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Linkage of genetics and ethics: more crossing over is needed.

Since the development of recombinant DNA technology in the mid 1970s, there has been increasing interest in the ethical, legal, and social implications of genetics and related fields. The web sites of five different organizations (government, academic, and independent not-for-profit) that deal explicitly with genetics and ethics are reviewed here. Some of the sites cover genetics and other issues in bioethics while others cover human genetics exclusively. The target audiences for the sites include medical and scientific professionals, students, and the general public. Among the issues examined are genetic testing, genetic discrimination in employment and health insurance, genetically modified foods, stem cells and DNA patenting. Resources for those interested in legal issues are particularly well-represented on these sites.

Bioethics↗

Public concern about genetics.

Throughout the twentieth century and continuing into the present, the general public has been fascinated by advances in genetic knowledge. At times, individuals and groups have either inadvertently or deliberately misused genetic knowledge in the service of political goals. At other times, advances in genetics have challenged deeply held societal or religious beliefs. During the 1990s, there were many advances that focused an unprecedented level of public attention and concern on genetics. In particular, the public has expressed deep concern about gene mapping, cloning, and genetically modified foods. In each case, the origin of the concern and the nature of the public response have been different. I consider these topics and argue that the scientific community must increase its commitment to public discourse.

Animals↗

Genetically modified soybeans and food allergies.

Allergenic reactions to proteins expressed in GM crops has been one of the prominent concerns among biotechnology critics and a concern of regulatory agencies. Soybeans like many plants have intrinsic allergens that present problems for sensitive people. Current GM crops, including soybean, have not been shown to add any additional allergenic risk beyond the intrinsic risks already present. Biotechnology can be used to characterize and eliminate allergens naturally present in crops. Biotechnology has been used to remove a major allergen in soybean demonstrating that genetic modification can be used to reduce allergenicity of food and feed. This provides a model for further use of GM approaches to eliminate allergens.

Allergens↗

From breeder reactors to butterflies: risk, culture, and biotechnology.

Social theories of risk suggest that a combination of scientific and cultural perspectives converge to influence risk perception. This article first surveys sociological perspectives suggesting that risks from modern technological development have become predominant concerns in the social consciousness. Particular attention is given to those theses describing how social elements work to create perception of risks in relation to new technologies. The themes that emerge from this survey are then related to contemporary debates concerning biotechnology. Specific attention is given to recent controversies regarding genetically modified crops, and parallels are drawn between debates over nuclear power and biotechnology. A procedural ethic for public discourse and decision making over the diffusion of genetically modified foods is offered. Ethical and social theories are linked with the hope that by recognizing the social dimensions of debates over new technologies a broader framework for conducting risk analysis may emerge.

Animals↗

GM frenzy: a lesson in communication.

Hysteria rather than rationality has characterised the debate over genetically modified foods, which erupted in Britain in 1998 and has since spread to other countries. This episode holds wider lessons for biologists, politicians and all concerned with the prudent assessment and application of novel technology.

Allergens↗

Generation of a novel Saccharomyces cerevisiae strain that exhibits strong maltose utilization and hyperosmotic resistance using nonrecombinant techniques.

A yeast strain capable of leavening both unsugared and sweet bread dough efficiently would reduce the necessity of carrying out the expensive procedure of producing multiple baker's yeast strains. But issues involving the use of genetically modified foods have rendered the use of recombinant techniques for developing yeast strains controversial. Therefore, we used strong selection and screening systems in conjunction with traditional mass mating techniques to develop a strain of Saccharomyces cerevisiae that efficiently leavens both types of dough.

Bread↗

Child health in the new millennium.

