Interpretation and Application

Interpretation

1 The definitions in this section apply in these Regulations.

Act

Act means the Nuclear Safety and Control Act. (Loi)

brachytherapy machine

brachytherapy machine[Repealed, SOR/2008-119, s. 5]

brachytherapy remote afterloader

brachytherapy remote afterloader means a device that is designed to place, by remote control, a sealed source inside or in contact with a person for therapeutic purposes and to remove, by remote control, the sealed source once a preset dose of radiation has been delivered or after a preset time has elapsed. (appareil de curiethérapie à projecteur de source télécommandé)

certificate

certificate means a document issued by the Commission or by a designated officer authorized under paragraph 37(2)(a) of the Act, indicating that a model of Class II prescribed equipment is certified. (homologation)

certified

certified means certified by the Commission under paragraph 21(1)(h) of the Act or by a designated officer authorized under paragraph 37(2)(a) of the Act. (homologué)

Class II nuclear facility

Class II nuclear facility means a facility that includes Class II prescribed equipment. (installation nucléaire de catégorie II)

Class II prescribed equipment

Class II prescribed equipment means

• (a) an irradiator that uses more than 10¹⁵ Bq of a nuclear substance;

• (b) an irradiator that requires shielding which is not part of the irradiator and that is designed to deliver a dose of radiation at a rate exceeding 1 cGy/min at a distance of 1 m;

• (c) a radioactive source teletherapy machine;

• (d) a particle accelerator that is capable of producing nuclear energy and has a beam energy of less than 50 MeV for beams of particles with a mass equal to or less than 4 atomic mass units;

• (e) a particle accelerator that is capable of producing nuclear energy and has a beam energy of no more than 15 MeV per atomic mass unit for beams of particles with a mass greater than 4 atomic mass units; or

• (f) a brachytherapy remote afterloader. (équipement réglementé de catégorie II)

hazardous substance

hazardous substance means a substance, other than a nuclear substance, that is used or produced in the course of carrying on a licensed activity and that may pose a risk to the environment or the health and safety of persons. (substance dangereuse)

irradiator

irradiator means a device that is designed to contain a nuclear substance and to deliver controlled doses of radiation from that substance to any target except persons. (irradiateur)

licensed activity

licensed activity means an activity described in paragraph 26(a), (c) or (e) of the Act that a licence authorizes the licensee to carry on in relation to a Class II nuclear facility or Class II prescribed equipment. (activité autorisée)

licensee

licensee means a person who is licensed to carry on an activity described in any of paragraphs 26(a), (c) or (e) of the Act in relation to a Class II nuclear facility or Class II prescribed equipment. (titulaire de permis)

radiation survey meter

radiation survey meter means an instrument that is capable of measuring radiation dose rates. (radiamètre)

radioactive source teletherapy machine

radioactive source teletherapy machine means a teletherapy machine that is designed to deliver doses of radiation produced by a nuclear substance. (appareil de téléthérapie à source radioactive)

sealed source

sealed source means a radioactive nuclear substance in a sealed capsule or in a cover to which the substance is bonded, where the capsule or cover is strong enough to prevent contact with or the dispersion of the substance under the conditions for which the capsule or cover is designed. (source scellée)

servicing

servicing, in respect of Class II prescribed equipment, means any maintenance of the equipment, including installation, repair or dismantling, other than any installation, repair or dismantling that constitutes routine operating procedures

• (a) as indicated in the manufacturer’s operating manual for the equipment; or

• (b) as authorized in the licence issued in respect of the possession or use of the equipment. (entretien)

teletherapy machine

teletherapy machine means a device that is designed to deliver controlled doses of radiation in a collimated beam for therapeutic purposes. (appareil de téléthérapie)

worker

worker means a person who performs work that is referred to in a licence. (travailleur)

Application

2 These Regulations apply in respect of Class II nuclear facilities and Class II prescribed equipment.

Licence Applications

Class II Nuclear Facilities

Licence to Construct

3 An application for a licence to construct a Class II nuclear facility shall contain the following information in addition to the information required by section 3 of the General Nuclear Safety and Control Regulations:

• (a) the proposed name and location of the nuclear facility;

