Indian Regulatory Mechanism for Genetically Modified Crops: A Critical Study

I. Introduction

“GM foods have the potential to solve many of the world’s hunger and malnutrition problems, and to help protect and preserve the environment by increasing yield and reducing reliance upon chemical pesticides. Yet there are many challenges ahead for governments, especially in the areas of safety testing, regulation, industrial policy and food labeling”.

• M.S.Swaminathan

India is a country with a population of about 1.3 billion which is likely to reach 1.5 billion by 2025. With every increase in the population, a strain is created on dwindling food resources. To fulfill the demand for food grains, with the limited land and water, expensive raw materials, deteriorating soil condition, uncertain rain, increasing debts on farmers and climate change, there is need of the hour to include novel scientific and technological tools in agricultural sector to ensure food sovereignty in India in the long run, considering its impact on the ecological order, biodiversity, biosafety and health of human beings and livestock.

Genetic engineering is one of the techniques of biotechnology applied for crop improvement. Genetically modified organisms (GMOs) are plant organisms, animal organism or microorganism wherein their DNA, the genetic material is manipulated. This process is also called as “modern biotechnology”, “gene technology”, “recombinant DNA technology”, and “genetic engineering”. Gene technology is specifically applied by using recombinant DNA process wherein the genes of one living organism is inserted into the other living organism which cannot occur naturally. The genetically modified crops or transgenic crops are developed by applying genetic engineering process to get the desired traits like increase in productivity, less use of pesticides, better agronomic, food and feed with enhanced nutritional value, more tolerant to biotic and abiotic stresses and cleaning soil polluted with heavy metal.

II. Conceptualization of agric-ulture biotechnology and genet-ic engineering

Biotechnology can be called as “revolutionary technology” ever known to mankind. Biotechnology is a scientific tool where living organism plants; animals and microorganism are improved and modified for commercial purpose. Biotechnology is not a new concept as in earlier days it was applied to bread baking, brewing alcoholic beverages and breeding of food crops or livestock. The introduction of agro biotechnology in biotechnology gave new meaning and potential to it. According to the “Convention on Biological Diversity (CBD)” biotechnology includes the application of technology to modify products for certain use in living organisms.³ Biotechnology provides mankind the unique power to amend or modify living organisms by inserting desired gene from other organism from same or different species. Biotechnology is utilized in producing genetically modified organism (GMOs) and it’s by- products. It enhanced the scope in agricultural sector, medicines and industrial field. Biotechnology is mainly divided into three types i.e. firstly, green biotechnology which focuses on the improvement of crop and plants by transferring foreign genes to plant species like “plant tissue culture, plant genetic engineering and plant molecular marker assisted breeding”. Secondly, red biotechnology which brings innovation in prevention, diagnosis and treatment of diseases like stem cell therapy, gene therapy and genetic testing and lastly, white biotechnology which is applied in industrial and environmental process.

Agriculture Biotechnology or Agritech is a part of biotechnology which is widely used in agriculture. Since a long time, agriculture biotechnology is used by way of traditional selection and breeding methods to improve the agriculture produce like cross breeding of many kinds of wheat to get new disease resistant variety. Modern biotechnology evolved innovative methods in agricultural sector like genetic engineering. “Genetic engineering” is a modern biotechnology, commonly used worldwide to improve crop quality. In the process of genetic engineering, a single gene is transferred from one organism to another organism or modifies the gene in a particular organism to include or exclude a desired characteristic. The outcome of genetic engineering is genetically modified crops.

“Genetically modified crop” are popularly called as “biotech crop or transgenic crop”. Genetically modified organism produces genetically modified crops. Presently, genetically modified crops are commonly used in agriculture sector as they are herbicides resistant, insects resistant, disease resistant as well as quality traits.

