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MISSOURI UNIVERSITY RESEARCH REACTOR AUTHORIZATION NO. 77-128

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  1. Operator Logs
  2. Strip Charts/Environmental and Effluent Measurements
  3. Records of Materials License Radioactive Material
  4. Records of Samples Irradiated & Transfers of By-Product Material
  5. Non-Health Physics Work Control (Work Packages, WAF Forms)
  6. Equipment and Instrumentation Documents
  7. Prints and Engineering Drawings/Facility Design and Construction Documents
  8. Primary Licensing Documents
  9. Operator Licensing
  10. Records of Transfer of Special Nuclear Materials
  11. Records of Transfer of Waste
  12. Training Records
  13. Health Physics Records
  14. MURR Procedures, Policies, and Directives, Strategic Plans
  15. Authorization of Experiments/Record of Experiments
  16. Regulator Correspondence Files
  17. License Committee Minutes
  18. Service Report Files
  19. Quality Records/Audit Reports
  20. Employment Records
  21. Current Good Manufacturing Practice (cGMP) Production, Packing and Labeling Documents for APIS and Finished Drug Products
  22. Good Laboratory Practice (GLP, ISO/IEC 17025) Production and Quality Documents
  23. Client Correspondence Files
  24. Project Files
  25. Research Papers/White Papers
  26. Third Party Billing

 

NOTE: Definitions & Acronyms and Recordkeeping Requirements & Citations at Bottom of Page

ITEM NUMBER

OPERATIONAL RECORDS

1. Operator Logs

These are logs and forms completed by reactor operators to document reactor related activities performed.  They may include:

  • console watch log, listing each activity performed by the operators
  • weekly reactor startup and shutdown checksheets
  • records of maintenance and repair, including compliance checks, special maintenance, and preventive maintenance
  • reactor routine patrol log, documenting checks made on various items of technical equipment of the reactor
  • nuclear data daily log, documenting readings taken from control room instrumentation panels

Authorized Retention: 

These records are license required. Per 50.71.c, must be retained for the life of the facility license. 

Final Disposition: Destroy

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2. Strip Charts/Environmental and Effluent Measurements

  • Strip Charts (reactor, pool, and demineralizer flow charts, reactor and pool temperature charts, channel 5 and 6 power range chart, source, intermediate, and wide range charts, stack monitoring (off-gas), and ARMS Charts).
  • Preoperational environmental monitoring surveys and reports.
  • Meteorological data (wind roses).

Considerations:  These records are license required. Per 50.71.c, must be retained for the life of the facility license. Any records that involve or reflect effluent or environmental reports or surveys must be kept life of policy + 10 years (ANI 80-1A).

Authorized Retention: 

Retain for life of the facility policy plus ten (10) years.

Final Disposition: Destroy

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3. Records of Materials License Radioactive Material

  • Applies only to radioactive material licensed under the MURR Broad Scope Materials License (24-00518-39), or any related or preceding license.
  • May contain a number of types of records associated with receipt, control, usage and disposition of radioactive material produced outside the MURR.

Includes:

A. Incoming and outgoing Records of Transfer of Radioactive Materials, including Receipt of Radioactive Material Forms

B. Materials License Inventories

C. Processing and shipping records for products generated from externally sourced radioactive materials

D. Verification of quality of packaging, including results of 71.85, may be included with shipping records.

Considerations: Life of the Facility Policy plus 10 years (ANI/MAELU 80-1A). These are also individually covered under several NRC Citations, including 30.51, 71.10, and 71.91(a), 3 years for NRC required shipping documents for nonexempt (71.10) shipments. Records where MURR, or a department within MURR, is the receiver or the transferrer should be retained for the duration of possession of the material and 3 years after disposal or transfer of the material (NRC 10 CFR 30.51(a)(1)).  Per 49 CFR 172.201, must be retained on-site for 2 years after the date of shipment.

Authorized Retention: 

Retain for life of the facility policy plus ten (10) years.

Final Disposition: Destroy

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4. Records of Samples Irradiated & Transfers of By-Product Material

These records are used to document irradiation and, if applicable, processing of samples. They may also include records of transfer of such material to another NRC licensee.

