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At least 19 recordsLinked to original sources
PubMed2002

[Genetically modified organisms--problems and legislation].

Genetically modified organisms are defined by law as entities capable of replication and/or transmission of hereditary material that had been altered by the insertion or removal of a DNA fragment. By the EU legal regulation as well as by the Czech law, such organisms are considered risky whereas other products of breeding, though obtained by, e.g., induced mutagenesis, are claimed as safe. Organisms transferred from other ecosystems are also considered safe. The Czech law on the use of genetically modified organisms is based on registers of users and organisms for specific use. Application for the registration that is valid as an approval should be submitted to the Ministry of Environment. The applicant is obliged to present the risk assessment of the particular use of genetically modified organisms. Genetically modified organisms are connected with certain risk to ecology, however health risks are brought about almost exclusively by microorganisms. Modified organisms used for food production are thoroughly tested for substantial equivalency with standard crops and with respect to health parameters of the protein(s) newly introduced due to genetic modification. Detail tests as well as their cost are close to the testing of new drugs. European as well as Czech rules for food labelling are motivated by the psychology of consumers rather than by health impact. They result to absurdities but do not meet the task of public psychology. This is why the EU authorities are looking for measures to change the present situation that other wise would bring Europe well behind the developed countries.

Czech Republic↗
PubMedDate not supplied

Detection methods and performance criteria for genetically modified organisms.

Detection methods for genetically modified organisms (GMOs) are necessary for many applications, from seed purity assessment to compliance of food labeling in several countries. Numerous analytical methods are currently used or under development to support these needs. The currently used methods are bioassays and protein- and DNA-based detection protocols. To avoid discrepancy of results between such largely different methods and, for instance, the potential resulting legal actions, compatibility of the methods is urgently needed. Performance criteria of methods allow evaluation against a common standard. The more-common performance criteria for detection methods are precision, accuracy, sensitivity, and specificity, which together specifically address other terms used to describe the performance of a method, such as applicability, selectivity, calibration, trueness, precision, recovery, operating range, limit of quantitation, limit of detection, and ruggedness. Performance criteria should provide objective tools to accept or reject specific methods, to validate them, to ensure compatibility between validated methods, and be used on a routine basis to reject data outside an acceptable range of variability. When selecting a method of detection, it is also important to consider its applicability, its field of applications, and its limitations, by including factors such as its ability to detect the target analyte in a given matrix, the duration of the analyses, its cost effectiveness, and the necessary sample sizes for testing. Thus, the current GMO detection methods should be evaluated against a common set of performance criteria.

Calibration↗
PubMed1998

[Genetically modified organisms (GMO): toxicological aspects].

The genetically modified organisms (GMO) are one of the major public concerns partially due to the activity of the non-governmental organizations which believe that public opinion must be duly informed on what leaves the laboratories and enters the environment or is proposed as food. This article discusses some major toxicological and nutritional aspects of GMO designed as food for humans. The range of current use of GMOs, potential hazards for humans, safety assessment, allergenic concerns, and some aspects of the use of marker genes are discussed in regard to human safety. The need for relevant regulations is stressed.

Food↗
PubMedDate not supplied

Controversy over genetically modified organisms: the governing laws and regulations.

Genetically Modified Organisms (GMOs) are increasingly becoming a topic of controversy in the U.S. and abroad. The public is questioning their safety and wanting the products labeled as genetically modified. There are other concerns from some of the scientific world and some government officials and organizations such as the Food & Agricultural Organization (FAO) that question whether adequate research has been done to qualify GMOs as safe for long-term use. Of particular concern are the allergenic properties, a GMO may impart, possible transfer effects of antibiotic resistance (given that antibiotic resistant marker genes are used for many GMOs), the expression of previously unexpressed traits, and the drift of pollen from genetically modified crops. It has also been noted that the laws and regulations governing the biotechnology world are outdated, are not comprehensive, and span too many agencies. The primary agencies currently regulating biotechnology are the U.S. Department of Agriculture (USDA), the Food and Drug Administration (FDA), and the Environmental Protection Agency (EPA).

Animals↗
PubMed2001

What makes genetically modified organisms so distasteful?

