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Strict regulation on indoor use of GMOs in the EU
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Within gene technology, resources and possibilities seem unlimited. By mixing different genes any crop or animal can be constructed to resist just about anything and at the same time be more nutritious to humans. But is this viable?
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The scenario of creating genetically modified organisms (GMOs) is scary to many people. Enquiries have revealed that Europeans do not want more than 1 per cent of their foods to contain genetically modified DNA. Approximately 70 per cent of the foods in the U.S. are from GMOs meaning that either the genetic characteristics, the DNA, in the organisms producing the food have been changed or that the food itself, for instance a tomato, is genetically modified.
One of the reasons for the reluctance in Europe is the risk of spreading GMOs into nature. The debate is ongoing and it seems that products containing GMOs will not be released for some years in Europe.
Products where GMOs have been used for the manufacturing process are more accepted because the end product itself does not contain any GMOs. Furthermore, when productions with GMOs are done indoors the production process and the product can be strictly controlled and regulated. The GMO does not come into contact with the consumer or perhaps not even with the worker in the production factory.
Life-saving medicines for use around the world can be made from GMOs. For instance, this is done by isolating a gene carrying the code for a desired product. The product could be human insulin, vital for diabetic people. By using gene technology the genetic code for the desired product is put into a microorganism. Microorganisms grow very fast and their rapid cellular processes are used to produce medicine. In this way the microorganism becomes a GMO that can make a product that does not contain any modified or original DNA. In this way medicine, vaccines and food for millions of people can be made. The counter side of all the gains from the products by using GMOs is the ethical decision that has to be made for or against the mixing of DNA between species.
Regulation by law
Exposure to and spreading of unwanted genetically modified organisms is of course to be avoided. All work with living GMOs carried out within the European Union is regulated tightly by EU directives. Each country implements the EU directives into its own legal system. In 1986 Denmark was the first country in the world to regulate gene technology and the environment. Since then the laws have continuously been revised and updated due to the rapid developments in the area. The aim is to protect employees from infections, citizens from exposure and the environment and food chain from contamination with the GMOs. The Danish law defines what gene technology is and precisely which conditions must be fulfilled before the handling of GMOs can be undertaken.
All work with gene technology needs to be covered by a permit from the authorities. The permit is awarded on the basis of a thorough application including risk assessments. EU directives formulate the regulatory standards for all storage and handling of genetically modified organisms. In Denmark this is implemented by the Ministry of Employment into legislation on Gentechnology and Work Environment. The law regulates that both the facilities e.g. the laboratory where GMOs are used, and the actual work with the GMOs must be described carefully and analysed for any possible risks there may be to the health and safety of both humans and nature. In praxis there are six different types of GMO applications, describing laboratories, pilot plants for larger volume scales and production factories. Each has an equivalent application describing the GMO being used at the facility.
The authorities regulating the external environment are involved in gene technology approvals when animals, viruses or large volumes of GMOs are handled. Local regional authorities control the management of the work with GMOs once the approval is given. All in all, three different authorities cover the GMO regulation described in several different laws.
All rooms where living GMOs are present must be approved by authorities. The surfaces of the facilities used must be smooth and easy to disinfect. Foods and drinks are not allowed in GMO-areas and personnel must wear white coats. All waste streams must be disinfected before leaving the area.
Laboratories for experimental research with small volumes of GMOs and pilot plants, where scale-up to larger volumes is tried, must operate with totally contained use of GMOs meaning that no leaks of GMOs are allowed. The reason for the contained use is that the health and environmental aspects of the used GMO may not yet be fully known.
Risk assessment
Any living genetically modified organism has to be approved by the authorities, whether it is a vegetable, an animal or a microorganism. The organisms that are being used for the work are grouped according to the level of risk to the health and safety of humans or the environment they may cause. Four levels are used, each demanding a higher level of security:
(1) Genetically modified organisms in level one cannot cause any human disease and could typically be baking yeast with genes coding for insulin production in them. Disinfection can be done by cleaning with detergents and/or chemicals.
(2) Genetically modified organisms at level two could contain viruses causing colds and disinfection must be done by severe heating.
(3) Genetically modified organisms at level three could contain HIV. Special facilities for changing clothes and severe heating of materials must be done.
(4) Genetically modified organisms at level four could contain Ebola and equipment looking mostly like space suits must be worn.
The more aggressive the genes in the GMO, the higher the level of classification of the organism. In Denmark only a few level three laboratories exist but the need for class four labs is again being discussed due to the terror attacks and exposures of anthrax-bacteria in the U.S. In Denmark only level one GMOs are being used for production purposes.
Any organism being genetically modified must carefully be risk assessed. Each bit of DNA taken from one organism and set into another organism is evaluated for prior, present and future genetic modifications according to health and safety. Biological terms like donor, host, vector, insert, growth rate, plasmid and final GMO must be risk assessed according to the possibility of an unwanted combination of the genes. In this way, a worst-case scenario in relation to health and safety of humans and nature is thought through. The consequences of exposure to the GMO and its products through skin, mouth, lungs or blood must be fully known. Accordingly the impacts of the GMO to the food chain in the external environment are analysed in case of an accidental leak.
Value for money?
The gain from the many man-hours put into the system of approvals of GMOs should be assurance of control with GMOs that might be able to affect humans and nature. When working with organisms at level one, the risk of an unwanted effect has to be non-existent. The organisms cannot cause diseases and furthermore they can only live under very controlled conditions — once they, for instance, are spilled on the floor they die. The paper work to get approval to work with a level one organism can seem bureaucratic, since the prevention of accidents and leaks with GMOs should be covered merely from working in a level one facility. The people working with the GMOs, the citizens or the food chain system are not at risk. One may argue that the system actually builds on trust and image because authorities cannot physically control the value of the GMO risk assessment. Unwanted focus can be devastating to any industry and the practice of being open and honest to the public about a sensitive topic such as genetically modified organism is highly important. In the U.S. and many other countries the indoor research and production with GMOs at level one is not strictly regulated. The possible threats from working with gene technology are not bigger than the desire to save lives by discovering and developing new medicines. If the laws regulating the handling of GMOs are too tight compared to the actual risks and gains from the laws, you will get left behind in the competitive race.
For the EU to hold a competitive position in the world market, it could be argued, a lot of administrative work should be stopped, but thereby the possibility to keep a systematic track of the work with GMOs will probably be lost. The long-term advantage in keeping track of resources and meeting the concerns of the critical consumer is far greater than the short-term disadvantage of the strict regulations operating in the EU.
CHARLOTTE KLINGE
A Copenhagen based consultant with Novo Nordisk, Denmark
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