Cuba

The Ministry of Science, Technology and Environment (CITMA)

Description In 1984, biological safety-related activities began in Cuba,
upon the creation of the Biosafety Committee by the Academy of Sciences. The development of research activities in the field of genetic engineering and biotechnology along with the participation of Cuba in international agreements led to the establishment of a National System for the safe and correct performance of activities involving organisms with a certain level of risk to the environment and human health.

The Ministry of Science, Technology and Environment (CITMA), created the National Center of Biological Safety that is in charge of organizing, implementing, supervising and monitoring all the activities pertaining to biological safety in the country. In addition, the institution monitors the fulfilment of international agreements on Biosafety.
On January 28, 1999 the Council of State issued Decree Law No.190 in order to implement the National System of Biological Safety adequately. Decree Law No.190 establishes the general principles that regulate the use, research, testing, production, import and export of biological agents. This Decree Law also regulates releases into the environment of biological agents, organisms and fragments with genetically modified information. In addition, it enforces the commitments assumed by the Cuban State on international agreements regarding biological safety.

To establish the safety requirements in those facilities where biological
agents are handled, CITMA promulgated the Resolution 42/99 in April 1999. The resolution approves and puts into force the official list of biological agents that cause negative effects on man, animals and plants. The list takes into account the individual risk that the laboratory workers face and the possible risks of the biological agents for the community and the environment.

CITMA also issued resolution 8/2000 concerning biological safety in those facilities where biological agents, organisms and parts of them with genetic information are handled, and may affect man, animals, plants, and other components present in the environment. The Resolution establishes the functions of the biological safety structures for the facilities and establishes the requirements for the infectious substances transport and dispatch together with the samples contained. In addition, it elaborates on emergency plans in the event of natural disasters and accidents. The above-mentioned resolution contains the different types of permits that a person, natural or legal, requires to have within the Cuban territory in order to carry out the activities related to the use, research, testing, production, import and export of biologically modified agents. Parallel to this, a national training system on biosafety matters has been implemented, which includes specialized, basic and advanced courses and facilities.

• Biological safety and release of genetically modified organisms to the environment (Chapter IX of the Barbados Programme of Action on Biodiversity Resources)
• Human resource development (Chapter XIV of the BPoA)

• Monitoring of research activities, use and testing and production of biological agents, genetically modified organisms or exotic organisms through authorizations, permits, inspections and audits.
• Risk assessment and the issuing of licenses and other authorizations.
• Improvement of safety conditions in situ and in the environment.
• Training on biosafety for CITMA personnel, as well as for per sonnel belonging to other facilities and institutions concerned with biosafety.

There is a need to further address the following issues:
• Preparation of technical and regulatory documentation;
• Training programmes and guidance for expert groups;
• Preparation of international cooperation projects within the biosafety field;
• Risk assessment and methodological assessment;
• Inspections in order to supervise the implementation of safety measures.

Hector Conde
E-mail: conde@dci.citma.gov.cu