Alexandra Ribarits, Werner Brüller, Josef Hartmann, Rupert Hochegger, Klemens Mechtler, Verena Peterseil, Josef Söllinger, Walter Stepanek, Ingomar Widhalm, Markus Wögerbauer, and Charlotte Leonhardt
Austrian Agency for Health and Food Safety

Genetically modified plants (GMP) are regulated by comprehensive EU legislation. Cisgenesis, intragenesis, oligo-directed mutagenesis (ODM), zinc-finger nucleases (ZFN), and agroinfiltration were examined concerning detection, traceability, labeling, and risk assessment. Similar transformation methods—as in transgenesis using genetic elements from same or crosscompatible plant species—characterize cisgenesis and intragenesis. Targeting the genome with ODM or ZFN minimizes unintended effects, but current data indicate limited efficiency and specificity; modifications are similar to those occurring during traditional plant breeding. The characteristics of plants produced by these techniques affect detection in the supply chains. Detection is possible when the target site is known, except for agroinfiltration that aims at transient expression of a gene/trait. The basis to assess potential risks arising from relevant plants and derived food and feed is similar to that of GMP. Depending on the specifics of the plant under investigation, data requirements for regulators may be reconsidered case-by-case.

Key words: Agroinfiltration, cisgenesis, food/feed safety, gene targeting, genetically modified plants, new breeding techniques, oligonucleotide-directed mutagenesis, protein engineering, risk assessment, zinc fingers.