Removing politics from innovations that improve food security

Genetically modified (GM) organisms and crops have been a feature of food production for over 30 years. Despite extensive science-based risk assessment, the public and many politicians remain concerned with the genetic manipulation of crops, particularly food crops. Many governments have addressed public concern through biosafety legislation and regulatory frameworks that identify and regulate risks to ensure human health and environmental safety. These domestic regulatory frameworks align to international scientific risk assessment methodologies on a case-by-case basis. Regulatory agencies in 70 countries around the world have conducted in excess of 4400 risk assessments, all reaching the same conclusion: GM crops and foods that have been assessed provide no greater risk to human health or the environment than non-GM crops and foods. Yet, while the science regarding the safety of GM crops and food appears conclusive and societal benefits have been globally demonstrated, the use of innovative products have only contributed minimal improvements to global food security. Regrettably, politically-motivated regulatory barriers are currently being implemented with the next genomic innovation, genome editing, the implications of which are also discussed in this article. A decade of reduced global food insecurity was witnessed from 2005 to 2015, but regrettably, the figure has subsequently risen. Why is this the case? Reasons have been attributed to climate variability, biotic and abiotic stresses, lack of access to innovative technologies and political interference in decision making processes. This commentary highlights how political interference in the regulatory approval process of GM crops is adversely affecting the adoption of innovative, yield enhancing crop varieties, thereby limiting food security opportunities in food insecure economies.

     

转基因食品安全性评价研究进展

自1996年全球转基因作物大规模商业化生产以来,转基因作物种植面积以年均10%左右的速度迅速增长,2013年种植面积已达1.75亿hm2。其在解决全球粮食问题、环境保护、提升粮食营养质量和品质、制药以及推动经济可持续发展方面展现了重要作用。但是,随着转基因商业化生产的深入,转基因技术的潜在风险性引起了社会以及国际上更广泛的关注。事实上,在转基因技术出现之初,科学家们就开始关注其安全性问题。相关国际组织（FAO、WHO、CAC、OECD等）经过数次研究制订了一系列与转基因食品安全性有关的评价原则、指南与措施等。随着转基因技术的发展,这些安全评价策略也在不断完善。我国目前已经基本建立了转基因食品的安全评价和管理体系。转基因食品在进入市场前要经过十分全面以及系统的安全性评价,包括营养学、毒理学、过敏性等方面,从而保障转基因食品的安全性。     

The impact of genetic modification of human foods in the 21st century: a review

Genetic engineering of food is the science which involves deliberate modification of the genetic material of plants or animals. It is an old agricultural practice carried on by farmers since early historical times, but recently it has been improved by technology. Many foods consumed today are either genetically modified (GM) whole foods, or contain ingredients derived from gene modification technology. Billions of dollars in U.S. food exports are realized from sales of GM seeds and crops. Despite the potential benefits of genetic engineering of foods, the technology is surrounded by controversy. Critics of GM technology include consumer and health groups, grain importers from European Union (EU) countries, organic farmers, environmentalists, concerned scientists, ethicists, religious rights groups, food advocacy groups, some politicians and trade protectionists. Some of the specific fears expressed by opponents of GM technology include alteration in nutritional quality of foods, potential toxicity, possible antibiotic resistance from GM crops, potential allergenicity and carcinogenicity from consuming GM foods. In addition, some more general concerns include environmental pollution, unintentional gene transfer to wild plants, possible creation of new viruses and toxins, limited access to seeds due to patenting of GM food plants, threat to crop genetic diversity, religious, cultural and ethical concerns, as well as fear of the unknown. Supporters of GM technology include private industries, research scientists, some consumers, U.S. farmers and regulatory agencies. Benefits presented by proponents of GM technology include improvement in fruit and vegetable shelf-life and organoleptic quality, improved nutritional quality and health benefits in foods, improved protein and carbohydrate content of foods, improved fat quality, improved quality and quantity of meat, milk and livestock. Other potential benefits are: the use of GM livestock to grow organs for transplant into humans, increased crop yield, improvement in agriculture through breeding insect, pest, disease, and weather resistant crops and herbicide tolerant crops, use of GM plants as bio-factories to yield raw materials for industrial uses, use of GM organisms in drug manufacture, in recycling and/or removal of toxic industrial wastes. The potential risks and benefits of the new technology to man and the environment are reviewed. Ways of minimizing potential risks and maximizing the benefits of GM foods are suggested. Because the benefits of GM foods apparently far outweigh the risks, regulatory agencies and industries involved in GM food business should increase public awareness in this technology to enhance worldwide acceptability of GM foods. This can be achieved through openness, education, and research.     

