TRANSGENIC CROPS : BIOSAFETY ISSUES AND REGULATIONS

Dr Vibha AhujaBiotech Consortium India Limited

December 18, 2006MAU,Parbhani

Biosafety

Protecting human & animal health and environment from the possible

adverse effects of the products of modern biotechnology

Precautionary Approach is adoptedfor assessment of Biosafety

Why Biosafety ConcernsWhy Biosafety ConcernsClassical plant breeding is limited to the introduction of required characters into plant by genetic crossing during sexual reproduction

Due to limitations of conventional breeding for attaining the desirable traits use of modern biotechnology particularly genetiengineering/ recombinant DNA technology has been taken advantage of and development of transgenics started

A transgenic crop is a crop which contains a gene or genes of a different species artificially inserted in its genome,which may come from an unrelated plant or from a completed different species.

TRADITIONAL PLANT BREEDINGDNA is a strand of genes, much like a strand of pearls. Traditional plant breeding combines many genes at once.

Desired Gene

X

Many genes are transferred

Donor Plant

Commercial Plant Variety

New Plant Variety

+

A single gene is transferred

Desired Gene

Commercial Plant Variety

Improved Commercial Plant Variety

GENETIC ENGINEERINGUsing genetic engineering, we can add a single gene to the strand.

Desired Gene

Donor

Genetic Engineering is an Extension of Genetic Engineering is an Extension of Traditional Plant BreedingTraditional Plant Breeding

Comparison of breeding and transgenic technology

No barrier

Breeding Transgenic Technology

Exchange of genes within a species

Simple Technology

History of Safety

Only Gene of Interest

Intensive Technology

New Technology Time needed for Safety History

Gene of interest with flanking sequence transferred

Development of GM Crop/Development of GM Crop/TransgenicsTransgenics

Identify gene(s) giving a desired trait

Make copies of the gene

Transfer to plant tissue

Regenerate plants

Lab analysis and safety testing

Development of a variety

Field tests

Approval by Government agencies

Commercialization

Monitoring of efficacy and safety

7-8 years

GLOBAL SCENARIO 2005GLOBAL SCENARIO 2005

First crop introduced was Flavr Savr tomato in USA in 1995So far 19 crops approved for commercial cultivationInclude canola, carnation, chicory, cotton, linseed, green pepper, maize, melon, potato, rice, soybean, squash, sugarbeet, sunflower, tobacco and tomatoMajor characteristics are insect resistance, herbicide tolerance, virus resistance and improved product quality

GLOBAL SCENARIO 2005GLOBAL SCENARIO 2005

Major countries include USA, Canada, Japan, China, EU, Argentina, South AfricaOnly four crops being marketed commercially I.e., corn, cotton, soybean and canolaCommercial production initiated for papaya, squash and tobacco in USAOthers are approved but not yet being marketed

GLOBAL SCENARIO 2005GLOBAL SCENARIO 2005

Area under cultivation: 90 million hectaresNo. of countries: 21No. of farmers: 8.25 millionCrops: Corn, soybean, cotton and canolaTransgenic traits: insect resistance & herbicide tolerance

1.7 11.027.8

39.944.252.658.767.781.090.0

020406080

100

1996

1997

1998

1999

2000

2001

2002

2003

2004

2005

Series1

Global area of transgenic crops from 1996 to 2005 (million hectares)

RESEARCH & DEVELOPMENT RESEARCH & DEVELOPMENT STATUSSTATUS

63 countries involved at various stages57 plants identified for developmentSecond generation of traits include modifications such as nutritional enhancement, disease tolerance, stress tolerance and production of pharmaceuticals

COMMERCIAL USE IN INDIACOMMERCIAL USE IN INDIAOnly one crop approved i.e. Bt cotton Three hybrids containing Cry1Ac gene

approved in 2002 and one in 200462 hybrids approved for Kharif 2006Three new events approved I.e.

i. Cry 1Ac gene (event 1) byM/s J.K.Agri Seeds Ltd.ii. Fusion genes (cry 1Ab+cry 1Ac) 'GFMby M/sNath Seedsiii. Stacked genes cry1Ac and cry1AbbyM/sMahyco