The debate concerning genetically modified organisms goes on unabated and reflects some genuine concerns. I suggest that a significantly large number of educated people believe that moving genes around between species is intuitively wrong and that this is based on an essentialist view of the world. This essentialist view has a long history that dates back to Plato and Aristotle and was eventually overthrown by the population thinking of Charles Darwin. The essentialist, who is antipathetic to population thinking, will naturally find the transfer of a gene from one organism to another distasteful, and this, I argue, is the result of Platonic thinking, which still remains and casts its spell over us today.

Culture↗
PubMed1999

Genetically modified organisms and monitoring.

The genetic modification of organisms for food use has raised serious concern about the potential for adverse effects on the environment, ecosystems and on the health of humans and animals. As a relatively new technology, its impacts remain uncertain but could range from disturbances to the genetic functioning of individual organisms to a reduction in the biodiversity of farmland. As a result, the question of how to monitor for potential impacts is beset with problems. The fact that genetic modification can be used on a range of organisms for a variety of purposes means that those developing monitoring systems will need to be as imaginative as those developing GMOs. In the case of genetically modified organisms (GMOs) for food use, concern has focussed on the transfer of genes to other organisms, the potential for effects on non-target organisms, or on the health of humans and animals, and the likelihood of adverse effects on wildlife due to changes in farming practice. As with other new and unfamiliar technologies, genetic modification is also plagued by the problem of uncertainty. Novel genes are inserted randomly into the genome of the host organisms, and this leads to the possibility of unexpected effects. Unanticipated environmental disasters, such as the concentration of persistent organic pollutants in ecosystems at high latitudes, have highlighted the need for monitoring despite the obvious difficulties inherent in monitoring for unexpected effects.

Agriculture↗
PubMed2001

The role of risk assessments in the governance of genetically modified organisms in agriculture.

Controversy abounds in the governance of genetically modified organisms (GMOs) for use in agriculture, partly due to ideological differences. Technological optimism and the "shallow" and the "deep" ecology movements are three influential ideologies that are seen to differ both on value commitments and factual beliefs with respect to GMOs. Factual matters are clarified but not resolved by science, since the scientific community faces uncertainty and apparent contradiction between different research perspectives, notably molecular biology, ecology and the social sciences. Scientific advice plays a key role in the governance of GMOs and ought to be construed so as not to exclude legitimate arguments from ideological perspectives present in the process of governance. This paper analyses the role and use of risk assessments and argues that they be replaced by forms of advice that consider a broader spectrum of scientific evidence and insights, e.g. impact assessments and evaluations of inherent sources of uncertainty and ignorance. A few practical measures to that effect are discussed.

Agriculture↗
PubMed2001

Biosensors as new analytical tool for detection of Genetically Modified Organisms (GMOs).

Three different biosensors for detection of Genetically Modified Organisms (GMOs) are presented. The sensing principle is based on the affinity interaction between nucleic acids: the probe is immobilised on the sensor surface and the target analyte is free in solution. The immobilised probes are specific for most inserted sequences in GMOs: the promoter P35S and the terminator TNOS. Electrochemical methods with screen-printed electrodes, piezoelectric and optical (SPR) transduction principles were applied.

Biosensing Techniques↗
PubMed2002

Traceability of genetically modified organisms.

EU regulations stipulate the labeling of food products containing genetically modified organisms (GMOs) unless the GMO content is due to adventitious and unintended 'contamination' and not exceeding the 1% level at ingredient basis. In addition, member states have to ensure full traceability at all stages of the placing on the market of GMOs. Both requirements ensure consumers 'right to know', facilitate enforcement of regulatory requirements and are of importance for environmental monitoring and postmarket surveillance. Besides administrative procedures, such as used in quality certification systems, the significance of adequate molecular methods becomes more and more apparent. During the last decade a considerable number of molecular methods have been developed and validated that enable the detection, identification and quantification of GMO impurities. Most of them rely on the PCR technology and can only detect one specific stretch of DNA. It can, however, be anticipated that in the near future the situation will become more complex. The number of GMO varieties, including 'stacked-gene' varieties, which will enter the European Market will increase and it is likely that these varieties will harbor more variable constructs. New tools will be necessary to keep up with these developments. One of the most promising techniques is microarray analysis. This technique enables the screening for a large number of different GMOs within a single experiment.

DNA↗
PubMed2002

Detection of genetically modified organisms in foods.

