Biosafety concerns range from science to socio-economics The following is a report on an important seminar held in conjunction with the

First Meeting of the Parties to the Cartegena Protocol on Biosafety in Kuala Lumpur, at which some key issues relating to biosafety (particularly the possible adverse effects of genetic engineering) were addressed. THE First Meeting of the Parties (MOP 1) to the Cartagena Protocol on Biosafety was held in Kuala Lumpur, Malaysia from 23-27 February. In conjunction with this, Third World Network, with the collaboration of the Norwegian Institute of Gene Ecology and the New Zealand Institute of Gene Ecology, organised a one-day International Biosafety Seminar on 22 February. The seminar highlighted some of the latest independent scientific biosafety research on the possible adverse effects of genetic engineering on human and animal health, as well as discussed the flawed scientific underpinnings of the technology. The socio-economic impacts of genetically engineered crops were aptly illustrated by various case studies. Important biosafety aspects such as addressing contamination, ensuring adequate post-release monitoring and the relationship with biological weapons control were also discussed. The objective of the seminar was to provide delegates to MOP 1, meeting for the first time on crucial issues related to the Biosafety Protocol, with critical information for their discussions and negotiations. Such a seminar was obviously timely and needed, judging by the numbers that turned up, more than 160 in all. Participants included government delegations from both North and South, NGOs, local Malaysian academics, and the foreign and local media. Committed to biosafety The seminar was opened by the Malaysian Deputy Minister of Science, Technology and the Environment, Dato' Zainal Haji Dahlan. Malaysia, as host of MOP 1 and as the country that first raised the issue of biosafety in the negotiations of the Convention on Biological Diversity (CBD), under which the Biosafety Protocol was adopted, is clearly committed to biosafety. The Deputy Minister stressed that the precautionary approach - reaffirmed and put into operation in the decision-making procedures under the Protocol - underpins biosafety. Mr Svein Tveitdal, Director of the Division of Environmental Conventions at the United Nations Environment Programme (UNEP), presented some remarks on behalf of Dr Klaus T_pfer, UNEP Executive Director. He stressed the need for democratising the genetic engineering debate and the regulatory processes, and the need to bring in multiple dimensions - health, environmental, ecological,

social, cultural and ethical. He acknowledged the gaps in scientific knowledge and thereby welcomed independent, holistic biosafety research, so that truly informed decisions can be made. Tveitdal urged participants to respond with urgency to scientific findings of adverse effects of genetic engineering, which he said are already emerging. The Executive Secretary of the CBD, Dr Hamdallah Zedan, emphasised that the Biosafety Protocol is a sustainable development treaty, and that it is not simply an environmental agreement. He stressed the importance of the precautionary approach in dealing with the uncertainties about the impacts of genetic engineering, and that there is no contradiction between scientific assessment and the precautionary approach. He also touched on socio-economic considerations and public participation as part of decision-making. The challenge, he concluded, is as follows: if the Protocol sets standards and guidelines in the absence of other organisations setting standards, will this be used by World Trade Organisation (WTO) members, given that the Protocol's ambit of concerns is much wider? Cause for concern Professor Terje Traavik from the Norwegian Institute of Gene Ecology (Gen"k), University of Troms_, reiterated the importance of the precautionary approach. He explained that biosafety science suffers from omitted research, as the relevant research is not carried out due to pervasive commercial interests. Traavik then described some of the current independent biosafety research that Gen"k is conducting, which includes feeding experiments in rats using genetically engineered materials, the effects of exposure to transgenic products and work on transgenic pox viruses. While the research is still in its initial stages, the preliminary results that Traavik unveiled are cause for concern, as they may be early warnings of potentially adverse impacts of genetically modified organisms (GMOs). For example, in the feeding experiments on rats, the cauliflower mosaic virus (CaMV) 35S promoter used in most commercial genetically engineered (GE) crops today could be detected intact in various organs up to three days after a single meal containing GE DNA construct (end of experiment). Traavik explained that this means that DNA is more persistent than previously claimed. Further work will need to be done to see if the CaMV 35S promoter is active in mammalian cells, and can hence exert a biological effect, although Gen"k's in vitro tests with various cell cultures show that it is active. Traavik also described the results of blood sera analyses of people living near Bt maize fields. Many had experienced respiratory and intestinal symptoms during the pollination season. While local health authorities attributed this to a viral

