Radiation Safety Manual. March 2006

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1 Radiation Safety Manual March 2006

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3 Table of Contents About This Manual... viii CHAPTER 1 Natural Resources Canada Radiation Safety Program Framework 1.1 Mandate of the Natural Resources Canada Radiation Safety Program for the Nuclear Substances and Radiation Devices Licence Issued for the Consolidated Use of Nuclear Substances Organizational Management Structure Radiation Safety Committee Duties and Responsibilities of the Radiation Safety Committee Radiation Safety Committee Members Duties and Responsibilities of the Radiation Safety Officer Institutional Duties and Responsibilities Radiation Safety Committee Duties and Responsibilities Duties and Responsibilities of the Site Radiation Safety Officer Duties and Responsibilities of Permit Holders Duties and Responsibilities of Users Working with Radioisotopes CHAPTER 2 Licensing and Administration 2.1 Nuclear Substances and Radiation Devices Licence Issued for the Consolidated Use of Nuclear Substances Application for the Nuclear Substances and Radiation Devices Licence Internal Permit Application Internal Permit Status of Permit Holder on Long-Term Leave Amendment of an Existing Permit Renewal of an Existing Permit Radioisotope Laboratory Approval Cancellation of an Internal Permit Purchasing and Receiving Radioactive Material Special Orders Inventory Procedures Compliance Inspection Policy Major Offences Moderate Offences Minor Offences Compliance Enforcement Policy Major Offence Actions Moderate and Minor Offence Actions Annual Compliance Report CNSC Approval for Special Projects CHAPTER 3 Policies and Procedures 3.1 New Policies and Procedures ALARA Policy Designation of Nuclear Energy Workers Policy Food and Drinks in a Radioisotope Laboratory Policy Room Designating and Posting Policy Access, Control and Security Policy Table of Contents March 2006 iii

4 3.6.1 Basic Laboratories Intermediate Laboratories Control of Nuclear Substances Policy Theft of Radioactive Material X-ray Producing ment Receiving Radioactive Material Responsibilities for Receiving Material Procedures for Receiving Packages Packaging and Transporting Radioactive Materials Monitoring Personal Dose Monitoring Policy During Pregnancy for n-news Policy Leak Testing of Sealed Sources Policy Action Levels Policy Radioactive Contamination Control Policies General Rules and Procedures Surface Contamination Measurements Wipe Test Procedures Direct Measurement of Surface Contamination Procedures for Decontamination of Areas and ment missioning Policy missioning Procedure Emergency Response Policy Radioactive Material Spills Radioactive Contamination of Skin or Clothing Treatment of Skin Contamination If the skin is intact In case of minor wounds not requiring hospitalization In case of serious injuries Treatment of Clothing Contamination Internal Contamination Emergency Procedures for Portable Nuclear Gauges Fire or Explosion Involving Radioactive Material Radioactive Waste Classification of Radioactive Waste Responsibility for Labelling and Packaging Radioactive Waste Location of Radioactive Waste Containers Waste Disposal Streams Specific Waste Requirements Solid Waste Liquids Containing Radioactive Material Liquid Scintillation Counting Vials Radioactive Material Containing a Biological Agent Liquid Scintillation Counters Gas Chromatography Units Miscellaneous Sealed Sources Refrigerators, Freezers and Other ment CHAPTER 4 Radioactivity 4.1 Radiation Physics Fundamental Particles The Atom Isotopes Table of Contents March 2006 iv

5 4.1.4 Radioisotopes Radiation Energy Nuclear Radiation Alpha Particle Emission Negative Beta Particle Emission Positive Beta Particle Emission Gamma Ray Emission Electron Capture (EC) Internal Conversions (IC) Neutron Emissions X-rays Activity Half-life Radiation Measurement Measurement of Radiation Exposure Radiation Exposure Dose Radiation Absorbed Dose (rad) Relative Biological Effectiveness (RBE) Radiation Weighting Factor Equivalent Dose External Radiation Exposure The ALARA Principle Nuclear Energy Workers Members of the General Public Internal Radiation Exposure Surface Contamination Ingestion or Inhalation of Radioisotopes Intakes Occurring from an Accident Principles of Radiation Protection Objective of Radiation Protection "Rules of Thumb" for Radioactive Material Alpha Beta Gamma Neutrons Radioactive Decay External Radiation Protection Time Distance Shielding Internal Radiation Protection Bioassay Bioassay Requirements - Radioiodine Radiation Dose Monitoring Monitors for External Radiation Exposure Personal Dosimeters Requirements During Pregnancy Surface Contamination Monitors CHAPTER Worker and Authorization Policy Short-Term Employees, Including Students and Volunteers Site Radiation Safety Officers Table of Contents March 2006 v