III. Genetically modified crops and continuing debate

The GM crops are into controversy since its introduction in India. The proponents of GM crops argue that genetic engineering is not more than an extended form of natural breeding⁴ and GM is a part of mutation breeding. GM crops are “safe for human consumption” and can solve the problem of malnutrition, increase yield and assist to achieve food security in future to sustain the challenges. They claim that Roundup is safe and biodegradable herbicide with low toxicity and it can reduce the use of chemical including pesticides and insecticides on crops thereby protecting and preserving environment. It is claimed that Bt crops affect only the targeted pests and their relatives thereby conserving biodiversity. GM crops are solution to climate change as genetic engineering develops climate ready crops. GM crops can solve the nitrogen crisis as well as can reduce the use of fossil energy.GM crops can “coexist” with conventional crops and organic crops. The cultivators of the GM crops get economic benefits due to high yield. ⁵

Opposition

The opponents argue that genetic engineering is inconsistent with the natural breeding and comes with its own unusual perils and shows serious biosafety concerns relating to GM crops and its harmful effect on the environment and biodiversity as it increases use of pesticides and insecticides. Conventional crops can feed the growing population with the help of political and financial will and agro ecological farming which is a sustainable food production system is the key to future food security. Traditional breeding techniques are more effective at developing useful traits in the crop. GM crops not only targets the specific pest but also their close relatives causing major concern on preserving biodiversity. They contend that it is the traditional breeding techniques that help to achieve climate ready crops. Genetic modification has not delivered nitrogen-efficient crops and it consumes more fossil energy.GM crops grown with the non-GM crops can cause contamination of conventional crops and organic crops due to cross pollination. Contamination can take away the choice from people to select from GM crops and GM free crops for cultivation, sale and consumption as well as Intellectual Property Rights issues arises.GM food and feed is also risky for animals and human health as “GM foods can be toxic and allergenic”. They argue that the safety data available are prepared in collaboration with the biotech industries and hence biased. The Roundup remains in the environment for long period and has toxic footprint on soil, plants and wildlife. The claim that Roundup to be safe herbicide is based on outdated and unpublished studies conducted by manufactures.⁶ They contended that as genetic engineering involves mutation breeding needs to be strictly regulated. The financial effect of cultivating GM crops on the farmers is mixed or in some cases negative. Genetically modified crops are unethical and immoral as it interferes in the process of nature.

The debate in favour of GM crops and against the GM crops is continuously going on due to non availability of scientific data. As we know that technological inventions are uncertain and the genetically modified crops, a biological invention may cause damage to ecological order and human and animal health.

IV. Global status of genetically modified crops

GM crops are commercially approved in all continents. The countries which have adopted GM technology and cultivating GM crops on 50,000 hectares are biotech mega-countries. They are the “Argentina, Australia, Bolivia, Brazil, Canada, China, Colombia, India, Mexico, Myanmar, Paraguay, Pakistan, Philippines, South Africa, Spain, Sudan, Uruguay, Veitnam and USA”. USA placed at top position and India ranks 5th with 11.9 million hectares. However, it also indicated that among 20 most developed countries, only 3 countries adopted GM crops and others raise uncertainty in usage like Europe, Japan, Russia, Israel etc.⁷

Country Wise Global Area of GM Crops in 2018 and 2019

(Areas in million hectares)

Source: ISAAA, 2019

International Organizations and Genetically Modified Crops

i. World Trade Organization (WTO) regulates international trade by controlling trade barriers.

ii. Codex Alimentarius ensures safety of food through international codes of practice, guidelines and recommendations. The WTO determines cases on the grounds of the provisions under Codex Alimentarius.

iii. Cartagena Protocol on Biosafety is an agreement which deals with transboundary transfer of living modified organisms which may cause damage to the biological diversity.

iv. Nagoya Kuala Lumpur Supplementary Protocol on Liability and Redress (NKSPLR) is an agreement which is supplement to the “Cartagena Protocol on Biosafety”. It aims in framing international rules and procedures relating to living modified organisms and its liability and remedies.

v. International Treaty on Plant Genetic Resources for Food andAgriculture is an agreement deals with genetic matters originated from plants with agriculture value.

