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Risk Assessment for Planned Introduction - Risk assessment for planned introduction of living organisms modified by recombinant DNA technology is done to identify and evaluate the potential adverse effects of such introductions on the environment, including biological diversity and human health. Risk assessment should be done on a case by case basis. Risk assessment takes into account the relevant technical and scientific details regarding the characteristics of the following factors.

1. The biological characteristics of the recipient or parental organisms, including taxonomic status, centres of origin and of genetic diversity, habitat where they are likely to persist or proliferate, etc.

2. Taxonomic status and the relevant biological characteristics of the donor organisms.

3. Characteristics of the vector, including its origin, source and host range.

4. Genetic characteristics of the DNA insert the function it specifies and/or characteristics of the modification introduced.

5. Identity of the GMO, and the differences between biological characteristics of the GMO and those of the concerned recipient or parental organisms.

6. Suggested detection and identification methods, and their specificity, sensitivity and reliability.

7. Intended use of GMO, including new or changed use in comparison to the recipient/parental organism.

8. Information on the location, geographical, climatic and ecological characteristics, including relevant information on biological diversity, of the receiving environment, i.e., the environment in which planned introduction is proposed.

In case of transgenic plants, the following are the main concerns related to their planned introduction.

1. The likelihood of a transgenic becoming a weed.

2. Likelihood of the transgene being transferred to wild relatives. Transfer of trans genes conferring herbicide resistance to weeds would be rather hazardous.

3. Introduction of novel genes may cause perturbation of the ecosystem.

4. Virus resistance genes may provide opportunities for evolution of newer virulent strains by recombination, etc.

5. Insect resistant plants would be cultivated on a large scale; this may lead to the evolution of insect biotypes resistant to the toxic effects of the concerned transgene.

6. It is also feared that transgenic plants may affect the flora and fauna of their phyllosphere as well as rhizosphere.

7. The product of transgenes may pose health hazard, e.g., allergy, to human consumers.

Molecular biologists and ecologists represent diagnally opposite views not only on the perception of risk but also about the manner in which risk should be assessed. Molecular biologists view modem biotechnology as an extension of classical genetics, and believe that the risk can be evaluated by studying the features of transgenes and host organisms.

But ecologists argue that there exist many uncertainties concerning the risks, and they emphasize the study of entire ecosystem in which biotechnological products, especially recombinant DNA products, are to be released.