Application of Food and Feed Safety Assessment Principles

Modern biotechnology is increasingly being used to achieve phenotypes that have been long sought through traditional breeding, such as increased tolerance to environmental stresses (e.g., drought, frost, salt), disease resistance, improved nutrition, increased yield, and altered growth or development.  These new phenotypes are often affected through modification of endogenous plant gene expression.  These modifications can be produced through gene suppression technologies or through alterations in regulatory or signaling pathways.  Though these processes occur naturally in plants and have been selected for during plant domestication and conventional breeding, there remains a possibility that use of these technologies may increase the probability of secondary effects on plant physiology due to pleiotropy or epistasis.  These newer technologies sometimes act differently than many of the genes currently used in commercialized biotech crops in which the gene product is able to directly confer the desired trait (e.g., expression of a Bt protein for insect protection). 

For the currently commercialized biotech crops, a comparative safety assessment process was implemented in the 1990s in which scientific studies identified the similarities and differences between the newly developed crop and a conventional counterpart that has a history of safe use.  The analysis assessed: (1) the agronomic/morphological characteristics of the plant, (2) macro- and micronutrient composition and content of important antinutrients and toxicants, (3) molecular characteristics and expression and safety of any proteins new to the crop, and (4) the toxicological and nutritional characteristics of the novel product compared to its conventional counterpart in appropriate animal models.  The identified differences were subjected to further scientific assessment, as needed, to clarify whether any safety issues or concerns existed and then to evaluate or address any such issues or concerns. 

The objective of this project is to clarify whether the comparative safety assessment process, as currently implemented, is sufficiently robust to assess the food and feed safety of products produced utilizing new technologies that affect endogenous plant regulatory pathways and gene expression, given the potential for increased production of secondary effects produced by such technologies.  A task force and an expert working group were convened in 2006 to prepare a monograph that describes how the principles of food and feed safety assessment should be applied to products developed using these technologies that affect endogenous plant gene expression or plant signaling pathways.  It is anticipated that the project will be completed and a manuscript published in early 2008.