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Redefining dining through genetically modified foods: A call for legal answers to consumer questions
‘The industry's not stupid. The industry knows that if those foods are labeled "genetically engineered," the public will shy away and won't take them.’ Jeremy Rifkin
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Ashish Virk and Aman A. Cheema focus on the legalities that affect genetically modified food with respect to an Indian perspective. |
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Introduction
We are living in an age where we are told, and we all to a great extend believe, that science has all the answers; and so, it is believed by its supporters that Genetic Engineering in agriculture is essential and an answer to meet the needs of a world population that is increasing by 88 million people every year (Brown. 1997) , especially in developing countries like India. Genetic Engineering (GE) usually involves taking genes from one species and inserting them into another in an attempt to transfer a desired trait or character. This is done for plants too in which they are engineered with genes taken from bacteria, viruses, insects, animals or even humans. It is the deliberate, controlled manipulation of the genes in an organism with the intent of making that organism better in some way. This is usually done independently from the natural reproductive process.
The product is a so-called genetically modified organism (GMO). To date, most of the effort in genetic engineering has been focused on agriculture, which results in GM foods. Genetically Modified (GM) or Genetically Engineered (GE) foods are developed and marketed because there is some perceived advantage either to the producer or consumer of these foods. This is meant to translate into a product with a lower price, greater benefit (in terms of durability or nutritional value) or both. Initially GE seed developers wanted their products to be accepted by producers so they have concentrated on innovations that farmers would appreciate by developing plants based on GMOs for crop protection. The GM crops currently in the market are mainly aimed at an increased level of crop protection through the introduction of resistance in plants against diseases caused by insects or viruses or through increased tolerance towards herbicides. However, new developments in agricultural biotechnology are being used to increase the productivity of crops, primarily by reducing the costs of production by decreasing the needs for inputs of pesticides, mostly for crops grown in temperate zones.
Hence, it believed that the application of agricultural biotechnology can improve the quality of life by developing new strains of plants that give higher yields with fewer inputs, can be grown in a wider range of environments, give better rotations to conserve natural resources, provide more nutritious harvested products that can be kept much longer in storage and transport, and supplies low-cost food to consumers. The benefits of these transgenic crops are better in weed and insect control, higher productivity, and more flexible crop management. This benefit accurate primarily to farmers, but it is also supposed there are economic benefits accruing to consumers in terms of their low prices. However, many people became aware of GE foods for the first time in 1996, when soya-beans grown in the US were genetically engineered by Monsanto to be resistant to their best selling herbicide called ‘Roundup’.
A necessitate for legal answers
It has been well said that Republic of India being above sixty is a senior citizen and at a pensionable age. Without any special inquiry one can assert that we are not living, in an India which we pledged to create on the independence eve. So we need to re-think on those principles, fight policies, and save India from the cooperate hawks like Enron, Monsanto etc., not only to save brinjal and cotton from them, but to retain the Freedom, Self-Respect, Equality, Peace and Harmony which we can steadily loose if we allow biotechnology to challenge and replace the natural species for whatever reasons and groundless justifications. However, India does not currently permit any GM food crop to be commercially cultivated, but this does not mean that there is no GM food ingredients in the food produced in India. There have been hundreds of acres of field trials and unmonitored processed and raw grain imports into the country.
Therefore, ‘No GM seeds being sold’ is not enough to assure consumers that their food is GM free today or will be GM free in the future. Going by 2008 figures, a total of 56 GM crops are undergoing various stages of research in the country. Of these, a whopping 41 comprise food crops around 169 varieties of cereals, oil seeds, cash crops, vegetables, fruits, pulses and spices. While a chunk of these are at the laboratory stage, 11 major food crops are undergoing different phases of field trial. These are brinjal, rice, potato, tomato, mustard, ladies finger, corn, cabbage, cauliflower, pigeon pea and groundnut (Greenpeace, 2009) . The Indian law on GE food, its regulation and its safety is full of ambiguities and does not consider various international principles, which are baseline to various other laws of the world. The critical study of the laws prevalent and sub-monitions for necessitate modifying, so as to match the international standards are summed underneath.
Simultaneous Implementation of PFAA, 1954 and FSSA, 2006 and Other Futile Laws
The Parliament of India enacted a new law in 2006 on food and its regulation, The Food Safety and Standards Act, 2006 , to be administered by the Ministry of Health and Family Welfare, Department of Health and Family Welfare instead of the Ministry of Food Processing Industries . The objective of the Act ‘is to consolidate the laws relating to food and to establish the Food Safety and Standards Authority of India for laying down science based standards for articles of food and to regulate their manufacture, storage, distribution, sale and import, to ensure availability of safe and wholesome food for human consumption and for matters connected therewith or incidental thereto’ .
