have received new genes, or for organisms that have had some of their own genes modified using molecular techniques. ➢Gene transfer is used worldwide to produce medicines, health care products, food processing aids, food supplements, environmental remediation tools, sustainable industrial resources and new materials. Biosafety and risk assessment ➢ These processes are not inherently dangerous, but the resulting GMOs may have characteristics that change their impact on their environment, which includes human and animal health. ➢ As these changes could be hazardous, it is customary to check the safety of all GMOs as they are being developed and before they are released for testing and general use. ➢ GM crops needs effective biosafety measures to ensure that GMOs will not impact negatively on the environment. Implications for nations In order to ➢ access, ➢ test and ➢ regulate the use of GMOs, governments need to establish national frameworks that can set ➢ policy, ➢ strategy, ➢ regulation and ➢ administrative processes to ensure the safe and effective use of appropriate GM products. Biosafety Regulation ➢ Decisions about GMOs are usually taken within a national biosafety framework that is established for this purpose. ➢ Countries initiate a national policy on the use of modern biotechnology that guides how decisions about GM activities should be taken. ➢ Extensive consultation is needed to ensure public awareness and input into the development process. ➢ Consultation between departments of environment, agriculture and health to ensure that the framework is efficient, cost-effective and can be implemented. Factors considered in national decisions ➢ potential role of biotechnology in meeting national goals and objectives in food production, food security, trade, and related areas. ➢ the risk they may pose to the environment or to human health ➢ the potential impact on trade, labour, food security, small business development, sustainable development and poverty alleviation. ➢ the benefits of a new technology and also the impact of not using the new technology. International biosafety agreements ➢The Cartagena Protocol on Biosafety (CPB) ➢Primary aim is to protect biodiversity by ensuring the safe and responsible ‘development, handling, use, transfer and release of any Living Modified Organism.’ ➢The CODEX Alimentarius Commission ➢sets standards for food safety, quality and labelling ➢It functions under the Food and Agricultural Organisation (FAO) in Rome. Components of a biosafety system ➢a single, harmonised biosafety review centre; ➢An efficient biosafety administration ➢confidential handling of commercial information; ➢Access to a trained pool of scientific expertise to independently assess the safety of each application on a case-by-case basis; ➢A transparent national decision making body ➢Issuing of a decision document that clarifies the safety issues of each GMO, reasons why decisions were made; Risk assessment ➢Risk assessment is the most critical component of biosafety implementation. ➢Risk the combination of the magnitude of the consequences of a hazard, ➢Hazard the potential of an organism to cause harm to human health or the environment. ➢Risk assessment a measure of the probability of a hazard occurring and the extent of the resulting damage (UNEP, 1995). ➢A common formula used in assessing risk is: Risk = hazard x exposure (R = H x E) Risk assessment principles General principles of a risk assessment review include the need for: ➢ Science-based assessments ➢ Flexibility, to address the different concerns raised by each GMO; ➢ Ability to distinguish between need-to-know and nice-to-know information; ➢ An iterative process to obtain additional information ➢ ensure adequate data is collected to move to the next stage of testing; ➢ Efficiency Scientific information required for risk assessment
➢Will GMOs be harmful in any way?
