Sending and Receiving Biologicals
It is important that you understand the requirements for sending and receiving biologicals PRIOR to arranging to send or receive. There are cases where documents are required, which may take up to three weeks to obtain. Any process that requies a document, and you have not obtained them, may result in the return or controlled destruction of that biological. It is your responsiblity to ensure compliant movement of biologicals.
The government is being increasingly strict on imports. Items that you may have received in the past without an import permit, may not pass the border without one now. Contact email@example.com to confirm any requirements for an importation permit.
Lab audit for a lab checklist= 2 hours or more depending on # of rooms and issues
Preparation of SOPs to satisfy lab audit = days/weeks depending on the number you require
Turnaround on a lab checklist for a compliance letter once submitted to the government = 2-4 weeks
Turnaround on an import permit once submitted to the government = 1-4 weeks
Biosafety Training online = 2-3 hours
Summary - All Supervisors Must Ensure This
- All supervisors must determine which documents are required to import their item.
- Please contact John Bentley in the Customs and Traffic office to determine document requirements.
- Please contact the Biosafety Office for assistance in acquiring documentation.
- Background information and decision charts are found here.
Although the item you wish to import may be harmless to humans, this may not be the case for animals, plants or the environment.
Importing and Biocontainment
"Importing" means that you are bringing something into Canada from another country. The Canadian Border Services Agency manages items that pass into and out of our country. They will check each item's documentation for its description and determine from that description if the item requires an import permit from the Canadian Government. Government agencies involved in the importation of pathogens, animals and other items into Canada are the Public Health Agency of Canada (PHAC), the Canadian Food Inspection Agency (CFIA) and Environment Canada (EC).
Some of the items listed below require handling at a prescribed containment level. The item may be a pathogen, a toxin, or a substance positively containing a pathogen, or a substance which may very likely contain a pathogen or a substance which may possibly contain a pathogen. In some cases, biosafety containment is not prescribed however the Biosafety Office can help you navigate the import process initially so that you may import your items directly in the future. Please be advised that the Biosafety Office does not handle all import permits, only those that require biosafety oversight.
Failure to obtain an import permit will have consequences, since an import permit cannot be obtained for a package that is already on Canadian soil at the border. The receiver may choose to send the package back to the sender or in the case of perishables, the sender may choose to have the package disposed at the border.
Customs Office at McMaster
McMaster has a customs office designed to facilitate import and export of goods both to and from the University. When you receive import permits or any documentation that you require for the border, please forward a copy to the customs office so that they may be prepared to receive the shipment at the border. For customs issues that are unrelated to biosafety and containment, please contact John Bentley by e-mail.
Human and Terrestrial Animal Pathogens
These imports are handled by the Public Health Agency of Canada (PHAC).
- Any item listed on the Pathogen Safety Data Sheet website found here is regulated by PHAC
- Any item NOT listed on that website is NOT regulated by PHAC - and it is likely regulated by CFIA.
- PHAC List of microorganisms not pathogenic to humans is found here. May require a CFIA permit.
- CFIA list of E. coli strains that are not pathogenic to animals is found here.
Importation of Microorganisms under the Environmental Protection Act
These imports are regulated by Environment and Climate Change Canada (ECCC).
These imports are regulated when the imported microorganism is:
- risk group 1 and cultured to a volume of over 1000L at any one time or
- risk group 2, 3 or 4 and cultured to a volume of over 250L at any one time or
- any microorganism that is released into the environment
- The New Substances Notification Regulations (Microorganisms) is found here.
Aquatic Animals, Aquatic Animal Pathogens, Animal Products and Foreign Animal Disease Agents
These imports are handled by the Canadian Food Inspection Agency (CFIA).
- the extent of regulation of aquatic animal pathogens does not depend on risk group level; all risk group level aquatic pathogens are regulated
- If you are importing aquatic animal pathogens, your containment laboratory must comply with the Containment Standards for Facilities Handling Aquatic Pathogens
- To import risk group 2 aquatic animal pathogens for in vitro use only, you must submit a AQ2 In Vitro Checklist to receive a compliance letter which allows importation. This checklist requires an audit of your laboratory carried out by the Research Compliance Auditor Carol Carte (firstname.lastname@example.org).
- If you are importing aquatic animals, please contact the local CFIA Animal Health office (Hamilton) 905-572-2201 for guidance.
- Requirement for an import permit for an aquatic animal or aquatic animal pathogen is on a case by case basis. Always consult the Biosafety Office prior to importation.
- The aquatic import permit application is found here.
- Species list requiring import permits from CFIA aquatic/FAD is found here.
- List of susceptible species of aquatic animals which require an import permit is found here. This list is NOT exhaustive. If your species does not appear on this list, you must further confirm the requirement for an import permit by contacting John Bentley in the Customs & Traffic Office email@example.com
Plant Pests (plants, microbes, invertebrates), Plants, Seeds, Soil and Related Matter
These imports are handled by the Canadian Food Inspection Agency (CFIA).
- Importing plant pests requires compliance with Containment Standards for Facilities Handling Plant Pests
- Importing plants requires a risk assessment. Please contact the Biosafety Office before proceeding to import any plants or plant material.
- To import risk group 1 plant pathogens, you must submit a PPC-1 checklist to receive a compliance letter which allows importation by import permit. This checklist requires an audit of your laboratory carried out by the Research Compliance Auditor Carol Carte (firstname.lastname@example.org).
