Commercializing genetically modified crops under EU regulations: objectives and barriers

Agriculture faces serious problems in feeding 9 billion people by 2050: production must be increased and ecosystem services maintained under conditions for growing crops that are predicted to worsen in many parts of the world. A proposed solution is sustainable intensification of agriculture, whereby yields are increased on land that is currently cultivated, so sparing land to deliver other ecosystem services. Genetically modified (GM) crops are already contributing to sustainable intensification through higher yields and lower environmental impacts, and have potential to deliver further significant improvements. Despite their widespread successful use elsewhere, the European Union (EU) has been slow to introduce GM crops: decisions on applications to import GM commodities are lengthy, and decision-making on applications to cultivate GM crops has virtually ceased. Delayed import approvals result in economic losses, particularly in the EU itself as a result of higher commodity prices. Failure to grant cultivation approvals costs EU farmers opportunities to reduce inputs, and results in loss of agricultural research and development from the EU to countries such as the United States and China. Delayed decision-making in the EU ostensibly results from scientific uncertainty about the effects of using GM crops; however, scientific uncertainty may be a means to justify a political decision to restrict cultivation of GM crops in the EU. The problems associated with delayed decision-making will not improve until there is clarity about the EU's agricultural policy objectives, and whether the use of GM crops will be permitted to contribute to achieving those objectives.     

Novel and potential application of cryopreservation to plant genetic transformation

The world population now is 6.7 billion and is predicted to reach 9 billion by 2050. Such a rapid growing population has tremendously increased the challenge for food security. Obviously, it is impossible for traditional agriculture to ensure the food security, while plant biotechnology offers considerable potential to realize this goal. Over the last 15 years, great benefits have been brought to sustainable agriculture by commercial cultivation of genetically modified (GM) crops. Further development of new GM crops will with no doubt contribute to meeting the requirements for food by the increasing population. The present article provides updated comprehensive information on novel and potential application of cryopreservation to genetic transformation. The major progresses that have been achieved in this subject include (1), long-term storage of a large number of valuable plant genes, which offers a good potential for further development of novel cultivars by genetic transformation; (2), retention of regenerative capacity of embryogenic tissues and protoplasts, which ensures efficient plant regeneration system for genetic transformation; (3), improvement of transformation efficiency and plant regeneration of transformed cells; (4), long-term preservation of transgenic materials with stable expression of transgenes and productive ability of recombinant proteins, which allows transgenic materials to be stored in a safe manner before being analyzed and evaluated, and allows establishment of stable seed stocks for commercial production of homologous proteins. Data provided in this article clearly demonstrate that cryo-technique has an important role to play in the whole chain of genetic transformation. Further studies coupling cryotechnique and genetic transformation are expected to significantly improve development of new GM crops.     

Do genetically modified crops affect animal reproduction? A review of the ongoing debate

In the past few years, genetically modified (GM) crops aimed at producing food/feed that became part of the regular agriculture in many areas of the world. However, we are uncertain whether GM food and feed can exert potential adverse effects on humans or animals. Of importance, the reproductive toxicology of GM crops has been studied using a number of methods, and by feeding GM crops to a number species of animals to ensure the safety assessment of GM food and feed. It appears that there are no adverse effects of GM crops on many species of animals in acute and short-term feeding studies, but serious debates of effects of long-term and multigenerational feeding studies remain. The aims of this review are to focus on the latest (last 3 to 4 years) findings and debates on reproduction of male and female animals after feeding daily diets containing the GM crops, and to present the possible mechanism(s) to explain their influences.     

