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Genetically Engineered Organism And Environmental Law

What Are GMOs?

A GMOs (genetically modified organism) is the result of a laboratory process where genes from the DNA of one species are extracted and artificially forced into the genes of an unrelated plant or animal. The foreign genes may come from bacteria, viruses, insects, animals or even humans. Because this involves the transfer of genes, GMOs are also known as “transgenic” organisms.[1]

Genetic Engineering - means the technique by which heritable materials which do not usually occur or will not occur naturally in the organism or cell concerned generated outside the organism of the cell is inserted into said cell or organism. It also means the formation of new combinations of genetic material by incorporation of a cell into a host cell, where they occur naturally as well as an modification of an organism or in a cell by delegation and removal of parts of the heritable material.[2]

For centuries crop plants and livestock have been crossbred such that the genetic make-up of offspring has been altered to select for desired traits and /or qualities. Traditional plant and animal breeding techniques require that the individual species involved are the same or closely related. However the discovery of genetic engineering techniques have made it possible to introduce, delete or enhance particular traits in an organism either by inserting genes from another organism or by otherwise altering its genetic make-up. Genetically Modified Organisms are defined in EU Legislation as ‘those in which the genetic material is altered in a way that does not occur naturally by mating or natural recombination.[3]

Where GMOs comprise bacteria, viruses, viroids and animal and plant cells in culture they are referred to as Genetically Modified Micro-Organisms or GMMs.Where GMOs comprise GM plants or GM animals otherwise known as transgenic plants or transgenic animals, they are referred to as GMOs.

Isobel Yeung reports: “Essentially, farmers have been modifying crops for thousands and thousands of years - most productive hybrids to create the best crops” she also said Savior Seeds. “Theoretically GMOs are just the next level of agricultural advancement. What’s different is a new gene is being inserted into a crop which otherwise wouldn't be there.”

Over the years, as humans chose certain qualities over others in plants, they molded crops into what they wanted them to be — bigger, tastier, and juicier. According to Bruce Chasey, executive associate director of the Biotechnology Center at the University of Illinois, we altered these plants so much that they developed into crops that would never survive in the wild without human care.

1800s. - Gregor Mendel was a scientist and Augustinian friar who lived in what is now the Czech Republic; he's considered the father of modern genetics due to his plant hybridization experiments. Hybridization involves breeding between plants (or animals) of different species — plants are more likely to hybridize because pollen often disperses onto the flowers of other species. He toyed primarily with pea plants between 1856 and 1863, and his work was later drawn upon in genetic engineering.

1954. -Watson and Crick described DNA’s shape as a double helix, paving the way for genetic engineering to make a real debut.

1970. - Monsanto, a major agriculture company that had its roots in the early 1900s and now controls most of the seed industry, employed chemist John Franz to redevelop glyphosate as an herbicide. The Monsanto glyphosate later came to be known simply as Roundup, which became one of the most commonly used herbicides among farmers, helping to keep pesky weeds at bay. Monsanto then went on to become the biggest supplier of glyphosate-resistant crops, known as “Roundup Ready” seeds.

1972. - Between 1972 and 1973, U.S. biochemists Herbert Boyer and Stanley Cohen did the unthinkable: They developed a technique that allowed them to cut pieces of DNA in certain places, and then attach the pieces to the DNA of other organisms, ushering in modern biotechnology. This was also around the time that the first debate over GMO health risks began to emerge. In 1976, biotechnology became commercialized, allowing companies to experiment with inserting genes from one species into another — whether for medicinal, food, or chemical reasons.

1982 - The U.S. Supreme Court ruled that GMOs could be patented, which allowed the Exxon Oil Company to begin using an oil-eating microorganism. In 1983, Monsanto scientists were some of the first to genetically modify plants, and five years later, they tested their first genetically engineered crops.

1988 - Scientists inserted genes into soybeans, ultimately creating which became the most common GMO: glyphosate-tolerant soybeans. Making a crop that was resistant to herbicide made it much easier, and cheaper, for farmers to control weeds while producing high yields. Soon, other GMO seeds were developed — including potato, cotton, rice, sugar beets, sugarcane, and tomatoes — with the intention of making these crops resistant to insects, antibiotics, diseases, herbicides, and pesticides.

