Flowchart ("Roadmap") for risk assessment: the necessary steps to conduct risk assessment according to Annex III of the Protocol

Dear colleagues,

Please, I would like to express Cuba´s opinion in relation to the topic Flowchart ("Roadmap") for risk assessment: the necessary steps to conduct risk assessment according to Annex III of the Protocol.

In the case of Cuba, the risk assessment process on LMOs is envisaged as a part of the decision making process. The information to be submitted by the applicants, according to the specific activity to be performed is detailed in  five annexes of the legal instrument that put in place this administrative process (Resolution No. 180/2007, is posted on the BCH). The risk assessment process is undertaken following a Guide on risk assessment and risk management elaborated with such purpose. The revision of the dossier is carried out by using a check list included in the mentioned guide which also establishes the different stages to be follow for the performing of a RA process.

These stages are the followings:

1. Definition of the relevants adverse effects.
2. Identification of hazard, using cualitative techniques.
3. Evaluation of the possibility of the occurrence of each identified hazard.
4. Evaluation of the consequence.
5. General estimation of the risk for each identified hazard.
6. Analysis of the uncertainty.
7. Parameters of acceptability of risks.

this guide will be post on the BCH shortly.

Best regards

Dra. Leticia Pastor Chirino.
National Centre for Biosafety. Cuba.