Bt cotton is the only commercially approved biotech crop in India – a total of six events and more than 300 hybrids have been approved for commercial cultivation. Bt cotton accounts for over 90 percent of the total cotton area under cultivation.
THIS REPORT CONTAINS ASSESSMENTS OF COMMODITY AND TRADE ISSUES MADE BY
USDA STAFF AND NOT NECESSARILY STATEMENTS OF OFFICIAL U.S. GOVERNMENT
Required Report - public distribution
GAIN Report Number: IN1187
Agricultural Biotechnology Annual
Bt cotton is the only commercially approved biotech crop in India ? a total of six events and more than
300 hybrids have been approved for commercial cultivation. Bt cotton accounts for over 90 percent of
the total cotton area under cultivation. There has not been any significant progress on the approval of Bt
eggplant since the Ministry of Environment and Forest announced a moratorium on its approval in
February, 2010. Recently, the Genetic Engineering Appraisal Committee (GEAC) decided that
applications for biotech crop field trials will need prior permission from state governments before
seeking approval from GEAC.
Section I. Executive Summary:
Agricultural trade between the United States and India is estimated at $2.34 billion in CY 2010 - U.S.
exports to India estimated at $752 million and imports estimated at $1.59 billion - with the trade balance
skewed 2:1 in India?s favor. India?s major agricultural exports to the U.S. include cashew, spices,
essential oils, rice, processed fruits & vegetables, vegetable oils, tea, dairy products, and other consumer
oriented products. Major U.S. agricultural exports to India are tree nuts, soybean oil, pulses, cotton,
fresh fruits, and other consumer food products.
India?s trade policy requires that all imports food and agricultural products derived from biotech
plants/organisms have 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. In CY 2010, U.S. soybean oil exports to India were estimated at
$133 million, accounting for nearly 18 percent of total U.S. agricultural exports to India.
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, both for commercial
cultivation and for imports. The EPA outlines the procedures for importing biotech products, both for
research and commercial release (See Annex 2).
In November 2007, the Government of India released the 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 inter-ministerial discussions, DBT has submitted a draft BRAI bill for parliamentary
approval. In the meantime, the existing regulatory framework will continue to oversee biotechnology
Bt cotton is the only biotech crop currently approved for commercial cultivation in India - a total of six
events and more than 300 Bt cotton hybrids have been approved for commercial cultivation.
In October 2009, the GEAC recommended the approval for environmental release of Bt eggplant for
commercial cultivation. A final decision is still pending with the Ministry of Environment and Forest
(MoEF). The MoEF organized a series of public consultations and, subsequently on February 9, 2010,
announced a moratorium on the approval of Bt eggplant until the government regulatory system can
ensure food and environmental safety. MOEF recommended a series of long term studies, but since
then, there has been very little progress on the biosafety assessment of Bt eggplant. Meanwhile, on July
22, 2010, the MoEF issued a notification changing the name of the apex biotech regulatory body GEAC
from Genetic Engineering Approval Committee to Genetic Engineering Appraisal Committee,
implicitly limiting the role of the GEAC.
Section II. Plant Biotechnology Trade and Production:
The successful 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. 24.8 billion ($557
million) in FY 2010/11 (April-March), a 28 percent growth over the previous year (Source:
BioSpectrum-ABLE Industry Survey 2011). The revenue share of agricultural in the total
biotechnology industry revenue has grown over the past five years from less than five percent to over 14
percent in 2010/11. Export revenue from agriculture biotechnology is estimated at Rs. 744 million in
The commercial success of Bt cotton is well-documented. Since its introduction in 2002, India?s Bt
cotton area has grown to over 90 percent of the total cotton area, accounting for over 95 percent of
India?s cotton production in 2010. As a result, India has emerged as the second largest producer and
exporter of cotton in the world. To date, the Government of India (GOI) has approved six cotton events
and more than 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 IN1131).
In addition to cotton, private Indian 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 like pest resistance, nutritional enhancement, drought tolerance and yield
enhancement. The crops currently being developed by public sector institutions include banana,
cabbage, cassava, cauliflower, chickpea, cotton, eggplant, rapeseed/mustard, papaya, pigeon pea, 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 various stages of event selection and field trials for regulatory approval ? banana,
castor, cotton, corn, rice, tomato, mustard, potato, sorghum, and papaya.
On October 14, 2009, the GEAC recommended the approval for the environmental release of Bt
eggplant. The recommendation, forwarded to the Ministry of Environment and Forest (MoEF), still
waiting for a final decision. The MoEF invited comments from the stakeholders and held series of
public consultations on the approval of Bt eggplant. On February 9, 2010, the MoEF announced a
moratorium on the environmental release of Bt eggplant until the government regulatory system can
ensure human and environmental safety through long term studies. On April 27, 2011, the GEAC held
a consultation with experts and scientists on the regulatory process for Genetically Modified Crops as
part of Bt eggplant post moratorium follow-up. However, the decision to undertake additional biosafety
studies was deferred to a future consultation. Industry sources report that there have not been any
further developments on the approval of Bt eggplant.
