How do I Know if I Need a Pathogen Transfer Letter?

Risk Group 1 Pathogens

• Risk group 1 pathogens do not require a pathogen transfer letter.
• If sending outside Canada or inside Canada but outside McMaster, the sender should use due diligence on behalf of McMaster University to ensure that the receiver has training and facilities capable of handling the Risk Group 1 pathogen. This may be in the form of a letter or an email affirming such capabilities that the sender will keep on file should that documentation ever be requested. If, as a result of the transfer, the sender ceases to possess that pathogen, the sender must update their BUP to reflect this.
• If sending within McMaster the receiver must update their BUP to add the Risk Group 1 pathogen to their inventory. If, as a result of the transfer, the sender ceases to possess that pathogen, the sender must update their BUP to reflect this.

Risk Group 2 Pathogens

• If the pathogen was NOT originally imported i.e. there is no import permit associated with that pathogen, OR the pathogen WAS imported but PHAC or CFIA import permit does NOT have restriction #9 or #5 ticked respectively then the sender does not require a pathogen transfer letter.
  • If sending outside Canada, the sender must follow TDG regulations and contact John Bentley or Jan Yeo for export instructions.
  • If sending inside Canada but outside McMaster, the sender must use due diligence on behalf of McMaster University to ensure that the receiver has a valid compliance letter, the documentation of which the sender shall keep on file should that documentation ever be requested. If, as a result of the transfer, the sender ceases to possess that pathogen, the sender must update their BUP to reflect this.
  • If sending within McMaster, the sender must ensure that the receiver has a valid compliance letter. The receiver must update their BUP to add the Risk Group 2 pathogen to their inventory. If, as a result of the transfer, the sender ceases to possess that pathogen, the sender must update their BUP to reflect this.
• If the pathogen WAS originally imported and the PHAC or CFIA import permit DOES have restriction #9 or #5 ticked respectively, then the sender does require a pathogen transfer letter as outlined below.

Human Pathogen Transfer (PHAC)

This requires a Transfer Letter from PHAC.

This section applies to those who:

1. Have a BSL2** agent in their possession and wish to transfer it to another researcher either inside or outside of McMaster University and within Canada and,
2. The BSL2** agent was originally imported and the import permit has restriction #9 checked
   • Restriction #9 states "No imported material may be removed to another location or transferred into the possession of a person other than the importer without the permission of the director."

The goverment legislation which applies to these transfers is:

Human Pathogens Importation Regulations

The HPIR describes in section 16(2):

A person who has imported a human pathogen and who intends to transfer the human pathogen to another person shall submit an application in writing to the Director that sets out

(a) the importation permit number for the human pathogen;

(b) the intended date of transfer;

(c) the name and address of the person to whom possession of the human pathogen is to be transferred together with that person’s written consent to the transfer and written undertaking to comply with the conditions of the importation permit;

(d) the address and description of the facilities to which the human pathogen is being transferred; and

(e) the transport arrangements for the movement of the human pathogen.

The Pathogen Transfer Application (PHAC) may be used.

Animal Pathogen Transfer (CFIA)

This requires a Transfer Letter from CFIA.**

Q16 Are we allowed to transfer an animal pathogen/product acquired with an import permit to another laboratory or facility?

As stated on the permit, imported animal pathogen/product can only be transferred to another laboratory or facility with the approval of the Office of Biohazard Containment & Safety, CFIA. To receive a transfer letter, which permits the relocation of the imported animal pathogen/product to another laboratory or facility, you will need to provide to the Office of BCS the following information:

• Permit number under which the product was imported
• Product description
• Name and address of product holder
• Name and address of product receiver and room # where the product will be manipulated
• Containment level 2 inspection checklist for the room where the product will be manipulated
• Objective of work

For specific questions regarding transfer of animal pathogens that were not originally imported, contact the Biosafety Office.

** Transfer of BSL1 agents does not require a transfer letter.

** For agents with a containment level higher than BSL2, please contact the Biosafety Office at ext 24956