Ecological Concerns
When the splicing of genes viruses became possible, there was general concern that if this were done in respect of specifically tumour viruses their inter-species pathogenicity might be enhanced. There might also be altered patterns of disease and geographical spread. Thus it was that at an early date in the history of biotechnology, around 1973, there existed among scientists a moratorium on constructing recombinant cancer viruses, whether human or plant, lest there be harm if they escaped into the environment, or that particular component of the environment thought so precious, ourselves as human beings. Obviously, were this to happen removal from the environment would be rather difficult, for experience has shown that even large animals like rabbits in Australia are impossible to eradicate if they reach threshold numbers. And viruses are notoriously resilient particles. However, neither at the stage of initiating the moratorium, nor for a long time afterwards, was public or legal opinion engaged.[4]

An important conference held at Asilomar, California in 1975 saw eminent molecular biologists agreeing to restraint in cloning DNA in those organisms which had not been specifically disabled in some way to restrict their growth outside the test tube. National Institutes of Health (NIH) guidelines were produced after the conference, which effectively forbade the use of recombinant DNA (DNA) techniques in cancer viruses. They were not applicable to private industry. In any case, however, they were revoked in 1979, for by then two safe plasmid vectors (rather than viruses) had been developed.[5] Many scientists came to view the concerns expressed in the 1970s were premature. Any GMO released into the environment is likely to be less well adapted to stress than the wild types being highly selected for survival under restricted conditions - and will tend to die out. Ordinary micro-organisms in the free-living state have been known, for many years, to mutate spontaneously, travelling long distances and even exchange genetic material with other micro-organisms.[6] If GMOs do this too, it is said, there is unlikely to be any dire consequence.

Recently, however, fresh warnings have been articulated by scientists and these find strong resonance among the public and in non governmental organisations (NGOs). There is concern that transgenic plants might become competitive and weed-like. And there is certainly evidence of genetic exchange between GMOs as crops and weeds. Some purely scientific research has shown this to be possible.[7] Transgenic livestock are held to be of low risk to the environment but transgenic fish and live virus-based vaccines pose greater risks.[8] Moreover agricultural botanists in France have shown that genes for herbicide resistance in oilseed rape can spread to wild radish and that potatoes engineered to resist aphids can also harm natural predators of the aphids, namely ladybirds. Above all the marker genes in some plants are those that confer antibiotic resistance; fears that these genes might be transferred to pathogenic bacteria are among the most frequently expressed in the context of the whole debate. In summary, the concerns lie under two main heads: direct harm to human beings (principally through bio-engineered food, but to a lesser extent, by live vaccines) and harm to the environment (of which a sub-head would be the harm caused by transboundary movement of GM’s).[9]

The fact that hitherto there has been no environmental mishaps does not mean that a disaster will never happen; every technological advance, ranging from steam engines and ocean liners to atomic power stations has imported mishaps which were foreseen but were not sufficiently protected against. Thus, regulatory and legislative responses to the risks of the new technology, namely the engineering of GMOs, are discernible and these would generally be considered to fall under the aegis of administrative and environmental law, both international andmunicipal. Many writers regard these as unsatisfactory.[10] Much is left to regulatory agencies whose terms of reference vacillate with ministerial directives and statutory instruments. There is not always detectable responsibility to the public. Until a binding bio-safety protocol to the 1992 Convention on Biological Diversity (CBD) is in place, each country is free, at the moment, to adopt its own regulations relating to GMOs. In respect of municipal systems even authoritative commentators declare themselves bemused by the complexity and impenetrability of such regulatory mechanisms as presently exist. To a large extent, however, this is a consequence of the science involved. GMOs may be classified according to their possible pathogenicity - in other words the potential release of an engineered tomato is one thing, of a bacillus engineered to act as a vaccine quite another matter. Regulations are generally framed separately for containment, usually in laboratories or depositories, and for release. And in the context of tomatoes again, authorities are struggling to find coherent regulations for genetically modified food in the shops.[11]

