Biotechnology - Cotton/Eggplant

An Expert's View about Crops and Support Services in India

Last updated: 19 Feb 2011

Bt cotton is the only commercially approved biotech crop in India. On February 9, 2010, the Ministry of Environment and Forest announced a moratorium on approval of Bt eggplant.

THIS REPORT CONTAINS ASSESSMENTS OF COMMODITY AND TRADE ISSUES MADE BY USDA STAFF AND NOT NECESSARILY STATEMENTS OF OFFICIAL U.S. GOVERNMENT POLICY Required Report - public distribution Date: 8/13/2010 GAIN Report Number: IN1073 India Biotechnology - GE Plants and Animals Annual 2010 Approved By: David Leishman Prepared By: Santosh Singh Report Highlights: Bt cotton is the only commercially approved biotech crop in India, where a total of six events have been approved for commercial cultivation. Over the last seven years, use of Bt cotton has grown to over 90 percent of the total cotton area under cultivation. On February 9, 2010, the Ministry of Environment and Forest announced a moratorium on approval of Bt eggplant. On May 21, 2010, the Food safety and Standard Authority of India circulated a ?Draft on Operationalizing the Regulation of Genetically Modified Foods in India? for comments by stake holders. Section I. Executive Summary: Ag [1]ricultural trade between the United States and India is estimated at $1.9 billion in CY 2009. However, the trade balance continues to remain skewed (2:1) in India?s favor. India?s major agricultural exports to the U.S. include cashew, spices, rice, essential oils, processed fruits & vegetables, tea, vegetable oils and other consumer oriented products. Major U.S. agricultural exports to India are almonds, soybean oil, pulses, cotton, fresh fruits, and other consumer food products. India?s trade policy requires that all imports of biotech food/agricultural products or products derived from biotech plants/organisms should receive prior approval from the Genetic Engineering Appraisal Committee (GEAC [2]) . Refined soybean oil derived from Round-up Ready soybeans is the only biotech food/agricultural product currently approved for import. India imported $120 million of soybean oil from the United States in CY 2009. Import of soybean oil in the five months of CY 2010 has already reached $129 million, more than 52 percent higher than imports during the same period last year. The Environmental Protection Act (EPA) of 1986 lays the foundation for India?s biotechnology regulatory framework (see Annex 1). The Indian biotech regulatory system adopts a precautionary approach for the assessment of biosafety of food and agricultural products. The EPA has set the procedures for the importation of biotech products, both for research and commercial release or consumption (See Annex 2). In November 2007, the Government of India released th [3]e National Biotech Development Strategy, outlining a plan to set up a national biotech regulatory authority as an independent, autonomous and professionally led body that would provide a single window mechanism for biosafety clearance of genetically engineered products and processes. The Department of Biotechnology (DBT) under Ministry of Science and Technology (MST) has the responsibility to establish and operationalize the new Biotechnology Regulatory Authority of India (BRAI). After organizing a series of stakeholder consultations and interministerial discussions, the draft BRAI bill has passed the first Cabinet clearance and is ready for presentation in the parliament for approval. The existing regulatory framework will continue to oversee biotechnology regulations until the BRAI bill is approved and enacted. Bt cotton is the only biotech crop currently approved for commercial cultivation in India, where a total of six events have been approved for commercial cultivation. In October 2009, the GEAC concluded that Bt eggplant is safe for environmental release. However, after a series of public consultations, the Ministry of Environment and Forest (MEF), announced on February 9, 2010 a moratorium on approval of Bt eggplant until the government regulatory system can ensure food and environmental safety through long term studies. The MEF decision may dampen the future prospects for research and development in India?s agricultural biotechnology sector. [1] Excludes fish and forest products; India?s exports to the U.S. estimated at $1.2 billion and U.S. exports to India estimated at a record $691 million. [2] On July 22, 2010, the Ministry of Environment and Forests issued a notification changing the name of genetic Engineering Approval Committee to Genetic Engineering Appraisal Committee. [3] Section II. Plant Biotechnology Trade