SARS-CoV-2 has been reclassified as a Hazard Group 2 (HG 2) agent in the Approved List of biological agents.

Users may therefore want to reassess their classification of existing activities with genetically modified (GM) SARS-CoV-2 under the Genetically Modified Organisms (Contained Use) Regulations 2014.

Reclassification of SARS‑CoV‑2 as a HG 2 agent does not automatically mean a GM SARS‑CoV‑2 Class 3 activity can be reclassified as Class 2. An updated GM risk assessment is still required to determine the correct classification.

You can view the sixth edition of the Approved List of Biological Agents on the HSE website.

The following scenarios show when you need, or don't need to take action as a result of this change:

When Class 3 consent is held

Scenario 1

A user holds consent for Class 3 activities with GM SARS-CoV-2. The notification did not incorporate any GM Class 2 activities with coronaviruses. The user now intends to reclassify all or part of those Class 3 GM SARS-CoV-2 activities as Class 2, to carry out at Containment Level 2:

Action:

• new Regulation 10 notification required for the Class 2 activities
  
  

Scenario 2

A user holds consent for Class 3 activities with GM SARS-CoV-2. The notification did incorporate GM Class 2 activities with coronaviruses. The user now intends to reclassify all or part of the GM SARS-CoV-2 activities as Class 2 to carry out at Containment Level 2:

Action:

• no notification is required if the reclassified elements are within scope of the previously included Class 2 activities
• a Regulation 15 significant change notification should be made where these activities fit within the scope of the previously included Class 2 activities but create a significant change (covered by paragraphs 95 to 100 of the Genetically Modified Organisms (Contained Use) Regulations 2014)
• a new Regulation 10 notification should be made for the Class 2 activities where these are beyond the scope of the previously included Class 2 activities
  
  

Scenario 3 

A user holds consent for Class 3 activities with GM SARS-CoV-2, and intends to continue those as Class 3 activities.

Action:

• no new notification required
  
  

When Class 2 clearance is held

Scenario 1

A user holds Class 2 clearance for activities with coronaviruses; they assess the use of GM SARS-CoV-2 as class 2 and its incorporation into the original Class 2 activity does not create a significant change (covered by paragraphs 95-100 of the Genetically Modified Organisms (Contained Use) Regulations 2014):

Action:

• no new notification required
  
  

Scenario 2

A user holds Class 2 clearance for activities with coronaviruses. They assess the use of GM SARS-CoV-2 as Class 2 and its incorporation into the original Class 2 activity does create a significant change:

Action:

• new Regulation 15 (significant change) notification required