BIOSAFETY CONCERNSBIOSAFETY CONCERNS

ENVIRONMENTAL SAFETYFOOD SAFETY TO HUMAN AND ANIMALHEALTHRISK MANAGEMENT

1. STUDIES ON ENVIRONMENTAL SAFETY1. STUDIES ON ENVIRONMENTAL SAFETY

POLLEN ESCAPE/OUT CROSSING: MULTI LOCATION EXPERIMENTS WERE CONDUCTED IN 1996, 1997 AND 2000

Due to stickiness pollen travel is limitedNo chance of transfer from tetraploid Bt hybrids to cultivated diploid speciesNo wild species occur in India

AGGRESSIVENESS AND WEEDINESSTO ASSESS THE WEEDINESS OF BT COTTON, THE RATE OF GERMINATION AND VIGOUR WERE COMPARED WITH NON BT COUNTERPARTS

No significant differences between Bt and non Bt cotton for germination and vigorHence there is no difference between Bt and non Bt cotton with regard to their weediness and aggressiveness potential

EFFECT OF Bt ON NON TARGET ORGANISMSSTUDIES CONDUCTED DURING THE MULTI LOCATION FIELD TRIALS Bt cotton hybrids did not have any TOXIC effects on non target species such as:

Sucking pest (aphids, jassids , whitefly and mites)The beneficial insects (ladybird, beetle, honeybees and spiders) remained active in both Bt and Non Bt cotton hybrids.

PRESENCE OF Bt PROTEIN IN SOILSTUDIES WERE CONDUCTED TO ASSESS THE POSSIBLE RISK OF ACCUMULATION OF BT PROTEIN IN THE SOIL

Bt protein was not detected in soil samples indicating that Cry1Ac protein was rapidly degraded in the soilThe half-life of the Cry1Ac protein in plant tissues was calculated to be 41 days which is comparable to the degradation rates reported for microbial formulations of Bt.

EFFECT OF BT PROTEIN ON SOIL MICROFLORASTUDIES WERE CONDUCTED TO EVALUATE ANY IMPACT OF BT PROTEIN LEACHED BY ROOTS OF BT COTTON ON THE SOIL MICROFLORA

Results showed that there was no significant difference in population of microbes and soil invertebrates ( like earthworms) between Bt and non Bt samples

2. STUDIES ON FOOD SAFETY

FOR EVALUATING FOOD SAFETY, THE STUDIES INCLUDED:

Compositional analysisAllergenicity studiesToxicological studiesPresence of Bt protein in cotton seed oilFeeding studies on cows, buffaloes, poultry and fish.

COMPOSITIONAL ANALYSIS

STUDIES REVEALED THAT THERE WAS NO CHANGE IN THE COMPOSITION IN THE Bt AND NON Bt COTTON SEEDS WITH RESPECT TO:

ProteinsCarbohydratesOilCaloriesAsh content

ALLERGENICITY STUDIES

ALLERGENICITY STUDIES WERE CONDUCTED ON BROWN NORWAY RATS BY FEEDING Bt AND NON Bt SEEDS. RESULTS SHOWED THAT:

No significant difference in feed consumption, weight gain and general healthThere was no significant change in endogenous allergens of Bt seed compared to non Bt cotton seed

TOXICOLOGICAL STUDIES

GOAT FEEDING STUDY WAS CONDUCTED FOR UNDERSTANDING THE TOXICOLOGICAL EFFECTS OF Bt COTTON SEED. THE ANIMALS WERE ASSESSED FOR GROSS PATHOLOGY AND HISTOPATHOLOGY:

No significant differences were found between animals fed with Bt and non Bt cotton seed

PRESENCE OF Cry1Ac PROTEIN IN Bt COTTON SEED OIL

STUDIES HAVE INDICATED THAT Cry1Ac PROTEIN WAS NO FOUND IN REFINED OIL OBTAINED FROM Bt COTTON SEEDS

FEEDING STUDIES ON COWS, BUFFALOES, POULTRY AND FISH

The feeding experiments using Bt cotton seed meal were conducted at National Dairy Research Institute, Karnal on lactating cows;Department of Animal Nutrition, College of Veterinary Sciences, G.B. Pant University of Agriculture & Technology, Pantnagar on lactating buffaloes.Central Avian Research Institute, Izatnagar on poultryCentral Institute on Fisheries Education, Mumbai on fishThese experiments indicated that Bt cotton seed meal was nutritionally as wholesome and safe as the non Bt cotton seed meal.

