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Bio-Safety Regulatory Systems!
Guidelines or regulations were quickly introduced in some countries, particularly to protect those who might come into contact with the modified organisms. In the UK the first regulations were introduced in 1978; the NIH guidelines were implemented in the United States soon after Asilomar and applied to work funded through grants received from the NIH.
Initially the regulations, applied primarily to work in laboratories because that was the only place in which the work could progress. They were aimed at the protection of those individuals who had access to the laboratories or facilities and attempted to assure that the work was contained and that workers were protected from the hazards posed by the modified organisms.
It was only in the late 1980s that the introduction of modified organisms into the environment became really feasible. At first it was expected that these releases would mainly be of micro-organisms, but as methods capable of modifying plants became available and efficient it was clear that most environmental releases would be of plants. Very few modified microorganisms have been released.
Many countries have decided to implement different systems of regulation for organisms intended for use in containment (or confined) and those that are released into the environment. Contained use included organisms used in industrial plant and processes for manufacturing where the organisms themselves are not intended to be marketed or exposed to the open, environment.
Most countries in the Southern African Region are considering the frameworks necessary for a regulatory system to ensure the safe use of modern biotechnology or have already enacted legislation. South Africa initially regulated transgenic organisms through a voluntary system but since 1997 have had legislation in place to ensure that the use of modified organisms in South Africa is done safely. It is the only country in the region that has, so far, permitted the commercial use of any transgenic plants.
Zimbabwe was the second country after South Africa to come up with bio-safety regulations; was the first to come up with an institutional framework and is one of the few countries to have post-graduate training in biotechnology.. Namibia was part of a UNEP/GEF financed Pilot project which permitted 18 countries to start the process of regulating Biotechnology and is now one of 12 countries financed by the GEF to implement the biosafety frameworks that have been devised for the country.
Zambia, Uganda and Kenya were also among the countries that participated in the Pilot project and Uganda and Kenya are among the twelve now implementing their frameworks with significant funding from the GEF. Botswana, Lesotho, Mozambique, Rwanda, Zimbabwe and others in the region are currently being funded through a follow up project to the Pilot which assists countries to design frameworks to assure safety of biotechnology Countries have chosen to use a variety of triggers for regulation of biotechnology.
In Europe it is the fact of using modem biotechnology as defined in the Directives that triggers the regulatory process. In the United States, because current law is used, the trigger tends to be the use of organisms that are pests plant pests for example – in the manufacture of the organism if the Department of Agriculture is to be involved. Canada has chosen to use a concept of novelty to trigger the regulatory process. Many analyses have suggested that once the process is started, the risk assessment and management processes are very similar.