According to World Health Organization, the main ecological concerns related to GMOs are:
# The capability of the GMO to escape and potentially introduce the engineered genes into wild populations
# The susceptibility of non-target organisms (e.g. insects which are not pests)to the gene product
# The stability of the gene
# The reduction in the spectrum of other plants leading to loss of biodiversity
# The increased use of chemicals in agriculture

The ecological concerns of GMOs stem from our inability to control them (or their environment) once “released” into nature and no longer subjected to the strict controls possible in a laboratory setting. This leads to the possibility of GMOs, or their genes, spreading to populations in which GMOs were not intended to be. Unfortunately, some of these concerns have already been realized. In North Dakota, GM canola has “escaped” and is growing like a weed in many different locations. Likely the original source of the GM canola “weeds” are the trucks that transport the canola seeds; seeds spill from the trucks as they drive along windy or bumpy roads. Researchers studying these canola plants have found evidence that they are breeding with one another in the wild. In another example, researchers in Mexico have found evidence of the spread of a modified gene in GM corn spreading to the traditional maize crop. Since 1998, Mexico has banned the planting of GM corn in an attempt to protect its many strains of native maize. The source of the transgene may have been illegally planted crops.[12]

The report prepared by the Law Centre of IUCN, the World Conservation Union (2004), enlists numerous environmental risks likely to occur by the use of GMOs in the field.

These risks are as follows:[13]
Genetic Contamination/Interbreeding
Introduced GMOs may interbreed with the wild-type or sexually compatible relatives. The novel trait may disappear in wild types unless it confers a selective advantage to the recipient. However, tolerance abilities of wild types may also develop, thus altering the native species’ ecological relationship and behaviour.

Competition with Natural Species
Faster growth of GMOs can enable them to have a competitive advantage over the native organisms. This may allow them to become invasive, to spread into new habitats, and cause ecological and economic damage.

Increased Selection Pressure on Target and Non target Organisms
Pressure may increase on target and nontarget species to adapt to the introduced changes as if to a geological change or a natural selection pressure causing them to evolve distinct resistant populations.

Ecosystem Impacts
The effects of changes in a single species may extend well beyond to the ecosystem. Single impacts are always joined by the risk of ecosystem damage and destruction.

Impossibility of Follow-up
Once the GMOs have been introduced into the environment and some problems arise, it is impossible to eliminate them. Many of these risks are identical to those incurred with regards to the introduction of naturally or conventionally bred species. But still this does not suggest that GMOs are safe or beneficial, nor that they should be less scrutinized.

Horizontal Transfer of Recombinant Genes to Other Microorganisms
One risk of particular concern relating to GMOs is the risk of horizontal gene transfer (HGT). HGT is the acquisition of foreign genes (via transformation, transduction, and conjugation) by organisms in a variety of environmental situations. It occurs especially in response to changing environments and provides organisms, especially prokaryotes, with access to genes other than those that can be inherited.

At present the main ecological concerns related to Genetically Engineered Organism are related to GMO crops and plants.

These are:
1. Firstly, toxicity is a huge issue surrounding chemical pesticides and herbicides, used commonly with GMOs, in addition to the toxicity inherent to these plants. GMOs may be toxic to non-target organisms, bees and butterflies being the most talked-about examples currently. Bees are hugely important in the pollination of many food crops, but are unfortunately extremely endangered by modern agricultural techniques, such as GM crops. Monarch butterflies are specifically at risk from GMO maize plants. In addition to bees and butterflies, birds are also at risk from pesticides, and work as biological control agents and pollinators, again, like bees.

2. The longterm effects of GMOs are not certain. Pests that are targeted by these agricultural methods can adapt to pesticides and herbicides, in addition to the DNA changes in GM plants to make them ¨resistant.¨ This means that they will not always be effective, but their toxic legacies will remain.

3. Cumulative effects of products such as GMOs are important to take into consideration. Evidence also suggests that small genetic changes in plants may produce even larger ecological shifts, meaning that there is potential for GMO織s to become persistent and weedy in agricultural conditions, since they are modified to be resistant to some modern agricultural techniques. This can also mean being invasive in natural settings, where GMOs, of course, do not occur naturally. It is not impossible for new, human modified, plants to become invasive species in delicate, natural ecosystems.

