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Comparative safety assessment for biotech crops.
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Is confidence in the monitoring of GE foods justified?
Often the limits of detection of genetically engineered organisms (GEOs, LMOs, GMOs) determine what legislation sets as thresholds of allowable contamination of the human food chain with GEOs. Many countries have legislation that is triggered by certain thresholds of contamination. Importantly, international trade in food and animal feed is becoming increasingly vulnerable to interruptions caused by the ambiguity GEOs can create when shipments are monitored at the border. We examine the tools available for detection. Four key error-generating stages are identified with the aim of prompting a higher uniform standard of routine analysis at export and import points. Contamination of the New Zealand corn crop with GEOs is used as a case study for the application of monitoring tools and vulnerability to errors. These tools fail to meet emerging food safety requirements, but some improvements are in development.
Consumer acceptance of biotechnology and the role of second generation technologies in the USA and Europe.
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Global trends in plant transgenic science and technology (1973-2003).
Transgenic science and technology are fundamental to state-of-the-art plant molecular genetics and GM crop improvement. Monitoring the scale and growth of this area of science is important to scientists, national and international research organizations, funding bodies, policy makers and, because of the GM debate, to society as a whole. Literature statistics covering the past 30 years reveal a dramatic increase in plant transgenic science in Asia during the past decade, a sustained expansion in North America and, recently, a slow down in the rest of the world. With the exception of the output of China and India, publications focusing on the development of transgenic technology have been slowing down, worldwide, since the early mid-1990s, a trend that contrasts with the increase in GM crop-related studies.
Genetic engineering of wheat--current challenges and opportunities.
Wheat is one of the major staple food crops grown worldwide; however, productivity in cereal crops has not kept pace with the world population growth. A significant increase in wheat production (>40% by 2020) is needed simply to keep up with the growing demand. This increase is unlikely to be achieved by conventional plant breeding methods because of the limited gene pool available. The application of recombinant techniques to improve wheat quality and yield is not only desirable but also has potential to open up new opportunities. Although there has been significant progress in developing gene-transformation technologies for improving these traits, this remains an important challenge for plant biotechnology. Obstacles to translate the full potential of the genomic era to wheat breeding include the need to develop elite wheat varieties without selectable markers, introducing minimal or nil intergenic DNA and social and market issues concerning genetically engineered food products.
Agbiotech: success depends on trust.
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Science, politics, and the GM debate in Europe.
Europe today stands at a crossroad, facing challenges but also opportunities. In its intent to make Europe a leading technology-based economy by 2010, the European Commission has identified biotechnology and genomics as fields for future growth, crucial for supporting the agricultural and food processing industry. Since first commercialization in 1996, GM crop areas have grown at double-digit rates, making this one of the most rapidly adopted technologies in agriculture. However, in contrast to other world areas and despite European Commission support, Europe has found itself 'bogged-down' in a polemic between opponents and supporters of plant biotechnology. As a result, planted areas have remained small. This stalemate is due to a lack of political leadership, especially at the Member State level, all the more surprising in light of European early development and competitive advantage with crop biotechnology. This situation proves once again that, for cutting-edge innovations, a solid science base alone is not sufficient. Acceptance or rejection of new technologies depends on interlinked political, economic, and societal factors that create a favorable or unfavorable situation at a given time. This article will look at GM crops in Europe and the role science and politics have played in the introduction of crop biotechnology.
Statistical analysis used in the nutritional assessment of novel food using the proof of safety.
The safety assessment of Novel Food, including GM biotechnology-derived crops, starts with the comparison of the Novel Food with a traditional counterpart that is generally accepted as safe based on a history of human food use. Substantial equivalence is established if no meaningful difference from the conventional counterpart was found, leading to the conclusion that the Novel Food is as safe and nutritious as its traditional counterpart. In general, the non-significance of p value is used for the proof of safety. From a statistical perspective, the problems connected with such an approach are demonstrated, namely that quite different component-specific false negative error rates result. As an alternative, the proof of safety is discussed with the inherently related definition of safety thresholds. Moreover, parametric and non-parametric confidence intervals for the difference and the ratio to control (conventional line) are described in detail. Finally, the treatment of multiple components for a global proof of safety is explained.
Compositional assessment of event DAS-59122-7 maize using substantial equivalence.