and Production: The adoption of Bt cotton has encouraged the development of agricultural biotechnology into one of fastest growing segments of the Indian biotech industry. Agricultural biotechnology is now the third largest sector in the domestic biotech industry, with total revenues of Rs. 19.4 billion ($318 million) in FY 2009 (April-March), a 37 percent growth over the p [1]revious year . Export revenue from agriculture biotechnology is estimated at Rs. 581 million in 2009/10. Source: BioSpectrum-ABLE Survey, 2010 Bt cotton is a well-documented success story in Indian agriculture after the ?Green Revolution? in wheat and rice crops in 1960?s. Since the introduction of Bt cotton in 2002, area under Bt cotton has grown to nearly 90 percent of the total cotton area in 2009. At the same time, India has also emerged as the second largest producer and exporter of cotton in the world. Since 2002, the Government of India (GOI) has approved six cotton events and nearly 300 hybrids for cultivation in different agro-climatic zones. Most of the approved Bt cotton hybrids are from the two Monsanto events that are already approved in the United States. Other approved events include the GFM event sourced from China and the locally developed Event 1, CICR event and Event 9124. For additional information on Bt cotton in India, please refer to the ?Cotton Annual Report? (GAIN IN1029). In addition to cotton, Indian private seed companies and public sector research institutions (government research institutes and state agriculture universities) are working on the development of various biotech crops mainly for traits such as pest resistance, nutritional enhancement, drought tolerance and yield enhancement. The crops being developed by public sector institutions include banana, cabbage, cassava, cauliflower, chickpea, cotton, eggplant, rapeseed/mustard, papaya, pigeon p [2] ea, potato, rice, tomato, watermelon and wheat . The private sector is focusing on cabbage, cauliflower, cotton, corn, rapeseed/mustard, okra, pigeon pea, rice and tomato. There are several new gene events in nine crops undergoing field ] trials for regulatory approv [3al . On October 14, 2009, the GEAC recommended that Bt eggplant is safe for environmental release after reviewing the recommendation made by an expert committee constituted in January 2009. The GEAC forwarded the recommendation to the government for final decision. The MEF invited comments from the stakeholders and held series of public consultation on approval of Bt eggplant. Finally on February 9, 2010, the Minister of Environment and Forests Mr. Jairam Ramesh announced a moratorium on environmental release of Bt eggplant until the government regulatory system can ensure human and environmental safety through long term studies. Industry sources report that there has not been any further development on approval of Bt egg plant from the Indian regulatory authorities. Thus India still awaits approval of the first biotech food crop. The only biotech food product currently allowed for importation into India is soybean oil derived from Round-up Ready soybeans. India exports biotech cotton and cottonseed meal, but does not export any significant quantity of cotton or cottonseed meal to the United States. [1] [2] International Service for the Acquisition of Agri-biotech Application (ISAAA) [3] Section III. Plant Biotechnology Policy: Regulatory Framework The regulatory framework for biotech crops, animals and products in India is governed by the ?Rules for the Manufacture, Use/Import/Export and Storage of Hazardous Microorganisms/Genetically Engineered Organisms or Cells, 1989? under the Environmental Protection Act of 1986. These rules cover the areas of research, development, large-scale use, and importation of biotech organisms and their products. These rules identify six competent authorities for handling these tasks (see Annex 1). In 1990, the Department of Biotechnology (DBT), in the Ministry of Science and Technology developed Recombinant DNA Guidelines, which were subsequently updated in 1994. Additionally, in 1998, the DBT issued separate guidelines for carrying out research of biotech plants and imports and shipment of biotech plants for research use. On May 28, 2008, the GEAC adopted new ?Guidelines and Standard Operating Procedures for the Conduct of Confined Field Trials.? The GEAC also adopted new ?Guidelines for Safety Assessment of Foods derived from Genetically Engineered Plants? The EPA Act of 1986, 1989 Rules, and all guidelines and protocols are available online at Status of the Proposed Biotechnology Regulatory Authority On November 13, 2007, the