3. RISK MANAGEMENTPEST POPULATION EXPOSED TO Bt CROPS CONTINUOUSLY FOR SEVERAL YEARS MAY DEVELOP RESISTANCE TO THE Bt TOXINS THROUGH NATURAL SELECTION MUTATION, AND SELECTION :

To prevent resistance build up it is recommended to plant sufficient non Bt cotton (20%) to serve as a refuge for Bt susceptibility in seedsThe refuge strategy is designed to ensure that Bt susceptible insects will be available to mate with Bt resistant insects, should they arise.Available genetic data indicates that susceptibility is dominantover resistance.Therefore, the offspring of these matings would most likely be Bt susceptible, thus mitigating the spread of resistance in the populations

4. OTHERS SAFEGUARDS

CONFIRMATION OF THE ABSENCE OF “TERMINATOR TEHNOLOGY”

Molecular detection test in the Bt cotton hybrids was performed for absence of any terminator gene.

5. CONDITIONS STIPULATED WITH APPROVAL

• Valid for three years: April 02 to March, 05 • Provide same non Bt seed to meet refuge

requirements• Conduct studies to monitor resistance

development • Provide information to government on distribution

of the seed through its dealers and agents• Labeling requirements such as GEAC number,

etc.,• Develop Bt based IPM program • Undertake education and awareness program• Meet other requirements as stipulated

The Genetically Modified Organisms (GMOs) and products thereof are regulated articles in India in view of potential risks to human health and environment by indiscriminate use under “Rules for Manufacture, Use, Import, Export and Storage of Hazardous Microorganisms/Genetically engineered organisms or cells, 1989 under the EPA (1986)”.

India has ratified the Biosafety Protocol in January 2003.

BIOSAFETY FRAMEWORK-GOVERNMENT COMMITMENT

32

THE INDIAN ENVIRONMENT (PROTECTION) ACT (EPA), 1986

Provides protection and improvement of “Environment”.

“Environment” includes water, air and land and the interrelationship , which exists among and between water, air and land, and human beings, other living creatures, plants, microorganism and property.

COVERAGE OF 1989 RULESCOVERAGE OF 1989 RULES

The 1989 Rules cover the entire spectrum of activities relating to research, development and use of Genetically Modified Organisms (GMOs) and their products.

Manufacture, import and storage of microorganisms and gene technological products

Genetically engineered organisms/microorganisms and cells and correspondingly to any substance and products and food stuffs, etc., of which such cells, organisms or tissues form part

New gene technologies in addition to cell hybridization and genetic engineering

RECOMBINANT DNA GUIDELINESRECOMBINANT DNA GUIDELINES

Recombinant DNA Safety Guidelines, 1990

Revised Guidelines for Research in Transgenic Plants, 1998

Guidelines for generatnig pre-clinical and clinical data for rDNA vaccines, diagnostics and other Biologicals, 1999.

IMPLEMENTING AGENCIESIMPLEMENTING AGENCIES

Department of Biotechnology

Ministry of Environment and Forests

State Governments

STATUTORY BODIESSTATUTORY BODIES

1. The Recombinant DNA Advisory Committee (RDAC).

2. Institutional Biosafety Committee (IBSC)

3. Review Committee on Genetic Manipulation (RCGM)

4. Genetic Engineering Approval Committee (GEAC)

5. State Biotechnology Coordination Committee (SBCC)

6. District Level Committee (DLC)

APPROVAL AND PROHIBITIONS (Rule 7-11 of Rule 1989)

i. No person shall import, export, transport, manufacture, process,use or sell any hazardous microorganisms or genetically engineered organisms/substances or cells except with the approval of the GEAC. This is applicable for

• All activities involving research and development of products containing GMOs/HMOs including transgenic crops,pharmaproducts,industrial products and food and foodstuffs.

