Are good ideas enough?: The impact of socio-economic and regulatory factors on GMO commercialisation

In recent years scientific literature has seen an increase in publications describing new transgenic applications. Although technically-sound, these promising developments might not necessarily translate into products available to the consumer. This article highlights the impact of external factors on the commercial viability of Genetically Modified (GM) animals in the pharmaceutical and food sectors. Through the division of the production chain into three Policy Domains -Science, Market and Public- I present an overview of the broad range of regulatory and socio-economic components that impacts on the path towards commercialisation of GM animals. To further illustrate the unique combination of forces that influence each application, I provide an in-depth analysis of two real cases: GM rabbits producing human polyclonal antibodies (pharmaceutical case study) and GM cows producing recombinant human lactoferrin (food case study). The inability to generalise over the commercial success of a given transgenic application should encourage researchers to perform these type of exercises early in the R & D process. Furthermore, through the analysis of these case studies we can observe a change in the biopolitics of Genetically Modified Organisms (GMOs). Contrary to the GM plant biopolitical landscape, developing states such as China and Argentina are placing themselves as global leaders in GM animals. The pro-GM attitude of these states is likely to cause a shift in the political evolution of global GMO governance.

Principles and costs in the regulation of microbially contaminated foods.

A strong code of regulations exists in the United States to control pathogens and other microbes in food and drink. Despite strict enforcement, food-borne illness persists. Parasitic animals in foods are particularly difficult to detect because there are no simple culture systems for their multiplication and because sanitary measures against fecal contamination are ineffective against parasite species transmitted by other routes. To attain a high degree of safety, total processing of foods by heat- and/or irradiation-pasteurization combined with sterile packaging may be required. The cost of regulating food-borne microbes, while large, is probably surpassed by the cost of food-borne illness (estimated to be US$50 billion annually), resulting in net savings.