Research - Centre for Integrated Research on Biosafety - University of Canterbury - New Zealand

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Is oligonucleotide directed mutagenesis (ODM) a technique of genetic modification?

30 October 2015

INBI was commissioned by Greenpeace International to provide a scientific opinion on whether the use of oligonucleotide directed mutagenesis (ODM) was a technique of genetic modification as described by the current European Union regulations.

The full report is available here:
Expert scientific opinion on the status of certain new techniques of genetic modification under Directive 2001/18/EC (PDF, 1MB)

Summary-
DNA and RNA are nucleic acids. Nucleotides are the components of nucleic acids. Short chains of nucleotides, called oligonucleotides, have been used for genetic engineering for decades. Until recently, this was done outside of the organism and reintroduced afterward, causing a genetic modification (GM) of the organism. This use was historically considered recombinant DNA work covered by GM regulations in the United Kingdom and then later in the European Union.

Techniques allowing oligonucleotides to create new combinations of genetic material within (in vivo) an organism became available progressively since well before the 2001 EU regulations on GM were written. However, it is this in vivo use that has caused some to consider techniques that are based on oligonucleotides to be ‘new techniques’ and to not have been anticipated by the regulations.

This report finds that in all ways that made the use of oligonucleotides subject to the regulations before 2001, they should remain covered when used in vivo. Oligonucleotides are recombinant nucleic acids in the way recombinant was commonly understood by the scientific and scientific regulatory community. The effects of their use leads to the formation of new combinations of genetic material which are propagated by the organism. The scientists leading research and discovery of oligonucleotides that can direct genetic modifications routinely refer to their use as a form of genetic engineering.

As composed in 2001, the EU GM regulations are scientifically and semantically consistent with the inclusion of all oligonucleotide-based techniques used to modify heritable characters of organisms.

Evaluation of risks from GM wheat modified to silence an enzyme involved in starch deposition

Professor Jack Heinemann, Director of INBI, recently provided an expert opinion on risk assessment procedures for a type of GM wheat modified to silence an enzyme involved in starch deposition. The full report, including appendixes, are available for free download below.

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