Genetically modified crops: success, safety assessment, and public concern

With the emergence of transgenic technologies, new ways to improve the agronomic performance of crops for food, feed, and processing applications have been devised. In addition, ability to express foreign genes using transgenic technologies has opened up options for producing large quantities of commercially important industrial or pharmaceutical products in plants. Despite this high adoption rate and future promises, there is a multitude of concerns about the impact of genetically modified (GM) crops on the environment. Potential contamination of the environment and food chains has prompted detailed consideration of how such crops and the molecules that they produce can be effectively isolated and contained. One of the reasonable steps after creating a transgenic plant is to evaluate its potential benefits and risks to the environment and these should be compared to those generated by traditional agricultural practices. The precautionary approach in risk management of GM plants may make it necessary to monitor significant wild and weed populations that might be affected by transgene escape. Effective risk assessment and monitoring mechanisms are the basic prerequisites of any legal framework to adequately address the risks and watch out for new risks. Several agencies in different countries monitor the release of GM organisms or frame guidelines for the appropriate application of recombinant organisms in agro-industries so as to assure the safe use of recombinant organisms and to achieve sound overall development. We feel that it is important to establish an internationally harmonized framework for the safe handling of recombinant DNA organisms within a few years.This is IMTECH Communication No. 038/2005.     

转基因作物生物安全:科学证据

通过对美国Web of Science数据平台的全部转基因作物生物安全SCI论文的检索,研究了有关转基因作物生物安全的科学证据。得出科学家比消费者更关心转基因技术的安全性;批准商业化生产的转基因技术经过了有史以来最为严格的生物学安全检验与检测,并建立了有史以来最为严格的监管体系;在所发表的全部9333篇转基因生物安全论文中,90%以上的论文证明转基因技术的安全性与传统非转基因作物无显著差异;而对于所有得出转基因食品不安全结论的论文的追踪研究发现,其研究结论被证明是在错误的研究材料或方法条件下得出的。     

Exploitation of molecular profiling techniques for GM food safety assessment

Several strategies have been developed to identify unintended alterations in the composition of genetically modified (GM) food crops that may occur as a result of the genetic modification process. These include comparative chemical analysis of single compounds in GM food crops and their conventional non-GM counterparts, and profiling methods such as DNA/RNA microarray technologies, proteomics and metabolite profiling. The potential of profiling methods is obvious, but further exploration of specificity, sensitivity and validation is needed. Moreover, the successful application of profiling techniques to the safety evaluation of GM foods will require linked databases to be built that contain information on variations in profiles associated with differences in developmental stages and environmental conditions.     

Allergenicity assessment of genetically modified crops--what makes sense?

GM crops have great potential to improve food quality, increase harvest yields and decrease dependency on certain chemical pesticides. Before entering the market their safety needs to be scrutinized. This includes a detailed analysis of allergenic risks, as the safety of allergic consumers has high priority. However, not all tests currently being applied to assessing allergenicity have a sound scientific basis. Recent events with transgenic crops reveal the fallacy of applying such tests to GM crops.     

Safe composition levels of transgenic crops assessed via a clinical medicine model

Substantial equivalence has become established as a foundation concept in the safety evaluation of transgenic crops. In the case of a food and feed crop, no single variety is considered the standard for safety or nutrition, so the substantial equivalence of transgenic crops is investigated relative to the array of commercial crop varieties with a history of safe consumption. Although used extensively in clinical medicine to compare new generic drugs with brand-name drugs, equivalence limits are shown to be a poor model for comparing transgenic crops with an array of reference crop varieties. We suggest an alternate model, also analogous to that used in clinical medicine, where reference intervals are constructed for a healthy heterogeneous population. Specifically, we advocate the use of distribution-free tolerance intervals calculated across a large amount of publicly available compositional data such as is found in the International Life Sciences Institute Crop Composition Database.     

