Biosecurity - Frequently Asked Questions
Security Sensitive Biological Agents (SSBAs)
1. What are SSBAs?
Security sensitive biological agents, or SSBAs, are a subset of Risk Group 3 and 4 human pathogens and prescribed toxins that are included in Schedule 1 of the Human Pathogens and Toxins Regulations (HPTR) and also on the Australia Group "List of Human and Animal Pathogens and Toxins for Export Control" (AG List). If they are misused, SSBAs can pose a risk to Canada's national security, which is why individuals who work with them will be assessed through the HPTA Security Clearance process. The Agency's list of SSBAs is available online and published in section 10 of the Human Pathogens and Toxins Regulations (HPTR).
2. What is the Australia Group?
The Australia Group (AG) is a cooperative and voluntary group of countries working to counter the spread of technologies and materials that may facilitate the development or acquisition of chemical and biological weapons by States of concern or terrorists. The principal objective of Australia Group members is to use licensing measures to better control exports of certain chemicals, biological agents, and dual-use chemical and biological manufacturing facilities and equipment, to reduce the risk that they contribute to the spread of Chemical or Biological Weapons. Canada's representation at the AG is coordinated through the Global Affairs Canada (GAC).
3. What happens if the Australia Group makes a change?
The SSBA list (published on the Agency's website) will reflect the most up-to-date version of the AG List. Amendments (additions or deletions) are made to the AG List only when consensus is achieved by participating member countries that the agent meets the criteria for inclusion or deletion (i.e., the risk profile, threat potential of the agent has changed).
4. What happens in the case of an emergency, can the Agency amend the list?
In cases where prompt action is required to address serious and imminent danger to the health or safety of the public, the Minister of Health may use an Interim Order under section 67 of the HPTA to prescribe a new and/or emerging risk group 3 or 4 human pathogen or toxin as an SSBA.
5. Will work with toxins require an HPTA Security Clearance?
The Agency has prepared a list of toxins that will require an HPTA Security Clearance if an individual is in possession of a toxin in an amount that exceeds the threshold limits stated in section 10 of the HPTR. Individuals working with toxins in quantities less than the indicated trigger quantity will not require an HPTA Security Clearance. Please consult the ePATHogen database for a complete list of SSBA toxins, and section 10(2) of the HPTR for associated trigger quantities.
The HPTA Security Clearance
6. What is the HPTA Security Clearance?
The HPTA Security Clearance is a new requirement under the Human Pathogens and Toxins Act (HPTA). The purpose of the HPTA Security Clearance is to validate that those who have access to and/or handle SSBAs are reliable and trustworthy, and do not pose a security or diversion risk by virtue of their access. HPTA Security Clearances will be valid for up to 5 years and will be portable between licensed facilities.
7. Who requires an HPTA Security Clearance?
You are required to obtain an HPTA Security Clearance if you conduct controlled activities with SSBAs, or have access to the part(s) of a facility where controlled activities with SSBAs are authorized. This requirement also extends to individuals that open SSBA shipments, or handle/care for animals experimentally infected with SSBA pathogens. The requirement to hold an HPTA Security Clearance does not apply if the SSBAs in question are not present or locked away and inaccessible.
Individuals who do not hold an HPTA Security Clearance may access part(s) of a facility where controlled activities with SSBAs are authorized if they are accompanied and supervised by an individual who holds an HPTA Security Clearance. The HPTR specify that accompaniment and supervision of non-cleared individuals means a one to one ratio with activities monitored at all times by an individual who holds an HPTA Security Clearance. Individuals who have had their HPTA Security Clearance suspended or revoked cannot access the part(s) of a facility where controlled activities with SSBAs are authorized, even when accompanied and supervised.
8. What if I share lab space where controlled activities with SSBAs are taking place? Do I need an HPTA Security Clearance?
Individuals who do not hold an HPTA Security Clearance will only be allowed to access the part(s) of a facility where controlled activities with SSBAs are authorized if the SSBAs are not present or locked away and inaccessible, or if the individual is accompanied and supervised by an individual who holds an HPTA Security Clearance.
9. I have a security clearance issued by a Canadian Government Department/from another country, does this exempt me from the security clearance requirement in the HPTA?
Possession of a different security assessment or clearance from the government of Canada or from any other entity or country is not considered as equivalent to an HPTA Security Clearance, however, this may be considered in support of an application.
10. How do I apply for an HPTA Security Clearance?
To apply for an HPTA Security Clearance, applicants will be required to fill out and submit the HPTA Security Clearance Application Form, the HPTA Security Clearance Endorsement form (signed by the relevant licence holder), and submit their fingerprints through an accredited agency. The application forms are available as fillable and accessible PDFs online.