6 5.4 Other Personnel NRCan's Radiation Safety Course Scheduling Retraining Administering the Program Records Written Exam Certification Radiation Safety Modules Other Workplace Hazardous Materials Information System NRCan Radiation Safety Matrix CHAPTER 6 Forms Form 1 Open Source Inventory Sheet Form 2 Sealed Source Inventory Sheet Form 3 User Radiation Safety-Related Record Form 4 Application for Internal Permit Form 5 Application for Internal Permit Amendment Form 6 Application for Internal Permit Renewal Form 7 missioning Records Form 8 Design Compliance Form for Laboratories Form 9 Waste Disposal Form 10 Wipe Test Results Form 11 Short-Term Employee Radiation Safety Record CHAPTER 7 Glossary of Terms CHAPTER 8 Special Procedures CHAPTER 9 CNSC Legislative Documents Annex A Radiation Safety Committee Terms of Reference... A 1 Annex B Internal Inspection Checklist... B 1 Annex C Emergency Contact Lists... C 1 Annex D Measurement Units Conversion Table... D 1 Annex E Laboratory Classification... E 1 Annex F Periodic Table... F 1 Annex G NRCan Internal Permits... G 1 Annex H Exemption Quantities... H 1 Annex I Regulatory Quantities for Typical Radionuclides... I 1 Table of Contents March 2006 vi

7 Annex J Information on Elements at NRCan... J 1 Annex K List of Radiation Protection Service Companies... K 1 Annex L List of Leak Test Measurement and Instrument Calibration Agencies... L 1 Table of Contents March 2006 vii

8 Natural Resources Canada Radiation Safety Manual About This Manual This manual was developed to provide information to all Permit Holders on the policies, practices, procedures and training programs in place related to the occupational use of radioactive materials and ionizing radiation-producing equipment at Natural Resources Canada. This manual also provides information on licencing requirements and how they are administered within the scope of the Radiation Safety Program for the Nuclear Substances and Radiation Devices Licence issued for the consolidated use of nuclear substances at Natural Resources Canada. Most procedures and rules apply wherever radiation sources are used. However, the diversity of radiation sources and devices used at Natural Resources Canada is such that additional procedures and regulations may be required in specially designated areas. These special procedures and recommendations are listed under Chapter 8 of this manual and are available upon request. Permit Holders must ensure that this manual is read and integrated in their in-house laboratory training for all users. If you have any questions, please contact either the Site Radiation Safety Officer or the Radiation Safety Officer. About This Manual March 2006 viii

9 Chapter 1: Natural Resources Canada Radiation Safety Program Framework 1.1 Mandate of the Natural Resources Canada Radiation Safety Program for the Nuclear Substances and Radiation Devices Licence Issued for the Consolidated Use of Nuclear Substances The Natural Resources Canada (NRCan) Radiation Safety Program for the Nuclear Substances and Radiation Devices Licence is charged with the total overall program of radiation protection for the consolidated licence at NRCan at all sites where nuclear substances are being used and stored. The control exercised is complete and all-embracing, having the necessary executive power delegated to it by the Assistant Deputy Minister (ADM), Corporate Management Sector (CMS), to enforce and maintain the required standards of radiation protection necessary for NRCan. This program has, as its foundation, federal regulations issued by the Canadian Nuclear Safety Commission (CNSC), Health Canada and the Human Resources and Skills Development Canada Labour Program, and environmental legislation. The responsibilities of the NRCan Radiation Safety Committee includes all sources of ionizing radiation (both materials and devices), for whatever use, on all properties occupied by NRCan employees. The ADM, CMS, delegates to the Chair of the NRCan Radiation Safety Committee power to sign on behalf of NRCan for all matters within the jurisdiction of the committee. The Radiation Safety Committee reports to the Deputy Minister (DM) through the ADM, CMS. The Radiation Safety Committee considers and advises on the establishment of radiation emergency measures within NRCan facilities, and co-operation and integration with other programs. The committee also conducts educational programs as required with respect to radiation hazards. The Radiation Safety Committee has the authority to consult with appropriate persons or institutions to revise the administrative procedures for the use of radioactive materials as circumstances warrant. The Permit Holders will be held responsible at all times for all aspects of radiation safety in areas under their supervision. Assistance from the Site Radiation Safety Officers (SRSOs) and the Radiation Safety Officer (RSO) will be available for monitoring and inspection, including procedures such as laboratory relocation and decommissioning. Permit Holders must also provide adequate training for employees under their supervision in the proper use, handling and storage of radioactive materials. Permit Holders must conform to conditions of the internal permit and the Radiation Safety Manual issued by the RSO and the Radiation Safety Committee, and maintain adequate security of all laboratories under their supervision. Failure to comply will result in the cancellation of the permit by NRCan's Radiation Safety Committee. Chapter 1 March

