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.
Required Report - public distribution
GAIN Report Number: IN1073
Biotechnology - GE Plants and Animals
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 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 ) . 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
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 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.
 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.
 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.
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 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  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.
International Service for the Acquisition of Agri-biotech Application (ISAAA)
Section III. Plant Biotechnology Policy:
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 http://dbtbiosafety.nic.in/.
Status of the Proposed Biotechnology Regulatory Authority
On November 13, 2007, the Minister of Science and Technology released the ?National Biotechnology Stra 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  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
Due to the various interventions by the Supreme Court of India in an  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).
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  , regulates the quality of certified seeds, while the 1983 Seeds Control Ord er regulates and
licenses the sale of seed, including transgenic seeds. A new Seeds Bill (http://agricoop.nic.in/seeds/seeds_bill.htm) 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
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 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
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)  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
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.
In 2006, the Ministry of Environment and Forests published the Procedure for GEAC Clearance for Imports of GM
Produ 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 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 http://agricoop.nic.in/gazette/gazette2003.htm.
 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.
 See Gain Report India Biotechnology Annual 2008 (IN8077) page 7.
In the recent years, Andhra and other states have further tempered the Bt cotton seed prices.
 For more information on the proposed regulation, refer our gain reports IN6024 and IN6060.
The procedures and format for filing an import application for a biotech product is detailed in Annex 2.
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.
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.
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
Scrutinize applications made to the
GEAC for the import of
Form Monitoring and Evaluation
Committee for biotech crop research
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
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
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
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
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
iv. Analytical/compositional report from the
country of export/origin;
v. Details on further processing envisaged after
vi. Details on commercial production,
marketing and use for feed/food in the country
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 http://www.envfor.nic.in/divisions/csurv/geac/gmo_lmo.htm
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 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
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  , DGFT Notification No. 2(RE-2006)
11  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 --
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
Article Unintentional transboundary movements and emergency 1989 rules
Article Handling, transport, packaging and identification 1989 Rules, guidelines to be developed
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 (www.indbch.nic.in) has
20 been set up.
Article Confidential information --
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  , GEAC  , DBT
Biosafety  , 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 --
Article Socio-economic considerations Socioeconomic analysis is an integral part of
26 decision making
Article Liability and redress National Consultation ongoing
Source: MOEF and Industry Sources.
 See Annex 2