Such records may contain any or all of the following:

A. Description of service requested. Currently this may take the form of a MURR Online Ordering System (MOOS) printout.

B. Customer requests for irradiation

C. Sample certification or pre-encapsulation approval

D. Company data sheet (gray sheet)

E. Target Material Control Check Sheet (original)

F. Irradiation history (original)

G. Processing history

H. If the sample was shipped to an external customer, additional information may include:

  • opening instructions and shipment request (original)
  • shipment packaging/release control check sheet (original)
  • transportation documentation (shipping declaration and/or straight bill of lading) (one of several originals)
  • release spectrum (one of several originals)
  • material transfer form (one of several originals)
  • sample shipment information sheet
  • also required, verification of quality of packaging, including results of 71.85   

With the exception of G. above, these items are typically contained in MURR ID folders for their respective irradiation types. G. above is typically stored separately as a packet including batch processing documentation, quality control and quality assurance data as applicable, and related radiation protection documents.

This retention does not apply to cGMP or GLP regulated products which are within their Part 21 records retention requirement, see 77-128-21 and 22.

Longest retention requirement: Life of the Facility Policy plus 10 years (ANI/MAELU 80-1A). These are also individually covered under several NRC Citations, including 50.71c, 71.10, and 71.91(a), 3 years for NRC required shipping documents for nonexempt 71.10 shipments. Records where MURR, or a department within MURR, is the receiver or the transferrer should be retained for the duration of possession of the material and 3 years after disposal or transfer of the material (NRC 10 CFR 30.51(a)(1)).

Authorized Retention: 

Retain for life of the facility policy plus ten (10) years.

Final Disposition: Destroy

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5. Non-Health Physics Work Control (Work Packages, WAF Forms)

Consists of work control packages for work performed outside the scope of the Radiation Work Permit and Modification Record programs. Such packages are not otherwise listed in the Records Retention Authorization.

Authorized Retention:   

Retain for life of the policy plus ten (10) years (ANI 80-1A)

Vital to Policy: Must be microfilmed and stored off-site for security.

Final Disposition:  Destroy

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FACILITY DESIGN & LICENSING

6. Equipment and Instrumentation Documents

Documents the design, procurement or construction, testing, and modification of major equipment associated with the research reactor center.

A. Commercially purchased large or unique instrumentation or equipment purchased commercially and utilized in daily activities, laboratory work or special maintenance.

Authorized Retention:

Retain for life of the equipment plus five (5) years, then destroy.

B. Unique or custom equipment or instrumentation built at MURR should include as-built drawings, design criteria, and installation and use instructions, if possible. 

Authorized Retention:

Retain for ten (10) years after the life of the equipment, then review for further need or interest.

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7. Prints and Engineering Drawings/Facility Design and Construction Documents

Includes documentation related to the design and building, or later modification of the research reactor itself, any primary or secondary support systems for the reactor, buildings associated with the facility, and any reactor instrumentation or integrated equipment such as sample handlers.

May include correspondence with architects, engineers, or designers, the Atomic Energy Commission/Nuclear Regulatory Commission, University Officials, and vendors, designs, reports of progress or design research, including investigative studies, and vendor contracts.

Authorized Retention: 

Retain for life of license (NRC, 10 CFR 50.71).

Final Disposition:  Archive (some material already exists at Archives).

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8. Primary Licensing Documents

Original licensing bases or licensing documents and amendments.

  • includes preparation documents of the types listed above for the 10 MW upgrade in 1973
  • includes re-licensing documents
  • decommissioning file, which includes any decommissioning correspondence or information, including:
    • spills where contamination remains after cleanup
    • drawings of areas with inaccessible contamination
    • records of cost estimates and funding availability

Authorized Retention:

Retain for life of the facility license (NRC, 10CFR50.71)

Other requirements: Decommissioning file "must be kept in an identified location in the facility until the license is terminated" (10 CFR 50.75.g).

Final Disposition:  Send to Archives.

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9. Operator Licensing

  • Includes all documentation of MURR Reactor Operator Requalification Program, as well as initial licensing
  • Operator requalification exams are kept until the renewal is complete (10 CFR 55.59)
  • Medical qualifications, test results, medical history documents are kept until the termination of the operator license (10 CFR 55.27)

Considerations: Until termination of operator's license (NRC 10 CFR 50.75) as part of training records (Item 13), life of the facility plus 10 years (ANI/MAELU Bulletin 80-1A).