The impact of the EU regulatory constraint of transgenic crops on farm income

World population and the need for nutritious food continue to grow. For 14 years farmers from a range of countries across the globe have been accessing transgenic technologies either to reduce crop production costs, increase yield and/or to exploit a range of rotational benefits. In 2009 134 Mha of transgenic crops was grown. The arable area of the EU 27 is approximately 102 Mha; however, only about 0.1 Mha of transgenic crops, mainly maize in Spain, is grown in the EU. This is in part due to limited approvals before the establishment of a moratorium on the cultivation of transgenic crops. In this paper we estimate the revenue foregone by EU farmers, based on the potential hectarages of IR and HT transgenic crops that have been economically successful elsewhere if they were to be grown in areas of the EU where farmers could expect an overall financial benefit. This benefit would accrue primarily from reduced input costs. We estimate that if the areas of transgenic maize, cotton, soya, oil seed rape and sugar beet were to be grown where there is agronomic need or benefit then farmer margins would increase by between €443 and €929 M/year. It is noted that this margin of revenue foregone is likely to increase if the current level of approval and growth remains low, as new transgenic events come to market and are rapidly taken up by farmers in other parts of the world.     

Ex-Ante Economic Impact Assessment of Genetically Modified Banana Resistant to Xanthomonas Wilt in the Great Lakes Region of Africa

Background

Credible empirical evidence is scanty on the social implications of genetically modified (GM) crops in Africa, especially on vegetatively propagated crops. Little is known about the future success of introducing GM technologies into staple crops such as bananas, which are widely produced and consumed in the Great Lakes Region of Africa (GLA). GM banana has a potential to control the destructive banana Xanthomonas wilt disease.

Objective

To gain a better understanding of future adoption and consumption of GM banana in the GLA countries which are yet to permit the production of GM crops; specifically, to evaluate the potential economic impacts of GM cultivars resistant to banana Xanthomonas wilt disease.

Data Sources

The paper uses data collected from farmers, traders, agricultural extension agents and key informants in the GLA.

Analysis

We analyze the perceptions of the respondents about the adoption and consumption of GM crop. Economic surplus model is used to determine future economic benefits and costs of producing GM banana.

Results

On the release of GM banana for commercialization, the expected initial adoption rate ranges from 21 to 70%, while the ceiling adoption rate is up to 100%. Investment in the development of GM banana is economically viable. However, aggregate benefits vary substantially across the target countries ranging from US$ 20 million to 953 million, highest in countries where disease incidence and production losses are high, ranging from 51 to 83% of production.

Conclusion

The findings support investment in the development of GM banana resistant to Xanthomonas wilt disease. The main beneficiaries of this technology development are farmers and consumers, although the latter benefit more than the former from reduced prices. Designing a participatory breeding program involving farmers and consumers signifies the successful adoption and consumption of GM banana in the target countries.     

Genetically modified crops and small-scale farmers: main opportunities and challenges

Although some important features of genetically modified (GM) crops such as insect resistance, herbicide tolerance, and drought tolerance might seem to be beneficial for small-scale farmers, the adoption of GM technology by smallholders is still slight. Identifying pros and cons of using this technology is important to understand the impacts of GM crops on these farmers. This article reviews the main opportunities and challenges of GM crops for small-scale farmers in developing countries. The most significant advantages of GM crops include being independent to farm size, environment protection, improvement of occupational health issues, and the potential of bio-fortified crops to reduce malnutrition. Challenges faced by small-scale farmers for adoption of GM crops comprise availability and accessibility of GM crop seeds, seed dissemination and price, and the lack of adequate information. In addition, R&D and production costs in using GM crops make it difficult for these farmers to adopt the use of these crops. Moreover, intellectual property right regulations may deprive resource poor farmers from the advantages of GM technology. Finally, concerns on socio-economic and environment safety issues are also addressed in this paper.     

Risk assessment strategies for transgenic plants

Advances in recombinant DNA technology have created advantages for the development of plants with high agro-economical values. Since the production of transgenic plants, some issues concerning the safe use of these plants and their products have been under debate throughout the world. In this respect, the potential risks and benefits of transgenic plants need to be evaluated objectively. Risk assessment of transgenic crops is a basic prerequisite for monitoring the possible risks that could arise upon the release and use of transgenic plants. To get a meaningful tool for decision making, risk assessment needs to be carried out in a scientific sound and transparent manner. There are specific governmental regulations in many countries for the safety assessment of genetically modified (GM) crops. Furthermore, there are some international agreements, which regulate the cultivation and commercialization of transgenic plants and their derivatives. Internationally accepted risk assessment strategies have been performed to evaluate the safe use of a large variety of GM crops. The main objectives of these regulations and risk assessment strategies are focused to protect human/animal health and the environment.     