In today's modern, industrialized and affluent countries, like Japan and Australia, better living conditions and hygiene, plentiful nutritious food and rapid advances in biology and medical technologies have helped to bring about dramatic improvements in child health. The previous heavy burdens of infections and undernutrition have been eliminated or can now be controlled or effectively treated. In these countries, child health standards are higher than ever and expectation of life at birth is much higher than in the past. Some of the technological advances that have helped bring about this transformation are immunization, antimicrobial therapy, successful treatment of childhood leukemias, transplantation of vital organs and implementation of genetic diagnosis and gene therapy. The use of genetically modified foods and the prospects for cloning of humans are areas of intense interest and controversy. However, these advances have their disadvantages (e.g. antibiotic-induced drug resistance). Urbanization has encouraged the 'westernization' of dietary patterns and the long-term 'lifestyle diseases' that can follow in adults. Accidents, violence and drug abuse are major problems in many parts of the world. Changes in attitudes to sexuality and the spread of HIV/AIDS is another major problem, especially in Africa and Asia. Environmental pollution and the degradation of agricultural lands, rivers and seas are also important. Ironically, standards of child health and the prospects for long life in countries like Japan are better than ever before, but social and environmental changes are presenting children and their carers with new and unanswered challenges as we enter the 21 st century and the new millennium.

Child↗

Social determinants of food choice.

Food choice is influenced by a large number of factors, including social and cultural factors. One method for trying to understand the impact of these factors is through the study of attitudes. Research is described which utilizes social psychological attitude models of attitude-behaviour relationships, in particular the Theory of Planned Behaviour. This approach has shown good prediction of behaviour, but there are a number of possible extensions to this basic model which might improve its utility. One such extension is the inclusion of measures of moral concern, which have been found to be important both for the choice of genetically-modified foods and also for foods to be eaten by others. It has been found to be difficult to effect dietary change, and there are a number of insights from social psychology which might address this difficulty. One is the phenomenon of optimistic bias, where individuals believe themselves to be at less risk from various hazards than the average person. This effect has been demonstrated for nutritional risks, and this might lead individuals to take less note of health education messages. Another concern is that individuals do not always have clear-cut attitudes, but rather can be ambivalent about food and about healthy eating. It is important, therefore, to have measures for this ambivalence, and an understanding of how it might impact on behaviour.

Attitude↗

Bioliteracy and teaching efficacy: what biologists can learn from physicists.

The introduction of the Force Concept Inventory (FCI) by David Hestenes and colleagues in 1992 produced a remarkable impact within the community of physics teachers. An instrument to measure student comprehension of the Newtonian concept of force, the FCI demonstrates that active learning leads to far superior student conceptual learning than didactic lectures. Compared to a working knowledge of physics, biological literacy and illiteracy have an even more direct, dramatic, and personal impact. They shape public research and reproductive health policies, the acceptance or rejection of technological advances, such as vaccinations, genetically modified foods and gene therapies, and, on the personal front, the reasoned evaluation of product claims and lifestyle choices. While many students take biology courses at both the secondary and the college levels, there is little in the way of reliable and valid assessment of the effectiveness of biological education. This lack has important consequences in terms of general bioliteracy and, in turn, for our society. Here we describe the beginning of a community effort to define what a bioliterate person needs to know and to develop, validate, and disseminate a tiered series of instruments collectively known as the Biology Concept Inventory (BCI), which accurately measures student comprehension of concepts in introductory, genetic, molecular, cell, and developmental biology. The BCI should serve as a lever for moving our current educational system in a direction that delivers a deeper conceptual understanding of the fundamental ideas upon which biology and biomedical sciences are based.

Biology↗

Dietary fats and oils: technologies for improving cardiovascular health.

The role of dietary lipids in the etiology of coronary heart disease (CHD) continues to evolve as we gain a better understanding of the metabolic effects of individual fatty acids and their impact on surrogate markers of risk. A recent meta-analysis of 60 human studies suggests that for each 1% energy replacement of carbohydrates in the diet with saturated fat or trans fat, serum low-density lipoprotein cholesterol concentrations increase by 0.032 (1.23 mg/dL) and 0.04 mmol/L (1.54 mg/dL), respectively. Current dietary recommendations to keep saturated fat and trans fat intake as low as possible, and to increase the intake of cis mono-unsaturated and polyunsaturated fatty acids, as well as growing recognition of these recommendations by consumers and food regulatory agencies in the United States, have been major driving forces for the edible oil industry and food manufacturers to develop alternative fats and oils with nutritionally improved fatty acid compositions. As solutions for use of trans fatty acids are being sought, oilseeds with modified fatty acid compositions are being viewed as a means to provide such solutions. Additionally, oilseeds with modified fatty acid composition, such as enhanced content of long-chain omega-3 fatty acids or conjugated linoleic acid, have been developed as a way to increase delivery of these fatty acids directly into the food supply or indirectly as use for feed ingredients for livestock. New processing technologies are being utilized around the world to create dietary fats and oils with specific physiologic functions relevant to risk factors for cardiovascular disease.

