National paper of Canada on the implementation of the Code of Conduct on the Safety and Security of Radioactive Sources 2023
This paper provides a summary of Canada’s continuing efforts related to the implementation of the International Atomic Energy Agency (IAEA) Code of Conduct on the Safety and Security of Radioactive Sources (the Code) and its supplementary Guidance on the Import and Export of Radioactive Sources (the Guidance), for the period of January 2019 to December 2022.
Canada has a well-established, risk-informed regulatory framework for the control of Category 1 and 2 sealed sources, which is the focus of this paper, as well as for Category 3, 4 and 5 sealed sources. This includes legislation and regulations addressing the safety and security of sealed sources, a comprehensive system of licensing, compliance verification, a Sealed Source Tracking System (SSTS), a National Sealed Source Registry (NSSR), and import and export controls.
Through the regulatory framework, the CNSC has established regulatory controls and measures from the production of sealed sources to their final disposition including a process for bringing orphaned sources back under regulatory control, effectively controlling sources throughout their life cycle. Key enhancements of regulatory controls related to Category 1 and 2 sealed sources during the reporting period, include:
- publication of the regulatory guide REGDOC-3.1.3 Reporting Requirements for Waste Nuclear Substance Licensees, Class II Nuclear Facilities and Users of Prescribed Equipment, Nuclear Substances and Radiation Devices
- coming into force of the amended Radiation Protection Regulations and work underway to amend the Nuclear Substances and Radiation Devices Regulations and the Class II Nuclear Facility and Prescribed Equipment Regulations
- efforts implemented by the CNSC to pursue the conduct of its regulatory oversight activities throughout the COVID-19 pandemic
- multiple international cooperation projects led by Global Affairs Canada in support of the Code
- several initiatives advocating for gender equity and diversity on the national and international stage
A. Infrastructure for regulatory control of the safety and security of radioactive sources
A.1 Legislation and regulations
At the top level of Canada’s nuclear regulatory framework is the Nuclear Safety and Control Act (NSCA). It came into force on 31 May 2000 and provides the Canadian Nuclear Safety Commission (CNSC) with its regulatory authority. Under the Act, the CNSC’s mandate is to regulate:
- the development, production and use of nuclear energy
- the production, possession and use of nuclear substances, prescribed equipment and prescribed information in order to prevent unreasonable risk to the environment, to the health and safety of persons and to national security to achieve conformity with Canada’s international commitments on the peaceful use of nuclear energy
The CNSC has in place a clear, pragmatic and comprehensive regulatory framework for facilities and activities authorized under the NSCA, which ensures effective regulatory oversight of sealed sources from the stage of initial production to their final disposition. This regulatory framework encompasses not only the NSCA and its regulations, licences and certificates, but also regulatory documents and bilateral arrangements with domestic and foreign authorities.
The CNSC regulatory system is based on risk-informed licensing and compliance verification processes which require licensees and other persons regulated under the NSCA to demonstrate that their activities are safe and secure. By implementing a risk-informed regulatory approach, the CNSC:
- regulates in a manner that is consistent with the risk posed by the activities
- recognizes that risk must be considered in the context of the CNSC’s duties and responsibilities under the NSCA
- makes regulatory decisions and allocates resources in a risk-informed manner
- indicates acceptable ways to meet regulatory requirements, and allows licensees to propose alternative methods
Achievements and planned improvements
Canada hosted an Integrated Regulatory Review Service (IRRS) mission from September 3 to 13, 2019. Overall, the IRRS mission confirmed that the CNSC has a comprehensive and robust regulatory framework for nuclear and radiation safety covering current facilities and activities. Specifically related to sealed sources, the 2019 IRRS Report to Canada identified 1 good practice and 2 suggestions:
- The good practice was related to the targeted, multi-faceted program for dealing with historic radium luminous devices in the public domain.
- One suggestion was related to the implementation of justification in the authorisation of all practices involving radiation sources. The regulatory framework embeds this concept already. However, internal procedures were updated to document how this was done.
- The second suggestion was to include notification alone as an option for the regulatory control of nuclear substances and radiation devices in accordance with a graded approach. The CNSC is considering whether there is merit in moving to a notification system for very low risk applications as part of a larger review of the CNSC’s overall risk-informed approach to licensing and compliance.
In March 2020, the CNSC published REGDOC-3.1.3 Reporting Requirements for Waste Nuclear Substance Licensees, Class II Nuclear Facilities and Users of Prescribed Equipment, Nuclear Substances and Radiation Devices. This document summarizes the requirements associated with reports and notifications that licensees using sealed sources must make to the Commission, provides details on events that must be reported (such as the loss or theft of a sealed source or a radiation device) as well as their associated reporting timeframes.
