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Human Pathogens and Toxins Act (HPTA)

Background

Over the past decade, many countries have developed more stringent controls over the possession, containment and movement of pathogens into and within their borders. In Canada, while imported human pathogens and toxins are subject to the Human Pathogens Importation RegulationsExternal Link (HPIR), there have been no comprehensive national controls or safety requirements for domestic human pathogens and toxins. Human pathogens and toxins pose a small but significant risk to human health and safety, either through accidental or deliberate release. Accidental release can result from inadequate controls on activities such as possession, use, transfer or disposal. A deliberate release could be possible if there are inadequate security measures in place.

The HPTA

To address the concerns outlined above, the HPTAExternal Link received Royal Assent on June 23, 2009. The purpose of the HPTA is to establish a safety and security regime to protect the health and safety of the public against the risks posed by human pathogens and toxins. The Public Health Agency of Canada (the Agency) enforces the HPTA and is developing a program and regulatory framework to bring the HPTA fully into force. The HPTA applies to everyone conducting specified activities with human pathogens and toxins whether imported or domestically acquired, including:

  • production,
  • possession,
  • handling,
  • use,
  • storage,
  • access to,
  • transfer,
  • disposal,
  • release,
  • abandonment,
  • import or export.

The HPTA does not apply to:

  • a human pathogen or toxin in an environment in which it naturally occurs, as long as it has not been cultivated or intentionally collected or extracted;
  • a drug in dosage form whose sale is permitted under the Food and Drugs Act or a human pathogen or toxin contained in such a drug.

On June 23, 2009, the following obligations and prohibitions (and their related offences and penalties) came into force:

  • Mandatory registration: all persons responsible for activities involving human pathogens or toxins must register their laboratory or facility (section 70).
  • An obligation to take reasonable precautions (a “duty of care”) to protect the health and safety of the public when knowingly dealing with human pathogens or toxins (Section 6).
  • An obligation to advise the Agency, within 90 days, of the risk groups of human pathogens or toxins in a person's possession, and their location. An obligation to designate a person with the appropriate safety training as a contact. This information must be updated annually (Section 70).
    • The same obligations will be imposed on people who now acquire pathogens or toxins, but they must register within 30 days of this acquisition.
  • A ban on any activity with pathogens or toxins listed in Schedule 5. Only smallpox is currently listed (Section 8).
    • If in possession of smallpox, you must notify the Agency within 30 days and dispose of materials as instructed (Section 71).
  • A prohibition on knowingly communicating false or misleading information to the Agency (Section 17).
  • A prohibition on knowingly obstructing or making false or misleading statements to inspectors (Section 41(6)).
  • A prohibition on intentionally releasing human pathogens or toxins causing risk to the health or safety of the public (Section 58).

The Minister can also appoint inspectors to administer and enforce the basic elements of the HPTA, such as to inspect places or conveyances, seize and detain materials, or order persons to take measures to reduce or eliminate serious or imminent dangers (sections 40 to 52).The HPTA also sets out, the power to make regulations in relation to human pathogens and toxins.

Statements of Administrative Intent

The Agency has developed a number of Statements of Administrative Intent to provide a clearer understanding on various aspects of the Human Pathogens and Toxins program. The following Statements of Administrative Intent are an elaboration on specific applications of the HPTA.

  1. Exclusions from the Human Pathogens and Toxins Act
  2. Defining the term Micro-organism in the context of the Human Pathogens and Toxins Act
  3. The Human Pathogens and Toxins Act Application to Helminths
  4. Determining if Cells and Cell Lines are under the authority of the Human Pathogens and Toxins Act

Each Statement of Administrative Intent will be reviewed on an annual basis to ensure it is up to date and consistent with program specific policies, guidelines and procedures for administering and enforcing the HPTA.

If you have any questions or comments in relation to the Statements of Administrative Intent, or would like to have clarity on other aspects or applications of the HPTA program, please contact the Centre for Biosecurity.

[Developing a program and regulatory framework]