Biosafety and biosecurity for pathogens and toxins news: Q2, July 2021 issue

On this page

• New Canadian biosafety guideline: Human Diagnostic Activities
• Risk factors for increased exposure incidents
• Are you exempt or excluded from requiring a licence
• RegFacts: #DYK
• Research security and collaboration
• Poliovirus potentially infectious material (PIM)
• Closing out PHAC's regulatory openness and transparency framework

New Canadian biosafety guideline: Human diagnostic activities

The Public Health Agency of Canada (PHAC) has published the new Canadian Biosafety Guideline on Human Diagnostic Activities. It outlines general biosafety considerations and best practices when conducting diagnostic activities with samples that may contain a human pathogen. It also describes:

• diagnostic activities for which theHuman Pathogens and Toxins Act (HPTA) and Human Pathogens and Toxins Regulations (HPTR) may apply
• diagnostic activities for which only the Health of Animals Act (HAA) and Health of Animals Regulations (HAR) may apply
• risks associated with certain diagnostic activities
• safe work practices for handling primary specimens during diagnostic activities
• risk mitigation measures used in diagnostic laboratories to prevent exposure to, and release of, human pathogens

You should use this guideline in conjunction with the Canadian Biosafety Standard.

Risk factors for increased exposure incidents

Applying laboratory biosafety and biosecurity measures reduces exposure incidents that could lead to outbreaks.

The Centre for Biosecurity (CB) has a mandatory Laboratory Incident Notification Canada (LINC) surveillance system. The LINC gathers data from submitted reports of laboratory incidents involving human pathogens and toxins. Using data from 2016 to 2020, we modelled incident exposures while controlling for factors that contribute to more exposure reporting. We identified the factors associated with increased incident exposures and assigned each one a magnitude.

After controlling for the factors in the model, we found that:

• for each root cause related to human interaction, the monthly number of exposure incidents was about 1.11 times higher than normal
• for each root cause related to lack of compliance with standard operating procedure (SOP), the monthly number of exposure incidents was about 1.13 times higher than normal

Previous LINC annual reports showed that technicians were involved in most of the exposure reports. This might be due to their high numbers in laboratories. The current analyses show that their contribution was not significant in predicting exposure incidents. To reduce exposure incidents, future laboratory biosafety and biosecurity measures should target human interaction and lack of compliance to SOPs.

Are you exempt or excluded from requiring a licence

You may be exempt or excluded from requiring a pathogen and toxin licence under the HPTA and its regulations if you're working with:

• risk group 1 micro-organisms
• a pathogen contained in an environment in which it naturally occurs (such as human tissue, blood, plant, soil, water), and it will not be extracted and propagated
  • if this pathogen is a terrestrial animal pathogen that will be imported, you may require a HAR import permit, issued by PHAC
  • if the pathogen is in an animal or animal product or by-product, the import permit will be issued by the Canadian Food Inspection Agency
• any nucleic acid (such as cDNA or fragmented nucleic acids) except the full genome of a regulated virus composed of positive sense single stranded RNA
• a protein that is not a prion
• a toxin that is not listed in Schedule 1 of the HPTA
• a cell line that does not contain an intact pathogen
• a drug in dosage form

or:

• you're conducting diagnostic testing as defined in section 27(1) of the HPTR and:
• the pathogen is not cultivated or produced, or
• any production uses a sealed container that prevents its release

If you have any questions or are unsure if you're exempt or excluded under the HPTA and its regulations, please contact the licensing program by email at licence.permis@phac-aspc.gc.ca or by phone at 613-957-1779.

RegFacts: #DYK

PHAC may order applicants, licence holders and biological safety officers to provide information relevant to the administration of the HPTA and the HPTR. An inspector does not need to be present on site to request this information. PHAC may require you to submit any information through an order under section 38 of the HPTA at any time.

You must keep all biosafety and biosecurity policies, standards, and practices up to date so that you can quickly respond to any such orders. This includes those related to document retention and records. Please refer to the Canadian Biosafety Standard to verify that you meet the minimum standards.

Research security and collaboration

Espionage and foreign interference activities by both human and cyber actors pose real threats to:

• research integrity
• intellectual property
• business interests

All Canadian research organizations have a role to play in safeguarding their valuable research.

The research community values its open and collaborative environment, which promotes creativity and innovation. This open and collaborative environment also makes an attractive target.

On March 24, 2021, the Government of Canada announced new steps in safeguarding research. These steps will help protect Canada's investments in science and research. The Ministers of Health, Public Safety and Emergency Preparedness, and Innovation, Science and Industry released a joint policy statement on research security and new collaborations with academia

In it, they asked the Government of Canada-Universities Working Group to develop specific risk guidelines to integrate national security considerations into the evaluation and funding of research projects and partnerships.

These risk guidelines will help researchers, research institutions, and government funders assess and reduce potential risks to research security. The Granting Councils and the Canada Foundation for Innovation are currently reviewing their security policies and procedures. Their goal is to better integrate national security considerations into their activities.

All organizations should remain vigilant and alert to the potential threats outlined in the September 2020 policy statement about research security and COVID-19.

Please explore these links for helpful tools and information:

• Safeguarding Your Research
• Safeguarding Science
• Building Security Awareness in the Academic Community
• Laboratory Biosafety and Biosecurity Training Portal

Poliovirus potentially infectious material (PIM)

All World Health Organization (WHO) member states have made an international commitment (PDF) for the containment of polioviruses. This includes setting up a national poliovirus inventory. CB maintains and updates the National Poliovirus Inventory for facilities that handle or store poliovirus and potentially infectious material (PIM).

Poliovirus potentially infectious materials (PIM) are:

• human fecal samples
• respiratory samples
• concentrated sewage samples
• derivatives of the above

They must have been:

• stored in conditions that support poliovirus survival and
• collected:
  • where poliovirus was circulating or
  • when oral polio vaccine (OPV Sabin) was in use

Poliovirus in clinical or environmental specimens survive:

• indefinitely in the laboratory freezer (≤-20°C)
• for many months in the refrigerator
• for hours-to-days on the laboratory bench-top

Laboratories storing eradicated wild-type poliovirus must obtain certification under the WHO's Global Action Plan III (GAPIII) as a Poliovirus-Essential Facility (PEF).

You may have poliovirus PIM if you have samples from a time and place where any of the following were circulating:

• wild poliovirus
• vaccine-derived poliovirus
• oral polio vaccine (Sabin)

The WHO published a guidance document (PDF) to help facilities determine whether they possess PIM.

If you believe you have poliovirus PIM, contact CB (biosafety.biosecurite@phac-aspc.gc.ca).

Closing out PHAC's Regulatory Openness and Transparency Framework

PHAC closed out the Regulatory Openness and Transparency Framework (ROTF) in March 2021. We did this to focus on regulatory initiatives with higher impact, while continuing to contribute to federal Open Government objectives.

PHAC launched the ROTF in 2017 as a reporting mechanism on its activities supporting the Government of Canada's goals of openness, transparency, and accountability.

Under the Government of Canada's "open by default" approach, CB continues to support and engage stakeholders regulated under the biosecurity regulatory framework. We do this by developing regulatory guidance and training webinars.