 CFR 20.2201 does not exempt licensees frommeeting the requirements from other sections in the regulations in regards to reporting.
                          Radionuclide              Quantity of        Quantity of Concern (TBq)       Concern (Ci )
                            Am-241                      0.6                16 Am-241/Be                      0.6                16 Cf-252                      0.2              5.4 Cm-244                      0.5                14 Co-60                      0.3              8.1 Cs-137                        1                27 Gd-153                      10                270
                            Ir-192                       0.8                22 Pm-147                      400            11,000
                            Pu-238                      0.6                16 Pu-239/Be                      0.6                16 Se-75                        2                54 Sr-90 (Y-90)                   10                270
                            Tm-170                      200              5,400
                            Yb-169                        3                81 (b) Written reports.
 
(1) Each licensee required to make a report under paragraph (a) of this section shall, within
    30 days after making the telephone report, make a written report setting forth the information contained in 10 CFR 20.2201(b)(1)(i) through (vi).
(c) A duplicate report is not required, under paragraph (b), if the licensee is also required to submit a report pursuant to paragraphs 10 CFR 30.55(c); 40.64(c); 50.72; 50.73; 70.52;
73.27(b); 73.67(e)(3)(vii); 73.67(g)(3)(iii); 73.71; or 150.19(c), of chapter 1 of the regulations. (d) Subsequent to filing the written report, the licensee shall also report any additional substantive information on the loss or theft, within 30 days after the licensee learns of such information.
 
The above paraphrases most of 10 CFR 20.2201, and additional information was cited to help clarify what is meant by the terms immediately and exposure could result. Consult the regulations for the full text.
 
This clarification of the requirements from 10 CFR 20.2201 does not exempt licensees from meeting the requirements from other sections in the regulations in regards to reporting.


==BACKFIT DISCUSSION==
==BACKFIT DISCUSSION==
This RIS requires no action nor written response and is, therefore, not a backfit under 10 CFR 50.109. Consequently, the staff did not perform a backfit analysis.
This RIS requires no action nor written response and is, therefore, not a backfit under
10 CFR 50.109. Consequently, the staff did not perform a backfit analysis.


===FEDERAL REGISTER NOTIFICATION===
===FEDERAL REGISTER NOTIFICATION===
A notice of opportunity for public comment on this RIS was not published in the FederalRegister because this RIS is informational and does not represent a departure from currentregulatory requirements.SMALL BUSINESS REGULATORY ENFORCEMENT FAIRNESS ACTNRC has determined that this action is not subject to the Small Business RegulatoryEnforcement Fairness Act of 1996.
A notice of opportunity for public comment on this RIS was not published in the Federal Register because this RIS is informational and does not represent a departure from current regulatory requirements.
 
SMALL BUSINESS REGULATORY ENFORCEMENT FAIRNESS ACT
NRC has determined that this action is not subject to the Small Business Regulatory Enforcement Fairness Act of 1996.


===PAPERWORK REDUCTION ACT STATEMENT===
===PAPERWORK REDUCTION ACT STATEMENT===
OF 1996The information collections contained in this RIS are covered by the requirements of 10 CFR20, 30, 40, and 70, which were approved by the Office of Management and Budget, approval numbers 3150-0014, 0017, 0020, and 009.
OF 1996 The information collections contained in this RIS are covered by the requirements of 10 CFR
20, 30, 40, and 70, which were approved by the Office of Management and Budget, approval numbers 3150-0014, 0017, 0020, and 009.


===PUBLIC PROTECTION NOTIFICATION===
===PUBLIC PROTECTION NOTIFICATION===
The NRC may not conduct or sponsor, and a person is not required to respond to, a request forinformation or an information collection requirement, unless the requesting document displays a currently valid OMB control number.
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 number.


==CONTACT==
==CONTACT==
Please direct any questions about this matter to the technical contact or the appropriateregional office./RA//RA/Charles L. Miller, Director Michael J. Case, DirectorDivision of Industrial Division of Inspection & Regional Support Medical Nuclear Safety Office of Nuclear Reactor Regulation and Safeguards Office of Nuclear Material Safety  
Please direct any questions about this matter to the technical contact or the appropriate regional office.
 
