Human Pathogens and Toxins Act (HPTA)

The information provided here is a simplified overview of some aspects of the HPTA, The Human Pathogens and Toxins Act. By its nature, this information cannot capture all the complexities of the Act. If you want to know the exact proposed requirements, please consult the Act itself.

Text of the HPTA, the Human Pathogens and Toxins Act

Register Now!

A new law passed by Parliament requires all persons responsible for activities involving human pathogens or toxins to register their laboratory or facility.

About the new Act

The Human Pathogens and Toxins Act (HPTA) establishes legal prohibitions and authorities to govern human pathogens and toxins in Canada.  It is designed to protect the health and safety of the public against the risks posed by human pathogens and toxins, while allowing science and research to progress. [More about the Act]

Registration is mandatory

Now that the HPTA has received Royal Assent, Sections 70 and 71 have come into force, along with a number of other sections. These two sections require that anyone responsible for activities involving human pathogens, or toxins on Schedule 1, must inform the Public Health Agency of Canada, must provide a point of contact, and must inform whether the activities relate to toxins or to particular risk groups of human pathogens. [More concerning the registration process]

Any person who possesses smallpox must inform the Public Health Agency of Canada by July 23, 2009.  PHAC may seek further information and will provide you with instructions on how to properly dispose of the smallpox virus.

Who Should Register

Note that registration is not intended to apply to every person “carrying out” activities involving human pathogens or toxins, but rather those who are “responsible for” the activities. So it is not necessary, for example, for every researcher in a facility, or every student at an educational institution, or every employee of a drug manufacturer to provide this information. It is sufficient, for example, that a single registration be received from a person, university or corporation covering all activities they conduct that involve human pathogens, or toxins on Schedule 1, and that a single contact individual be provided for all relevant activities and all locations for which the person, university or corporation is responsible.

Exemptions for Registration

This Act does not apply to any human pathogen or toxin that is in an environment in which it naturally occurs provided the human pathogen or toxin itself has not been cultivated or intentionally collected or extracted.  Substances such as wastewater and human blood are, in fact, a natural environment for human pathogens - so this general exemption will be particularly important for those persons who may possess, collect or treat such substances but who do not actually cultivate the human pathogen itself, or intentionally collect or extract the human pathogen itself from the substance that is its natural environment.

As well, drugs that have been authorized for sale under the Food and Drugs Act and controlled activities under the Assisted Human Reproduction Act are also exempt.

No registration is required with respect to an activity to which the Transportation of Dangerous Goods Act applies.  Also, no registration is required for a person who, in the course of their employment, collects a sample for the purpose of laboratory analysis or diagnostic testing. For example, a nurse or technician collecting a sample such as blood or sputum for laboratory analysis or diagnostic testing would not need to register.

Safe Laboratory Practices

The HPTA, once fully in force, will include new requirements and prohibitions relating to the range of laboratory activities relating to human pathogens or toxins. A licensing and regulatory regime will be developed in consultation with provinces, territories and stakeholders and be based on requirements of the Laboratory Biosafety Guidelines (LBGs).  Laboratories and other facilities should familiarize themselves with the LBGs before the requirements come into force.