4. Biodiversity is put at risk by GMOs. When GM crops are planted, generally in a monocrop fashion, many heritage seeds are no longer used. The nature of GMOs means fewer weed flowers and, therefore, less nectar for pollinators. Toxins released into the soil through the plants´ routes mean fewer soil bacteria, which are integral to healthy soil for plants to grow without the use of chemical fertilizers. Toxic residues are left in the soil of GM crops. Nutrients are not returned to the soil in mono crops and from GMO foods, meaning that soil is becoming dry and void of all nutrients, generally integral to the growing process. A cycle of dependence on GMO seeds and chemical fertilizers, pesticides, and herbicides is then created in order to grow a single crop. In addition to soil issues, the irrigation used to grow GM foods naturally carries all of these problems into water sources and into the air. This exposes different bacteria, insects, and animals to the same problems.

Environmental issues and GM forest trees

Research on the genetic modification of forest trees is undertaken almost exclusively with a view to application in plantation forestry. One of the first reported trials with GM forest trees was initiated in 1988 using poplars. Since then, there have been more than 100 reported trials in at least 16 countries, involving at least 24 tree species - mostly timberproducing species for use in intensively managed plantations. There is no reported commercial-scale production of GM forest trees.

Traits for which genetic modification can realistically be contemplated in the near future include insect and virus resistance, herbicide tolerance and modified lignin content. Investments in GM technologies should be weighed against the possibilities of exploiting the large amounts of generally untapped genetic variation that are available within forest tree species in nature.Biosafety aspects of GM trees need careful consideration because of the long generation time of trees, their important roles in ecosystem functioning and the potential for long-distance dispersal of pollen and seed.

Environmental issues and GM fish
In the fisheries sector, most GMOs show increased growth rates; therefore, concerns about environmental risk focus more on predation, competition and genetic pollution. GM fish may pose risks to the environment because of their increased rates of feeding on prey species; their wider environmental tolerances, which allow them to invade new territories and possibly to displace local native populations; and their potential for genetic mixing with, and thus the altering of, the composition of natural fish populations.

GMOs and Environmental Law

International Efforts
The most direct approach to these dangers would of course be treaty agreements, in effect hard international law. The growing awareness of the danger to biodiversity highlighted by IUCN in the 1980s led to an initiative by UNEP which culminated in the formation of the Biological Diversity Group at the UN Earth Summit in Rio de Janeiro in 1992, then the Cartagena Protocol on Biosafety or Convention on Biodiversity (CBD), followed by a growing movement within the CBD for an international binding framework treaty on the safety of GMOs.

The relevant context of Article 8 (g)[14] of the CBD provides:
“[Each contracting party shall ...] establish or maintain means to regulate, manage or control the risks associated with the use and release of living modified organisms resulting from biotechnology which are likely to have adverse environmental impacts that could affect the conservation and sustainable use of biological diversity taking also into account the risks to human health.”

Moreover Article 19[15] reads:
“The parties shall consider the need for ... a protocol setting out appropriate procedures in the field of safe transfer, handling and use of any living modified organism resulting from biotechnology that may have adverse effects on the conservation and use of biological diversity.”

Thus, the twin heads of danger to humans and danger to the environment were addressed in the initial drafts. It is clear that the CBD is one of the new "framework" conventions, in that it identifies various sectors which can be subject to future agreements as protocols on the basis of expanding scientific knowledge and indeed, by expanding necessity for international cooperation. The Conference of Parties thus set up a body to consider the perils of GMOs - the Open-ended Ad Hoc Working Group on Biosafety (OEAHWGB), though there was no conclusive result[16]. The problem seems to centre round the question of Advanced Informed Agreement (AIA), that is agreement between importer and exporter of GMOs. One group of countries (the "Miami Group"), importantly including the US, wish this to be the responsibility of the importer. Other, mostly developing countries, cannot accept this. There was also no consensus on regulations for commodities, such as GMOs for processing and consumption, not breeding. The OEAHWBG is able to avail itself of other codes of conduct and regulation as models. These range from the Codex Alimentarius (a FAO/WHO sponsored set of food standards) to the FAO Code of Conduct on Plant Biotechnology and the 1984 Organisation for Economic Cooperation and Development (OECD) Safety Considerations for Biotechnology.