/RA/                                               /RA/
Charles L. Miller, Director                     Michael J. Case, Director Division of Industrial                         Division of Inspection & Regional Support Medical Nuclear Safety                         Office of Nuclear Reactor Regulation and Safeguards Office of Nuclear Material Safety  


===Technical Contact:===
===Technical Contact:===
Joe DeCicco, NMSS           301-415-7833     E-mail: jxd1@nrc.gov Attachment: List of Recently Issued NMSS Generic CommunicationsNote: NRC generic communications may be found on the NRC public website,http://www.nrc.gov, under Electronic Reading Room/Document Collections.
Joe DeCicco, NMSS
                      301-415-7833 E-mail: jxd1@nrc.gov Attachment: List of Recently Issued NMSS Generic Communications Note: NRC generic communications may be found on the NRC public website, http://www.nrc.gov, under Electronic Reading Room/Document Collections.


==CONTACT==
==CONTACT==
Please direct any questions about this matter to the technical contact or the appropriateregional office./RA//RA/Charles L. Miller, Director Michael J. Case, DirectorDivision of Industrial Division of Inspection & Regional Support Medical Nuclear Safety Office of Nuclear Reactor Regulation and Safeguards Office of Nuclear Material Safety  
Please direct any questions about this matter to the technical contact or the appropriate regional office.
 
/RA/                                                 /RA/
      Charles L. Miller, Director                       Michael J. Case, Director Division of Industrial                           Division of Inspection & Regional Support Medical Nuclear Safety                           Office of Nuclear Reactor Regulation and Safeguards Office of Nuclear Material Safety  


===Technical Contact:===
===Technical Contact:===
Joe DeCicco, NMSS           301-415-7833     E-mail: jxd1@nrc.gov Attachment: List of Recently Issued NMSS Generic CommunicationsNote: NRC generic communications may be found on the NRC public website,http://www.nrc.gov, under Electronic Reading Room/Document Collections.Distribution
Joe DeCicco, NMSS
:IMNS/ r/fNMSS/rfADAMS ML052700314OFFICEMSIB-ATECH EDMSIB-AMSIBOSTPFCSSSFPONAMEJDeCicco EKrausTHarris  TEssigPLohausR PiersonW BrachDATE 12/ 28 /04 12/28/04      01/13/05 01/26/05   09/08/0501/28/05   09/07/05OFFICEDWMNRRIROBD:DLPMOGC (NLO)OGC(SBREFA)PMASNAMELCamperTQuayTHBoyceTMarshSTrebySCrockettVTharpeDATE01/28/0502/02/05 10/28/05   10/31/0509/22/0510/05/0510/18/05OFFICEOISIROBNRRIROBIMNSIROBNAMEBSheltonAMarkleySKlementowiczMJRoss-LeeCLMillerPLHilandDATE10/25/0511/01/0509/27/0511/04/05     11/14/05     11/7/05OFFICIAL RECORD COPY  
                              301-415-7833 E-mail: jxd1@nrc.gov Attachment: List of Recently Issued NMSS Generic Communications Note: NRC generic communications may be found on the NRC public website, http://www.nrc.gov, under Electronic Reading Room/Document Collections.
Attachment Recently Issued NMSS Generic CommunicationsDateGC No.Subject
 
Distribution:
      IMNS/ r/f              NMSS/rf        ADAMS ML052700314 OFFICE MSIB-A          TECH ED      MSIB-A        MSIB              OSTP      FCSS              SFPO
NAME JDeCicco            EKraus      THarris      TEssig            PLohaus    R Pierson        W Brach DATE    12/ 28 /04     12/28/04      01/13/05     01/26/05         09/08/05  01/28/05         09/07/05 OFFICE DWM              NRR          IROB          D:DLPM          OGC (NLO)     OGC           PMAS
                                                                                  (SBREFA)
NAME    LCamper        TQuay        THBoyce      TMarsh          STreby        SCrockett    VTharpe DATE    01/28/05        02/02/05     10/28/05     10/31/05        09/22/05      10/05/05      10/18/05 OFFICE OIS              IROB          NRR                IROB          IMNS            IROB
NAME BShelton          AMarkley      SKlementowicz      MJRoss-Lee CLMiller            PLHiland DATE    10/25/05        11/01/05      09/27/05          11/04/05         11/14/05       11/7/05 OFFICIAL RECORD COPY
 
Attachment Recently Issued NMSS Generic Communications Date    GC No.                 Subject                              


==Addressees==
==Addressees==
2/11/05BL-05-01Material Control and Accounting atReactors and Wet Spent Fuel
2/11/05  BL-05-01  Material Control and Accounting at  All holders of operating licenses for Reactors and Wet Spent Fuel         nuclear power reactors, decommissioning Storage Facilities                  nuclear power reactor sites storing spent fuel in a pool, and wet spent fuel storage sites.