Minister of Science and Technology released the ?National Biotechnology Stra [1]tegy ? prepared by the Department of Biotechnology (DBT). One of the cornerstones of the strategy was to reinforce India?s biotech regulatory framework by setting up a National Biotech Regulatory Authority (NBRA) that would provide a single window mechanism for biosafety clearance. The DBT was entrusted with the responsibility of setting up the authority. In May 2008, the DBT issued a draft ?National Biotechnology Regulatory Bill? and a draft ?Establishment Plan for Setting up the National Biotechnology Regulatory [2] Authority .? Following inter-ministerial consultations with different stakeholders, the DBT subsequently drafted a revised ?Biotechnology Regu ]latory Authority [3 of India Bill ?, which is ready for submission in the Parliament for approval. Until the BRAI bill is approved by the parliament and enacted by the government, and the proposed BRAI becomes fully functional, the existing regulatory mechanisms under the EPA 1986 and Rules of 1989 will continue to be in force. Role of Various Ministries/State Governments: Field Testing of Biotech Crops In 2008, the GEAC adopted an ?event based approval system,? wherein the focus of the field testing is on biosafety issues, particularly the environmental and health safety, and efficacy of the event/trait. The responsibility of the agronomic evaluation is with the National Agricultural Research System consisting of Indian Council of Agricultural Research institutions and state agriculture universities. A stacked event, even if consisting of already approved events, is treated as a new event for approval purposes. The GOI does not have any specific regulations on coexistence between biotech and non-biotech crops. Due to the various interventions by the Supreme Court of India in an [4] ongoing case against the Government , the GEAC continues to be the authority that gives approval to all field trials. The GOI maintains a policy that the biotech field trials should be conducted in either the applicant?s own farm or in the SAU research farm. On January 10, 2007, the GEAC decided not to allow multi-location biotech rice field trials in basmati rice growing areas, especially in the states of Punjab, Haryana and Uttaranchal. Before any biotech event can be approved for commercial use, it must undergo extensive field trials for agronomic evaluation under the supervision of an ICAR institution or a state agriculture university for at least two crop seasons Product developers can conduct agronomic trials in conjunction with biosafety trials, or they can conduct separate trials after the GEAC recommends environmental clearance and the government takes a final decision. Once an event is approved for commercial use, the applicant can register and market the seeds in various states following the provisions of the National Seed Policy 2002 and the other relevant seed acts specific to a state. Following the commercial release of a biotech crop, the performance in the field is monitored for 3-5 years by the Ministry of Agriculture and by the various state departments of agriculture. In December 2008, the GEAC implemented the (i) Guidelines and Standard Operating Procedures (SOPs) for the Conduct of Confined Field Trials of Regulated Genetically Engineered Plants, 2008 and (ii) Guidelines for Safety Assessment of Foods Derived from Genetically Engineered Plants, 2008. The new guidelines set out various food safety assessment tests to be undertaken before and during the BRL-I and BRL-II trials. On this basis, the GEAC approves (or denies) the environmental clearance of the particular event (see Annex 5). Seed Policy 5] India?s Seed Policy [ issued by the Ministry of Agriculture in 2002, covers seed use issues relating to transgenic crops. According to the seed policy, all biotech crops must be tested for environmental and bio-safety concerns prior to their commercial release as per the regulations and guidelines of the EPA 1986. The National Bureau of Plant Genetic Resources (NBPGR) is the designated agency responsible for reviewing and approving the importation of biotech seeds for research purposes. Biotech crops must be tested by the Indian Council of Agricultural Research (ICAR) for at least two seasons to determine their agronomic potential. The Seed Policy advocates ?protection,? of transgenic varieties under the P 6]rotection of Plant Variety and Farmers Right Rules, 2003 [ . The Seeds Act of 1966 [7] , regulates the quality of certified seeds, while the 1983 Seeds Control Ord [8]er regulates and licenses the sale of seed, including transgenic seeds. A