Strategies to enable the adoption of animal biotechnology to sustainably improve global food safety and security

The ability to generate transgenic animals has existed for over 30 years, and from those early days many predicted that the technology would have beneficial applications in agriculture. Numerous transgenic agricultural animals now exist, however to date only one product from a transgenic animal has been approved for the food chain, due in part to cumbersome regulations. Recently, new techniques such as precision breeding have emerged, which enables the introduction of desired traits without the use of transgenes. The rapidly growing human population, environmental degradation, and concerns related to zoonotic and pandemic diseases have increased pressure on the animal agriculture sector to provide a safe, secure and sustainable food supply. There is a clear need to adopt transgenic technologies as well as new methods such as gene editing and precision breeding to meet these challenges and the rising demand for animal products. To achieve this goal, cooperation, education, and communication between multiple stakeholders—including scientists, industry, farmers, governments, trade organizations, NGOs and the public—is necessary. This report is the culmination of concepts first discussed at an OECD sponsored conference and aims to identify the main barriers to the adoption of animal biotechnology, tactics for navigating those barriers, strategies to improve public perception and trust, as well as industry engagement, and actions for governments and trade organizations including the OECD to harmonize regulations and trade agreements. Specifically, the report focuses on animal biotechnologies that are intended to improve breeding and genetics and currently are not routinely used in commercial animal agriculture. We put forward recommendations on how scientists, regulators, and trade organizations can work together to ensure that the potential benefits of animal biotechnology can be realized to meet the future needs of agriculture to feed the world.     

Insect-resistant biotech crops and their impacts on beneficial arthropods

With a projected population of 10 billion by 2050, an immediate priority for agriculture is to achieve increased crop yields in a sustainable and cost-effective way. The concept of using a transgenic approach was realized in the mid-1990s with the commercial introduction of genetically modified (GM) crops. By 2010, the global value of the seed alone was US $11.2 billion, with commercial biotech maize, soya bean grain and cotton valued at approximately US $150 billion. In recent years, it has become evident that insect-resistant crops expressing δ-endotoxin genes from Bacillus thuringiensis have made a significant beneficial impact on global agriculture, not least in terms of pest reduction and improved quality. However, because of the potential for pest populations to evolve resistance, and owing to lack of effective control of homopteran pests, alternative strategies are being developed. Some of these are based on Bacillus spp. or other insect pathogens, while others are based on the use of plant- and animal-derived genes. However, if such approaches are to play a useful role in crop protection, it is desirable that they do not have a negative impact on beneficial organisms at higher trophic levels thus affecting the functioning of the agro-ecosystem. This widely held concern over the ecological impacts of GM crops has led to the extensive examination of the potential effects of a range of transgene proteins on non-target and beneficial insects. The findings to date with respect to both commercial and experimental GM crops expressing anti-insect genes are discussed here, with particular emphasis on insect predators and parasitoids.     

A Meta-Analysis of the Impacts of Genetically Modified Crops

Background

Despite the rapid adoption of genetically modified (GM) crops by farmers in many countries, controversies about this technology continue. Uncertainty about GM crop impacts is one reason for widespread public suspicion.

Objective

We carry out a meta-analysis of the agronomic and economic impacts of GM crops to consolidate the evidence.

Data Sources

Original studies for inclusion were identified through keyword searches in ISI Web of Knowledge, Google Scholar, EconLit, and AgEcon Search.

Study Eligibility Criteria

Studies were included when they build on primary data from farm surveys or field trials anywhere in the world, and when they report impacts of GM soybean, maize, or cotton on crop yields, pesticide use, and/or farmer profits. In total, 147 original studies were included.