epidemic, some families that moved away from the area were relieved of the symptoms but experienced them again when they moved back. Traavik explained that this is more indicative of an immunological response, rather than an infectious disease. The blood sera had IgG, IgA and IgM antibodies directed to Bt toxin. The IgG antibodies show that an individual has been exposed to the antigen (Bt toxin) during the person's lifetime; this could be due to exposure to the naturally-occurring bacterial toxin. However, the IgA and the IgM antibodies show that an individual has been exposed to the antigen in the last few months. While he cautioned against over-interpreting the results or drawing any cause-and-effect relationship, the coincidence of the timing of symptoms, the production of serum antibodies and the pollination season warrants further investigation. Indeed, the gaps in risk-associated research are plentiful; thus any conclusions that GMOs are safe are premature because there is insufficient evidence to inform the decision-making process. In the meantime, as Dr Arpad Pusztai highlighted, the few well-designed studies published to date demonstrate potentially worrisome biological effects of GE food. He described some of these studies that looked at the alimentary tract (as GE food, like all foods, will first affect the gut). Feeding trials with the Flavr-Savr tomato, the first commercialised GMO, resulted in stomach erosions (necrosis) in rats. Research by Egyptian scientists showed that Bt potatoes caused adverse effects in the ileum of rats. In addition, the Cry1Ac protoxin (a Bt toxin) has been shown to be a potent systemic and mucosal immunogen (capable of causing an immune response) and adjuvant (a substance that enhances immune response). In Pusztai's own research on GE potatoes expressing the snowdrop lectin (GNA), these potatoes induced proliferative growth in rats' stomachs, small intestines and large intestines. As this effect was not shown in controls fed nonGE potatoes or non-GE potatoes supplemented with GNA, he said that the effect is not due to transgene expression, but rather may be due to insertion into the genome. Miscalculations Professor Jack Heinemann from the New Zealand Institute of Gene Ecology, University of Christchurch, used a case study of transgenic contamination of non-GE maize in New Zealand to illustrate how the limitations of detection techniques and assumptions that were made led to miscalculations of, in the first instance, whether contamination had occurred, and also the actual level of contamination. He stressed that detection limits are not related to impacts, and that thresholds that trigger labelling should not be used as safety thresholds. In fact, what seem like small numbers can quickly become big numbers.

Heinemann reiterated that accidental contamination will occur despite rules and regulations, and that there is no clear way to guarantee containment of GMOs. Dr Mae-Wan Ho from the Institute of Science in Society, UK, stressed that genetic engineering breaks all the rules of evolution. She critiqued the scientific paradigm that underpins genetic engineering, which claims that genes determine the characteristics of organisms in linear, one-way chains. Instead, the 'fluid genome' is a more apt description of how genes and the genome behave in an organism, reflecting constant intercommunication between all its parts. Genetic engineering disrupts this perfect coordination. Ho described how genetic engineering recombines new combinations of DNA from widely different sources, and deliberately inserts the artificial constructs into the genomes of organisms. As integration into the genome is random, unpredictable effects may arise. Furthermore, she pointed out that recent molecular characterisation of the structure of transgenic insert(s) has shown that the transgenic inserts of five commercial lines have rearranged. This transgenic instability may be linked to the widely used CaMV promoter, which has a 'recombination hotspot'. Thus, she stressed, there are inherent hazards associated with transgenic DNA. Long-term monitoring Given all these biosafety concerns, Dr Susan Bardocz emphasised that postrelease monitoring of GMOs is important. Genetic engineering is a technology that cannot be turned off as GMOs are self-replicating, and long-term monitoring is needed to record trends in predicted effects and to detect effects that were not predicted. She stated that governments should be responsible for the monitoring, with the involvement of public sector scientists, whilst industry should shoulder the costs. Bardocz described the steps needed in effective monitoring of the various components of the environment - soil, air and water and of human and animal health. She also highlighted what aspects should be monitored, where, how and for how long. Edward Hammond from The Sunshine Project discussed emerging trends in genetic engineering and biological weapons, and the implications for biosafety regulation. The very rapid developments in genetic engineering have increased biowarfare risks, and Hammond shared some particular examples. As the common focus of the Biosafety Protocol and the Biological and Toxin Weapons Convention is on modern biotechnology risks, he called for a strengthening in their linkages and mutual supportiveness in regulating the safety of GMOs and preventing the development of biological weapons. Argentine experience

The adverse environmental, health and socio-economic impacts of GMOs were starkly outlined by Argentina's experience in commercially growing GE crops. Adolfo Boy from Grupo de Reflexion Rural showed how the country, once known as the 'world's granary', has spiralled into despair, experiencing hunger, internally displaced rural populations and the loss of traditional food crops. The exponential expansion of concentrated and large land areas planted to GE Roundup Ready (RR) soya, exacerbated by the need to service foreign debt by catering to the export market, has led to this situation. According to Boy, weeds have multiplied, as tolerance and resistance to glyphosate (the herbicide used with RR soya) have increased, resulting in more frequent herbicide applications using higher spray concentrations. He pointed out that the need to control difficult weeds, including RR soya itself after harvest, has led to the use of toxic older herbicides, such as 2,4 D and Paraquat, banned in many countries. Planes are used to spray herbicides on RR soya, but with devastating impacts on the health of local populations and on their environment and food crops. The increased use of herbicides in Argentina is not an isolated case. Lim Li Ching from Third World Network and the Institute of Science in Society described recent research in the United States, which found that the overall impact of GE crops over the first eight years of commercial planting (19962003) had been to increase pesticide (herbicides and insecticides) use by over 50 million pounds. This, she said, is mainly due to the need to use more herbicides in herbicide-tolerant crops, particularly RR soya, to achieve adequate weed control. Shifts toward tougher-to-control species, coupled with the emergence of genetic resistance in certain weed populations, have triggered the need to apply additional herbicides and/or increase application rates. The seminar closed with a discussion session on linkages to MOP 1, including the critical issues on which decisions had to be taken, such as liability and redress, compliance and Article 18 (handling, transport, packaging and identification). Participants were urged to use the knowledge gained to inform their discussions in MOP 1. - TWN