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Online Journal, URL - http://bioline.bdt.org.br/by
Field Testing and Commercialisation of Genetically Modified Plants in Developing Countries - Biosafety Aspects
Ivar Virgin
Received March 3rd, 1997
Code Number: BY97003
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Graphics: No associated graphics filesABSTRACT The application of biotechnology research in developing countries has to a large extent occurred in the agricultural sector. In many of these countries traditional agriculture and plant breeding programmes are now being supplemented by genetic engineering techniques. These include tissue culture techniques to produce disease free seedlings, new formulations for animal vaccines, and more recently the development of transgenic plants. An often used benchmark for the progress of agricultural biotechnology is the number of field tests done to date. World-wide more than 3600 official field trials of genetically modified plants were conducted between 1986 and end of 1995 in more than 30 countries. More than ninety per cent of the field trials have been performed in North America and Europe. Many developing countries have to a large extent served as winter nurseries for various international seed companies. However, a larger number of developing countries are now building significant capacities in biotechnology. As a result, more and more of these countries will test transgenic crops constructed in their own national laboratories and in collaboration with research institutes in the North or International Agricultural Centres. Judging from the current development these will be crops with transgenic traits which to a greater extent address specific national needs. While the large majority of industrialized countries have biosafety regulatory procedures in place, the situation in developing countries is dramatically different. The results of a 1995 Biotechnology Advisory Center survey showed that only roughly ten percent of the developing countries had any established biosafety regulations. The situation is improving and the establishment of an international biosafety protocol under the Convention on Biological Diversity will probably increase the pressure on developing countries to establish biosafety regulatory procedures. However, it is important to note that neither an international biosafety protocol nor national regulations will of themselves facilitate the safe development of biotechnology. There must also be the national capacity to implement the regulations. THus, the capacity to regulate biotechnology through risk assessment and management is as important as the regulations themselves. Even though much of the work in building a biosafety regulatory capacity has to be done by the developing countries themselves, there is a clear need for continued assistance from international organisations.
Keywords:Agricultural biotechnology, biosafety, regulations, capacity building, developing countries, transgenic plants, field trials, risk assessment. INTRODUCTION An environmentally conscious world looks at technological developments with mixed feelings. Excitement and optimism are tempered with large measures of scepticism, uncertainty and fear. Many people are sceptical about claims such as "new is better", uncertain that benefits will be shared equally and not enjoyed by only a few and afraid that new technology brings with it unacceptable adverse impacts. This is particularly evident with modern biotechnology. Biotechnology and more specifically genetic engineering have given rise to certain socio-economic, environmental, legal and policy concerns. The following article attempts to give an overview of the field testing of transgenic plants and briefly discuss some of the current thinking in biotechnology regulation and its implications for developing countries. Biotechnology is the use of biological material to achieve some purpose. It includes techniques like tissue culture and micropropagation to produce disease free plant seedlings and medical biotechnology producing new vaccines. Like many technologies, it is not new but is constantly changing. The majority of these changes are incremental; for example a more productive series of antibiotic producing microbes is developed that increases yield by 10%, then 20 %, and so on. These changes generally go on unnoticed except by those directly involved. Other changes, however, can be much more dramatic, even revolutionary in form and scope. Such was the discovery of recombinant DNA techniques in the early 1970s. Suddenly, it seemed, powerful genetic modification tools became available to laboratories world-wide and with them the capacity to transfer genes across species barriers. The potential