WHAT SHOULD BE DONE BEFORE RELEASE OF A GMO

Socio-economic analysis: Is there a need? If so, are there cheaper and better alternatives? If not, the following should be done:  Characterization of the transgene: Vector Transgene number including incorporated transgene fragments Sequence of inserted transgene and its fragments Sequence of flanking regions

Socio-economic analysis: contd….  Characterisation of transgene expression: Aminoacid sequence Quantitation of expression of transgene and marker genes Proteomic, transcriptomic and metabalomic analyses: changes in glycosylation patterns  DNA fingerprinting  Changes in surface properties: Scanning electron microscopy and atomic force microscopy

 Reproductive interference  Gene flow  Dispersal into areas where harm could be done (e.g. water hyacinth and parthenium)  Stability of transgene product (e.g. on storage, cooking)  Technique to determine 0.01 percent contamination with GMO or its product  Effect on (cattle) GI microflora  Any contraindication in regard to drugs / probiotics in humans?

 Effect on useful insects  Effect on soil microflora, micronutrients and overall fertility in various regions  Allergenicity  Acute toxicity studies on farm and lab animals with native (not “surrogate”) protein, GM seeds and GM plant material  Chronic toxicity studies (including carcinogenicity) as above  Bruce Ames’ test using native protein and appropriate plant extracts, for mutagenicity Contd…

 Development of resistance (measurement, mechanism, management)  Increasing requirement for refuge crops  Growth characteristics of GMO  Emergence of new dangers, e.g. super weeds  Effect on population density of non- susceptible pests, after ≥5 plantations  Automated karyotyping and gross chromosomal analysis

 Biomass productivity  Inputs for optimal growth of GMO  Impact on ecology (e.g. bees, other useful insects). Therefore, ecological mapping RELATED QUESTIONS : THE PRESENT SITUATION WHO DOES THE TESTS? WHO VALIDATES?