This document provides a comprehensive review of information and data relevant to the environmental risk assessment of Cry1Ab and presents a summary statement about the environmental safety of this protein. All sources of information reviewed herein are publically available and include: dossiers presented to regulatory authorities; decision summaries prepared by regulatory authorities; peer reviewed literature; and product summaries prepared by product developers.
Since the first regulatory approval of a genetically engineered (GE) plant was issued in 1992, hundreds of additional GE plants, thousands of regulatory decisions and millions of tons of GE grain and seed have been produced. In an increasingly global economy, the grain and seeds move relatively freely across national jurisdictions, but the regulatory decisions and associated data and analyses do not. Combined with the realities of agricultural production, this has led to a legal and regulatory challenge due to the low level presence (LLP) of GE grain or seeds that do not have regulatory approvals in the country of destination. In order to assist regulators in conducting environmental risk assessments related to LLP, reviews of environmental safety data, including associated regulatory analyses and decisions, for proteins commonly introduced in GE plants have been produced.
Since the first regulatory approval of a genetically engineered (GE) plant was issued in 1992, hundreds of additional GE plants, thousands of regulatory decisions and millions of tons of GE grain and seed have been produced. In an increasingly global economy, the grain and seeds move relatively freely across national jurisdictions, but the regulatory decisions and associated data and analyses do not. Combined with the realities of agricultural production, this has led to a legal and regulatory challenge due to the low level presence (LLP) of GE grain or seeds that do not have regulatory approvals in the country of destination. In order to assist regulators in conducting environmental risk assessments related to LLP, reviews of environmental safety data, including associated regulatory analyses and decisions, for proteins commonly introduced in GE plants have been produced.
We assessed the effects of cultivating two genetically modified (GM) glyphosate-tolerant soybean varieties (Glycine max (L.) Merr.) derived from Event 40-3-2 and a Japanese conventional variety on arthropods under field conditions, with weed control using glyphosate and conventional weed control for two years. Plant height and dry weight of the conventional variety were significantly larger than those of the GM varieties, but the GM varieties bore more pods than the conventional variety. We found arthropods of nine taxonomic orders (Araneae, Acari, Thysanoptera, Homoptera, Heteroptera, Coleoptera, Diptera, Lepidoptera, and Hymenoptera) on the plants. The arthropod incidence (number per plant unit weight pooled for each taxonomic order) on the soybean stems and leaves generally did not differ significantly between the GM and conventional varieties. However, the incidence of Thysanoptera and total incidence (all orders combined) were greater on the GM variety in the second year. The weed control regimes had no significant influence on the arthropod incidence on the soybean stems and leaves. The number of flower-inhabiting Thysanoptera (the dominant arthropod in the flowers) was not significantly different between the GM and conventional varieties. Asphondylia yushimai (Diptera, Cecidomyiidae) was more numerous on the pods of the GM variety in both years. Neither the soybean variety nor the weed control regime significantly affected the density of soil macro-organisms. However, the glyphosate weed control affected arthropods between the rows of plants by decreasing the abundances of Homoptera, Heteroptera, Coleoptera and Lepidoptera, and diversity of arthropods.
A procedure is presented for developing environmental risk hypotheses associated with the deployment of forest trees genetically modified to have altered wood properties and for selecting non-target species to test these hypotheses. Altered-lignin Pinus radiata trees intended for use in New Zealand are used as a hypothetical case study to illustrate our approach. Firstly, environmental management goals (such as wood production, flood control or preservation of biodiversity) were identified and linked to the forest attributes they require. Necessary conditions for each attribute were listed and appropriate assessment endpoints for them developed. For example, biological control of pests may be one condition necessary for a forest to have healthy trees, and the diversity and abundance of natural enemy species in the forest could be an appropriate assessment endpoint for measuring this condition. A conceptual model describing the relationships between an altered-lignin GM pine tree and potentially affected invertebrates and micro-organisms in a plantation forest was used to develop a set of risk hypotheses describing how the GM trees might affect each assessment endpoint. Because purified lignin does not represent the properties it imparts to wood, maximum hazard dose tests with non-target organisms, as are used to inform toxin risk assessment, cannot be conducted. Alternative experiments, based on current knowledge of the responses of organisms to lignin, must be designed. A screening method was adapted and applied to a database of invertebrate species known to inhabit New Zealand pine forests to identify and prioritize non-target invertebrate species that could be used as experimental subjects for examining these hypotheses. The screening model and its application are presented, along with a set of recommendations for pre-release tests with GM pines and potentially affected invertebrates and micro-organisms.