10 1.2 Organizational Management Structure 1.3 Radiation Safety Committee The members of the NRCan Radiation Safety Committee are, in part, SRSOs who are appointed by senior management in each building site. Special advisors will also sit on the Radiation Safety Committee to provide technical advice as required by the committee on such areas as training, radiation safety information, monitoring for contaminates and other issues as they develop. All members will have professional experience and expertise in the use of radioactive materials. The RSO will provide secretarial support for the committee and co-chair the committee with the sector senior management appointee. Research work using radioactive material is carried out and devices capable of producing ionizing radiation are used at NRCan facilities. All work with ionizing radiation, regardless of how small a radiation dose is received, is regarded as a potential risk to health. The rules and regulations established are designed to minimize exposure to ionizing radiation, ensure safe working conditions and provide for the protection of the environment. The NRCan Radiation Safety Committee is committed to the concept of ALARA where all radiation exposures are kept As Low As Reasonably Achievable. In Canada, the possession and the use of radioactive materials is governed by the Canadian Nuclear Safety and Control Act administered by the CNSC. The CNSC has requested that NRCan be granted a Nuclear Substances and Radiation Devices Licence for the consolidated use of nuclear substances. The ADM, CMS, authorizes the Radiation Safety Committee for NRCan to administer this licence and to be responsible to the ADM for all aspects of radiation safety at NRCan. Ensuring compliance with the terms of federal regulations for the procurement and management of radioactive materials within NRCan is therefore the exclusive responsibility of the NRCan Radiation Safety Committee. Chapter 1 March

11 1.3.1 Duties and Responsibilities of the Radiation Safety Committee Regulations require that each licence have a Radiation Safety Committee with sufficient authority to implement and enforce the radiation safety program encompassing the department's ordering, usage, handling, monitoring, storage and disposal of radioactive materials. The committee shall also have the authority to recommend the suspension, when necessary, of the use of any radioisotope or radiation-producing devices regardless of the source of authorization. The Radiation Safety Committee shall be appointed by the ADM and have the following responsibilities: 1. Establish and review the training and experience requirements for users of radioactive materials to ensure that they are able to perform their duties safely and in accordance with the licensee's radiation safety program and regulatory requirements; 2. Ensure that appropriate equipment and facilities exist and are in compliance with CNSC regulatory requirements; 3. Ensure that there are sufficient resources allocated to the radiation safety program; 4. Ensure that the doses of ionizing radiation received by any person involved with the use of radioisotopes do not exceed the limits specified in the Radiation Safety Regulations and be kept as low as reasonably achievable (ALARA principle); 5. Develop policies with respect to the safe use of radioactive materials and techniques capable of producing hazardous emissions, including X-rays, lasers, electromagnetic radiations, such as microwave, and other potentially hazardous emissions such as ultrasound; 6. Advise the Permit Holder of the committee's policies and of the special requirements relating to research and transport of the above materials and devices; 7. Receive reports from the RSO and make recommendations concerning the actions to be taken on specific aspects of radiation matters as they arise or any remedial action to correct any deficiencies; 8. Advise on the development of appropriate procedures for the handling of emergency situations relating to radiation within the department; 9. Serve on behalf of the department as reviewing agency for all permits for radioisotopes; 10. Provide, as required to the department and to external agencies, reports on (a) situations and activities involving radiation, and (b) all radiation incidents and accidents that require reports on safety aspects; 11. Maintain a program to ensure that all persons whose duties may require them to work in the vicinity of radioactive material are properly instructed; 12. Review the designation of any person to be considered as a "nuclear energy worker" under the regulations that has occurred on a semi-annual basis; 13. Be available for consultation on problems dealing with radioactive materials and radiation hazards; 14. Review the entire radiation safety program at least annually to determine that all activities are being conducted safely and in accordance with the Canadian Nuclear Safety and Control Act and the conditions of the licence; 15. Maintain written records of all meetings, actions, incidents or unusual occurrences, recommendations and decisions, and supply the CNSC with a copy of these, as well as an annual report; and 16. Invoke sanction, including suspension or revocation of internal permits, as necessary. See Annex A, "Radiation Safety Committee Terms of Reference." Chapter 1 March

12 1.3.2 Radiation Safety Committee Members Currently, the committee is composed of the members listed on the NRCan intranet <wwwint.nrcan.gc.ca/ci/ems/3/r-ssemdc-e.htm#rad-com>. 1.4 Duties and Responsibilities of the Radiation Safety Officer The RSO shall administer the Nuclear Substances and Radiation Devices Licence issued to NRCan by CNSC by overseeing and managing all aspects of radiation safety within the institution. The RSO will act as the liaison for NRCan with other organizations, as well as the Radiation Safety Committee and users Institutional Duties and Responsibilities With respect to the institution, the RSO shall 1. act as the agent of the institution with respect to licensing matters; 2. be available to radioisotope users as a backup to the SRSOs and Permit Holders; this information will be provided to all Permit Holders; 3. establish, implement and maintain a radiation safety control and assessment program in conjunction with the Radiation Safety Committee; 4. systematically and periodically review survey programs for radiation and contamination levels in all areas where radioactive materials are used, stored or disposed of; 5. establish and conduct internal inspections as designated under the licence conditions and participate in inspections requested by CNSC; 6. ensure that a personnel monitoring program is implemented including bioassays, when applicable; 7. ensure radiation safety instruments are available in sufficient number, and are calibrated and serviced as required; 8. conduct an annual review of occupational radiation exposures and recommend ways of reducing exposures in the interest of the ALARA principle; 9. supervise decontamination procedures as required; 10. provide waste disposal procedures in accordance with conditions of the radioisotope licence; 11. ensure necessary leak testing of sealed sources is performed; 12. control the purchasing, use and disposal of radioactive materials via enforcement of conditions of internal permits; 13. ensure appropriate radiation safety training is provided on a regular basis as part of an ongoing radiation protection awareness program for all users and for those who occasionally come into contact with radioactive materials (e.g., cleaning staff, maintenance people); 14. maintain required records; 15. ensure that each internal permit is amended when necessitated by changes to facilities, equipment, policies, isotopes, conditions of use, procedures or personnel; 16. coordinate the development of plans to be used in the case of an emergency involving radioactive materials; Chapter 1 March