In November 2020, the amended Radiation Protection Regulations (RPR) were published, with transitional provisions coming into force on January 1, 2021. The RPR amendments are available here; they were the result of various developments since the regulations were first introduced in 2000, including the publication of the International Commission on Radiological Protection (ICRP) Recommendations (ICRP 103, 2007) and the IAEA’s General Safety Requirements (GSR) Part 3, Radiation Protection and Safety of Radiation Sources: International Basic Safety Standards (2014). For example, new requirements were introduced regarding risk information to be provided by licensees to nuclear energy workers, including their responsibilities during an emergency and radiological risks to breast-fed infants. In July 2021, the CNSC published two new regulatory documents, namely: REGDOC 2.7.1, Radiation Protection, and REGDOC 2.7.2, Dosimetry, Volume I: Ascertaining Occupational Dose. These 2 documents provide further guidance on the requirements outlined in the regulations.
The Nuclear Substances and Radiation Devices Regulations (NSRDR) are currently under review and some of the anticipated changes are intended to clarify existing definitions and requirements, codify existing practices and expectations into the regulations, and introduce an ambulatory incorporation by reference to the IAEA’s General Safety Requirements (GSR) Part 3 to preclude the requirement to update the NSRDR periodically.
The Class II Nuclear Facility and Prescribed Equipment Regulations are currently under review and some of the proposed changes include the addition of a requirement that the proposed method of disposing of Class II prescribed equipment (and any incorporated nuclear substances, activated components or materials) be provided when the facility containing prescribed equipment is constructed, or, if the prescribed equipment is not contained within a facility, when the prescribed equipment is first licensed. In addition, a new requirement would apply to manufacturers of Class II prescribed equipment whereby they would need to provide the proposed method for securing Class II prescribed equipment that contains a nuclear substance at the design stage.
In an effort to modernize its nuclear security framework, the CNSC is working to revise REGDOC-2.12.3 Security of Nuclear Substances: Sealed Sources and Category I, II and III Nuclear Material, Version 2.1, which sets out the minimum security measures to prevent the loss, sabotage, illegal use, illegal possession or illegal removal of sealed sources while in transport or in storage. REGDOC 2.12.3 is aligned with the Code, as well as with the IAEA Nuclear Security Series (NSS) 14 Nuclear Security Recommendations on Radioactive Material and Associated Facilities.
A.2 Establishment and responsibilities of the regulatory body
The CNSC is a “3S” nuclear regulator: it is responsible for nuclear safety, security and safeguards. CNSC’s safety and security staff work closely together to harmonize and integrate safety and security requirements and measures. The CNSC recognizes the importance of safety, security and safeguards in all aspects of its regulatory oversight. In fact, the CNSC is one of the few regulators that is solely responsible for all three. The CNSC regulates the use of nuclear energy, material and substances to protect health, safety, security and the environment. The CNSC also implements Canada’s international commitments on the peaceful use of nuclear energy and disseminates objective scientific, technical and regulatory information to the public.
The NSCA established the CNSC in 2000 under paragraph 8(1) of the Act to replace the former Atomic Energy Control Board (AECB). The CNSC reports to Parliament through the Minister of Natural Resources on the Commission’s activities under the Act. Decisions made by the Commission are not subject to government or political review and cannot be overturned by the Government of Canada. Only the Federal Court or the Supreme Court of Canada may review and overrule a decision made by the Commission.
The CNSC’s Commission has up to 7 appointed permanent members whose decisions are supported by 857 employees (CNSC staff) as of March 31, 2021. CNSC staff review applications for licences according to regulatory requirements, make recommendations to the Commission or Designated Officer (DO), and enforce compliance with the NSCA, regulations, and any licence conditions imposed by the Commission. A person designated as a DO under section 37 of the NSCA is considered qualified to perform duties specified under the Act, on behalf of the Commission.
All activities in Canada involving the development, production and use of nuclear energy and the production, possession, use, and import and export of nuclear substances, prescribed equipment and radiation devices, and prescribed information may only be carried out under an authorization (i.e., licence) granted by the Commission, or a DO, except where expressly exempted by regulations. The NSCA and regulations made under the NSCA include regulatory requirements that must be met by all licensees.
Under the NSCA, the CNSC has the authority to verify licensee compliance with all regulatory
. This is done by CNSC inspectors whose powers are outlined in paragraphs 30 to 35 of the NSCA. The CNSC has a variety of enforcement tools to bring licensees back into compliance with the NSCA and associated regulations, such as the notices of non-compliances, issuance of orders or administrative monetary penalties.
The CNSC receives its budget from 2 sources: fees paid by applicants and licensees and other special projects, as well as through parliamentary appropriation to ensure that the CNSC is adequately funded to perform its mandate. The CNSC can, in accordance with its Cost Recovery Fees Regulations, recover costs associated with some of its regulatory activities under the NSCA. Since April 1, 2021, the CNSC is subject to requirements from the Service Fees Act, whereby related costs are indexed annually and a portion of the fees must be remitted when the CNSC service standards are not met. Hospitals, public institutions such as schools, and not-for-profit institutions that receive funds from the government (federal, provincial, municipal) are exempt from licensing fees.