was great and modern biotechnology quickly found applications in areas as diverse as medicine, agriculture, food processing, chemical production and environmental improvement. Concentrating only on the potential, however, was not enough. In order to benefit as many people as much as possible, it had to be developed and applied judiciously. Policies and procedures were created to ensure environmentally safe application of biotechnology and with them the concept of biosafety was defined. While biosafety issues have been discussed for over twenty years in the developed world, only in the last four years have the issues been extensively explored in the global arena. The Convention on Biological Diversity and Agenda 21 program extensions will apply pressure on developing countries looking to adopt biotechnology. The Convention couples access to genetic resources with scientific co-operation and transfer of technology from developed to developing countries. It also contains provisions on national and international biosafety oversight mechanisms. Jeffrey McNeely, Chief Scientist at The World Conservation Union (IUCN) (McNeely, 1994) recently described the issues in this way "...The new biotechnologies may increase the value of the world's biodiversity if they allow increased use of the genetic diversity of both wild and domesticated species, thereby increasing their economic importance. But biotechnology also poses significant ecological and economic risks that could ultimately undermine its potential contribution to the conservation of biodiversity. The introduction of any new organism poses a risk to the environment, and many of the world's known extinctions have been caused primarily by the introduction of exotic species. The release of genetically engineered organisms into the environment thus deserves the most careful oversight and monitoring." (McNeely, 1994). AN ACCELERATING DEVELOPMENT What is the level of activity as regards the construction and field testing of transgenic plants in developing countries? One of the often used benchmarks for the progress of agricultural genetic engineering is the number of field tests done to date. World-wide, more than 3600 field trials of genetically modified plants were performed up to the end of 1995 in more than 30 countries (Ahl Goy and Duesing 1995, James and Krattiger, 1996). Not unexpectedly there is a great imbalance between industrialised countries and the developing world. (For simplicity, the term developing countries will also include newly industrialised countries and economies in transition. Hence, countries like Brazil, Argentina, Mexico and South Africa are here referred to as developing countries). The vast majority of the field trials, more than ninety percent, were performed in North America and Europe. Looking at the developing world, 0.7% of these field trials were conducted in Africa, 1.7% in Asia (excluding Japan, Australia and New Zealand) and 5.7% were performed in Latin America and the Caribbean (Ahl Goy and Duesing 1995, James and Krattiger, 1996). There is an even greater imbalance when one looks at the number of transgenic plants that actually were developed within the country of test. Most developing countries have, so far, served as winter nurseries and counter season seed production sites for international biotechnology and seed companies. To a large extent these transgenic plants have been crop varieties more suitable for the agricultural systems in temperate regions, particularly in North America and Europe. There are exceptions like China and Cuba, who have developed and tested their own transgenic plants. It is also important to add that the situation is beginning to change and many developing countries will soon be field testing transgenic plants developed by their own national institutes. This serves as an indication that several developing countries are beginning to adapt technological advances made in the North and elsewhere to their own local needs. TRANSGENIC PLANTS IN LATIN AMERICA AND THE CARIBBEAN Among developing and newly industrialised countries Latin America and the Caribbean (LAC) region have the largest number of field trials. The numbers are steadily increasing and field trials with transgenic plants have been carried out in Argentina, Belize, Bolivia, Costa Rica, Chile, Cuba, Dominican Republic, Guatemala, Mexico and Peru (Frederick and Virgin, 1995, James and Krattiger, 1996). The most frequently tested transgenic traits are: herbicide tolerance (35%), disease and insect resistance (50%) and product quality (10%). Table 1 shows the countries the number of field tests and the most tested crops in individual countries. Table 1. Transgenic Field Tests in Latin America and the Caribbean (up to end of 1995).
