Important Notice: Human Pathogens and Toxins Act
Attention: Persons handling human pathogens and toxins
The Human Pathogens and Toxins Act is designed to protect the health and safety of the public against risks posed by the accidental or deliberate release of human pathogens and toxins from research or other facilities.
Under the Human Pathogens and Toxins Act, if you are handling human pathogens and toxins, you may be subject to certain obligations. The best way to know if the Act affects you is to register with the Agency.
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 nationally consistent controls for non-imported human pathogens and toxins. As a result, there are no nationally consistent safety requirements (e.g. no comprehensive inventory of who has what pathogen and in what quantity, nor knowledge of how safely they are being handled).
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 and unsafe containment of a pathogen through unsafe possession, use, transfer or disposal. A deliberate release could result from having a lack of proper security measures in place.
To address the concerns outlined above, Parliament passed the Human Pathogens and Toxins Act (HPTA) in 2009. The Public Health Agency of Canada is charged with enforcing the Act and developing a program and regulatory framework. HPTA Regulations will move beyond the scope of importation controls in the HPIR and address safety and security risks associated with the:
of human pathogens and toxins, whether imported or domestically acquired.
On June 23, 2009, the following obligations and prohibitions (and their related penalties) came into force:
The Minister can also appoint inspectors to administer and enforce the basic elements of the Act, 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). Upon Royal Assent, the power to make regulations in relation to human pathogens and toxins also came into effect.
The next stage of implementing the HPTA and achieving policy objectives is the development of a program and regulatory framework. The principles and practices contained in the Laboratory Biosafety Guidelines (LBG), currently being updated in the Canadian Biosafety Standards and Guidelines, will be the cornerstone of the new framework. A mixture of implementation tools, including the following, will also be developed:
To help inform this process, cross-Canada consultations are being undertaken and will focus on the following key elements:
The final stage in implementing the HPTA is the making of regulations by the Governor in Council, who is the Governor General acting on the advice of Cabinet, and the coming into force of the remaining parts of the Act, including:
As the regulatory framework will contain a wide range of mandatory requirements, stakeholders will be given a reasonable period of time to adjust to the new requirements. After that, the legislative and regulatory framework will be entirely in force. At this point, the Agency will continue to do compliance and enforcement activities, training, performance measurement and evaluation.
The current Human Pathogens Importation Regulations will continue to apply until they are repealed.
The establishment of new regulations under the 2009 Human Pathogens and Toxins Act (HPTA) will enhance the existing biosafety and security regime in place for individuals and facilities working with human pathogens and toxins. The regulatory impact analysis process includes consultation input and feedback provided by stakeholders and a formal cost-benefit analysis. The early identification of potential cost drivers and implementation challenges is encouraged to help PHAC develop a regulatory framework that is risk-based, cost-effective, and results in minimal impact to regulated parties.