G/TBT/N/CAN/421  
 
25 August 2014  
(14-4881)  Page: 1/2  
Committee on Technical Barriers to Trade  Original: English/French  
 
  NOTIFICATION 
The following notification is being circulated in accordance with Article 10.6 
 
1. Notifying Member: CANADA 
If applicable, name of local government involved (Article 3.2 and 7.2):    
2. Agency responsible: Public Health Agency of Canada 
Name and address (including telephon e and fax numbers, email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above : 
Canada's SPS & TBT Notification Authority and Enquiry Point 
Foreign Affairs, Trade and Development Canada 
Technical Barriers and Regulations Division (TIB) 111 Sussex Drive Ottawa, ON  K1A 0G2 
Canada 
Telephone: (343)203-4273 Fax: (613)943-0346 
E-mail: enquirypoint@international.gc.ca  
3. Notified under Article 2.9.2 [ X ], 2.10.1 [   ], 5.6.2 [   ], 5.7.1 [   ], other:  
4. Products covered (HS or CCCN where applic able, otherwise national tariff heading. 
ICS numbers may be provided in addition, where applicable): Human pathogens and 
toxins  
5. Title, number of pages and language(s) of the notified document: Proposed Human 
Pathogens and Toxins Regulations (39 pages, available in English and French) 
6. Description of content: Human pathogens and toxins pose a risk to human health and 
public safety. Prior to 2009, the Human Pathogens Importation Regulations  (HPIR) 
regulatory program had oversight over imported human pathogens and toxins, but not 
domestic agents. With the passage of the Human Pathogens and Toxins Act  (HPTA) in 2009, 
select provisions came into force to provide interim measures until a complete program and 
regulatory framework could be developed. The impact of an intentional or unintentional 
misuse of human pathogens and toxins on public  health and safety ca n be significant, and 
the proposed Human Pathogens and Toxins Regulations  (HPTR) would further reduce that 
risk. 
The HPTR would establish licensing and security requirements for all Canadians who possess, 
handle, use, produce, store, transfer or release human pathogens or toxins. This will replace the current HPIR requirement to hold an import permit to acquire these agents from a non-
domestic source.  
The HPTR would be complemented by additional non-regulatory facility and operational 
standards for the same list of activities conducted with human pathogens and toxins in 
Canada. Previous versions of this standard have been in place since 1990. 
Note: Canada is notifying the Regulation under the TBT Agreement in the interest of 
transparency. G/TBT/N/CAN/421 
 
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  7. Objective and rationale, including the nature of urgent problems where applicable: 
Protection of human health or safety  
8. Relevant documents:  Canada Gazette , Part I, 21 June 2014, Pages 1564-1602 (available 
in English and French) 
9. Proposed date of adoption:   Normally within 6 to 8 months of publication in the Canada 
Gazette, Part I. 
Proposed date of entry into force:   The proposed Regulations come into force 
1 December 2015. This licensing scheme would replace the current import permit regime 
under the HPIR. Once the proposed HPTR come into force, those subject to the new licensing regime would have 90 days to apply for a licence so that ongoing activities would not be interrupted or ad versely impacted. 
10. Final date for comments: 4 September 2014 
11. Texts available from: Nati onal enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:  
The electronic version of the regulatory text can be downloaded at: 
http://www.gazette.gc.c a/rp-pr/p1/2014/2014-06 -21/pdf/g1-14825.pdf 
http://www.gazette.gc.c a/rp-pr/p1/2014/2014-06 -21/html/reg2-eng.php  
http://www.gazette.gc.c a/rp-pr/p1/2014/2014-06 -21/html/reg2-fra.php