• (b) evidence that the applicant is the owner of the proposed site or has authority from the owner of the site to construct the nuclear facility;

• (c) a description of the Class II prescribed equipment that is proposed to be used, including its design operating conditions;

• (d) the proposed measures to control access within the nuclear facility and any other safety-related features, including the schematics of the devices involved and their wiring;

• (e) the proposed plans, elevations and drawings of the nuclear facility, showing its layout, location, the location of its components and the location of adjacent areas that may be occupied by persons;

• (f) the proposed purpose of the adjacent areas, including a description of their uses and the estimated levels of occupancy;

• (g) the proposed location, type, composition, thickness and density of shielding material, including the method that will be used to verify the composition and density and the calculations that will be used to determine the adequacy of the shielding;

• (h) the proposed location and dimensions of voids in the shielding, including access ways and service ducts;

• (i) a description of the proposed ventilation system, including the ventilation flow rate, air circulation and location of intake and discharge points in respect of any irradiator or particle accelerator;

• (j) the proposed quality assurance program for the design and construction of the nuclear facility;

• (k) the type and energy of radiation produced by any particle accelerator to be encompassed by the licence;

• (l) the anticipated maximum dose of radiation that may be received by any person as a result of the commissioning of and during the operation of the nuclear facility;

• (m) the direction of the direct beam of any teletherapy machine to be encompassed by the licence and a description of the physical means that may be used to limit the direction of that beam;

• (n) the expected and maximum radiological workloads during the commissioning and operation of the nuclear facility, per week in grays at 1 m, for any teletherapy machine to be encompassed by the licence;

• (o) the anticipated number of hours per week that the Class II prescribed equipment in the nuclear facility will be operated for the purpose of treatment, dosimetry, servicing or research;

• (p) the effects on the environment and the health and safety of persons that may result from the activity to be licensed;

• (q) the proposed responsibilities of and qualification requirements and training program for workers during the operation of the nuclear facility;

• (r) the program to inform persons living in the vicinity of the site of the general nature and characteristics of the anticipated effects on the environment and the health and safety of persons that may result from the nuclear facility; and

• (s) the proposed plan for the decommissioning of the nuclear facility.

Licence to Operate

4 An application for a licence to operate a Class II nuclear facility shall contain the following information in addition to the information required by section 3 of the General Nuclear Safety and Control Regulations:

• (a) the name and location of the nuclear facility;

• (b) the proposed commissioning plan;

• (c) a description of the results of any commissioning work;

• (d) evidence that the applicant is the owner of the site or has authority from the owner of the site to operate the nuclear facility;

• (e) a description of the components, systems and equipment proposed to be used, including their design operating conditions;

• (f) the proposed measures, policies, methods and procedures for operating and maintaining the nuclear facility;

• (g) a description of the proposed procedures for handling, storing, loading and transporting nuclear substances and hazardous substances;

• (h) the proposed quality assurance program;

• (i) the type and energy of radiation produced by any particle accelerator to be encompassed by the licence;

• (j) the proposed measures to ensure that the type of beam producible by, and the maximum output energy, limits to the beam orientation and maximum radiation dose rate of, the Class II prescribed equipment cannot be inadvertently altered;

• (k) the proposed method for measuring the effectiveness of the shielding of the nuclear facility and any results of those measurements;

• (l) a description of the proposed portable radiation detection equipment, including its type, sensitivity, range and accuracy and the methods and procedures for calibrating it;

• (m) the proposed methods, procedures and equipment for conducting the leak tests required by these Regulations;

• (n) a description of any proposed area radiation monitoring system;

• (o) the anticipated maximum dose of radiation that may be received by any person as a result of the commissioning of the nuclear facility;

• (p) the expected and maximum radiological workloads, per week in grays at 1 m, for any teletherapy machine to be encompassed by the licence;

• (q) the anticipated number of hours per week that the Class II prescribed equipment in the nuclear facility will be operated for the purpose of treatment, dosimetry, servicing or research;

• (r) the proposed methods, procedures and equipment for conducting radiation surveys, including the frequency of the surveys and the location of radiation survey points;

• (s) the proposed responsibilities of and qualification requirements and training program for workers; and

• (t) the proposed plan for the decommissioning of the nuclear facility.