Determining the effects of genetically modified (GM) crops on non-target organisms is essential as many non-target species provide important ecological functions. However, it is simply not possible to collect field data on more than a few potential non-target species present in the receiving environment of a GM crop. While risk assessment must be rigorous, new approaches are necessary to improve the efficiency of the process. Utilisation of published information and existing data on the phenology and population dynamics of test species in the field can be combined with limited amounts of experimental biosafety data to predict possible outcomes on species persistence. This paper presents an example of an approach where data from laboratory experiments and field studies on phenology are combined using predictive modelling. Using the New Zealand native weevil species Nicaeana cervina as a case study, we could predict that oviposition rates of the weevil feeding on a GM ryegrass could be reduced by up to 30% without threat to populations of the weevil in pastoral ecosystems. In addition, an experimentally established correlation between feeding level and oviposition led to the prediction that a consistent reduction in feeding of 50% or higher indicated a significant risk to the species and could potentially lead to local extinctions. This approach to biosafety risk assessment, maximising the use of pre-existing field and laboratory data on non-target species, can make an important contribution to informed decision-making by regulatory authorities and developers of new technologies.
The bucket and the searchlight are metaphors for opposing theories of the growth of scientific knowledge. The bucket theory proposes that knowledge is gained by observing the world without preconceptions, and that knowledge emerges from the accumulation of observations that support a hypothesis. There are many problems with this theory, the most serious of which is that it does not appear to offer a means to distinguish between the many hypotheses that could explain a particular set of observations. The searchlight theory proposes that preconceptions are unavoidable and that knowledge advances through the improvement of our preconceptions - our hypotheses - by continuous criticism and revision. A hypothesis is a searchlight that illuminates observations that test the hypothesis and reveal its flaws, and knowledge thereby increases through the elimination of false hypotheses. Research into the risks posed by the cultivation of transgenic crops often appears to apply the bucket theory; many data are produced, but knowledge of risk is not advanced. Application of the searchlight theory, whereby risk assessments test hypotheses that transgenic crops will not be harmful, seems to offer a better way to characterise risk. The effectiveness of an environmental risk assessment should not be measured by the size of the bucket of observations on a transgenic crop, but by the power of the risk hypothesis searchlights to clarify the risks that may arise from cultivation of that crop. These points are illustrated by examples of hypotheses that could be tested to assess the risks from transgenic crops and their hybrids becoming weeds or invading non-agricultural habitats.
Regulators are acutely aware of the need for meaningful risk assessments to support decisions on the safety of GM crops to non-target invertebrates in determining their suitability for field release. We describe a process for developing appropriate, testable risk hypotheses for invertebrates in agroecosystems that might be exposed to plants developed by GM and future novel technologies. An existing model (PRONTI) generates a ranked list of invertebrate species for biosafety testing by accessing a database of biological, ecological and food web information about species which occur in cropping environments and their potential interactions with a particular stressor (Eco Invertebase). Our objective in this contribution is to explore and further utilise these resources to assist in the process of problem formulation by identifying potentially significant effects of the stressor on the invertebrate community and the ecosystem services they provide. We propose that for high ranking species, a conceptual food web using information in Eco Invertebase is constructed, and using an accepted regulatory risk analysis framework, the likelihood of risk, and magnitude of impact for each link in the food web is evaluated. Using as filters only those risks evaluated as likely to extremely likely, and the magnitude of an effect being considered as moderate to massive, the most significant potential effects can be identified. A stepwise approach is suggested to develop a sequence of appropriate tests. The GM ryegrass plant used as the “stressor” in this study has been modified to increase triacylglyceride levels in foliage by 100% to increase the metabolisable energy content of forage for grazing animals. The high-ranking “test” species chosen to illustrate the concept are New Zealand native species Wiseana cervinata (Walker) (Lepidoptera: Hepialidae), Persectania aversa (Walker) (Lepidoptera: Noctuidae), and the self-introduced grey field slug, Deroceras reticulatum (Müller).