new Seeds Bill ( was introduced in December 2004, but is still awaiting final approval. India enacted the Protection of Plant Varieties and Farmers? Rights Act 2001 to protect the new plant varieties, including transgenic. The Protection of Plant Varieties and Farmers? Right Authority (PPVFRA) was established in 2005, which is [9] currently registering 30 notified crops including transgenic cotton hybrids and varieties . The PPVFRA is planning to gradually expand the list of crop species to be notified for registration. Cotton Seed Pricing/Technology Fee India does not regulate seed pricing or set technology fees. Seed companies are free to fix seed prices, and a technology provider is free to establish its technology fees. Nevertheless, several biotech companies have faced seed pricing and technology fee difficulties with individual state governments. In January 2006, the State Government of Andhra Pradesh filed a complaint with the Monopolies and Restrictive Trade Practices Commission (MRTPC) contending that the technology fees were too high. The MRTPC asked the technology provider to review technology fees, and urged a more modest pricing structure for sales to farmers. Following the MRTPC order, the Andhra state government issued a directive to all biotech seed companies not to price Bt cotton seeds above Rs. 750 per packet (450 gm Bt seeds and 150 gm non-Bt seeds) in the 2006 season. Several other state gov [10]ernments issued similar orders . The pricing order directives have been challenged in the Supreme Court, and while the case is still pending, some observers worry that state government interference in seed pricing could deter investment in new technologies. Food Policy On August 24, 2006, the GOI enacted an integrated food law, namely the ?Food Safety and Standards Act of 2006.? The Act brings all existing food laws under one single authority the Food Safety and Standard Authority of India (FSSAI). FSSAI?s mandate is to establish science-based standards for articles of food, and align Indian food standards with international standards. The new FSSAI also has specific provisions to regulate genetically engineered food products, including processed foods. On May 21, 2010, the FSSAI circulated the ?Draft on Operationalizing the Regulation of Genetically Modified Foods in India? for comments by stake holders (See Gain report IN1044). Until new FSSAI regulations are in place, the regulatory system continues to come under the EPA 1986. On August 23, 2007, the Ministry of Environment and Forests (MOEF) issued a notification that processed food products derived from genetically engineered products (where the end-product is not an LMO - a living modified organism) do not require approval from GEAC for production, marketing, import and 11] use in Ind [ia . As processed food products are not replicated in the environment, they are not considered to be an environmental safety concern under the 1989 EPA. Food Labeling: In March 2006, the Ministry of Health and Family Welfare issued a draft amendment to the 1955 Prevention of Food Adulteration (PFA) Rules, extending a labeling requirement for ?Genetically Modified? ] food [12s.? Although the draft amendment has not been finalized, the Ministry of Health is consulting with various stakeholders to consider options under the new Food Safety and Standard Act. Cartagena Protocol and Other International Agreements India ratified the Cartagena Protocol on Biosafety on January 17, 2003, and has established rules for implementing the provisions of the articles (see Annex 3). A Biosafety Clearing-House (BCH) [13] has been set up within the Ministry of Environment and Forests to facilitate the exchange of scientific, technical, environmental and legal information on living modified organisms (LMOs). The regulatory body, GEAC, has the responsibility of approving trade of biotech products, including seed and food products. India is traditionally a vocal advocate of strict liability and redress related to the trans- boundary movement of LMOs, a position that may lead to some difficulty with the movement of Bt cotton seed to neighboring countries. In Codex Alimentarius discussions, India supports mandatory labeling of GM foods, requiring a clear declaration whenever food and food ingredients are composed of or contain genetically modified organisms. Trade Policy In 2006, the Ministry of Environment and Forests published the Procedure for GEAC Clearance for Imports of GM Produ [14]cts . The GOI?s Foreign Trade Policy (2004-2009), which took effect on July 8, 2006, specifies that all imports containing biotech products must have prior approval