Pathogen Transfer Letter (Human Pathogens Importation Regulations and Health of Animals Act)

A Pathogen Transfer Letter is required if the pathogen (including viable human or animal cells) to be transferred meet ALL FOUR of the following criteria.

1. Risk group 2 or higher.
2. To be transferred to another Canadian institution.
3. Originally imported.
4. Transfer or distribution restrictions are specified on the import permit(s).

Otherwise a pathogen transfer letter is not required. If a pathogen transfer letter is not required, please ensure that due diligence is followed such that the receiver of the material has the laboratory facilities and trained workers capable of handing the pathogen that is being transferred.

• If risk group 1, regardless of destination, this can be in the form of an email or printed letter that shall be kept on file in the laboratory.
• If risk group 2 and in Canada, this shall be in the form of a valid compliance number from the receiving lab.
• If risk group 2 and outside Canada, this can be in the form of an email or printed letter that shall be kept on file within the laboratory.

All shipments of infectious substances of all risk groups shall comply with TDG regulations.

The sender should liase with McMaster Customs (John Bentley or Jan Yeo) for export instructions if applicable. Also see our website on Sending Biologicals.

If the receiver is a McMaster laboratory, their Biohazard Utilization Protocol must be updated to reflect the addition of the pathogen to their inventory.

If as a result of the transfer, the sender ceases to possess the pathogen, their Biohazard Utilization Protocol must be updated to reflect this.

Also see the Laboratory Biosafety Guidelines, Chapter 10, Regulatory Aspects of Handling Infectious Substances.

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 23453