Starlink corn: a risk analysis.
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Abstract:
Modern biotechnology has dramatically increased our ability to alter the agronomic traits of plants. Among the novel traits that biotechnology has made available, an important group includes Bacillus thuringiensis-derived insect resistance. This technology has been applied to potatoes, cotton, and corn. Benefits of Bt crops, and biotechnology generally, can be realized only if risks are assessed and managed properly. The case of Starlink corn, a plant modified with a gene that encodes the Bt protein Cry9c, was a severe test of U.S. regulatory agencies. The U.S. Environmental Protection Agency had restricted its use to animal feed due to concern about the potential for allergenicity. However, Starlink corn was later found throughout the human food supply, resulting in food recalls by the Food and Drug Administration and significant disruption of the food supply. Here we examine the regulatory history of Starlink, the assessment framework employed by the U.S. government, assumptions and information gaps, and the key elements of government efforts to manage the product. We explore the impacts on regulations, science, and society and conclude that only significant advances in our understanding of food allergies and improvements in monitoring and enforcement will avoid similar events in the future. Specifically, we need to develop a stronger fundamental basis for predicting allergic sensitization and reactions if novel proteins are to be introduced in this fashion. Mechanisms are needed to assure that worker and community aeroallergen risks are considered. Requirements are needed for the development of valid assays so that enforcement and post market surveillance activities can be conducted.Keywords:
Bacillus thuringiensis
Agricultural Biotechnology
Regulatory Science
Summary This paper reviews the history of the federal regulatory oversight of plant agricultural biotechnology in the USA, focusing on the scientific and political forces moulding the continually evolving regulatory structure in place today. Unlike most other jurisdictions, the USA decided to adapt pre‐existing legislation to encompass products of biotechnology. In so doing, it established an overarching committee (Office of Science and Technology Policy) to study and distribute various regulatory responsibilities amongst relevant agencies: the Food and Drug Administration, Environmental Protection Agency and US Department of Agriculture. This paper reviews the history and procedures of each agency in the execution of its regulatory duties and investigates the advantages and disadvantages of the US regulatory strategy.
Agricultural Biotechnology
Biosafety
Regulatory Science
Genetically engineered
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Biotech crops, including those that are genetically modified (GM) with Bacillus thuringiensis (Bt) endotoxins for insect resistance, have been cultivated commercially and adopted in steadily increasing numbers of countries over the past 14 years. This review discusses the current status of insect resistant transgenic crops and the often raised concern that its resilience is limited and that its efficacy will be compromised by insect resistance. We consider this trait as it is currently deployed in fields across the world as well as potential candidates that are at various stages of development along the pathway between the laboratory and deregulation. Future trends and prospects for biotechnological applications to mediate crop protection against insects are also considered. These include strategies employing stacked genes, modified Bt toxins, vegetative insecticidal proteins, lectins, endogenous resistance mechanisms as well as novel approaches. In addition, the benefits and risks associated with the adoption of GM insect resistant crops, especially for developing countries and resource-poor smallholder farmers are also discussed. Key words : Bacillus thuringiensis (Bt), endotoxins, Cry proteins, transgenic crops, insect resistance
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Crop Protection
Genetically engineered
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Bacillus thuringiensis
Cry1Ac
Bt Cotton
Biosafety
Crop Protection
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Technical progress is an inexhaustible source of agricultural development.According to the determinants,structure and changing type,agricultural biotechnology falls into traditional agricultural biotechnology(genetic breeding technology) and modern agricultural biotechnology(transgenic biotechnology).Different causes of the advance of agricultural biotechnology resulting from different mechanism follow different consequences,of which the possible socioeconomic effects should be scrutinized and treated seriously.
Agricultural Biotechnology
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Bt Cotton
Bacillus thuringiensis
Genetically engineered
Agricultural Biotechnology
Gossypium
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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.
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RETURN TO ISSUEPREVNewsNEXTWHAT'S HIDING IN TRANSGENIC FOODS?Federal agencies seek allergenicity protocols to test and regulate genetically modified foodsBETTE HILEMANView Author Information C&EN WASHINGTONCite this: Chem. Eng. News 2002, 80, 1, 20–22Publication Date (Print):January 7, 2002Publication History Published online13 November 2010Published inissue 7 January 2002https://pubs.acs.org/doi/10.1021/cen-v080n001.p020https://doi.org/10.1021/cen-v080n001.p020newsACS PublicationsCopyright © 2002 American Chemical SocietyArticle Views28Altmetric-Citations4LEARN ABOUT THESE METRICSArticle Views are the COUNTER-compliant sum of full text article downloads since November 2008 (both PDF and HTML) across all institutions and individuals. These metrics are regularly updated to reflect usage leading up to the last few days.Citations are the number of other articles citing this article, calculated by Crossref and updated daily. Find more information about Crossref citation counts.The Altmetric Attention Score is a quantitative measure of the attention that a research article has received online. Clicking on the donut icon will load a page at altmetric.com with additional details about the score and the social media presence for the given article. Find more information on the Altmetric Attention Score and how the score is calculated. Share Add toView InAdd Full Text with ReferenceAdd Description ExportRISCitationCitation and abstractCitation and referencesMore Options Share onFacebookTwitterWechatLinked InRedditEmail Other access options SUBJECTS:Genetic engineering Get e-Alerts
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Bacillus thuringiensis
Bt Cotton
Agricultural Biotechnology
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The adoption of agricultural technologies, whether developed through biotechnology or other methods, depends on social, political, regulatory and biological parameters. This article first presents an example of a low-input, non-biotechnological method of pest control that, while seemingly reasonable to researchers and extension agents, was not adopted by farmers. It then analyses a method for insect management developed through biotechnology that is becoming widely adopted: transgenic plants expressing insecticidal proteins from the bacterium Bacillus thuringiensis (Bt). Globally increasing adoption of Bt plants, by small and large farmers in both low- and high- income countries requires explanation in terms of biological properties of cropping systems and insect populations, alternative control techniques and social policy considerations.
Bacillus thuringiensis
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Insect pest
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