Policies on the Safe use of Modern Biotechnology!
Policy on the safe use of biotechnology set precedents. It is often the case that safety legislation is brought in because an accident has occurred and systems need to be put into place in order to ensure that it does not reoccur. The possible risks of modern biotechnology were recognised at the very beginning of its use, and steps were taken to ensure that it was used safely.
With the discovery (during the 1960s) of enzymes that could cut the DNA sequences at specific points in the sequence mechanisms became available for transferring information between organisms in a precise and controlled manner. If two molecules are cut using the same enzyme, they will be cut at identical sequences, and can therefore be wrongly re-assembled. It is thus possible to cut a piece of DNA and insert a desired sequence precisely at that point.
This technique was only initially effective in microorganisms, as the insertion of specific molecules into the whole genome of plants is much more complicated. It only became possible when a bacterium was discovered capable of inserting a sequence of DNA into a random position in the plant genome. The ability to regenerate a complete plant from a single cell (impossible in other higher organisms) made it possible to easily modify many plant species.
It was later discovered that if ballistics was used to literally fire DNA into cells a small proportion would have sequences stably integrated into their genome. Selection techniques involving (usually) choosing to have one of the inserted sequences express antibiotic tolerance mean that the tiny proportion of cells modified using the technique can be identified relative to the rest.
The potential uses of genetic modification were obvious from the moment that the techniques that enabled the transfer of genes from one organism to another unrelated organism were first identified. A United Kingdom government initiated committee reported in 1975 that genetic manipulation techniques would provide .substantial though unpredictable benefits application of the techniques might enable agricultural scientists to extend the climatic range of crops and to equip plants to secure their nitrogen supply from the air.
A meeting of scientists using the very new recombinant DNA technology in Asilomar in California in February 1975 produced a set of guidelines for the use of biotechnology: The formal goals of the meeting included the need to identify the possible risks involved for the investigator and or others, and the measures that can be employed to test for and minimise the biohazards so that the work can go on. The benefits of the new technology far outweighed the risks if suitable precautions were put in place in the view of the Ashby committee in 1975.
The use of modem biotechnology, however, extends far beyond arable agriculture, and it is heavily used in the industrial manufacture of high value chemicals and pharmaceuticals. In addition animals are being modified; higher animals acting as factories or to use them more efficiently for food; insects for research purposes and to attempt to eliminate disease, etc.
For safety reasons the contained or confined use of genetically modified organisms is likely to be favoured over crop plant modifications particularly where they are used as factories for the manufacture of toxic chemicals and pharmaceuticals.
Transgenic organisms may be used for human and animal medicine that are then purified for chemicals rather than sold as organisms. Transgenic viruses may be used as vaccines through to vectors for inserting needed gene sequences into other organisms. Bacteria and fungi are likely to be used industrially for making chemicals. It is likely that these modified microorganisms will be traded to be used industrially, or used in factories to produce wanted chemicals.
Modified micro-organisms are already being used for all sorts of purposes, and are likely to be used directly as bio-control agents in the future. Small animals, (insects for example) may be manufactured either because they are the only organisms identified for a particular use, or because they are a perfect vector for a particular reason e.g. mosquitoes incapable of carrying the malaria parasite. In most instances these will be released into the environment and will impact on the ecology into which they are released.
Large animals are being used as factories or the production of high Value chemicals. Animals that Express pharmacologically active compounds in their milk, for example, are contained and effective factories but care has to be taken to ensure that the animals are treated humanely and are not seriously affected because of the nature of the chemical they are being used to fabricate.
Although the public in many countries has been fearful of the introduction of the .products of this technology. Parliaments have not been as reticent, and have recognised both benefits that may arise from its use and the risks that it theoretically poses. In 1993 the Parliamentary Assembly of the Council of Europe passed recommendation 1213 on developments in biotechnology, for which there were many wonderful prospects, but also for which there were many concerns.
The Council of Europe includes many countries in Central and Eastern Europe as well as those of the affluent European Union. The resolution noted that the gene pool has been widened far beyond the limits of sexual compatibility to encompass the possibility of transferring genes from almost any organism to others.