13 17. investigate all overexposure, accidents and losses of radioactive materials, and report to the CNSC when necessary; and 18. grant approval for use of radioisotopes to users only if the use will comply with all regulatory, environmental and institutional requirements, and ultimately deny the use of radioactive materials given sufficient cause Radiation Safety Committee Duties and Responsibilities With respect to the Radiation Safety Committee, the RSO shall 1. function as the link between the Radiation Safety Committee and Permit Holders within the institution; 2. prepare and review in consultation with the Radiation Safety Committee a comprehensive radiation safety manual; 3. have input in matters pertaining to (a) facility and equipment design, (b) work practices and procedures, (c) waste storage and disposal management, (d) evaluation, issuance and enforcement of internal permits, (e) the invoking of sanctions required by non-compliance, and (f) radiation safety training; 4. prepare in consultation with the SRSOs an annual report to the CNSC according to licence condition; and 5. receive a report on any survey programs pertaining to contamination levels in all areas where radioactive materials are used, stored or disposed of, as applicable. 1.5 Duties and Responsibilities of the Site Radiation Safety Officer The SRSO is the contact for the Permit Holders and users under the SRSO's direction and coordinates all aspects of radiation safety according to the conditions of the internal permits for sites within the building in which they are located. If the SRSO relocates, he or she will ensure that the RSO is notified and another SRSO will be appointed to carry out the SRSO duties. The SRSO should be limited to a maximum of 10 room sites. If additional sites are licensed, additional SRSOs may be appointed. The SRSO shall 1. participate in and attend the Radiation Safety Committee meetings; 2. be available to radioisotope users effectively on a full-time basis; 3. maintain a radiation safety control and assessment program in conjunction with the Radiation Safety Committee; 4. review with the RSO survey programs for radiation and contamination levels in all areas within their mandate where radioactive materials are stored or disposed of; 5. participate with the RSO in internal and external inspections as per licence conditions; Chapter 1 March

14 6. ensure that current users are using an appropriate monitoring program including bioassays, when applicable; 7. review internal permits and instruct Permit Holders to register new equipment prior to ordering or receiving of equipment; this will include monitoring of permit updates in advance; 8. monitor records to ensure that all equipment identified for disposal has been properly decommissioned and disposed of in accordance with licence conditions; this will include providing the information to the RSO to update permit; 9. participate in the development of an appropriate radiation protection training program and ensuring that participation under the licence conditions are met as required; and 10. monitor each incident or accident that is reported and when necessary either investigate or contact the RSO for additional investigation of the incident or accident; this includes any accidental exposures. 1.6 Duties and Responsibilities of Permit Holders The internal permits will be issued to one individual, the Permit Holder, who will be responsible for the monitoring of all functions within the designated area that fall under compliance with the licence. Permit Holders must have experience in the handling of radiation-emitting sources and materials. They are responsible for the location identified on the permit. The Permit Holder shall 1. ensure that the conditions on the permit are fulfilled and ensure compliance with policies and procedures of the Radiation Safety Committee and CNSC licence conditions; 2. be available to provide support to users within the permit designated area on a full-time basis and ensure that safe laboratory practices are followed; 3. ensure that all users of radioactive material are listed individually on the permit; no users other than those listed are permitted to use radioisotopes within the permit site; 4. maintain the radiation safety control and assessment program in conjunction with the SRSO; 5. ensure that all monitoring and other compliance protocols required under the consolidated licence are conducted and records maintained; 6. ensure that current users are using an appropriate monitoring program, including bioassays, when applicable; 7. ensure that all new equipment, open source material or sealed source material is registered on their internal permit prior to receiving the material or equipment on site; 8. participate in an appropriate radiation protection training program and ensure that participation as per licence conditions are met; 9. participate in surveys, and internal and external inspections as per licence conditions; and 10. report and follow up on any accident or incident with the SRSO for additional investigation of the incident or accident; this includes all accidental exposures. 1.7 Duties and Responsibilities of Users Working with Radioisotopes Each individual worker who uses radioactive material has a responsibility to ensure that safety practices in the workplace are adhered to for their own safety and that of their co-workers. They must comply with the Radiation Safety Committee policies and procedures and with those established for the Permit Holder's internal permit. They shall accomplish this by 1. working in compliance with all policies, procedures and requirements at NRCan; 2. using any protective or monitoring equipment that is required for the safe use of radioactive materials; Chapter 1 March