Storage Facilities All holders of operating licenses fornuclear power reactors, decommissioning nuclear power
10/28/05 RIS-05-22  Requirements for the Physical      All holders of licenses for the possession Protection During Transportation of of special nuclear material (SNM) that Special Nuclear Material of        ship Category II and III quantities of this Moderate and Low Strategic          material.


reactor sites storing spent fuel in a pool, and wet spent fuel storage sites.10/28/05RIS-05-22Requirements for the PhysicalProtection During Transportation of Special Nuclear Material of Moderate and Low Strategic Significance: 10 CFR Part 72 vs.
Significance: 10 CFR Part 72 vs.


Regulatory Guide 5.59 (1983)
Regulatory Guide 5.59 (1983)
All holders of licenses for the possessionof special nuclear material (SNM) that ship Category II and III quantities of this material.9/27/05RIS-04-17,Rev. 1Revised Decay-in-StorageProvisions for the Storage of Radioactive Waste Containing Byproduct MaterialAll licensees regulated under 10 CFR
9/27/05 RIS-04-17, Revised Decay-in-Storage           All licensees regulated under 10 CFR
Parts 30, 32, 33, 35, 39, and 50.8/25/05RIS-05-18Guidance for Establishing andMaintaining a Safety Conscious Work Environment All licensees, applicants for licenses, holders of certificates of compliance, and their contractors subject to NRC authority8/10/05RIS-05-16Issuance of NRC ManagementDirective 8.17, "Licensee Complaints Against NRC
          Rev. 1  Provisions for the Storage of      Parts 30, 32, 33, 35, 39, and 50.
Employees"
 
All licensees and certificate holders.8/3/05RIS-05-15Reporting Requirements forDamaged Industrial Radiographic
Radioactive Waste Containing Byproduct Material
8/25/05 RIS-05-18  Guidance for Establishing and      All licensees, applicants for licenses, Maintaining a Safety Conscious      holders of certificates of compliance, and Work Environment                    their contractors subject to NRC authority
8/10/05 RIS-05-16  Issuance of NRC Management          All licensees and certificate holders.


Equipment All material licensees possessing industrial radiographic equipment, regulated under 10 CFR Part 34.7/13/05RIS-05-13NRC Incident Response and theNational Response Plan All licensees and certificate holders.7/11/05RIS-05-12Transportation of RadioactiveMaterial Quantities of Concern NRC Threat Advisory and Protective Measures SystemLicensees authorized to possessradioactive material that equals or exceeds the threshold values in the Additional Security Measures (ASM) for transportation of Radioactive Material Quantities of Concern (RAMQC) under their 10 CFR Part 30, 32, 50, 70, and 71
Directive 8.17, Licensee Complaints Against NRC
                    Employees
  8/3/05 RIS-05-15  Reporting Requirements for          All material licensees possessing Damaged Industrial Radiographic    industrial radiographic equipment, Equipment                          regulated under 10 CFR Part 34.


licenses and Agreement State licensees similarly authorized to possess such
7/13/05 RIS-05-13  NRC Incident Response and the      All licensees and certificate holders.


material in such quantities under their
National Response Plan
7/11/05 RIS-05-12  Transportation of Radioactive      Licensees authorized to possess Material Quantities of Concern      radioactive material that equals or NRC Threat Advisory and            exceeds the threshold values in the Protective Measures System          Additional Security Measures (ASM) for transportation of Radioactive Material Quantities of Concern (RAMQC) under their 10 CFR Part 30, 32, 50, 70, and 71 licenses and Agreement State licensees similarly authorized to possess such material in such quantities under their Agreement State licenses.


Agreement State licenses.7/11/05RIS-05-11Requirements for Power Reactor Licensees in Possession of Devices Subject to the General License Requirements of 10 CFR
7/11/05 RIS-05-11  Requirements for Power Reactor     All holders of operating licenses for Licensees in Possession of         nuclear power reactors and generally Devices Subject to the General     licensed device License Requirements of 10 CFR     vendors.