• Field trials

• Deliberate/unintentional release

ii. The GEAC shall give directions to the occupier to determine or take measures concerning the discharge of micro-organisms/genetically engineered organisms or cells mentioned inthe schedule

GRANT OF APPROVALS

1. In connection with the granting of approval, terms and conditions shall be stipulated, including terms and conditions as to the control to be exercised by the applicant, supervision, restriction on use, the layout of the enterprise and as to the submission of information to the SBCC or to the DLC.

2. All approvals of the GEAC shall be for a specified period not exceeding four years at the first instance renewable for 2 years at a time.

3. The GEAC shall have powers to revoke such approval in the following situations

SUPERVISION

The GEAC may supervise the implementation of the terms and conditions laid down in connection with the approvals accorded by it.

The GEAC may carryout this supervision through the State Biotechnology Coordination Committee or the State Pollution Control Boards/District Level Committee or through any person authorized in this behalf.

PENALTIES

1. If an order is not complied with, the DLC or SBCC may take measures at the expenses of the person who is responsible.

2. In cases where immediate interventions is required in order to prevent any damage to the environment, nature or health, the DLC or SBCC may take the necessary steps without issuing any orders or notice. The expenses incurred for this purpose will berepayable by the person responsible for such damage.

3. The SBCC/DLC may take samples for a more detailed examination of organisms and cells.

4. The SBCC/DLC shall be competent to ask for assistance from any other Government authority to carry out its instructions.

APPEAL AND EXEMPTION MECHANISM

Appeal to National Environment Appellate Authority:

Any person aggrieved by the decision of GEAC/ SBCC to appeal within 30 days

Exemption:

The MoEF wherever necessary may exempt an occupier handling particular GMOs from the provisions of 1989 rules (7-11).

Procedure for GEAC approval for field trials and environmental rProcedure for GEAC approval for field trials and environmental release of elease of transgenic crops.transgenic crops.

Institutional Biosafety Committee (IBSC)(forwarding applications for approval of RCGM)

Review Committee on Genetic Manipulation (RCGM)(green house experiments, contained field trials i.e. in-house trials/initial hybrid trials, generation of data on gene

stability and expression, biosafety data

RCGM[approval for conduct of multi-location field trials on the selected varieties) /hybrids)] and biosafety data

Evaluation of field trials by Monitoring-cum-Evaluation Committee (MEC ) through SAUs

Genetic Engineering Approval Committee (GEAC)

ICAR trials1st Year

GEAC(environmental clearance of the event/gene in a given background)

Large Scale Trials (LST)

Seed Production 10 ha

Material cleared from Environmental sensitivity by MoEF/or otherwise

MEC

Seed Production100 ha ICAR trials 2nd Year

Large Scale Trials (LST)

RECENT INITIATIVES BY GOVT OF INDIA

ENVIRONMENT POLICY, 2006 FORMULATED BY MINISTRY OF ENVIRONMENT & FORESTS.

FOOD SAFETY and STANDARDS, 2006 FORMULATED BY MINISTRY OF FOOD PROCESSING INDUSTRY HAS BEEN PASSED BY THE PARLIAMENT.

DGFT NOTIFICATION RELATING TO INCLUSION OF GM POLICY IN THE FOREIGN TRADE POLICY (2006-09) BY MINISTRY OF COMMERCE.

DRAFT NOTIFICATION ON MANDATORY LABELLING OF GM PRODUCTS, 2006 NOTIFIED BY MINISTRY OF HEALTH UNDER PFA. CONTD/-

REPORT OF THE SUB-COMMITTEE ON BT COTTON AND RELATED ISSUES, 2006 CONSTITUTED BY MINISTRY OF ENVIRONMENT & FORESTS.

REPORT OF THE TASK FORCE ON RECOMBINANT PHARMA, 2005 CONSTITUTED BY MINISTRY OF ENVIRONMENT & FORESTS.