- To import risk group 2 plant pathogens for in vitro use only, you must submit a PPC-2 Checklist to receive a compliance letter which allows importation. This checklist requires an audit of your laboratory carried out by a CFIA Inspector or the Research Compliance Auditor Carol Carte (email@example.com).
- Importing soil requires that your containment laboratory must meet the phytosanitary requirements listed directive D-95-26. This involves arranging for an inspection by local CFIA inspectors.
- For questions regarding importing and containment with respect to plant pathogens, plants, soil and related matter, email Import Permit Office - Plant Health <PermitOffice@inspection.gc.ca>
- There are some plant pests that are regulated by Canada even if they were not imported. These plant pathogens or pests require an Authorization for Use, regardless of where they were sourced. The list of regulated plant pests is found here.
- The CFIA plant pathogen import permit webpage is here.
- If you possess a plant pest listed in the "Plant Pests Regulated Under the Plant Protection Act", regardless of it source, you must apply for "Written Authorization For Use"
- Species list requiring import permits from CFIA (plants) is found here. This list is NOT exhaustive. If your species does not appear on this list, you must further confirm the requirement for an import permit by contacting John Bentley in the Customs & Traffic Office firstname.lastname@example.org
- Another species list to check for plant pest importation requirements is found here.
- if you are importing *SEEDS* please review the ABCs of Importing Seeds on the CFIA website.
You may require multiple permits to import any plant, insect, animal or pathogen on this list:
Archaeological remains are those which were not previously alive i.e. not fossils. They may be pottery, metals, wood or other items. The concern for importing these items comes from their propensity to contain soil and plant pathogens found in soil. In this case it is imperative that the artifacts do not contain soil or plant material.
Paleontological remains are those which were previously alive i.e. are fossils. The concern for importing these items comes from the ability for fossils to contain live human or terrestrial animal pathogens, soil and plant pathogens found in soil.
- If you are importing human skeletal remains, the Quarantine Act applies. Please follow the guidance found in memorandum D19-9-3. Our contact person at the Canadian Border Services Agency with respect to importing human archaeological/paleontological remains is Martha Nino and her direct line is 1-613-948-4836 – “Commercial Border Services Program”.
- If you are importing human remains, cadavers or other human specimens, the Anatomy Act and the Coroner's Act may also apply.
- If you are importing any type of animal remains, please contact the local CFIA Animal Health Office (Hamilton) 905-572-2201 for guidance.
Animal Products, By Products, Sperm, Embryos and Feeds Containing Animal Products
These imports are handled by CFIA. Please contact the local CFIA Animal Health Office (Hamilton) 905-572-2201 for guidance. Direct line is veterinarian Dr. Sean Marshall 905-572-4347.
For special animal-based reagents or products, you may also contact veterinarian Dr. Susan Wray-Atkins (Program Specialist - Import - CFIA - Guelph Office) at 226-217-8302
Purchasing BSL2 Organisms or Cell Lines from a Distributor for in vitro work
The distributor often imports the material then transfers that material to you. They may send a number of documents. Some incoming materials may require a Material Transfer Agreement (MTA) by the Provider Institution. If you have an MTA that requires review and signature processing by an authorized representative of McMaster University, please contact Bertha Monrose in the McMaster Industry Liaison Office (MILO) at ext. 22416 or email at email@example.com for assistance.
Exporting and Shipping
Sending biological material to other institutions inside or outside of Canada requires a number of tasks to be completed.
A material transfer agreement can be obtained by contacting Bertha Monrose should such an agreement be required. This should be completed prior to sending any materials.
The sender should verify that the receiving institution has the laboratory and trained personnel suitable for handling the material. A compliance number if available, or a letter or email from the receiver attesting that the laboratory and personnel training are suitable for handling the material, is sufficient. This letter or email should be kept on file by the sender for future reference.
Depending on the nature of the material, a pathogen transfer may also be required if the receiver is in Canada.
The sender should recieve all import permits and other documentation required by the receiver's country in order to import the materials. These permits and documentation are attached to the outside of the package.
The sender should fill in a Customs Invoice and attach it to the outside of the package.
The sender requires a UN3373 sticker on the outside of the package, from Scientific Stores.
The sender requires a Dry Ice sticker on the outside of the package, from Scientific Stores.
The sender requires the waybill information on the outside of the package.
The PACKAGING must be carried out by a TDG trained individual. Packaging of the material has some requirements associated with it, found here. (Biological Substance, Category B). You must provide McMaster Customs and Traffice a copy of your valid TDG wallet card (or the card of the TDG trained person who either prepared the package or witnessed the preparation of the package) before sending your package.
McMaster Customs representatives are John Bentley.
A official Pathogen Transfer Letter is no longer required from PHAC or the division of CFIA that manages terrestrial animal pathogens. The University Biological Safety Officers of Canada have collectively created a form to use for domestic transfer of biologicals. The form is found here. You are also required to inform the Biosafety Officer prior to sending or receiving a biohazard within Canada. This is a requirement of the Human Pathogens and Toxins Regulations.
If you wish to domestically transfer an aquatic animal pathogen, or a plant pest that has an import permit associated with it, check the restrictions on that import permit first to determine if goverment approval is required. If so, contact the Biosafety Office to initiate the documents.