Legislation enacted worldwide to regulate the presence of genetically modified organisms (GMOs) in crops, foods and ingredients, necessitated the development of reliable and sensitive methods for GMO detection. In this article, protein- and DNA-based methods employing western blots, enzyme-linked immunosorbant assay, lateral flow strips, Southern blots, qualitative-, quantitative-, real-time- and limiting dilution-PCR methods, are discussed. Where information on modified gene sequences is not available, new approaches, such as near-infrared spectrometry, might tackle the problem of detection of non-approved genetically modified (GM) foods. The efficiency of screening, identification and confirmation strategies should be examined with respect to false-positive rates, disappearance of marker genes, increased use of specific regulator sequences and the increasing number of GM foods.

Blotting, Southern↗
PubMed2002

The precautionary principle and ecological hazards of genetically modified organisms.

This paper makes three points relevant to the application of the precautionary principle to the regulation of GMOs. i) The unavoidable arbitrariness in the application of the precautionary principle reflects a deeper epistemological problem affecting scientific analyses of sustainability. This requires understanding the difference between the concepts of "risk", "uncertainty" and "ignorance". ii) When dealing with evolutionary processes it is impossible to ban uncertainty and ignorance from scientific models. Hence, traditional risk analysis (probability distributions and exact numerical models) becomes powerless. Other forms of scientific knowledge (general principles or metaphors) may be useful alternatives. iii) The existence of ecological hazards per se should not be used as a reason to stop innovations altogether. However, the precautionary principle entails that scientists move away from the concept of "substantive rationality" (trying to indicate to society optimal solutions) to that of "procedural rationality" (trying to help society to find "satisficing" solutions).

Animals↗
PubMed2002

Risk assessment for release of genetically modified organisms: a virus to reduce the fertility of introduced wild mice, Mus domesticus.

Risk assessment is a key task in developing genetically modified organisms (GMOs) intended for release into the environment. A risk assessment protocol is described, focusing on genetically modified biological control agents intended to reduce fertility in mammalian pests. The protocol is being applied to development of an immunocontraceptive murine cytomegalovirus vaccine intended to reduce the frequency and extent of costly troublesome plagues of introduced house mice, Mus domesticus, in southern Australia. Success of the agent, including regulatory approval for release to target populations, will depend on demonstrated biosafety, on the biophysical consequences of releasing the agent, and on public perceptions of the consequences and ongoing risks. The proposed risk assessment protocol addresses biosafety and the biophysical and social risks. It elicits perceptions of interaction and risk from the project scientists and from representatives of interested or affected sectors of society. The perceptions are documented for examination interactively in subsequent socially inclusive formal risk assessments. Representatives of the relevant social sectors participate with the scientists, iteratively if needed, in a workshop to assess the risks of releasing the particular GMO into the environment, using a formal inductive procedure, GENHAZ, designed specifically for assessment and management of the risks of GMOs. Use of this protocol is intended to precede and complement risk assessment and risk management procedures specified by gene technology legislation and regulations.

Animals↗
PubMed1999

Genetically modified organisms: an analysis of the regulatory framework currently employed within the European Union.

BACKGROUND: Genetic engineering technology is starting to bring many commercial products to the market. These genetically modified organisms (GMOs) and their derived products are subject to topical debate as to their benefits and risks. The strengths and weaknesses of the regulatory framework that controls their development and application is central to the question of whether this technology poses significant risk to the public health during this critical phase of its evolution. METHODS: A critical review was carried out of the legal framework regulating the contained use, deliberate release and some aspects of consumer protection relevant to the control of GMOs in Europe and the United Kingdom. RESULTS: The current legal framework is failing to provide a speed of adaptation commensurate with the development of the science of genetic engineering; failing to properly respond to democratic control; failing to resolve significant conflict between the protection of free markets and protection of public health and the environment; and failing to implement obligations on biodiversity. CONCLUSION: The present legal framework must be replaced. Current European Union proposals for new standards of regulation are welcome, but provide only for further incremental change, and do not address some significant fundamental flaws in our current laws.

Consumer Product Safety↗
PubMed1999

Genetically modified organisms in food-screening and specific detection by polymerase chain reaction.