In 2020, the global COVID-19 pandemic impacted CNSC staff and licensees, as it did every other aspect of Canadian society. Within a short timeframe, CNSC staff received the necessary equipment to work remotely and were able to conduct their activities with effectively no interruption of service during the pandemic. For the compliance activities that required onsite inspections, CNSC staff pivoted to remote inspections for most of 2020. In cases where physical presence was necessary, CNSC inspectors were issued authorization letters allowing them to travel across provincial boundaries while travel restrictions were in place. Since then, the CNSC continues to balance the need for in-person compliance activities with the health and safety of the public and of CNSC and licensee staff.
The CNSC import and export programme was declared a critical service and within a week, it went from a hybrid electronic/paper-based process to exclusively digital licensing. As a major exporting nation of Co-60, which was vital in the fight against COVID-19, the CNSC was able to ensure Canadian suppliers were able to export to authorized facilities in accordance with the Code and Guidance. This digital licensing continues to this date, demonstrating that the CNSC can fulfil its obligations in an efficient and effective manner while giving its staff the choice to work remotely from anywhere in Canada.
The CNSC’s approach to the pandemic and the return to the workplace was guided by the latest and best information available. Accordingly, as part of the CNSC’s Return to the Workplace plan, a Gender Based Analysis Plus (GBA+) assessment was undertaken to ensure that working from home arrangements and the return to the workplace plans were as accessible, equitable and inclusive as possible. GBA+ is a best practice that provides a rigorous method for the assessment of systemic inequalities (race, ethnicity, religion, age, and mental or physical disability).
A.3 National and international coordination
The CNSC has powers under paragraph 21(1) of the NSCA to enter into cooperative arrangements with domestic and international authorities in order to attain the objectives of the CNSC. With respect to national coordination related to the safety and security of sealed sources, the CNSC coordinates and cooperates with domestic agencies on relevant areas of concern, such as the transport of dangerous goods, border controls, radioactive waste management and emergency planning and preparedness. For example, Global Affairs Canada (GAC) and the CNSC have in place a Memorandum of Understanding (MoU) which outlines key areas for GAC and CNSC collaboration. In particular, the MoU allows for GAC to fund CNSC staff to attend meetings internationally, where they provide in-kind support for trainings and capacity building activities. Further to this, GAC and CNSC staff supported the program committees involved in planning the International Conference on the Safe and Secure Transport of Nuclear and Radioactive Materials (December 2021) and the International Conference on the Safety and Security of Radioactive Source (June 2022). Both conferences were co-presided either by staff from the CNSC or Global Affairs Canada.
Through the Federal Nuclear Emergency Plan (FNEP), the CNSC contributes to the technical assessment to manage the consequences involving a significant radiological hazard. The FNEP can also be used in conjunction with other federal coordinating plans (such as the Federal Emergency Response Plan and the Federal Chemical, Biological, Radiological, Nuclear and Explosives Plan) to support emergency response authorities. To prepare for nuclear emergencies, the CNSC collaborates with other federal, provincial, and municipal/regional government organizations through emergency preparedness committees, joint-exercises, and sharing-of-information.
Internationally, the CNSC establishes and maintains cooperation arrangements with international counterparts to share information and best practices, with a view to further enhancing nuclear safety and security in Canada and abroad. Currently, the CNSC has Memoranda of Understanding (MoUs) with 29 counterpart authorities in 25 countries. These MoUs provide a framework and instrument for cooperation and information exchange in the event of an incident with potential transboundary effects and include arrangements on the import and export of sealed sources.
Further, the CNSC submits incidents on behalf of Canada to the IAEA’s Incident and Trafficking Database (ITDB). The ITDB is the IAEA’s “information system on incidents of illicit trafficking and other unauthorized activities and events involving nuclear and other radioactive material outside of regulatory control.” Canada is one of the most active contributors to the ITDB and encourages other Member States in doing so. The CNSC has trained staff to report incidents in a timely manner.
Key international cooperation initiatives
Canada is one the world’s leading donors to the IAEA’s Nuclear Security Fund, Peaceful Uses Fund and other extra-budgetary programs. A number of Canada’s voluntary contributions directly support projects that strengthen the implementation of the Code. A summary of key projects that were launched, and to which Canada made voluntary contributions of over $40 million, before and during the 2019-2022 reporting period follows:
- Provide travel support to 111 nuclear security experts from developing states in Africa, Latin America, Middle East and Southeast Asia to attend major international meetings on the Code from 2016 to 2021.
- Provide financial support for the convening of Code of Conduct meetings between 2021 and 2024, promote guidance documents and self-assessment tools, and train National Points of Contact to coordinate and collaborate on implementation of the Code.