31.5 All holders of operating licenses fornuclear power reactors and generally licensed device vendors. DateGC No.Subject
31.5 Date    GC No.                 Subject                                


==Addressees==
==Addressees==
6/10/05 RIS-05-10 Perform ance-Based Approach forAssociated Equipment in 10 CFR
6/10/05 RIS-05-10 Performance-Based Approach for      All industrial radiography licensees and Associated Equipment in 10 CFR       manufacturers and distributors of
 
                  34.20                                industrial radiography equipment.
34.20All industrial radiography licensees and manufacturers and distributors of industrial radiography equipment.4/18/05RIS-05-06Reporting Requirements forGauges Damaged at Temporary


Job Sites All material licensees possessingportable gauges, regulated under 10 CFR
4/18/05 RIS-05-06 Reporting Requirements for          All material licensees possessing Gauges Damaged at Temporary          portable gauges, regulated under 10 CFR
                  Job Sites                            Part 30.


Part 30.4/14/05RIS-05-04Guidance on the Protection ofUnattended Openings that Intersect a Security Boundary or
4/14/05 RIS-05-04 Guidance on the Protection of        All holders of operating licenses or Unattended Openings that             construction permits for nuclear power Intersect a Security Boundary or     reactors, Area                                research and test reactors, decommissioning reactors with fuel on site, Category 1 fuel cycle facilities, critical mass facilities, uranium conversion facility, independent spent fuel storage installations, gaseous diffusion plants, and certain other material licensees.


Area All holders of operating licenses orconstruction permits for nuclear power
2/28/05 RIS-05-03 10 CFR Part 40 Exemptions for        All persons possessing aircraft Uranium Contained in Aircraft        counterweights containing uranium under Counterweights - Storage and        the exemption in Repair                              10 CFR 40.13(c)(5).
10/31/05  IN-05-28 Inadequate Test Procedure Fails      All licensees authorized to possess a to Detect Inoperable Criticality    critical mass of special nuclear material.


reactors, research and test reactors, decommissioning reactors with fuel on site, Category 1 fuel cycle
Accident Alarm Horns
10/07/05  IN-05-27 Low Dose-Rate Manual                All medical licensees.


facilities, critical mass facilities, uranium conversion facility, independent spent
Brachytheraphy Equipment Related Medical Events
7/29/05  IN-05-22 Inadequate Criticality Safety        All licensees authorized to possess a Analysis of Ventilation Systems at  critical mass of special nuclear material.


fuel storage
Fuel Cycle Facilities
6/23/05  IN-05-17 Manual Brachytherapy Source          All medical licensees authorized to Jamming                              possess a Mick applicator.


installations, gaseous diffusion plants, and certain other material licensees.2/28/05RIS-05-0310 CFR Part 40 Exemptions forUranium Contained in Aircraft Counterweights - Storage and Repair All persons possessing aircraftcounterweights containing uranium under the exemption in
5/17/05  IN-05-13 Potential Non-conservative Error in All licensees using the Keno-V.a criticality Modeling Geometric Regions in       code module in Standardized Computer the                                  Analyses for Licensing Evaluation Keno-v.a Criticality Code            (SCALE) software developed by Oak Ridge National Laboratory (ORNL)
10 CFR 40.13(c)(5).10/31/05IN-05-28Inadequate Test Procedure Failsto Detect Inoperable Criticality Accident Alarm HornsAll licensees authorized to possess a critical mass of special nuclear material.10/07/05IN-05-27Low Dose-Rate ManualBrachytheraphy Equipment Related Medical Events All medical licensees.7/29/05IN-05-22Inadequate Criticality SafetyAnalysis of Ventilation Systems at Fuel Cycle FacilitiesAll licensees authorized to possess a critical mass of special nuclear material.6/23/05IN-05-17Manual Brachytherapy Source JammingAll medical licensees authorized topossess a Mick applicator.5/17/05IN-05-13Potential Non-conservative Error inModeling Geometric Regions in
5/17/05  IN-05-12 Excessively Large Criticality Safety All licensees authorized to possess a Limits Fail to Provide Double        critical mass of special nuclear material.


