Due to the involvement of scientific, industrial, commercial and public sectors of society, the complexity of the issues concerning the safety of genetically modified organisms (GMOs) for the environment, agriculture, and human and animal health calls for a wide coverage of information. Accordingly, development of the field of biotechnology, along with concerns related to the fate of released GMOs, has led to a rapid development of tools for disseminating such information. As a result, there is a growing number of databases aimed at collecting and storing information related to GMOs. Most of the sites deal with information on environmental releases, field trials, transgenes and related sequences, regulations and legislation, risk assessment documents, and literature. Databases are mainly established and managed by scientific, national or international authorities, and are addressed towards scientists, government officials, policy makers, consumers, farmers, environmental groups and civil society representatives. This complexity can lead to an overlapping of information. The purpose of the present review is to analyse the relevant databases currently available on the web, providing comments on their vastly different information and on the structure of the sites pertaining to different users. A preliminary overview on the development of these sites during the last decade, at both the national and international level, is also provided.

What is negative about negative data? Scientists understand negative data from our training in data analysis and statistics, where we use a positive concept of negative data. Negative data are data that do not enable us to reject our null hypothesis. Such data are often difficult to publish because it is not possible to prove the null hypothesis. Every active research scientist has a large drawer where these data languish. In the area of environmental biosafety, however, some scientists have begun to use “negative data” in a second, normative way. This normative concept of negative data has socio-political connotations, where “negative” data has come to connote results that GMO proponents could use to support, and GMO opponents could use to oppose the development of GMOs. This politicization of GMO biosafety research is worthy of study in its own right, but EBR is prepared to accept any kind of “negative” or “positive” data.

With the rapid advancement of transgenic biotechnology, large numbers of transgenic crops have been produced and released for commercial cultivation (James, 2001), raising considerable biosafety concerns all over the world. One of the major issues is the potential ecological risk resulting from transgenes escaping into and persist-ing in the environment. The extensive on-going debate on this issue (Arriola, 1997; Wolfenbarger and Phifer, 2000; Crawley et al., 2001; Prakash, 2001; Dale et al., 2002) poses challenging questions regarding the research direc-tions that need to be taken to ensure that biotechnology outputs are responsibly deployed worldwide. Unless these biosafety issues are satisfactorily addressed, large-scale commercial release of the transgenic crops developed and further advancement of transgenic bio-technology are likely to be hampered. For an in-depth review of crop-to-wild gene flow, see Jenczewski et al. (2002) in this number of EBR. Here the more specific issue of the effectiveness of preventing gene flow from occurring will be discussed.

One prominent concern about genetically modified crops is the possibility of environmental impacts from the movement of fitness-enhancing traits to wild plant populations. Decisions to deregulate Bt crops in the USA have relied strongly on arguments that these crops will not interbreed with wild relatives in the permitted growing regions. Limited attention therefore has been directed to analyses of the consequences of gene flow. To provide a transparent evaluation process for risks associated with insecticidal transgene escape, we crafted a series of questions designed to guide this aspect of the risk assessment. We then explored the current knowledge base available for answering such risk-related questions for three Bt crops (cotton, rapeseed, and rice). First, we generated a list of wild relatives of these crops. A definitive list of potential transgene recipients is not yet possible for some crops. Sufficient data are not available for some crops to eliminate certain related plant species from consideration of fertile hybrid formation, thus making lists for these crops subject to speculation. Second, we queried the HOSTS database (UK) to obtain a worldwide listing of lepidopteran species that feed on these crops and their wild relatives, and to determine the host range of the larvae. To our knowledge, this list of 502 lepidopteran species is the first such list published for these crops and wild crop relatives. Third, we used a data set maintained by the Canadian Forest Service to assess Bt toxin susceptibility for these lepidopterans. Only 3% of those species have been tested for susceptibility; and the literature suggests that generalizations about susceptibility among taxa are difficult due to the variability within families. Fourth, we consulted the literature to interpret what is known about the ability of lepidopterans to regulate plant fitness or invasiveness. We could not eliminate the possibility of ecological release due to plant resistance against lepidopterans. In fact, there is strong experimental evidence that lepidopteran herbivores do limit the distribution and/or abundances of at least some wild plant species. Neither could we eliminate the possibility that non-target lepidopterans might have important functions in the ecosystem as pollinators or alternate hosts to natural enemies of pest species. This study suggests that crucial data are lacking for the development of a credible scientific basis to confirm or deny environmental risks associated with the escape of Bt transgene constructs to wild relatives. Given the absence of information on the identity, level of susceptibility, and ecological roles of lepidopterans exploiting specific wild relatives of Bt crops, we suggest that new efforts be directed to assessing possible consequences of lepidopteran mortality on resistant wild relatives.

