Synthetic biology (SB) and gene editing (GE) are enabling platform technologies that are expected to form the basis of the bioeconomy and to transform production processes in many areas of the developed and developing worlds. Crop related developments have the potential to transform food production for the world’s major commodity crops and to create a niche-market sector populated by small companies delivering benefits to markets that are not of interest to the major agro-biotechnology multinational companies.
However, these products are the subject of intense debate on whether and/or how they should be regulated, particularly in the EU. A decision by the Court of Justice of the EU in 2018, has determined that GE will be regulated, along with SB, through the existing regulatory system for genetically modified (GM) crops, which is widely regarded as dysfunctional. This has led to speculation that these technologies will not be developed in the EU, although they will be developed in the rest of the world, with significant disadvantages to the EU economy and environment.
Problems identified with the EU regulatory system for GM crops include:
- politicisation of EU regulatory decisions, preventing the adoption of crops that have already been approved by the EU regulatory system;
- basing the regulatory system on the nature of the foundational biotechnology (GM, SB, GE) rather than on the properties of the eventual crop product;
- the requirement for 90-day feeding trials on rats (a test based on the one used to regulate chemicals that is inappropriate for whole food-related products, and leads to unnecessary use of laboratory animals);
- while the cost of compliance with the current GM regulatory system is regarded as acceptable by multinational companies, it prevents any small company with an innovative product based on these technologies from finding a route to market and thus stops disruptive innovations from making progress in this sector.
The UK Synthetic Biology Leadership Council has sent a letter to Lord Henley, the Minister for Better Regulation and Regulatory Reform, proposing that the Government should be prepared to act promptly should an opportunity arise to adapt the UK regulatory system for GM and GE techniques to be more in tune with those of other major global trading blocs, by developing a new model for their future UK regulation.
ISAAA (2017) Global Status of Commercialised biotech/GM crops in 2017. Brief 53, ISAAA Briefs. http://www.isaaa.org/resources/publications/briefs/53/download/isaaa-brief-53-2017.pdf
Huw D Jones (2015) Future of breeding by genome editing is in the hands of regulators. GM Crops & Food, 6:4, 223-232, DOI: 10.1080/21645698.2015.1134405
Tait, J. and Barker, G. (2011) Global food security and the governance of modern biotechnologies: opportunities and challenges for Europe EMBO Reports, 12, pp763-768.
Mittra, J., Mastroeni, M. and Tait, J. (2014) Engaging with Uncertainty and Risk in Agricultural Biotechnology Regulation: Delivering Safety and Innovation. Report from ESRC Knowledge Exchange Project with Syngenta, Jan. 2014.
Devos, Y et al. (2016) 90-day Rodent Feeding Studies on Whole GN Food/Feed. EMBO Reports, 17(7) 942-945.