The term GMOs - Genetically Modified Organism is most commonly used to refer to crop plants created for human or animal consumption using molecular biology techniques.  These plants are modified in the laboratory to enhance desired traits  such as increased resistance to plant diseases, germs or improved nutrition content.  The conventional plant breeding methods are very time consuming   and often not very  accurate.  Thus GM Foods offers a novel way to improve crop characteristics such as   yield, pest resistance, herbicide tolerance.

Genetically Modified Organisms

Genetically modified organisms are  organisms in which the genetic material  (DNA) has been altered in a way that does not occur naturally by mating or natural recombination.  This technology is known as modern biotechnology or genetic engineering or recombinant DNA technology.  It allows selected individual genes to be transferred from one organism into another, also between non-related species, to give new traits to the recipient.

Transgenic Plants

A transgenic plant is a  genetically modified organism, which contains artificially inserted gene or genes from an unrelated organism.  The inserted gene ( known as trans-gene ) may   come from another unrelated plant, or from completely different species, for example Bt. Cotton, contains a gene from a bacterium.

The Ministry of Environment and Forests  has formulated the ‘Rules for the Manufacture, Use, Import and Export and Storage of Hazardous Micro Organisms/Genetically Engineered Organisms or  Cell, 1989’, commonly known as  ‘Rule 1989’.  These rules  and regulations cover the areas of research as well as large scale applications of GMOs and their products.These include recombinant pharma products, transgenic crops, GM Food and product containing GM ingredients.

Biosafety Assessment’ Of Transgenic Crop

There are extensive rules and guidelines for evaluating environmental and health safety aspects of genetically modified organism.  Any Company involved in the use of genetic engineering techniques has to obtain approval of the Review Committee on Genetic Manipulation (RCGM) set up under the 1989 Rules in the Department of Biotechnology for conducting tests under laboratory  conditions and confined field conditions.  Based on these results, the RCGM makes its recommendation to the GEAC.  Thereafter approval of GEAC is required for conduct of large-scale field trails for a number of parameters, which includes bio-safety, efficacy of the variety, agronomic benefits and economic advantage of the GM crop.  The results of  the large-scale field trials are evaluated by the Monitoring-Cum-Evaluation Committee (MEC).

             The GM crops approved for large scale trials are also evaluated under the Indian Council of Agriculture & Research (ICAR) testing system.  The GEAC takes into consideration the recommendations of the  MEC and ICAR before approving the GM groups for commercial cultivation.

The bio-safety assessment  include environmental safety assessment as well as food and feed safety.   

Only those transgenic crops which are found to be safe for human consumption as well as  the environment are approved  for commercial release.

Generating The Bio-Safety Data

Biotechnology product development and associated regulations for ensuring bio-safety is capital-intensive requiring skilled personnel.  Therefore, food safety studies are being conducted in public institutions such as  Indian Veterinary Research  Institute, Izatnagar;National Dairy Research Institute, Karnal; Indian Toxicological  Research Institute, Lucknow; Avian Research Institute, Rae Bareilly; Central  Fish Institute and Education, Mumbai; Rallies India Ltd. Bangalore.  The data generated in these institutions are further scrutinized by independent experts as well as expert members   of the regulatory bodies (RCGM and  the GEAC).

The concept of testing toxicity and allergenicity is not new and is a common practice in the Pharma sector where the  DCGI under the Drugs and Cosmetic Act accept the data generated by the applicants.

Further, to ensure that the data submitted by the company is correct, the provisions under EPA provide for post- release monitoring and revoking of the clearance.

 Policy For Approving Transgenic Crops

In the case of modern agricultural biotechnology, the benefits as well as risks vary from crop to crop, region to region and technology.  It is a scientifically established fact that Gene functions differently in different crop and the impacts vary from species to species and the environment in which it is hosted.  Further the performance of a transgenic crop species depends on the gene-environment interaction.  Therefore  a policy of case by case approval  in case of genetically  modified (GM) foods or food crop is being followed.  As of date, the Genetic Engineering Approval Committee has approved the commercial  cultivation of  only one transgenic crop namely Bt. Cotton.

Various Stakeholder Ministries have initiated the process of evolving a GM policy pertinent to their sector.  Important initiatives  are: The Food Safety and Standards Act, 2006 by the Ministry of Food Processing and Industry; Import Policy for GMO/LMO Products Under Foreign Trade Policy (2005-2009) by Ministry of Commerce (DGFT); Draft notification on mandatory Labeling   by Ministry of Health and Family Welfare; Draft National Biotech Strategy, 2005 by Department of Biotechnology and National Environment Policy, 2006 by Ministry of Environment and Forests.

Bt Cotton

Bt  cotton is the only transgenic crop  approved for commercial cultivation in India.  Bt. Cotton containing Cry 1 AC gene (MON 531 event) of M/s Mahyco was the first transgenic crop released in India in April 2002 with the approval of the GEAC.  Subsequently, 62 new Bt cotton varieties have been released.

Bt. Stands for Bacillus Thurigniensis, a soil bacterium which synthesizes a crystal (Cry) protein .  In the insect gut, the protein breaks down to release toxin, which kills the insect. These  Cry genes are known as Bt genes.  Through genetic engineering, the Bt. Gene is inserted into cotton, so that the plant produces its own Bt toxin.  Cotton plants with these genes provide resistance to ballworm, a major cotton pest.  Bt cotton is under commercial cultivation in USA, Australia, China, Mexico, South Africa and Argentina.

Experience In Cultivation Of Bt Cotton

The Bt cotton technology has been beneficial to farmers.  The total area under Bt cotton has increased from 72,682 acres in 2002 to 8600000 acres in 2006.  The total estimated production during 2005-06 is about 25 million bales (170 kg. each).  Bt cotton has reduced pesticide usage by 2260 MT of  pesticides.  Among five cotton growing States of Gujarat, Punjab, Maharashtra, Andhra Pradesh and Karnataka, Gujarat tops the list with maximum yield.

World over, all GM crops are assessed for its  toxicity and allergenicity prior to market  authorization.

GM crops containing Bt protein are being consumed in several countries (including developed countries like Japan, EU, Australia and New Zealand) for many   years and there has been no scientific evidence generated on toxicity of Bt cotton to human and animal health.

Bt Brinjal (Egg Plant)

M/s. Mahyco has produced transgenic brinjal plants with Cry I AC  gene from Bacillus thuringiensis tolerant to the fruit and shoot borer, one of the major pests which attack the brinjal crop throughout its life cycle.  This is the first GM food crop under evaluation for release in India but it is also the first GM eggplant to be released globally.

A number of public institutions and private sector companies are in various stages of developing and   attesting of GM with the approval of RCGM.  Of the   genetic modifications attempt, the vast majority are intended to confer pest resistance.

Another focus of genetic transformations has been the production of higher value hybrids in crops such as mustard.

The Genetically modified crops  under field trials in the country are: brinjal, cabbage,  cauliflower, chickpea, cotton, groundnut, maize, mustard, okra, pigeon pea, potato, rice, sorghum and tomato.

*Media & Communications Officer, PIB, New Delhi.