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

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.

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.