15 3. reporting to the Permit Holder or SRSO any defective equipment or violation that may endanger a worker or create a potential unauthorized release of radioactive material to the environment; and 4. not creating or participating in any activity that may endanger themselves, any other worker or create the potential for unauthorized release of radioactive material to the environment. Chapter 1 March

16 INTENTIONALLY LEFT BLANK Chapter 1 March

17 Chapter 2: Licensing and Administration 2.1 Nuclear Substances and Radiation Devices Licence Issued for the Consolidated Use of Nuclear Substances The licence issued for the consolidated use of nuclear substances is a departmental licence that regulates the purchasing, possession and use of open and sealed source material at all Natural Resources Canada (NRCan) facilities. The licence is valid for five years from the date it is issued by the Canadian Nuclear Safety Commission (CNSC). The renewal of this licence is processed at the request of NRCan through the Radiation Safety Officer (RSO) in conjunction with the Radiation Safety Committee. Qualified individual researchers are granted, under the authority of this Nuclear Substances and Radiation Devices Licence, internal permits by the RSO for each room where radioactive materials are stored or used. These internal permits are valid for a maximum period of five years, which does not exceed the expiry date of the Nuclear Substances and Radiation Devices Licence issued by the CNSC Application for the Nuclear Substances and Radiation Devices Licence The RSO, with the required information gathered from all Permit Holders and Site Radiation Safety Officers (SRSOs), will complete the application and provide it to the Radiation Safety Committee for their review. Once approved, it will be sent to the CNSC for renewal. 2.2 Internal Permit Application Internal permits are required for the purchase, possession, use and disposal of sealed (including gauges) and open source radioactive materials. This applies to all acquisitions of radioactive material, either purchased or donated. Permits are issued only to staff currently employed by NRCan who possess documented training and experience in the use of radioactive material. Laboratory facilities for open source radioisotope work must be approved by the Radiation Safety Committee and the RSO. See Form 8, "Design Compliance Form for Laboratories," in Chapter 6. The internal permit is limited to the radioactive materials listed and only covers the use of these materials within the designated areas. If the radioactive material is being transported to another site within the facility, the new location must also have an internal permit that covers the radioactive material accordingly. If the radioactive material is being transported to another site within the building or to another building site within NRCan, the SRSO must be notified for approval. If the radioactive material is being transferred to another institution (e.g., university or other government department), the RSO must be contacted for approval or information concerning the transfer. If the radioactive material is being transported for use at another location (sites across Canada), an internal permit with the appropriate information will be granted to each vehicle (or pool of vehicles) used for transporting. To apply for an internal permit, see Form 4, "Application for Internal Permit," in Chapter 6. Chapter 2 March

18 2.3 Internal Permit Following the approval of the application, an Internal Radioisotope Permit is issued to each laboratory or vehicle, with a designated Permit Holder for each permit. All personnel using radioactive material must be listed on the internal permit. Three copies of each permit are produced: one for posting, one for the SRSO and one for the RSO. All permits will have original signatures of the RSO, SRSO and Permit Holders. A copy of the signed permit must be posted by the Permit Holder in the laboratory listed on the permit. A permit is not valid unless the Permit Holder has signed all three copies. A permit is not valid beyond the expiry date shown, unless a renewal application has been submitted. The internal permit is divided into the following five parts: Part 1 shows the internal permit number and the period during which the permit is valid. It lists the Permit Holder's name and phone number, the sector, branch, division, the revision number of the permit and the room number or vehicle number. The radioactive material must not be used or stored in a location not listed on each permit. This section also contains the name and phone number of the contact person in case of emergencies, and the names and phone numbers of the SRSO and the RSO. Part 2 lists all radioisotopes that may be in the possession of the Permit Holder. Devices containing sealed source material, the isotope type of device and activity for open source material, the isotope and the delivery rate of the material are specified. The rate of delivery must not be exceeded. Radioisotopes not listed on the permit must not be purchased or obtained by the Permit Holder. Part 3 lists users approved for work with radioisotopes. Each of the users must be properly trained and have read this manual. Any changes to this list, including the names of students, must be communicated to the RSO for appropriate authorization. Part 4 lists the conditions specific to the individual internal permit. Permit Holders and staff should ensure that they have read, understood and followed all of the permit conditions. Part 5 contains a statement affirming that by signing, the Permit Holder agrees to the terms and conditions under which the permit is issued. changes may be made to the permit without prior approval by the RSO or Radiation Safety Committee. This includes changes to the rooms, buildings, users, isotopes ordered or the quantity permitted. To change any part of the permit, an application for a permit amendment must be submitted (see Form 5, "Application for Internal Permit Amendment," in Chapter 6). 2.4 Status of Permit Holder on Long-Term Leave A permit is granted on the grounds that the Permit Holder is aware of and responsible for the activities within the designated area. If a Permit Holder takes a long-term leave of absence or a long-term medical leave, arrangements must be made prior to the leave, or as soon as it is established that the absence will be extensive. The management, the SRSO and the RSO must be individually notified in writing of this change. Any Permit Holder acting on behalf of another Permit Holder is responsible for all activities under both permits and will be subject to any necessary compliance enforcement. 2.5 Amendment of an Existing Permit To amend an existing permit, an "Application for Internal Permit Amendment" (Form 5 in Chapter 6) must be completed and forwarded to the SRSO and the RSO. The application must also include the reason for the change, and the current internal permit number. The form must be signed by the Permit Holder. Permit amendment requests may not be signed on behalf of the Permit Holder. Chapter 2 March