Regulatory aspects of gene editing in Argentina

Argentina is a world leader in regards to regulation and adoption of genetically modified (GM) crops. As a consequence, the regulatory aspects of gene editing applied to agriculture were considered proactively by the Argentinian regulators, who implemented simple but solid pioneering regulatory criteria for gene edited crops. At present, the Argentine regulatory system is fully able to establish if a gene-edited crop should be classified (and handled) either as a GM crop or a conventional new variety. To this end, the concept of “novel combination of genetic material” derived from the Cartagena Protocol on Biosafety is of decisive importance. After some pilot cases that have been managed under this criteria, now applicants appreciate the ease, speed and predictability of the regulation. Moreover, it has been considered by other countries in the course of developing their own regulations, thus acting also as a harmonization factor for the safe and effective insertion of these technologies in the global market.

     

Characterization of scientific studies usually cited as evidence of adverse effects of GM food/feed

GM crops are the most studied crops in history. Approximately 5% of the safety studies on them show adverse effects that are a cause for concern and tend to be featured in media reports. Although these reports are based on just a handful of GM events, they are used to cast doubt on all GM crops. Furthermore, they tend to come from just a few laboratories and are published in less important journals. Importantly, a close examination of these reports invariably shows methodological flaws that invalidate any conclusions of adverse effects. Twenty years after commercial cultivation of GM crops began, a bona fide report of an adverse health effect due to a commercialized modification in a crop has yet to be reported.     

Moving beyond the GM Debate

Once again, there are calls to reopen the debate on genetically modified (GM) crops. I find these calls frustrating and unnecessarily decisive. In my opinion the GM debate, on both sides, continues to hamper the urgent need to address the diverse and pressing challenges of global food security and environmental sustainability. The destructive power of the debate comes from its conflation of unrelated issues, coupled with deeply rooted misconceptions of the nature of agriculture.

This article is part of the PLOS Biology Collection “The Promise of Plant Translational Research.”