Country Number of Principal crops
field trials tested
______________________________________________________
Argentina 78 Maize, cotton, soybean
Belize 5 Maize, cotton, soybean
Bolivia 6 Maize and potato
Chile 39 Maize, soybean
Costa Rica 17 Soybean, cotton, banana
Cuba 13 Potato, sugarcane,
sweet potato
Dominican Republic 1 Soybean
Guatemala 3 Squash and tomato
Mexico 38 Tomato, cotton, squash
Peru 2 Potato
(James and Kratttiger, 1996) Argentina and Chile have to a large extent served as winter nurseries for international seed companies. It is, however, interesting to note that a dozen research groups within these countries are now developing transgenic crops with traits more relevant to the national needs. Argentina has also approved commercialisation of transgenic herbicide tolerant soybeans. Cuba has, with very little external support, developed a strong program on plant genetic engineering. The Plant Biotechnology Division at the Center for Genetic Engineering and Biotechnology has performed 13 field trials with five different transgenic plants (tobacco, sugarcane, sweet potato, cabbage and potato). The trials in Peru reflect the activities at the International Potato Center (CIP). At CIP, the production of transgenic plants is conceived to increase pest and disease resistance in order to reduce pesticide use in potato crop management. Potatoes expressing Bt-toxin for insect resistance have been produced and field tested. Virus resistant potatoes, expressing the viral coat proteins for the potato viruses PVY, PVX and PVRL have also been field tested. Transgenic potatoes resistant to frost have been field tested in Bolivia in collaboration with the Bolivian Institute of Agricultural Technology (IBTA). The latter research project is a joint effort between CIP, IBTA, the Central University of Venezuela and University of Louisiana. Mexico being so close to United States and a member of NAFTA has a special situation in the region. Several transgenic crops have been tested by seed and biotechnology companies from United States. National institutes like CINVESTAV have also developed and field tested several transgenic crops. However, being the centre of diversity for maize, the Mexican National Committee for Agricultural Biosafety (CNBA) for a long period denied approval of work with transgenic maize. The members of CNBA felt that they needed more information on the impact of transfer of transgenic traits in wild maize and teosinte populations, the wild relative and ancestor of maize. At an international conference at the Maize and Wheat Improvement Center (CIMMYT) in 1995, the impact of certain transgenic traits on the teosinte and wild maize populations were considered. The workshop participants discussed how to evaluate impact and how to design informative experiments. The CNBA has since then decided to allow field tests of transgenic maize for information gathering and, in 1996, the Committee approved two field trials performed by CIMMYT. Mexico is also the second Latin American country that has deregulated transgenic crops. These are tomatoes with delayed ripening (FlavrSavr), herbicide resistant canola and soybeans, insect resistant Bt-cotton and potato. This reflects the deregulation in United States for the same crops but with the important exception that maize is not deregulated. Given the circumstances, it will probably take some time before Mexico deregulates transgenic maize even though there will be an illegal flow of transgenic seeds over the Mexican border. Transgenic Plants in Centers of Origin in Latin America: Potato as model Potatoes are one of the most popular transgenic crops in Latin America and the Caribbean and more than ten research groups are active in developing transgenic varieties. Several of these groups are now approaching field testing. However, the biosafety assessment of these new varieties represent a special challenge to regulatory authorities, since very little risk assessment on release of transgenic potatoes has been performed relevant to the region. In general, most risk assessments previously done on the release of transgenic potatoes have been in countries where the possibilities of geneflow to wild Solanum populations has been virtually non-existing. With this background the Biotechnology Advisory Commission (BAC) and the Inter-American Institute for Co-operation in Agriculture (IICA) organised a workshop on environmental concerns with transgenic potatoes in Latin America (Frederick and Virgin, 1995). The objective of the workshop was to make a comprehensive review of the environmental concerns specifically associated with the release of transgenic potatoes in their centres of origin. Particular emphasis was placed on transgenic constructs currently developed in Latin America in order to assist regulatory authorities and scientists in the region. Participants included South American researchers, members of national biosafety committees and additional resource persons with experience in releases of transgenic potatoes in the North. In the United States and Europe, the possibility of gene transfer to interfertile species is virtually non-existent due to the lack of wild relatives. In Latin-American centres of origin there will be gene flow between commercially grown fertile transgenic potatoes and the wild Solanum populations. Therefore, the discussion was not so much concerned with the containment of transgenes as with the possible impact these transgenes would have on the environment; more specifically, the consequences of transgene-flow in centres of diversity. There was general agreement that the centres of diversity are of great value not only locally, but also world-wide. Furthermore, participants felt that one should take all reasonable measures to preserve this diversity. It was clear that the major efforts in transgenic potato development in the region are and will be made in the evolution of plants