➢Can introduced genetic material be passed to other organisms? ➢consideration of risk will include: ➢Recipient organism or parent organism ➢Donor organism(s) ➢Vector ➢Inserts and/or characteristics of modification ➢The GMO Risk assessment procedures ➢ Identification of concerns ➢ Classification of these concerns ➢ Evaluation of the potential harm associated with each concern ➢ Evaluation of the likelihood of the harm being realised ➢ Evaluation of the consequence should the harm be realised; ➢ Identification of risk management strategies to minimise harm ➢ Consensus on the acceptability of the risk posed by each harm ➢ Consideration of the overall potential environmental impact, including a consideration of potential harmful impact, potential beneficial impact and the impact of not using the new technology. Application of Biotechnology Application of biotechnology Application of biotechnology in Agriculture ✓Agriculture biotechnology is the application of technology to modify genes of animals, plants, and microorganisms to create new species which have desired ✓ Production, ✓ Marketing ✓ Nutrition related properties. ✓Biotechnology includes a wide range of diverse technologies and they may be applied in each of the different food and agriculture sectors. Application of biotechnology Gene technologyin can Agriculture be used in agriculture and food production to ✓Increase crop or animal resistance to pests while reducing the use of chemicals ✓Increase crop or animal tolerance to chemicals that are used to kill harmful pests ✓ Create disease resistance in crops and animals ✓ Improve the food yield per plant or animal ✓Make plants and animals more suited to environmental conditions e.g. drier regions or salty water ✓Improve the nutritional quality of the food produced by the plant or animal. Genetically modified crops Genetically modified crops ("GM crops", or "biotech crops") are plants used in agriculture, the DNA of which has been modified with genetic engineering techniques. In most cases the aim is to introduce a new trait to the plant which does not occur naturally in the species. Crop modification techniques Advantages of Genetically modified crops Genetically modified crops Various GM crops are being produced all over the world for many benefits over traditional crops. Some examples are: PLANT AND ANIMAL REPRODUCTION ✓Enhancing plant and animal behavior by traditional methods like cross- pollination,grafting, and cross-breeding is time-consuming. Biotech advance let for specific changes to be made rapidly, on a molecular level through ✓ over-expression of genes ✓ removal of genes ✓ the introduction of foreign genes. ✓The last is possible using gene expression control mechanism such as specific gene promoters and transcription factors. ✓Methods like marker-assisted selection improve the efficiency of "directed" animal breeding, without the controversy normally associated with GMOs FLOWERS ✓ There is some simply aesthetic application. ✓For example the use of gene recognition and transfer techniques to improve the color, smell, size, ther features of flowers. ✓Biotech has been used to make improvement to other common ornamental plants, in particular, shrubs and trees. ✓Some of these changes are similar to those made to crops, such as enhancing cold confrontation of a breed of tropical plant, so it can be grown in northern gardens. Better flavor Fruits ✓Flavor can be altered by enhancing the activity of plant enzymes that transform aroma precursors into flavoring compounds. ✓Transgenic peppers and melons with improved flavor are currently in field trials. Fresher produce Genetic engineering can result in improved keeping properties ✓ To make transport of fresh produce easier ✓Giving consumers access to nutritionally valuable whole foods ✓ Preventing decay, damage, and loss of nutrients Pesticide-Resistant and herbicide tolerant crops ✓Not to be mystified with pest-resistance, these plants are broadminded of pesticides, allow farmers to selectively kill nearby weeds with no harming their crop. ✓The most well-known example of this is the Roundup-Ready technology, urbanized by Monsanto. ✓First introduced in 1998 as GM soybeans, Roundup- Ready plants are unaffected by the herbicide glyph sate, which can be applied in copious quantity to get rid of any other plants in the field. NUTRIENT SUPPLEMENTATION ✓In an attempt to get better human health, mainly in developing countries, scientists are creating crops that hold nutrients known to help fight disease or starvation. ✓An example of this is Golden Rice, which contain betacarotene, the forerunner for Vitamin A manufacture in our bodies. People who eat the rice create more Vitamin A, and necessary nutrient lacking in the diets of the poor in Asian countries. Nutrients Intake ✓One of the most important and innovative applications