Human Pathogens and Toxins Act

Proposed Program and Regulatory Framework

A consultative approach to biosafety

The Public Health Agency of Canada's (PHAC) Office of Laboratory Security is the national leader for human pathogen biosafety in Canada.  PHAC is taking a consultative approach to implementing the provisions of the proposed new Human Pathogens and Toxins Act and will be working with stakeholders to develop the program and regulatory framework for this legislation. PHAC will also be providing stakeholder with the information, advice, and practical training they need to ensure smooth compliance with the proposed legislation.

Registration

In the first phase of implementation, laboratories carrying out activities with Risk Groups 2, 3 or 4 human pathogens, or select toxins, have to register with the Public Health Agency of Canada's (PHAC) Office of Laboratory Security.  PHAC will collect information through the registration process such as name, address, and the risk groups of human pathogens or toxins they possess.  Laboratories will need to provide this information to PHAC within 90 days of the legislation receiving Royal Assent.

Currently regulated laboratories

Laboratories currently compliant with the Laboratory Biosafety Guidelines by virtue of their compliance with the existing Human Pathogens Importation Regulations (HPIRs) are expected to have a straightforward transition to the new program and regulatory framework.

Non-regulated Laboratories - guidance and assistance

Even before the proposed Human Pathogens and Toxins Act comes into force, the PHAC will provide advisors to non-regulated laboratories that voluntarily request site visits to assess their compliance with the Laboratory Biosafety Guidelines.

Online self assessment for all Canadian laboratories

When the proposed Human Pathogens and Toxins Act receives Royal Assent and comes into force, self-assessments, consisting of a series of questions related to laboratories, laboratory work and human pathogens will be available to all laboratories in Canada to determine the risk associated with their inventories.

Registration and Licensing of toxins and Risk Group 2 human pathogens

If the self assessment indicates possession of only toxins and/or Risk Group 2 human pathogens, people conducting activities with these human pathogens or toxins would simply need to complete a registration form, either on-line or in hard-copy, attesting that they possess only Risk Group 2 human pathogens and/or toxins and that they are compliant with the Laboratory Biosafety Guidelines in order to obtain a licence.  They will also have to maintain a simple inventory of the human pathogens that they possess. This inventory would need to be made available to PHAC upon request. Licensees with Risk Group 2 human pathogens would likely be subject to risk-based and spot inspections under the new program and regulatory framework.

Registration and Licencing of Risk Group 3 and 4 pathogens (and possibly select toxins)

If an online self assessment indicates possession of Risk Group 3 or Risk Group 4 human pathogens, people conducting activities with these agents must submit their information to PHAC on paper - and not via the Internet - as there are security implications for this kind of information.

Once the licensing system is in place (to be developed by PHAC in consultation  with stakeholders), a licensee carrying on activities with Risk Group 3 or 4 human pathogens would be required to provide a detailed inventory of their Risk Group 3 or 4 human pathogens, as well as information relating to their quantity, concentration, location, storage and use.

Under the proposed regulatory regime, people conducting activities with Risk Group 3 and 4 human pathogens would be required to prepare and submit site-specific biosecurity plans, and be subject to site inspections.  PHAC will perform an on-site inspection before granting a licence and carrying out periodic inspections of laboratory facilities.

Security screening

Anyone accessing the particular part of a facility where activities are being conducted with Risk Group 3 (or a selected list of Risk Group 3, as prescribed by regulation) and 4 human pathogens and/or a select list of toxins would require a security clearance.  Changes to Risk Group 3 or 4 human pathogen and/or select toxin inventories (i.e. missing pathogens) would have to be reported to PHAC.

Possession and handling - application of Laboratory Safety Guidelines

Laboratory possession and handling of human pathogens and toxins must be carried out in compliance with PHAC Laboratory Biosafety Guidelines (LBGs) to reduce the risks to the health and safety of laboratory personnel and the Canadian public.

Importation

Consistent with existing Human Pathogen Importation Regulations, anyone wishing to import a human pathogen or toxin would have to apply for and receive an importation permit.  A single permit for all moderate-risk human pathogens (i.e. toxins and Risk Group 2 human pathogens) would be granted on an annual basis, while a separate and discrete permit would be required for importing each high-risk human pathogen (i.e. select toxins and Risk Group 3 or 4 human pathogens).

Transfer

Sending and receiving any human pathogen or toxin between laboratories within Canada that are not part of the same facility would require a transfer permit.  Under the proposed program and regulatory framework, the receiving laboratory must demonstrate that it is properly certified to the level required to possess the pathogen.  Laboratories would have to notify PHAC if a transferred human pathogen or toxin is not received within an identified time frame.  PHAC will be exploring ways to simplify the transfer process between associated laboratories where significant numbers of moderate-risk human pathogens and toxins are transferred on a regular basis.

Export

Continuing with current practice, the export of agents on the Export Control List would require authorization from the Department of Foreign Affairs and International Trade Canada (DFAIT). A laboratory exporting human pathogens not listed on the Export Control list would need to have this activity included in the scope of its license.

Disposal

As part of their annual or biannual updates of inventories, licensees would be required to notify PHAC of the nature of the disposal of human pathogens and toxins.  Licensees would also be responsible for ensuring that the disposal of these substances renders them non-viable or non-functional.