Authorized Retention:  

Retain for life of the facility policy plus ten (10) years (ANI/MAELU 80-1A).

Final Disposition:  Destroy

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10. Records of Transfer of Special Nuclear Materials

Records of transfer of special nuclear material to and from the MURR. Includes forms 741 (Nuclear Material Transaction Report) and 742 (Material Status Report).

Authorized Retention:

Retain until termination of the R-103 facility license(s) (NRC 10 CFR 70.51(b)(5)).

Final Disposition:  Destroy

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11. Records of Transfer of Waste

Any records pertinent to the receipt, transfer, shipping or other disposal of waste, unless covered in another item of this Records Retention Authorization.

Considerations:  NRC 10 CFR 70.51(b)(5), or 20.2108(b), until termination of pertinent license(s). Requirements for disposition prior to license termination are located in §30.51, 40.61, 70.51, and 72.80 for activities licensed under these parts.

Authorized Retention:

Retain for life of the Facility Policy plus ten (10) years (ANI/MAELU 80-1A).

Final Disposition:  Destroy

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REGULATORY ASSURANCE RECORDS

12. Training Records

Records of any personnel training, including radioactive material handling, occupational safety, operator training, radiation worker training (indoctrination), procedure training, Facility Emergency Organization training and drills, and any other training.

Authorized Retention:

Retain for life of the Facility Policy plus ten (10) years (ANI/MAELU 80-1A).

Vital to policy: Must be microfilmed and stored off-site for security.

Final Disposition:  Destroy

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13. Health Physics Records 

Considerations:  Life of the Facility Policy plus 10 years (ANI/MAELU 80-1A).

These records consist of a variety of records generated by Health Physics and some are individually covered under several NRC citations shown below but must be retained per the retention requirements of ANI/MAELU 80-1A.

  • Instrumentation Calibration records
  • Radiological surveys (radiation, air sampling and contamination)
    • Surveys required by 20.1501 & 20.1906(b), 3 years, as per 20.2103(a)
    • Radiological Survey including air sampling, surveys, and bioassays required pursuant to 20.1703(a)(3)(I) and (ii), 20.2103(b)(3) until termination of pertinent licenses
  • Health Physics Work Control (RWPs and controlled special exposures, minutes of ALARA and pre-job briefings)
  • Planned special exposures, 20.2105(b), until termination of pertinent licenses
  • Personnel Exposure Records, Root Cause Analysis, Corrective Actions.  CAP program entries and finished forms
    • Personnel Exposure Records (including individual dose equivalents and surveys to determine dose from external sources):  20.2103 1(b), termination of the pertinent license
    • Occupational dose received during the current year (includes Beam Port Floor visitor’s logs and NRC form 4), records of cumulative occupational radiation dose, 20.2104(f), until termination of pertinent licenses.  Information used in preparing the form 4 (MURR Access Request Form) shall be retained for three (3) years after the record is made
    • Visitor Records
      • Records of dose to individual members of the public, 20.2107(b), until termination of pertinent licenses
    • Environmental and effluent measurements
      • Including waste discharge reports, Health Physics daily logs, 20.2103(b)(4), until termination of pertinent licenses
  • Release of uncontaminated materials
  • Verification of quality of packaging
    • 10 CFR 71.91(c) 3 years after the life of the packaging to which they apply

Authorized Retention: 

Retain for life of the facility policy plus ten (10) years (ANI/MAELU 80-1A).

Vital to policy:  Must be microfilmed and stored off-site for security.

Final Disposition:  Destroy

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ADMINISTRATIVE

14. MURR Procedures, Policies, and Directives, Strategic Plans

These records capture management's directions about how to perform work and conduct of operations/business and may include:

  • ALL procedures, regardless of relationship to FDA or NRC regulation, are retained life + 10 if they describe handling of radioactive materials
  • Strategic plans include reports, correspondence, studies and background materials related to the development of strategic or long range plans prepared at all levels of the University
  • cGMP and GLP Quality Manuals and Validation Master Plans

Authorized Retention:

Retain for life of the Master Worker's Policy plus 10 (ten) years (ANI/MAELU 80-1A). All Leak Rate Tests must be available at the facility, per 10 CFR 50, Appendix J, V.B.

