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 Regulations (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.
To address the concerns outlined above, the HPTA 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:
The HPTA does not apply to:
On June 23, 2009, the following obligations and prohibitions (and their related offences and penalties) came into force:
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.
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.
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.