with increased resistance to diseases and pests. The traits most analysed at the workshop were resistance to insects, bacteria, virus and fungi. Stress resistance traits (in particular to frost) were also discussed whereas herbicide resistance and quality modifications (altered starch composition and protein content) were considered only briefly. There was no clear consensus among the participants whether introduction of transgenic traits in wild and cultivated potatoes would erode Solanum diversity by changing growth patterns and thus displacing the natural population? Many felt that in most cases transgenic potato varieties would be no different from plants used in conventional breeding. Others argued that a trait that drastically increases the fitness (weediness) of plants would, at least theoretically, pose a threat to Solanum diversity. In general, there was a feeling that the available information and current research efforts in this field, specifically in relation to the Latin American situation, are inadequate. Regarding the disease resistance traits (insect, bacterial, virus and fungi resistance) most participants took the view that the benefits would, in most cases, outweigh the environmental concerns. It was argued that these traits already were present in the wild Solanum populations in many Latin American regions and that the transgenic traits were no different from those having been selected by potato breeders for many years. Therefore, the risks a priori are not different from those present after introduction of traditionally bred cultivars. In conclusion, many countries will make decisions, based on their needs, on whether they will or will not introduce transgenic plants. The view taken by many at the workshop was that it is a matter of balancing the environmental concerns with the potential benefits. The benefits will in many cases outweigh the perceived risks, but the balance between these needs to be assessed. However, in several cases more information is needed on the environmental impacts of certain transgenic traits in specific regions of Latin America. TRANSGENIC PLANTS IN AFRICA AND ASIA In Africa field tests have been done in Egypt, South Africa and Zimbabwe. In Asia field tests have been performed in China and Thailand (excluding tests performed in Australia, Japan and New Zealand). The most frequently tested transgenic traits have been disease and insect resistance, herbicide tolerance and product quality (James and Krattiger, 1996). Table 2 shows the countries, the number of field tests and the most tested crops.
Table 2. Transgenic Field test in Africa and Asia (to the end of 1995)
Country Number of Principal crops
field trials tested
_______________________________________________
Africa
Egypt 2 Potatoes, Tomatoes
South Africa 22 Cotton, Maize
Zimbabwe 1 Tomato
Asia
China 60 Tobacco, Cotton,
Tomato
Thailand 2 Tomato, Cotton
(James and Krattiger, 1996) In Egypt close collaboration between the Agricultural Engineering Research Institute AGERI and the USAID supported Agricultural Biotechnology for Sustainable Production (ABSP) has resulted in a number of transgenic crops. So far transgenic potatoes and tomatoes have been tested and maize and water melons will soon be field tested. South Africa has been the winter nursery nation for international seed companies, but there are now several research institutions within the country that are ready to go to the field. Zimbabwe is understood to have conducted one trial with a delayed ripening gene. After the trial, Zimbabwe has been very restrictive and is awaiting guideline approval. The newly developed Biotechnology Research Institute (BRI) have started to develop transgenic crops (e.g. transgenic cotton and maize) in collaboration with other institutes world-wide. In Asia, China is developing and testing transgenic crops on a large scale. China initiated field trials with transgenic crops as early as 1989. The most important crops tested are tobacco, cotton and tomato. Transgenic virus resistant tomato and tobacco have been commercialised and the latter crop has been tested on a very large number of locations and large areas. There are different figures on the estimated acreage in 1996, ranging from 10,000 to 2 million acres (James and Krattiger, 1996). Chinese scientists have also made field trials with a recombinant nitrogen fixing soil bacterium (Rhizobium) which has been spread over more than a million hectare. Altogether this makes China an interesting place for post monitoring of ecological impacts of specific GMOs. In Thailand, Calgene's FlavrSavr tomato has been tested as well as transgenic cotton expressing Bt-toxin. The University of Kasetsart has developed a transgenic virus resistant papaya which will be field tested soon. FUTURE OUTLOOK International seed companies will continue to test transgenic plants in developing countries, but will most likely concentrate on countries which have a functional biosafety regulatory structure and a sufficient scientific infrastructure. At the same time, a larger number of developing countries are building significant capacities in plant biotechnology. As a result, more and more of these countries will test transgenic crops constructed in their own national laboratories and in collaboration with Northern research institutes. Judging from the current development this will be crops with transgenic traits which to a large extent address specific national needs. If one looks at the specific countries again, Latin America, Brazil, Colombia and Venezuela will probably make their first field trials with transgenic crops. In Africa, Zimbabwe, Kenya, Nigeria and Uganda will probably do the same in the near future. In Asia, Malaysia, India and Indonesia will soon field test transgenic crops developed within their countries. The international agricultural research centres, such as the centres in the Consultative Group on International