Last week was the deadline for submissions to the European Commission on its consultation concerning novel breeding techniques in the European Union. The Commission consultation is a response to the CJEU’s ruling in C-528/16 – Confédération paysanne and Other[i] where the CJEU concluded that novel genomic techniques (NGT) could and should be defined as genetically modified organisms (GMOs). As such NGTs, like GMO’s are subject to environmental risk assessment and authorisation requirements.[ii]
The European Commission’s scientific advisers point out that applied gene editing technologies have evolved rapidly in the past two decades[iii] and definitions dating to 2001 are no longer appropriate to 2021.[iv] The speed with which this particular technology has and continues to advance, however, makes regulatory attempts to control it comparable to “trying to hit a moving target.”[v] The challenge for the EU, therefore is to enact regulatory reform that is “resilient, future-proof and capable of being uniformly applied whilst contributing to a sustainable agri-food system.”[vi]
In my response I propose that should the EU choose to amend the existing Directive they should avoid past mistakes by applying legal not scientific definitions to novel breeding techniques of all living organisms. Legal definitions in environmental risk regulation should be linked to the strict criteria applied by the public authorities in biotechnology patents and plant cultivar rights. The criteria are novelty, inventiveness, industrialisation, distinctiveness, and uniformity. Where a NGT has or is seeking a biotechnology patent and/or a plant cultivar right, environmental risk regulation should label, define and describe the process as well as the end products as
- untested, unknown, non-conventional, non-traditional, anthropogenic, synthetic, manmade, artificial, unnatural, industrial, uniform, standardised, unsustainable, monoculture.
Any novel breeding technique cannot be defined, labelled or described in law as :
- having a history of safe use, natural, organic, conventional, traditional, heritage, landraces, artisanal, sustainable, agroecological, regenerative, pastoral, green or stewarded.
This approach is resilient, future-proof, and capable of being uniformly applied whilst contributing to a sustainable agri-food system. Reformed definitions linked to technical criteria in biotechnological innovations and plant variety/cultivar rights:
- allows the EU to keep the fast-moving target of applied and commercialised novel gene technologies firmly within the crosshairs of regulatory control in a fair and legally balanced manner,
- is compatible with the EU’s objective of creating a sustainable, green EU within the parameters of its Green New Deal and its Farm to Fork ambitions,
- offers small European family run farms, who steward their agricultural land in accordance with knowledge accumulated over generations and unique to the varied EU’s geographical topography, the chance to sell highly competitive organic, food and produce to a global market,
- acts as a useful model within environmental and public health risk regulation on when to trigger the precautionary principle and precautionary measures,
- offers EU citizens and Europe’s diverse environment protection from unforeseeable direct and indirect harm arising out of untested and radically novel gene technologies,
- eradicates legal complexities linked to evolving technocratic developments and scientific uncertainties,
- offers the EU a simplified regulatory approach in environmental risk regulation – a key objective of the EU’s REFIT and Better Regulation Agenda.
- it offers the EU an opportunity to align its legal commitments to intellectual rights with those of its legal commitment to offering EU citizens a high level of public health and environmental protections.
For a more detailed analysis of my consultation see my submission attached in PDF.
[i] Case C‐528/16, Confédération Paysanne & Others (Confédération), ECLI:EU:C:2018:583 2018.
[ii] For an analysis of the CJEU’s findings see K. Garnett ‘Hold your pipettes: The European Court of Justice’s findings in Confédération Paysanne & Others stirs GMOtions’, RECIEL 2019;00:1–7.
[iii] W. Broothaerts, et al, ‘New Genomic Techniques: State-of-the-Art Review’, (2021, Office of the European Union, Luxembourg, 2021, Joint Research Centre (JRC).
[iv] Commission (EU), ‘Statement by the Group of Chief Scientific Advisors: A Scientific Perspective on the Regulatory Status of Products derived from Gene Editing and the Implications for the GMO Directive’ (2018).
[v] SWD(2001),92, 51.
[vi] ibid 2, 5 & 60.