Modern biotechnology has led to the development and use of Living Modified Organisms (LMOs) for agriculture and other purposes. Regulators at the national level are increasingly depending on risk assessment as a tool for assessing potential adverse effects of LMOs on the environment and human health. In addition, the Cartagena Protocol on Biosafety, an international agreement expected to enter into force in the near future, requires risk assessment as the basis for decision-making regarding import of some LMOs. While LMO risk assessment is relatively new, there are other risk assessment disciplines which have developed over longer time periods. The field of assessment of the environmental and human health risks of chemicals is particularly well developed, and is similar in application to LMO risk assessment. This paper aims to draw lessons for LMO risk assessment from the vast experience with chemical risk assessment. Seven general principles are outlined which should serve as a useful checklist to guide assessments of risks posed by LMOs.

In Europe, there seems to be widespread, morally based scepticism about the use of GMOs in food production. In response to this scepticism, the revised EU directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms stresses the importance of respecting ethical principles recognized in the Member States. However, the directive fails to reflect the critical role of value judgements in scientific risk assessment and any subsequent approval procedure. In this paper we argue that it is important to make all ethically relevant assumptions involved in the approval procedure transparent and thus available for public scrutiny. Mapping the value judgements that are made in an environmental risk assessment and approval procedure, we describe the political liberal nature of the EU legislation. We then look more closely at the prescriptions for environmental risk assessment and approval of GMOs outlined in the directive. An environmental risk assessment views the world through a “risk window” that only makes visible that which has been predefined as a relevant risk. The importance of the value judgements that define the risk window consists in limiting the information the risk assessment can provide. In the penultimate section of the paper, the significance of the risk window is demonstrated through a case study of the approval of glyphosate resistant fodder beets (Beta vulgaris L. ssp. vulgaris) in Denmark.

Crop-to-wild gene flow has received close attention over the past ten years in connection with the development and cultivation of transgenic crops. In this paper, we review key examples of crop/wild sympatry and overlapping flowering phenology, pollen and seed dispersal, the barriers to hybridisation and introgression, the evolution and fate of interspecific hybrids, their fitness, and the potential cost of transgenes. We pay particular attention to ways in which the evolution and divergence between crops and their wild relatives may interfere with these successive steps. Our review suggests that crop-to-weed gene flow is highly idiosyncratic and that crop gene dispersion will certainly be very difficult to preclude totally. Future directions for research should thus focus on the long-term establishment and effects of transgenes on natural communities.

We examine the characteristics and limitations of the existing system of tort liability for addressing potential environmental damages from GM crops and consider whether environmental bonding could be used to address these risks. We find that in the case of GM crops, a bonding mechanism would complement some of the strengths of tort liability. Specifically, the bonding mechanism provides some protection against bankruptcy, and also shifts the burden of risk toward life science companies that develop the technology. These factors could encourage additional early research by life science firms. However, a bonding mechanism adds to the regulatory apparatus, and would likely increase administrative costs, over tort liability, for public and private parties. Nevertheless, an attractive possibility is that the cumulative outcomes of bonding, e.g., shifting the risk burden, providing a measure of bankruptcy protection, and introducing an additional regulatory component, would mitigate some of the political and social objections to the environmental release of GM crops.

