HPTA Security Clearance Program
The HPTA Security Clearance is a requirement under the Human Pathogens and Toxins Act (HPTA). The supporting process and information requirements are set out under the Human Pathogens and Toxins Regulations (HPTR).
You are required to obtain an HPTA Security Clearance if you work with, or have access to, prescribed human pathogens and toxins, known as Security Sensitive Biological Agents (SSBAs), that if misused, can pose a risk to Canada's national security. This requirement also extends to individuals that open SSBA shipments, or handle/care for animals experimentally infected with SSBAs, excluding toxins. If you currently work with toxins, refer to subsection 10(2) of the HPTR to determine the quantities which trigger the requirement to obtain an HPTA Security Clearance.
To address the issue of shared lab spaces, an HPTA Security Clearance is not required where no SSBA is present in a lab, or when any SSBA is locked up and inaccessible to any person who does not have an HPTA Security Clearance.
An HPTA Security Clearance is not the same as a general security clearance issued by the Government of Canada. 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. The HPTA Security Clearance is one component of a robust biosecurity program that will help improve the management and oversight of potential security risks in laboratories and their surrounding environments.
Applying for an HPTA Security Clearance
To apply for an HPTA Security Clearance, applicants must submit the following:
- The HPTA Security Clearance Application Form: Includes information required by the HPTR such as the applicant's name, address, and date of birth; information regarding spouse or common-law partner; and residence, employment, and travel history. It lists the supporting documents to be submitted along with the completed form.
- The HPTA Security Clearance Endorsement Form: Must be co-signed by the licence holder to certify that the applicant requires an HPTA Security Clearance to access the specified containment zone(s). A new endorsement form is required if a security cleared individual requires access to other organizations or part(s) of a facility containing SSBAs not previously identified in their initial application.
As part of a security risk assessment, the Royal Canadian Mounted Police and the Canadian Security Intelligence Service will conduct database checks on the information provided in your application. A credit check will also be conducted.
The HPTA Security Clearance will be valid for up to five (5) years, and is portable between licenced facilities.
The Public Health Agency of Canada (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.
HPTA Security Clearance Appeal Process
If an applicant or HPTA Security Clearance holder has had their clearance denied, suspended, or revoked, they will have the option to appeal by requesting a reconsideration of this decision within 30 calendar days after the day on which the notice of denial, suspension, or revocation was received.
The Agency will provide written notice to every licence holder or licence applicant when a decision is made to issue, refuse to issue, suspend, or revoke an HPTA Security Clearance. The criteria for the suspension and revocation of HPTA Security Clearances are set out in sections 20 and 21 of the HPTR.
Frequently Asked Questions
Mandatory reporting of missing and stolen human pathogens and toxins
Biosecurity events that involve missing or stolen human pathogens or toxins are subject to mandatory reporting under Section 14 of the Human Pathogens and Toxins Act. The reporting requirements specify that your organization submit 1) a description of the event; 2) the name of the human pathogen or toxins involved; and 3) any other relevant information about the event.
For immediate reporting of biosecurity events involving missing or stolen pathogens or toxins, submit the event via the biosecurity portal using your login credentials. For all other inquiries, contact the Public Health Agency of Canada by telephone or email.
Voluntary reporting of suspicious activities involving human pathogens and toxins
Suspicious activities and behaviour involving human pathogens and toxins or related assets, not otherwise mandated for reporting under section 14 of the Human Pathogens and Toxins Act, can be voluntarily reported to the Public Health Agency of Canada. For more information contact the Centre for Biosecurity.
Centre for Biosecurity, Public Health Agency of Canada
Voluntary reporting of other suspicious activities within your organization
If you suspect that you have received an email from an unrecognized person, or observed activities in and around your organization's facility that is suspicious in nature, it is encouraged that you report the incidents to the Government of Canada as well as your organization's internal security department.
Suspicious email and cyber event
Suspicious emails received from unrecognized contacts can be reported to the Canadian Centre for Cyber Security (the Cyber Centre) by telephone or email.
Suspicious activities and behaviours
Suspicious activities and behaviour observed in and around your organization's facility by unrecognized individuals should be reported to local law enforcement or the Royal Canadian Mounted Police (RCMP). The RCMPs National Critical Infrastructure Team manages Canada's Suspicious Incident Reporting System (SIR). Contact the RCMP for more information on the SIR.
Royal Canadian Mounted Police
Non-urgent national security-related threats or suspicious activities
For non-urgent national security-related threats or suspicious activities of unrecognized persons, suspicious events, or computer-related activities, contact the Canadian Security Intelligence Service.
Laboratory Biosafety and Biosecurity
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