the Keno-v.a Criticality Code All licensees using the Keno-V.a criticalitycode module in Standardized Computer Analyses for Licensing Evaluation (SCALE) software developed by Oak Ridge National Laboratory (ORNL)5/17/05IN-05-12Excessively Large Criticality SafetyLimits Fail to Provide Double Contingency at Fuel Cycle FacilityAll licensees authorized to possess a critical mass of special nuclear material.4/7/05IN-05-10Changes to 10 CFR Part 71 PackagesAll 10 CFR Part 71 licensees and certificate holders. DateGC No.Subject
Contingency at Fuel Cycle Facility
  4/7/05  IN-05-10 Changes to 10 CFR Part 71           All 10 CFR Part 71 licensees and Packages                            certificate holders. Date        GC No.                   Subject                                


==Addressees==
==Addressees==
4/1/05IN-05-07Results of HEMYC ElectricalRaceway Fire Barrier System Full Scale Fire Testing All holders of operating licenses fornuclear power reactors, except those who have permanently ceased operations and have
4/1/05      IN-05-07    Results of HEMYC Electrical          All holders of operating licenses for Raceway Fire Barrier System Full      nuclear power reactors, except those who Scale Fire Testing                    have permanently ceased operations and have certified that fuel has been permanently removed from the reactor vessel, and fuel facilities licensees.


certified that fuel has been permanently removed from the reactor vessel, and fuel facilities
3/10/05      IN-05-05    Improving Material Control and       All licensees authorized to possess a Accountability Interface with        critical mass of special nuclear material.


licensees.3/10/05IN-05-05Improving Material Control andAccountability Interface with Criticality Safety Activities at Fuel Cycle FacilitiesAll licensees authorized to possess a critical mass of special nuclear material.Note: NRC generic communications may be found on the NRC public website athttp://www.nrc.gov, under Electronic Reading Room/Document Collections.
Criticality Safety Activities at Fuel Cycle Facilities Note: NRC generic communications may be found on the NRC public website at http://www.nrc.gov, under Electronic Reading Room/Document Collections.
}}
}}


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Latest revision as of 00:59, 24 November 2019

Clarification of the Reporting Requirements in 10 CFR 20.2201
ML052700314
Person / Time
Issue date: 11/14/2005
From: Michael Case, Chris Miller
NRC/NMSS/IMNS, NRC/NRR/ADRO/DIRS
To:
DeCicco J, NMSS/IMNS, 415-7833
References
RIS-05-021
Download: ML052700314 (9)


UNITED STATES

NUCLEAR REGULATORY COMMISSION

OFFICE OF NUCLEAR REACTOR REGULATION

OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS

WASHINGTON, DC 20555-0001 November 14, 2005 NRC REGULATORY ISSUE SUMMARY 2005-21 CLARIFICATION OF THE REPORTING REQUIREMENTS IN

10 CFR 20.2201

ADDRESSEES

All U.S. Nuclear Regulatory Commission (NRC) licensees and Part 76 certificate holders authorized to possess licensed material.

INTENT

NRC is issuing this regulatory issue summary (RIS) to clarify the reporting requirements regarding lost, stolen, or missing licensed material in 10 CFR 20.2201. This RIS does not transmit any new requirements or new staff positions. No specific action or written response is required.

BACKGROUND

There has been an increased interest in ensuring the security of NRC-licensed material during the last several years. In addition, every radiation protection program, to be both efficient and effective, requires accountability of its licensed material. For these reasons the reporting requirements for lost, stolen, or missing sources as specified in 10 CFR 20.2201 are being clarified.

SUMMARY OF ISSUE

Section 20.2201 mandates that each licensee report, by telephone, its discovery of any lost, stolen, or missing licensed material, including sources. The regulations require, in 10 CFR 20.2201(a)(1)(I), an immediate report by telephone if the material in question is equal to or greater than 1000 times the quantity specified in Appendix C to 10 CFR Part 20, under such circumstances that an exposure could result to persons in unrestricted areas. In accordance with 10 CFR 20.2201(a)(1)(ii), each licensee shall report by telephone, within 30 days after the occurrence of any lost, stolen, or missing licensed material becomes known to the licensee, licensed material that is greater than 10 times the quantity specified in Appendix C to Part 20,

that is still missing at the time. A written report is required by 10 CFR 20.2201(b), within 30

days of either telephone call; the information required in the written report is described in 10 CFR 20.2201(b)(1)(I) - (vi). Subsequent to the written report, 10 CFR 20.2201(d) requires the licensee to report any additional substantive information on the loss or theft of the licensed material within 30 days after the licensee learns of such information.

