Ghent Outline of course content
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Module 1. Course Background
This is an orientation unit intended to present the overall structure of the course, introduce the faculty and students and familiarize them with the distance learning techniques, the use of the DTREE and the type of assessments to be used throughout the course. In addition it will provide a general introduction to genetic modification techniques with special emphasis on recombinant technologies. This module is mainly intended for those will little prior exposure to the subject matter (e.g. agronomists, chemists, lawyers, etc.).
- Biosafety: a historical overview
- A historical overview of biosafety from Asilomar to the present time. Summary of the key issues of the public debate on biosafety that will be dealt with in detail in the other Course Modules.
- Are biotechnology-derived products needed?
- From the Green Revolution to present day needs. Trends in agriculture in the developing world. The effectiveness of new technologies to address intractable problems.
- Genetic modification - an introduction
- Cells, DNA -->RNA -->proteins, genes, promoters, terminators, control of expression
- Tools of GM: Sources of genes, restriction enzymes, ligation, plasmids, bacterial transformation, genetic construct
- Genetics, conventional breeding, sources of variation (somaclonal, mutagenesis, etc.), recombination
- Molecular biology basics. Review of conventional breeding techniques and comparison with GM technologies
- Principles and methods of genetic transformation
- Targets for transformation (embryonic cell suspensions, etc.), Agrobacterium, biolistics, tissue culture
- A description of the techniques used for transforming plants and characterising the transformants"
Module 2. Applications of Biotechnology
Modern biotechnology through a range of molecular and bioinformatic techniques has revolutionised medical, agricultural and industrial applications. It brings about unprecedended opportunities in our efforts to solve intractable problems related to human, animal, plant diseases, as well as problems related to industrial productivity and environmental sustainability. It is one of the main drivers of the transition from resource- to knowledge-based economies. This module juxtaposes biotechnology approaches to solve such problems against conventional approaches, where the latter are still possible, and provides the knowledge base to evaluate and quantify, whenever possible, the derived benefits. Potential risks related to specific technologies are dealt with in Module 5.
- Agri-biotech Applications
- Herbicide resistance
- Pest resistance (bacterial, fungal, viral)
- Agri-forestry products
- This unit introduces the technologies involved and provides a description of the natural defences of untransformed plants as a basis for comparison of the use of genetic transformation to protect plants against biotic and abiotic stresses.
- Food applications
- Novel biofortified foods
- Transgenic fish
- The unit analyses applications of biotechnology related with the nutritional enhancement of foods giving special attention to what is known as "functional foods". It also provides an overview of the techniques employed in the production of transgenic fish.
- Industrial applications
- Energy crops and biofuel production
- Industrial crops
- This unit provides an overview of current approaches to improve the quality of plants used as energy crops as well as the processing characteristics of agricultural wastes (e.g. straw) for biofuel production. Furthermore, it explores the potential for using crop plants for producing products of interest to medicine (e.g. pharmaceuticals and vaccines) and the industry (e.g. high-added value oils and fine chemicals).
- Environmental applications
- Bio- and phytoremediation
- Bio-control agents
- The unit presents technologies applied in the microbial and plant-mediated degradation of environmental pollutants as well as in the detection of pollutants (biosensors). It provides an overview of the needs and successes of biocontrol agents in controlling weeds, insects and diseases.
Module 3. Theoretical and Practical Foundations of Biological Risk Assessment
Science-based assessment and management of potential risks is a precondition for field research and large-scale applications involving transgenic organisms. Prediction of potential risks to human health and the environment can be aided by the use of hazard identification techniques such as checklists, logic-trees and hazard and operability analysis. These techniques were originally developed for the chemical and engineering industries but there also exist some antecedents in the identification of biological hazards particularly in contained environments. In the case of environmental releases of transgenic organisms their applicability is limited by a number of systemic factors, such as a lack of validated prediction models on the fate, dispersal and establishment of transgenes and paucity of information of ecosystem interactions. However, coupled with relevant biological databases in the form of computer-assisted decision support systems for the assessment of ecological risks they can provide an invaluable tool to preserve, disseminate and interpret available data and information regarding specific organism/transgene/environment combinations.
This Module is based on a computer-based decision support system for the assessment of GMO-related risks (DTREE) and provides hands-on experience on risk assessment through the evaluation of specific applications for environmental releases of GMOs. Risk assessment will be conducted both by the use of DTREE as well by simulation of Expert Panel analyses.