The only imported biotech food product currently allowed in India is soybean oil derived from Round-
up Ready soybeans, which is imported from several countries like Brazil, Argentina and the United
States. India exports biotech cotton and cottonseed meal to several countries, but does not export any
significant quantity of cotton or cottonseed meal to the United States.
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 import 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
Role of Various Ministries/State Governments:
Status of the Proposed Biotechnology Regulatory Authority
On November 13, 2007, the Ministry of Science and Technology released a ?National Biotechnology
Strategy?. One of the cornerstones of this 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 Department of Biotechnology (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 Regulatory Authority of India Bill?, which is ready for submission in the Parliament for
approval. Until the BRAI bill is approved by the parliament, 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.
Field Testing of Biotech Crops
In 2008, the GEAC adopted an ?event based? approval system, wherein the focus of field testing is on
biosafety issues, particularly environmental and health safety, and the efficacy of the event/trait. The
responsibility for the agronomic evaluation is with the National Agricultural Research System
consisting of Indian Council of Agricultural Research institutions and the 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-
Due to the various interventions by the Supreme Court of India (see GAIN Report IN8077 page 7), the
GEAC continues to be the deciding authority for approval of all field trials. The GOI maintains a policy
that the biotech field trials should be conducted on either the applicant?s own farm or on an 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.
State Permission for Conducting Field Trial: In early March 2011, the GEAC withdrew permission to
conduct Bt corn field trials in the state of Bihar on the request of the Chief Minister of Bihar.
Subsequently on July 6, 2011, the GEAC decided that it would issue approval for field biotech crop
field trials in a particular state only after the applicant provides a ?no objection certificate? (NOC) from
the relevant state government. Applications that are already approved by GEAC must also obtain an
NOC from the state government before field trials can proceed.
Once an event is approved for commercial use, the applicant can register and market seeds in various
states according to the provisions of the National Seed Policy 2002 and other relevant seed regulations
specific to each 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
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 a
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 Indian 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 the agronomic potential. India?s seed policy advocates ?protection,? of transgenic
varieties under the Protection of Plant Variety and Farmers Right Rules, 2003.
The Seeds Act of 1966, regulates the quality of certified seeds, while the 1983 Seeds Control Order
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 waiting for
final parliamentary approval.
In 2001, India enacted the Protection of Plant Varieties and Farmers? Rights Act to protect new plant
varieties, including transgenic plants. The Protection of Plant Varieties and Farmers? Right Authority
(PPVFRA) was established in 2005, and to date has registered 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 challenges 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. Subsequently, several other state governments issued similar orders. The
pricing order directives have been challenged in the Supreme Court; these cases are still pending.
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 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 use in India. As processed food products are not replicated in the environment, they are not
considered to be an environmental safety concern under the 1989 EPA. However, imports of products
that are LMOs will continue to be under the purview of GEAC under EPA 1986.
Given that the FSSAI does not specifically regulate biotech food products, the Ministry of Health and
Family Welfare (MHFW) has requested the GEAC to continue to regulating biotech processed food
products under the 1989 Rules. Thus the MoEF notification on processed food products has been
deferred and the GEAC continues to regulate imports of processed biotech food products.
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). However until new
regulations are in place, the regulatory system continues to come under the EPA 1986.
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 to
?Genetically Modified foods? (For more information on the proposed regulation, refer GAIN reports
IN6024 and IN6060). Although the draft amendment has not been finalized, the FSSAI 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 GEAC has the
responsibility of approving trade of biotech products, including seed and food products. India has
traditionally advocated strict liability and redress to the trans-boundary movement of LMOs, a position
that could complicate the movement of Bt cotton seed to neighboring countries.
In Codex Alimentarius discussions, India has supported mandatory labeling of GM foods, requiring a
clear declaration whenever food and food ingredients are composed of or contain genetically modified
In 2006, the Ministry of Environment and Forests published the Procedure for GEAC Clearance for
Imports of GM Products. The specific procedures for filing an import application for biotech products
are found in Annex 2 of this report.
On July 8, 2006, the Ministry of Commerce and Industries issued a notification that 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 import. 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 the authorizing authority for issuing import permits. A complete text of this order is available at
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 without any restrictions or labeling requirements.
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 programs 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.
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
Appraisal 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 7 Application of the Advanced Informed Agreement procedure Competent authority (GEAC) notified. Border
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 8 Notification ? The Party of export shall notify, or require the Rules 1989 and competent authorities in place.
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 9 Acknowledgement of receipt of notification-The Party of import Point of contact notified, the regulatory body
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
Article Procedure for LMOs intended for direct use as food or feed, or 1989 Ru  les , DGFT Notification No. 2(RE-2006)
11 for processing / 2004-2009
Article Simplified Procedure to ensure the safe intentional 1989 rules
13 transboundary 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