Other Requirements: On-site till 5 years after superseded (MU).                  

Final Disposition:  Send to Archives

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15. Authorization of Experiments/Record of Experiments

Includes forms used to document irradiation services performed on samples for which individual "sample sheets" are not required. Includes RL/ ML/ SR/ Reactor license/materials license/state registration project files and Reactor Utilization Requests.

Authorized Retention:  

Retain for life of the facility policy plus ten (10) years (ANI/MAELU 80-1A XIV).

Other Directions:  RURs must be microfilmed and stored off-site for security.

Final Disposition:  Destroy

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16. Regulator Correspondence Files

Includes NRC, ANI, FDA, DOE, and any other correspondence with agencies regulating the University of Missouri Research Reactor.

  • Includes LERs (License Event Reports) (50.75(g) may be applicable)

Authorized Retention:   

Retain for life of the facility per 10 CFR 50.71(c)

Vital to policy:  Must be microfilmed and stored off-site for security.

Other Requirements:  Controlled Area Access Authorization files must be on-site, as per 10 CFR 25.13.

Final Disposition:  Send to Archives per MU00-013

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17. License Committee Minutes

These are minutes from the License Required Committees and their subcommittees.

Authorized Retention:  

Retain for life of the facility policy plus ten (10) years (ANI/MAELU 80-1A XIV).

Other Directions:  On-site at least 2 years.

Final Disposition:  Archive

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18. Service Report Files

Applies only to records outside the scopes of the MURR cGMP and GLP programs and records which do NOT contain documentation of radioactive material handling or transfer. May originate in any MURR department. May contain:

  • preliminary service request,
  • records indicating procedures used to perform service,
  • service summary, indicating name of requester, departmental affiliation, nature of service performed,    
  • shipping papers of any irradiated samples leaving the center,
  • report on laboratory finding if analysis services were requested,
  • forms itemizing charges to be made for service, if any.          

Authorized Retention:

Retain for seven (7) years after completion, MU00-018.

Final Disposition:  Destroy

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19. Quality Records/Audit Reports

Applies only to records outside the scope of the MURR compliance programs.

  • Radiological Audit Reports
  • QA or other internal audits not FDA regulated
  • Customer/supplier audits not FDA regulated
  • Tracking and trending records
  • Corrective Action Program (CAP) files

Considerations:  For Radiological or Regulatory Audits, life of the policy + 10 (ANI/MAELU Bulletin 80/1A). For non-regulatory External Financial and Management Audits, 5 years then to Archives, internal 2 years, then destroy (MU00-013). 

Authorized Retention:

A. Financial and Management Audits External - retain five (5) years then to Archives,

B. Internal audits - not related to a formal Quality program, retain two (2) years, then destroy per (MU00-013)

C. Radiological Audits - retain for life of policy + 10 (ANI/MAELU Bulletin 80/1A), then destroy.

D. Quality Program related audits - retain seven (7) years after completed, then reevaluate for historical interest.

Final Disposition:  Archive external audits.

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20. Employment Records

Employment records - for persons entering radiation areas, airborne radioactivity areas, and contamination areas. Exempt from University Records Retention Authorization 00-016 due to additional retention required by ANI/MAELU 80-1A.

Authorized Retention:

Retain for life of the facility policy plus ten (10) years (ANI/MAELU 80-1A).

Other directions: Must be microfilmed and stored off-site for security.

Final Disposition:  Destroy

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REGULATORY MATERIALS - cGMP AND GLP PROCESSES

21. Current Good Manufacturing Practice (cGMP) Production, Packing and Labeling Documents for APIS and Finished Drug Products

Includes records listed below, only where other sections of this retention are not applicable, does not include any training records or records of radioactive materials handling or transfer.

