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The European Directive 2001/18/EC sets rules for the deliberate release of genetically modified organisms (GMOs). These rules require priorauthorization forreleasing GMOs in the environment for commercial or otherpurposes. The Directive makessuch authorization dependent of an assessment of risksthat suchGMOsmay present for human health and the environment and makes them subject to traceability, labelling and monitoring obligations. Exemptedfrom the Directive are organisms produced by one or more of the techniques/methods listed below:(1)mutagenesis; (2)cell fusion (including protoplastfusion) of plant cells of organisms which can exchange genetic material throughtraditional breeding methods.“The background of these exemptions is that those organisms have been obtained through certain techniques of genetic modification which have conventionally been used in a number of applications and have a long safety record” (Recital 17 of the Directive).
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In a rulingof 25 July 20181the Court of Justice of the European Union (CJEU) specifiedthat themutagenesis exemptionfromthe authorisation requirement is limited to GMOs developed through conventionalmutagenesistechniques involving the use of radiation and chemicals,while itdoes not apply to more recent forms of directed mutagenesis involving genetic engineering.
Since this ruling there have been many public reactionsfrom a variety of stakeholders. Some reactions welcomed the ruling, while other reactions called for furtherclarification of the ruling and/or changing the EU legislation.Reactionsfocused onthe consequences of the rulingfor the legal status ofthe release in the environment and commercialisation oforganisms developed through genome editing.
Genome editing is a technique through which changes can be made at precise locations in an organism’s genetic material. An additional relevant characteristic of this technology is that the so-called ‘off targetchanges’ on DNA level are much lower than is the case with conventional crossing and conventional mutagenesis. Currently this technique is mostly used to make small changes in genomes, changesthat could also occur in arandom way in nature. An example of that approach is making a few base pair changes in a gene that has undesirable effects, such as allergenicity, thereby ‘knocking out’ that undesirable gene. It is well established that genomechanges in organisms generated by mutagenesis using conventional methods (involving the use of radiation and chemical) are randomand de factofar less precise and unpredictable than when those genetic changes are obtained by state of the art gene editing technologies, including CRISPR/Cas or designer nucleases. Hence, based on these scientific arguments, VUBquestions why the exemption from the authorisation requirement would belimited to GMOs developed through conventionalmutagenesis techniques, while it wouldnot apply to more recent forms of directed mutagenesis based on more precise gene editing technologies.
The Vrije Universiteit Brussel (VUB)recognizes that -because of its precision -genome editing has the potential to contribute significantly to improving human well-being and the environment,and the VUB emphasises the need to further explorethe possibilitiesand opportunitiesofgenome editing to improvehuman well-being,health care and food production,includingthe experimental release of organisms modified by genome editing.In this context, research at the VUBaimsat gaining insight in fundamental life processes, but also at contributing to human and environmental welfare.Genome editing can also be applied to make changes in an organism’s genome that are not likely to occur in nature.The VUB recognisesthat the release in the open of organisms with genetic changes that are unlikely to occur in nature requires to address, on a case by case basis,the question whether those organisms are as safe as the non-modified organism from which they are derivedwith respect to human health and the environment.
Fromthis perspective, the VUB supports regulatory systems thatthat aim to maximise benefits and minimise risks, including -in line with the precautionary principle a steady assessment and mitigation of identified risksof organisms developed through new biotechnologies, when they leave the controlled environment of laboratories. To ensure that regulatory systems accomplish this double objective,it is important that they arethemselvesregularly evaluated.
The VUB supports calls for further clarification of the scope of the Directive as well as calls for amultidisciplinary evaluationof the EU regulatorysystem forthe release ofGMOs. Such evaluationshould assesswhether the regulatory system has kept pace with scientificandtechnologicaldevelopments andinclude an evaluation ofalternative ways to reach the same aims both in technological and in economic, societal and policy terms.
Regulatory aspects such as clarity, consistency, proportionality and workabilityin line with the EU’s Better Regulation policymust also be considered. Such an evaluationshould be conducted in a transparent fashionand involve allstakeholdersand shouldhenceforthprovide reliable information as a basis for a further democraticdiscussion andlegislative process about the risks that the European constituencycollectivelyacceptsto take or not.The evaluation process must be balanced, multidisciplinaryand involve stakeholders, and it must also be efficient and allow forfurther responsible research and innovation.
The above evaluationshould also be placed in broader context, such as the overall issues and aims of the production of food, feed and biomass. In that context it will be important to recognise that the futureof agricultureis not a choice between ‘either this or that technology’,but rather the combination of the best components of all availablepractices andtechnologies, tailored to local needs, conditions and cultures.From that perspective the evaluation should also take into consideration all approachesto reach the sameor even strongeraims.Similarly,it will be important to recognise the statement by the European Commission that in the interest of food security, no form of agriculture should be excluded, be it traditional, conventional or innovative.