REPORT OF THE TASK FORCE ON AGRICULTURE BIOTECHNOLOGY, 2004 CONSTITUTED BY MINISTRY OF AGRICULTURE.

RECOMMENDATIONS OF SUB-COMMITTEE ON BT COTTON AND RELATED ISSUES.

1. New Procedure and Protocols for approval of Bt cotton Expressing cry 1 Ac gene ( Mon 531 event).

2. No specific approval required for seed production for Bt cotton Expressing cry 1 Ac gene ( Mon 531 event).

3. New Mechanism for evaluation of field trials both pre and post release through the SAUs.

3. Financial Mechanism for field evaluation through SAUs

3. Protocols for MLT, SAU trials, LST & specified field notebook for recording of observations

PRE AND POST RELEASE PRE AND POST RELEASE

MONITORINGMONITORING MECHANISMMECHANISMSBCC

Chief Secretary - Chairman

Secretary, Department of Environment -Member Secretary

Secretary, Department of Health - Member

Secretary, Department of Agriculture -Member

Secretary, Department of Industries and Commerce - Member

Secretary, Department of Forests - Member

Secretary, Department of Public works/Chief Engineer, Department of Public Health Engineering - Member

State microbiologists and Pathologists -Member

Chairman of State Pollution Control Board

DLC

District Collector - Chairman

Factory Inspector - Member

A representative of the Pollution Control Board - Member

Chief Medical Officer (District Health Officer) – Member (Convener)

District Agricultural Officer - Member

A representative of the Public Health Engineering Department - Member

District Microbiologists pathologist (Technical expert) - Member

Commissioner Municipal Corporation -Member

The Committees may coThe Committees may co--opt other members/ experts as necessary.opt other members/ experts as necessary.

PRE RELEASE MONITORINGPRE RELEASE MONITORING TEAMTEAM(for(for monitoring Multimonitoring Multi--location field trials (MLT) and Large Scale field trials (LST) blocation field trials (MLT) and Large Scale field trials (LST) byy SAUsSAUs))

1) Director of Research, SAU, Nodal person - Team Leader2) Plant Breeder (concerned crop), SAU - Member3) Entomologist- Head of the Department - Memberor Nominee State Agriculture University4) Agronomist- Head of the Department - Memberor Nominee State Agriculture University5) Pathologist- Head of the Department - Memberor Nominee State Agriculture University6) Subject matter specialist - MemberRelevant to the transgene (Biotechnologist).7) Joint Director/ Deputy Director, Agriculture - MemberState Government8) Agriculture Officer of the concerned district - MemberState Government9) Nominee of RCGM - Member10) Nominee of GEAC - Member

POST RELEASE MONITORING TEAMPOST RELEASE MONITORING TEAM

1) Director – Extension, SAU, Nodal person - Team Leader2) Plant Breeder (concerned crop), SAU - Member3) Entomologist- Head of the Department - Memberor Nominee State Agriculture University4) Agronomist- Head of the Department - Memberor Nominee State Agriculture University5) Pathologist- Head of the Department - Memberor Nominee State Agriculture University6) Subject matter specialist relevant to - Membertransgene (Biotechnologist)7) Biostatistician - Member

Statutory Provisions for Implementation of Pre and Post Release Monitoring

Gazette Notifications empowering Seed Inspectors, Seed Analysts and Laboratories notified under Seed Act 1966 and Seed Control Order, 1983 under EPA, 1986 have been issued on 1st September 2006.

TOR FOR PRE RELEASE MONITORING COMMITTE1. Responsible for monitoring of transgenic cotton/ and other

field trials conducted in the jurisdiction of SAU by constituting Monitoring Teams as per the composition given.

• Responsible for maintenance of grants received from GOI/ fees collected from the applicants for this purpose.

• Visit the fields for minimum of two times during the cotton crop season matching boll development and other important stages of the cotton crops.

• Monitor all the replicated field trials being conducted by the applicants in its SAU’s jurisdiction and at least 25% of large-scale field trials in its jurisdiction as per the conditions given in the experimental trial permits issued by the DBT/ MoE&F.

