Risk assessment and risk management of transgenic microorganisms and viruses

My name is Leticia Pastor Chirino, I am the Head of the Authorization Department of the National Centre for Biological Safety in Cuba. In the case of Cuba the risk assessment process is undertaken according to the Resolution 180/2007 that put in place the decision making process. There are not substantial differences concerning the treatment given by the legislation to LMOs in a general sense. The differences are appointed, mainly, in the information that the applicants for authorizations must submit to the regulatory agency. The Resolution has 5 annexes regarding LMOs, which are the base for the technical dossier to be submitted by the applicants to the regulatory body. Three of them are referred to microorganisms and viruses. The first one is aimed at the facilities in which activities involving microorganisms and viruses are undertaken. The second involves activities like research, trial and release of biological agent (LMOs are included). Finally, we have a third one directed to import and export of LMOs (microorganisms and viruses are included).

Those annexes have a little difference concerning the annex 3 of the Cartagena Protocol. This difference is aimed at focusing the elements contained in annex 3 to the case of microorganisms and viruses. Those aspects are the risk group, its capacity of producing some diseases to the man, animals and plants, incubation period, infection ways, prophylaxis measures and treatment, among other.