Genetic Stability, Inheritance Patterns and Expression Stability in Biotech Crops

Abstract

Demonstration of the stability of traits newly introduced into a plant genome via genetic engineering approaches comprise a significant portion of the safety assessment that these products undergo prior to receiving the requisite regulatory approvals enabling commercial authorization. Different regions of the world have different regulatory requirements and many ask similar questions from multiple and overlapping perspectives. The entire central dogma, that is stability at the DNA level, mRNA level and protein level, is assessed for each product, although only a few regulatory authorities request data at the mRNA level. In this article, we present inheritance data obtained during the safety assessment of biotech products representing specific transgenic events in several crop species including Brassica napus (canola); canola quality Brassica juncea (yellow seeded canola); Glycine max (soybean), and Gossypium hirsutum (cotton) in which different traits have been introduced. The data presented confirm that all events examined were nuclear insertions that resulted in typical Mendelian Inheritance patterns and that the proteins are expressed similarly across multiple generations regardless of whether they were from backcrossed or outcrossed generations. These results demonstrate that newly inserted genes are transmitted to their progeny in a stable manner similar to that of endogenous genes. Further, the findings demonstrate that assessments of multigenerational stability have very limited value to a safety assessment.