By MSc. Juan Acosta Giraldo
The objective of this first article is to briefly expose the development of biosafety in Cuba, which obviously does not intend to cover everything related to this activity, especially since it has increasingly become a discipline that crosses almost all of them horizontally. activities that involve the use of biological agents.
Biosafety is a discipline that has been in Cuba for a long time, perhaps not as we conceive it today, and not under the name of biosafety, but it has always been present in laboratory practices where biological agents are manipulated with the name of good practices of laboratory.
When we hear about Biosafety, we immediately think of containment levels, high-risk facilities and maximum security or something very dangerous of biological origin that must be controlled, and we are not far from reality. Conceptually Biosafety is defined in Decree Law 190 of Biological Safety as:
"Set of scientific - organizational measures, among which are human, and technical - engineering, which include physical ones, aimed at protecting the facility worker, the community and the environment from the risks involved in working with agents biological organisms to the release of organisms into the environment, whether they are genetically modified or exotic; minimize the effects that may arise and quickly eliminate their possible consequences in case of contamination, adverse effects, leaks or losses "...
The objective of this first article is to briefly expose the development of biosafety in Cuba, which obviously does not intend to cover everything related to this activity, especially since it has increasingly become a discipline that crosses almost all of them horizontally. activities that involve the use of biological agents. In successive articles, we will talk about each of the activities carried out by the National Center for Biological Safety, the topics that it imparts for the professional training of specialists who face biological risk on a daily basis, in research, diagnosis, production and field release.
In the beginings
In our country, the activities related to Biosafety began in 1984 with the creation by the then Academy of Sciences of Cuba, of a Biosafety Commission. Organizational work in this sphere gained strength in 1992, after the Rio de Janeiro summit; and they acquired institutional character in 1993, when the now defunct National Commission for the Protection of the Environment and the Rational Use of Natural Resources (COMARNA) was designated as the entity in charge of proposing to the State and the Government the policy to be followed in this matter .
The scientific and technical development, the necessary advance of biotechnology, genetic engineering, the production of medicines, vaccines, and other products, where bacteria, yeasts and cultured animal and plant cells participate, whose metabolism and biosynthesis capacity are oriented towards the manufacture of specific substances, and that today constitutes one of the principles on which biosafety is based, the results obtained in the transformations at the level of genes in Agroindustry, aquaculture, in animals and products for human use, are beginning to worry , to the international scientific community, which sees the need to regulate the advance, by leaps and bounds, of modern biotechnology.
Appears at the end of the nineties, the phenomenon of cloning, the so-called human genome project, in many laboratories in the developed world there is talk of creating the man of the future, and a series of theories and hypotheses, which could change the natural course of life. All this may or may not be possible but in a controlled manner, with strict regulations and with this we are not denying the development of future research.
Cuba in this sense manifested itself in 1996 with the creation of the National Center for Biological Security (CNSB), by the Ministry of Science, Technology and Environment, and began to take the first legislative steps in the field of Biosafety, responding to state criteria based on the principles of the safety culture that we have already been accumulating, which establish an integral character and its close relationship with the other disciplines that attend to security both in the facilities that handle biological agents and in the areas of releases of organisms to the environment.
Need for a strong legislative apparatus to face the challenge.
Biotechnology began to develop in Cuba at the end of the 1970s, gaining strength from 1982 with the creation of the Center for Biological Research (CIB), an institution that undertook the production of human interferons Alpha and Ganma by the so-called conventional route. At the same time, this Institute achieved the cloning and production of these elements by recombinant route.
Given the successes obtained and the need to achieve a greater diversification of work topics, the Center for Genetic Engineering and Biotechnology (CIGB) emerged in 1986, as a colossus of research, ten years later the Center emerged as we have already said. National Biological Security, this difference in years between the emergence of the biotechnological research and development centers and the creation of the regulatory center, makes the CNSB, in its beginnings, have to face a Biosecurity, characterized by its legislative and practical dispersion, Seen differently by each of our research, diagnosis and production centers, until the end of the decade of the 90s its concrete legal manifestation only reached the levels of internal regulations in some facilities that ruled on this matter. From a practical or functional point of view, there were biosafety inspectors and sometimes commissions were formed in those centers that, due to the complexity of their work, warranted it, so that it was necessary to prepare legislative documents, to strengthen the activity and face the development of biotechnology in Cuba and the creation of new Research and Development Centers.
Thus, in 1999, Decree Law 190 of Biological Safety was published in the Official Gazette, which establishes the general precepts that regulate use in the national territory; the investigation; essay; the production; import; the export of biological agents and their products, organisms and fragments of these with genetic information and the releases of these to the environment; in addition to the actions aimed at guaranteeing compliance with the international commitments assumed by Cuba in matters of biological security; and accident prevention and measures to protect the environment; the population and others. This document constitutes the most important legislative tool available to the national regulatory body for biological security to enforce its functions.
Today, in addition to Decree Law 190, we have resolutions that strengthen the work of the CNSB, from an organizational point of view; We already have a biosafety specialist for each province, each provincial specialist prepares and trains the specialists in each of their municipalities in Biosafety matters.
As part of the necessary Training, two national courses and one international one in biosafety are taught, a master's degree in biosafety is offered, and Training courses can be given directed to certain sectors according to the needs.
How is Biosafety conceived in Cuba?
Biosecurity is conceived as a national system that is structured from the government to the worker, each with its own objectives and specific functions.
The CNSB, as a national regulatory center, has among its work objectives,
- Organize, direct, execute, supervise and control the national system of biological security.
- Organize, direct and control the measures to comply with the obligations contracted in international legal instruments on biosafety.
Within its powers and functions it has:
- Carry out risk assessments for human health and the environment of those activities that involve biological risk.
- Organize and direct inspections of biomedical and biotechnological facilities and areas for the release of organisms into the environment.
- Grant licenses for transfers, research and release of organisms to the environment.
How is the National Center for Biological Safety constituted?
The CNSB, according to the type of work it performs, has a heterogeneous group of specialists, with vast experience; trained in Microbiology, Biology, Epidemiology, Biochemistry, Chemical Engineering and Industrial Engineering, Veterinary Medicine, Specialists in Plant Health, Law and Specialists in Automated Systems, who respond to the needs of the Center, relative to legislation, analysis and risk assessment, review and evaluation of technical files, grant authorizations and carry out inspections, in addition to complying with international agreements to which Cuba is a party.
Functionally it is designed as follows:
Teamwork and the flow of information both vertically and horizontally is a fundamental premise. Although each work group performs specific functions, all have points of dependence on each other and added together they give authenticity and strength to the work of the CNSB, this is vital to obtain good results.
Today, with five years of work as a regulatory body for biosafety in Cuba, the CNSB can already provide encouraging results, especially regarding legislative materials created as we have already said to strengthen the work, we already have a Decree Law 190 of Security Biological, Resolution 76, which organizes biosafety in Cuba, Resolution 42, which groups biological agents into risk groups, and Resolution 8, a series of regulations are already being drawn up to serve as a guide to facilities that handle biological agents or toxins.
Another important aspect to take into account in these five years is that approximately 1,400 facilities with biological risk have been identified in the country, an average of 1,387 inspections of risk facilities and release areas have been carried out at the national level, approximately 93 biological safety authorizations, out of a total of 137 requests made, 4 have been denied, and 54 opinions have been issued.
Obviously, the National Center has gained experience in these years and has managed to link its work with the Central State Administration Bodies that have facilities where Biological agents are manipulated.
* Bachelor of Microbiology, Bachelor of Biochemistry, Master of Health Administration, Master of Bacteriology - Mycology.