• Observe and advise on collection of data by the applicants on the objectives of large scale and replicated field trials on transgenic crop

• Advise minor modifications in the collection of data based on the nature of gene expression in transgene an prevailing situation at the site of experimentation.

• Collect the data during its visit and hand over a copy of the data sheet to the applicant for their records along with suggestions if any, for improvement on the conduct of the trial.

• Submit the Monitoring Team(s) report on the large-scale field trials to MEC/GEAC and replicated multi-location field trials to RCGM/ MEC within 15 days from conclusion of the last visit. The Director of Research shall maintain the records of monitoring which may be called for by the GOI, if required

• The Monitoring Team(s) shall maintain all the information provided by the applicant and/or collected by the Team as confidential.

• The members of the Monitoring Team(s) shall be entitled TA/DA as per the State Agriculture University norms/ State Government’s rules & regulations. TA/DA shall be disbursed to the Members by the SAU.

TOR FOR POST RELEASE RELEASE MONITORING TEAMS

• Responsible for post –release monitoring of transgenic cotton in the jurisdiction of State Agriculture University by constituting Monitoring Team(s) as per the given composition given . To carry out the monitoring through a scientifically designed survey.

• Responsible for maintenance of grants received from the GOI/ fees collected from the applicants for this purpose.

The Monitoring Team(s) shall visit the fields for minimum of two times during the cotton crop season matching boll development and other important stages of the cotton crop. The Monitoring Team will record the following information:

• _ Date of sowing• _ Seed Rate• _ Method of Planting• _ Spacing• _ Fertilizer Application• _ Micro-nutrient application• _ Irrigation if any• _ Control of pest/disease measures undertaken• _ IPM practices followed• _ Method of harvesting• _ Performance of the hybrid• _ Economic benefits• _ Views of public acceptability / other comments• _ Compliance of GEAC conditions.• _ Any other parameter of relevance

Period of validity of approval - three years

Monitoring for CLCV incidence and resistance (only for north zone)

Planting of refugia (20%) for which each packet of seeds of the approved varieties should also contain a separate packet of the seeds of the same non-Bt cotton variety

Label indicating the contents and the description of the Bt hybrid including the name of the transgenes, the GEAC approval reference, physical and genetic purity of the seeds along with agricultural practice with detailed directions for use including sowing pattern, pest management, suitability of the hybrids specifically for irrigated conditions etc., in vernacular language.

Agreements with their dealers/agents to provide details about the sale of seeds, acreage cultivated, and state/regions where Bt cotton is sown.

Annual reports on dealers, acreage, locality (state and region)

CONDITIONS FOR COMMERCIAL RELEASE BY GEAC

Plans for Bt based ‘Integrated Pest Management’ and include this information in the seed packet. To monitor annually the susceptibility of bollworms to Bt gene vis-à-vis baseline susceptibility data and submit data relating to resistance development, if any, to the GEAC.

Monitoring of susceptibility of bollworms to the Bt gene also byCICR,Nagpur at applicant’s cost

Awareness and education program for farmers, dealers and others.

To deposit 100 g seed each of approved hybrids and parental lines with the National Bureau of Plant Genetic Resources (NBPGR) and deposit DNA fingerprints of the approved varieties and provide testing procedures for identifying transgenic traits in the approved varieties by DNA and protein methods.

Additional conditions if so necessitated on the basis of feedback received from the Monitoring cum Evaluation Committee / State Department of Agriculture/ District Collector / other field functionaries under the Seed Act and other sources.

CONDITIONS FOR LARGE SCALE TRIALS ANDSEED PRODUCTION

All new hybrids to undergo a minimum of 2 years of LST and 2 years of ICAR trials (Kharif 2006 and Kharif 2007) prior to its consideration for commercial release.

LST at 40 locations as per the Protocol by GEAC.

The Agricultural Universities to be involved in the monitoring of LST with specific reference to incidence of CLCuV.

To look for the incidence of sucking pests on these hybrids during large-scale trials and also artificial screening for CLCV resistance.