Cardiovascular Diseases↗

The modular analytical procedure and validation approach and the units of measurement for genetically modified materials in foods and feeds.

Food and feed analysts are confronted with a number of common problems, irrespective of the analytical target. The analytical procedure can be described as a series of successive steps: sampling, sample processing, analyte extraction, and ending, finally, in interpretation of an analytical result produced with, e.g., real-time polymerase chain reaction. The final analytical result is dependent on proper method selection and execution and is only valid if valid methods (modules) are used throughout the analytical procedure. The final step is easy to validate-the measurement uncertainty added from this step is relatively limited and can be estimated with a high degree of precision. In contrast, the front-end sampling and processing steps have not evolved much, and the corresponding methods are rarely or never experimentally validated according to internationally harmonized protocols. In this paper, we outlined a strategy for modular validation of the entire analytical procedure, using an upstream validation approach, illustrated with methods for genetically modified materials that may partially apply also to other areas of food and feed analyses. We have also discussed some implications and consequences of this approach in relation to reference materials, measurement units, and thresholds for labelling and enforcement, and for application of the validated methods (modules) in routine food and feed analysis.

Animal Feed↗

Ultrastructural analysis of pancreatic acinar cells from mice fed on genetically modified soybean.

No direct evidence that genetically modified (GM) food may represent a possible danger for health has been reported so far; however, the scientific literature in this field is quite poor. Therefore, we investigated the possible effects of a diet containing GM soybean on mouse exocrine pancreas by means of ultrastructural, morphometrical and immunocytochemical analyses. Our observations demonstrate that, although no structural modification occurs in pancreatic acinar cells of mice fed on GM soybean, quantitative changes of some cellular constituents take place in comparison to control animals. In particular, a diet containing significant amount of GM food seems to influence the zymogen synthesis and processing.

Animals↗

Insect-resistant GM rice in farmers' fields: assessing productivity and health effects in China.

Although no country to date has released a major genetically modified (GM) food grain crop, China is on the threshold of commercializing GM rice. This paper studies two of the four GM varieties that are now in farm-level preproduction trials, the last step before commercialization. Farm surveys of randomly selected farm households that are cultivating the insect-resistant GM rice varieties, without the aid of experimental station technicians, demonstrate that when compared with households cultivating non-GM rice, small and poor farm households benefit from adopting GM rice by both higher crop yields and reduced use of pesticides, which also contribute to improved health.

Agriculture↗

Allermatch, a webtool for the prediction of potential allergenicity according to current FAO/WHO Codex alimentarius guidelines.

BACKGROUND: Novel proteins entering the food chain, for example by genetic modification of plants, have to be tested for allergenicity. Allermatch http://allermatch.org is a webtool for the efficient and standardized prediction of potential allergenicity of proteins and peptides according to the current recommendations of the FAO/WHO Expert Consultation, as outlined in the Codex alimentarius. DESCRIPTION: A query amino acid sequence is compared with all known allergenic proteins retrieved from the protein databases using a sliding window approach. This identifies stretches of 80 amino acids with more than 35% similarity or small identical stretches of at least six amino acids. The outcome of the analysis is presented in a concise format. The predictive performance of the FAO/WHO criteria is evaluated by screening sets of allergens and non-allergens against the Allermatch databases. Besides correct predictions, both methods are shown to generate false positive and false negative hits and the outcomes should therefore be combined with other methods of allergenicity assessment, as advised by the FAO/WHO. CONCLUSIONS: Allermatch provides an accessible, efficient, and useful webtool for analysis of potential allergenicity of proteins introduced in genetically modified food prior to market release that complies with current FAO/WHO guidelines.

Allergens↗

Event-specific plasmid standards and real-time PCR methods for transgenic Bt11, Bt176, and GA21 maize and transgenic GT73 canola.