Synthesis Methods

Analysis of mean impacts and meta-regressions to examine factors that influence outcomes.

Results

On average, GM technology adoption has reduced chemical pesticide use by 37%, increased crop yields by 22%, and increased farmer profits by 68%. Yield gains and pesticide reductions are larger for insect-resistant crops than for herbicide-tolerant crops. Yield and profit gains are higher in developing countries than in developed countries.

Limitations

Several of the original studies did not report sample sizes and measures of variance.

Conclusion

The meta-analysis reveals robust evidence of GM crop benefits for farmers in developed and developing countries. Such evidence may help to gradually increase public trust in this technology.     

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.     

Letting the gene out of the bottle: the population genetics of genetically modified crops

Genetically modified (GM) plants are rapidly becoming a common feature of modern agriculture. This transition to engineered crops has been driven by a variety of potential benefits, both economic and ecological. The increase in the use of GM crops has, however, been accompanied by growing concerns regarding their potential impact on the environment. Here, we focus on the escape of transgenes from cultivation via crop x wild hybridization. We begin by reviewing the literature on natural hybridization, with particular reference to gene flow between crop plants and their wild relatives. We further show that natural selection, and not the overall rate of gene flow, is the most important factor governing the spread of favorable alleles. Hence, much of this review focuses on the likely effects of transgenes once they escape. Finally, we consider strategies for transgene containment.     

Community Structure of Arbuscular Mycorrhizal Fungi in Rhizospheric Soil of a Transgenic High-Methionine Soybean and a Near Isogenic Variety

The use of transgenic plants in agriculture provides many economic benefits, but it also raises concerns over the potential impact of transgenic plants on the environment. We here examined the impact of transgenic high-methionine soybean ZD91 on the arbuscular mycorrhizal (AM) fungal community structure in rhizosphere soil. Our investigations based on clone libraries were conducted in field trials at four growth stages of the crops each year from 2012 to 2013. A total of 155 operational taxonomic units (OTUs) of AM fungi were identified based on the sequences of small subunit ribosomal RNA (SSU rRNA) genes. There were no significant differences found in AM fungal diversity in rhizosphere soil during the same growth stage between transgenic soybean ZD91 and its non-transgenic parental soybean ZD. In addition, plant growth stage and year had the strongest effect on the AM fungal community structure while the genetically modified (GM) trait studied was the least explanatory factor. In conclusion, we found no indication that transgenic soybean ZD91 cultivation poses a risk for AM fungal communities in agricultural soils.     

The release of genetically modified crops into the environment. Part II. Overview of ecological risk assessment

Despite numerous future promises, there is a multitude of concerns about the impact of GM crops on the environment. Key issues in the environmental assessment of GM crops are putative invasiveness, vertical or horizontal gene flow, other ecological impacts, effects on biodiversity and the impact of presence of GM material in other products. These are all highly interdisciplinary and complex issues. A crucial component for a proper assessment is defining the appropriate baseline for comparison and decision. For GM crops, the best and most appropriately defined reference point is the impact of plants developed by traditional breeding. The latter is an integral and accepted part of agriculture. In many instances, the putative impacts identified for GM crops are very similar to the impacts of new cultivars derived from traditional breeding. When assessing GM crops relative to existing cultivars, the increased knowledge base underpinning the development of GM crops will provide greater confidence in the assurances plant science can give on the risks of releasing such crops.     

转Bt基因抗虫作物对非靶标害虫的影响

转基因作物的长期大面积种植, 在为农业生产带来惠益的同时, 对农业生态系统的健康和稳定可能会产生潜在的影响。转基因作物表达的Bt蛋白对靶标害虫起到较好的控制效果, 而对Bt蛋白不敏感的非靶标害虫种群可能会迅速发展起来, 对作物造成为害。随着抗虫转基因作物的连续多年种植, 科学家们对于田间杀虫剂施用量的增减看法不尽一致。通过总结已有的研究报道, 本文以Bt玉米和Bt棉花为例, 分析了大田中非靶标害虫暴发的现状, 以及暴发的主要原因(如杀虫剂的使用、害虫天敌减少和物种替代)。在生产实践中, 抗虫作物的长期大面积释放导致广谱杀虫剂施用量减少, 田间非靶标害虫数量上升。因此今后需要继续开展更多的研究来综合评估种植转Bt基因作物产生的长期潜在影响, 优化害虫防治措施, 避免非靶标害虫暴发。     

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.     