Specially favoured are the documents for the Second Meeting of the United Nations Environmental Programme (UNEP) International Technical Guidelines for Safety in Biotechnology which date from 1995. They emphasise that the free exchange of information is an important safety mechanism and this includes advance notification. That is, a potentially affected country should be informed immediately in the event of any adverse effect of the use of an organism with novel traits which could affect it.[17]

Parallel to the efforts deriving from the CBD specifically, there were moves related to the safety references in Chapter 16 of Agenda 21.[18] This led to a Commission on Sustainable Development, the responsibility of the UN Industrial Development Organisation (UNIDO) and a 1993 paper by the Dutch and UK Environmental agencies. It was debated at the 1994 Intergovernmental Commission on the CBD (ICCBD) meeting but led to little result. Deriving from the non-binding Chapter 16, it could have been adopted rapidly on a voluntary basis, whereas the ICCBD was and still is groping towards a binding protocol. The Dutch/UK voluntary guidelines have however been adopted for bilateral agreements, notably between UK and Argentina.

The international agreements such as Cartagena Protocol on Biosafety, Convention on Biological Diversity (CBD), and the International Plant Protection Convention (IPPC) address the environmental aspects of GMOs. The Article 15 of the Cartagena Protocol on Biosafety (CBD 2000) implies risk assessment to be in compliance with criteria of science and transparency using already existing and recognized techniques.

The characterization process should adopt a multidisciplinary approach that:
(i) analyses methodologies in statistics,
(ii) considers the individual components employed to produce the GMOs (such as characteristics of the donor organism, vector, and inserted DNA),
(iii) evaluates the final result in its totality (characteristics of the organism with new traits, information related to intended use, and characteristics of the potential receiving environment),
(iv) considers relevant information produced from both public and private research institutes and from international agencies.[19]

The Cartagena Protocol on Biosafety in the year 2006 introduced an Annex III in the protocol of Article 15 for scientifically sound and transparent risk assessment taking into account risk assessment techniques. Such risk assessments shall be based at a minimum, on information provided in Article 8, and other available scientific evidence in order to identify and evaluate the possible adverse effects on human health and environment. The principles and methodology described in Annex III of the protocol follows the proven, well-accepted risk assessment paradigm, including identification of potential harmful characteristics of modified organisms that may have an adverse effect.[20] It also evaluated the effectiveness of the protocol (COP-MOP) for risk assessment in the Article 35 in the year of 2008 for the safe transfer, handling, and use of living modified organisms (LMO) to protect the significant loss of biological diversity.

As in the year 2010, biodiversity target is approaching to revise the current Strategic Plan of the Convention and adopt a new biosafety strategic plan (2011–2020) to implementation of more effective risk assessment strategic plans to protect the risk of GMO/LMO according to the Bureau of COP-MOP/4.

In 1986, a publication by the Organization for Economic Cooperation and Development (OECD), called “Recombinant DNA Safety Considerations,’’ became the first intergovernmental document to address issues surrounding the use of GMOs. This document recommended that environmental risk assessments can be performed on a case-by-case basis. Since then, the case-by-case approaches of risk assessment for GMO have been widely accepted. However, the USA. has generally taken a product-based approach of risk assessment and Europe adopted a process-based risk assessment approach for GMO.

Environmental risk assessment (ERA) considers the impact of introducing a GM plant into a given environment. The ERA is concerned with evaluating the potential for harm to ecosystem components given that there is exposure to the GM plant. Importantly, the focus and degree of emphasis on elements of the ERA will change during the development process for the GM plant as the scope of environmental release ranges from confined field trials of limited extent through to larger-scale trials and seed increases in more environments, and to the final unconfined commercial release.Risk assessment also focused on the change brought about by genetic engineering allows for detailed consideration of the potential consequences of the change relative to the way the GM plant is intended to be used and the environments in which it may be found. In terms of potential genetically modified food safety, key considerations are how the change may result in toxicity or allergenicity.


