Cuba Capacity Building Project for the Implementation of National Biosafety Framework

GEF - $646500
Co-financing - $284142

In 1993, the Cuban Government decided to focus its interests on the organisation of activities associated with biosafety within the country. By Law 81 on the Environment the Ministry of Science, Technology and Environment (MSTE) was established to hold responsibility for outlining, executing and controlling the policy of the State and the Government in the matter of biological safety.

MSTE, as per Resolution 67/96, created the National Centre for Biological Safety in order to organise, conduct, perform, supervise, and control the National System of Biological Safety. It also organises, conducts and controls the measures aiming at complying with the obligations assumed by the country as State Party in international instruments on biosafety.

As result of the first stage of the UNEP/GEF Pilot Project on Biosafety, which allowed the inception of a National Biosafety Framework and the adoption of an ad-hoc Decree N.190 on Biological Safety in 1999, the following needs for strengthening capacity building have been identified:

1) To develop national capacities, both in human resources and institutions, to fulfill the activities related to Biosafety at national, regional and international level. This need is the main element that required urgent attention. Its fulfillment will help implementing the Cartagena Protocol on Biosafety.
2) To organise and strengthen a national infrastructure in order to be able to meet the requirements of the Cartagena Protocol on Biosafety.
3) To increase the capacity to evaluate risks associated to LMOs at both national and regional level and to develop regional co-operation to harmonize and validate data and guarantee mutual acceptance.
4) To enhance awareness at the level of the public and policy-makers on risks and benefits coming from LMOs so as to guarantee the safe and rational use of modern technology.

The Cuba Project on capacity building for the implementation of the National Biosafety Framework includes wide range of activities in the areas such as:
- implementations of national biosafety/biotechnology related legislations;
- institutional strengthening;
- human resource development;
- risk assessment and risk management;
- information sharing, data management and public awareness, participation and education.

National level activities
Development of national biosafety frameworks
Human-resources development
Information exchange & data management
Institutional strengthening
Public awareness, education and participation
Risk assessment

Regional level activities
Coordination and harmonization of regulatory frameworks
Regional collaborative initiatives

International level activities
Publications

Goals
To support the implementation of Decree Law N.190/99 on Biological Safety by drafting and enacting additional relevant regulations and therefore enable an adequate level of protection in the field of the safe transfer, handling and use of living modified organisms (LMOs) resulting from modern biotechnology, with a specific focus on transboundary movements, in Cuba.

To develop methodologies to assess, manage and monitor the risks associated with LMO handling, transport, use, transfer and release; and to produce and validate the related data at national level and in cooperation with other countries in the region.

To strengthen capacity at national and regional level  by setting up a National Centre of Capacity Building and running national and distance courses in Biosafety.

To promote and strengthen information sharing and dissemination among the relevant stakeholders, and enhance public awareness at national and regional level so as to guarantee the safe and rational use of modern technology, and demonstrate -on scientific basis- the results of risk management and monitoring.

Objectives
The main goal of the project is to provide the needed capacity building for implementation of the National Biosafety Framework according to the obligations of the Cartagena Protocol.

Main outcomes
At the National level the main expected outcomes are:

1) Finalization of the following regulations: "Rule of Licenses of Biological Safety"; "Rule of Biological Safety for facilities handling biological agents at small and large scale that may affect animals, man and plants" and "Rule for the State Environmental Inspection of Biological Safety" (part of decree 190/99 on Biological Safety);

2) Establishment of the Standardization Committee for biosafety and definition of the technical rules;

3) National Biosafety strategy worked out and approved;

4) Organization of the national and local workshops: National workshop on the implementation of legal documents, technical rules and methodologies; Local workshops for defining, analyzing and approving the national Biosafety Strategy; National workshop for adopting the National Strategy of Biological safety.

At the regional/international level, main expected outcomes are:

1) Harmonization process at regional and international level of the legal framework started;

2) Finalized methodology for risk assessment/management/monitoring of LMOs released into the environment and Granting licenses;

3) Harmonized data production and validation on LMOs risks started;

4) National/Regional Centre for Capacity Building set up and national and distance courses conducted;

5) A biosafety Masters postgraduate course and a distance course set and run;

6) A National Database System set up and linked to the BCH for information exchange in Cuba;

7) A workshop on the use, handling of database and system evaluation organized;

8) A Centre of Technical Literature on Biosafety set up;

9) Enhanced public awareness, information disseminated through teaching materials, specialized magazine, public education programme, database access.

Responding to the increasing complexity of research and the potential risks of biological contamination for organisms and micro-organisms as well as for human health, a Decree-Law on Biological Safety was approved in 1999. Such a Decree was the answer to the public demand for a proper legal framework on biological safety.

Cuba is therefore developing and consolidating its National Biosafety System by implementing mentioned Decree and drafting complementary regulations in order to guarantee the fulfillment and management of safety in biotechnology as per the Cartagena Protocol. It aims at protecting human health, improving the environment and reducing to the minimum the negative effects on the preservation and sustainable use of biological diversity.

The National Centre of Biological Safety is in charge of the co-ordination and fulfillment of the project through the establishment of a working group identified as NEA which has been responsible for planning and carrying out the above activities. This working group has been carrying out quarter meetings to check the results and the progress of the project taking proper measures for each case.

Other collaborating organizations
UNEP/GEF