Exemptions from the Licensing Requirements of the Human Pathogens and Toxins Act and Human Pathogens and Toxins Regulations

This Statement of Administrative Intent (SAI) is intended to clarify the exemptions from the licensing requirements of the Human Pathogens and Toxins Act (HPTA) and Human Pathogens and Toxins Regulations (HPTR).

  1. Conducting Controlled Activities

    Every person knowingly conducting a controlled activity is required to have a licence issued by the Minister authorizing that activity, unless they are exempted from requiring a licence (Section 7 of the HPTA).

  2. Exemptions from Requiring a Licence under the Human Pathogens and Toxins Act

    There are two specific cases under the HPTA where exemptions from the Licensing requirement apply:

    1. Covered by other regulatory regimes

      The requirement for a licence does not apply to any activity to which the Transportation of Dangerous Goods Act, 1992 applies; or the export of human pathogens or toxins authorized under the Export and Import Permits Act, 1985 (Section 7 (2) of the HPTA).

    2. Exemptions of certain persons in the course of their work

      There are some exemptions from the licensing requirement listed in Section 37 of the HPTA. These are:

      • For an inspector or analyst carrying out their functions under the HPTA.
      • For a peace officer carrying out their functions under any federal or provincial law or a person providing assistance to a peace officer.
      • For any person who collects samples in the course of their employment, outside a facility in which controlled activities are authorized, for laboratory analysis or diagnostic testing.
      • For any person working under a federal or provincial Act, in exigent circumstances.
  3. Exemptions from Requiring a Licence under the Human Pathogens and Toxins Regulations

    There are two specific cases under the HPTR listed in section 27, where exemptions for licensing requirement apply:

    1. Laboratory Analyses/Diagnostic Testing

      A person who carries out laboratory analyses or diagnostic testing with a human pathogen that is neither a prion nor a prescribed human pathogen is exempt from requiring a licence as long as:

      • they do not cultivate or otherwise produce a human pathogen; or
      • if there is production, it is done using a sealed container that prevents the release of the human pathogen and the sealed container is decontaminated before its disposal or reuse.

      For administrative clarity, this exemption to the licence requirement applies to a person who in the process of carrying-out laboratory analysis or diagnostic testing, comes into possession of quality control samples and/or proficiency panels containing infectious Risk Group 2 or Risk Group 3 agents that mimic primary specimens and these samples are used to calibrate an instrument, determine the performance of a laboratory's tests or measurements, and/or monitor a laboratory's continuing performance.

      A licence will be required if human pathogens are being produced, cultivated, cultured, and/or grown during any part of the process to conduct laboratory analyses and/or diagnostic testing:

      • if done outside of a sealed container;
      • if the sealed container is opened for any purpose prior to decontamination and/or disposal.

      A sealed container includes water testing vials, where the water sample is added, incubated and then discarded after looking at a fluorescent read-out. In addition, petri dishes or normal culture tubes could be considered to be sealed containers if they are inoculated, sealed with a sealing film (to prevent the release of the pathogen), incubated, examined for growth, and then decontaminated without proceeding to any secondary cultures.

    2. Veterinary Clinics

      A veterinarian who is registered under the laws of a province - and any persons under their supervision - who carry out laboratory analyses or diagnostic testing with a human pathogen that falls into Risk Group 2 are exempt from requiring a licence (Section 7 of the HPTA) on condition that any controlled activities that they conduct in respect to that pathogen are conducted in the course of providing care to animals in a clinical practice in that province.

      This exemption does not apply to veterinary research institutions or to dedicated veterinary diagnostic laboratories that receive samples from multiple clinics.

  4. Other Sections of the HPTA still apply

    It is important to note that although these activities are exempt from the licensing requirement, they are still in the scope of the HPTA and other provisions continue to apply. This includes taking all reasonable precautions to protect the health and safety of the public against risks posed by that activity (section 6) and knowingly communicating false or misleading information to the Minister (section 17). In addition, the Agency has the power to inspect any facility that an inspector believes on reasonable grounds to contain human pathogens and toxins (Section 41). Anyone who contravenes the HPTA or the HPTR is guilty of an offence and is subject to penalties (Sections 53 and subsequent related Sections 54 to 58).

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