Human Pathogens and Toxins Act

Questions and Answers

1. What are human pathogens? What are toxins?
2. What is this legislation all about?
3. How is this initiative related to the government's other priorities?
4. Why are you proposing this legislation now?
5. What is the gap with the current safety and security controls over human pathogens and toxins?
6. What are you proposing in this legislation?
7. How are you working with stakeholders?
8. What will the impact be on laboratories?
9. What are the implications of an inadvertent release of human pathogens or toxins?
10. What federal controls are in place for plant and animal pathogens?

---

 

1. - What are human pathogens? What are toxins?

A - A human pathogen is a micro-organism capable of causing disease or death in a human, such as Salmonella or Anthrax.  For the purposes of this legislation, toxins are defined as substances produced by or derived from a micro-organism that can cause disease in a human. They are listed in Schedule 1 of the proposed Bill.

2. - What is this legislation all about?

A - The goal of the Human Pathogens and Toxins Act is to establish consistent safety and security requirements for the handling of the most dangerous pathogens and toxins while continuing to advance scientific research.

3. - How is this initiative related to the government's other priorities?

A - This initiative is consistent with Government of Canada's priority to protect the health and safety of all Canadians. 

4. - Why are you proposing this legislation now?

A - The Human Pathogens Importation Regulations came into force in 1994 to regulate the importation of human pathogens.  These regulations require that importing laboratories follow standard biosafety guidelines.  Since 1994, there have been no changes in the law to require laboratories that do not import pathogens into Canada (those that acquire them from another lab within Canada) also follow standard biosafety guidelines.  It is time to level the playing field to ensure that all laboratories in Canada operate under the same basic safety regime.

As well, there is no system for security screening in Canada for people who work with these agents.  We need to take steps now to ensure that laboratories in Canada are not only safe but also secure.

5. - What is the gap with the current safety and security controls over human pathogens and toxins?

A - Canada currently has a “two-tiered” regime with regards to the biosafety and biosecurity of human pathogens and toxins.  The Human Pathogens Importation Regulations only cover human pathogens imported into Canada.  Human pathogens acquired in Canada are not covered under the biosafety regime associated with the importation regulations. 

6. - What are you proposing in this legislation?

A - We are proposing a new legislative and regulatory regime for the safety and security of both imported and non-imported human pathogens and select toxins.  This new legislative and regulatory regime will include a range of prohibitions; security screening of persons handling specified higher risk human pathogens and select toxins; enhanced inspection powers; a new licensing regime; inventory requirements, and a requirement to follow standard laboratory biosafety guidelines.

7. - How are you working with stakeholders?

A - The Office of Laboratory Security (OLS) at the Public Health Agency of Canada has engaged stakeholders across the country in the development of this legislation.  The OLS will continue to work with stakeholders and will lead cross-country consultations on all aspects of the program and regulatory framework that will implement the legislation. This approach will help ensure that stakeholders' concerns are addressed and seeks to balance the need for enhanced safety and security with the needs of science and research. 

8. - What will the impact be on laboratories?

A – Once the Act receives Royal Assent, there will be a requirement to provide information to the regulator, such as the name of the facility using human pathogens.  The bulk of the new requirements will come at a later date in the form of the program and regulatory framework and associated standards and guidelines.  Regulations will be developed following extensive consultations with stakeholders to ensure the implementation issues are considered.  

Generally, the legislation and the accompanying regulations would require anyone working with a human pathogen or toxin to comply with the requirements of standard biosafety guidelines.   Impacts on laboratories that are already in compliance with these standard guidelines should be minimal. 

For other facilities, the Office of Laboratory Security will conduct wide-ranging consultations in the development of the program and regulatory framework to better ensure that impacts are as minimal as possible.

9. - What are the implications of an inadvertent release of human pathogens or toxins?

A – The implications of a release would vary depending on the situation. Inadvertent release of a human pathogen or toxin can result in an isolated laboratory-acquired infection or a public health disease outbreak. One of the most highly publicized incidents occurred in April 2004, when four laboratory workers were infected with the SARS virus after working in China's National Institute of Virology.  The infected workers unknowingly transmitted the virus to individuals outside the laboratory causing a SARS outbreak in Beijing. While we believe laboratories in Canada are safe and we have had no reports of similar incidents, it is important that the Government of Canada further strengthen regulations governing the handling of human pathogens and toxins to help prevent this circumstance.

10. - What federal controls are in place for plant and animal pathogens?

A - The Canadian Food Inspection Agency administers the Health of Animals Act and the Plant Protection Act with an import permit program similar to the one administered by the Office of Laboratory Security at the Public Health Agency of Canada for human pathogens.