• A human pathogen is a micro-organism (such as a bacterium, virus or fungus), a nucleic acid or protein capable of causing disease in a human and fall into Risk Group 2, 3 or 4.
• A toxin is a substance that is (in the Minister’s opinion) produced by or derived from a micro-organism, is (in the Minister’s opinion) capable of causing disease in a human, and listed in Schedule 1 or Part 1 of Schedule 5 (External link) to the HPTA.
• They are often used for research and diagnostic purposes.
• Human pathogens (e.g. Salmonella, Listeria and Influenza virus) and toxins (e.g. Botulinum neurotoxin) are inherently dangerous and pose a risk to human health and public safety either through accidental or deliberate release.
• Being able to control the way they are used and contained is necessary to reduce the risk of working with and being otherwise exposed to human pathogens and toxins.

Under this Act, human pathogens are divided into risk groups, as defined in Section 3. These definitions outline the criteria to be used in assessing which risk group a human pathogen may fall into. These criteria include the level of risk to the health of a person or to public health, as well as the likelihood that the human pathogen will cause disease in a human, and whether or not treatment and preventative measures are available.  Examples of human pathogens that fall into each Risk Group are provided in Schedules 2 to 4. Toxins are those listed in Schedule 1.

The Public Health Agency of Canada will establish an advisory committee to advise the Minister on the risk group classification of human pathogens and toxins and what should be in Schedules 1 to 5.  The advice of this committee will be made public.

Once the forms are received and reviewed, a registration number will be sent to you.  If the information you provided is insufficient, you will be contacted and a request will be made for a completed registration form.

For a complex entity with multiple facilities (with many laboratories, storage units, and researchers), it is recommended that a single individual register with the Agency. Please refer to the guide for assistance in determining who is an appropriate individual to complete the registration on behalf of the complex entity. 

Any laboratory/facility in Canada working with risk group 2, 3 or 4 human pathogens or toxins could be subject to inspections under the Human Pathogens
and Toxins Act to verify compliance.

You need to register if you are responsible for activities involving micro-organisms or toxins that:

a) are toxins listed on schedule 1 of the Human Pathogens and Toxins Act; or

b) are micro-organisms that fall into any of the categories of Risk Groups 2, 3 or 4 as defined in section 3 of the Human Pathogens and Toxins Act.

If you are not responsible for activities involving human pathogens in Risk Groups 2-4, nor any toxins listed in Schedule 1, you do not need to register.

No. E. coli is listed in Schedule 2.  However, this does not mean that all strains of E. coli fall within Risk Group 2.  If you have established that the strain you have is indeed K-12, then it does not fall into Risk Group 2, as it is a non-pathogenic strain i.e. cannot cause disease in a human.

Yes. Every person who is responsible for activities involving human pathogens in Risk Groups 2-4 or any toxins must register under the Human Pathogens and Toxins Act.

Yes. Every person who is responsible for activities involving human pathogens in Risk Groups 2-4 or any toxins must register under the Human Pathogens and Toxins Act.

No. Registration is required by x date under the Human Pathogens and Toxins Act. The program and regulatory framework, including licensing, have yet to be developed and will only be developed after extensive consultation with provinces, territories and stakeholders.

It is a requirement to register by September 21, 2009.  If you are having difficulty meeting this deadline, please contact the Agency for assistance.  Failing to register may result in penalties as set out in section 53 of the Human Pathogens and Toxins Act.

No. A simple evaluation of your microbiological collection to determine the risk groups of agents present is all that is required (i.e. do you have Risk Groups 2, 3 or 4?). However, it is recommended that all collections be inventoried over the coming years.

The Schedules 2, 3 and 4 are not an exhaustive and complete list of human pathogens covered by the Human Pathogens and Toxins Act.  If your human pathogens are not on these schedules, the characteristics of your pathogens must be assessed against the definitions of the Risk Groups 2, 3 or 4 for human pathogens within the scope of the Human Pathogens and Toxins Act. These definitions can be found in section 3 of the HPTA. If the human pathogens that you work with fall into Risk Group 2, 3 or 4, then you need to register.

If you have questions or need more information, please contact 1-877-842-5590 or email.

If you work in a large complex/facility it is recommended that a responsible individual register with the Agency.  Please refer to the guide for assistance in determining who is an appropriate individual to complete the registration on behalf of the facility. If your facility is registered, you do not need to register separately.

If you do possess strains of a pathogen that could be categorized as belonging to risk group 2, then you would have to register.  Whether or not you deal in pathogens or non-pathogenic surrogates, you are preparing students for future scientific study: consider acquainting yourself and your students with the good laboratory practices that are described in the Laboratory Biosafety Guidelines.

You do not have to register if you are collecting samples for the purpose of laboratory analysis or diagnostic testing.  If you are cultivating these samples or maintaining pure cultures of human pathogens in risk groups 2 to 4 or toxins, you have to register. Whether or not you have to register, you should be aware that good practices for your laboratory are described in the Laboratory Biosafety Guidelines. Generally speaking, diagnostic labs should operate at containment level 2.

No. You do not have to register if you are collecting samples for the purpose of laboratory analysis or diagnostic testing. 

The Act does not apply to human pathogens and toxins that remain in an environment in which they naturally occur, as long as they have not been cultivated or intentionally collected or extracted.  A water treatment facility that takes water samples simply for testing purposes, and not for the specific purpose of cultivating, collecting or extracting a human pathogen or toxin from a sample is therefore not required to register.

You do not have to register if the human pathogens you are dealing with remain in an environment in which they naturally occur, as long as they have not been cultivated or intentionally collected or extracted. 

The program and regulatory framework will be based on the existing Laboratory Biosafety Guidelines. If laboratories are following these Guidelines, the impact on them should be minimal. These Guidelines have been in existence since 1990.

PHAC will work with stakeholders to attempt to find ways or timelines that will minimize costs incurred by laboratories as a result of the HPTA.  PHAC will consult with provinces, territories and other stakeholders on the details of the program and regulatory framework which will come into force over an appropriate time to allow stakeholders time to come into compliance.

Persons who face new costs because of the requirements of the new Act will have a reasonable amount of time to allow them to adjust to the changes and factor in these costs. This time frame will be discussed as part of our consultations with provinces, territories and stakeholders to develop the program and regulatory framework under the new Act.

The Public Health Agency of Canada will be engaging in extensive and meaningful consultations on the development of the program and regulatory framework to achieve the right balance between biosafety and biosecurity, and the need to foster innovation and research activities.

No. Facilities with the less-dangerous human pathogens in Risk Group 2 will be subject to less stringent requirements than the laboratories with the more dangerous human pathogens in Risk Groups 3 and 4.  We will be engaging in extensive and meaningful consultations on the development of the program and regulatory framework to achieve the right balance without unduly interfering with research activities.

The program and regulatory framework under the HPTA will be based on the Laboratory Biosafety Guidelines.

The HPIRs will remain in force until new regulations are developed under the Human Pathogens and Toxins Act. 

The Canadian Food Inspection Agency administers the Health of Animals Act and the Plant Protection Act . It uses an import permit program like the one used by the Public Health Agency of Canada for imported human pathogens.

PHAC will be consulting with the provinces, territories and stakeholders through consultations across Canada.  As the program and regulatory framework are developed, PHAC will seek to balance the needs of science with the needs of biosafety and biosecurity.