- A pilot project for the Regulatory Infrastructure Development Program (RIDP) aiming to provide comprehensive assistance that would strengthen both nuclear security and radiation safety in 8 Latin America states. This project resulted in training 130 regulatory staff; improved capacity by beneficiary states to review and assess authorization and conduct inspections and enforce regulations; completing national inventories of sealed sources; and making progress to establish or enhance integrated management systems within their respective regulatory bodies. This RIDP project was expanded to 15 in Latin America in which to implement activities such as updating national inventories of radioactive material, developing national nuclear security and safety strategies, and engaging of senior policymakers on sustaining nuclear security and safety regimes. The project aims to be completed in December 2024. Canada provided additional funding to the IAEA to apply the RIDP model to strengthen the regulatory infrastructure for nuclear security and radiation safety in 39 countries in Africa. The project aims to be completed in 2025.
- Canada launched 3 inter-related projects with the IAEA to strengthen the security of disused sealed radioactive sources (DSRS). First, in 2016 Canada provided funds to the IAEA for a project to remove DSRS from 6 countries in Latin America. To date, 27 DSRS have been removed from the inventories of beneficiary countries. Second, in 2019, Canada provided funds to provide comprehensive assistance for 20 countries in Africa, Latin America, and the Pacific to strengthen the management of DSRS over their entire lifespan. Project activities include needs assessments, developing national inventories of nuclear substances, developing nuclear security regulations, formulating nuclear security management strategies, training operators and regulators, engaging senior policymakers, and removing 39 DSRS from 4 beneficiary countries. Finally, in March 2021, Canada provided funds to the IAEA to expand the project to strengthen the management of DSRS over their entire lifespan to an additional 14 countries in Africa, Central Asia, Europe, Latin America, and Southeast Asia. In addition to undertaking the capacity-building activities in the 2019 project, a further 69 DSRS will be removed from beneficiary countries. Work on all 3 projects will continue through 2024.
- The CNSC is invested in promoting a healthy safety culture across the nuclear community, which is essential to reach the common objectives of safety and security. The CNSC collaborated with the Nuclear Energy Agency (NEA) and the World Association for Nuclear Operators (WANO) to host the third Country Specific Safety Culture Forum (CSSCF) in Canada on September 7-8, 2022. The CSSCF provided Canada with a forum for dialogue and reflection on how the Canadian national attributes can influence nuclear safety culture and highlight common responsibility that all actors must have to pursue enhanced nuclear safety.
The CNSC and the IAEA co-chair the International Gender Champions Impact Group on Gender Equality in Regulatory Nuclear Agencies. This group aims to take collective action to improve gender equality and diversity in the nuclear regulatory workforce, including:
- implementing policies and initiatives to recruit and retain women in the field of nuclear energy
- sharing visions and experiences of gender equality in the nuclear regulatory community
- promoting a workplace environment that values diversity, and that identifies and remove barriers to women in nuclear scientific and operations positions
- promoting gender parity on panels and in delegations
- supporting efforts to focus on youth education in order to build the female talent pipeline
The CNSC is also part of the Organization for Economic Co-operation and Development’s Nuclear Energy Agency Gender Balance Task Group, which published the Gender Balance in the Nuclear Sector report in March 2023 featuring the first publicly available data on gender balance in the nuclear sector at the international level and a proposed comprehensive, evidence-driven policy framework with practical recommendations.
B. Facilities and services available to the persons authorized to manage radioactive sources
The CNSC already has robust and comprehensive regulatory programs to oversee the control of sealed sources. In the interest of continuous improvement, the CNSC has initiated the following enhancements to its regulatory oversight programs during the reporting period:
- The CNSC coordinated 3 separate transport security tabletop exercises involving one with an industrial radiography licensee, one with a transport carrier and one with a source manufacturer. These exercises yielded positive feedback and led to the proposal of new requirements for the conduct of security exercises as part of a security plan in the CNSC’s Nuclear Security Regulations.
- The CNSC carries out stakeholder engagement and outreach activities to facilitate communication between the CNSC and the nuclear substance licensees and other stakeholders on licensed activities and regulatory expectations. These activities are reported on an annual basis in the Regulatory Oversight Report on the Use of Nuclear Substances in Canada. Due to limitations imposed by the pandemic, most outreach activities since the last paper were done virtually or through written communication. Outreach activities included participation in town hall sessions, regular circulation of the DNSR Digest (a monthly email containing short articles of interest to licensees, including items of regulatory importance amongst items of general interest), emails to targeted groups of licensees, meetings with associations or working groups, presentations at industry conferences, and the publishing of articles in industry publications. In particular, the DNSR Digest included articles on the management of disused sources and importance of rigorous inventory controls, on sealed source security requirements and on reporting requirements related to events, including in the event of lost or stolen sources.
C. Training of staff in the regulatory body, law enforcement agencies and emergency service organizations
The CNSC has various training opportunities for the development of staff competencies. One key training program, which assists in ensuring compliance with all regulatory requirements related to sealed sources, is the CNSC’s Inspector Training and Qualification Program (ITQP). The goal of the ITQP is to ensure and document that designated inspectors are trained and qualified to carry out their authorized duties. The ITQP specifies mandatory core training, service-line-specific training and on-the-job training that is required prior to being designated as an inspector. These qualifications must be maintained through the completion of refresher training on a 5-year cycle and the demonstration of the use of inspector designation.