Association of South East Asian Nations (ASEAN) It is reported that countries in South-east Asia are enthusiastic about the biotechnology proposals in the drafts following on from the CBD; this is in the interests of integrating ASEAN's nascent biotechnology industry into the world scene, thereby to attract investment and also, of course, to benefit from the pre-existing wealth of biodiversity in the region.
With exploitation and conservation must come safety regulations. The 1985 ASEAN Agreement on Conservation of Nature and Natural Resources contains language which could be relevant.
Article 20 states: “Contracting parties have in accordance with generally accepted principles of international law the responsibility of ensuring that activities under their jurisdiction or control do not cause damage to the environment or the natural resources under the jurisdiction of other Contracting Parties or of areas beyond their limits of natural jurisdiction.” It further provides: "Contracting Parties shall in particular endeavour to refrain from actions which might directly or indirectly adversely affect wildlife habitats." Advance notification of a release near to a national border of a GMO with potential hazards would seem to be obligatory in terms of Article 20(b).[21]

Environmental law and provisions related to GMOs

The Rules for Manufacture, Use, Import, Export, and Storage of Hazardous Micro-organisms, Genetically Engineered Organisms or Cells, 1989 promulgated under the Environment (Protection) Act, 1986 was entered into force on 13 September 1993
The Rules purport to protect the environment, nature and health in relation with the application of gene technologies and micro-organisms. They regulate 'genetically engineered organisms , micro-organisms, cells and any substance, and products and foodstuffs etc. of which such cells, organisms or tissues form part (rule 2(2)). The Rules extends to the following activities:[22]
(a) sale, offer for sale, storage for the purpose of sale, offers and any kind of handling over with or without a consideration;
(b) exportation and importation of genetically engineered cells or organisms
(c) production, manufacturing, processing, storage, import, drawing off, packaging and replacing of the genetically engineered products;
(d) production, manufacture etc. of drugs and pharmaceuticals and food stuffs, distilleries and tanneries etc. which make use of genetically engineered micro-organisms in one way or other [rule 2(4)].
The two main agencies responsible for implementation of the rules are the Ministry of Environment and Forests (MoEF) and the Department of Biotechnology (DBT), Government of India. The rules have also defined competent authorities and the composition of such authorities for handling of various aspects of the rules.

There are six competent authorities as per the rules:[23]
1. Recombinant DNA Advisory Committee (RDAC): The Recombinant DNA Advisory Committee (RDAC) constituted by DBT takes note of developments in biotechnology at national and international level and prepares suitable recommendations.
2. Review Committee on Genetic Manipulation (RCGM)
3. Genetic Engineering Approval Committee (GEAC)
4. Institutional Biosafety Committees (IBSC)
5. State Biosafety Coordination Committees (SBCC): The State Biotechnology Coordination Committees (SBCCs) set up in each state where research and application of GMOs are contemplated, coordinate the activities related to GMOs in the state with the central ministry. SBCCs have monitoring functions and therefore have got powers to inspect, investigate and to take punitive action in case of violations.
6. District Level Committees (DLC): District Level Committees (DLCs) are constituted at district level to monitor the safety regulations in installations engaged in the use of GMOs in research and application.

Out of these, the three agencies that are involved in approval of new transgenic crops are:
a) IBSC set-up at each institution for monitoring institute level research in genetically modified organisms. This committee is to assist the occupier or any person including the research institution in handling micro-organisms or genetically engineered organisms in preparing an upto date site emergency plan according to the manuals/ guidelines of RCGM and make available copies of the District Level Committee/ State Biotechnology Coordination Committee and Genetic Engineering Approval Committee.

b) RCGM functioning in the DBT to monitor ongoing research activities in GMOs and small scale field trials. It functions are to monitor safety related aspects in respect of research or projects, bring about guidelines specifying procedures for regulatory process, review on-going process and to lay down procedures restricting or prohibiting sale or production or import etc.

c) GEAC functioning in the MoEF to authorize large-scale trials and environmental release of GMOs. The Committee works under the Department of Environment Forest and Wildlife and has power to take punitive action under Environment (Protection) Act.

