Human Pathogens and Toxins Act

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 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.

The Human Pathogens and Toxins Act

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:

• 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 Minister, 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 acquiring pathogens or toxins after coming into force of Act, but they must do so within 30 days.
• 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 Minister within 30 days and dispose of materials as instructed by the Minister (Section 71).
• A prohibition on knowingly communicating false or misleading information to the Minister (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).
• All related offences and penalties (Sections 53-58).

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.

Developing a program and regulatory framework

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:

• Canadian Biosafety Standards and Guidelines
• Licencing regime
• Regulations
• Information, Training and Tools for Compliance Promotion

To help inform this process, cross-Canada consultations are being undertaken and will focus on the following key elements:

• Licences: what specific procedures will be required for the different risk groups of human pathogens, or toxins
• Security screening: for whom and for which Risk Group 3 and Risk Group 4 human pathogens and toxins
• Inventories: what level of detail and content would be required for which human pathogens and toxins
• Laboratory Incidents: reporting on laboratory acquired infections and other incidents involving human pathogens and toxins
• Biological Safety Officers: what specific qualifications and training will be required, and what will be their duties and functions.

Creating HPTA Regulations

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:

• Prohibition to engage in controlled activities, such as possessing, producing, storing, transferring, importing/exporting or disposing of human pathogens or toxins, without a licence (sections 7 and 56)
• The entire licensing scheme, including requirements to keep a list of persons authorized to access the facilities, to obtain security clearances, and to appoint biological safety officers (sections 18 to 36)
• Obligation to report an inadvertent release, or an incident that has or may have caused disease, or missing human pathogen or toxin, to the Minister (sections 12(1), 13 to 16).

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.

HPTA Regulatory Impact Assessement Process

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.