Over the period covered by this paper, other resources have been made available to inspectors. The CNSC joined the Canadian Federal Government’s Women in Regulatory Enforcement (WIRE) network. It is an interdepartmental network created to support a coalition of women and allies to be agents of change within the public service, while providing members with a platform to foster connections, discuss issues and challenges, and share tools, resources and solutions. Several CNSC employee-led networks have also been established, such as the Black Employees Network, the Indigenous Network, the Pride Network. These employee-led networks provide opportunities for staff to gain insight into issues pertaining to diversity and inclusion.
With similar intentions, the CNSC also established a Women in STEM (Sciences, Technology, Engineering and Mathematics) initiative in 2019 that is championed by the CNSC’s President and CEO. The initiative is guided by a strategic plan, which supports the CNSC’s vision of being a leader in Canada for gender equity in STEM and a supporter of STEM education. It consists of 5 pillars: network, coaching and mentoring, research, outreach, and advocacy. It promotes the balanced participation of women in STEM careers at the CNSC and in broader nuclear and scientific communities. Some key outcomes include:
- establishing an internal WISTEM mentoring program to foster personal and professional development
- establishing a network and hosting regular events to empower women in STEM and in nuclear
- providing fundamental coaching training to strengthen staff leadership skills
- sponsoring organizations that support women in STEM and STEM education
- participating and supporting various national and international gender equity activities and initiatives
Internally, the CNSC provides training opportunities on topics relevant to radioactive sources, such as training on source recovery and contamination control for inspectors who may be requested to provide assistance during events involving radioactive material outside of regulatory control. Further to this, field response procedures were developed and a subsequent workshop involving field response exercises for CNSC inspectors was held in 2019.
Externally, the CNSC continues to provide training to law enforcement and emergency services organizations (first responders) enabling them to address radiological events. Since 2010, the CNSC has assisted in the development and delivery of the radiological / nuclear portion of the Federal Chemical, Biological, Radiological and Nuclear (CBRN) counter-terrorism programs training courses (basic, intermediate and advanced training) to first responders in conjunction with other Canadian federal government departments.
D. Establishment and maintenance of a national register of radioactive sources
In 2006, the CNSC implemented the Sealed Source Tracking System (SSTS) and the National Sealed Source Registry (NSSR) as components of the CNSC’s efforts in implementing the Code. The CNSC was the first nuclear regulator among the G7 countries to implement a national registry of high-risk sealed sources (Category 1 and 2 sealed sources) and track inventory using a Web-based tracking system. The SSTS is a secure Web-based system that keeps track of inventories of high-risk radioactive sealed sources by allowing licensees to conduct online reporting of source creation, transfer, receipt, import, and export and source exchanges in radiation devices. The information contained in the NSSR is as current as the reporting timeframes required by the licence (e.g., reporting within 2 days of receipt, 24 hours in advance of a domestic transfer and 7 days in advance of an export). The sources are tracked in the NSSR following their manufacturing or importation into Canada. Data related to exported sources, such as their serial number, activity and reference date as well as details related to the export transaction remains available in the NSSR.
The NSSR, which is populated by the SSTS, enables the CNSC to maintain an accurate and secure inventory of Category 1 and 2 sealed sources in Canada. For sealed sources used in high-risk activities such as industrial radiography, licensees are required to report transfer of all sources regardless of their category. Licensees are obligated to submit their inventory for all of their sources via their annual compliance report. The CNSC consolidates these inventories into a searchable file.
By the end of December 2022, the NSSR contained information on 164,239 radioactive sealed sources of all categories in Canada tracked by the SSTS. This represented an increase of 32% over the number of sealed sources in the NSSR at the end of December 2018. The increase has been steady, between 7 and 10% year-over-year, for the 4 years covered by this paper. At the end of December 2022, the NSSR contained information on 5,054 Category 1 sources, 71,361 Category 2 sources and 82,033 Category 3 sources.
In 2022, the SSTS registered 74,790 individual source transactions of all types. Of these, 94% (70,349) of the transactions were done via the Web interface. Since 2014, each year, over 90% of the source transactions were done via the Web interface demonstrating successful adoption of the system by Canadian licensees. The remaining transactions were conducted by fax and email and processed by a CNSC staff member directly in the NSSR.
Achievements and planned improvements
As part of efforts related to continuous improvement, the CNSC initiated an improvement project for the SSTS and the NSSR in 2018. This project was subsequently incorporated into the CNSC’s Digital Program, aimed at modernizing the full scope of the CNSC’s systems. Under this Digital Program, the CNSC is currently focused on upgrading its fundamental information technology infrastructure. A subsequent phase of the strategy will include the delivery of a new information management system and the replacement of legacy applications, including the national registry and source tracking system, with modern, composable applications.