V. India and GM crops

The Government of India has commercially approved Bt cotton resistant to cotton bollworm for cultivation in 2002. It is the only genetically modified (GM) cash crop approved in India. It was released after considering the report on the effect of Bt cotton in India submitted by Indian Council of Agricultural Research after elaborate research. However, there were no evidences found which can show the injurious effect of Bt Cotton cultivation on soil, micro flora and health of livestock. Bt Cotton has reshaped cotton sector in India. It has doubled the cotton yield within the span of six years. India’s contribution in the cotton production worldwide has escalated to 25 percent in 2014 from12 per cent in 2002. India exports cotton worldwide and holds second place.⁸

Bt Brinjal which is developed by M/S Mahyco in collaboration with “University of Agricultural Sciences, Dharwad; Tamil Nadu Agricultural University, Coimbatore and ICAR-Indian Institute of Vegetable Research, Varanasi”. It is developed to resist the brinjal shoot fly which used to damage brinjal crops at large. “Genetic Engineering Appraisal Committee”, the regulatory body in India has approved Bt Brinjal in the year 2009. However, a moratorium of 10 years has been imposed on GM crops by the Hon’ble Supreme Court of India on the recommendation of the Technical Expert Committee. Till now no action has been taken on its commercialization. ⁹ The “Genetic Engineering Appraisal Committee (GEAC)” under the “Ministry of Environment, Forest &Climate Change” recently granted permission to eight states to conduct biosafety field trial research on two novel GM varieties of Bt Brinjal during 2020-23. The concerned states have to issue no-objection certificate and check the availability of isolated land before conducting the field trial.¹⁰

Dhara Mustard Hybrid 11 which is developed by scientists in Delhi University. It has not been approved for commercial release by “Genetic Engineering Appraisal Committee (GEAC)”. The regulatory body “Genetic Engineering Appraisal Committee (GEAC)” has recommended preparing a comprehensive biosafety assessment data on environmental and biodiversity. At present in this matter no such request is pending.¹¹

Indian Laws to Regulate Genetically Modified Crops

Genetically modified organism and related products are regulated in India as well as other countries of the world. The Constitution of India under Article 21 includes right to health and pollution free environment. The Constitution of India provides under Article 51A(g) made the citizens of India responsible to safeguard and enhance the natural resources like forests, lakes, rivers and wildlife and treat the living creatures with kindness. Article 51A (h) provides that all Indian citizens have “to develop the scientific temper, humanism and the spirit of inquiry and reform”. The conservation and preservation of environment and human and animal health as well as use of technology are significantly important to be applied with precautionary approach. The unsystematic use of biotechnological invention including genetically modified crops can cause risk to environment and human health. Under the “Environment (Protection) Act, 198”6, the “Rules for the Manufacture, Use, Import, Export and Storage of Hazardous Microorganisms/ Genetically Engineered Organisms or Cells 1989 (Rules, 1989)” was formulated to regulate the production, use, import, research and release of Genetically Modified Organisms products. The agencies regulating the GM products are “Ministry of Environment, Forest and Climate Change and Department of Biotechnology”. These agencies are responsible for implementation of the Rules 1989 in India. There are six regulatory authorities constituted under the Rules, 1989:

i. Recombinant DNA Advisory Committee (RDAC): The “Recombinant DNA Advisory Committee” is established under the “Department of Biotechnology”. The committee has an advisory role and it is vested with the responsibility to examine and analyse the growth and progress in the arena of biotechnology at national and international domain. It also recommends safety measures for regulations GM crops.¹²

ii. The Institutional Biosafety Committees (IBSC): The “Institutional Biosafety Committee” is established by research institutions performing research involving genetically modified organisms (GMO’s) or other microorganisms. The members of the committee is constitutes the head of the concerned research institution, scientists of the institution engaged in genetic engineering field, one medical expert and at least one nominee from the Department of Biotechnology. The concerned research institution is required to prepare a latest emergency plan of action with the assistance of the “Institutional Biosafety Committee” following the guidelines of the “Review Committee on Genetic Manipulation (RCGM)”. It has duty to provide copies of the emergency plan to the “District Level Committee, State Biotechnology Co-ordination Committee and the Genetic Engineering Approval Committee”. ¹³

iii. Review Committee on Genetic Manipulation (RCGM): The “Review Committee on Genetic Manipulation” is constituted and supervised by the “Department of Biotechnology”. The members are officials from the “Department of Biotechnology, Indian Council of Medical Research, Indian Council of Agricultural Research, Council of Scientific and Industrial Research and other independent experts”. The “Review Committee on Genetic Manipulation” can also constitute sub committees for effective functioning.¹⁴ It formulates guidelines defining the mechanism to be adopted in respect of the production, sale, importation, use and research involving genetically modified organisms (GMO’s) activities. Hence, it focuses on environmental safety issues while forming regulatory framework. It also monitors the high risk projects and ensures the biosafety rules are being followed according to prescribed guidelines.

