Abstract

Risk assessment is a procedure normally carried out prior to decision-making on the release of genetically modified organisms (GMOs) into the environment. Most countries dealing with the release of GMOs have appropriate guidelines. The objectives of this paper are to critically examine the risk assessment provisions of the Malaysian Biosafety Act (2007), and to compare it with several risk assessment provisions in the Cartagena Protocol, as well as regulations in developed countries. There are inadequacies in the risk assessment provisions of the Malaysian Biosafety Act (2007 Act), compared to those of the Cartagena Protocol, as well as those found in European Commission Directives. Although the central objective of the 2007 Act was similar to the Cartagena Protocol, the Act was found to be very basic with only a brief provision on risk assessment and there is no specific coverage on the socio-economic and ethical aspects as well as the precautionary approach. It is hoped that these inadequacies will be improved upon, in order to bring the Malaysian Biosafety Act closer to the level seen in the biosafety laws of more developed countries and to ensure adequate level of protection for the Malaysian people against any adverse effects of GMOs and products.

Key words: Risk assessment, biosafety, Malaysian Biosafety Act 2007, genetically modified organisms (GMOs).

Abbreviation

GMOs, genetically modified organisms; GM, genetically modified;EU, European Union; LMOs, living modified organisms; NBB, National Biosafety Board; DNA, Deoxyribonucleic acid.