This RIS clarifies the term immediately in the context of reporting the occurrence of lost, stolen, or missing licensed material, how the term exposure could result is used, and the licensees responsibility to inform the NRC of the recovery of lost or stolen licensed material.

The NRC staff has reviewed the reporting requirements for 10 CFR 20.2201 and has included clarifications for the following requirements:

10 CFR 20.2201, Reports of theft or loss of licensed material (a) Telephone reports.

(1) Each licensee shall report by telephone as follows:

(i) Immediately after its occurrence becomes known to the licensee, a lost, stolen, or missing licensed material in an aggregate quantity equal to or greater than 1000 times the quantity specified in Appendix C, to Part 20, under such circumstances that it appears to the licensee that an exposure could result to persons in unrestricted areas.

10 CFR 30.50(a), 40.60(a), and 70.50(a) indicate NRC reporting requirements for an event that involves exposure to byproduct, source, and special nuclear material, respectively, in excess of applicable limits. These paragraphs require an immediate report, and each licensee shall notify NRC as soon as possible, but not later than 4 hours4.62963e-5 days <br />0.00111 hours <br />6.613757e-6 weeks <br />1.522e-6 months <br />, after the discovery of an event that prevents immediate protective actions necessary to avoid exposures to radiation or radioactive materials that could exceed regulatory limits, or releases of licensed materials that could exceed regulatory limits (events may include fires, explosions, toxic gas releases, etc.). Therefore, for the immediate reporting requirements of 10 CFR 20.2201, NRC desires notification within 4 hours4.62963e-5 days <br />0.00111 hours <br />6.613757e-6 weeks <br />1.522e-6 months <br /> after the occurrence becomes known to the licensee of any lost, stolen, or missing licensed material, including sources.

In the context above, the phrase "exposure could result connotes having the possibility to result in exposure to a person, and a licensee would be required to report unless exposure to a person was not possible.

(ii) Within 30 days after the occurrence of any lost, stolen, or missing licensed material becomes known to the licensee, all licensed material in a quantity greater than 10 times the quantity specified in Appendix C to Part 20, that is still missing at this time.

10 CFR 30.9(a), 40.9(a), and 70.9(a) require that information provided to the Commission by a licensee shall be complete and accurate in all material respects.

Thus, when licensed material is recovered that has been reported under 10 CFR

20.2201 as lost, stolen, or missing, the licensee must notify the NRC of the recovery. NRC desires that licensees make a telephone report within 4 hours4.62963e-5 days <br />0.00111 hours <br />6.613757e-6 weeks <br />1.522e-6 months <br /> regarding the recovery of any lost, stolen, or missing licensed material that is equal to or greater than Category II levels. Category II material and level are defined in the International Atomic Energy Agency, Code of Conduct on the Safety and Security of Radioactive Sources

2004, and in the NRC proposed rule for the National Source Tracking of Sealed Sources

(70 FR 43646; July 28, 2005). Below is a table that provides the thresholds for Category II material and level:

Radionuclide Quantity of Quantity of Concern (TBq) Concern (Ci )

Am-241 0.6 16 Am-241/Be 0.6 16 Cf-252 0.2 5.4 Cm-244 0.5 14 Co-60 0.3 8.1 Cs-137 1 27 Gd-153 10 270

Ir-192 0.8 22 Pm-147 400 11,000

Pu-238 0.6 16 Pu-239/Be 0.6 16 Se-75 2 54 Sr-90 (Y-90) 10 270

Tm-170 200 5,400

Yb-169 3 81 (b) Written reports.

(1) Each licensee required to make a report under paragraph (a) of this section shall, within

30 days after making the telephone report, make a written report setting forth the information contained in 10 CFR 20.2201(b)(1)(i) through (vi).

(c) A duplicate report is not required, under paragraph (b), if the licensee is also required to submit a report pursuant to paragraphs 10 CFR 30.55(c); 40.64(c); 50.72; 50.73; 70.52;

73.27(b); 73.67(e)(3)(vii); 73.67(g)(3)(iii); 73.71; or 150.19(c), of chapter 1 of the regulations. (d) Subsequent to filing the written report, the licensee shall also report any additional substantive information on the loss or theft, within 30 days after the licensee learns of such information.