While significant progress has been made on the modification of crops for the benefit of producers, the same cannot be said in regards to eliciting the potential impact that these crops may have on the wider landscape and the diversity of life therein. Management impacts can create difficulties when making policy, regulation and licensing decisions in those countries where agriculture has a significant social and ecological position in the landscape. To begin to gauge the potential impacts of the management of a selection of GM crops on an agricultural landscape, four key biodiversity stressors (Chemicals, Introgression, Nutrients and Management: CINMa) were identified and a grading system developed using published data. Upon application to five selected GM crops in a case study area, CINMa identifies areas in the wider landscape where biodiversity is likely to be negatively or positively impacted, as well as agricultural zones which may benefit from the land use change associated with the management of GM crops and their associated post market environmental monitoring.
The cultivation of genetically modified (GM) Bt maize (Zea mays L.) events MON810 and Bt11 is permitted in Uruguay. Local regulations specify that 10% of the crop should be a non-GM cultivar as refuge area for biodiversity, and the distance from other non-GM maize crops should be more than 250 m in order to avoid cross-pollination. However, the degree of cross-fertilization between maize crops in Uruguay is unknown. The level of adventitious presence of GM material in non-GM crops is a relevant issue for organic farming, in situ conservation of genetic resources and seed production. In the research reported here, the occurrence and frequency of cross-fertilization between commercial GM and non-GM maize crops in Uruguay was assessed. The methodology comprised field sampling and detection using DAS-ELISA and PCR. Five field-pair cases where GM maize crops were grown near non-GM maize crops were identified. These cases had the potential to cross-fertilize considering the distance between crops and the similarity of the sowing dates. Adventitious presence of GM material in the offspring of non-GM crops was found in three of the five cases. Adventitious presence of event MON810 or Bt11 in non-GM maize, which were distinguished using specific primers, matched the events in the putative sources of transgenic pollen. Percentages of transgenic seedlings in the offspring of the non-GM crops were estimated as 0.56%, 0.83% and 0.13% for three sampling sites with distances of respectively 40, 100 and 330 m from the GM crops. This is a first indication that adventitious presence of transgenes in non-GM maize crops will occur in Uruguay if isolation by distance and/or time is not provided. These findings contribute to the evaluation of the applicability of the "regulated coexistence policy" in Uruguay.
In many domains, risk assessment is a defined methodology aimed at determining and quantifying risks associated with a specific activity, including the identification and characterization of potential hazards and their probability of occurrence. It relies on the gathering and interpretation of scientific and technical data and must be carried out in a scientifically sound and transparent manner. With regard to the use of genetically modified organisms (GMOs), risk assessment relies primarily on the results of research and studies aiming at evaluating the potential impacts of GMOs on the environment and/or human health. Given the increasing number of GMOs tested or commercialized worldwide and the development of new types of GMOs, new and up-to-date scientific information generated by basic or applied research in various fields can strengthen the risk assessment and/or provide answers to potential knowledge gaps identified during risk assessment. The gathering of data obtained from scientific research relevant to the risk assessment, as well as the implementation of new research activities resulting from the identification of potential knowledge gaps, would be facilitated by regular exchanges of views between experts involved in risk assessment/evaluation and scientists involved in basic or applied research (from public institutions or companies). As this interaction could be of mutual benefit and could also serve to inform competent authorities and policy-makers, platforms bringing together these communities are considered of relevance.
Prunus species are important commercial fruit (plums, apricot, peach and cherries), nut (almond) and ornamental trees cultivated broadly worldwide. This review compiles information from available literature on Prunus species in regard to gene flow and hybridization within this complex of species. The review serves as a resource for environmental risk assessment related to pollen mediated gene flow and the release of transgenic Prunus. It reveals that Prunus species, especially plums and cherries show high potential for transgene flow. A range of characteristics including; genetic diversity, genetic bridging capacity, inter- and intra-specific genetic compatibility, self sterility (in most species), high frequency of open pollination, insect assisted pollination, perennial nature, complex phenotypic architecture (canopy height, heterogeneous crown, number of flowers produced in an individual plant), tendency to escape from cultivation, and the existence of ornamental and road side Prunus species suggest that there is a tremendous and complicated ability for pollen mediated gene movement among Prunus species. Ploidy differences among Prunus species do not necessarily provide genetic segregation. The characteristics of Prunu s species highlight the complexity of maintaining coexistence between GM and non-GM Prunus if there were commercial production of GM Prunus species. The results of this review suggest that the commercialization of one GM Prunus species can create coexistence issues for commercial non-GM Prunus production. Despite advances in molecular markers and genetic analysis in agroecology, there remains limited information on the ecological diversity, metapopulation nature, population dynamics, and direct measures of gene flow among different subgenera represented in the Prunus genus. Robust environmental impact, biosafety and coexistence assessments for GM Prunus species will require better understanding of the mechanisms of gene flow and hybridization among species within the Prunus species complex.
