Biosafety and biosecurity for pathogens and toxins news: Q1, April 2021 issue

On this page

• Public consultation: Canadian Biosafety Standard, third edition
• Changes in risk group classification for some biological agents
• Measuring delays in submission of exposure incident reports
• The Centre for Biosecurity is conducting virtual inspections
• Reminder: Licence renewals and contact information
• RegFacts: #DYK

Public consultation: Canadian Biosafety Standard, third edition

The Public Health Agency of Canada (PHAC) and the Canadian Food Inspection Agency (CFIA) are pleased to announce the April 1, 2021 launch of the public consultation on the Canadian Biosafety Standard (CBS), third edition. Once published, the third edition will supersede the second edition, which was published in 2015.

The third edition of the CBS aims to:

• improve clarity in the requirements
• eliminate redundancies where possible
• underscore the biosafety and biosecurity intent of the requirements

We invite feedback on targeted sections of the third edition, including:

• Glossary
• Chapter 3: Physical containment requirements
• Chapter 4: Operational practice requirements
• Chapter 5: Performance and verification testing requirements
• Appendix: Explanatory notes

The online questionnaire is available from April 1, 2021 until June 15, 2021.

The public consultation is open to everyone. We strongly encourage biosafety and biosecurity professionals and those with an interest in the subject to review and provide feedback. This is a great opportunity to help improve the next iteration of the CBS.

Changes in risk group classifications for some biological agents

The Centre for Biosecurity (CB) recently completed risk assessments on the following biological agents, resulting in an increase in the human risk group (RG) classification from RG 1 to RG 2.

• Suid alphaherpesvirus 1 is now classified as RG 2 for humans and remains classified as RG 3 for animals.
• Candida auris is now classified as RG 2 for humans and remains classified as RG 1 for animals.
• Klebsiella oxytoca is now classified as RG 2 for humans and RG 2 for animals.

These biological agents are now regulated under the Human Pathogens and Toxins Act (HPTA).

We've also completed the risk assessment for Fusarium solani, which remains classified as RG 2 for humans and is now classified as RG 1 for animals.

These changes are now in effect, and we've updated our ePATHogen database accordingly. You will require a licence under the HPTA if you are conducting controlled activities with the pathogens listed above. In addition, if you wish to import Suid alphaherpesvirus 1 or K. oxytoca, you will need to contact CFIA at cfia.permission.acia@canada.ca for an import permit.

ePATHogen is updated weekly with newly added biological agents and, occasionally, with changes to RG classifications. Consult ePATHogen often to confirm that the RG of the biological agents you are using have not changed. Regulated parties will be notified of any database update that results in either:

• an increase in RG of a biological agent, or
• a decrease from RG 4 to RG 3 or from RG 3 to RG 2

For questions or concerns, contact the Biosafety Risk Assessment office at pathogens.pathogenes@phac-aspc.gc.ca.

Measuring delays in submission of exposure incident reports

A metric to measure the timeliness of reporting an exposure incident would be the time between the incident and the date of submission to Laboratory Incident Notification Canada (LINC). In 2020, the median time was 6 days with an interquartile range of 2 to 14 days. Of all reports in 2020:

• 25% were submitted within 2 days of the incident
• 50% were submitted within 6 days of the incident
• 75% were submitted within 14 days of the incident

The shortest time was 0 days, meaning that the report was submitted the same day the incident occurred. The longest was 76 days. More details will be available in LINC's annual report.

Reports for any exposure incidents involving laboratory acquired infections, suspected or confirmed, must be submitted without delay. The Canadian Biosafety Guideline on notification and reporting has not set a deadline for submitting notifications involving other reports. LINC is working to establish a baseline that would help measure and determine whether submission timelines are met.

Delays in exposure incident notification can result in delays in incident response. This can then delay actions to prevent similar incidents or disease spread. Because of this, we strongly encourage you to submit notification reports promptly. You can provide available information when an incident occurs and add more details later in a follow-up submission. Timelines for the follow-up submission could range from 2 to 4 weeks, depending on whether a security sensitive biological agent is involved.

The Centre for Biosecurity is conducting virtual inspections

CB is conducting virtual inspections of RG2 licences to monitor compliance under the Human Pathogens and Toxins Act (HPTA) and the Health of Animals Act.

Last year, PHAC diverted many resources, including biosecurity program inspectors, to the COVID-19 pandemic response, and many of these activities remain ongoing. In addition, inspector travel was cancelled due to federal and provincial government restrictions on travel. To continue compliance monitoring amid ongoing public health restrictions, inspectors will contact laboratories with RG2 licences to schedule virtual inspections. They will also provide information about how to prepare for these inspections, which will follow the same format as our on-site inspections.

The virtual inspection plan aims to minimize the impact on laboratories currently undertaking critical COVID-19 response efforts.

We carried out a virtual inspection pilot with 4 organizations that volunteered to assist us in developing our processes. We also consulted with the Canadian Public Health Laboratories Network and other regulators doing similar work, such as:

• Health Canada
• U.S. Centers for Disease Control and Prevention (CDC)

Reminder: Licence renewals and contact information

Because the Human Pathogens and Toxins Regulations (HPTR) came into force in December 2015, most RG2 licences will expire in 2021. As many of you continue to face pressures from the pandemic, we are taking a proactive approach to help you remain compliant with the HPTA/R. We are contacting organizations well before their RG2 licences expire to offer the appointed biological safety officer (BSO) or licence holder (LH) the option to renew their licence via email.

During this renewal period, please ensure that your contact information in the Biosecurity Portal is correct so that you receive emails about your licence renewal and other relevant messages. You must notify us if there will be a change in the LH or BSO.

If you have any questions, please contact the licensing program by email at licence.permis@phac-aspc.gc.ca or by phone at 613-957-1779.

RegFacts - #DYK

Did you know that the HPTA and associated regulations do not apply to the following specimens:

• a primary specimen, which is a human pathogen or toxin in an environment where it naturally occurs, as long as it has not been cultivated or intentionally collected or extracted
• a drug in dosage form whose sale is permitted under the Food and Drugs Act, or a human pathogen or toxin contained in such a drug

When working with such specimens (specifically primary specimens not regulated by PHAC) you are not required under the HPTA to report exposure incidents in a laboratory setting. This includes specimens of SARS-CoV-2 collected directly from patients.

However, there have been increasing reports of exposure incidents involving primary specimens, including SARS-CoV-2, and such incident reports may be significant in PHAC's data collection. We encourage you to disclose these incidents as part of voluntary reporting.