AAV PF-06838435 Added to Substances List

Summary#

Order 2020-112-09-01 Amending the Domestic Substances List adds one living organism — Non-replicating recombinant adeno-associated virus PF-06838435 containing AAV‑Spark100 capsid and encoding a codon-optimized human coagulation Factor IX variant with a high specific activity — to the Domestic Substances List. The order took effect on June 19, 2020.

What it does#

• Adds the named non-replicating recombinant adeno-associated virus to Part 5 (organisms) of the Domestic Substances List.
• Because it is now on the list, that organism is no longer subject to the New Substances Notification Regulations (Organisms).
• The change was made under the Canadian Environmental Protection Act, 1999 and came into force on the day the order was registered (June 19, 2020).
• The government notes this is an administrative action; it does not mean the government endorses the substance, nor does it exempt the substance from any other laws or rules that might apply.

Who's affected#

• The company or person who submitted the required information about the organism (they met the rules for adding it).
• Biotech companies, researchers, and labs that work with adeno‑associated viruses or related gene‑therapy tools — they may find it easier to obtain or use this specific organism in Canada.
• Importers or manufacturers of that organism in Canada.
• Regulators and public health or environmental officials who track listed substances.
• The general public is unlikely to notice any direct change; the order is primarily about regulatory status. If it’s unclear who will use this exact virus, that is because the order does not name a company or intended use.

Why it matters#

• Being on the Domestic Substances List means the organism is treated as an existing substance in Canada. That removes the requirement for new‑substance notification under the NSNR (Organisms), which can lower paperwork and speed access for research or commercial use.
• This is an administrative step, not a safety finding: it does not itself change how the substance must be handled under other health, safety, or environmental laws.
• People following developments in biotechnology, gene therapy, or regulatory oversight may want to know this because it affects how that specific viral product is regulated in Canada.