iv. Genetic Engineering Appraisal Committee (GEAC): The “Genetic Engineering Appraisal Committee (GEAC)” is formed under the “Rules for the Manufacture, Use /Import /Export and Storage of Hazardous Microorganisms/Genetically Engineering Organisms or Cells, 1989”. It is a supreme regulatory committee which functions under the “Ministry of Environment, Forests and Climate Change”. The Committee is composed of the Chairman who shall be “Additional Secretary, Department of Environment, Forests and Wildlife, the Co-Chairman who shall be the representative of Department of Biotechnology and other members are the representatives from Ministry of Industrial Development, Department of Biotechnology and the Department of Atomic Energy”. The Committee grants approval to the research institutions and industries engaged in the large-scale use of genetically modified organisms or other hazardous microorganisms taking into consideration the environmental safety. It also regulates experimental field trials which involves environmental release of genetically modified organisms. Further, the committee is empowered to punish the offender committed offence under the “Environment Protection Act, 1986”.

v. State Biotechnology Coordination Committees (SBCC): The State Biosafety Coordination Committee is formed in the respective states by the State Governments of India. It has power to take disciplinary action after conducting proper inquiry in matters of non observance of legal framework. The committee further analyze from time-to-time safety and controlling remedies in different industries and organisations dealing with genetically modified organisms and other hazardous microorganisms.¹⁵

vi. District Level Committees (DLC): The “District Level Committees (DLC)” is formed in a district where it is required to do so. The District Collector is the head of the DLC who has been vested with the responsibility to assess the safety regulations followed by the research institutions and industries engaged in the activities involving genetically modified organisms (GMO’s) or any other hazardous microorganisms. The DLC or any other person on that behalf should bring into light any danger involved in the activity and give suggestions to meet the emergency cases. The DLC is required to submit update report on a regular basis to the “State Biotechnology Coordination Committees or Genetic Engineering Approval Committee”.

The Rule 1989 under Section 7 to Section 11 provides certain guidelines for the approval and prevention on the application of GMO’s or other hazardous microorganisms. For the import, export, production or sell of the GMO’s or any hazardous microorganisms, approval from GEAC is required. ¹⁶ GMOs or other pathogenic organism can be used for research in laboratories under Environment Protection Act, 1989.¹⁷GEAC laid down measures for the prohibition and prevention of the discharge of GMO’s from the laboratories, hospitals or other concerned areas.¹⁸GEAC issues license in the prescribed manner to the concerned person for the use of the GMO’s mentioned in the schedule of the Rules for the operation of the pilot projects.¹⁹

The Institutional Biosafety Committee monitors and issue guidelines for conducting experiments for the educational purpose inside or outside the laboratories involving gene technology or microorganisms.²⁰Deliberate release of the GMO’s or other hazardous microorganisms into the environment is not allowed except in special cases.²¹ GEAC’s has to grant permission for production, use, import and sell of food articles containing GMO’s.²²It monitors that the terms and conditions of approval documents are implemented appropriately.²³ There is a specific procedure for confined field trial and approval of GM crop.

The Rule of 1989 is supported by many statutes and guidelines which are framed in the course of time for ensuring the biosafety of GM products. Some statues are “The Environment (Protection )Act, 1986; Recombinant DNA Safety Guidelines, 1990; Recombinant DNA Safety Guidelines and Regulations, 1994; Revised Guidelines for research in transgenic plants & Guidelines for toxicity and allergencity evaluation of transgenic seeds, plants and plant part, 1998; Guidelines for generating Pre-clinical and clinical data for rDNA Vaccines, Diagnostics and other Biologicals, 1999; ; Plant Quarantine (Regulation of Import into India) Order, 2003; Food Safety and Standards Act, 2006; Industries (Development & Regulation) Act, 1951 - New Industrial Policy & Procedures, 1991; Seeds Act, 1966; Seeds Rules, 1968; Seeds (Control) Order, 1983; Seeds Policy 1988 & 2002; Protection of Plant Varieties and Farmers' Rights Act 2001, PPV & FR Regulations 2006; Guidelines & Standard Operating Procedures (SOPs) for Confined Field Trials of Regulated, GE Plants, 2008; Guidelines for the Safety Assessment of Foods Derived from Genetically Engineered Plants, 2008-ICMR; and Protocols for Food and Feed Safety Assessment of GE Crops, 2008”.²⁴Few more legislations and bills are Patent Act, 1970, Consumer Protection Act, 1986 and the Biotechnology Regulatory Authority of India Bill, 2013”. There are several ministries and departments which regulate and monitor the food quality to safeguard human health and protect the environment from GM crops. They are as follows:-