Licence to Decommission

5 An application for a licence to decommission a Class II nuclear facility shall contain the following information in addition to the information required by section 3 of the General Nuclear Safety and Control Regulations:

• (a) the name and location of the nuclear facility;

• (b) the proposed nature of and schedule for the decommissioning;

• (c) the land, buildings, structures, components, systems, equipment, nuclear substances and hazardous substances that will be affected by the decommissioning;

• (d) the nature, quantity and activity of any radioactive nuclear substances at the nuclear facility;

• (e) the nature and extent of any radioactive contamination at the nuclear facility, including radiation dose rates;

• (f) the proposed measures to control releases of radioactive nuclear substances and hazardous substances into the environment;

• (g) the anticipated maximum dose of radiation that may be received by any person as a result of the decommissioning;

• (h) the maximum quantities and concentrations of nuclear substances and hazardous substances that may be released into the environment;

• (i) the effects on the environment and the health and safety of persons that may result from the decommissioning, and the measures that will be taken to prevent or mitigate those effects;

• (j) the proposed responsibilities of and qualification requirements for workers; and

• (k) a description of the planned state of the site upon completion of the decommissioning.

Class II Prescribed Equipment

General Requirement

6 An application for a licence in respect of Class II prescribed equipment, other than a licence to service, shall contain a copy of or the number of any certificate relating to the equipment in addition to the information required by section 3 and, where applicable, section 4 of the General Nuclear Safety and Control Regulations.

Licence to Service

7 An application for a licence to service Class II prescribed equipment shall contain the following information in addition to the information required by section 3 of the General Nuclear Safety and Control Regulations:

• (a) the name, model number and characteristics of the equipment or the number of the certificate relating to the equipment;

• (b) a description of the nature of the servicing proposed to be carried on;

• (c) the proposed methods, procedures and equipment for carrying on the servicing;

• (d) the proposed qualification requirements and training program for workers; and

• (e) the proposed procedures to be followed after completion of the servicing to confirm that the equipment is safe to use.

Exemptions from Licence Requirement

Activities in Relation to Class II Nuclear Facilities

8 A person may carry on any of the following activities without a licence:

• (a) prepare a site for a Class II nuclear facility;

• (b) construct, operate, modify, decommission or abandon a Class II nuclear facility that includes a geophysical logging particle accelerator; or

• (c) decommission a Class II nuclear facility that includes a brachytherapy remote afterloader.

Activities in Relation to Class II Prescribed Equipment

9 A person may, without a licence to carry on an activity in relation to Class II prescribed equipment, possess, transfer or produce Class II prescribed equipment that does not contain a nuclear substance.

Certification of Class II Prescribed Equipment

Certification Requirement

10 No person shall use Class II prescribed equipment unless

• (a) it is a certified model; or

• (b) it is used in accordance with a licence that authorizes its use for development purposes or for scientific research that is not conducted on humans.

Application for Certification

• 11 (1) The Commission or a designated officer authorized under paragraph 37(2)(a) of the Act may certify a model of Class II prescribed equipment after receiving an application that includes the following information:

  • (a) the applicant's name and business address;

  • (b) the name and business address of the manufacturer of the equipment;

  • (c) the brand name and model number of the equipment;

  • (d) the design of the equipment and its components, including any standards used in the design;

  • (e) the intended use of the equipment;

  • (f) the name, quantity in becquerels and form of the nuclear substance to be incorporated into the equipment;

  • (g) the method of incorporating the nuclear substance into the equipment;

  • (h) the expected radiation dose rates around the equipment in all modes of operation, including the method, calculations and measurements used to establish them;

  • (i) the maximum radiation dose rate that the equipment can deliver;

  • (j) instructions for the use, transportation and storage of the equipment;

  • (k) instructions for conducting leak tests on the equipment;

  • (l) instructions for dealing with accidents involving the equipment;

  • (m) a description of the labelling of the equipment;

  • (n) the quality assurance program that was followed during the design of the equipment and that will be followed during the production of the equipment;

  • (o) the type of package for and the procedures for packaging and transporting any equipment that may contain a nuclear substance, including the emergency response plan to be followed in case of a transportation accident involving the equipment;

  • (p) the recommended inspection and servicing program for the equipment;

  • (q) the type of beam producible by, and the maximum output energy and limits to the beam orientation of, any particle accelerator or radioactive source teletherapy machine;

  • (r) the estimated maximum photon and neutron leakage during the use of any teletherapy machine; and

  • (s) the half-lives of activated components of any particle accelerator and the radiation dose rate at 30 cm from those components.

