Licensing of Class II nuclear facilities and prescribed equipment
Requirements for the licensing of Class II nuclear facilities are prescribed by the Class II Nuclear Facilities and Prescribed Equipment Regulations, as well as the General Nuclear Safety and Control Regulations and the Radiation Protection Regulations.
This page contains information on licensing of Class II nuclear facilities, including:
- Class II nuclear facility licences:
- Class II prescribed equipment licences:
- Representatives of Applicants and licensees
- Licence application guides and forms
- Changes to licences
- Exempted activities
- Use types
- Consolidated licensing
- Service standards
- Licensing and compliance decisions
Class II nuclear facility licences
The Canadian Nuclear Safety Commission (CNSC) may only issue a licence to an applicant when:
- the Commission considers the applicant to be qualified
- the applicant has made adequate provision for the protection of the environment and the health and safety of persons
- the applicant otherwise meets the requirements prescribed by the Nuclear Safety and Control Act (NSCA) and its regulations.
There are three categories of Class II nuclear facility licences:
If you wish to construct a Class II nuclear facility in Canada, you must first obtain a licence to do so. An application for a licence to construct is assessed to ensure:
- the applicant has control of the site upon which the Class II nuclear facility will be built
- the facility design is in compliance with the requirements prescribed by the NSCA and its regulations
The facility design must take into account the safety and security of the public, as well as environmental considerations. Note that a licence to construct does NOT authorize the licensee to possess nuclear substances or produce radiation.
Before possessing nuclear substances or producing radiation, you must first obtain a licence to operate. Licences to operate are separated into two categories:
1. Licence to operate for the purpose of commissioning
Licensees in this category can operate Class II prescribed equipment for the purposes of confirming the robustness of their facility design and for ensuring that all associated safety systems are functioning properly. Licensees must report back to the CNSC on their findings and provide satisfactory test results. Note that medical facilities with this type of licence may NOT use the prescribed equipment for patient treatment.
2. Licence for routine operation
Once the licensee has demonstrated to the CNSC that the facility is operating as expected, that it has properly trained staff and that all safety systems are in place and functional, a licence for routine operation can be issued. This allows the prescribed equipment to be operated for its intended purpose but still within the confines of the NSCA, its regulations and any licence conditions that have been imposed.
Applicants for a licence to decommission are required to demonstrate that any Class II prescribed equipment under their supervision will be properly dismantled, with particular care taken to ensure proper handling and disposal of radioactive substances.
Class II prescribed equipment licences
Applicants for prescribed equipment licences must also meet the same three conditions outlined above for nuclear facility licences. These licences cover the prescribed equipment and do not encompass a specific facility.
There are two categories of Class II prescribed equipment licences.
In order to perform servicing activities of prescribed equipment in Canada, a licence to service must be obtained. There are two categories of service licences:
- Licence to service (by operator) – allows operators of Class II nuclear facilities to have their own in-house servicing staff. Servicing operations may only be carried out at facilities owned by the licensed operator.
- Licence to service (third party) – allows entities such as prescribed equipment manufacturers or independent servicing companies to service prescribed equipment, typically throughout Canada.
Before receiving a licence to service, applicants must demonstrate that they have the correct expertise in terms of equipment maintenance, as well as radiation safety.
Once the applicant has demonstrated to the CNSC that it has properly trained staff and that all adequate measures are in place to protect persons and the environment, a licence for operation may be issued. This licence allows the prescribed equipment to be operated for its intended purpose, in compliance with the Nuclear Safety and Control Act, its regulations and any licence conditions that have been imposed.
Representatives of applicants and licensees
Pursuant to paragraph 15(a) of the General Nuclear Safety and Control Regulations, every applicant and licensee must notify the Commission of persons who have authority to act for them in their dealings with the Commission. These dealings may include licence applications, amendments and revocations, reporting to the Commission as required by the regulations or licence, and responding to notices of non-compliance. Statements and representations made by a representative of an applicant or licensee are binding on the applicant or licensee. The Representatives of Applicants and Licensees form must be completed and submitted for new licensees or upon any change in the licensee's representatives.
Licence application guides and forms
In order to apply for a licence, please fill out the appropriate form below.
|Licence category||Licence application guide||Licence application form||Applicable
License to construct, operate and decommission the following facilities:
|Radiotherapy Application Form (PDF)||521, 522, 523, 524, 525, 526, 527, 541, 542, 551, 552, 554, 555, 560, 561|
|License to service any Class II prescribed equipment||Service Class II prescribed equipment application form (PDF)||565, 566|
|Licence to construct, operate and decommission a Class II Non-Radiotherapy Accelerator Facility||Licence application form – Class II Non-radiotherapy accelerator facilities(PDF)||100, 101, 102, 103, 104, 504, 506, 507, 508, 515, 516, 517, 518, 519, 520, 534, 535, 536|
The CNSC is also creating a consolidated licence application guide that can be used for all use types associated with Class II prescribed equipment, including those missing from the above table. This document will replace the three guides mentioned above. It is currently in draft form, but can be used to apply for a licence. The draft guide and all its associated forms can be found on under section 1.4. of the Regulatory Documents Web page.
