Human Pathogens and Toxins Act (HPTA)

Guide for Registering under The Human Pathogens and Toxins Act (HPTA)

Table of Contents

Before you start…

Step–by–Step Guide to Form 1: Contact Information

Step–by–Step Guide to Form 2: Location of Human Pathogens and Toxins

Annex A: Additional guidelines for assessing the risk group levels  of your human pathogens

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Before you start…

Please take a few moments to read these guidelines before completing the forms.

Not all of the information requested on the forms is required by the HPTA. The optional information will help the Public Health Agency of Canada communicate with you to consult on the development of regulations.

Section 70 of the HPTA details what information is required. This includes:

• Name of responsible person;
• Risk groups of human pathogens for which you or your organization is responsible;
• Address of any building in which activities involving human pathogens or toxins take place;
• Name of a contact person.

The questions that relate directly to those requirements are marked with an asterisk on the forms and this information is required for the registration to be considered complete.

Any of the other information may be submitted on a voluntary basis.

Fax or mail – not both
Download and print Form 1: Contact Information and Form 2: Location of Human Pathogens and Toxins

Fax or mail your registration forms only. Email forms are not accepted.

Once you have completed your forms, please mail them to:

HPTA Laboratory Registration
Office of Laboratory Security
Public Health Agency of Canada
100 Colonnade Road, P.L.: 6201A
Ottawa, Ontario K1A 0K9

Or Fax them to: 1-877-248-3528

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.

Who does not have to register?

There are exemptions and exclusions in the HPTA that are designed to narrow the application of the Act.

Section 4 of the HPTA provides an exclusion for human pathogens or toxins that are found in the environment in which they naturally occur, if the human pathogen or toxin 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.

Natural environments for a human pathogen or toxin include blood, soil, or water samples. If you only deal with such samples, 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 the human pathogen or toxin from the sample, you are not required to register under section 70.  Examples include municipal water treatment facilities that often collect water that is known to contain human pathogens or toxins, and medical professionals who collect blood samples for diagnostic testing purposes.

Section 4 also contains exclusions from the application of the HPTA for drugs authorized for sale under the Food and Drugs Act and any controlled activity within the meaning of the Assisted Human Reproduction Act. 

There are also exemptions for persons who collect samples for the purposes of laboratory analysis or the purposes of 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.

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

 

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