The UNIDO e-Biosafety Training Platform
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Course Outline:
The structure of the UNIDO e-Biosafety Training Programme ensures that trainees from different backgrounds such as life sciences, social sciences, law or economics successfully acquire the skills necessary to gain proficiencies in basic biotechno
logical knowledge, regulatory concepts and risk assessment procedures. The Programme is delivered in modular form covering the entire range of disciplines related to biosafety. For each module, students engage in real-time online tutorials and the preparation of specific training assignments. The modular character allows the material to be tailored to specific regional or national needs.

The e-Biosafety training course comprises the following modules:


Module 1. Course Background

Module 2. Applications of Biotechnology

Module 3. Theoretical and Practical Foundations of Biological Risk Assessment

Module 4. Food and Feed Safety

Module 5. Environmental Safety

Module 6. National and International Regulatory Systems

Module 7. Risk Perception and Risk Communication



Module 1. Course Background

  • 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.
  • Are biotechnology-derived products needed?
Science and technology trends and their relevance to the developing world. The effectiveness of new technologies to address intractable problems.
  • Genetic modification - an introduction
Molecular biology basics. Review of conventional breeding techniques and comparison with GM technologies.
  • Principles and methods of genetic transformation
A description of the techniques used for transforming prokaryotic and eukaryotic cells and characterising the transformants.


Module 2. Applications of Biotechnology

  • Agri-biotech Applications
Biotic and abiotic stress resistance in food crops. Agri-forestry products.
  • Food applications
Novel biofortified foods.
  • Industrial applications
Energy crops and biofuel production. Industrial and pharmaceutical crops.
  • Environmental applications
Bio- and phytoremediation. Bio-control agents.

Module 3. Theoretical and Practical Foundations of Biological Risk Assessment

  • Definitions and Concepts in Risk Assessment
Techniques for hazard identification, risk estimation, risk evaluation and management. Risk benefit analysis. The concept of familiarity and the precautionary principle.
  • Information Resources and Knowledge-based Systems
Biosafety databases and techniques of data analysis and management.
  • Case Studies
Case studies using computer-based decision support systems (DTREE )and simulation of expert panels.


Module 4. Food and Feed Safety

  • Overview of Safety Assessment. Food-related Risks
Food-related risks: toxic compounds, allergens, antinutritional factors, undesired interactions between food components. Limitations of conventional toxicology studies.
  • Components of Food Safety Assessment
Toxic compounds in foods (biological role, removal by processing and/or cooking procedures, health effects). The allergic response. 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
Experimental, compositional basis of the substantial equivalence approach. Situations of non-equivalence.
  • Procedures for Food Safety Assessment
Information and data management. Checklists: from molecular characterisation to consumption. Post-commercialisation monitoring.
  • Food Labelling
Scientific and public policy issues. Labelling and public perception of technology. Social and economic issues. Consequences on trade: traceability and identity preservation of food commodities.


Module 5. Environmental Safety

  • Risks related to host/transgene/environment combinations
Gene flow, spread, establishment and invasiveness.
  • Ecological considerations
Weediness. Gene introgression. Impacts on biodiversity. Changes in agricultural practice.
  • Best practice for the design and management of GM-crops – an overview
Physical and biological containment. Risk mitigation and integrated resistance management.
  • Environmental monitoring of GMOs
Traceability: analytical tools and implementation procedures.


Module 6. National and International Regulatory Systems

  • National and International Regulatory Systems
Comparative analysis of regulations (European Union, USA and Canada, etc.). Regulatory systems in Africa, Asia, Latin America and the Caribbean.
  • 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

  • Risk perception
Factors shaping public perception and acceptance of biotechnology.
  • Scientific Uncertainty and the Precautionary Approach
Coping with scientific uncertainty. The Precautionary Approach and decision making. the role of public institutions. Separating biological from socio-economic risks. Risk communication as an integral part of risk assessment.
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