Auchenorrhyncha (planthoppers and leafhoppers) are herbivorous organisms that can ingest Cry proteins from genetically engineered Bt-crops depending on their feeding behaviour. Consequently, they might be directly affected by non-target Bt-protein action and more importantly serve as a source of Cry protein exposure to beneficial predatory arthropods. During a three year field study, we surveyed the community of Auchenorrhyncha in Diabrotica-resistant Bt-maize DKc5143-Bt (event MON88017), its near-isogenic line and two conventional hybrids using sweep netting and custom made sticky traps. Zyginidia scutellaris (Herrich-Schäffer) (Hemiptera: Cicadellidae) represented more than 60% of all captured individuals, indicating that it is the dominant leafhopper within the maize community. The statistical analysis of Z. scutellaris data using confidence intervals for the ratios of mean abundance showed no consistent differences between the Bt-maize and the near-isogenic cultivar, indicating no negative impact of event MON88017. The two conventional hybrids Benicia and DK315 exhibited differences in terms of Z. scutellaris densities, which were greater than those observed between MON88017 and the near-isogenic line, but also not consistent over the years. Six more species accounted for an additional 39% of all captured specimens, while ten more species were found only as single individuals and can be considered vagrants from neighbouring habitats. These results inform future field work on the non-target impact of Bt-maize on this group of arthropods and monitoring approaches to assess biological control function by surveying herbivore communities.
With the extensive adoption of transgenic crops, an understanding of transgene flow is essential to manage gene flow to non-GM crops. Thus, a flexible and accurate numerical model is required to assess gene flow through pollen dispersal. A three-dimensional atmospheric model combined with a diffusion transport model would be a useful tool for predicting pollen dispersal since it would be flexible enough to incorporate the effects of factors such as the spatial arrangement of crop combinations, land use, topography, windbreaks, and buildings. We applied such a model to field measurements of gene flow between two adjacent maize (Zea mays) cultivars, with suppression effects due to windbreaks, in an experimental cornfield in Japan. This combined model reproduced the measured cross-pollination distribution quite well in the case of maize plots with plant windbreaks slightly taller than the maize and without windbreaks, but the model underestimated the effect of a 6-m-tall windbreak net beyond 25 m from the donor pollen source on cross-pollination. The underestimation was most probably due to the problem of assimilated wind data. The model showed that the 6-m-tall windbreak and the plant wind break suppressed average cross-pollination rate by about 60% and 30%, respectively. Half-tall and coarser mesh windbreak net suppressed cross-pollination rates by 40% by reducing the swirl of donor pollen by reduced wind speed.
Plant to plant gene flow is a route of environmental exposure for GM plants specifically since crosses with wild relatives could lead to the formation of more vigorous hybrids, which could increase the rate of introgression and the environmental impact. Here, we test the first step in the process of potential transgene introgression: whether hybrid vigor can be inherited to the next generation, which could lead to fixation of altered, i.e., elevated, quantitative traits. The potential for a permanent elevated fitness was tested using individual autogamous progeny lineages of hybrids between the crop Lactuca sativa (Lettuce) and the wild species Lactuca serriola (Prickly Lettuce). We compared progeny from motherplants grown under either greenhouse or field conditions. The survival of young plants depended strongly on maternal environment. Furthermore, we observed that offspring reproductive fitness components were correlated with maternal fitness. Our study demonstrates that post-zygotic genotypic sorting at the young plants stage reduces the number of genotypes non-randomly, leading to inheritance of high levels of reproductive traits in the surviving hybrid lineages, compared to the pure wild relatives. Consequently, directional selection could lead to displacement of the pure wild relative and fixation of more vigorous genome segments originating from crops, stabilizing plant traits at elevated levels. Such information can be used to indentify segments which are less likely to introgress into wild relative populations as a target for transgene insertion.