For many people, genetic modification (GM) has become the poster child for everything they consider bad about modern agriculture. It represents the domination of the food supply chain by profit-driven multinational companies. It represents the systematic replacement of important ecosystems with huge high-intensity farms growing monocultures of commodity crops. It represents humankind''s evil manipulation of Nature for personal gain and greed, at the expense of the planet and of future generations. These are important concerns. It is reasonable to be disturbed by some of the current trends in agricultural practices, with fears fuelled by past errors, such as the previous emergence in the UK of bovine spongiform encephalopathy (BSE). However, none of these issues has anything to do with GM as a technique for improving or introducing plant traits. A complete ban on the use of GM in crop development would have no impact on any of them. For as long as we imagine that GM itself is the cause of these problems, they are free to escalate unchecked.A defining question of the 21^st century is: How can we achieve a reliable, sustainable, equitable supply of nutritious food for a growing and increasingly urbanized world population in the face of climate change? This is a complex question with agricultural productivity constituting only a small part of it, and in turn, GM only a small part of that. It is essential that we move forward to address this question without being continuously sidetracked by the GM debate. How can this be achieved?First, it is necessary to move on from the well-worn logical fallacy that anything natural is good, and anything unnatural is bad. The application of this fallacy to agriculture is an excellent illustration of why it is so flawed. Plants evolved by natural selection, driven by the survival of the fittest. As a result, naturally, they are defended to the hilt from herbivores of all kinds, including humans. We know this. No one sends their children into the woods saying “Eat anything you find. It''s all natural, so it must be good for you.” The seeds of plants are particularly well protected, because they are, of course, the plant''s children, their ticket to posterity. Seed is therefore usually tough, indigestible, minimally resourced, and often laced with toxins. Yet plant seeds are now our major source of calories. The cereal crops we eat bear little resemblance to their naturally selected ancestors, and the environments in which we grow them are equally highly manipulated and engineered by us. We have, over the last 10,000 years, bred out of our main food plants all kinds of survival strategies that natural selection put in. This has drastically reduced their competitiveness in nature, but equally dramatically increased their utility in feeding us. Agriculture is the invention of humans. It is the deliberate manipulation of plants (and animals) and the environment in which they grow to provide food for us. The imperative is not that we should stop interfering with nature, but that we should interfere in the best way possible to provide a reliable, sustainable, equitable supply of nutritious food. To do this we need to understand how nature works. That''s what science is all about.This is easy to say, but concepts of the inherent goodness of Nature, and the inherent dangers of human interventions through science, are deeply ingrained in the way many people think, particularly in the context of food. This is an understandable response to concerns over the industrialization and unsustainable intensification of agriculture described above. You only have to walk down the aisles of a supermarket to see that “all natural” and “nothing artificial” sells things. These words sell products because they are so strongly culturally associated with environmental sustainability and well-being, exploiting people''s interest in protecting the environment and their health. However, many of the products people think of as natural, such as cereal crops, are profoundly unnatural and wouldn''t exist without human intervention; and many things people think of as artificial, such as “chemicals,” can be made with no human involvement at all. Similarly, many “natural” things are extremely bad news, such as aflatoxins, and many “artificial” things are widely accepted to be an extremely good idea, such as cereal crops (again). The only way to determine whether something is environmentally sustainable or healthy is to do the science and find out. Guessing based on cultural norms, amplified by aggressive marketing strategies is understandable, but will not deliver the desired outcome: a sustainable supply of healthy food. People need to be empowered to make decisions in a different way. For example, in the UK there is now a well-established health wheel traffic light system on foods in supermarkets, indicating through a simple graphic the sugar, fat, salt, and calorific content of the product. Perhaps there could be a similar sustainability wheel, building on such initiatives as Leaf (for Linking Environment and Farming – a UK organization that promotes sustainable food and farming and that identifies food produced to high environmental standards to consumers with a Leaf logo) [1]. This could be combined with the stricter application of advertising standards, preventing the fostering of misleading claims about what counts as “natural” and of misleading implications about the associated health and environmental benefits.Second, we need to get past the idea that GM, as a technique for crop genetic improvement, is specifically and generically different from other approaches, including conventional selective breeding. GM involves introducing a gene directly into the genome of an organism. The introduced gene can be one found in other members of that species or it could be from a different species. The most distinctive generic thing about a GM crop, in comparison to one produced by conventional selective breeding, would therefore appear to be the insertion of a piece of DNA into its genome, a process that is certainly not unique to GM crops. Even the movement of genes between species is not GM-specific, and indeed GM crops need not be modified with genes from a different species. Many viruses can insert their genomes into that of their host as a normal part of their life cycle. These viral sequences, and many related genetic elements, such as retroposons, accumulate over evolutionary time and can continue to move about the genomes of their hosts, creating new DNA insertion sites. Thus, every conventionally bred rice crispy or cornflake you had for breakfast probably differs from every other one by the insertion of a piece of DNA at an unknown site in its genome.There is really nothing generic to be said about GM as a plant breeding technique. Almost all the media reports