Registration under the Human Pathogens and Toxins Act

Registration is Mandatory

When the HPTA (External link) received Royal Assent on June 23, 2009, Sections 70 and 71, along with a number of other sections, came into force. Section 70 requires that anyone responsible for activities involving human pathogens in Risk Group 2, 3 or 4, or toxins on Schedule 1 of the Act to provide the following information:

• A confirmation that they are responsible for human pathogens or toxins;
• The risk groups to which the human pathogens belong;
• The location where activities involving human pathogens or toxins are conducted;
• The name of a contact person with appropriate safety training or relevant work experience relating to human pathogens and toxins.

Even if you have an importation permit under the Human Pathogens Importation Regulations (External link) , you still need to register under the HPTA.

Who Should Register

Only those responsible for activities involving human pathogens or toxins need to register. It is not necessary, for example, for every researcher in a facility, student at an educational institution, or employee of a drug manufacturer to provide this information. It is sufficient that a single registration be received covering all activities and all locations for which the person, university or corporation is responsible.

Exemptions for Registration under the HPTA

The exemptions and exclusions include the following:

• 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.
  • This includes a human pathogen or toxin found in a person who has a disease caused by the human pathogen or toxin; a human pathogen or toxin that has been expelled by a person suffering from a disease caused by a human pathogen or toxin (e.g. expelled from someone who sneezes); or a human pathogen or toxin that is in a corpse, or other human remains.
  • Soil and water are other natural environments for human pathogens and toxins. If you deal with samples of these, even if you know that the sample may contain a particular human pathogen or toxin, as long as you do not cultivate or intentionally collect or extract it from the sample, you are not required to register. 
• Drugs that have been authorized for sale under the Food and Drugs Act (External link) and controlled activities under the Assisted Human Reproduction Act (External link) (ss 4(b) and (c) of the HPTA)
• Any activity to which the Transportation of Dangerous Goods Act (External link) applies, or any export of human pathogens or toxins authorized under the Export and Import Permits Act (External link) . (ss 7(2) of the HPTA)
• Any person described in s 37 of the HPTA, including:
  • 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.
  • An inspector or analyst carrying out their functions under the HPTA.
  • A peace officer carrying out their functions under any federal or provincial Act, or a person providing assistance to the peace officer.

How to Register

To register, please see the Step-by-Step Guide to Form 1 and Step-by-Step Guide to Form 2. Also see Annex A for additional guidelines. When completed, please fax or mail (but not both; e-mail submissions are not accepted) the documents to:

HPTA Laboratory Registration
Public Health Agency of Canada
100 Colonnade Road, P.L.: 6201A
Ottawa, Ontario K1A 0K9
Fax: 1-877-248-3528

Please note that only those sections marked by an asterisk must be completed for a registration to be considered complete. This information will also help the Public Health Agency of Canada communicate with you to consult on the development of regulations.

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.

If you have questions or need more information, please contact 1-877-842-5590 or e-mail us at: hpta_lapht_questions@phac-aspc.gc.ca.