of biotechnology is to improve the nutrient uptake like calcium level in our food stuff. ✓Researchers have shown that oligo-fructose, a naturally occurring, low-digestible oligosaccharide, increases calcium absorption by as much as 22%. ✓Such studies can open the flood gates for new areas of health application and new classes of ingredients. ✓These findings can be used to create new products in dairy, bakery, confectionery and drinks. Biotechnology in Animal Feed Biotechnology is used to improve livestock feed by: ✓ Improving nutrient content ✓ Improving the digestibility of low quality animal feeds ✓ Increasing production capability ✓ Eliminating the deficiency of mineral ions or proteins Value added feed ❖ Low oligosaccharide soybean: •Soybeans contain oligosaccharides that act as anti-nutritive factors . •So less oligosaccharide content means increased amino acid and dry matter digestibility. ❖ Soybeans with high Lysine: • Lysine is essential for animal diet • 3 to 4.5% increase in lysine • Reduces the supplementation addition of lysine ❖ Golden rice: • Reduced allergens in food • Improved nutritional content • More quantity and Good quality • Combats hunger and malnutrition diseases. Enzymes Enzymes are the biological catalyst which when added to animal feed: 1.Improve the nutrient availability from feed stuffs 2. Lower feed costs 3.Reduce anti-nutritional effects from some feed ingredient EXAMPLE: ✓Microbial phytase is an enzyme which breaks down the indigestible phytic acid ✓In cereals and oilseeds and release digestible phosphorus. ✓This reduces the use of expensive supplement inorganic phosphorus (dicalcium phosphate) ✓Phyate also releases other minerals like (Ca, Mg and Zn) Application of biotechnology in Industry ✓ Industrial Biotechnology plays an important role in ✓ food fermentations ✓ food additives and processing aids ✓ food safety through advances in microbial genetics ✓ detection of pathogens ✓ mycotoxin detection ✓ identification of foods and food ingredients. ✓ Industrial Biotechnology targets the selection and improvement of microorganisms with the objectives of improving ✓ process control , ✓ yields ✓ efficiency ✓ quality, ✓ safety ✓ consistency of bioprocessed products. VACCINES ✓Oral vaccines have been in the works for much existence as a likely solution to the increase of disease in developing countries, where costs are excessive to extensive vaccination. ✓Engineered crops, frequently fruits or vegetables, planned to carry antigenic proteins from transferable pathogens that will activate an immune reply when injected. ANTIBIOTICS ✓Plants are used to create antibiotics for both human and animal use. ✓An expressing antibiotic protein in stock feed, fed straight to animals, is less expensive than traditional antibiotic production. ✓But this practice raise many bioethics issues, because the result is widespread, possibly needless use of antibiotics which may encourage expansion of antibiotic-resistant bacterial strain. Emulsifiers ✓Acacia gum is predominantly used as an emulsifier in the food industry due to its emulsifying and stabilization properties. ✓Using new molecular tools, emulsifiers are now synthesized from covalently coupled carbohydrates like starch, pectin, sugar and proteins from wheat, milk and soya bean. Allergy Testing ✓Many people have been found to display allergic reactions after eating some products like peanuts. ✓To combat this problem, it is essential to identify the cause of this allergy. ✓For this purpose, a highly sensitive immunological assay has been developed by a Netherland based company to detect peanut proteins in foods. ✓This is the first assay with commercial applications. Effective Monitoring ✓Scientists are developing versatile gastrointestinal models for detailed monitoring of ✓ digestibility ✓ bioconversion ✓ biodegradability of foods and drugs and contaminants from the point of safety and functionality. ✓These models are now used for studying the digestive effect of nutraceutical foods. Foods from Microbes ✓While brewing and baking have existed for ages, we are now using genetically pure strains in the process. ✓Studies show that nearly 1.5 million tons of bakers’ yeast (Saccharomyces cervisiae) is produced throughout the world every year. ✓Modern plants have also reduced the time required in the fermentation process from months to days. ✓The fungus Aspergillus oryzae is being used to produce a wide range of important enzymes. BIOFUELS ✓ The agricultural industry plays a big role in ✓ the biofuels industry, ✓ the feedstock's for fermentation ✓cleansing of bio-oil, bio-diesel and bio- ethanol. ✓Genetic engineering and enzyme optimization technique are being used to develop improved quality feedstocks for more efficient change and higher BTU outputs of the resulting fuel products. BIOFUELS BIOFUELS BIOFUELS