- Definitions and Concepts in Risk Assessment
- Hazard Identification, risk estimation, risk evaluation and management. Risk benefit analysis. Case by case and event based risk assessment. Pros and cons.
- Information Resources and Knowledge-based Systems
- Worldwide databases of relevant information and techniques of data analysis and management.
- Hands-on Practice. Case Studies
- Case studies using DTREE and simulation of expert panels. The use of protein databases for the search of amino acid sequence and epitope homologies as criteria to assess food safety.
Module 4. Food and Feed Safety
The number of crop species have been genetically modified is increasing by the year together with the number of those that are being released commercially. As with foods derived from the application of other technologies (e.g. sexual and mutational breeding), the safety of foods grown from genetically modified crop varieties depends on the specific content of the food itself. The effect of such foods on human and animal health can be either beneficial or on occasions potentially harmful. For example, foods with a higher content of digestible iron are likely to have a positive health effect if consumed by iron-deficient individuals. Alternatively, transfer of genes from one species to another may also transfer allergic risk and these risks need to be evaluated and identified prior to commercialisation. Individuals allergic to certain nuts, for example, need to know if genes conveying this trait are transferred to other foods such as soybeans and whether, in such cases, labelling would be required if such crops were to be commercialised. Labelling also may be needed in some countries to identify other novel content resulting from genetic modification for cultural and religious reasons or simply because the consumers want to know what is the content of the food and how it was produced to make an informed choice, independent of any health risks. Issues pertaining to the use of antibiotic marker genes are dealt with in depth in this unit which provides a systematic roadmap for the assessment of food-derived risks. Special attention will be given to “functional” foods and the concept of substantial equivalence. International developments through the work of Codex Alimentarius and of other international bodies will be thoroughly analysed.
- Overview of Safety Assessment. Food-related Risks
- General outline of food-related risks: toxic compounds, allergens, antinutritional factors, undesired interactions between food components. The concept of familiarity as applied to foods with a long history of use by large populations (e.g., the GRAS concept). Issues involved in the introduction of novel proteins in GMO-derived foods. The "Precautionary Approach". The limitations of the application of the conventional toxicology studies (e.g. Bt proteins, antibiotic-inactivating enzymes, compositional changes).
- Components of Food Safety Assessment
- Toxic compounds in foods (biological role, removal by processing and/or cooking procedures, health effects). The allergic response (Basic concepts. Allergies to foods as a significant health concern. Scope of the problem with traditional foods). The distinction between food allergies and other food intolerances (e.g., gluten sensitive enteropathy, celiac disease). Removal of allergens in food by biotechnology methods.
- The Concept of Substantial Equivalence
- Use of the concept as an approach for the safety assessment of GMO-derived foods, or how to get around the difficulties implied in conventional toxicology measurements. The experimental, compositional and GMO development-related basis of the substantial equivalence approach. Situations of non-equivalence.
- Procedures for Food Safety Assessment
- The data and the risks. Main data to be taken into account in the science-based analysis of food safety. A checklist for the analysis: from molecular characterisation of the genetic modification to safe consumption. Post-commercialisation monitoring: what and how to monitor.
- Food Labelling
- The scientific and the emotional issues behind labelling. When and how a GMO-derived food should be labelled. The effects on public perception and the reverse: how public perception will affect labelling. Social and economic issues. Other relevant consequences: traceability and identity preservation of food commodities. Problems for exporting countries. The Precautionary Approach revisited.
Module 5. Environmental Safety
This Module follows up material delivered in Module 2 and gives emphasis on specific trait/organism combinations in terms of gene flow potential, impacts on beneficial non-target organisms and effects on biodiversity and agricultural ecosystems. The effects of changes in agricultural practice are also given due attention. Techniques and approaches that limit or mitigate potential risks of environmental introductions of GMOs such as Good Developmental Practice, use of non-antibiotic marker genes, biological containment, etc. are dealt with exhaustively.
- Risks related to host/introduced gene/environment combinations
- This unit provides an introduction on the potential risks related to the reproductive biology of selected organisms, genes introduced by means of genetic modification and indicative ecosystems. Furthermore, it provides a list of the common regulatory requirements necessary to identify such risks.
- Ecological considerations
- Weediness. Gene introgression
- Understanding differences between volunteer weed, weeds and wild species and the likelihood of crossing and becoming established. Biology of ferality. Assessing the ramifications of transgenics going volunteer – then feral. What genes are more/less consequential? Why introgression has been faster than has been anticipated in some models? What biological aspects should be given greater/less weight. Horizontal gene transfer.