The approvals and prohibitions under Rules 1989 are summarized below:[24]
1. No person shall import, export, transport, manufacture, process, use or sell any GMOs, substances or cells except with the approval of the GEAC.
2. Use of pathogenic organisms or GMOs or cells for research purpose shall be allowed under the Notifi cation, 1989 of the EPA, 1986.
3. Any person operating or using GMOs for scale up or pilot operations shall have to obtain permis- sion from GEAC.
4. For purpose of education, experiments on GMOs IBSC can look after, as per the guidelines of the Government of India.
5. Deliberate or unintentional release of GMOs not allowed.
6. Production in which GMOs are generated or used shall not be commenced except with the approval of GEAC
7. GEAC supervises the implementation of rules and guidelines.
8. GEAC carries out supervision through SBCC, DLC or any authorized person.
9. If orders are not complied, SBCC/DLC may take suitable measures at the expenses of the person who is responsible.
10. In case of immediate interventions to prevent any damage, SBCC and DLC can take suitable measures and the expenses incurred will be recovered from the person responsible.
11. All approvals shall be for a period of 4 years at fi rst instance renewable for 2 years at a time.

12. GEAC shall have powers to revoke approvals in case of:
# Any new information on harmful effects of GMOs.
# GMOs cause such damage to the environment as could not be envisaged when approval was given.
# Non-compliance of any conditions stipulated by GEAC

Safety Guidelines
The National Biotechnology Board of India formulated a set of safety guidelines for the protection of workers in laboratory environment as early as 1983. The DNA Advisory Committee of the Department of Biotechnology prepared the first Indian Recombinant DNA safety regulations.[25]

Bio-safety Guidelines in 1990 for conducting research and handling of GMOs. In 1994 and subsequently in 1998, the Review Committee of Genetic Manipulation revised the 1990 guidelines. The scope of the 1990 Guidelines extends to research, large-scale operations and environmental risks.[26] The Revised Guidelines for Safety in Biotechnology, 1994 pertain to research involving GMOs, vaccine and diagnostics development using DNA technology, large scale production of GMOS and their deliberate and accidental production, GMO import and shipments for laboratory research and large scale use. Principles relevant to the quality control of biological produced by DNA technology are also provided for in the Guidelines. The Revised Guidelines for Research in Transgenic Plants and Guidelines for Toxicity and Allergen city Evaluation a/Transgenic Seeds, Plants and Plant Parts, 1998 recommends norms for research in DNA plants (their development and growth in soil for molecular and field evaluation) and import and shipment of transgenic material for research. A protocol for allergen city testing of GM products in animal model is also suggested, even in the absence of any established animal models. Guidelines for the Conduct of Confined Field Trials of Regulated, GE plants in India (2008) increments the 1998 guidelines. Standard Operating Procedures (SOPs) for Confined Field Trials of Genetically Engineered Plants: Transport, Storage, Management, Harvest or Termination and Post Harvest Management set down safety requirements, conditions for labeling and accompanying documentations, records and corrective actions in case of accidental releases.[27]

Food Control System

As the Government has the prime responsibility for the establishment and operation of national food safety programs and quality control systems that must ensure safe and wholesome food to meet the nutritional needs of consumers and do not endanger the consumer’s health through chemical, biological or other contaminants, it has set up a ‘food control system’ that includes the national, state and municipal organizations involved in either the regulation, inspection or analysis of food and agricultural products, together with their supporting legislation and rules and compliance activities.

1. Prevention of Food Adulteration Act
In India, the Ministry of Health and Family Welfare (MOH&FW) in the Central Government is the nodal Ministry for ensuring the quality and safety of food marketed in the country. A comprehensive legislation called the Prevention of Food Adulteration Act (PFA Act) has been enacted in 1954, which came into effect from June 1, 1955, with the objective of assuring the quality and safety of food as well as to encourage fair trade practices.
The responsibilities of the PFA cell in food control system are as follows:
# Enhance the availability of safe and wholesome food.
# Consumer protection from deception, fraud and food-borne diseases.
# Risk analysis, risk management and risk communication.
# Ensure safety of genetically modified food.
# Enhance the involvement of NGOs and Home Science Institutes.
# Educational authorities to ensure better consumer protection.
# Promote a voluntary management system, the Code of Ethics, through principles of GMPs and the HACCP.

