Conclusions: After the GMO
Genome editing technologies hold the promise of crop and livestock improvement and even of curing patients of what have been up to now incurable diseases. The applications are vast, and the human condition as a whole could be changed by genome editing. CRISPR-Cas9 as a genome editing platform, for example, has proved to be flexible across species, has high multiplexing potential, though as yet indeterminate intellectual-property constraints. Since the technology leaves no sign of transgenesis, plants generated by genome editing are not considered to be GMOs and thus do not provoke the political and social emotional energy that often accompanies biotechnology in agriculture. While inexpensive and relatively simple to implement, genome editing still has some drawbacks, including off-target effects and our inability to conclude what the long-term impact of this technology will be over many generations. Concerns regarding deliberate changes that genome editing can make to the course of human evolution seem for now to belong within the pages of a science fiction novel; so did many modern technologies at some point in history.
The immediate issue is that risk assessment guidelines to address environmental and human health effects lag far behind the rapid adoption of the technology in research labs around the world, outpacing biosecurity frameworks for responsible regulation. More daunting, any workable mechanistm for enforcing guidelines on a global scale is hard to conjure. One emergent agreement among practitioners is that genome-editing be prohibited in germ lines, as results would otherwise be permanent over generations, altering evolution in unknowable ways. Yet how could such an agreement be enforced? Who would decide? One proposal has been to write restrictions into patents – the ‘ethical license’ — as the Harvard group did in licensing to Monsanto (Guerrini, Curnutte, Sherkow and Scott, 2017)
Ethical license would seem a sensible solution but has two great flaws. First, it is not clear that so versatile and available a technology will necessitate patents before deployment. Second, suppose a patent contains an ethical license: how do patents get enforced? Patent laws are national, and idiosyncratic, not global; battles over interpretations in the courts go on for years, especially in technically complex platforms (consider lines of code in gaming platforms). Even with transgenic plants, bio-property in seeds has proved virtually impossible to enforce internationally (Herring 2007).
While CRISPR-Cas9 technology becomes more effective and easier to use, research into other editing systems such as mega-nucleases are in the pipeline and will soon offer an even more diverse toolkit for scientists (Lambert et al., 2016). The term GMO – always arbitrary in definition — is becoming even more problematic as a basis for regulation and trade; it is even more decisively a normative and political construct than a biologically meaningful one. Genome editing as a whole thus challenges existing governmental regulatory structures designed to manage differences among organisms bred for new traits by different technologies (Esvelt, 2016).
There is no robust and parsimonious explanation for differences in acceptance and rejection of agricultural biotechnology across countries or across time. Variables that delineate common political rifts in international trade and politics fail to explain variation (Herring and Paarlberg 2016). The one constant is a risk-utility balance, but of course risk means different things to different segments of civil society, as does utility. So the vector sum is filtered through structures of regulatory mechanisms and their associated political ecology: Agriculture vs Environment ministries, eg. Opposition has targeted unnatural plants contaminated by genetic sequences from other species, including viruses and bacteria. Regulation of ‘the GMO’ has restricted the market and dimmed development, leaning toward internationally traded commodities developed by very large firms. The risk-utility balance for urban consumers has been negative, though the risk itself is hypothetical, not hazard-based.
This paper has shown a fundamental alternation of the risk-utility balance. Just as rDNA transgenic drugs are regulated not as GMOs but as normalized pharmaceuticals, precisely becuas of their risk/utility balance, so too will new techniques shift that political equation. Moreover, the frontiers of plant breeding are moving away from transgenesis, which has been the dominant regulatory test of what constitutes a plant that requires special regulation — a ‘GMO’ or ‘LMO.’ Biologically, and so far legally, gene-edited plants are closer to mutagenized crops – common and considered GMOs nowhere – though mutagenized in a targeted way, not by scrambling the genome with unknown random consequences. Since mutagenized agricultural plants have been immune to regulation as ‘GMOs,’ this political battle for definition will shape the future diffusion of agricultural – and other — biotechnology globally. Because of the utility of new techniques for consumers and farmers alike – unlike transgenic plants for the most part – as well as for the environment and human health, the risk-utility balance is being fundamentally altered.
It is then not a reach to predict the end of the GMO as a cornerstone of regulating agricultural technology and flashpoint of conflict restricting progress. Genome editing offers a new frontier for plant technology that is unprecedented but brings along with it with unprecedented challenges, particularly with the advent of gene drives. We expect these legitimate and consequential questions — practical, legal and ethical — to replace the irresolvable and largely pointless ‘GMO’ debate.