19 The Permit Holder may not implement the requested changes until the permit amendment has been approved. Following approval of the amendment, a revised permit will be issued. te: The five year period for the permit begins from the date the original permit was issued, not from the date the amended permit is issued. If the Permit Holder is unable to request a particular amendment, the manager of the Permit Holder can request it. The request must briefly describe the reason for the change of applicant. 2.6 Renewal of an Existing Permit Permit renewals (Form 6, "Application for Internal Permit Renewal," in Chapter 6) are initialized by the RSO. A permit renewal form is sent to each current Permit Holder. The Permit Holder is required to complete all requested information, sign the application and obtain the signature of the SRSO to complete the form. The permit renewal application will indicate the date by which the form must be returned. Failure to return the renewal application by this date may cause disruption in the work with radioisotopes, as no purchase or use of radioactive material is permitted without a valid permit. If a permit renewal application request is not received by the expiry date of the current permit, it is automatically assumed that the Permit Holder has requested that the permit be cancelled. At this point, the RSO will contact the SRSO and the Permit Holder for decommissioning of the laboratory and removal of any remaining radioactive material. If a Permit Holder is not currently using or storing radioisotopes and their use is not foreseen in the immediate future (six months), it is recommended that the permit be cancelled and the room decommissioned. New permits can be issued upon request when a future need arises. Following approval of the permit renewal, a new permit is issued with a term corresponding to the renewed Nuclear Substances and Radiation Devices Licence. If the new permit has not arrived prior to expiry date of the current permit, Permit Holders who have an approved permit renewal application on file at the time of expiry will not be affected by any purchasing or use restrictions. 2.7 Radioisotope Laboratory Approval All rooms intended to be used for the handling, storage or disposal of more than one scheduled quantity of an open source radioactive material, must conform to the requirements of the CNSC Regulatory Document R 52, Design Guide for Basic and Intermediate Level Radioisotope Laboratories, which applies to all new or renovated facilities designed after January 1, Any area in which radioactive material has been previously used may have an approval on file and an inspection may not be required. Where extensive renovations or modifications have been carried out within the area, an inspection must be completed prior to issuing of the permit. Any area that has not been used for storage or handling of radioactive material, including new or renovated laboratory facilities, will require an inspection by the SRSO or the RSO to ensure compliance with the Regulatory Guide. A "Design Compliance Form for Laboratories" (Form 8 in Chapter 6) is completed for the proposed room and approval is based on the existence of the control factors required on the form. If a laboratory does not meet the requirements for a basic-or intermediate-level designation (see Annex E, "Laboratory Classification," for requirements), it may require modification prior to approval. Chapter 2 March

20 2.8 Cancellation of an Internal Permit Cancellation of a permit may be required because of a change in the activities or staffing within the area, or because of a change in methodology. A permit may also be cancelled at the time of permit renewal. If no current requirements for a radioisotope permit exist and the Permit Holder has no immediate plans to resume this activity, it is recommended that the permit be cancelled until the need to resume work with radioisotopes arises. The permit may be reactivated if the need arises in the future. te: If radioisotopes are being stored or instruments with radioactive sources are being retained, then a permit will have to be maintained. To cancel the permit, a "missioning Records" form (Form 7 in Chapter 6) must be completed and forwarded to the RSO, and copied to the SRSO requesting the permit cancellation. A complete copy of the final contamination survey with a detailed diagram of the test sites must be attached, as outlined in the "missioning Policy" (Section 3.12). If special disposition of any radioisotope material held under the permit is required, this must be noted in the decommissioning records form (e.g., transfer of radioactive material to a new location, transfer of instruments or disposal confirmation). 2.9 Purchasing and Receiving Radioactive Material The purchasing of radioactive materials must be done with management's approval. All orders and requisitions must be copied to the SRSO. The SRSO will then forward the records to the RSO on an annual basis or upon request. The RSO will retain all records for six years as required by the CNSC or the period specified, or for the period ending one year after the expiry of the licence that authorizes the activity in respect of which the records are kept. All purchase orders must have the permit number on the requisition. A copy of the purchase order, packing slips, Transportation of Dangerous Goods (TDG) documents and any other documents associated with the order must be attached to the inventory sheets (one sheet per vial; see Chapter 6 for Form 1, Open Source Inventory Sheet, and Form 2, Sealed Source Inventory Sheet ). The purchase order information may be used as a source of information for inventories during inspections (see Section 3.8, "Receiving Radioactive Material") Special Orders Special orders, including standing orders, special gifts, transfer, exchanges, must be approved by the RSO, prior to delivery of the material. This will ensure that all licence conditions are met. If any changes are required for the permit, this will ensure that it is completed prior to the delivery of material Inventory Procedures The following procedures should be followed to keep an inventory of radioactive materials: 1. All isotopes received are to be entered, one purchase per sheet, on inventory sheets (Form 1, "Open Source Inventory Sheet," and Form 2, "Sealed Source Inventory Sheet," in Chapter 6). Subsequent use and disposal are entered on the same sheets as soon as the isotope is used. 2. All purchase orders must be kept with the inventory sheets. 3. Each Permit Holder must maintain a complete inventory of radioactive materials in use and in storage. 4. Inventories are to be up to date and available for inspection by the RSO or the CNSC. 5. All inventory records must be kept for a minimum of six years or another specified period, or for the period ending one year after the expiry of the licence that authorizes the activity in respect of which the records are kept. 6. Total inventory for each isotope must not exceed permit requirements. 7. The cumulative inventory and disposal records are summarized annually. Chapter 2 March