purporting to be about the effects of GM are in fact about effects of the specific trait that has been introduced into the GM crop. Currently, there are only two widely deployed GM traits: herbicide tolerance and insect resistance. Concerns purporting to be about GM are almost all about one or other of these traits. For example, a large, farm-scale evaluation of the environmental impacts of three herbicide-tolerant GM crops conducted in the UK between 1999 and 2006 [2] was widely reported as demonstrating that GM is bad for wildlife. What in fact it showed was that effective weed control is bad for wildlife. Weeds are required to support biodiversity in agricultural environments, and are currently under threat from winter planting regimes, non-GM herbicide-tolerant crops, and a range of increasingly sophisticated weed control strategies. Banning GM crops will not address this problem. It is wrong to imply that growing GM crops, rather than effective weed control, is the cause of negative effects on biodiversity. It is not because a crop is GM that weeds are reduced; many GM crops have no impact on weeds at all. It is because a crop, GM or otherwise, is herbicide tolerant and sprayed with weed killers that reduce weed populations. The claim that biodiversity is reduced because a GM crop was grown detracts attention from the real issue, namely how to balance the positive effects of weeds in supporting biodiversity with their negative impacts on agricultural productivity.This confusion between the effects of a new trait and the method by which it has been introduced is enshrined in the way new crops are licensed for commercial release in many countries. In the European Union (EU), a new herbicide-tolerant GM crop, produced by introducing a single gene conferring herbicide tolerance, must go through a lengthy procedure of testing aimed at assessing its potential health and environmental impacts [3]. Such an assessment would include concerns about impacts on wildlife, as described above, and about the generation of so-called super weeds by out-crossing of the GM crop to wild relatives or caused by the over-use of herbicides. Meanwhile, a herbicide-tolerant crop produced by mutation of a single endogenous gene has no such testing, and the breeders need only to demonstrate that it is stable and significantly different from already registered crops. All the environmental concerns associated with GM herbicide tolerance are equally applicable to non-GM herbicide tolerance. There are also considerable agronomic and environmental benefits that could accrue from herbicide tolerant crops, such as reduced soil erosion through reduced need for ploughing [4]. These need to be weighed against the risks and an appropriate decision reached. This decision is about weed control, not about GM. In my opinion, there is therefore no justification for considering GM vs non-GM herbicide tolerant crops differently. Their assessment, from a regulatory viewpoint and in terms of their environmental impact, should be based on the distinctive trait they carry.The GM-specific regulatory system currently in place creates huge financial barriers for GM crop introduction, which ironically is one of the main reasons why almost the only applications in the field today are driven by big business. These days, the cost of developing a GM crop is relatively affordable. Meanwhile, non-GM crops, sometimes with new traits, are released with relatively little scrutiny of their impacts on the environment or on food safety. This is increasingly an issue as we continue to develop new and ever more sophisticated ways to introduce desirable traits into crops, for example by genomic assisted breeding or by genome editing [5]. These new tools provide exciting and much needed opportunities for crop genetic improvement, but in my view they also demand a more sensible licensing system that assesses all new crops based on the traits they carry rather than on the method by which they were introduced [5],[6].The current system does little to protect the environment or the food chain and is ill-equipped to cope with the new approaches to plant breeding now coming on line. A trait-based system, bringing a proportional level of scrutiny to all crops that carry a new trait, could provide the checks and balances that should go hand in hand with innovation. We definitely need crop genetic improvement [4], using whatever method is best, and it is precisely because we do that we also need an evidence-based and proportional system for assessing new crops for environmental and health impacts.A related issue, which will be similarly challenged by new genetic improvement techniques, is that of patent protection for crops. While conventionally bred crops can be protected by various means, such “variety” protection systems include exemptions for farmers that permit them to save seed for next year''s planting and for breeders to include the variety in breeding programmes. In contrast, GM crops can be protected by so-called utility patents, which can protect the use of a specific gene to confer a trait. These patents are much more restrictive and prohibit both seed saving by farmers and exemptions for plant breeders. The harmonisation of the crop variety licensing system to focus on novel traits, however introduced, could reasonably be widened to include an examination of the patent protection system for such traits. If the licensing system were to become less expensive, the argument for restrictive utility patents on such traits is reduced.We now have a wealth of opportunities for crop genetic improvement, with an impressive arsenal of tools and techniques available. To deploy these effectively, we need to move well beyond the GM debate to a much wider debate about food production. What methods of farming provide reliable and high yields in a sustainable way? What is the role of multinational companies in delivering food security? What political and societal changes are needed to drive more equitable food distribution? How can waste be reduced? These are big complex questions with big complex answers and no simple dogmatic solution. No single farming method or crop improvement technique is a panacea, nor is it the cause of the problem. Such complex problems with correspondingly complex and multifaceted solutions are difficult. They don''t make rousing campaign slogans or eye-catching tabloid headlines, but we have got to find a way to address them, in all their complexity.The most frustrating thing about this situation is that almost everyone wants the same outcome: a reliable, sustainable, equitable supply of nutritious food. For issues this big, there will of course be differences of opinion about how to move forward, what to prioritise, and how to decide. These are important areas for debate. GM, as a technique, is not.     