The new law aimed to replace the acts and orders relating to various food sectors in country and to be administered and monitored by Food Safety and Standard Authority of India. Under the implementation of Section 97 of FSSA, 2006, the Prevention of Food Adulteration Act, 1954, (PFAA) needs to be repealed; however, the notification to this effect has not been issued by the government yet. Under such circumstances the PFAA, 1954, is still into practice and implemented, though in pursuance to Section 90 of FSSA, 2006, all work and subjects of PFA Division along with the entire staff has been transferred from Directorate General of Health Services, Ministry of Health and Family Welfare to Food Safety and Standards Authority of India . This all has led to confusion in the actual working of the food departments, and serious issues relating to food sector is under neglect. The government needs to clear this confusion immediately by officially repealing PFAA, 1954, and notifying it in the official gazette; so as to save the food sector of India from exploitive objectives of international cooperates.
Moreover, there are other Indian legislations that address various aspects of biotechnological applications which can influence larger governance of agricultural biotechnology. Such as Seeds Bill, 2004, which will soon replace the Seeds Act 1966, and Competition Act 2002; however, none of the above mentioned acts have emerged as functional instrument capable of serving the desired purpose, that is, regulation of technological development of agriculture.
Role of MOEF and GEAC- Some Legal Lacunas
On 9th February 2010, the Ministry of Environment and Forests (MOEF) in its decision on commercialization of Bt-Brinjal quoted:
‘as this decision of the Genetic Engineering Approval Committee (GEAC) had very important policy implications at the national level, the GEAC decided its recommendation for environmental release may be put to the government for taking final view on the matter.’
The question which arises is whether the Government of India (GOI) has the legal authority to review, revise or overturn the GEAC? Moreover, if the GEAC had not recommended its decision for review by the GOI, could the GOI suo-motu authorize this process of review of GEAC decision? The GEAC was set up as a statutory body under the 1989, Rules for the Manufacture, Use, Import, Export, and Shortage of Hazardous Microorganisms, Genetically Engineered Organisms or Cells (1989 Rules), that was notified under the Environmental Protection Act 1986, and here lies the important aspect of relationships between the MOEF and GEAC. The GEAC, as a statutory body is duty bound to oversee regulatory approvals of GE substances and products. However, unlike other statutory bodies which by definition are structurally and functionally independent regulatory authorities; the GEAC functions under the department of Environmental Forests and Wildlife of the MOEF. Such an institutional linkage is bound to influence and to an extent undermine the independent mandate of GEAC. This is also reflected from Rule 20 of 1989 Rules.
The power of blanket exemption has been used by the MOEF to provide for subject specific waivers and had thereafter, also been challenged in the court. Secondly, the 1989 Rules do not provide for any scope of review of the approvals granted by the GEAC other than via individual judicial appeals. Thus, this is necessary to underline that although judicial challenges can be mounted against approvals or any other regulatory decisions granted by the GEAC, there is no legal basis provided under the statue to take suo-motu action to review or revise its decisions by an executive order of the MOEF. Moreover, several doubts have been raised on the integrity of the GEAC process itself, as it has violated the International Cartagena Protocol on Bio-safety that India is a signatory.
As these are very serious charges which need to be thoroughly investigated, so as to restrict the hazardous activities relating to Bt-crops in India (Chowdhury. 2010). Hence, it is important that the GEAC be reconstituted as a separate regulatory authority within an independent mandate and functioning purview and there should be no institutional linkage between the MOEF and the GEAC.
Legal Attention towards GM Contamination
The Food Safety and Standards Authority of India (FSSA) has been setup under the Food Safety and Standards Act, 2006, which was envisaged to be a single authority on food safety and standards in the country, consolidating other food related laws of the country . It is held under the law that the food authority shall establish scientific panels, which may consist of independent scientific experts , such as panels on GMOs and GE foods . The FSSA has recently set up scientific panels on genetically modified organisms and foods and deputed a representative into GEAC to deal with issues related to processed GM foods. However, the authority has so far not taken any initiative to formulate legal rules for GM contamination and has in effect left the country without a law to identify and penalise offenders related to GM contamination. Instantaneous steps should be taken by the authority to put a check on the growth of GM contamination as it is not only threat to the biodiversity and environment but also food security of the consumers.