21 2.12 Compliance Inspection Policy Compliance inspections are required to be conducted internally under the Radiation Safety Program. The internal inspections will be conducted annually for sites using and storing open source material and every two years for sealed source materials (as of 2004). The internal inspections may be more frequent if necessary. The SRSOs and RSO will visit each lab to which an internal permit is issued. The visits will be announced and at times unannounced. The compliance inspections are generally based on the CNSC s Risk-based Regulatory Program, whereas legislative requirements are rated (from exceeding requirements to unacceptable) depending on the risk associated with the requirement. The levels of risks are 1. High: immediate health, safety or security risk; 2. Medium: health, safety or security risk, but not immediate; and 3. Low: no health, safety or security risks; administrative issues only. Annex B, a comprehensive Internal Inspection Checklist, will be used. In general, items of compliance that will be reviewed during an inspection include, but are not limited to 1. administrative requirements (e.g., permit posting, training, personnel monitoring, signs and posting of rules); 2. record keeping (e.g., monitoring, inventory, purchasing, etc.); 3. storage and handling in labs (e.g., in laboratory storage, work area safety and security); 4. protection (e.g., laboratory coat, gloves and shielding); 5. spills and contamination (e.g., procedure and cleaning); 6. waste disposal and storage sites (e.g., long-term disposal and short-term storage, other than in a laboratory); and 7. training. Violations will be categorized as either major, moderate or minor offences, depending on the risk associated with the violation Major Offences A major offence (high risk) results from violations that cause immediate risk or danger to health or safety, that release reportable quantities of radiation to the environment, that expose staff to substantial doses or that place the departmental licence for the consolidated use of nuclear substances in jeopardy. Examples of a major offence include 1. contamination above licence criteria; 2. inadequate monitoring program; 3. use or storage of food or drink in the laboratory; 4. inadequate training of new staff; 5. non-participation in required bioassay programs; 6. inadequate or unsafe work and storage areas for radioisotopes; or 7. inadequate or unsafe storage areas for radiation waste. Chapter 2 March

22 Moderate Offences A moderate offence (medium risk) results from violations that can bring about a health, safety and security risk, but the risk is not immediate. Examples of a moderate offence include 1. inadequate training records; 2. contamination or survey meters not calibrated; or 3. changes to the SRSO, Permit Holders or users not reported to the RSO within 15 days Minor Offences A minor offence (low risk) is an infraction that poses no immediate risk or threat to health, safety, the environment or the licence. Examples of a minor offence include 1. inadequate posting (e.g., internal permit, CNSC posters); 2. inadequate inventory records; 3. inappropriate use of warning labels; or 4. routine leak testing not followed Compliance Enforcement Policy NRCan is issued a Nuclear Substances and Radiation Devices Licence for the consolidated use of nuclear substances by the CNSC for the possession, use and import of radioactive prescribed substances or devices containing radioactive prescribed substances. Since this licence is a single licence and cancellation of the licence would result in all work involving radioactive material within NRCan being suspended, it is essential that there be a procedure and policy in place to deal with non-compliance. Upon issue of this licence, NRCan assumes the responsibility to ensure that any use of radioactive prescribed substances on all NRCan sites complies with the CNSC Nuclear Safety and Control Act and its regulations, as well as all conditions that apply to the licence. Failure to comply with a policy or procedure established by the Radiation Safety Committee will result in the actions described in the following subsections Major Offence Actions Items of serious non-compliance that would place the NRCan licence in jeopardy will be dealt with immediately. This will include any situation that is considered an immediate risk to health and safety. The RSO and the SRSOs have the power to suspend operations or cancel the permit. The RSO will provide a report of this action to the Radiation Safety Committee, senior representative for the Assistant Deputy Minister (ADM), SRSO, and to the Director, Security, Safety and Emergency Management Division. On the first offence, the Permit Holder will be notified in writing of the offence and the required action to correct this offence. Immediate attention and correction of the violation is required. If a second occurrence of an offence recurs within a year or the Permit Holder fails to correct the first offence, the Permit Holder will be notified in writing that the permit will be revoked until a meeting can be held with the Radiation Safety Committee. The Permit Holder may attend the meeting to explain why the permit in question should be renewed. If a third occurrence of an offence recurs within a year, the permit will be transferred to the Permit Holder s manager and all work will have to be conducted under the control of the Permit Holder s manager. All purchases of radioactive material will require the approval of the manager. The Radiation Safety Committee will review the permit and make recommendations to the manager in writing. Chapter 2 March

