When are baculoviruses assigned to risk group 2?

Viruses of the family Baculoviridae (Baculoviruses) infect larval stages of insects of the order Lepidoptera (butterflies), Hymenoptera (hymenoptera), and Diptera (diptera). They are also taken up by vertebrate cells, including human cells, but the viral genome is neither expressed nor replicated in these cells. According to Section 5 and Annex 1 No. 1 of the GenTSV, baculoviruses are considered donor and recipient organisms for genetic engineering work by Risk group 1 assigned.

Recombinant baculoviruses have become very important for the expression of heterologous proteins in insect cells and the baculovirus that is usually used and best characterized for this purpose is the Alphabaculovirus aucalifornicae (Autographa californica multiple nucleopolyhedrovirus, AcMNPV). Recombinant AcMNPV with an unaltered or pseudotyped envelope, which transmits a heterologous gene without potential hazard, are Risk group 1 assigned.

Recombinant AcMNPVs with an unaltered envelope that encode heterologous genes with a potential risk to insects under the control of an insect-specific promoter are assigned to risk group 1 according to Section 5 and Annex 1 No. 2 of the GenTSV if the chiA, v-cath, p10, and ph genes in their genome have been inactivated. Recombinant AcMNPVs with an unaltered or pseudotyped envelope that encode an oncogene (ZKBS statement on nucleic acids with neoplastic transforming potential) Ref. No.: 6790-10-01 ) or a** prion protein** (PrP) gene or PrP variants with a high probability of spontaneous conversion (Statement of the ZKBS on the risk assessment of genetic engineering work for the expression of PrP in mammalian cells Az. 6790-10-75 ) are, according to § 5 and Annex 1 No. 2 GenTSV of the Risk group 2 When handling GMOs of risk group 2, the ZKBS recommends the following additional safety measures for personal protection: wearing protective goggles, disposable gloves, a mouth/nose mask to prevent nasal or oral ingestion through direct contact, and ensuring that work is not carried out by people with skin barrier disorders.

The full statement can be found at the File number 6790-05-02-41 on the ZKBS website.