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4. Licensing authorisation

4.1 CNSC LICENCES

The acquisition, possession and use of most radiation sources are subject to licensing by the Canadian Nuclear Safety Commission (CNSC). The University is issued a consolidated radioisotope license by the CNSC that is renewed every 5 years. In turn, the University issues "Internal Permits" to individual users, and this permit is renewed annually by Environmental Health & Safety.

The following categories of non-medical* sources are covered by CNSC Consolidated Radioisotope Licenses issued to universities:

  • unsealed radioisotopes (open sources) used for investigations not involving human subjects;
  • small sealed radioisotope sources used for instrument calibration and other special purposes, whether or not the source is permanently housed in the instrument or equipment;
  • large sealed sources housed in equipment intended for the irradiation of materials; and
  • particle accelerators capable of giving rise to high-energy particles, either as the useful product (e.g. a beam of high-energy electrons, protons or ions) or as a by-product (e.g. stray neutrons). In practice this category covers all accelerators except those accelerating electrons to an energy of less than 8 MeV.

Additionally, the license serves as a blanket import permit and separate import permits are not normally required for out-of-country purchases.

* The use of radiation sources for medical purposes i.e., diagnosis and therapy involving human subjects, lies outside the scope of this Manual.

X-ray machines, including radiographic units, diffraction equipment and electron accelerators operating below 8 MeV, are not at present subject to licensing provided that they are not used for the irradiation of human subjects. Similarly, equipment that may emit X-rays as a by-product, such as electron microscopes, is not licensable. These machines are, however, all subject to control at the manufacturing stage, under the Radiation Emitting Devices Act. Furthermore, equipment in this category is subject to the issue of a McGill Internal Permit on the same basis as radiation sources covered above.

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4.2 INTERNAL PERMITS

Staff and researchers wishing to use radiation sources and radiation-emitting equipment must apply to Environmental Health & Safety for an "Internal Permit for the Acquisition and Use of Radiation Sources". NB. An exception to this requirement is a major particle accelerator, which requires a separate license and is therefore not covered by a Consolidated Radioisotope License (see Section 4.1).

The application form for an Internal Permit is available at http://www.mcgill.ca/ehs. A copy of the form is shown in Appendix H-1. The form requires information on the following items:

  1. administrative data on the applicant, including address, telephone, e-mail and a summary of his/her experience in handling radiation sources;
  2. list of other persons involved in the work, including position, work load and with special mention of persons who are to be classified as Nuclear Energy Workers;
  3. storage and usage locations(s) of radiation-emitting equipment or radioactive sources;
  4. nature and activities of radionuclides to be:
    • stored;
    • purchased or acquired at any one time; and
    • handled or applied at any one time;
  5. arrangements for delivery and storage of radioactive materials;
  6. brief description of applications and procedures involving radioactive materials;
  7. arrangements for monitoring radioactive contamination and dose; and
  8. arrangements for disposal of radioactive waste.

Usually the answers to items 5, 7 and 8 will be "In accordance with the procedures authorized in the McGill Radiation Safety Policy Manual", but significant deviations from procedures may be justified in some cases provided that they are properly documented.

An Internal Permit is issued to a named Permit Holder for the acquisition and use of the radiation-emitting equipment and/or radioactive sources listed in the application form. Any change in the details, for example the addition of a new radionuclide, an increase in the maximum activity required, a significant change in the procedure or a change in personnel must be the subject of a written request for an amendment of the permit.

The individual Permit Holder has the right to order radiation sources only of the type and activity specified in his own permit. Environmental Health & Safety monitors adherence to this rule and infringement may lead to cancellation of an Internal Permit.

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4.3 IRRADIATION OF HUMAN VOLUNTEERS IN RESEARCH

The use of radiation sources in medicine (diagnosis and therapy) falls outside the scope of this Manual. However, from time to time a laboratory in the University whose work is covered by this Manual may wish to proceed from animals to human volunteers. The application of radiation sources to human subjects, whether internally or externally, for any purpose not directly linked to the welfare of the individuals concerned, is subject to further restriction. Investigations of this kind should first be referred to the Research Ethics Officer at the Research Grants Office.

