Recent scientific developments in genetic technologies: Implications for future regulation of GMOs in developing countries

In the early 1970s the first man-made transgenic organisms, popularly referred to as genetically modified organisms (GMOs) were created. At the time, this technology was regarded as a potentially revolutionary scientific development that could create entirely new, and possibly harmful, life forms. The resulting transgenic organisms contained combinations of DNA sequences either copied from existing organisms or created synthetically in a form that had never previously existed in the biological world. At the time, many leading researchers were concerned that novel biohazards might arise from this new technology. As a result, the Committee on Recombinant DNA Molecules was set up and an international conference convened at Asilomar, California in 1975 (Berg, 2008). Following this conference, a series of non-binding guidelines relating to GMOs was issued to inform future scientific research and the regulation of GMO use. As Paul Berg from Stanford University later stated, Participants agreed on the final day of the conference that research should continue, but under stringent restrictions. The recommendations formed the basis of the official US guidelines on research involving recombinant DNA, issued in July 1976. They have proved remarkably effective. (Berg, 2008) During the late 1970s, different types of systems were drawn up by governments in the USA and Europe to regulate GM microbes. As the scope of GM technology expanded, further regulations were enacted during the 1980s and 1990s to cover more complex multicellular organisms, including plants and animals. These original systems are still the basis for the more recently established regulatory systems set up in some developing countries. Indeed, all the regulatory systems in use in 2016 are still based on decades-old GM technologies dating from the twentieth century. Moreover, there is still a fundamental dichotomy between the product-based regulatory paradigm, in countries such as the USA and Canada, and the process-based paradigm prevalent in Europe, where no account is taken of potential benefits of the technology (see Chapter 4). Since the turn of the 2010s both of these regulatory models have come under increased scrutiny and challenge in the face of recent developments in GM technology. This is especially true for some of the new gene-editing methods discussed in this chapter. For example, in contrast to classical twentieth-century GM technologies, gene editing can sometimes leave no detectable trace in the recipient genome and therefore no evidence that the organism has been subjected to any form of genetic modification.