Security of sealed sources
Licensees who possess category 1 or 2 sources as part of their licensed activity also need to provide information on how they will ensure the security of these sources. Certain security requirements that must be met are outlined in REGDOC-2.12.3, Security of Nuclear Substances: Sealed Sources. The requirements outlined in this document have been in effect since May 31st, 2015 for category 1 and 2 sources and will come into effect on May 31, 2018 for category 3, 4 and 5 sources. Although this information is required as part of your licence application, it is considered prescribed information because of its sensitivity and must be submitted to CNSC via letter post or courier. It can be submitted separately if you wish to submit the rest of your application electronically.
Public information and disclosure programs
Certain Class II nuclear facilities are also required to have a public information and disclosure program. Some Class II facilities are exempt from this requirement. Other Class II facilities may be required to develop and implement a public information and disclosure program, depending on the size and nature of the nuclear materials and activities they engage in. The requirements of the program are described in REGDOC-3.2.1, Public Information and Disclosure. Program details should be included with the licence application.
If you wish the Commission to amend, revoke or replace a licence, you must make your request in writing and provide any additional information required regarding your request. The request should be made by contacting your project officer.
Under certain circumstances – as per the Nuclear Safety and Control Act (NSCA), sections 24(2) and 24(4) – the CNSC may authorize the transfer of a licence from one licensee to another, or to a new licence applicant, provided there has been no significant change in the licensed activity. This process is intended to simplify the regulatory process for licensees, while ensuring that all regulatory requirements are met.
A request for licence transfer can be triggered by the following changes:
- change to a corporation’s name or corporate number
- corporate merger
- corporate restructuring
To request a licence transfer, the existing licensee must complete and submit a licence transfer form to their CNSC project officer, including a copy of the new proof of legal status. If there is a change to current RSO, an application for certification of the proposed candidate is required with supporting information, in order to process the transfer application.
The Class II Nuclear Facilities and Prescribed Equipment Regulations also exempt certain activities from licensing requirements. For Class II nuclear facilities, the following activities may be carried out without a licence:
- site preparation for a facility
- construction, operation, modification, decommissioning or abandonment of a facility that holds a geophysical logging accelerator
- decommissioning of a facility that consists of a brachytherapy remote afterloader
A person may possess, transfer or produce Class II prescribed equipment without a licence as long as it does not contain any nuclear substances.
A financial guarantee is a tangible commitment by a licensee that there will be sufficient resources available to safely terminate licensed activities authorized under all CNSC-issued licences for nuclear substances, prescribed equipment and Class II facilities. Failure to properly terminate licensed activities can result in risk to the health and safety of persons and the environment. A financial guarantee does not relieve licensees from complying with regulatory requirements for termination of licensed activities, but ensures there are funds available when licensees are unable to carry out safe termination.
The CNSC categorizes various licensed equipment and activities into what are known as "use types". A use type is a single licensed activity or type of equipment in a particular stage of licensing.
In most cases, only one use type may appear on a particular licence. A cancer treatment centre operating medical particle accelerators, remote brachytherapy afterloaders and with servicing personnel on staff is said to have three separate use types. Use types are defined by the licensing stage of the prescribed equipment; a particle accelerator in the routine operation phase is a different use type than a particle accelerator that is in the decommissioning phase.
Many common use types can now be consolidated into a single new use type. There are many advantages to a consolidated facility licence, including reduced paperwork throughout the licensing cycle and a 10-year renewal period (most current radiation therapy licences have five-year renewal periods).
When a licence application is received at the CNSC, it goes through the following steps:
- entry into our electronic records system
- assessment for relevant fees, if applicable
- entry into our licensing database
- technical assessment by a project officer
- quality assurance
- sign-off by a designated officer
- licence issued and sent electronically to the/a licensee
The chart below shows the typical time it takes to perform the technical assessment of a licence application. The timelines assume that the application received was complete, and that no further clarification was needed on the information submitted. If the CNSC receives an incomplete application, the processing time will restart from the date the updated information is obtained.
|Licence type||Processing time*|
|Routine operation||4 weeks|
|Licence amendments||3 weeks or more depending on scope|
Questions from licensees will be answered within two business days.
Licensing and compliance decisions
Under section 37 of the NSCA, the Commission has delegated signing authority of licences issued under the Class II Nuclear Facilities and Prescribed Equipment Regulations to designated officers, who make most licensing and compliance decisions regarding Class II facilities. If a licensee or applicant disagrees with a decision, they have the opportunity to be heard by the designated officer and, if necessary, by the Commission.
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