Consumers Right to Know-Limited Labelling is not an Answer
As discussed before the survey at various countries showed that majority of the people wanted comprehensive labelling of GE Foods, even though they did not mind eating it. It is also argued that labelling would be essential in order to be able to trace any health problem that may arise. In May 1998, Codex Alimentarius, the UN body responsible for establishing international rules on food policy, rejected the demands in favour of a limited labelling regime that suited the food and GE industries. Julian Edwards, Director General of Consumer International, which represents 245 consumer organizations in 110 countries pointed out:
‘One of the ironies of this issue is the contrast between the enthusiasm of food producers to claim that their biologically engineered products are different and unique when they seek to patent them and their similar enthusiasm for claiming that they are just the same as other foods when asked to label them.’
By the end of 1999, however, mounting public pressure had forced regulatory authorities in Australia, New Zealand, South Korea, and Japan to begin to implement mandatory and complete labelling of GE foods (Lilliston, 1998) . The practice of labelling GE foods is not very strictly prevalent in India as it has only enforced an unauthorized import restriction. This naturally has given rise to illegal, and untraceable GM imports- processed and unprocessed. Though the GEAC has issued GM free certificates to rice and mustard exporters in the past, however, the lack of any initiative to formulate a standard on labelling had led to hazy situation in the country. Moreover, as there are no labelling regulations in India, big companies are not open about the ingredients of foods stuffs they sell in market. Though companies like MTR Foods, Ruchi Soya, PepsiCo, ITC Foods, Haldirams, and Dabur have said they do not use GM ingredients, while others like Britannia, Safal, AgroTech, Parle, Bambino, Kellogg, and Godrej have not responded at all, indicating indecisiveness.
Still others like Bharati Enterprises suggest that they follow the law of the land, while Cadbury's has not said a word about their stand on GM foods. On the other extreme are corporations like Nestlé and Hindustan Unilever, which have stated they use GM-derived ingredients (Greenpeace, 2009) .The Food Safety and Standards Act, 2006, imposes the duty on the scientific panels to constitute a team of experts which could work to frame labelling laws for such kinds of foods , though no initiative has been taken by the conserved authorities till now. GM foods should be sold with the label, so a consumer will know and can decide accordingly, his preference to eat traditional food or GM food. Every consumer has a right to choose safe food and avoid GM food for various reasons, primarily health concerns, ethics, and environmental sustainability. Hence, it should be the legal responsibility of food businesses to be aware of this right of the consumer, and act towards providing this choice to the consumers.
Legal Acceptance of Safety-Assessment Framework- Substantial Equivalence
Recognizing that the development of GM Foods was progressing rapidly, the WHO convened an expert consultation in 1990 on the ‘Assessment of Biotechnology in Food Production and Processing as Related to Food Safety.’ The consultation recommended that more structured approach towards safety assessment for GE foods should be developed. It was further refined from time to time through expert consultation meetings held in 1993, and then in Rome in 1996. It finally led to the development of concept of ‘Substantial Equivalence.’ The concept requires that measures of safety assessment of foods should show that a genetically modified variety is as safe as its traditional counterparts, through a consideration of intended and untended effects. The comparison should result in one of the three conclusions.
- The GMO or the food product obtained from it is substantially equivalent to a conventional counterpart. In such cases no further safety assessment is required.
- The GMO or the food product obtained from it is substantially equivalent to a conventional counterpart except for a few clearly defined differences. In these cases the safety implications of the differences need to be fully assessed.
- The GMO or the food product obtained from it is not substantially equivalent to a conventional counterpart, either because the differences cannot be defined or because there is no existing counterpart to compare it with. In such cases it does not mean that the food is unsafe; however, there would be a need for extensive data to be provided to demonstrate its safety.
The concept of ‘Substantial Equivalence’ has been legally integrated into safety assessment procedures and are used by regulatory authorities in many countries like EU, Australia, Canada, United States etc. (Tomlinson, 2002) . In India, regulatory body called, GEAC, is an inter-ministerial committee under the Ministry of Environmental and Forests, which is the final nodal agency for the approval of any import, export, transport, manufacture, process, use or sale of any genetically engineered organisms/substances or cells. The enforcement of the regulations framed under the committee to prevent the accidental release of GM crops during field trials is almost absent. This has led to several mishaps in the last few years. In a similar manner, the imports of GM grains and processed foods have also been poorly monitored.