The above paraphrases most of 10 CFR 20.2201, and additional information was cited to help clarify what is meant by the terms immediately and exposure could result. Consult the regulations for the full text.

This clarification of the requirements from 10 CFR 20.2201 does not exempt licensees from meeting the requirements from other sections in the regulations in regards to reporting.

BACKFIT DISCUSSION

This RIS requires no action nor written response and is, therefore, not a backfit under

10 CFR 50.109. Consequently, the staff did not perform a backfit analysis.

FEDERAL REGISTER NOTIFICATION

A notice of opportunity for public comment on this RIS was not published in the Federal Register because this RIS is informational and does not represent a departure from current regulatory requirements.

SMALL BUSINESS REGULATORY ENFORCEMENT FAIRNESS ACT

NRC has determined that this action is not subject to the Small Business Regulatory Enforcement Fairness Act of 1996.

PAPERWORK REDUCTION ACT STATEMENT

OF 1996 The information collections contained in this RIS are covered by the requirements of 10 CFR 20, 30, 40, and 70, which were approved by the Office of Management and Budget, approval numbers 3150-0014, 0017, 0020, and 009.

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 number.

CONTACT

Please direct any questions about this matter to the technical contact or the appropriate regional office.

/RA/ /RA/

Charles L. Miller, Director Michael J. Case, Director Division of Industrial Division of Inspection & Regional Support Medical Nuclear Safety Office of Nuclear Reactor Regulation and Safeguards Office of Nuclear Material Safety

Technical Contact:

Joe DeCicco, NMSS

301-415-7833 E-mail: jxd1@nrc.gov Attachment: List of Recently Issued NMSS Generic Communications Note: NRC generic communications may be found on the NRC public website, http://www.nrc.gov, under Electronic Reading Room/Document Collections.

CONTACT

Please direct any questions about this matter to the technical contact or the appropriate regional office.

/RA/ /RA/

Charles L. Miller, Director Michael J. Case, Director Division of Industrial Division of Inspection & Regional Support Medical Nuclear Safety Office of Nuclear Reactor Regulation and Safeguards Office of Nuclear Material Safety

Technical Contact:

Joe DeCicco, NMSS

301-415-7833 E-mail: jxd1@nrc.gov Attachment: List of Recently Issued NMSS Generic Communications Note: NRC generic communications may be found on the NRC public website, http://www.nrc.gov, under Electronic Reading Room/Document Collections.

Distribution:

IMNS/ r/f NMSS/rf ADAMS ML052700314 OFFICE MSIB-A TECH ED MSIB-A MSIB OSTP FCSS SFPO

NAME JDeCicco EKraus THarris TEssig PLohaus R Pierson W Brach DATE 12/ 28 /04 12/28/04 01/13/05 01/26/05 09/08/05 01/28/05 09/07/05 OFFICE DWM NRR IROB D:DLPM OGC (NLO) OGC PMAS

(SBREFA)

NAME LCamper TQuay THBoyce TMarsh STreby SCrockett VTharpe DATE 01/28/05 02/02/05 10/28/05 10/31/05 09/22/05 10/05/05 10/18/05 OFFICE OIS IROB NRR IROB IMNS IROB

NAME BShelton AMarkley SKlementowicz MJRoss-Lee CLMiller PLHiland DATE 10/25/05 11/01/05 09/27/05 11/04/05 11/14/05 11/7/05 OFFICIAL RECORD COPY

Attachment Recently Issued NMSS Generic Communications Date GC No. Subject

Addressees

2/11/05 BL-05-01 Material Control and Accounting at All holders of operating licenses for Reactors and Wet Spent Fuel nuclear power reactors, decommissioning Storage Facilities nuclear power reactor sites storing spent fuel in a pool, and wet spent fuel storage sites.

10/28/05 RIS-05-22 Requirements for the Physical All holders of licenses for the possession Protection During Transportation of of special nuclear material (SNM) that Special Nuclear Material of ship Category II and III quantities of this Moderate and Low Strategic material.

Significance: 10 CFR Part 72 vs.

Regulatory Guide 5.59 (1983)

9/27/05 RIS-04-17, Revised Decay-in-Storage All licensees regulated under 10 CFR

Rev. 1 Provisions for the Storage of Parts 30, 32, 33, 35, 39, and 50.

