Class II Nuclear Facilities and Prescribed Equipment Regulations (SOR/2000-205)

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.

Radiation Safety Officers

Appointment and Certification

• 15.01 (1) Every licensee who operates a Class II nuclear facility shall appoint a radiation safety officer.

• (2) Every licensee who services Class II prescribed equipment shall appoint a radiation safety officer.

15.02 No person shall hold the position of radiation safety officer unless the person has been certified by the Commission or a designated officer authorized under paragraph 37(2)(b) of the Act.

Application for Certification

15.03 An application by a licensee for certification of a person as a radiation safety officer shall include the following information:

• (a) the name of the person;

• (b) a record of that person’s education, training and experience;

• (c) a statement by the licensee that, in their opinion, the person is capable of performing the duties of the position; and

• (d) the Class II prescribed equipment in respect of which the person may be certified.

• 15.04 (1) The Commission, or a designated officer authorized under paragraph 37(2)(b) of the Act, may certify a person for the position of radiation safety officer if

  • (a) the person has successfully completed a certification examination that is recognized by the Commission; and

  • (b) in the opinion of the Commission, or of the designated officer, the person is capable of performing the duties of the position.

• (2) A certificate issued under subsection (1) shall specify the Class II prescribed equipment in respect of which it is valid.

15.05 A certificate comes into effect on the day on which it is issued and is valid for the period in which the person is employed by the licensee as a radiation safety officer.

• 15.06 (1) A person who is employed as a radiation safety officer on the day on which these Regulations come into force is deemed to have been certified in accordance with section 15.04.

• (2) A licensee shall notify the Commission of the name of the radiation safety officer and the Class II prescribed equipment in respect of which the deemed certification is valid within 30 days after the day on which these Regulations come into force.

Refusal to Certify

• 15.07 (1) The Commission or a designated officer authorized under paragraph 37(2)(b) of the Act shall notify a licensee who has applied for the certification of a person, and the person in respect of whom certification is being sought, of a proposed decision not to certify the person and the basis for that proposed decision at least 30 days before refusing to certify the person.

• (2) The notice shall include a description of the licensee’s and the person’s right to be provided with an opportunity to be heard in accordance with the procedure referred to in section 15.09.

Decertification

• 15.08 (1) The Commission or a designated officer authorized under paragraph 37(2)(b) of the Act shall notify a person in respect of whom a certificate has been issued, and the licensee concerned, of a proposed decision to decertify the person and the basis for that proposed decision at least 30 days before decertifying the person.

• (2) The notice shall include a description of the licensee’s and the person’s right to be provided with an opportunity to be heard in accordance with the procedure referred to in section 15.09.

Opportunity To Be Heard

• 15.09 (1) If a licensee or a person referred to in section 15.07 or 15.08 has received a notice and has requested, within 30 days after the date of receipt of the notice, an opportunity to be heard orally or in writing, the licensee or the person shall be provided with an opportunity to be heard in accordance with the request.

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

Temporary Replacement

15.1 Every licensee shall designate in writing a person qualified to replace the certified radiation safety officer during the radiation safety officer’s absence.

15.11 A person designated under section 15.1 may replace the certified radiation safety officer for not more than 60 working days in any consecutive 365-day period.

Exemption from Certification

15.12 The requirement in section 15.01 does not apply in respect of a Class II nuclear facility for which a person who has duties equivalent to those of a radiation safety officer is designated and who is certified under subsection 9(2) of the Class I Nuclear Facilities Regulations.

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.