from the GEAC. This policy also requires a biotech declaration at the time of impo [15]rt. On June 22, 2007, the GEAC gave a permanent approval for importation of soybean oil derived from Roundup Ready soybeans for consumption after refining. No other biotech food products, bulk grain, semi-processed or processed, are officially permitted for commercial importation. The import of biotech seeds and planting material is also regulated by the 2003 ?Plant Quarantine Order (PQO Regulation of Import into India),? which came into force in January 2004. The PQO regulates the import of germplasm/bioengineered organisms/transgenic plant material for research purposes. NBPGR is authorizing authority to issue import permits. A complete text of the order is available at [1] [2] [3] The document is not available in the public domain. While the revised draft bill and establishment plan for setting up the regulatory authority have undergone revisions since May 2008, industry sources report that the basic structure remains largely the same. [4] See Gain Report India Biotechnology Annual 2008 (IN8077) page 7. [5],%202002.pdf [6] [7] [8] [9] [10] In the recent years, Andhra and other states have further tempered the Bt cotton seed prices. [11] [12] For more information on the proposed regulation, refer our gain reports IN6024 and IN6060. [13] [14] The procedures and format for filing an import application for a biotech product is detailed in Annex 2. [15] Section IV. Plant Biotechnology Marketing Issues: Marketing of biotech crops in India is currently confined to Bt cotton. There are no restrictions in marketing domestically produced biotech cottonseed oil and meal. Imported soybean oil is also authorized for domestic marketing. Biotechnology Stakeholders: Aside from the exceptional case of Bt cotton, Indian farmers are generally unaware of the potential benefits of biotechnology. Some farmers have expressed their concern over the role of private companies in introducing hybrid seeds that are higher priced and have to be replaced every year. Indian farmers are traditionally used to varietal seeds that have been developed by public sector research institutions, and that are therefore available at reasonable prices and can easily be reused year after year. Export oriented farmers producing crops like basmati rice and soybean are also very concerned that biotech products could adversely affect their ability to export, particularly to markets like the EU. Within India?s scientific community, and among various farm associations, the general public is largely favorably disposed to agricultural biotechnology. While there may be some reservations over the private interests of multinational companies, there is an increasing public awareness of the benefits of herbicide tolerance, insect resistance and drought tolerance. Aggressive anti-biotech campaigns generate a lot of attention in the media, but uninformed opinion and factual distortions fail to persuade many producers and consumers that champion progress and education. Section VI. Animal Biotechnology: Research on genetically engineered animals is at an infancy stage in India. Most of the research work is focused on the genomics of important livestock, poultry and fish species, which can be subsequently used in breeding prog 1]ram [s for important traits - production (milk/meat), reproductive, drought/heat tolerance and pest/disease resistance. Research is generally conducted by public sector research organizations like ICAR institutions, Council of Scientific and Industrial Research (CSIR) institutions, SAUs, and other research organizations supported by DBT. Currently there are no animals or products derived from genetically engineered animals in commercial production. The EPA 1986 governs the development, commercial use and /or import of genetically engineered animals or products. [1] Identifying superior animals with required trait and/or development of genetically engineered animals for breeding purpose. Section VII. Author Defined: Annex 1: Existing Biotech Regulatory Authorities ? Function/Composition Committee Members Functions Genetic Engineering Chairman-Additional Secretary, Ministry of Environment Approve the use of bio-engineered Approval Committee and Forests (MOEF) products for commercial applications. (GEAC); functions under Co-Chairman - Nominee of Department of Biotechnology Approve activities involving large- Ministry of Environment (DBT) scale use of bio-engineered and Forests (MOEF). Members: Representatives of concerned agencies and organisms and recombinants in departments namely Ministry of Industrial Development, research and