To gauge the effectiveness of the SSTS and verify the accuracy of the data in the system, CNSC inspectors physically cross-reference SSTS data against licensees’ actual inventory of sealed sources. Routine CNSC compliance inspections include verification of sealed source tracking information. Between January 2019 and December 2022, CNSC staff conducted 292 inspections related to the SSTS requirements. Of the inspections conducted, 277 or 95% of these confirmed that licensees were compliant with CNSC requirements, demonstrating a high degree of compliance by the licensees. In the remaining 15 inspections (5%), the licensees were not compliant with all regulatory requirements related to sealed source tracking. Examples of non-compliances included licensees not providing notification of a source movement within the required timeframe and inconsistencies in serial numbers recorded in the system versus what was present in the physical inventory at a licensee’s location; none of the non-compliances were safety-significant. In all cases, the CNSC ensured that non-compliances were adequately addressed by licensees and corrections were made to the NSSR, if required.
E. National strategies for gaining or regaining control over orphan sources
The Canadian regulatory framework holds licensees responsible for the recovery and safety of lost, stolen and found sealed sources. In these instances, the licensee is responsible to notify the CNSC immediately, as well as relevant police authorities, and to conduct a thorough search. When a sealed source is deemed to be orphaned, the CNSC can and does intervene to identify the licensee owner. For cases where this identification cannot be achieved, the CNSC has a procedure on actions to take and can allocate financial and human resources to ensure that the source is brought back under regulatory control. Expenses incurred through this activity may be recovered under the CNSC’s financial guarantee program via an insurance policy claim (more details in section F).
To ensure licensee compliance with respect to maintaining control of sealed sources, CNSC inspectors regularly inspect licensees in possession of Category 1, 2 (as described in Section D above), as well as Category 3 or 4 sealed sources.
Canada continues to promote awareness among industry, health professionals, the public, and government bodies of the safety and security hazards associated with orphan sources. The CNSC encourages bodies and persons likely to encounter orphan sources during the course of their operations (such as scrap metal recyclers and customs posts) to implement appropriate monitoring programs to detect such sources.
Publication of reports on the safety performance of licensees
The CNSC publishes the Regulatory Oversight Report on the Use of Nuclear Substances in Canada on an annual basis and the Regulatory Oversight Report – Uranium and Nuclear Substance Processing Facilities every 3 years. The reports provide an overview of the safety performance of CNSC licensees with respect to the production of sealed sources and their use in medical, industrial and commercial applications, as well as for academic and research purposes. These comprehensive reports provide performance data related to various safety and control areas. These reports also consider other oversight metrics including reportable events, effective doses to workers and enforcement actions.
In addition, since 2006, the CNSC has been publishing and will continue to publish operational data contained in Canada’s national sealed source registry in the National Sealed Source Registry and Sealed Source Tracking System Report and on the Open Government Portal. The CNSC also publishes a continuous report on Lost or Stolen Sealed Sources and Radiation Devices on its external web site that summarizes the reports of lost, stolen and found sealed sources and radiation devices in Canada.
F. Approaches to end-of-life management for radioactive sources
Regulatory framework for radioactive sealed sources at end-of-life cycle
In September 2018, Canada made a political commitment to the Guidance on the Management of Disused Radioactive Sources, a supplementary guidance to the Code. The CNSC’s regulatory framework does not currently define disused sources as a separate regulatory category. Instead, the CNSC imposes stringent requirements on all sealed sources throughout their life cycle. In addition, an analysis of the reported events involving lost or stolen sources over the 2017 – 2020 period showed that in most cases, sealed sources were lost or stolen while they were in active use; of those that could be presumed as “disused” at the time of having been lost or stolen, all of them were of Category 5.
The CNSC is currently pursuing with the analysis of the guidance for disused sealed sources to determine whether we need to take any additional measures to ensure we have satisfied all elements of this guidance. For instance, the CNSC is currently drafting a policy and strategy document that will describe how we are meeting the guidance on the management of disused sealed sources and this work is expected to be completed in 2023.
The CNSC has been actively involved in the drafting of the IAEA’s TecDoc titled Reuse and Recycling of Disused Sealed Radioactive Sources: Approaches and Practical Experiences throughout 2022.
