Human Pathogens and Toxins Regulations set to begin

Effective December 1, 2015 the Human Pathogens and Toxins Regulations (HPTR) will come into effect and the HPTR regulations will establish national licensing and security clearance requirements. The Public Health Agency of Canada (PHAC) published the regulations in Canada Gazette Vol.149.

When the new licensing requirement comes into force the importation permit program will be repealed and an application for a license will be required under the HPTA to conduct controlled activities (i.e. possess, use, transfer, import, etc.) with human pathogens and toxins in Canada. It will also replace the requirement to register.

All organizations that perform controlled activities with human pathogens or toxins and are not specifically exempted from the license requirement will need to apply for a new license. The license application will be available in the Fall 2015, and organizations will have 90 days (from December 1, 2015 until February 29, 2016) to submit their license application. A human pathogen is any microorganism or parasite that causes disease in humans, including zoonotics and may be contained in cultures, diagnostic specimens, or tissue.

For more information on licensing, importing, transportation and import permit requirements, FAQ’s on the new Human Pathogens and Toxins Regulations are available on the Public Health Agency of Canada website.

Contact PHAC for further guidance:
Tel.: (613) 957-1779
Fax: (613) 941-0596