More recently, in July 2009, the authority clearly indicated in its 95th meeting on July 8, 2009 that it so far has not been able to control the contamination of illegal Bt-cotton that has taken place in several states across the country for over two years. In the Warangal district of Andhra Pradesh, India, more than 70 Indian shepherds report that 25 percent of their herds died within 5-7 days of continuous grazing on the leaves and pods of harvested Bt cotton plants. The shepherds noticed that the sheep became dull or depressed two to three days after grazing on the plants. They developed ‘reddish and erosive’ lesions in the mouth, became bloated, had episodes of blackish diarrhea, and sometimes had red-colored urine. Post-mortem examinations of the animals revealed the presence of black patches in the small intestines, enlarged bile ducts, discolored livers, and the accumulation of pericardial fluid. Investigators suspect that the deaths were likely due to the Bt toxin in the leaves and pods of the Bt cotton plants.
Researchers from the Centre for Sustainable Agriculture and the group Anthra later submit a report on the sheep deaths to India’s GEAC, but the government agency dismisses the reports as ‘exaggerated.’ The incidents prove that the body is not able to work efficiently in controlling the mis-happenings relating to GE farming. Hence, legal acceptance and development of a safety-assessment framework such as substantial equivalence for GM farming and foods is urgent requirement which needs to be legally enforced by the concerned authorities. Similarly, various references are made towards doubts raised as to reliability to the tests relating to human safety of Bt-Brinjal since these tests were carried out by the applicants themselves and not by the independent laboratory.
So the current regulatory regime does not mandate independent tests and in fact, it is upon the applicant to conduct tests in order to prove the safety of the product. It is GEAC which is supposed to authenticate these tests. The entire system needs to be overhauled. Either in case of independent tests conducted by the applicant, independent third party supervision should be required to verify the tests or the tests should be conducted by the independent laboratories. In both the cases GEAC should be the final authority to validate the tests and therefore, needs to be equipped with the necessary resources to consider this authorization.
Legal Enforcement of Precautionary Principle
The precautionary principle should be the cornerstone of the biotechnology law and policy in India. It ensures the adequate level of protection in the field of the safe transfer, handling and use of living modified organisms resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, and specifically focusing on trans-boundary movements . Number of farming organizations, including US National Family Farm Coalition, have joined together with environment and development groups around the world to launch a multi-billion dollar lawsuit against the biotech industry, alleging that companies like Monsanto had ‘forced genetically-modified seeds onto the market at fixed prices without taking precautions and sufficient testing for safety to human health and the environment’ (Kirby, 1999) .
Hence, while the development of biotechnology is considered essential by its supporters; it should be done taking into consideration its effects on human health, and environment and so precautionary principle should be legally enforced. As far as Indian law on food sector, PFAA, 1954 and FSSA, 2006, is concerned, they are silent about the principle, though UN Convention had showed its eagerness for the legal acceptance of it by the countries. However, the recent decision (9th February, 2010) of MOEF towards temporary suspension of commercialization of Bt-Brinjal for public consideration is a positive step. The decision of public consultations on the basis of precautionary principle, enhances public policy decision on the regulation of large scale utilization of technology that bear an environmental and public health risk; however, this decision relates to Bt-Brinjal alone, so precautionary principle needs to be legalized so that it can be compulsorily applied to all GE crops and foods (Chawdhury, 2010).
Legal Control over Research on GM Foods
Total Transparency on the research of GM foods is an immediate need of the time. Concerned legal authorities made in India should have full control on research and publications on GM foods. In UK, for example, the Agriculture and Food Research Council was replaced by the Biotechnology and Biological Science Research Council (BBSRC), an organization which is fully responsible for future development and expansion of genetic engineering (Anderson, 2000) . Hence, similar organization should be formulated under the law having full control over the research on GM foods. Similarly, commercialization of GE foods, like Bt-Brinjal may challenge the food sovereignty of India, as Monsanto may control food chain in India because the Approval Committee that is formed under the Environment Protection Act, is neither suited nor capable of looking into issues such as market, monopoly and food security. This is primarily a larger public policy question that needs to be addressed by bodies like the Planning Commission that allocates public research finding nationally.
