Animal agriculture and the importance of agnostic governance of biotechnology

Human population growth and rising income levels in developing countries are increasing demand for animal protein. One of the key enablers of the associated increase in global animal protein production has been biotechnology, defined as, “any technological application that uses biological systems, living organisms or derivatives thereof to make or modify products or processes for specific use.” Biotechnologies have directly benefitted the three core scientific disciplines of animal science—genetics, nutrition, and health. Significant potential remains to use biotechnologies to improve animal health. Globally, more than 20 % of animal protein is lost as a result of disease. A number of diseases have been targeted by using recombinant DNA (rDNA) techniques in the breeding process to develop disease-resistant food animals, although no such animals have yet been approved anywhere in the world. Part of the reason for this is that “modern” biotechnologies involving the use of rDNA are subject to a unique set of governance and regulatory requirements under the Cartagena Protocol on Biosafety and other national regulatory frameworks. The Protocol defines “modern biotechnology” as the application of in vitro nucleic acid techniques, including recombinant deoxyribonucleic acid (DNA) and direct injection of nucleic acid into cells or organelles, or fusion of cells beyond the taxonomic family, that overcome natural physiological reproductive or recombination barriers and that are not techniques used in traditional breeding and selection. In considering the impact of this modern biotechnology trigger for additional governance and regulatory oversight, a case study is presented of the various biotechnological approaches that might be employed to address the important tropical disease problem of African trypanosomiasis. Some approaches involve the use of natural gene drive systems (“selfish” gene elements that skew inheritance in their favor) and irradiation-induced sterile insect technique. Others involve techniques that trigger the modern biotechnology definition and include the use of an rDNA-derived paratransgenesis, a strategy that employs symbiotic microbes to control pathogens in vector populations, and the development of genetically engineered trypanosomiasis-resistant cattle. Despite the fact that all of these approaches are associated with potential harms and potential benefits, only those that involve the use of modern biotechnology such as rDNA techniques are subject to exceptional regulatory requirements. Triggering governance and regulatory oversight based on an arbitrarily-defined subset of techniques rather than on the outcomes or products resulting from the use of those techniques, does nothing to address the potential harms that might be associated with non-governed processes and disadvantages governed technologies with unique regulatory burdens. Even-handed evaluation that agnostically weighs the potential benefits and risks of products rather than the techniques used to produce those products is essential to ensure that the biotechnology best suited to addressing a problem can be employed, rather than a potentially less efficient approach that is chosen solely because it avoids the complicated regulatory frameworks that are uniquely triggered by the use of a modern biotechnology.