Long-term management of radioactive sealed sources in Canada
A radioactive sealed source may only be transferred in accordance with the conditions of a licence issued by the CNSC. For long-term management, radioactive sealed sources may be returned to the manufacturer in Canada or to their country of origin. In Canada, certain source manufacturers recycle radioactive sealed sources at the end of their useful life by either reusing decayed sources for other applications, re-encapsulating them or reprocessing them for other useful applications. For example, over the 2019 – 2021 period, a Canadian source manufacturer diverted more than 99% of the cobalt-60 in their end-of-life program to recycling. The radioactive sealed sources may also be sent to a licensed radioactive waste management facility (such as the facility operated by Canadian Nuclear Laboratories in Chalk River, Ontario) or transferred to a person licensed by the CNSC to possess the radioactive sealed sources. If a radioactive sealed source has decayed below its exemption quantity or its clearance levels (as identified in schedule 1 and schedule 2 of the Nuclear Substances and Radiation Devices Regulations (NSRDR)), it may also be released from CNSC regulatory control, pursuant to subsection 5.1 of the NSRDR. Even though the radioactive sealed sources may no longer be under CNSC regulatory control, persons possessing them must still follow applicable federal, territorial, provincial, and/or municipal regulations.
On-going key initiatives
In November 2020, Canada launched an effort to modernize its policy for radioactive waste management and decommissioning under the direction of Natural Resources Canada. In parallel, Canada is developing an integrated strategy for radioactive waste under the direction of the Nuclear Waste Management Organization.
Financial guarantee program for users of sealed sources and radiation devices
In 2015, the CNSC established a financial guarantee program for users of sealed sources and radiation devices. The CNSC has put in place an insurance program through contract with a private institution. Under the program, the CNSC is the sole insured party and licensees pay an annual premium, a variable percentage of their total liability (up to a maximum liability of $1 million). The premium is revised on an annual basis. Licensees that choose not to participate or are excluded from the program are required to establish an alternate financial guarantee that is acceptable to the Commission. The establishment of this financial guarantee regime ensures adequate funds will be available for the safe termination of licensed activities in the event of licensee default. The financial guarantee ensures ongoing regulatory control of sealed sources and does not absolve the licensee of their obligations for safe termination of licensed activities. The CNSC is actively participating in recent initiatives by the IAEA to develop guidance on financial provisions associated with the management of disused radioactive sealed sources.
Paragraph 36(1)(c) of the NSRDR requires every licensee to keep a record of any transfer, receipt, disposal or abandonment of a nuclear substance.
Radioactive sealed sources in the international community
The re-entry into Canada of previously exported radioactive sealed sources is permitted either by an import licence (with respect to controlled nuclear substances) or in accordance with a general import authorization licence issued by the CNSC. For Category 1 sealed sources, it is expected that the Exporting State Authority seek prior consent from the CNSC’s Point of Contact prior to authorizing the export, in accordance with the Guidance on the Import and Export of Radioactive Sources.
G. Experience with arrangements for implementing the import and export provisions of the Code and of the Guidance on the Import and Export of Radioactive Sources
The export of Category 1 and 2 sealed sources as identified in Table 1 of Annex 1 of the Code requires a risk-informed, transaction-specific authorization issued pursuant to the NSCA. Additional requirements for sealed sources transiting through Canada are prescribed by the Packaging and Transport of Nuclear Substances Regulations 2015.
By implementing import and export control measures as outlined in the Code and Guidance, the CNSC enhances national and international safety and security. These measures ensure that only authorized persons can receive Category 1 and 2 sealed sources. The CNSC’s import and export control program is consistent with the Code and Guidance and aims to:
- achieve a high level of safety and security regarding Category 1 and 2 sealed sources
- reduce the likelihood of accidental harmful exposure to Category 1 and 2 sealed sources or the malicious use of such sources intended to harm individuals, society and the environment
- mitigate or minimize the radiological consequences of any accident or malicious act involving Category 1 and 2 sealed sources
Since implementation of import and export controls consistent with the Code and Guidance in April 2007, Canadian exporters have exported over 24.4 million TBq of Category 1 and 2 sealed sources to 100 States under CNSC licences. Through interaction with these States during licensing assessments and authorizations, the CNSC has observed that the level of implementation of the Code and Guidance continues to be uneven amongst States and in some instances appears inconsistent with provisions of the Code and Guidance. The CNSC import and export control program remains fully consistent with the provisions of the Code and Guidance.
To outline expectations related to the import and export of Category 1 and 2 sealed sources and to assist exporters applying for export licences, the CNSC published REGDOC-2.13.2, Import and Export, Version 2 in April 2018.
Importing State End-of-life Management Strategy
In support of efforts to ensure continuous control of sealed sources throughout their life-cycle, the CNSC examines the importing State’s long-term strategy and end-of-life management for sources as part of the overall State assessment prior to authorizing exports. Obtaining this information remains challenging for States that do not have a fully mature regulatory framework and occasionally the State’s need for the source taxes its capacity to assure effective management of the source during and at the end of its life-cycle. The CNSC has observed that end-of-life management remains a challenge for some importing States. Sealed sources exported from Canada may be returned to Canada under a contractual arrangement between the end-user and source supplier, provided that the source supplier is authorized to import, receive, possess and store the source. Canadian-origin and some foreign-origin sources return to Canada during routine source changes, thus assisting many States in their end-of-life management strategy.