PCR methods for the detection of genetically modified organisms (GMOs) were developed that can be used for screening purposes and for specific detection of glyphosate-tolerant soybean and insect-resistant maize in food. Primers were designed to amplify parts of the 35S promoter derived from Cauliflower Mosaic Virus, the NOS terminator derived from Agrobacterium tumefaciens and the antibiotic marker gene NPTII (neomycin-phosphotransferase II), to allow for general screening of foods. PCR/hybridization protocols were established for the detection of glyphosate-tolerant RoundUp Ready soybean and insect-resistant Bt-maize. Besides hybridization, confirmation of the results using restriction analysis was also possible. The described methods enabled a highly sensitive and specific detection of GMOs and thus provide a useful tool for routine analysis of raw and processed food products.

Blotting, Southern↗
PubMed2001

Environmental risks of chemicals and genetically modified organisms: a comparison. Part II: Sustainability and precaution in risk assessment and risk management.

The principles of precaution and sustainability require more consideration in the assessment of environmental risks posed by chemicals and genetically modified organisms. Instead of applying risk reduction measures when there are serious indications for damage, full scientific certainty is often waited for before taking action. The precautionary principle particularly should be applied in those cases in which the extent and probability of damage are uncertain, e.g. in the case of persistent chemicals which are additionally bioaccumulative or highly mobile. Based on these principles, environmental action targets for risks associated with GMOs and chemicals can be developed. Risk management not only includes statutory measures but also instruments designed to influence behaviour indirectly are important to achieve the goals. Particularly for risks of GMOs which provoke fear, risk communication is important. Some rules to which attention should be paid in communication with the public are presented.

Animals↗
PubMedDate not supplied

Production of certified reference materials for the detection of genetically modified organisms.

Certified reference materials (CRMs) are an essenIial tool in the quality assurance of analytical measurements. They are produced, certified, and used in accordance with relevant ISO (International Organization for Standardization) and BCR (Community Bureau of Reference) guidelines. The Institute for Reference Materials and Measurements (IRMM; Geel, Belgium) has produced the first powdery genetically modified organism (GMO) CRMs in cooperation with the Institute for Health and Consumer Protection (Ispra, Italy). Until now, different weight percentages in the range of 0-5% for 4 GMOs in Europe were produced and certified: Bt (Bacillus thuringiensis)-11 and Bt-176 maize, Roundup Ready soybean, and MON810 maize. Bt-11 and Bt-176 maize and Roundup Ready soybean were produced by IRMM on behalf of Fluka Chemie AG (Buchs, Switzerland). Characterization of used base material is the first step in production and is especially important for GMO CRMs. The production of powdery GMO CRMs and methods used for production control are described. Thorough control of homogeneity and stability are essential for certification of reference materials and ensure validity of the certificate for each bottle of a batch throughout a defined shelf-life. Because production of reference materials and their maintenance are very labor- and cost-intensive tasks, the usefulness of new types of GMO CRMs must be estimated carefully.

DNA, Plant↗
PubMedDate not supplied

Detection of genetically modified organisms in foods by protein- and DNA-based techniques: bridging the methods.

According to European Commission (EC) Regulation 1139/98, foods and food ingredients that are to be delivered to the final consumer in which either protein or DNA resulting from genetic modification is present, shall be subject to additional specific labeling requirements. Since 1994, genetically altered tomatoes, squash, potatoes, canola, cotton, and soy have been on the market. Recently, insect-resistant and herbicide-tolerant maize varieties have been introduced. Soy and maize are 2 of the most important vegetable crops in the world. During the past 4 years, both protein- and DNA-based methods have been developed and applied for detection of transgenic soy and maize, and their derivatives. For protein-based detection, specific monoclonal and polyclonal antibodies have been developed; for immunochemical detection, Western blot analysis and enzyme-linked immunosorbent assays are the most prominent examples. For detection of genetically modified organisms (GMOs) at the level of DNA, polymerase chain reaction-based methods are mainly used. For these reactions, highly specific primer sets are needed. This study compares the principally different methods. Specificity of methods and the possible risks of false-positive or false-negative results are considered in relation to sampling, matrix effects, and food processing procedures. In addition, quantitative aspects of protein- and DNA-based GM detection methods are presented and discussed. This is especially relevant as EC regulation 49/2000, which defines a threshold for an unintentional comingling of 1%, came into force on April 10, 2000.

DNA, Plant↗