  • (t) [Repealed, SOR/2008-119, s. 9]

• (2) The Commission or the designated officer may request any other information that is necessary to enable the Commission or the designated officer to determine whether the equipment model in question poses an unreasonable risk to the environment, the health and safety of persons or national security and whether certification of the equipment model would be in conformity with measures of control and international obligations to which Canada has agreed.

Refusal to Certify

• 12 (1) The Commission or a designated officer authorized under paragraph 37(2)(a) of the Act shall notify a person who has applied for the certification of a model of Class II prescribed equipment of a proposed decision not to certify the model, as well as the basis for the proposed decision, at least 30 days before refusing to certify it.

• (2) The notice shall include a description of the person's right to be provided with an opportunity to be heard in accordance with the procedure referred to in section 14.

Decertification

• 13 (1) The Commission or a designated officer authorized under paragraph 37(2)(a) of the Act shall notify a person to whom a certificate for a model of Class II prescribed equipment has been issued, and any licensee who is licensed in respect of that model, of a proposed decision to decertify the model, as well as the basis for the proposed decision, at least 30 days before decertifying it.

• (2) The notice shall include a description of the person's and the licensee's right to be provided with an opportunity to be heard in accordance with the procedure referred to in section 14.

Opportunity To Be Heard

• 14 (1) Where a person referred to in section 12 or 13 or a licensee referred to in section 13 has received a notice and has requested, within 30 days after the date of receipt of the notice, an opportunity to be heard either orally or in writing, the person or the licensee shall be provided with such an opportunity in accordance with the request.

• (2) On completion of a hearing held in accordance with subsection (1), every person and licensee who was notified in accordance with section 12 or 13 shall be notified of the decision and the reasons for it.

• (3) Where neither a person referred to in section 12 or 13 nor a licensee referred to in section 13 requests an opportunity to be heard within the period referred to in subsection (1), they shall be notified of the decision and the reasons for it.

Radiation Protection Requirements

Class II Nuclear Facilities

General Requirements

• 15 (1) This section applies to licensees who operate Class II nuclear facilities other than facilities that include brachytherapy remote afterloaders that incorporate pure beta emitters as their only nuclear substances or facilities that include particle accelerators used for geophysical logging.

• (2) Each entrance door to a room in which Class II prescribed equipment is located shall be

  • (a) equipped with a device that stops the equipment when the door is opened and prevents the equipment from being used when the door is open;

  • (b) equipped with a device that prevents the equipment from being used until a person activates the device from inside the room, leaves the room and closes the door within a preset time; and

  • (c) designed to prevent any person from being locked inside the room.

• (3) Each entrance, other than a door, to a room in which Class II prescribed equipment is located shall be equipped with

  • (a) a device that stops the equipment when a person passes through the entrance; and

  • (b) a device that prevents the equipment from being used until a person activates the device from inside the room and leaves the room within a preset time.

• (4) Every room in which Class II prescribed equipment that is used on persons is located shall be equipped with a viewing system that allows the operator to view the interior of the treatment room during operation of the equipment.

• (5) Each entrance to a room in which Class II prescribed equipment is located shall be equipped with a readily visible display that indicates the irradiation state of the equipment.

• (6) Every room in which Class II prescribed equipment — other than a particle accelerator — is located shall be equipped with an area radiation monitoring system that

  • (a) is independent of the Class II prescribed equipment;

  • (b) produces an audible alarm when a person enters the room while the equipment is delivering a dose of radiation; and

  • (c) has an independent back-up power supply.

• (7) Every room in which Class II prescribed equipment that is not used on persons is located shall be equipped with a device that, before the irradiation begins, provides a continuous audible alarm of sufficient duration to enable a person inside the room to operate one of the emergency stop buttons or other emergency stop devices referred to in subsection (8).

