Recombinant Pasts & CRISPR Futures: US & EU GE Regulation Beneficial Constraints

• In Event: Regulatory Politics and Executive Leadership

Abstract

Full Title: Recombinant Pasts and CRISPR Futures: The Processes and Outcomes of Beneficially Constraining GMO Regulation in the US and Europe, 1975 to Present.

Following the 1973 development of recombinant DNA, American and European regulators sought to corral its dangers and encourage its benefits through beneficially constraining regulation. The US Asilomar Conference (1975) gathered scientists and policymakers to define what became the Coordinated Framework: GMOs would be considered ‘substantially equivalent’ to non-GMOs unless ‘fundamentally altered (Berg 2008).’ Europe took the opposite tack: based on a ‘precautionary principle,’ GMOs would be considered intrinsically different from non-GMOs and subjected to heightened scrutiny (Vogel 2012, 74–81).

Through interview data and Bayesian Type Verification (BayesTV), this paper explores how diametrically opposite regulatory outcomes arose from the same principle: both represent constraints on GMOs which their societies considered beneficial. An impromptu US process gathered a technoscientific subset of stakeholders leading to a technoscientifically beneficial outcome. A structured EU process brought together diverse social stakeholders leading to a socially acceptable outcome.

Each regime successfully constrained its society into different intended forms. From the technoscientific principles of the US Coordinated Framework, the R&D of GMO technologies flourished. Less emphasized were social costs such as inequalities in global exports of ‘suicide gene’ crops from rich companies to developing countries. From Europe’s social scientific Precautionary Principle, the R&D of GMOs stalled yet European society remained content with how GMOs were integrated into their political economy.

GMO’s benefits are technoscientific while their dangers are social scientific. Since CRISPR/Cas-9 magnifies the power of GMO, this mismatch must be readdressed. In the first round of GMO regulation around recombinant DNA technology, the EU lost the economic battle while the US lost the social one. A central question in the interviews was how the recombinant pasts affect their CRISPR futures of the US and EU. Do scientists and public officials believe their systems can repeat the successful regulatory response processes which beneficially constrained their political economies for 47 years? Do they believe that successful processes will lead to convergence or divergence? Which stakeholders favor which approaches?

While recombinant DNA lead to biomedical products such as human insulin from E. coli (1978), genetic characterization of complex disorders such as thalassemia (1984), and targeted genetic testing for human disease such as Huntington’s disease (1993), CRISPR pushes the boundaries of what is possible further into the precise correction of a disease producing gene in an individual. By making possible the benefits and dangers which were only specters during the recombinant DNA era of gene editing, CRISPR thus increases the tensions in the regulatory process between social scientific and technoscientific understandings. This creates an exceptional opportunity to observe how these often separate communities collide in the process of crafting regulations which navigate the benefits and dangers of gene editing technologies.

Works Cited:

Berg, Paul. 2008. “Asilomar 1975: DNA Modification Secured.” Nature 455 (September): 2.
Vogel, David. 2012. The Politics of Precaution: Regulating Health, Safety, and Environmental Risks in Europe and the United States. Princeton University Press.

Author

• Konrad Posch, University of California, Berkeley