Gene flow is a potential concern associated with the use of transgenic crops because it could affect genetic diversity of related landraces and wild relatives. This concern has taken on added importance with the looming introduction of transgenic crops in centers of crop domestication (Mexico, China) and those producing pharmaceutical compounds. For gene flow to take place among cultivars and their wild relatives, several steps have to be fulfilled, including the presence of cultivars or wild relatives within pollen or seed dispersal range, the ability to produce viable and fertile hybrids, at least partial overlap in flowering time, actual gene flow by pollen or seed, and the establishment of crop genes in the domesticated or wild recipient populations. In contrast with domestication genes, which often make crops less adapted to natural ecosystems, transgenes frequently represent gains of function, which might release wild relatives from constraints that limit their fitness. In most sexually reproducing organisms, the chromosomal region affected by selection of a single gene amounts to a small percentage of the total genome size. Because of gene flow, the level of genetic diversity present in the domesticated gene pool becomes a crucial factor affecting the genetic diversity of the wild gene pool. For some crops, such as cotton and maize, the introduction of transgenic technologies has led to a consolidation of the seed industry and a reduction in the diversity of the elite crop gene pool. Thus, diversity in improved varieties grown by farmers needs to be monitored. Several areas deserve further study, such as the actual magnitude of gene flow and its determinants in different agroecosystems, the long-term effects of gene flow on genetic diversity both across gene pools and within genomes, the expression of transgenes in new genetic backgrounds, and the effects of socio-economic factors on genetic diversity.

Since genetically modified (GM) lactic acid bacteria (LAB) might be released in open environments for future nutritional and medical applications, the purpose of this study was to determine an upper limit for the horizontal gene transfer (HGT) in the digestive tract (DT) from Lactococcus lactis carrying heterologous genes (lux genes encoding a bacterial luciferase) to Enterococcus faecalis. Two enterococcal wide host-range conjugative model systems were used: (i) a system composed of a mobilizable plasmid containing the heterologous lux genes and a native conjugative helper plasmid; and (ii) a Tn916-lux transposon. Both systems were tested under the most transfer-prone conditions, i.e. germfree mice mono-associated with the recipient E. faecalis. No transfer was observed with the transposon system. Transfers of the mobilizable plasmid carrying heterologous genes were below 102 transconjugants per g of faeces for a single donor dose and reached between 103 and 104 transconjugants per g of faeces when continuous inoculation of the donor strain was used. Once established in mice, transconjugants persisted at low levels in the mouse DT.

Pest management can have substantial impacts on non-target species both within and outside the units being managed. Assessment of these impacts is hampered by the lack of even the most basic checklist of the species present in most systems. The maize agroecosytem is of particular interest because of the large area covered and the intensity of widely varying forms of pest management. In this study a database of lepidopteran species that occur within the maize agroecosystem in the United States was compiled. The process was initiated by developing a list of plants present in maize using published sources and the first-hand knowledge of “weed” experts. This list of plant species associated with maize was then cross-listed with lepidopteran host feeding records using published sources. Finally, phenological profiles and conservation rankings were added. Although our list is not exhaustive, we found 132 plant species in 33 families associated with maize, and 229 lepidopteran species in 21 families that feed on these plants. The database of plants and lepidopteran species can be a starting point for assessment of risk to non-target Lepidoptera in maize from chemical control, biological control, and the use of transgenic Bt maize. The lepidopteran species associated with maize were found to be significantly less imperiled, as measured by their conservation rankings, than lepidopteran species as a whole in all habitats. This finding suggests that rare or endangered lepidopteran species are unlikely to be impacted by pest management in maize. Based on the likely lack of impact of pest management in maize on individual species, future studies should focus on potential impacts on the ecological services that lepidopteran species provide.

Release of transgenic insect-resistant crops creates the potential not only for the insect pest to evolve resistance but for the escape of transgenes that may confer novel or enhanced fitness-related traits through hybridization with their wild relatives. The differential response of diamondback moth (Plutella xylostella) populations in eastern and western Canada to Bt-producing (GT) Brassica napus and the potential for enhanced fitness of GT B. napus and weedy GT Brassica rapa × B. napus hybrid populations (F1, BC1, BC2) were studied. Comparative bioassays using neonates and 4th instars showed that GT B. napus and GT B. rapa × B. napus hybrids are lethal to larvae from both populations. No measurable plant fitness advantage (reproductive dry weight) was observed for GT B. napus (crop) and GT B. rapa × B. napus hybrid populations at low insect pressure (1 larva per leaf). At high insect densities (>10 larvae per leaf), vegetative plant weight was not significantly different for GT B. napusand non-GT B. napus, whereas reproductive plant weight and proportion of reproductive material were significantly higher in GT B. napus. Establishment of the Bt trait in wild B. rapa populations may also increase its competitive advantage under high insect pressure.