23 Moderate and Minor Offence Actions Moderate offences must be corrected within 14 calendar days. Minor offences must be corrected within 28 calendar days. On the first occurrence, the Permit Holder will be notified verbally by the RSO or the SRSO of the violation observed. If a second occurrence of an offence recurs within a year or the Permit Holder fails to correct the first offence, the RSO will send written notification of the observed violation to the Permit Holder, with a copy to the manager of the Permit Holder. If a third occurrence of an offence recurs within a year, the RSO will arrange to transfer the permit to the manager of the Permit Holder. If the manager agrees to assume the responsibility, all work will be under his or her direct control. In this case the manager s name and signature must appear on all purchase requisitions. Written notification of the above action will be sent to the Radiation Safety Committee. If a fourth occurrence of an offence takes place within a year, the Permit Holder s manager will be required to show cause to the Radiation Safety Committee why the permit should not be revoked. A report of this action detailing the Radiation Safety Committee s recommendations will be prepared and provided to the senior representative for the ADM. If the permit is revoked, the radioactive material will be removed from the area and disposed of or locked up for retention until the violations are rectified to the satisfaction of the Radiation Safety Committee Annual Compliance Report The NRCan Nuclear Substances and Radiation Devices Licence includes the condition that the licencee submit an annual report. This report is intended to keep the CNSC advised of the current status of the licence, and the circumstances, operations, performance and authorized activities that are related to the care and control of radioactive materials and devices. The RSO, in consultation with and with the assistance of the SRSOs, will prepare the annual report and submit it to the CNSC by the required due date. The annual report will contain some of the following information: 1. A summary of the major activities over the reporting year and any anticipated future change to the radiation safety program; 2. Copies of the minutes of the Radiation Safety Committee meetings or meetings of other groups; 3. A listing of all internal permits; 4. A brief review of internal compliance activities, including the inspection schedule and results; 5. A summary of acquisitions, transfers and disposal of any radioactive materials or devices; 6. Copies of occupational radiation doses; and 7. A summary of investigation conducted, and incidents or significant occurrences, along with descriptions of the consequences and any remedial action CNSC Approval for Special Projects Authorization for projects involving unsealed nuclear substances that are in a quantity of more than 10,000 times any exemption quantity will be issued only after obtaining a written approval from the CNSC. Contact the RSO to begin the process of obtaining approval. Chapter 2 March

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25 Chapter 3: Policies and Procedures 3.1 New Policies and Procedures The Radiation Safety Committee and the Radiation Safety Officer (RSO) may impose additional requirements, as necessary, which will be issued in the form of new or revised policies or procedures. These policies and procedures will not be effective until they are reviewed and approved by the Radiation Safety Committee. After being approved and finalized, these new policies and procedures will be distributed to all Permit Holders by and the Radiation Safety Manual will be revised. The Permit Holders will be responsible for ensuring that the users listed on the permit are notified of new or revised policies and procedures. 3.2 ALARA Policy It is the policy of Natural Resources Canada (NRCan) that all activities involving ionizing radiation or radiation-emitting devices be conducted so as to keep hazards from radiation to a minimum. Radiation doses to all staff and the public during routine use of radioactive materials or operation of analytical X-ray equipment, and in the case of an emergency, must remain As Low As Reasonably Achievable (the ALARA principle). A high standard of radiological safety will be maintained at all times in the work environment. All activities that use radioisotopes will be appropriately licensed by the Canadian Nuclear Safety Commission (CNSC). NRCan is committed to the achievement of compliance in accordance with the relevant regulations and licence conditions. The holder of any such licence will ensure that all conditions of the licence are fulfilled on behalf of the department. Persons involved in these activities are expected to comply fully with the Nuclear Safety and Control Act and its regulations and with the Occupational Health and Safety Act and its regulations regarding X-ray sources, lasers and sound. 3.3 Designation of Nuclear Energy Workers Policy The General Nuclear Safety and Control Regulations and the Radiation Protection Regulations require that nuclear energy workers (NEWs) be notified of their status as NEWs and all associated implications, including risks related to the radiation to which NEWs may be exposed, applicable effective dose limits, typical dose levels received and the NEWs' rights and obligations. (See Table 4.5, "CNSC Annual Limits of Exposure for NEWs and Members of the Public," in Section 4.2.2, External Radiation Exposure. ) If operational requirements make it essential that a user becomes a NEW, the Site Radiation Safety Officer (SRSO) must contact the RSO. 3.4 Food and Drinks in a Radioisotope Laboratory Policy The storage or consumption of food and beverages in any laboratory, including radioisotope laboratories, at NRCan, is prohibited under any circumstances. The prohibition against eating, drinking or the application of cosmetics in a radioisotope laboratory is used to prevent the accidental ingestion of radioactive material. Chapter 3 March