industrial production DBT, and the Department of Atomic Energy from an environmental safety angle. Expert members: Director General-ICAR, Director General- Consult RCGM on technical matters ICMR; Director General-CSIR; Director General of Health relating to clearance of bio- Services; Plant Protection Adviser; Directorate of Plant engineered crops/products. Protection; Quarantine and storage; Chairman, Central Approve imports of bio-engineered Pollution Control Board; and few outside experts in food/feed or processed product individual capacity. derived thereof. Member Secretary: An official from the MOEF Take punitive actions on those found violating GM rules under EPA, 1986. Review Committee on Representatives from: Develop guidelines for the regulatory Genetic Manipulation DBT, Indian Council of Medical Research (ICMR), Indian process for research and use of bio- (RCGM); function under Council of Agricultural Research (ICAR), Council of engineered products from a bio-safety Department of Scientific and Industrial Research (CSIR) angle. Biotechnology (DBT). Other experts in their individual capacity. Monitor and review all ongoing GM research projects up to the multi location restricted field trial stage. Undertake visits to trial sites to ensure adequate security measures. Issue clearance for the import of raw materials needed in GM research projects. Scrutinize applications made to the GEAC for the import of bioengineered products. Form Monitoring and Evaluation Committee for biotech crop research projects. Appoint sub-groups when required in topics of interest to the committee. Recombinant DNA Scientists from DBT and other public sector research Take note of developments in Advisory Committee institutions biotechnology at the national and (RDAC); function under international level. DBT Prepare suitable guidelines for safety in research and applications of GMOs. Prepare other guidelines as may be required by the GEAC. Monitoring Cum Experts from ICAR institutes, State Agricultural Universities Monitor and evaluates trial sites, Evaluation Committee (SAUs) and other agricultural/crop research institutions and analyze data, inspect facilities and (MEC) representatives from DBT. recommend safe and agronomically viable transgenic crops/plants for approval to RCGM/GEAC Institutional Biosafety Head of the Institution, Scientists engaged in biotech work, Develop a manual of guidelines for Committee Medical Expert, and Nominee of the Department of the regulatory process on bio- (IBC); functions at Biotechnology engineered organisms in research, use research institution/ and application to ensure Organization level. environmental safety. Authorize and monitor all ongoing biotech projects to the controlled multi location field stage. Authorize imports of bio-engineered organisms/transgenic for research purposes. Coordinate with district and state level biotechnology committees. State Biotechnology Chief Secretary, State Government; Secretaries, Departments Periodically reviews the safety and Coordination Committee of Environment, Health, Agriculture, Commerce, Forests, control measures of institutions (SBCC); functions under Public Works, Public Health; Chairman, State Pollution handling bio-engineered products. the state government Control Board; State microbiologists and pathologists; Other Inspect and take punitive action where biotech research experts. through the State Pollution Control occurs. Boards or the Directorate of Health in case of violations. Nodal agency at the state level to assess damage, if any, due to release of bio-engineered organisms and take on-site control measures. District-Level Committee District Collector; Factory Inspector; Pollution Control Monitor safety regulations in research (DLC); functions under the Board Representative; Chief Medical Officer; District and production installations. district administration Agricultural Officer, Public Health Department Investigate compliance with rDNA where biotech research Representative; District Microbiologists/Pathologists; guidelines and report violations to occurs. Municipal Corporation Commissioner; other experts. SBCC or GEAC. Nodal agency at district level to assess damage, if any, due to release of bio-engineered organisms and take on-site control measures. Source: Department of Biotechnology (DBT) and Ministry of Environment and Forest (MOEF), GOI. Annex 2: Procedure and Application Formats for Import of Biotech Products Item APPROVAL GOVERNING FORM LINKS FOR ACCORDING RULES NO. DOWNLOADING AGENCY GMOs / IBSC/RCGM/ Rules 1989; Biosafety guidelines of 1990 and I GEAC Form I LMOs for NBPGR 1998; Plant