The European Food Safety Authority (EFSA’s) Genetically Modified Organisms (GMO) Panel has published a new scientific opinion on the use of synthetic biology (SynBio) and new genomic techniques (NGTs) for the breeding of farmed food animals, the potential novel hazards and risks they present, and the adequacy of EFSA’s current risk assessment guidance for evaluating new biotechnology.
NGTs considered in the opinion include those developed after the publication of EU Directive 2001/18/EC,used to intentionally alter the genetic material of an animal in a targeted way. They include 1) targeted mutagenesis, and 2) targeted insertion of a DNA cassette encoding a transgene, intragene, or cisgene of interest.
SynBio is the application of science, technology, and engineering to facilitate and accelerate the design, manufacture, and/or modification of genetic materials in living organisms. It is possible to create novel genetic information, biological networks (including complete genomes), and/or novel biological functions, either completely de novo or by combining and/or modifying existing naturally occurring DNA modules.
A horizon-scanning exercise confirmed that several NGT animals have been authorized for market placement in the EU. It also identified a variety of NGT animals obtained, with the potential to reach the EU market in the short, medium, and long term.
EFSA concluded that, when the original EFSA risk assessment guidance documents for GM animals were first developed, genetic modification primarily involved the random insertion of exogenous gene cassettes into the genomes of recipient animals, and there was considerable uncertainty about the potential effects of these modifications. Since that time, significant scientific advancements have been made that make NGTs much more precise, minimizing hazards associated with earlier methods.
No novel hazards have been identified that are linked to either the modification process or the newly introduced trait when compared to established genomic techniques (EGTs) or conventional breeding. Off-target mutations from genome editing are similar in nature to those from conventional breeding and do not pose novel hazards. Consequently, based on the currently available data, no new potential hazards, and thus, no new risks to humans, animals, or the environment have been identified.
Read the full scientific opinion here.