Risk assessment and risk management of transgenic microorganisms and viruses

Introduction to the topic

by Kaare Magne Nielsen, Department of Pharmacy, University of Tromsø, Tromsø, Norway.

The basis for risk assessments (RA) is the knowledge available and its quality denominators, the use of inferences where necessary, and a transparent treatment of the identified uncertainties and knowledge gaps. A key challenge is to communicate how these conditions define the strength of the risk conclusions drawn; Continue reading »

Suggested points for discussion

1. How to apply Annex III when assessing the risks of transgenic microorganisms and viruses;
2. Experience in conducting risk assessment of transgenic microorganisms, including but not limited to those for bioremediation, industrial applications, food and feed production, biocontrol, diagnostic kits and veterinary pharmaceuticals;
3. Difficulties in accessing or reviewing baseline information related to the recipient and parental organisms, receiving environment, environmental interaction, etc.;
4. Elements necessary to conduct risk assessments of transgenic microorganisms;
5. Issues that are unique to this topic;
6. Recommendations for preparing risk assessment reports.

Selected readings

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