Establishment of GE Free Zones
Another way in which law can protect the interest of consumers is to develop ‘GE Free Zones’. The governments of Austria and Luxemburg in 1997 established such zones legally by banning Novartis’ insect and herbicide resistance maize (Meister, 1999) . Similarly, the Governor of Rio Grande del Sul, Brazil’s major soybean growing state, declared the state as GE Free Zone in March 1999 (Zanatta, 1999) . Similar successful initiatives have been taken in UK, where people persuaded shops and restaurants to source GE-free supplies, and parents and teachers have urged local councils to remove GE ingredients from school meals. This has led Local Government Association to take a decision to remove GE foods from outlets like schools, town halls, and residential homes for elderly . Hence, the law in India should also establish such zones so that consumers should at least have an option to decide which kind of food they want to consume.
Encouragement to Organic and Ecological Farming
The law in India should encourage organic and ecological farming in the country by giving subsidies to the farmers. This kind of farming is an ecologically-based farming method that avoids the use of synthetic fertilizers and pesticides (Ronald, 2008) . Ecological farming can also provide a safe and sustainable alternative. It is free of synthetic agrochemicals and genetically modified crops, is sustainable, with low external inputs, and which protects biodiversity and helps meet local food and employment needs. The fact that ecological farming practices ensure a healthy environment is enough to suggest that this is the way to look forward. Safe and sustainable food production has been advised by the latest and the most comprehensive review of agricultural technologies by the U.N. and the World Bank in their International Assessment of Agricultural Research and Technology for Development (IAASTD), to which India is also a signatory (Tirado, 2009) . These kinds of farming is an answer to various other problems faced by farmers especially in State of Punjab, and Haryana, as these methods rely on farming methods like crop rotation, cover crops, compost, and mechanical cultivation to maintain soil productivity and fertility, to supply plant nutrients, and to control weeds, insects, and other pests. The surveys discussed in the last part of the paper also render that consumers prefer organic foods as compared to GE foods.
Hence, the law making authorities and other bodies regulating food stuffs in the country should take stringent steps to augment and push organic foods because they are not only better for consumers’ health but will preserve environment and is an answer to the escalating agricultural problems. Moreover, ‘Bt-Biotechnology is not the only route for reducing pesticide use.’ There are other options available like non-pesticide management (NPM) that has been adopted by many districts in Andhra Pradesh as an example of a technology that completely eliminates chemical pesticide use and, therefore, is a viable alternative to Bt-Brinjal that only reduces the pesticide usage (Report of MOEF, 2010). Hence, the presence of viable alternatives is an important factor that can be considered in decisions for commercialization of technologies that have potential environmental and public health risks associated with them.
Creation of Global and National Organization
There is an urgent need to create an international organization which will monitor around the world all research made on the GM foods. This organization will allow or disallow, certify the GM foods. GM foods should also go through the same strict procedure, which is used when new medicine is made or developed by medicine companies. The global organization can also have a control on the price of GM foods and seeds. Moreover, it can frame legal regulations such as patent laws etc., for development and control of GMOs and GE foods which can be bacon light for laws of various countries domestically. At the national level there is also a need for setting up of National Biotechnology Regulatory Authority as a professional science-based, independent regulatory authority, reviewing the protocol of public health and environmental safety tests and application of precautionary principle based approach within the regulatory approval process.
Conclusion
In this technology-driven age, it is all too easy for us to forget that mankind is a part of nature and not apart from it. We need to rediscover the unity and order between man and nature; this will also avoid disintegration of our overall environment. The overall tide towards GE products is turning and world opinion is going back to basics. Biotechnology industry is beginning to face serious difficulties. Apart from regulatory hurdles which is delaying commercialisation of GE products, they are getting resistance from market places also especially in European countries. So, India should also take some legal initiatives towards such products only if GE is considered essential and only option for the growing population of the country. In 1998, in State of Karnataka, the main farmers association launched a campaign called ‘Operation Cremate Monsanto’, uprooting and burning fields’ trials of GE cotton, which was planted illegally . Such kinds of campaigns will be encouraged in India if strict restrictions remedies are not placed by the concerned authorities, Hence, the Indian consumers dining have been redefined by GE Foods and so they necessitate lawful answers to their mounting questions.
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ASHISH VIRK & AMAN A. CHEEMA are Assistant Professors with the Panjab University Regional
Centre at Ludhiana.
Acknowledgments: Mr. Harjosh Singh (Student, International Business, University of Maryland) working on impact of Imports/Export of GM Foods, USA, Mr.Victor Goraya (Attorney, Washington D.C.) for enlightening on laws relating to Biotechnology, Dr. Ahujla (Internal Medicine) attending patients of food allergy etc, Library Staff of University of Maryland, and Montgomery College, Rockville, USA, without which the research work would not have been possible.
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