A. Development-related records:

  • Papers, correspondence, articles, etc. that document a developing method
  • Lab notebooks, etc. adding facts leading toward idea fruition
  • Drawings, plans, photos, and other visualizations of potential programs

B. Batch-related records:

  • Raw data and specimens, training, equipment, information protocols, QA documents, 1 year after approval of the NDI to which they are related 
  • Production, control or distribution, 1 year after expiry date of the batch
  • Components, drug product containers, closures and labeling, including records relating to examination, inventory and disposition of rejected materials

C. Program-related records:                 

  • Data derived from tests performed to ensure compliance with specifications and standards, including testing and standardization of laboratory reference standards, reagents and standard solutions
  • Modifications of an established test method, including the reason(s) for the modification and data to verify the accuracy and reliability are acceptable
  • Periodic calibration and maintenance of laboratory instruments, gauges and recording devices
  • Stability testing
  • Inspection or audit reports and associated documentation

Authorized Retention: 

A. Development-related records: Retain for the life of the related program plus seven (7) years, then reevaluate for further retention.

B. Batch-related records: Retain for seven (7) years, unless otherwise required by a contract or agreement with a customer, an FDA submission, including a research or marketing permit, IND, ANDA, or DMF. After seven (7) years, reevaluate for further retention.

C. Program-related records: Retain for the life of the related product plus seven (7) years, then reevaluate for further retention.

Other Directions:  Batch records must be kept on-site during full term of retention period for use of FDA inspectors per 21 CFR 211.180.               

Final Disposition:  Destroy or transfer to appropriate retention category.

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22. Good Laboratory Practice (GLP, ISO/IEC 17025) Production and Quality Documents

Includes records listed below, only where other sections of this retention are not applicable, does not include any training records or records of radioactive materials handling or transfer.

A. Development-related records:

  • Papers, correspondence, articles, etc. that document a developing study method
  • Lab notebooks, etc. adding facts leading toward idea fruition
  • Drawings, plans, photos, and other visualizations of potential studies

B. Study-related records:

  • Raw data and specimens, training, equipment, information protocols, QA documents
  • Processing or control records, along with report to client

C. Program-related records:                 

  • Records relating to purchasing, examination, and inventory of materials and disposition of rejected materials
  • Data derived from tests performed to ensure compliance with specifications and standards, including testing and standardization of laboratory reference standards, reagents and standard solutions
  • Modifications of an established test or calibration method, including the reason(s) for the modification  and data to verify the accuracy and reliability are acceptable
  • Calibration and maintenance of laboratory instruments, gauges and recording devices
  • Inspection or audit reports and associated documentation
  • Records of nonconforming work, complaints, and corrective actions

Authorized Retention:

A. Development-related records: Retain for the life of the related program plus seven (7) years, then reevaluate for further retention.

B. Batch-related records: Retain for seven (7) years, unless otherwise required by a contract or agreement with a customer, an FDA submission, including a research or marketing permit, IND, ANDA, or DMF.  After seven (7) years, reevaluate for further retention.

C. Program-related records: Retain for the life of the related product plus seven (7) years, then reevaluate for further retention.

Other Directions:  Must be kept on-site during full term of retention period for inspectors use.

Final Disposition:  Destroy or transfer to appropriate retention category.

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GENERAL ADMINISTRATION

23. Client Correspondence Files

General correspondence with companies, institutions, and other departments of the University that have utilized, or are considering the use of, the facilities of the reactor for experimental research or commercial purposes.  They may include:

  • requests for price quotations
  • correspondence regarding irradiation services requested
  • phone conversation notes
  • copies of contracts with non-University organizations (officially retained by office of the Associate Vice President for Management Services)
  • originals of contract development correspondence
  • purchase order from non-University organizations
  • correspondence regarding billing or irradiation services performed.

Essential data is maintained in Reactor Utilization Request files and Client Authorization files.

Authorized Retention:  

Retain for a period of reference, not to exceed five (5) years (MU).  Purchase orders from companies outside the University for irradiation services and billing data sheets are recommended to have a two (2) year retention (MU).

Final Disposition:  Destroy

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RESEARCH PROJECTS

24. Project Files

May include any research or technical project undertaken at MURR which does not have an overriding regulatory classification as a radiological material transfer, a reactor-related design or fabrication project, or an FDA or NRC regulated project.

  • correspondence regarding objectives and methodology of project
  • resultant papers, publications, posters, presentations, or data packages
  • final report on project 

Authorized Retention:  

Retain for seven (7) years after completion (MU 00-018).

Final Disposition: Destroy

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25. Research Papers/White Papers

These include student work, graduate and undergraduate, as well as MURR staff produced work.  Included are theses supporting projects, experiments and facility and component design.

