Consolidated Radiotherapy Facility Licence
Canadian cancer centres operate many different types of radiotherapy equipment, such as medical accelerators, cobalt teletherapy units and brachytherapy remote afterloaders. Operation of such facilities is regulated under the Class II Nuclear Facilities and Prescribed Equipment Regulations of the Nuclear Safety and Control Act. Previously, each different type of radiotherapy facility at an institution required a separate licence, and each institution had to maintain and administer multiple licences. This resulted in a large amount of duplication in licensing documentation.
The CNSC has now established two new licence classifications or “usetypes”, which will permit such institutions to consolidate their existing operating and servicing licenses under a single CNSC licence. These usetypes are:
525 - operate medical accelerator and other radiotherapy facilities
524 - operate and service medical accelerator and other radiotherapy facilities
- Usetypes that may be consolidated
- Restrictions on consolidation
- Eligibility of consolidation
- Application process
- Consolidated licence application, licensing guide cross-reference
522: operate a medical accelerator facility
542: operate a radioactive source teletherapy facility
552: operate a LDR brachytherapy facility
555: operate a HDR brachytherapy facility
561: operate a radioactive source stereotactic teletherapy facility
566: service class II prescribed equipment
Consolidation is only available for operating licences, which permit routine operation, and for Class II prescribed equipment servicing licences. Consolidated licences will require renewal every 10 years.
Licences can be consolidated if:
- all of the licensed activities are conducted under a single, integrated radiation safety program
- the same organizational management structure and radiation safety officer (RSO) is responsible for overseeing all of the licences to be consolidated
- there is a single radiation safety manual with a common set of radiation safety policies and procedures that apply to all of the licensed activities.
Note that new Class II nuclear facilities that are to be constructed, including replacement equipment being installed in existing bunkers, are still subject to the normal process of applying for separate construction and commissioning licences. New equipment can be integrated into a consolidated operating licence once commissioning has been completed.
Any licensee who currently possesses operating licences for at least two of the categories listed above may apply for consolidation under the appropriate new usetype. Licensees who have a licence to service class II prescribed equipment (usetype 566) and who wish to incorporate this activity into the consolidated licence should apply for a licence to operate and service medical accelerators and other radiotherapy facilities (524) while licensees who do not perform such servicing activities should apply for a licence to operate medical accelerators and other radiotherapy facilities (525).
Licences for activities regulated under the Nuclear Substance and Radiation Device Regulations, such as manual brachytherapy (912) cannot be included under the new consolidated licences at this time. Class II licences held by non-radiotherapy institutions, such as those for research accelerators (519) and irradiators (535) at academic/research institutions, are also not eligible for consolidation at this time.
To apply for consolidation, licensees must submit a written request to the CNSC. The request must include:
- the licence numbers which are to be consolidated
- the Class II prescribed equipment to be included under the consolidated licence
In general, it is expected that all of the equipment contained under the operating licences specified will be included in the consolidation. If not, simply provide a clear statement to this effect.
- a copy of the radiation safety manual containing the policies and procedures applicable to all of the licences and licensed activities being consolidated
If this has already been submitted to the CNSC in support of a licence application, a simple reference to the appropriate document, using the CNSC document number listed in the appendices to each licence, will suffice.
- a detailed description of the appended licence documents (or parts thereof) that still apply
Any documents that are commonly applicable to all of the licensed activities should be clearly identified. Documents or parts of documents containing information specific to a particular type of facility, such as operating procedures, structural shielding details, or safety systems, should be itemized according to the facilities or prescribed equipment to which they apply. Documents or parts of documents that have been superseded by information submitted more recently must also be clearly identified and linked to the documents replacing them.
- a request to revoke all of the operating licences being consolidated once the consolidated license has been issued
In preparing requests, licensees are encouraged to consult the following reference documents:
Licensees must address the issues in the table below when preparing a request for consolidation of their operating and servicing licences.
|A,B,C||B, C, G||
If you have any questions about the consolidated radiotherapy facility licence application process, please contact your CNSC Specialist or Project Officer.
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