Along with the introduction of genetically modified organisms in the field, both biotechnology companies and academic institutes have conducted biosafety research in order to study the potential ecological impact of the modified organisms. With the growing concerns among various stakeholders, priority has been given to academic research on biosafety-related issues. For instance, the European Commission begun funding biosafety research of genetically modified plants in 1989, right after the first experimental releases of those modified crops. In the 5th Framework EC Research program biosafety research became a key action supporting 81 projects (for details see: http://europa.eu.int/comm/research/quality-of-life/gmo/index.html).

During this period, researchers gathered regularly to exchange ideas and their latest research results in this field at different workshops and also at a series of symposia held biennially since 1990. As early as the 5th International Symposium on the Biosafety of Genetically Modified Organisms, held in Braunschweig (Germany) in 1998, the Symposium's International Advisory Committee supported an idea to launch a new peer-reviewed journal, Environmental Biosafety Research (EBR), to facilitate communication in this research area, where controversial views are constantly expressed. It is hoped that EBR will contribute to clarifying the scientific terms of the debate, and that this will be useful for decision makers and other members of society. Another important event was the incorporation of a new learned Society, the International Society for Biosafety Research (ISBR), which was decided at the the 6th Symposium held in Saskatoon (Canada) in 2000.

At the most recent Symposium, the first ISBR officers were elected: President, Alan McHughen (USA); Vice-President, Mark Tepfer (France); Secretary/Treasurer, Allison Snow (USA). Scientists who met at the 7th International Symposium in Beijing appreciated the quality of the first issue of EBR (a sample copy can be requested, and subscription purchased at: http://www.edpsciences.org/ebr/) and the possibility of registration for membership of the newly-incorporated Society. Information on becoming an ISBR member, which gives the right to a reduced subscription price for EBR, can be obtained from Allison Snow (snow.1@osu.edu).

In Beijing, where more than 300 scientists registered from more than 30 countries, participants were able to learn not only the latest results on biosafety research, and in particular received first hand information about biosafety research in China, where GM crops are grown for commercial purposes. At this latest Symposium, the opening ceremony reflected the importance of the new technology, along with the safety considerations. This was followed by the different scientific sessions on new science for enhanced biosafety, consequences of gene flow, the possible implications of the releases of transgenic crops in centers of origin or diversity, the rationale of GMO regulations, biosafety considerations in China, transgenic insects for pest management programs and the effect of GMOs on microbial communities. The Symposium Programme Committee selected the above mentioned hot topics, among which two had outstanding interest for the audience. First, this was the first time that biosafety considerations on the release of transgenic insects were discussed, and second, the different questions raised by the detection of a Bt gene in landraces of Mexican corn were debated. These sessions were followed by a field trip to Langfang (Hebei Province) to visit a transgenic Bt cotton field.

The opening lectures, delivered by the Vice Minister of China's Ministry of Science and Technology, followed by the Vice Minister of China's Ministry of Agriculture, emphasized that Chinese agriculture is the fourth largest in the world, feeding over 20This fact underlines that food safety and security are of great concern to Chinese society. The introduction of modern technology into agricultural practice could start a new green revolution by helping to meet with the growing food demand especially from the point of view of quality. China issued safety administration regulations on genetic engineering as early 1993. Implementing the regulations was started in 1996, by regulating field tests, environmental releases, and commercialization of transgenic plants. Since 1997, a total of 703 applications for biosafety evaluations were registered, and 517 were approved. Last year, ten lines of transgenic plants were approved, including the most important crops for China, such as rice, soybean and cotton. After the inaugural lectures, Axel Hebel, representing UNESCO, expressed the importance of biosafety research on a global scale, while Charles Kessler (EC) presented the view of the European Union member states, and the actions taken by the Commission, which supported the organization of this symposium and is strongly committed to the organization of the following ISBR Symposium in France in 2004.