Authorized Retention:  

Unless required by regulatory group, retain copy for period of reference, forward originals to the campus academic department involved, if any.  If there is no campus department involved, forward the original work to Archives and retain copy as above.  If required by regulatory group, retain as part of the project it supports.

Final Disposition: Send to Archives.

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FISCAL SOURCE DOCUMENTS

26. Third Party Billing

These are source documents regarding the rebilling of third parties for MURR services. The originals are not forwarded to the Accounting Office.

Authorized Retention:

Retain for the life of any billed equipment or facilities design, otherwise retain for seven (7) years.

Final Disposition:  Destroy

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Supersedes Records Retention Authorization 77-128 dated 09/14/04.  

DEFINITIONS & ACRONYMS

AEC: Atomic Energy Commission. This government agency may appear on older records; it is the predecessor of the NRC.

ALARA: As Low As Reasonably Achievable. 10 CFR Part 20 mandates that radiation exposure be maintained ALARA; many MURR records are created in support of this mission.

ANI: American Nuclear Insurers.

ARMS: Area Radiation Monitor Systems.

CAP: Corrective Action Program.

CFR: Code of Federal Regulations. Title 10 – Energy, Title 49 – Transportation, and Title 21 – Food and Drug Administration are applicable to MURR.

cGMP: Current Good Manufacturing Practices, for the maintenance of pharmaceuticals, as required by 21 CFR Part 210 and 211, for Active Pharmaceutical Ingredients and for Finished Drug Products, respectively.

DOE: Department of Energy.

DOT: Department of Transportation.

FDA: Food and Drug Administration.

GLP: Good Laboratory Practices, as defined by ISO/IEC 17025, a set of guidelines with which MURR voluntarily complies for some reporting purposes.

IATA: International Air Transport Association.

ISO/IEC: International Organization for Standardization & International Electrotechnical Commission.

License Event Reports (LER): Reports submitted to the NRC per the requirements of 10 CFR 50.73.

MW: Megawatt.

NFPA: National Fire Protection Association.

NRC: Nuclear Regulatory Commission.

Reactor Utilization Requests (RUR): Safety analysis which documents consideration of hazards for irradiation of specific materials.

WAF: Work Authorization Form, an internal form generated by MURR’s Work Control Department.

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RESEARCH REACTOR RECORDKEEPING REQUIREMENTS AND CITATIONS

 Chapter 10 of the Code of Federal Regulations (CFR) pertains to energy. Parts 1 thru 199 reflect the requirements of the Nuclear Regulatory Commission (NRC). Several sections contain requirements for recordkeeping. Among the records required are those documenting:

  • the packaging, handling and shipment of radioactive materials (Part 71) and shipments of by-products of radiation (Part 30),
  • the introduction of radioactive byproducts into other materials, e.g. pharmaceuticals (Part 30),
  • licensing reactor operators (Part 55),
  • facility licensing and decommissioning (Parts 50 and 70),
  • financial protection and/or insurance (Part 140).

Chapter 49 CFR pertains to transportation. Part 173 governs shipping radioactive materials and Parts 177 and 178 contain recordkeeping requirements.

MURR voluntarily complies with the current Good Manufacturing Practices for pharmaceuticals spelled out in 21 CFR Parts 210 and 211.

None of the aforementioned retention requirements call for longer retention than those listed below.

Primarily affecting the MURR Records Retention Authorization are:

10 CFR 50.71 which stipulates that lacking specific requirements for retaining a class of records, they must be kept for as long as a facility is licensed.

10 CFR 140.19 which states that a facility license may be suspended or revoked if the licensee fails to provide financial protection (usually insurance).

The MURR insurance is carried by American Nuclear Insurers (ANI) and their publication, “ANI Information Bulletin 80-1A, Revision 5” calls for records relating to the Master Workers Policy to be retained for the life of the policy plus 1 year during which claims may be filed. ANI further states that it may be in the insured’s own interests to maintain the records longer.

Records of effluent and environmental issues relating to the Facility Form Policy and must be kept at least 10 years beyond the life of the policy.

Items within the Records Retention Authorization may contain complete citations.

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Reviewed 2012-07-13.