i. Ministry of Environment, Forest & Climate Change: The “Ministry of Environment, Forest and Climate Change” is primarily responsible for implementation of environmental policies and programs in India for the protection, preservation and conservation of environment. It is also responsible to monitor the release of “Genetically Modified Organisms (GMOs) and Living Modified Organisms (LMO’s)” and assess the concerns relating to health of human beings and protection of the ecological order. It implements the “Rules for the Manufacture, Use/Import/Export and Storage of Hazardous Micro Organisms/ Genetically Engineered Organisms or Cells (Rules, 1989)” and “Cartagena Protocol on Biosafety” through its nodal agencies. In the “Genetic Engineering Approval Committee”, the Secretariat is the supreme body granting permission for the production, sale, import and export of GM products.²⁵

ii. Ministry of Science and Technology: Under the “Ministry of Science and Technology”, the “Department of Biotechnology” is established which encourage the agro-biotech research and providing scientific data for the proper implementation of the biosafety regulations. The Biosafety Research Program under the Department of Biotechnology has emphasized on the effective application of Environment (Protection) Act 1986 and Rules 1989 and other biosafety rules and guidelines framed under it to ensure safe use of GM products. A three-tier regulatory mechanism is responsible to grant permission for conducting research on GM goods and commercial release of GM crops.

iii. Ministry of Agriculture and Farmers’ Welfare: The “Ministry of Agriculture” is responsible for the agricultural growth and development in India. It consists of three main departments, “Department of Agriculture, Cooperation and Farmers’ Welfare, Department of Animal Husbandry, Dairying and Fisheries and Department of Agriculture and Research & Education”. “Indian Council for Agricultural Research” is the vested with the responsibility to monitor the agricultural benefits of the GM crops and approve GM crops in accordance to Seed Policy, 2002. It further evaluates the effect of GM crops after it is released.

iv. Ministry of Health and Family Welfare: The “Department of Health” under the “Ministry of the Health and Family Welfare” is responsible to frame policies to ensure the safety of public health and monitor it regularly. It promotes research in the fields relating to medical, bio-medical and health. The “Food Safety and Standards Authority of India” is set up under the “Food Safety and Standards Act, 2006”. It implements food safety laws provided under the Act, 2006 which ensures the quality and safety of the food. It is under the duty to provide safe, nutritious and hygienic food to the citizen of India. It also motivates the food business to follow safe manufacturing and hygienic method to ensure good quality of food to the people.

v. Ministry of Commerce and Industry: Under the “Ministry of Commerce and Industry” there are the “Department of Commerce and Department” for advancement of industries and internal trade. The “Ministry of Commerce and Industry” is engaged in formulating and implementing the import and export policies for the increase of the trade among various countries. It also implements the laws which control the quality of the trading goods. It develops and promotes steps for the growth of industries in India. It also enables and increases the flow of foreign direct investments. The intellectual property rights issues including patents, trademarks, industrial designs and geographical indication of product are regulated by the department.

Judicial Response

The judiciary in India emphasized on the effective regulatory system for GMOs and Scientific risk assessment for Genetically Modified Crop.

In Gene Campaign vs. Union of India,²⁶ Dr Suman Sahai, the petitioner who is the convener of Gene Campaign, a research and advocacy organization which aims to conserve genetic resources of crops. The petitioner urged effective regulatory system for GMOs which should be competent, accessible and transparent to public and moratorium imposed on commercial use of GM crops. The Court directed the concerned authorities to publish technical data concerning the GM crops in October 2006.