The independent scientific sessions chaired by distinguished scientists from all over the world presented the state of the art of the selected topics. In this special section of EBR, the session chairs have been asked to collaborate closely with the speakers, in order to summarize the major achievements of their sessions.

Plenary scientific sessions at 7th International Symposium on the Biosafety of Genetically Modified Organisms :

• New science for enhanced biosafety – Joachim Schiemann

• Consequences of gene flow – Allison Snow

• Possible implication of the release of transgenic crops in centers of origin or diversity –Ariel Alvarez–Morales

• Why regulate and how? – Julian Kinderlerer

• Research and regulation on Biosafety of GMOs in China – Hongguang Wang (overview written by Yufa Peng and Shirong Jia)

• Transgenic insects for pest management programs: status and prospects – Marjorie Hoy

• Effects of GMOs on microbial communities – Kornelia Smalla

Gene flow via seed or pollen is a basic biological process in plant evolution. The ecological and genetic consequences of gene flow depend on the amount and direction of gene flow as well as on the fitness of hybrids. The assessment of potential risks of transgenic plants should take into account the fact that conventional crops can often cross with wild plants. The precautionary approach in risk management of genetically modified plants (GMPs) may make it necessary to monitor significant wild and weed populations that might be affected by transgene escape. Gene flow is hard to control in wind-pollinated plants like beet (Beta vulgaris). In addition, wild beet populations potentially can undergo evolutionary changes which might expand their geographical distribution. Unintended products of cultivated beets pollinated by wild beets are weed beets that bolt and flower during their first year of planting. Weed beets cause yield losses and can delay harvest. Wild beets are important plant genetic resources and the preservation of wild beet diversity in Europe has been considered in biosafety research. We present here the methodology and research approaches that can be used for monitoring the geographical distribution and diversity of Beta populations. It has recently been shown that a century of gene flow from Beta vulgaris ssp. vulgaris has not altered the genetic diversity of wild Beta vulgaris L. ssp. maritima (L.) Arcang. in the Italian sugar beet seed production area. Future research should focus on the potential evolution of transgenic wild beet populations in comparison to these baseline data. Two monitoring models are presented describing how endpoints can be measured: (1) “Pre-post” crop commercialization against today's baseline and (2) “Parallel” to crop commercialization against GMP free reference areas/populations. Model 2 has the advantage of taking ongoing changes in genetic diversity and population dynamics into account. Model 1 is more applicable if gene flow is so strong that most areas/populations contain GMPs. Important traits that may change the ecology of populations are genes that confer tolerance to biotic and abiotic stress. An assessment of environmental effects can realistically only be based on endpoints and consequences of gene introgression, which may include economic values of biodiversity in littoral and other ecosystems containing wild beet. In general, there is still a great need to harmonize worldwide monitoring systems by the development of appropriate methods to evaluate the environmental impact of introgressed transgenes.

Endotoxins from Bacillus thuringiensis (Bt) produced in transgenic pest-resistant Bt crops are generally not toxic to predatory and parasitic arthropods. However, elimination of Bt-susceptible prey and hosts in Bt crops could reduce predator and parasitoid abundance and thereby disrupt biological control of other herbivorous pests. Here we report results of a field study evaluating the effects of Bt sprays on non-target terrestrial herbivore and natural enemy assemblages from three rice (Oryza sativa L.) fields on Luzon Island, Philippines. Because of restrictions on field-testing of transgenic rice, Bt sprays were used to remove foliage-feeding lepidopteran larvae that would be targeted by Bt rice. Data from a 546-taxa Philippines-wide food web, matched abundance plots, species accumulation curves, time-series analysis, and ecostatistical tests for species richness and ranked abundance were used to compare different subsets of non-target herbivores, predators, and parasitoids in Bt sprayed and water-sprayed (control) plots. For whole communities of terrestrial predators and parasitoids, Bt sprays altered parasitoid richness in 3 of 3 sites and predator richness in 1 of 3 sites, as measured by rarefaction (in half of these cases, richness was greater in Bt plots), while Spearman tests on ranked abundances showed that correlations, although significantly positive between all treatment pairs, were stronger for predators than for parasitoids, suggesting that parasitoid complexes may have been more sensitive than predators to the effects of Bt sprays. Species accumulation curves and time-series analyses of population trends revealed no evidence that Bt sprays altered the overall buildup of predator or parasitoid communities or population trajectories of non-target herbivores (planthoppers and leafhoppers) nor was evidence found for bottom-up effects in total abundances of non-target species identified in the food web from the addition of spores in the Bt spray formulation. When the same methods were applied to natural enemies (predators and parasitoids) of foliage-feeding lepidopteran and non-lepidopteran (homopteran, hemipteran and dipteran) herbivores, significant differences between treatments were detected in 7 of 12 cases. However, no treatment differences were found in mean abundances of these natural enemies, either in time-series plots or in total (seasonal) abundance. Analysis of guild-level trajectories revealed population behavior and treatment differences that could not be predicted in whole-community studies of predators and parasitoids. A more conclusive test of the impact of Bt rice will require field experiments with transgenic plants, conducted in a range of Asian environments, and over multiple cropping seasons.

