Two recombinant viruses added to Domestic Substances List

Summary#

Order 2020-112-15-01 Amending the Domestic Substances List: SOR/2020-274 adds two living organisms to the federal Domestic Substances List. The order was registered (and therefore came into force) on December 13, 2020 and was published in the Canada Gazette on December 23, 2020.

What it does#

• Adds these two living organisms to the Domestic Substances List:
  • Recombinant non-replicating Human adenovirus C, EI/E3 deleted, encoding for a human interferon alpha-2b cDNA driven by cytomegalovirus and adenovirus type 2 tripartite leader N
  • 19493-1 N Recombinant paramyxovirus encoding transgene (MRK-RPET-001)
• Once listed, these organisms are no longer subject to the notification/assessment steps in the New Substances Notification Regulations (Organisms). That means the specific paperwork and assessment process for “new” organisms under those rules no longer applies to them.
• The order does not mean the government endorses these organisms. Other laws or rules (health, transport, workplace safety, or import controls) may still apply.

Who's affected#

• Companies, research labs or institutions that manufacture, import, sell or use the two listed organisms.
• Biotechnology and pharmaceutical firms, and public health or clinical labs, if they work with these specific strains.
• Regulators and safety officers who track whether organisms are treated as “new” under federal rules.

It is not clear from the order which specific companies or groups originally submitted the information or first brought these organisms into Canada.

Why it matters#

• For businesses and researchers dealing with these two organisms, the change removes a specific federal new‑substance notification step. That can make it faster or simpler to continue using or importing them.
• The change is administrative: the government says it does not create costs or new obligations for small businesses.
• Listing does not mean the organisms are judged “safe” in every context, nor does it remove other legal or safety requirements (for example, for transport, workplace safety, clinical use, or environmental release).