The CNSC requests import consent from the Importing State Authority for the export of all Category 1 sealed sources from Canada, regardless of the Importing State’s commitment to the Code and Guidance. For States that have made a commitment to the Code and Guidance, it is an expectation of the CNSC that a response to the request will be provided by the Importing State Authority within the specified timelines. Adherence to timelines is important in order not to delay legitimate transfers of sources. To this effect, the CNSC has established a service standard for the processing of applications for export licences of 30 days.
Point of Contact
If an importing State has not provided the IAEA with a point of contact, or has not adequately maintained point of contact information, identifying an appropriate regulatory authority in the importing State can be a challenge and cause delays in authorizing export transactions. The CNSC supports initiatives by the IAEA in providing training to the Points of Contact to clarify their roles and responsibilities under the Code and Guidance and in promoting better communication between Member States with regards to import and export of Category 1 and 2 sealed sources. The CNSC encourages the Point of Contact to add or revise their details on the IAEA’s List of National Contact Points.
The use of bilateral Administrative Arrangements (AA) has improved the import consent process and, since the 2018 IAEA Code of Conduct Review Meeting, the CNSC has seen a very modest increase in the number of import consent requests from exporting States for the import of Category 1 sealed sources into Canada. This increase is a result in part of broader communication with counterparts in other exporting States, IAEA regional workshops on implementation of the Code and Guidance, established arrangements between the CNSC and foreign regulators and also from increases in States’ commitments to the Code and Guidance. There remain ongoing implementation issues with States that have made a political commitment to the Code and Guidance but who fail to respond to import consent requests or who fail to request import consent for the export of Category 1 sealed sources to Canada. Although the CNSC encourages these Member States to address their implementation challenges, the CNSC may proceed with the transfer of sources in these situations in order to enable legitimate trade of needed sources, and only if it is satisfied that the sources can be safely and securely managed. Canada supports recent initiatives by the IAEA to enhance the understanding of the role and responsibilities of the Points of Contact and to improve response and communication between states.
Assessment of State Regulatory Framework
In accordance with the Code and Guidance and also to ensure that Canada meets its international commitments, the CNSC reviews the importing State’s regulatory framework as part of its export application assessment. The CNSC relies on information provided by the importing State, open-source information, the Guidance Questionnaire responses and various other methods. The level of responses to the revised Guidance Questionnaire remains low in comparison to the number of States that have provided political commitment to the Guidance, which lessens its overall impact. The CNSC encourages Member States to complete the questionnaire and agree to make it available to other Member States.
Prior Shipment Notifications
All export licences issued by the CNSC for the export of Category 1 and 2 sealed sources require the licensee to issue prior shipment notifications to the Importing State Authority and to the CNSC. Conversely, the CNSC expects States committed to the Code and Guidance to submit prior shipment notifications for Category 1 and 2 sealed sources exported to Canada. These sources are frequently received in Canada without prior shipment notification. Not consistently receiving prior shipment notifications for the import of sealed sources into Canada remains an issue of concern for the CNSC. This issue is further compounded when the CNSC is not provided the opportunity to grant import consent for the import of Category 1 sealed sources into Canada.
Confirmation of Receipt of Imported Sources
No provision exists under the Code and Guidance for the importing authority to confirm receipt of the sealed source by the intended end-user to the Exporting State Authority. On occasion, the CNSC has requested information and has also provided information related to the receipt of sealed sources. Although no instances of loss or diversion of Canadian-origin sealed sources have been identified, establishment of a procedure to confirm receipt of exported sources can enhance the safety and security of such sources by providing assurances that the intended end-user is in receipt of the exported sources.
A key element of the CNSC’s regulatory control program for the import and export of sealed sources involves the establishment of bilateral Administrative Arrangements (AA), pursuant to section 21(1) of the NSCA, with regulatory authorities in countries with which Canada has substantial trade in risk-significant sealed sources (Category 1 and 2 sealed sources) and with countries which also share Canada’s commitments to effective international controls on transfers of sealed sources. The establishment of bilateral AAs helps to harmonize and streamline the import export process. Canada continues to seek opportunities to negotiate bilateral AAs with other Member States.
The practice, which is consistent with paragraph 20(n) of the Code and paragraphs 5, 6, 9, and 12 of the Guidance, is highly regarded internationally, as it assists other States in implementation of the Code and Guidance and forms part of Canada’s international obligations related to security cooperation. As of December 31, 2022, the CNSC has 12 bilateral AAs with other countries.
In keeping with Canada’s political commitments to the IAEA, the CNSC continues to effectively implement the provisions of the Code and supplementary guidance. Over the past 4 years, the CNSC has continued to improve regulatory controls of sealed sources of all categories by strengthening regulatory requirements and guidance and sharing best practices. The best practices implemented by Canada contribute to international successes in achieving the goals established in the Code and supplementary guidance on the safety and security of sealed sources. The CNSC remains committed to continuous improvements of regulatory programs and will continue to monitor these initiatives to ensure that they are working to achieve their intended objectives.
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