Since the 18th of April 2004, two new regulations, EC/1829/2003 on genetically modified food and feed products and EC/1830/2003 on traceability and labeling of GMOs, are in force in the EU. This new, comprehensive regulatory framework emphasizes the need of an adequate tracing system. Unique identifiers, such as the transgene genome junction region or a specific rearrangement within the transgene DNA, should form the basis of such a tracing system. In this study, we describe the development of event-specific tracing systems for transgenic maize lines Bt11, Bt176, and GA21 and for canola event GT73. Molecular characterization of the transgene loci enabled us to clone an event-specific sequence into a plasmid vector, to be used as a marker, and to develop line-specific primers. Primer specificity was tested through qualitative PCRs and dissociation curve analysis in SYBR Green I real-time PCRs. The primers were then combined with event-specific TaqMan probes in quantitative real-time PCRs. Calibration curves were set up both with genomic DNA samples and the newly synthesized plasmid DNA markers. It is shown that cloned plasmid GMO target sequences are perfectly suitable as unique identifiers and quantitative calibrators. Together with an event-specific primer pair and a highly specific TaqMan probe, the plasmid markers form crucial components of a unique and straighforward tracing system for Bt11, Bt176, and GA21 maize and GT73 canola events.

Base Sequence↗

A 90-day safety study of genetically modified rice expressing Cry1Ab protein (Bacillus thuringiensis toxin) in Wistar rats.

An animal model for safety assessment of genetically modified foods was tested as part of the SAFOTEST project. In a 90-day feeding study on Wistar rats, the transgenic KMD1 rice expressing Cry1Ab protein was compared to its non-transgenic parental wild type, Xiushui 11. The KMD1 rice contained 15mg Bt toxin/kg and based on the average feed consumption the daily intake was 0.54mg Bt toxin/kg body weight. No adverse effects on animal behaviour or weight gain were observed during the study. Blood samples collected one week prior to sacrifice were analyzed and compared for standard haematological and biochemical parameters. A few parameters were significantly different, but all within the normal reference intervals for rats of this breed and age and not in relation to any other findings, thus not considered treatment related. Upon sacrifice a large number of organs were weighed, macroscopic and histopathological examinations were performed with only minor changes to report. The aim of the study was to use a known animal model in performance of safety assessment of a GM crop, in this case KMD1 rice. The results show no adverse or toxic effects of KMD1 rice when tested in the design used in this 90-day study. Nevertheless the experiences from this study lead to the overall conclusion that safety assessment for unintended effects of a GM crop cannot be done without additional test group(s).

Animals↗

Lack of cross-reactivity between the Bacillus thuringiensis derived protein Cry1F in maize grain and dust mite Der p7 protein with human sera positive for Der p7-IgE.

Cry1F protein, derived from Bacillus thuringiensis, is effective at controlling lepidopteran pests and a synthetic Cry1F transgene was transferred into maize. For the safety assessment of genetically modified food crops, the allergenic potential of the introduced novel trait(s) is evaluated. Because no single parameter is currently predictive of allergic potential, a 'weight of evidence' approach has been proposed. As part of this assessment, the amino acid (aa) sequence of the Cry1F protein was compared to a database of known allergens using recommended criteria. The Cry1F protein did not show significant similarity or a match of eight contiguous identical aa with any allergen. However, a single six contiguous aa match was identified between Cry1F and the Der p7 protein of the dust mite, Dermatophagoides pteronyssinus. To investigate whether Cry1F was cross-reactive with Der p7, sera from 10 dust mite allergic patients containing Der p 7-specific IgE antibody were used to compare IgE-specific binding. No evidence of cross-reactivity was observed between Cry1F and Der p7. This study provides in vitro IgE sera screening data, that when considered in the context of other bioinformatic data [Hileman R.E., Silvanovich, A., Goodman R.E., Rice E.A., Holleschak G., Astwood J.D., Hefle S.L., 2002. Bioinformatic methods for allergenicity assessment using a comprehensive allergen database. Int. Arch. Allergy Immunol. 128, 280-291; Stadler, M.B., Stadler, B.M., 2003. Allergenicity prediction by protein sequence. FASEB J. 17, 1141-1143.], adds further evidence arguing against the use of a six contiguous identical amino acid search to identify potential cross-reactive allergens. Cry1F is heat labile, rapidly hydrolyzed in an in vitro pepsin resistance assay, not glycosylated and not from an allergenic source. Taken together, these data indicate a lack of allergenic concern for Cry1F.

Allergens↗