• (8) Every room in which Class II prescribed equipment is located shall be equipped with emergency stop buttons or other emergency stop devices located as specified in subsections (9) and (10) that, when any one of them is operated, cause all Class II prescribed equipment in the room to automatically revert to a safe state until the safety circuit is reset from inside that room and a switch on the control console of the equipment is operated.

• (9) The emergency stop buttons or other emergency stop devices shall be unobstructed, accessible and located at a minimum in each of the following places:

  • (a) on the control console of all Class II prescribed equipment;

  • (b) near each entrance to the room in which Class II prescribed equipment is located; and

  • (c) on both sides of all Class II prescribed equipment — other than a brachytherapy remote afterloader — or on the wall on both sides of the equipment.

• (10) In the case of a teletherapy machine, the emergency stop buttons or other emergency stop devices shall be unobstructed, accessible and located in accordance with paragraphs (9)(b) and (c) in places that are not in the machine’s direct beam.

• (11) Every licensee shall post and keep posted at every entrance to a Class II nuclear facility a visible, durable and legible sign that indicates the name or job title and the telephone number of a person who can initiate any required emergency procedure and who can be contacted 24 hours a day.

• (12) Class II prescribed equipment shall be equipped with a key switch or code-operated device that prevents persons who are not authorized by the licensee from operating the equipment.

• (13) After a device or system referred to in subsection (2), (3), (5), (6), (7) or (8) is serviced, the licensee shall not use the Class II prescribed equipment until the licensee performs a test or an inspection that establishes that the device is functioning as prescribed by those subsections.

• (14) Subsections (2), (3) and (7) and paragraphs (9)(b) and (c) do not apply in respect of a particle accelerator that meets at least one of the following criteria:

  • (a) its radiation dose rate at 30 cm is not greater than 200 µSv per hour when it is being operated in the manner that produces the maximum dose rate as limited either by its characteristics or by its interlocks, and it is located in a room that is equipped with a lock and that can be unlocked and entered only by persons who have been authorized by the licensee; or

  • (b) its radiation dose rate at 30 cm is not greater than 25 µSv per hour when it is being operated in the manner that produces the maximum dose rate as limited either by its characteristics or by its interlocks.

• (15) Paragraphs (2)(b), (3)(b) and (9)(b) do not apply in respect of a brachytherapy remote afterloader that contains a total quantity of nuclear substance that, if exposed, would produce a radiation dose rate in air of less than 10 mGy per hour at a distance of 1 m.

Irradiators

• 16 (1) Every person who enters a room in which an irradiator that uses more than 10¹⁵ Bq of a nuclear substance is located shall, on entering the room, ascertain that the radiation field in the room is safe by using a radiation survey meter.

• (2) A person referred to in subsection (1) shall, immediately before entering the room, verify that the radiation survey meter is in working order.

Brachytherapy Remote Afterloaders

• 16.1 (1) Every licensee who uses a brachytherapy remote afterloader shall ensure that patients who have received treatments by means of that equipment are surveyed by a radiation survey meter and are free of nuclear substances from the remote afterloader immediately following each treatment.

• (2) Every licensee shall ensure that when the brachytherapy remote afterloader is being used, the treatment room is equipped with the following:

  • (a) a remote alarm system to detect and warn of any interruption in treatment if the control panel area is not continuously occupied by staff during treatment;

  • (b) a shielded storage container of sufficient size to hold the radioactive sources in an emergency; and

  • (c) the remote handling tools necessary to recover the radioactive sources in an emergency.

Sealed Source Installation

• 17 (1) Every licensee who installs a sealed source in any Class II prescribed equipment other than a pool-type irradiator shall, after installing the source, take measurements of radiation dose rates when the equipment is not in the irradiation mode and notify the Commission in writing as soon as practicable if the dose rate at any location that is 1 m from any sealed source in its shielded position exceeds the manufacturer’s specifications.

• (2) Every licensee who possesses a radioactive source teletherapy machine shall, after the installation of a sealed source in the machine, take measurements of radiation dose rates at all accessible locations outside the room in which the machine is located, with the machine in the irradiation mode and operating under conditions that will result in the maximum dose rate at each location.