Amongst the many uses of biotechnology it identified were the raising of agricultural outputs (or reducing inputs), the replacement of chemical herbicides and insecticides or more efficient targeting, the use of plants in industry, changes in responses of crop plants to stress and even the cloning of meat animals .for particular markets or to form embryo banks to maintain genetic diversity. The resolution noted that there might be significant drawbacks resulting from the application of the new biotechnology.
The possibility of new diseases was raised, as were the potential environmental effects of transgenic organisms. Many of the benefits have been effected, although many do not realise that vaccines, pharmaceuticals and food additives (such as chymosin and ascorbic acid) are often the products of modern biotechnology.
The Cartagena Protocol was agreed in 2000 after years of negotiation and argument, with many misgivings, but in an atmosphere which had changed from that which pertained at the time the negotiations started. Article 19(3) of the Convention on Biological Diversity had required parties to consider the possibility of a Protocol to the convention that addressed the use (and primarily trans-boundary movement) of living modified organisms that might have an adverse impact on biological diversity.
Eight years later Europeans were no longer accepting modern biotechnology; products had disappeared from the shops, and there was a gloom and distrust in many countries not observed elsewhere. Few if any products derived using modem biotechnology are now available in Europe. In North America, farmers adopted transgenic organisms with little opposition, and products derived from them have been in the shops for over 5 years.
The Developing Countries had wanted far more in the Protocol than they were able to get, with many more safeguards. The producer countries fought hard to ensure that, insofar as it was possible, few if any controls were applied particularly to commodity goods. The size of the commodity market alone, they argued, made it difficult to contemplate a regime which required what amounted to visas, at country entry points.
The Protocol requires 50 ratifications to come into force. To date it has received 45 ratifications, one of which is by the European Union, which does not count as part of the 50 required (not all the European Union countries have ratified. When they do, the number will exceed the threshold). More than 100 countries have signed. Southern African countries that have signed but not yet ratified are Malawi, Namibia, Uganda and Zimbabwe.
Amongst those which have ratified or acceded to the protocol are Mozambique, Botswana, Mauritius, Kenya, Uganda and Lesotho. Most of these countries do not yet have the legal systems in place to implement the requirements of the Protocol. The major user of transgenic organisms in southern Africa, South Africa, was involved in the discussions during its adoption but has not (yet) signed or ratified.
The need for specific legislation in regard to the use of genetically modified organisms was never a presumption even though it was recognised that regulation was needed from the earliest days of the use of this technology.
The UK had regulated the genetic manipulation, of micro-organisms starting in 1978, and by 1983 had a full set of legally binding regulations in place. The United States, on the other hand, had specified guidelines (the NIH Guidelines) which identified the manner in which such organisms should be used by those funded by the National Institutes of Health.
In 1986 the US Government published its Coordinated Framework for the Regulation of Biotechnology which described the comprehensive federal regulatory policy for ensuring the safety of biotechnology research and products.
Existing statutes provide a basic network of agency jurisdiction over both research and products; this network forms the basis of this coordinated framework and helps assure reasonable safeguards for the public. This framework is expected to evolve in accord with the experiences of the industry and the agencies.
The laws that already existed in the United States regulated specific product uses, such as foods or pesticides. It was considered that genetically modified organisms posed no new risks that could not be covered using the existing system.
This approach provides the opportunity for similar products to be treated similarly by particular regulatory agencies. The underlying policy question was whether the regulatory framework that pertained to products developed by traditional genetic manipulation techniques was adequate for products obtained with the new techniques.
Upon examination of the existing laws available for the regulation of products developed by traditional genetic manipulation techniques, the working group concluded that, for the most part, these laws as currently implemented would address regulatory needs adequately. For certain microbial products, however, additional regulatory requirements, available under existing statutory authority, needed to be established.
The US Administration decided to identify the various tasks needed to regulate biotechnology and clearly indicate the Agency and even the law which would be used to ensure that these technologies were used safely.
Other countries did not (at the time) have the range of environmental, food, drug and safety legislation in place that permitted effective use of existing legislation. In the US it was decided that jurisdiction over the many different biotechnology products would be determined by their use rather than the manner of their products, just as was the case for traditional products.