In Aruna Rodrigues v. Union of India²⁷, Aruna Rodrigues, contended that it is unconstitutional to release GMOs without required scientific biosafety assessment as it infringes Article 21 which prescribes the right to health and safe environment. It has been pointed out that the assessment of the GM crops was conducted by the biotech company was desired approval and the result were unavailable for public scrutiny. It has been alleged that the government policy was violating the precautionary principle as there is no proper system, transparency and accessibility of the scientific data relating to the biosafety. It was prayed to prohibit release of GMOs into the environment in any manner including import, manufacture or use.

The Supreme Court has ordered that “Genetic Engineering Approval Committee” approval is necessary for conducting field trials of GMOs. Thereafter, no open field tests were allowed by the Court. In 2007, the Supreme Court lifted ban on open field trials, and allowed it on only on the basis of certain conditions including a directive to maintain isolation distance of 200 meters while performing field tests of GMOs.

Further applications were filed to impose total ban on GMOs and constitution of an “Technical Expert Committee”. The Government suo motu imposed a complete ban on Bt Brinjal.The court further directed the constitution of “Technical Expert Committee (TEC)” and ordered to submit within three months time an interim report to Court. The “Technical Expert Committee in 2012 recommended a moratorium of 10 years on field trial of GM crops but the Supreme Court in 2012 rejected the Technical Expert Committee recommendations on the ground of want of receipt of complete report.

VI. Existing regulatory struct-ure in india: a critique

In India though there is no umbrella legislation to regulate and monitor the GM crops but most of the aspects relating to GM crops are dealt under various laws, rules and regulation. But what matters is the efficacy of these rules and regulations to protect ecological order and biodiversity and monitor the quality of food for human and animal consumption. Hence, it is imperative to analyze the efficacy of existing regulatory framework.

i. The existing regulatory mechanism is not conducting closed field trial itself instead it is dependent on the seed developer to provide data to grant permission. As the decision of GEAC is primarily based on this available data, there is wide scope for data manipulation in primary documents according to the requirements.

ii. The head of the GEAC is a member from the “Ministry of Environment, Forest and Climate Change” and other members in various committees of the GEAC are engaged in various departments of the government. There is no representation in GEAC from the State cultivating GM crops, expert from biotechnology stream and civil society.

iii. The composition and appointment of members in the committees are matter of concern. The constitution of RCGM consists of scientists from government institutions and departments who are involved in agro-biotech research. Experts are nominated by the government in the RCGM and the GEAC from non-Government organizations. But there is no qualification prescribed for the experts. It has been witnessed that mostly the experts are from academic field and scientist in government universities or research institutions. These experts are appointed by the Government on the recommendation of official members of the various committees. There is no provision in the present statute prescribing the terms and conditions of appointment, term of office, conditions of disqualification and removal.

iv. There is a conflict of interest in the regulatory authorities. It is noted that the member of GEAC is also associated with an organization funded by the promoters of GM. This can cause biased decision in the approval process.

v. The regulatory body lacks independent source of funds. The funds sanctioned to the committees are granted by the “Department of Biotechnology” and the “Ministry of Environment, Forests and Climate Change” under which the committees functions.

vi. Specific schedules of meetings held by committee are not provided either in the Rules or Guidelines. According to the number of applications to be considered the meetings are conducted which causes uncertainty and difficulty to the applicants to complete the required formalities.

vii. States are unaware of the fact that GM crops are cultivated in their areas illegally due to lack of institutional infrastructure. There is an absence of monitoring bodies to check these challenges.

viii. The District Level Committee (DLC) in States and Union Territories is essential component of the regulatory framework to monitor the growth of GM crops and check the efficacy of the regulation. It has not contributed significantly thereby causes suspicion regarding GM crops to the stakeholders like farmers, environmentalist, common man, etc.

ix. Public at large are not aware about the risk involved in the full fledged cultivation of GM crops. There is no coordination and communication between states and center authorities.

x. Decision making process is not transparent relating to clearance and information is not published in public platform. There is a lack of involvement of various stakeholders in decision making. Before granting an approval to the GM crops various sections of society does not get a chance to participate in the decision making. It indicates that the GM crops are pushed by the self interest groups without adhering required legal formalities. The information is avoided to be shared by both public and the private organisations.