Class II Prescribed Equipment

Radiation Survey Meters

• 18 (1) Every licensee who uses, decommissions or services Class II prescribed equipment shall make available to each worker a radiation survey meter that

  • (a) has been calibrated within the 12 months preceding its use;

  • (b) is capable of measuring the gamma, X-ray and, if applicable, neutron radiation from the sealed source and the Class II prescribed equipment; and

  • (c) indicates whether the power level of its batteries is sufficient for its operation.

• (2) No person shall use, for the purposes of the Act, the regulations made under the Act or an order or a licence, a radiation survey meter that has not been calibrated within the 12 months preceding its use.

Leak Tests

• 19 (1) Every licensee who possesses or uses, in or for Class II prescribed equipment, either a sealed source containing 50 MBq or more of a nuclear substance or a nuclear substance as shielding shall, at the following times, conduct leak tests on the sealed source or shielding using instruments and procedures that enable the licensee to detect a leakage of 200 Bq or less of the nuclear substance:

  • (a) if the sealed source or shielding is used after being stored for 12 or more consecutive months, immediately before using it;

  • (b) if the sealed source or shielding is being stored, every 24 months;

  • (c) if an event that may have damaged the sealed source or shielding has occurred, immediately after the event; and

  • (d) in all other cases,

    • (i) if the sealed source or shielding is located inside Class II prescribed equipment, every 12 months, and

    • (ii) if the sealed source or shielding is not located inside Class II prescribed equipment, every six months.

• (2) Where a licensee, in the course of conducting a leak test on a sealed source or on shielding, detects the leakage of 200 Bq or more of a nuclear substance, the licensee shall

  • (a) discontinue using the sealed source or shielding;

  • (b) discontinue using the Class II prescribed equipment in which the sealed source or shielding is located or may have been located;

  • (c) take measures to limit the spread of radioactive contamination from the sealed source or shielding; and

  • (d) immediately after complying with paragraphs (a) to (c), notify the Commission that the leakage has been detected.

• (3) Subsection (1) does not apply in respect of a sealed source that is used or stored underwater in a Class II nuclear facility that consists of a pool-type irradiator equipped with a device capable of detecting water-borne contamination of 200 Bq or less of a nuclear substance.

Medical Supervision

20 No licensee shall use Class II prescribed equipment on a person except as directed by a medical practitioner who is qualified to give such direction under the applicable provincial legislation.

Records to Be Kept and Retained

• 21 (1) Every licensee shall keep a record of each measurement of the radiation dose rates required by the licence and retain the record for the period ending three years after the earlier of the expiry date and the date of revocation, if any, of the licence.

• (2) Every licensee who uses Class II prescribed equipment shall keep a record of

  • (a) the daily output of radiation resulting from the operation of the equipment;

  • (b) the training received by each worker, including the date and subject of the training; and

  • (c) any inspection, verification, servicing, measurement or test required by the Act, the regulations made under the Act or the licence, including a description of the actions performed, the date on which they were performed and the results.

• (3) Every licensee shall retain a record of the training referred to in paragraph (2)(b) for the period that the worker is employed by the licensee.

• (4) Every licensee who transfers Class II prescribed equipment shall keep a record of

  • (a) the date of the transfer;

  • (b) the licence number of the person to whom the equipment was transferred; and

  • (c) the model and serial number of the equipment.

• (5) Every licensee shall keep a record of each leak test conducted on a sealed source or on shielding in accordance with section 19 and that person shall retain the record for the period ending three years after the date on which it is made.

• (6) Every licensee shall keep a record of each measurement of the radiation dose rates made under subsections 17(1) and (2) and retain the record for the period ending three years after the earlier of the expiry date and the date of revocation, if any, of the licence.

• (7) Every licensee who holds a licence to service Class II prescribed equipment shall keep a record of the following information in respect of each servicing performed:

  • (a) the name and address of the client for whom the servicing was performed;

  • (b) the licence number of the client for whom the servicing was performed;

  • (c) the brand name, model number and serial number of the prescribed equipment; and

  • (d) a summary of the work and the date on which the servicing was performed.

• (8) Every person who is required to keep a record referred to in subsection (7) shall retain the record for the period ending three years after the earlier of the expiry date and the date of revocation, if any, of the licence.

Coming into Force

22 These Regulations come into force on the day on which they are approved by the Governor in Council.