Nature-identical Outcomes, Artificial Processes: Governance of CRISPR/Cas Genome Editing as an Ethical Challenge

Abstract

CRISPR/Cas is a newly developed genome editing technique that is viewed as revolutionary to crop breeding. It allows for modifications of genes by adding, cutting out or suppressing certain gene sequences of the DNA. Compared with former genetic modification (GM) techniques, this system is considered relatively easy to apply, more precise, quicker and much cheaper (Baker, 2014). For example, according to Ledford (2015), the cost difference between applying RISPR/Cas vs zinc finger nucleases (ZFN), another common genome editing technique, is in the range of two orders of magnitude (US$30 vs US$5000). Therefore, CRISPR/Cas is expected to have great innovative potential in agriculture by speeding up breeding, increasing yields and allowing plant production under less favorable conditions (Baltes et al., 2017). It has already been successfully applied in breeding of different agricultural plants, such as soybean (Jacobs et al., 2015;Li et al., 2015), maize (Svitashev et al., 2015), tobacco, sorghum, rice (Woo et al., 2015) and tomato (Brooks et al., 2014; Ueta et al., 2017).

Although CRISPR/Cas generally allows for trangenesis, that is, transferring DNA sequences across species, its current application in agricultural biotechnology mainly remains within species boundaries, including transfers of genes between varieties (cisgenesis sensu stricto), allele replacement, gene knockout and gene silencing. In the following we use ‘cisgenesis’ as a generic term encompassing all those non-transgenic variants for simplicity. In other words, cisgenesis allows for creating new products that could also be the outcome of natural evolution or conventional breeding. A unique characteristic of CRISPR/Cas-based cisgenesis is that it does not leave detectable traces of genetic engineering (especially foreign DNA snippets) in the resulting organism, thus its results effectively cannot be identified as genetically modified organisms (GMOs): they are so-called nature-identical genetically modified organisms (nGMOs). Since CRISPR/Cas is extremely quick and, in contrast to earlier genome editing techniques, cheap, it can be seriously considered as an alternative to conventional breeding for some applications.

The former GM debate was dominated by discussions on risk assessment and general objections against the transgression of species boundaries (e.g. Gaskell et al., 2010; Kvakkestad and Vatn, 2011). It was embedded in a general critique of modern agriculture, especially the property rights to genetic resources (e.g. patents on genetically modified plants). In the face of the differences between former GM and CRISPR/Cas technology, the question arises how this has shaped the societal debate on genetic engineering of plants, and how it will shape it in the future. Because nGMOs can be molecularly identical to conventionally bred or wild plants, the question arises of whether they should be viewed as GMOs at all. The decision regarding their classification has consequences for the general need and possible ways of governing genetically engineered products. The classification of CRISPR/Cas modified plants as GMO is more than a scientific and legal issue: governance is key to balancing diverging interests and values within a society and thus avoiding a loss of public trust in certain technological developments. In a democratic society, legitimacy is at the center of governance (Vatn, 2016; Meinard, 2017); in normatively sensitive contexts, such as genetic engineering, it is particularly important that governance constitutes an attempt to strike a balance between the diverging interests and values.

Against this background we provide a brief introduction to the CRISPR/Cas genome editing technology and introduce the critical concept of nature-identical GMOs. We then outline the current societal debate on regulating cisgenic plants created by means of CRISPR/Cas genome editing, with a particular focus on the European Union (EU). We discuss the different value concepts and ethical tensions that lead to different perspectives on regulation and frame possible governance solutions that may help to balance those diverging values by highlighting governance-specific challenges. Finally, we offer conclusions about how CRISPR/Cas genome editing gives rise to a set of ethical tensions that go well beyond previous debates surrounding GM crops, particularly by opening up a debate about a product vs process perspective –in both ethical and governance discourses.