Several biological containment methods have been developed to reduce pollen dispersal; many of them only have a proof of concept in a model plant species. This review focuses on biological containment measures which were tested for their long-term efficiency at the greenhouse or field scale level, i.e. plastid transformation, transgene excission, cleistogamy and cytoplasmic male sterility (CMS). Pollen-mediated gene transfer in transplastomic tobacco could occur at very low frequencies if the predominant mode of inheritance is maternal. Transgene excision from tobacco pollen can be made highly efficient by coexpression of two recombinases. For cleistogamous oilseed rape it was shown that some flowers were partially open depending on genotypes, environment and recording dates. Reports on the stability of CMS in maize and sunflower indicated that there is a high variability for different genotypes under different environmental conditions and over successive years. But for both crop types some stable lines could be selected. These data demonstrate that the biological containment methods discussed are very promising for reducing gene flow but that no single containment strategy provides 100% reduction. However, the necessary efficiency of biological containment methods depends on the level of containment required. The containment level may need to be higher for safety purposes (e.g. production of special plant-made pharmaceuticals), while much lower containment levels may already be sufficient to reach coexistence goals. It is concluded that where pollen-mediated gene flow must be prevented altogether, combinations of complementary containment systems will be required.
Since the first commercial release of genetically modified (GM, also referred to as genetically engineered, GE) crops in the middle of 1990s, the research and development of transgenic biotechnology has made dramatic progress. To date, global cultivation area of GM crops has exceeded 120 million hectares (James, 2009) with extensive cultivation of herbicide-tolerant soybean and canola, insect-resistant cotton and maize, as well as other GM products, which has offered great opportunities for agriculture development. However the extensive commercial releases of GM plants have caused concerns and debates over their biosafety, both for consumers and the environment. The heat of debates over environmental biosafety issues has been fuelled by certain new developments, most recently proposal to farm GM salmon and the issuance of biosafety certificates for two insect-resistant GM rice lines in China. Therefore, biosafety issues related to the commercialization of GMOs are as important today as when the technology was first launched.
In recent times, it has become imperative for countries to define and implement policy in biosafety due to the widespread adoption of genetically modified crops. As such, countries wishing to utilise transgenic technologies in the development of advanced agricultural products must have regulations in place coupled with trained personnel in national competent authorities able to contribute effectively to the decision-making process. Capacity building initiatives play an important role in supporting such individuals, institutions and governmental authorities by providing training and/or physical structures/equipment and technical assistance. There are many types of capacity building activities; however not all have the same relevance in different regions of the world. For capacity building to be effective, a strategic approach incorporating a variety of forms and disciplines is desired. This commentary discusses the importance of factors such as: the targeting of support to relevant beneficiary(ies); the identification of specific needs and the incorporation of socio-economic conditions when elaborating effective strategies designed to help building capacity. Moreover, the importance of interaction and collaboration amongst the various capacity builders is also discussed such that unnecessary duplication of efforts and best use of available human and economic resources results.
More than 10 years after registration of the first Bt maize cultivar in Europe, there still exists a remarkable lack of data on effects on Lepidoptera which would be necessary for a complete and comprehensive environmental risk assessment. So far only very few European butterfly species have been tested in this aspect. In our study the effect of transgenic Bacillus thuringiensis (Bt) maize pollen (event Bt-176) on the development and survival of neonate larvae of the Peacock butterfly, Inachis io (L.) was for the first time shown. The results of our study suggest that the Peacock butterfly may serve as a model organism for assessing potential side effects of new developed transgenic Bt crops on non-target butterflies in a GMO environmental risk assessment. The study was done under laboratory conditions by exposing larvae of the Peacock butterfly to various pollen doses of transgenic maize event Bt-176 (cv. PACTOL CB) or the conventional isogenic maize (cv. PACTOL) using a no-choice test. Larvae feeding for 48 h on nettle plants (Urtica dioica) that were contaminated with higher pollen concentrations from Bt-176 maize (205 and 388 applied pollen.cm⁻²) suffered a significantly higher mortality rate (68 and 85% respectively) compared to larvae feeding on leaves with no pollen (11%), or feeding on leaves with pollen from conventional maize (6 to 25%). At lower Bt maize pollen doses (23-104 applied pollen.cm⁻²),mortality ranged from 11-25% and there were no apparent differences among treatments. The corresponding LC₅₀-and LC₉₀-values for neonate larvae of the Peacock butterfly were 187 and 448 applied pollen grains.cm⁻² of Bt-176, respectively.Weight of larvae surviving consumption of Bt-176 maize pollen declined between 10 and 81% with increased pollen doses (r = -0.95). The highest weight reduction (81%) corresponded to the highest pollen concentration (388 pollen grains applied.cm⁻²). Ingestion of pollen from the conventional maize hybrid did not have negative effects on larval weight gain or survival rate.