The Food Safety and Standards Act, 2005
The Ministry of Food Processing Industries has introduced “The Food Safety and Standards Bill, 2005” which led to The Food Safety and Standards Act, 2005, it seeks to consolidate the laws relating to food and establish the “Food Safety and Standards Authority of India”. This step has been taken keeping in view the fact that presently eight ministries are administering food laws in diverse ways which has been found to be not conducive to the growth of the food processing industry.[28]

The “Food Safety and Standards Authority of India” facilitates scientific standards for food articles and regulate their manufacture, storage, distribution, sale and import to ensure the availability of safe and wholesome food for human consumption. The authority will consist of members from various ministries, and representatives from State Governments, the food industry, consumer organisations and even farmers’ organisations. Scientific committees and panels will assist it in fixing standards, while a Central Advisory Committee will prioritise the work.

Genetic Engineering is the technique by which heritable materials which do not usually occur or will not occur naturally in the organism or cell concerned generated outside the organism of the cell is inserted into said cell or organism. It also means the formation of new combinations of genetic material by incorporation of a cell into a host cell, where they occur naturally as well as an modification of an organism or in a cell by delegation and removal of parts of the heritable material. Thus, A genetically modified organism (GMO) also called Genetically Engineered Organisms, are organisms in which the genome, that is the DNA which determines its characteristics, has been modified by human intervention.

The ecological concerns of GMOs stem from our inability to control them (or their environment) once “released” into nature and no longer subjected to the strict controls possible in a laboratory setting Growing concerns include: their toxicity level, The susceptibility of non-target organisms, effect of reduction in biodiversity. Since, the creation and release of GMOs has a huge impact on the environment and thus it falls in the domain of environmental law.

Various efforts have been made in form of international and regional treaties and domestic legislations to deal with the adverse effects of GMOs. Indian environmental jurisprudence has also deal with this issue and have introduced number of provisions to deal with the concerns related to genetically engineered organism.

[2]Rule 3(iii), The Hazardous Micro-organism Rules
[4] John Candlish, Releasing Genetically Modified Organisms into the Environment: Legal Concerns East and West, ASIA PACIFIC JOURNAL OF ENVIRONMENTAL LAW, VOL 4, ISSUE 2, 1999
[5] H. Abelson "Biotechnology: an Overview" (1983) 219 Science 611
[6] M. G. Lorenz and W. Wackernagel "Bacterial Gene Transfer in the Environment" in K. Wohrmann and J. Tomiuk (eds) Transgenic organisms: Risk Assessment of Deliberate Release (Birkhauser, Basel: 1993).
[7] A. M. Timmins, Y. M. Charters and J. W. Crawford "Risks from Transgenic Crops" (1996) 380 Nature 487
[8]John Candlish, Releasing Genetically Modified Organisms into the Environment: Legal Concerns East and West, ASIA PACIFIC JOURNAL OF ENVIRONMENTAL LAW, VOL 4, ISSUE 2, 1999
[9]John Candlish, Releasing Genetically Modified Organisms into the Environment: Legal Concerns East and West, ASIA PACIFIC JOURNAL OF ENVIRONMENTAL LAW, VOL 4, ISSUE 2, 1999
[10] S. Bell Ball and Bell on Environmental Law: The Law and Policy Relating to the Protection of the Environment (4th, Blackstone Press, London: 1997) 23
[11]John Candlish, Releasing Genetically Modified Organisms into the Environment: Legal Concerns East and West, ASIA PACIFIC JOURNAL OF ENVIRONMENTAL LAW, VOL 4, ISSUE 2, 1999
[14]Convention on Biodiversity, 1992
[15]Convention on Biodiversity, 1992
[18]J.J. R. Upadhyay, Environmental Law, 3rd ed., Central Law Ageny, 2012
[21]J.J. R. Upadhyay, Environmental Law, 3rd ed., Central Law Ageny, 2012
[23]J.J. R. Upadhyay, Environmental Law, 3rd ed., Central Law Ageny, 2012

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