Tracking genes from seed to supermarket: techniques and trends

Analytical techniques to track plant genes in the environment and the food chain are essential for environmental risk assessment, government regulation and production and trade of genetically modified (GM) crops. Here, I review laboratory techniques to track plant genes during pre-commercialization research on gene flow and post-commercialization detection, identification and quantification of GM crops from seed to supermarket. At present, DNA- and protein-based assays support both activities but the demand for fast, inexpensive, sensitive methods is increasing. Part of the demand has been generated by stringent food labeling and traceability regulations for GM crops. The increase in GM crops, changes in GM crop design, evolution of government regulations and adoption of risk-assessment frameworks will continue to drive development of analytical techniques.     

Genetically modified and organic crops in developing countries: A review of options for food security

Since two decades ago, when the first GM crops were introduced, there have increasingly been hot debates on the applications of gene manipulation. Currently, the development of GM crop varieties has raised a wide range of new legal, ethical and economic questions in agriculture. There is a growing body of literature reflecting the socio-economic and environmental impacts of GM crops which aims to criticize their value for farming systems. While organic crops are promoted as environmentally-friendly products in developed countries, they have provoked great controversy in developing countries facing food security and a low agricultural productivity. Discussion has been especially vigorous when organic farming was introduced as an alternative method. There are in fact, a few tradeoffs in developing countries. On the one hand, farmers are encouraged to accept and implement GM crops because of their higher productivity, while on the other hand, organic farming is encouraged because of socio-economic and environmental considerations. A crucial question facing such countries is therefore, whether GM crops can co-exist with organic farming. This paper aims to review the main considerations and tradeoffs.     

Safety assessment of lepidopteran insect-protected transgenic rice with <Emphasis Type="Italic">cry2A*</Emphasis> gene

Numerous genetically modified (GM) crops expressing proteins for insect resistance have been commercialized following extensive testing demonstrating that the foods obtained from them are as safe as that obtained from their corresponding non-GM varieties. In this paper, we report the outcome of safety studies conducted on a newly developed insect-resistant GM rice expressing the cry2A* gene by a subchronic oral toxicity study on rats. GM rice and non-GM rice were incorporated into the diet at levels of 30, 50, and 70 % (w/w), No treatment-related adverse or toxic effects were observed based on an examination of the daily clinical signs, body weight, food consumption, hematology, serum biochemistry, and organ weight or based on gross and histopathological examination. These results demonstrate that the GM rice with cry2A* gene is as safe for food as conventional non-GM rice.     

Biosafety management and commercial use of genetically modified crops in China

As a developing country with relatively limited arable land, China is making great efforts for development and use of genetically modified (GM) crops to boost agricultural productivity. Many GM crop varieties have been developed in China in recent years; in particular, China is playing a leading role in development of insect-resistant GM rice lines. To ensure the safe use of GM crops, biosafety risk assessments are required as an important part of the regulatory oversight of such products. With over 20 years of nationwide promotion of agricultural biotechnology, a relatively well-developed regulatory system for risk assessment and management of GM plants has been developed that establishes a firm basis for safe use of GM crops. So far, a total of seven GM crops involving ten events have been approved for commercial planting, and 5 GM crops with a total of 37 events have been approved for import as processing material in China. However, currently only insect-resistant Bt cotton and disease-resistant papaya have been commercially planted on a large scale. The planting of Bt cotton and disease-resistant papaya have provided efficient protection against cotton bollworms and Papaya ringspot virus (PRSV), respectively. As a consequence, chemical application to these crops has been significantly reduced, enhancing farm income while reducing human and non-target organism exposure to toxic chemicals. This article provides useful information for the colleagues, in particular for them whose mother tongue is not Chinese, to clearly understand the biosafety regulation and commercial use of genetically modified crops in China.     

Consideration of familiarity accumulated in the confined field trials for environmental risk assessment of genetically modified soybean (Glycine max) in Japan

To date, there have been 160 regulatory approvals for environmental safety in Japan for the major genetically modified (GM) crops, including corn, soybean, canola and cotton. Confined field trials (CFTs) have been conducted in Japan for all single events, which contain various traits. The accumulated information from these previously conducted CFTs, as well as the agronomic field study data from other countries, provides a rich source of information to establish “familiarity” with the crops. This familiarity can be defined as the knowledge gained through experience over time, and used to inform the environmental risk assessments (ERA) of new GM crops in Japan. In this paper, we compiled agronomic data from the CFTs performed in Japan for 11 GM soybean events which obtained food, feed and environmental safety approvals from regulatory agencies in Japan. These CFTs were conducted by multiple developers according to Japan regulations to support the ERA of these GM soybean, covering standard measurement endpoints evaluated across developers in Japan. With this dataset, we demonstrate how familiarity gained from the CFTs of GM soybeans in Japan can be used to inform on the ERA of new GM soybean events. By leveraging this concept of familiarity, we discuss potential enhancements to the ERA process for GM soybean events in Japan.

     

Safety of <Emphasis Type="Italic">Pseudomonas chlororaphis</Emphasis> as a gene source for genetically modified crops

Genetically modified crops undergo extensive evaluation to characterize their food, feed and environmental safety prior to commercial introduction, using a well-established, science-based assessment framework. One component of the safety assessment includes an evaluation of each introduced trait, including its source organism, for potential adverse pathogenic, toxic and allergenic effects. Several Pseudomonas species have a history of safe use in agriculture and certain species represent a source of genes with insecticidal properties. The ipd072Aa gene from P. chlororaphis encodes the IPD072Aa protein, which confers protection against certain coleopteran pests when expressed in maize plants. P. chlororaphis is ubiquitous in the environment, lacks known toxic or allergenic properties, and has a history of safe use in agriculture and in food and feed crops. This information supports, in part, the safety assessment of potential traits, such as IPD072Aa, that are derived from this source organism.     