- Impacts on biodiversity
- Releases of transgenic crops in centers of diversity and potential impacts on biodiversity. Potential impacts of gene flow. Centers of diversity, the case of Mexican maize in Oaxaca, is there gene flow from modern maize towards the landraces and the wild relatives of maize? What is the impact of potential gene flow in Mexico? Comparison of transgenic and alien species releases.
- Changes in agricultural practice
- Examples are provided for both positive changes (less pesticides, better application timing, greater flexibility, less cultivation) and negative changes (potentially less crop rotation, greater reliance on fewer solutions, more rapid evolution of pest and pesticide resistances).
- Best practice for the design and management of GM-crops – an overview
- Biological containment
- Chloroplast transformation – problems and risks. Transgenic mitigation by stacked genes to preclude stable introgression. Single generation transformation using viruses.
- Risk mitigation and integrated resistance management
- Other biological and physical containment methods and approaches. Green house containment and confined releases.
- Pest and herbicide resistance management
- The history and basis for resistance problems. Potential resistance management approaches. Special problems and opportunities posed by transgenics. Current employed strategies. The role of resistance monitoring. Practical barriers to implementation of resistance management. Adapting resistance management to different cropping systems, particularly smallholder-based systems.
- Environmental monitoring of GMOs
- Marking and tracking transgenics. Traceability: analytical tools.
Module 6. National and International Regulatory Systems
Regulation in biotechnology is determined by a number of institutional, political and socio-economic factors. Whereas several countries have opted to modify existing procedures (e.g. phytosanitary and quarantine regulation) to accommodate products derived by recombinant technologies, others have chosen to promulgate regulations specifically for biotechnology-derived products. As a result, there are countries that regulate the end product whereas others that regulate the technology.
This Module considers similarities and differences in the regulatory systems of the leading biotechnology countries (e.g. Canada, European Union, USA) and critically surveys existing systems in Latin America. Special emphasis is placed on regulatory instruments emerging from international conventions and agreements (e.g. the Cartagena Protocol of the Convention on Biological Diversity, Codex Alimentarius, the World Trade Organization).
- National and International Regulatory Systems
- Comparative analysis of regulations (European Union, USA - USDA, FDA, EPA - Canada, etc.). Regulatory systems in Latin America and the Carribean.
- International Conventions and Agreements Relevant to Biotechnology
- In-depth analysis of the Cartagena Protocol, the WTO agreements (SPS, TBT), Codex Alimentarius and their respective implementation requirements.
Module 7. Risk Perception and Risk Communication
Biotechnology is a powerful tool that presents a range of potential environmental, social and economic benefits and demands rigorous oversight. However, in recent years, modern biotechnology has been under public scrutiny and is currently the focus of intense public and political debate. Many supporters of the technology are worried that the benefits of the technology may be overshadowed by the potential risks magnified by the media and opponents of the technology.
In democratic societies, public perceptions can both promote and hamper commercial introduction and adoption of new technologies. Public perceptions of biotechnology have received extensive attention in recent years in most Western countries, including articles, book chapters, conferences, a public perception bibliography series, studies of social implications and public concerns about biotechnology and entire books. There have been several surveys on public perceptions of biotechnology in Europe (Eurobarometer), in USA (National Science Foundation 2000), Canada (Angus Reid 2000), Japan and Latin America.
Public opinion surveys have shown that people’s attitudes vary toward biotechnology and there are major influences on consumer acceptance or rejection of the technology. Analysis of survey results show that consumer acceptance of biotechnology is driven by a number of inter-related factors. The major influences on acceptance seem to be knowledge level, awareness of benefits, confidence and trust.
Surveys have shown that global differences in support for specific applications of agricultural biotechnology are based on factors that include a country’s culture and history, economic conditions, and government initiatives or responses related to the issue. This Unit will examine in-depth the interplay of these factors particularly in the context of the Latin American continent.
- Risk perception - general considerations
- Diversity of risk perception worldwide. Risk and risk perception, a complex interdependency, the risk society of developed countries.
- Scientific uncertainty and the Precautionary Approach
- How can we cope up with scientific uncertainty? The Precautionary Approach as a decision making process in highly complex systems.
- Perception of risks and benefits related to the application of modern biotechnology.
- Separating biological from socio-economic risks. The role of public institutions in influencing public acceptance of new technologies.
- Risk communication
- In-depth analysis of cases that have had a major impact on public opinion (e.g. the Monarch butterfly, StarLink, etc.)