A misprint occurred in this article:The graphs from Figure 1 and Figure 2 should be exchanged with the graphs from Figure 3 and Figure 4, respectively. The corresponding legends are in the correct position and should not be moved.

Genes of Bacillus thuringiensis var. kurstaki (Berliner) that encode lepidopteran-specific toxins were engineered into maize for protection against the European Corn Borer, Ostrinia nubilalis (Hbn.). Recent data suggest that Lepidoptera may be negatively affected, if maize pollen contains high amounts of Bt toxin and is diposited on host plants near maize fields. Monitoring the environmental effects of commercial Bt maize fields requires effective use of limited financial and logistical resources. The aim of this study was to develop and apply tools for selecting relevant herbivore species for the field monitoring of environmental Bt toxin effects via pollen deposition. We first present a theoretical selection tree based on “risk index of Bt pollen for herbivores” (IBtp). Our index consists of five classes from zero (not relevant) to four (highly relevant) derived from data on potential temporal and spatial coincidence of pollen exposure (A), feeding mode (B), susceptibility to lepidopteran-specific Bt toxins (C) and hazard to rare and/or endangered species (“Red List”) (D). We then screened the Macrolepidoptera database LEPIDAT to identify relevant species in Germany. Finally, we also applied the index to species found in a local biocoenotic field study (Bonn, Western Rhineland, Germany). Approximately 7% of the German Macrolepidoptera species mainly occur in farmland areas and were selected as being potentially affected by Bt pollen exposure. Of these species, 14% (= 1% of total) were found to be potentially exposed on a regional scale. The combination of IBtp and database screening enables us to pre-select species for monitoring purposes.

Recent concerns regarding within-crop transgene flow stimulated this research to update natural cross-pollination rates in conventional sowings of modern soybean [Glycine max (L.) Merr.] in the Mississippi Delta. Two experiments were conducted in 2001 and 2002 using two soybean cultivars, “Pace” (white-flowered) and “DP3588” (purple-flowered), selected for their equivalent flowering dates. The experiments utilized the dominance of purple flower color over white flower color to identify natural cross-pollinations. In the first experiment, 12 rows of Pace (white-flowered) flanked on each side by four rows of DP3588 (purple flowered) were sown on 10 May 2001. Seed were harvested by row from each of the Pace rows and examined for natural cross-pollinations in the next generation. In total, 73 512 potential hybrid plants were examined and natural cross-pollination rates ranged from 0.41% at 0.9 m from the pollen source to 0.03% at 5.4 m from the pollen source. These values were consistent with values previously reported in the literature. In the second experiment, seed of Pace and DP3588 were alternately sown 15.2 cm apart within a row in 2001. At maturity, 167 Pace plants (white-flowered) were harvested and a total of 19 151 progeny were evaluated for natural cross-pollinations in the next generation. The progeny of 56 (33.5%) of the 167 parent plants showed no evidence of natural cross-pollination. The progeny of the remaining 111 plants exhibited natural cross-pollination rates ranging from 0.65 to 6.32% and averaged 1.8%. The maximum rates reported here are considerably higher than most previously reported rates. The results of these two experiments highlight the potential for within-crop transgene flow in soybean.