Agricultural Research (CG-centres) are also working intensively with the development of transgenic crops. The activities at CIP have been described above. Other examples include the construction of transgenic cassava and cowpea. The International Institute of Tropical Agriculture (IITA) in Nigeria, works on advanced cowpea breeding and transgenic cowpea plants will be growing in their containment facilities within 1996. IITA has strong collaborative partnerships with Purdue University, University of California and Naples. So far the work in these laboratories has concentrated on the construction of virus and insect resistant cowpeas. Work on transgenic cassava is carried out at the International Center for Tropical Agriculture (CIAT) in Colombia. The Centre concentrates on transgenic cassava plants with increased insect resistance, modified starch quality and decrease of cyanoglucoside content. The French research organisation ORSTOM and the International Laboratory for Tropical Agricultural Biotechnology (ILTAB) are collaborating on the production of genetically engineered cassava plants resistant to the African Cassava Mosaic Virus (ACMV). ILTAB is also working intensively on transgenic rice. CIMMYT is working on the development of transgenic maize varieties resistant to pest suitable for LAC countries and Africa. The point is that many of these crops will be ready to be field tested in the near future (1-5 years) and made available to developing country breeding programs. As previously said, many transgenic plants field tested in developing countries will be the results of joint research efforts with developing country institutes and institutes in the North (or South-South transfer). Subsequently, a large part of the transboundary movement of GMOs to developing countries will be movements resulting from research collaborations between industrialised countries (or CG centres). These joint collaborations are for many developing countries vital for building biotechnology research capacity and accessing key technologies. Care must therefore be taken in the formulation of an International Biosafety Protocol so that it does not stifle the scientific and technical collaboration between countries. BIOSAFETY IN DEVELOPING COUNTRIES The majority of the trials described above have been made under some sort of regulatory review, approved by an official or ad hoc biosafety committee and performed according to national or institutional biosafety guidelines. But, there has been exceptions where no or little regulatory process has been involved. These are, to my knowledge, the field tests performed by international seed companies in the Dominican Republic (1991), Belize (1992), Guatemala (1991, 1994, 1995). However, as previously mentioned, it seems that the companies today prefer to collaborate with countries where a formal regulatory process has been established. Current Status of Regulations A large majority of the industrialised countries have biosafety regulatory procedures in place. In developing countries, the situation is dramatically different. The results of a 1995 BAC survey showed that less than ten percent of developing countries have any established biosafety regulations. This is not to say there has been no progress. As shown in Table 3, today at least 16 developing countries have regulatory procedures in place. The majority of these countries are in Latin America and Asia. The large majority of African countries lack regulations.
Table 3. Biosafety regulations world-wide (up to 1996)
Regulations/Guidelines Adopted Currently
Drafting
Industrialised Developing Regulations
Countries Countries
________________________________________________
Australia Argentina Estonia
Austria Brazil Malaysia
Belgium Bulgaria Hungary
Canada Chile Indonesia
Denmark China Kenya
Finland Costa Rica Turkey
France Cuba Uganda
Germany Egypt Zimbabwe
Ireland India
Israel Mexico
Italy Nigeria
Japan Peru
Luxembourg Philippines
New Zealand South Africa
Norway Thailand
Portugal
Russia
Spain
Sweden
Switzerland
The Netherlands
United Kingdom
United States
The Challenge To facilitate the safe transfer of biotechnologies, the developing countries need to formulate and implement biosafety guidelines and/or regulations. The Biosafety Protocol being negotiated under the Convention has the potential to speed up and harmonise the regulatory development globally. However, it is clear that neither an international protocol nor national guidelines of themselves will facilitate the safe development of biotechnology. There must also be capacity to implement regulations based on sound scientific principles with consistency and expedience. One could therefore argue that the capacity to regulate biotechnology is as important as are the regulations themselves. Accordingly, there is a need for developing countries to strengthen their technical expertise and build capacity for implementation of regulatory instruments in order to facilitate the safe transfer and development of biotechnologies in these countries. To achieve this several things are needed, including training at all levels to address shortage of human resources, access to information and international expertise. Biosafety Research An increasingly important factor when building confidence in the safe handling of biotechnology is biosafety research and the ability to share scientific data. It is therefore of no surprise that there has been a growing interest, also from developing countries, in risk assessment/management research. Existing research program have addressed some urgent needs for data such as:
- stability and safety of used transgenic vectors - the probability of gene transfer from crops to crop relatives - horizontal (asexual) gene transfer - monitoring and tracking of genetically engineered micro-organisms - negative impacts on surrounding ecosystem including production of toxic waste products - food safety issues.