Radioactive Waste Containing Byproduct Material

8/25/05 RIS-05-18 Guidance for Establishing and All licensees, applicants for licenses, Maintaining a Safety Conscious holders of certificates of compliance, and Work Environment their contractors subject to NRC authority

8/10/05 RIS-05-16 Issuance of NRC Management All licensees and certificate holders.

Directive 8.17, Licensee Complaints Against NRC

Employees

8/3/05 RIS-05-15 Reporting Requirements for All material licensees possessing Damaged Industrial Radiographic industrial radiographic equipment, Equipment regulated under 10 CFR Part 34.

7/13/05 RIS-05-13 NRC Incident Response and the All licensees and certificate holders.

National Response Plan

7/11/05 RIS-05-12 Transportation of Radioactive Licensees authorized to possess Material Quantities of Concern radioactive material that equals or NRC Threat Advisory and exceeds the threshold values in the Protective Measures System Additional Security Measures (ASM) for transportation of Radioactive Material Quantities of Concern (RAMQC) under their 10 CFR Part 30, 32, 50, 70, and 71 licenses and Agreement State licensees similarly authorized to possess such material in such quantities under their Agreement State licenses.

7/11/05 RIS-05-11 Requirements for Power Reactor All holders of operating licenses for Licensees in Possession of nuclear power reactors and generally Devices Subject to the General licensed device License Requirements of 10 CFR vendors.

31.5 Date GC No. Subject

Addressees

6/10/05 RIS-05-10 Performance-Based Approach for All industrial radiography licensees and Associated Equipment in 10 CFR manufacturers and distributors of

34.20 industrial radiography equipment.

4/18/05 RIS-05-06 Reporting Requirements for All material licensees possessing Gauges Damaged at Temporary portable gauges, regulated under 10 CFR

Job Sites Part 30.

4/14/05 RIS-05-04 Guidance on the Protection of All holders of operating licenses or Unattended Openings that construction permits for nuclear power Intersect a Security Boundary or reactors, Area research and test reactors, decommissioning reactors with fuel on site, Category 1 fuel cycle facilities, critical mass facilities, uranium conversion facility, independent spent fuel storage installations, gaseous diffusion plants, and certain other material licensees.

2/28/05 RIS-05-03 10 CFR Part 40 Exemptions for All persons possessing aircraft Uranium Contained in Aircraft counterweights containing uranium under Counterweights - Storage and the exemption in Repair 10 CFR 40.13(c)(5).

10/31/05 IN-05-28 Inadequate Test Procedure Fails All licensees authorized to possess a to Detect Inoperable Criticality critical mass of special nuclear material.

Accident Alarm Horns

10/07/05 IN-05-27 Low Dose-Rate Manual All medical licensees.

Brachytheraphy Equipment Related Medical Events

7/29/05 IN-05-22 Inadequate Criticality Safety All licensees authorized to possess a Analysis of Ventilation Systems at critical mass of special nuclear material.

Fuel Cycle Facilities

6/23/05 IN-05-17 Manual Brachytherapy Source All medical licensees authorized to Jamming possess a Mick applicator.

5/17/05 IN-05-13 Potential Non-conservative Error in All licensees using the Keno-V.a criticality Modeling Geometric Regions in code module in Standardized Computer the Analyses for Licensing Evaluation Keno-v.a Criticality Code (SCALE) software developed by Oak Ridge National Laboratory (ORNL)

5/17/05 IN-05-12 Excessively Large Criticality Safety All licensees authorized to possess a Limits Fail to Provide Double critical mass of special nuclear material.

Contingency at Fuel Cycle Facility

4/7/05 IN-05-10 Changes to 10 CFR Part 71 All 10 CFR Part 71 licensees and Packages certificate holders. Date GC No. Subject

Addressees

4/1/05 IN-05-07 Results of HEMYC Electrical All holders of operating licenses for Raceway Fire Barrier System Full nuclear power reactors, except those who Scale Fire Testing have permanently ceased operations and have certified that fuel has been permanently removed from the reactor vessel, and fuel facilities licensees.

3/10/05 IN-05-05 Improving Material Control and All licensees authorized to possess a Accountability Interface with critical mass of special nuclear material.

Criticality Safety Activities at Fuel Cycle Facilities Note: NRC generic communications may be found on the NRC public website at http://www.nrc.gov, under Electronic Reading Room/Document Collections.