Quarantine (Regulation of Imports R&D into India) ? Order, 2004 issued by NBPGR; and Guidelines for the import of germplasm, 2004 by NBPGR GMOs / IBSC/RCGM/ Rules 1989; II B GEAC Form II B LMOs for GEAC /ICAR Biosafety guidelines of 1990 & 1998 intentional release (including field trials) GM food GEAC Provide biosafety & food safety studies, III GEAC Form III /feed as Compliance with the Rules 1989 and Biosafety LMOs per se guidelines of 1990 & 1998 GM processed GEAC One time ?event based? approval given based IV GEAC Form IV food derived on importer providing the following from LMOs information: i. List of genes/events approved in the crop species for commercial production in the country of export/country of origin; ii. Approval of the product for consumption in countries other than producing countries; iii. Food safety study conducted in the country of origin; iv. Analytical/compositional report from the country of export/origin; v. Details on further processing envisaged after import; vi. Details on commercial production, marketing and use for feed/food in the country of export/origin; vii. Details on the approval of genes / events from which the product is derived Processed GEAC If the processed food contains any ingredient IV , if GEAC Form IV B food derived from category 2 and 3 mentioned required containing above, and if the LMO / product thereof has ingredients been approved by the GEAC, no further derived from approval is required except for declaration at GMO the port of entry. In case it does not have the approval of GEAC, the procedure mentioned in category 3 above to be complied. Source: MOEF Website Annex 3: India?s Compliance on Various Articles of the Cartagena Protocol Article Provisions Present Status Article Application of the Advanced Informed Agreement procedure Competent authority (GEAC) notified. Border 7 prior to the first transboundary movement of LMOs intended for control through NBPGR only for contained use. direct use as food or feed, or for processing. Projects initiated to strengthen DBT and MOEF?s capabilities to identify LMOs. Article Notification ? The Party of export shall notify, or require the Rules 1989 and competent authorities in place. 8 exporters to ensure notification to, in writing, the competent authority of the Party of import prior to the intentional transboundary movement of LMOs that falls within the scope of Article 7 Article Acknowledgement of receipt of notification-The Party of import Point of contact notified, the regulatory body 9 shall acknowledge receipt of the notification, in writing to the (GEAC) in place notifier Article Decision Procedure-Decision taken by the Party of import shall Regulatory body (GEAC) in place 10 be in accordance with Article 15 A rticle Procedure for LMOs intended for direct use as food or feed, or 1989 Rules [1] , DGFT Notification No. 2(RE-2006) 11 [2] for processing / 2004-2009 Article Simplified Procedure to ensure the safe intentional transboundary 1989 rules 13 movement of LMOs Article Bilateral, regional and multilateral agreements and arrangements -- 14 Article Risk assessment DBT Biosafety Guidelines for research in plants, 15 guidelines for confined field trials guidelines for safety assessment of foods derived from GE plants. Article Risk Management DBT Guidelines for research 16 Article Unintentional transboundary movements and emergency 1989 rules 17 measures Article Handling, transport, packaging and identification 1989 Rules, guidelines to be developed 18 Article Competent National Authorities and National Focal Point Ministry of Environment and Forests designated as 19 competent authority and national focal point Article Information sharing and the Biosafety Clearing House Biosafety Clearing House ( has 20 been set up. Article Confidential information -- 21 Article Capacity building Ongoing capacity building activities by DBT, 22 MOEF, USTDA and USAID-sponsored SABP Article Public awareness and participation Ongoing, MOEF and DBT have specific websites 23 on biotech developments and regulatory system including website of IGMORIS [3] , GEAC [4] , DBT Biosafety [5] , etc Article Non-Parties (transboundary movements of LMOs between 1989 rules in place for all import and export 24 Parties and non-Parties) Article Illegal transboundary movements -- 25 Article Socio-economic considerations Socioeconomic analysis is an integral part of 26 decision making Article Liability and redress National Consultation ongoing 27 Source: MOEF and Industry Sources. [1] See Annex 2 [2] [3] [4] [5]
Posted: 30 November 2010, last updated 19 February 2011

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