The ability to do risk assessment and risk management of environmental and health impact evaluations is important for any country developing or using genetically modified organisms (GMOs). The capacity to do risk assessment aand management in developing countries would be greatly facilitated by in-country biosafety research addressing questions pertinent to local conditions. This would also enhance the national capacity to share and evaluate biosafety data and experiences from other regions in the world (e.g. research data from United States and Europe). Existing biotechnology research institutions in developing countries should therefore be supported1 to also incorporate and develop biosafety research in their programmes. The Biotechnology Advisory Center Looking at the international biosafety scene today, it is obvious that the dominant problem facing developing countries is the lack of functioning organisation structures and the human capacity to ensure adequate biotechnology and biosafety policy implementation. Therefore, in 1993, the Stockholm Environment Institute (SEI) established the Biotechnology Advisory Commission (BAC). The BAC mission is helping to meet the challenge of biosafety capacity building in developing countries. During its three years of existence BAC has been instrumental in helping to meet the challenge of biosafety capacity building. Recognising that achieving technical competence in biosafety implementation is a critical prerequisite for the safe application of biotechnology, the BAC support to developing countries has mainly consisted of two components. Firstly, training in biosafety risk assessment and risk management. Secondly, biosafety information exchange and information interpretation to support scientific and environmental biosafety assessments. In order to provide assistance in a more efficient manner, the BAC has recently been restructured. BAC members now act as a SEI team of external biotechnology/biosafety associates recruited on an "as needed" basis. The acronym BAC is retained, but the full name is changed to Biotechnology Advisory Center Finally, even though much of the work in building a biosafety regulatory capacity has to be done by the developing countries themselves, there is a clear need for continued assistance from international organisations, REFERENCES Ahl Goy, P. and Duesing J.H. 1995 Pots to Plots: Recombinant Plants on Trial, Biotechnology, 13, 454-458. Frederick, R. J., Virgin, I. and Lindarte, Eduardo (Eds.), (1995) Environmental Concern with Transgenic Plants in Latin America: Potato as a model. Proceedings of a BAC/IICA workshop. Publisher: Biotechnology Advisory Commission, ISBN: 91- 88714 21- 7. 90 pp. Frederick, R. J. 1995. International Activities in Support of Safety in Biotechnology In; Proceedings of an Central and Eastern European Conference for Regional and International Cooperation on Safety in Biotechnology. September 4-6, 1995, Keszthely, Hungary. pp 65-74. James, C. and Krattiger, A.F. 1996. Global Review of the Field Testing and Commercialization of Transgenic Plants. The First decade of Crop Biotechnology. ISAAA Briefs, No 1, ISAAA, Ithaca, NY pp.31. McNeely, J.A. 1994. Critical Issues in the Implementation of the Convention on Biological Diversity. pp. 7 - 10. In Widening Perspectives on Biodiversity. (Krattiger, A. F., et al. Eds.) IUCN, Gland, Switzerland and International Academy of the Environment, Geneva, Switzerland. Virgin, I. and Frederick, Robert J. 1995. The Impact of International Harmonization on Adoption of Biosafety Regulations, African Crop Science Journal. Vol. 3, No 3, 387-395. Anonymous 1996. Symposium: Safety in Biotechnology. Beijing, China 1-2 April, 1996. Published by China National Center for Biotechnology Development, Beijing, China and Institute for Safety In Biotechnology, Eschborn, Germany. This paper is an extended version of a contribution to the Friends of the Earth Workshop on International Biosafety, 12-13 September 1996, Brussels. Copyright held by the author. Published by Bioline Publications and Science and Technology Letters Editorial Office: biosafe@biostrat.demon.co.uk
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