The firm shall provide to the GEAC/MEC/ State Department of Agriculture/ District Collector and other field functionaries under the Seed Act, the State/District wise details of locations (area, village, name of the farmer) where it intends to undertake large-scale field trials within 30 days of issue of this clearance letter. The location of large-scale trials should be carefully chosen so as to represent adequately the various agro-climatic zones and agricultural practices in the region. Detailed justification for selection of the LST locations shall also be furnished.

The firm shall make available socio-economic data like cost of Bt cotton seed/projected demand of Bt cotton seeds/cost of Bt cotton production vs. non-Bt cotton production under various agro-climatic conditions and agricultural practices/cost benefit analysis etc.

The Monitoring cum Evaluation Committee (MEC) set up by the RCGM would evaluate the performance of Bt cotton hybrid in the North Zone during the large scale trials in Kharif 2006 and Kharif 2007 on a random and representative sampling basis. The MEC would submit its two year combined report on performance of the Bt cotton hybrid for consideration of the GEAC. The MEC may seek additional information / stipulate additional conditions if so necessitated based on the observations made during the monitoring of large-scale field trials.

The firm shall be completely liable to pay compensation for damages to the environment caused by them while conducting the field trials.

The permission letter for first year large-scale trials is valid only for the period Kharif 2006 and second year LST is valid only for the period Kharif 2007 from the date of issue and would lapse automatically after the season.

CONDITIONS FOR SEED PRODUCTIONThe Bt cotton hybrid selected for entry into LST and ICAR trials during Kharif 2006 may undertake seed production in an area of 10 ha during first year LST and 100 ha during second year LST subject to thefollowing conditions:

The firm shall provide to the GEAC/MEC / State Department of Agriculture/ District Collector and other field functionaries under the Seed Act, the State wise details of location (area, village, name of the farmer) where it intends to undertake seed production within 30 days of issue of the clearance letter.

Bt cotton seeds produced by the company shall be regulated as per the provisions of the Seeds Act, 1966 and subsequent Rules/amendments. The firm shall maintain records of the seed production and shall make them available for inspection if it so desired by the GEAC/MEC/State Department of Agriculture/ District Collector and other field functionaries under the Seed Act.

Seed generated shall not be sold or diverted for commercial purpose without the approval of GEAC.

The lint produced and Bt cotton plant residue after harvesting should be destroyed by burning and records to this effect needs to be maintained and submitted to the GEAC/ State Department of Agriculture/ District C ll t d th fi ld f ti i d th S d A t

Area under Bt cotton cultivation in India

CROPS UNDER FIELD TRIALSCROPS UNDER FIELD TRIALS

10 crops under various stages of contained field trials

Include brinjal, cotton, corn, groundnut, pigeon pea, mustard,tomato, rice, okra,

cabbage and cauliflowerTraits include insect resistance, herbicide tolerance, virus resistance, nutritional enhancement, salt tolerance, fungal resistance, etc

Bt BRINJAL Bt BRINJAL -- FACT SHEETFACT SHEET

Developed M/s Mahyco

Patent Holder Monsanto

Request Large Scale trials of 7 hybrids:MHBJ 4 Bt, MHBJ 9 Bt, MHBJ 10 Bt, MHBJ 80 Bt, MHBJ 99 Bt, MHBJ 11 Bt, MHBJ 39 Bt, MHBJ 112 Bt

Gene Construct Cry 1 Ac, nptII and aad genes, CaMV 35S promoter

Status of approval Biosafety studies conducted as per the protocol prescribed by RCGM.

Based on the biosafety data and results of multi-locational trials, RCGM has recommended LST to GEAC

Discussed in two GEAC meetings. Company given an opportunity to present their case in the GEAC.Biosafety Data Posted on MoEF website from 22.7.2006.Constituted an Expert Committee for review of feed back received on Bt BrinjalTo evaluate comments received from the various stakeholders vis-à-vis the biosafety data generated by the Company and available scientific /technical data/literature from studies conducted by various national and international institutions.Suggest additional studies (if any) to be conducted.

To evaluate the adequacy of the protocol proposed for LST and recommend additional safeguards (if any). Recommend protocol for socio economic studies.

Any other recommendation on related aspects.

TOR OF EXPERT COMMITTEE

Status of Approval --contd