The development and status of Bt rice in China

Multiple lines of transgenic rice expressing insecticidal genes from the bacterium Bacillus thuringiensis (Bt) have been developed in China, posing the prospect of increases in production with decreased application of pesticides. We explore the issues facing adoption of Bt rice for commercial production in China. A body of safety assessment work on Bt rice has shown that Bt rice poses a negligible risk to the environment and that Bt rice products are as safe as non‐Bt control rice products as food. China has a relatively well‐developed regulatory system for risk assessment and management of genetically modified (GM) plants; however, decision‐making regarding approval of commercial production has become politicized, and two Bt rice lines that otherwise were ready have not been allowed to enter the Chinese agricultural system. We predict that Chinese farmers would value the prospect of increased yield with decreased use of pesticide and would readily adopt production of Bt rice. That Bt rice lines may not be commercialized in the near future we attribute to social pressures, largely due to the low level of understanding and acceptance of GM crops by Chinese consumers. Hence, enhancing communication of GM crop science‐related issues to the public is an important, unmet need. While the dynamics of each issue are particular to China, they typify those in many countries where adoption of GM crops has been not been rapid; hence, the assessment of these dynamics might inform resolution of these issues in other countries.     

Transgenic plants and biosafety: science, misconceptions and public perceptions

One usually thinks of plant biology as a non-controversial topic, but the concerns raised over the biosafety of genetically modified (GM) plants have reached disproportionate levels relative to the actual risks. While the technology of changing the genome of plants has been gradually refined and increasingly implemented, the commercialization of GM crops has exploded. Today's commercialized transgenic plants have been produced using Agrobacterium tumefaciens-mediated transformation or gene gun-mediated transformation. Recently, incremental improvements of biotechnologies, such as the use of green fluorescent protein (GFP) as a selectable marker, have been developed. Non-transformation genetic modification technologies such as chimeraplasty will be increasingly used to more precisely modify germplasm. In spite of the increasing knowledge about genetic modification of plants, concerns over ecological and food biosafety have escalated beyond scientific rationality. While several risks associated with GM crops and foods have been identified, the popular press, spurred by colorful protest groups, has left the general public with a sense of imminent danger. Reviewed here are the risks that are currently under research. Ecological biosafety research has identified potential risks associated with certain crop/transgene combinations, such as intra- and interspecific transgene flow, persistence and the consequences of transgenes in unintended hosts. Resistance management strategies for insect resistance transgenes and non-target effects of these genes have also been studied. Food biosafety research has focused on transgenic product toxicity and allergenicity. However, an estimated 3.5 x 10(12) transgenic plants have been grown in the U.S. in the past 12 years, with over two trillion being grown in 1999 and 2000 alone. These large numbers and the absence of any negative reports of compromised biosafety indicate that genetic modification by biotechnology poses no immediate or significant risks and that resulting food products from GM crops are as safe as foods from conventional varieties. We are increasingly convinced that scientists have a duty to conduct objective research and to effectively communicate the results--especially those pertaining to the relative risks and potential benefits--to scientists first and then to the public. All stakeholders in the technology need more effective dialogues to better understand risks and benefits of adopting or not adopting agricultural biotechnologies.     

Environmental release of living modified organisms: current approaches and case studies

Agricultural biotechnology is being rapidly adopted as evidenced by the acreage of genetically modified (GM) crops planted and tonnes of product (grain and fiber) harvested. Concurrent with this technological progress, is a growing concern that the worlds biological diversity is coming under increasing threat from human activities. As such, ecological risk assessment approaches are being developed for GM crop plants as international agreements regulating the transboundary movements of these products are being implemented. This paper reviews the ecological risk assessment approach that has been used to date to approve GM crops to date. The process has been case-by-case, using a comparative, science-based approach balancing the potential risks and benefits of the new technology versus those present with the currently accepted practices. The approach used to evaluate and approve these products is consistent with the conditions and requirements outlined in the Cartagena Protocol.