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The following points highlight the four major risks of modern biotechnology. The risks are: 1. Health Risks 2. Environmental Risks 3. Risks to Biodiversity 4. Socioeconomic Risks.
1. Health Risks:
Potential health risks of genetically improved organisms relate to assessing and minimizing the risk of food allergens in genetically improved food. New biotechnology based methods allow the identification, characterization, and minimization of risks of food allergens. Genetically improved crops and food, and the risk of allergens associated with them, are now a concern throughout the world, especially in industrial countries.
More than 90 per cent of food allergens that occur in 2 per cent of adults and 4-6 per cent of children are associated with eight food groups. Allergenicity of genetically improved foods can be raised in crops and foods either by raising the level of endogenous allergen or by introducing a new allergen.
Assessment of the risk of allergens is a challenge. The International Life Sciences Institute (ILSI) has developed a decision tree that provides a framework for risk assessment.
It uses the following criterion: that an introduced protein in a food is not a concern if there is:
(1) No history of common allergenicity,
(2) No similar amino acid sequence to known allergens,
(3) Rapid digestion of the protein, and
(4) The protein is expressed at low levels.
Protocols enable assembly of the data to judge food against this criterion. It is also important to inform consumers of any potential risk. A key concern of consumers is being able to identify where allergens are found.
Consumers want to know where the potential for food allergens exists. Any protein added to food should be assessed for potential allergenicity, whether it is added by genetic engineering or by manufacturing.
There are several related areas of concern with regard to potential human health risks of genetically improved foods: toxicity, carcinogenicity, food intolerances; the risk of the use of gene markers for antibiotic resistance; other macromolecules aside from protein that could be potential allergens; and nutritional value.
Methods of testing and evaluating risks of toxicity and carcinogenicity are well established for food. The question remains as to whether developing countries can implement and use currently available technologies and protocols to assess food allergens and other health risks.
The techniques are well established, and should be readily implementable by trained professionals. Although no clear cases of harmful effects on human health have been documented from new genetically improved food that does not mean that risks do not exist and they should be assessed on a case by case basis.
2. Environmental Risks:
The risks policymakers and regulators need to assess include the potential for spread of traits from genetically improved plants to the same or related species, plants, the build-up of resistance in insect populations, and the potential threat to biodiversity posed by widespread monoculture of genetically improved crops.
i. A transparent, science-based framework is required, which assesses risks on a case by case basis and takes account of all stakeholder views.
ii. Environment-related issues to be considered in each case include the possibilities for gene transfer, weediness, specific trait effects, genetic and phenotypic variability, and expression of pathogenic genes.
iii. Risk management needs to consider the prospects for managing any specific risks identified with a proposed release.
iv. Experience is accumulating in the management of the Bt genes in transgenic cotton varieties in several countries and this needs to be closely monitored.
v. An agricultural sustainability protocol that balances risks and benefits may have value for the approval and use of new crop varieties.
The risks lie in the management of the cropping system involving soil, water and other inputs. There is a need for the establishment of baseline information in the environment where such introductions are to be made. There is very little known on this, although some understanding has been gained over recent years, and further R&D is required.
The information derived from such an assessment needs to be handled through risk management associated with “plants as plants.” Risk management involves the consideration of traditional cultural practices that have evolved over time, and new knowledge gained from research in agronomy, plant pathology, entomology, weed science, plant biology, soils, microbiology, and other disciplines.
3. Risks to Biodiversity:
Risks to biodiversity and wildlife are important issues in particular environments. Careful assessment is necessary of the risks associated with the possible creation of new selection pressures coming from the introduction of genetically improved organisms into the environment.
Of special concern is the potential impact on biodiversity of genetically improved organisms as the selection pressures wield influence in the species composition of the ecosystem. These concerns merit further study, especially on the behaviour of genetically improved organisms in the open environment.
The framework for strategic planning in the deployment of genetically improved organisms should be formulated with sustain-ability as the primary concern. Both food safety and biosafety regulations should reflect international agreements and best practice and a given society’s acceptable risk levels, including the risks associated with not using biotechnology to achieve desired goals.
The principles and practices for assessing the risks on a case-by-case basis are well established in most Organization for Economic Cooperation and Development (OECD) countries and several emerging economies. These principles and practices have been summarized in a series of OECD reports published over the past decade or more.
National, regional, and international guidelines for risk assessment and risk management provide a basis for national regulatory systems. Biosafety guidelines are available from several international organizations including the OECD, United Nations Environment Program, United Nations Industrial Development Organization, and the World Bank.
Regulatory trends to govern the safe use of biotechnology to date, include undertaking scientifically based, case-by-case, hazard identification and risk assessments; regulating the end product rather than the production process itself; developing a regulatory framework that builds on existing institutions rather than establishing new ones; and building in flexibility to reduce regulation of products after they have been demonstrated to be of low risk.
Biotechnology is not inherently different to other technologies with respect to economic and social impacts, as long as it focuses on the problems that affect poor people.
One important difference is that research on biotechnology has largely taken place in the private sector with proprietary technologies and an orientation to commercial agriculture. This implies the need for a strong role for the public sector, including increased resources, to address developing country priorities.
4. Socioeconomic Risks:
There is a risk that modern science may bypass the needs of poor people. Biotechnology is only one tool in addressing the challenges of food security and poverty. There is a need for biotechnology to be integrated with appropriate policies and other conventional R&D programs.
The positive and negative impacts of biotechnology should be monitored over time in terms of who and what are affected and how they are affected. Monitoring impact will provide guidance for public policymakers in the future.
Unless countries have policies in place to ensure that small farmers have access to delivery systems, extension services, productive resources, markets, and infrastructure, there is a risk that the introduction of agricultural biotechnology could lead to increased inequality of income and wealth.
In such cases, larger farmers are likely to capture most of the benefits through early adoption of the technology, expanded production, and reduced unit costs.
Biotechnology has potential to reduce input use, reduce risk to biotic and abiotic stress, increase yields, and enhance quality-all traits which should enable the development of new crop varieties that are appropriate to poor producers and consumers.
Modern biotechnology is not a silver bullet for achieving food security, but, used in conjunction with other agricultural research, it may be a powerful tool in the fight against poverty.
It has the potential to help enhance agricultural productivity in developing countries in a way that further reduces poverty, improves food security and nutrition, and promotes sustainable use of natural resources. Solutions to the problems facing small farmers in developing countries could benefit both farmers and consumers.
The benefits and risks need to be assessed on a case by case basis, weighing the risks and benefits for each particular situation. The benefits of new genetically improved food to consumers are likely to vary according to how they earn their income and how much of their income they spend on food.
Consumers outnumber farmers by a factor of more than 20 in the European Union, and Europeans spend only a tiny fraction of their incomes on food.
Similarly, in the United States, farms account for less than 2 per cent of all households, and the average consumer spends less than 12 per cent of income on food. In the industrial countries, consumers can afford to pay more for food, increase subsidies to agriculture, and give up opportunities for better tasting and better-looking food.
In developing countries, poor consumers depend heavily on agriculture for their livelihoods and spend the bulk of their income on food. Strong opposition to genetically improved foods in the European Union has resulted in restrictions on modern agricultural biotechnology in some countries.
The opposition is driven in part by perceived lack of consumer benefits, uncertainty about possible negative health and environmental effects, widespread perception that a few large corporations will be the primary beneficiaries, and ethical concerns.