Regulatory Dysfunction inhibits the Development and Application of Transgenic Livestock for Use in Agriculture

Abstract

Since the production of the first transgenic livestock, the technology for producing the animals and controlling transgene expression has matured. Initially, the lack of knowledge about promoter, enhancer, and coding regions of genes of interest greatly hampered efforts to create transgenes that would express appropriately in livestock and be useful to industry. There have been many developments in the technology to create transgenic animals, including somatic cell nuclear transfer-based cloning and gene editing. In the 31 years since the first report of transgenic livestock, a number of potentially useful animals, including cattle, goats, pigs, and sheep, have been made. However, there still are no genetically engineered animal-based food products on the market. There has been a failure of the regulatory processes to effectively move forward across the world, with many countries adopting process-based regulations, rather than product-based, and some countries having no regulatory framework at all. Additionally, there is a perception among some consumers that transgenic technology is potentially harmful in spite of a large, and growing, body of evidence to the contrary. Estimates suggest the world will need to approximately double our current food production by 2050, including animal-based foods; that is, we will have to produce an amount of food each year equal to that consumed by mankind over the past 500 years. The practical benefits of transgenic animals in agriculture have not yet reached consumers, and in the absence of predictable, science-based regulatory programs, it is unlikely that the benefits will be realized in the short to medium term.