The HPTA Security Clearance Application form contains information about the applicant such as, name, date of birth, nationality, address, employment, education, travel, and marital status, whereas the HPTA Security Clearance Endorsement form is a statement from the licence holder endorsing the applicant's need for an HPTA Security Clearance. As a Security Clearance is directly tied to the applicant and not the laboratory, each time a Security Clearance holder is to work elsewhere a new endorsement must be submitted by license holder
11. How will the information I submit in my application be used?
The information provided in an HPTA Security Clearance Application will be used to conduct record checks for the purpose of making a determination that the applicant does not pose an undue risk to the health or safety of the public.
The applicant's information will be provided to the RCMP, CSIS, and other relevant law enforcement/intelligence agencies for the purpose of conducting the following record checks:
- a criminal record check;
- a check of the relevant files of law enforcement/intelligence agencies, including intelligence gathered for law enforcement purposes;
- a CSIS security assessment;
- a credit check; and
- a check of the applicant's immigration and citizenship status (if applicable).
12. How long will it take to get an HPTA Security Clearance?
The Agency commits to service delivery standards for the issuance of an acknowledgement of receipt of a HPTA Security Clearance application and for the issuance of a HPTA Security Clearance upon receipt of a complete application that contains no adverse information.
13. How will the HPTA Security Clearance process affect foreign nationals?
Foreign nationals are eligible to apply for an HPTA Security Clearance. It is anticipated that these applications may require more time to process as consultation with the home country may be required. In addition to the standard information required by Canadian citizens and permanent residents, foreign nationals will be also be asked to supply a copy of their curriculum vitae, a valid visa (if applicable), and the results of a police record check from every jurisdiction where they have lived for the past five years.
Finally, all applicants are required to submit fingerprints taken by a company accredited by the RCMP; therefore, foreign nationals who are outside Canada at the time of the application may need to travel to Canada to submit their fingerprints for processing. Please contact the Agency if you are in this position.
14. Will there be a fee for a security clearance?
There will be no fee charged by the Agency to apply for an HPTA Security Clearance however there will be a fee associated to the taking of fingerprints by RCMP accredited agencies.
15. Why do I have to submit my fingerprints and how do I submit them?
Fingerprinting is a means of accurately identifying a person in the event they have been printed in the past and a record is held at the RCMP. Applicants will be asked to provide digital finger prints which will be automatically sent to the RCMP for verifications.
The cost to have your fingerprints taken is at the discretion of the law enforcement or other RCMP-accredited agency taking them, and as such, the Agency will not cover these costs.
The cost for this service will vary from one agency to another (approximately $30-$150).
16. Why do you need personal information on my spouse/common-law partner?
The collection of personal information about an applicant's spouse/common-law partner is necessary to determine if the applicant has, or has had, association of concern with individuals who may pose an undue risk to the health or safety of the public.
17. I have a criminal charge that is still not resolved; will this affect my ability to get an HPTA Security Clearance?
If any criminal charge is outstanding against the applicant, the Minister may postpone processing of the HPTA Security Clearance application until the charge is disposed of by the courts, and will notify the applicant in writing of such postponement.
18. I am working with a risk group 2 human pathogen that can produce an SSBA toxin - do I need an SSBA licence/HPTA security clearance?
Laboratories that work with strains of bacteria that produce SSBA toxins are not captured by the SSBA designation as long as the SSBA toxin is not produced to levels (mass) above the trigger quantity. If work with strains of bacteria that produce SSBA toxins results in the production of quantities of SSBA toxins that exceed the SSBA toxin trigger quantities, the work would be subject to the SSBA designation.
19. I am using a plasmid to express an SSBA toxin subunits or fragments - do I need an SSBA licence/HPTA security clearance?
It depends on the circumstance; if the plasmid does not encode for the functional form of the SSBA toxin, then no. However, if the plasmid encodes for the functional form of an SSBA toxin (not a fragment of the toxin) and is in a vector or host chromosome and/or can be expressed in vivo or in vitro, and the amount of toxin produced is in excess of the trigger quantity, then the SSBA designation would apply.
20. How will my personal information be protected?
The Privacy Act regulates the collection and use of all personal information by the federal government and governmental departments. In addition, Treasury Board Secretariat guidelines require that a Privacy Impact Assessment be conducted to examine how personal information is collected, used, retained, and shared whenever a government program gathers personal information.
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