Event DAS-59122-7 (Herculex RW) maize (Zea mays L.) plants were transformed to express the Cry34Ab1 and Cry35Ab1 binary insecticidal crystal proteins originally isolated from Bacillus thuringiensis Berliner (Bt) strain PS149B1. These proteins protect maize roots from attack by corn rootworms, Diabrotica spp. DAS-59122-7 maize also contains the pat gene, originally isolated from Streptomyces viridochromogenes, which confers tolerance to glufosinate-ammonium herbicides (e.g. Liberty). We assessed the composition of these transgenic plants (with and without Liberty herbicide treatment), grown at a total of eight fields sites over 2 years, by applying the principle of substantial equivalence. Forage and grain samples were analyzed for proximates, fiber and minerals, and grain was further analyzed for amino acids, fatty acids, vitamins, secondary metabolites and anti-nutrients. Data plots were prepared that allow for efficient investigation of equivalency between event DAS-59122-7 maize and a non-transgenic near-isogenic maize line grown contemporaneously. Results demonstrated that DAS-59122-7 maize is equivalent to non-transgenic maize with respect to these important constituents.
Regulation of Bt crops in Canada.
The Canadian Food Inspection Agency (CFIA) regulates environmental releases of plants with novel traits, which include transgenic plants such as Bt crops. Bt crops are regulated in Canada because they express insect resistance novel to their species. Commercialization of crops with novel traits such as the production of insecticidal Bt proteins requires an approval for environmental release, as well as approvals for use as feed and food. Environmental factors such as potential impacts on non-target species are considered. Insect resistance management (IRM) may be imposed as a condition for environmental release of Bt crops to delay the development of resistance in the target insect. Bt potato and European corn borer-resistant Bt corn have been released with mandatory IRM. The CFIA imposes an IRM plan consisting of appropriate refugia, education of farmers and seed dealers, and monitoring and mitigation. Industry, regulators, government extension staff and public researchers provide expert advice on IRM.
Legal and regulatory concerns about transgenic plants in Brazil.
Brazil has a biosafety law that was approved in 1995. This law provides for a horizontal type of regulation that coordinates other existing regulatory frameworks in the areas of agriculture, health and environment. Various federal government departments are responsible for implementing the law. The National Technical Biosafety Commission is the national competent authority on biosafety with overall responsibility. In the case of Bt plants or any insecticidal organism, the Agrochemical Law also applies and authorization for laboratory, greenhouse and field studies must be obtained from the Plant Protection Secretariat, the Brazilian Institute of Environment and the National Agency of Health. Furthermore, the National Environmental Council must issue a license for commercialization of any GMO. There is pressure needed for capacity building and to harmonize the regulatory and administrative frameworks among the different federal departments involved. Some perspectives and challenges for the commercial registration of transgenic crops are discussed.
Considerations for conducting research in agricultural biotechnology.
Science has shown its increased vulnerability because of two recent high-profile articles published in major journals on corn produced through biotechnology: a laboratory report suggesting profound consequences to monarch butterfly populations due to Bt corn pollen and a report suggesting transgenic introgression into Mexican maize. While both studies have been widely regarded as having flawed methodology, publishing these studies has created great consternation in the scientific community, regulatory agencies and the general public. There are roles and responsibilities of scientists, scientific journals, the public media, public agencies, and those who oppose or advocate a specific technology, and serious consequences when those roles and responsibilities go awry. Modern communication may exacerbate the flow of misinformation and easily lead to a decline in public confidence about biotechnology and science. However, common sense tells us that scientific inquiry and the publication and reporting of results should be performed with high standards of ethical behavior, regardless of one's personal perspective on agricultural biotechnology.
Precautionary risk assessment of Bt maize: what uncertainties?
GM crops have become a test case for the conflicting slogans of 'the precautionary principle' versus 'sound science.' The issues can be illustrated by developments in regulatory science for Bt maize in the European Union. As this case study suggests, risk assessment is always framed by some account of the relevant uncertainties. These in turn depend upon how the environment is valued and how scientific questions are posed about cause-effect pathways of potential harm. The slogan of 'sound science' hides such judgements, by representing ignorance or value-judgements as 'science.' By contrast, precaution can challenge such judgements, identify new unknowns, generate different criteria for evidence, open up new scientific questions, and make these judgements more transparent. It is doubtful whether these complexities have been fully acknowledged by specialists, and thus whether the continued risk debate is due solely to a public misunderstanding of science.
Europe moves to loosen restriction on GM foods.
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Uganda tries to learn from Zambia's GM food controversy.
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Codex adopts new standards on GM foods, irradiation, and animal feed.
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GM foods in Spanish newspapers.
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