Development of a construct-based risk assessment framework for genetic engineered crops

Abstract

Experience gained in the risk assessment (RA) of genetically engineered (GE) crops since their first experimental introductions in the early nineties, has increased the level of familiarity with these breeding methodologies and has motivated several agencies and expert groups worldwide to revisit the scientific criteria underlying the RA process. Along these lines, the need to engage in a scientific discussion for the case of GE crops transformed with similar constructs was recently identified in Argentina. In response to this need, the Argentine branch of the International Life Sciences Institute (ILSI Argentina) convened a tripartite working group to discuss a science-based evaluation approach for transformation events developed with genetic constructs which are identical or similar to those used in previously evaluated or approved GE crops. This discussion considered new transformation events within the same or different species and covered both environmental and food safety aspects. A construct similarity concept was defined, considering the biological function of the introduced genes. Factors like environmental and dietary exposure, familiarity with both the crop and the trait as well as the crop biology, were identified as key to inform a construct-based RA process.

Keywords: Construct similarity; Familiarity; Genetic engineering; Problem Formulation; Risk assessment.

Fig. 1

Risk assessment approach for identical or similar constructs. Affirmative answers to all questions indicate that a simplified RA is justified and no additional RA is required. Any negative answers may call for additional RA. All cases will need to provide a full description of the event and a basic set of data. The type and extent of data will be defined on a case by case basis (see text)