VII. Conclusion

Agro-biotechnology has its own challenges like conventional practices of agriculture. There are various gray areas like creation of super weeds, increased use of toxic pesticides and herbicides, toxic or allergenic effects, unethical and immoral. These issues require sincere and persistent review. GM crops are able to solve several agricultural related problems which are faced by the farmers. As we have relative risks of all technologies, we also have risk of not accepting the biotechnological inventions like African countries have to witness many challenges in absence of Green Revolution. A report by European Commission in 2010,titled “A Decade of EU-Funded GMO Research”, observed “biotechnology, and in particular GMOs, are not per se riskier than e.g. conventional plant breeding technologies”. The acceptance of biotechnological inventions has several environmental benefits. GM crops have suppresed the release of greenhouse gases by decreasing pesticide application as pesticides manufacture requires more energy and gases. The farmers are saved from heavy exposure to these chemicals. The use of herbicide-tolerant crops allows farmers to reduce ploughing and weeding that releases carbon from soil. Solving world hunger is not the only purpose of GM crops but more than that is being done. Non acceptance of the technology can do more harm than good. The existing regulatory mechanism is unsatisfactory. An effective and rigorous monitoring process requires huge investment in science and technology. The policies should have precautionary approach without discriminating GM crops and should aim to conserve ecological order, biological diversity and preserve human health. On 25^th August 2017, the report was submitted by “the Parliamentary Standing Committee on Science and Technology, Environment and Forests” titled “Genetically modified crops and its impact on environment”, suggested “GM crops should be introduced in the country only after critical scientific evaluation of its benefit and safety, and also recommended restructuring of regulatory framework for unbiased assessment of GM crops”. A pragmatic approach by the international community that accommodates technology as well as precautionary measures to reduce the concerned risk from it would better serve the world’s most vulnerable people.

Prof. Swaminathan stressed that “a balanced approach to harness the positive aspects of biotech and to minimize the negative effects should be adopted. The policy framework should adequately address the issues of priorities, biosafety and regulatory aspects. The farmers’ leaders and the farmer achievers shall put forth their experiences and views towards finalization of the National Biotechnology Policy which may most effectively serve the farming community and the nation. Above all, our agricultural biotechnology policy and strategy should be pro-poor and pro-environment. Genetic engineering is a mean to ease out hurdles and provide solution if implemented vigilantly for a long term”.

Recommendations

i. There is huge debate on the effects of GM crops on ecological order, biodiversity, human and livestock health. Therefore, a scientific, detailed and comprehensive research is needed by the experts or scientist. A stringent and transparent regulatory mechanism is required for monitoring GM crops. The process of trials, assessment and granting permission should be rigorous, extensive and scientific taking into consideration the short and prolonged consequences of GM crops on ecological order and human health .There is an urgent need to conduct extended and multigenerational research to observe the effect of GM crops on health of human beings.

ii. The regulatory body should itself conduct closed field trials and make report accordingly. It will provide independent, unbiased and authentic data and thereby a reasonable decision can be taken with respect to GM crops. For the systematic and transparent field trials it is important that the government should collect data relating to institutions constituted and functions according to the guidelines for conducting field trials The interested party can select provided institutions for relevant studies relating to its product.

iii. There is a need to set up an autonomous body by statute which constitutes expert members specialized in the field of biotechnology and biosafety. An autonomous entity is vital in generating the “necessary public, political, professional and commercial confidence in the science based regulatory mechanism”. GEAC can only focus on environmental clearance. For efficacious application of the regulations, it is necessary to strengthen the institutional infrastructure.’

iv. In case of commercial release of GM crops, there is a need to frame mandatory labelling policy for GM goods and its by-products.

v. A regulatory mechanism should be established for transboundary movements to implement the “Advanced Informed Agreement (AIA)” under the “Cartagena Protocol” and “Nagoya Kuala Lumpur Supplementary Protocol” should be established.

vi. District Level Committees should function efficiently to builds confidence among stakeholders. It should nominate Members of Parliament as its member so that affairs handled by the Committees can be shared in public domain.

For an effective biosafety regime, it is significant to initiate public participation in decision- making procedure through discussions and debates. At the implementation level also stakeholders can be involved. For instance, the farmers can be engaged in the implementation of the regulatory rules by setting up infrastructure and capacity building at grass root level.

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