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4.4 PURCHASE AND DELIVERY OF RADIOACTIVE MATERIALS

The Nuclear Safety and Control Act requires strict control over radioisotope acquisitions. Changes in the procedures for radioisotope purchases were introduced on June 1, 2000 with the implementation of the Banner program and the inauguration of the RadioIsotope Requisition web (RAIR web) site in September 2002. Then in June 2010 myLab replaced RAIR as a tracking system. The new guidelines state:

  • radioisotopes cannot be purchased with minor & major purchase order forms nor via the "Banner" system;
  • orders from McGill researchers for delivery to McGill campuses will be processed using the myLab web computer program;
  • for all orders from McGill researchers (using McGill accounts) located in McGill affiliated hospitals for delivery to those hospitals, they must be processed using the McGill Radioisotope Order Form. However, the completed form must be sent to the Hospital RSO for approval, and then the Hospital RSO will send the form to McGill Purchasing.

For information on myLab web, contact the RSO at McGill Environmental Health & Safety at 398-2245 and for billing and payment procedures the McGill Purchasing Office at 398-6048.

Each Permit Holder must maintain continuous inventory records for each type of radioactive material (see Appendix J). The current inventory activity for each nuclide, plus the activity to be purchased, must not exceed the "Possession Limit" specified in the Internal Permit. The inventory must be available for inspection by authorized persons including Environmental Health & Safety and CNSC inspectors.

Each package containing radioactive material must bear at least two RADIOACTIVE warning labels displaying information about the content and activity of the package. Packages are classified according to the dose-equivalent rate at the surface and at a distance of 1 meter from the surface:

  • Category I-White: Less than 0.005 mSv/hr (0.5 mrem/hr) on the surface;
  • Category II-Yellow: Less than 0.1 mSv/hr (10 mrem/hr) on the surface and a Transport Index of less than 0.005 mSv/hr (0.5 mrem/hr); and
  • Category III-Yellow: Less than 2 mSv/hr (200 mrem/hr) on the surface and a Transport Index of less than 0.1 mSv/hr (10 mrem/hr).

The Transport Index is the dose equivalent rate (in mrem/hr) at 1 metre from the surface of the package (see Appendix D).

Clear and reliable arrangements must be made for the reception of incoming radioactive materials. The Permit Holder must designate a room or other area as the reception point for a given laboratory or laboratories; and the person or persons authorized to accept delivery of packages containing radioactive materials. Under no circumstances should it be possible for radioactive materials to be delivered and left unattended, without the knowledge of an authorized person.

Normally all deliveries should be made during working hours. Occasionally, a delivery may need to be made during a vacation or off-duty period, e.g. when a McGill holiday is not also a general Canadian or Quebec holiday. In such cases, only security personnel may accept the package. The Security Officer on duty will have a key to an appropriate storage room and must be instructed to leave incoming packages of radioactive material there under lock and key, and to inform the Permit Holder as soon as possible.

As soon as possible after the delivery of a package of radioactive material, the Permit Holder or delegate must examine the package for damage, leakage and contamination. A clear policy for such examination must be laid down in each department or laboratory. Damage, leakage and contamination must be assessed using visual inspection and wipe test techniques (see Sections 5.4.2 and 5.7). If a package is damaged and/or contaminated, the emergency procedures described in Chapter 12 should be followed. The supplier should be notified of any discrepancy between the content of the package, in terms of the type of radioactive source or the activity, as compared with the original order and/or the information given on the label of the package. A copy of the notification should be sent to Environmental Health & Safety.

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4.5 RADIATION TRACKING SYSTEM

As a result of another Canadian Nuclear Safety Commission (CNSC) directive regarding a tighter control over radioisotope usage and disposal, Radiation Tracking System (RTS) was created to monitor the use of radioisotopes in laboratory facilities. In June 2010, RTS was replaced by myLab. myLab is a web based computer program that generates an electronic running log inventory for each radioisotope acquired. myLab monitors the usage of the radioactive material until the vial becomes empty and associated contaminated materials are sent for disposal.

For information on myLab, contact the RSO at Environmental Health & Safety at 398-2245.