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.     

Attitudes in China about Crops and Foods Developed by Biotechnology

Transgenic Bt cotton has been planted in China since 1997 and, in 2009, biosafety certificates for the commercial production of Bt rice and phytase corn were issued by the Chinese government. The public attitude in China toward agricultural biotechnology and genetically modified (GM) crops and foods has received considerable attention worldwide. We investigated the attitudes of consumers, Bt cotton farmers and scientists in China regarding GM crops and foods and the factors influencing their attitudes. Data were collected using interview surveys of consumer households, farmer households and scientists. A discrete choice approach was used to elicit the purchase intentions of the respondents. Two separate probit models were developed to examine the effect of various factors on the choices of the respondents. Bt cotton farmers had a very positive attitude because Bt cotton provided them with significant economic benefits. Chinese consumers from developed regions had a higher acceptance and willingness to pay for GM foods than consumers in other regions. The positive attitude toward GM foods by the scientific community will help to promote biotechnology in China in the future. Our survey emphasized that educational efforts made by government officials, the media and scientists can facilitate the acceptance of GM technology in China. Further educational efforts will be critical for influencing consumer attitudes and decisions of government agencies in the future. More effective educational efforts by government agencies and public media concerning the scientific facts and safety of GM foods would enhance the acceptance of GM crops in China.     

Molecular strategies for gene containment in transgenic crops

The potential of genetically modified (GM) crops to transfer foreign genes through pollen to related plant species has been cited as an environmental concern. Until more is known concerning the environmental impact of novel genes on indigenous crops and weeds, practical and regulatory considerations will likely require the adoption of gene-containment approaches for future generations of GM crops. Most molecular approaches with potential for controlling gene flow among crops and weeds have thus far focused on maternal inheritance, male sterility, and seed sterility. Several other containment strategies may also prove useful in restricting gene flow, including apomixis (vegetative propagation and asexual seed formation), cleistogamy (self-fertilization without opening of the flower), genome incompatibility, chemical induction/deletion of transgenes, fruit-specific excision of transgenes, and transgenic mitigation (transgenes that compromise fitness in the hybrid). As yet, however, no strategy has proved broadly applicable to all crop species, and a combination of approaches may prove most effective for engineering the next generation of GM crops.     

Regulatory challenges for GM crops in developing economies: the African experience

Globally, transgenic or genetically modified (GM) crops are considered regulated products that are subject to regulatory oversight during trans-boundary movement, testing and environmental release. In Africa, regulations for transgenic crops are based on the outcomes of the historic Earth Summit Conference held in Rio, Brazil two decades ago, namely, the adoption of the Convention on Biological Diversity (CBD) and the subsequent adoption of the Cartagena Protocol on Biosafety. To exploit the potential benefits of transgenic crops while safeguarding the potential risks on human health and environment, most African countries have signed and ratified the CBD and the Cartagena Protocol on Biosafety. Consequently, these countries are required to take appropriate legal, administrative and other measures to ensure that the handling and utilization of living modified organisms are undertaken in a manner that reduces the risks to humans and the environment. These countries are also expected to provide regulatory oversight on transgenic crops through functional national biosafety frameworks (NBFs). While in principle this approach is ideal, NBFs in most African countries are steeped in a host of policy, legal and operational challenges that appear to be at cross-purposes with the noble efforts of seeking to access, test and deliver promising GM crops for use by resource-limited farmers in Africa. In this paper we discuss the regulatory challenges faced during the development and commercialization of GM crops based on experiences from countries in Sub-Saharan Africa.