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Biosafety testing of gm crops icar november 29 2011
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  • 1. Biosafety Tests for GM Crops K. V. Prabhu IARI, New Delhi kvinodprabhu@rediffmail.com head_gen@iari.res.in ICAR Meeting on Field Testing with GM Crops NASC, 29 November, 2011
  • 2. Biosafety Test Biosafety test is an exercise carried out with a GM material in recognizing the risks to human being, animals and environment and then introducing• Procedures• Practices• Equipment and• Facilities to control the identified risks or reduce them to acceptable levels
  • 3. EVENT BASED APPROVAL SYSTEM OF A GM PLANTExtensive safety assessment required; only limited lines under confined field trials are finally approved New trait moved into varieties using Traditional breeding. 100’s – 1000’s Few 1 or 2 Events Tech provider Potential Potential Approved by Sublicenses Lines Lines GEAC Contained Event Confined Commercial utilization Lab & Greenhouse selection Field Trial as per relevent laws Experiments (IBSC) Application for Biosafety Approval Confined Field Trial
  • 4. Status of GM Monitoring for Biosafety in India Environment Protection Act 1986 8th Amendment to drugs and cosmetics Act, 1988 Notification of rules for implementation, 1989Guidelines for research, trials and commercial applications on biotechnological products, 1990 Guidelines for research in transgenic plants, 1998 Guidelines for research for clinical products, 1999 Protection of Plants and Farmers’ Rights Act, 2001 New drugs policy, 2002 New Guidelines and SOPs 2008 Seeds policy, 2002, Food Safety Act, 2006, BRAI Bill 2009 Ministries involved in implementation of the Act1. Ministry of Environment and Forests (1 Department, BCIL)2. Ministry of Agriculture (3 Departments, 1 Res. Council)3. Ministry of Science & Technology (2 departments)4. Ministry of Health (1 Department and 1 Res. Council)5. Ministry of Food and Food Supply
  • 5. Agencies Involved in Rules,1989 of EP Act 1986 GOVERNMENT OF INDIA Dept. of Environment RDAC Dept. of BiotechnologyApplicant GEAC RCGM Compliance Committee ICAR and SAUs Large Scale Imports, Production and SBCC R&D, Release IBSC Limited experimental field trials and imports for R&D. DLC PI/ Applicant 5Where are AICCIPs, CVRC & DAC, and Seed Act 1966?
  • 6. Procedures involved in Commercialization of Transgenic crops Applicant GEAC IBSC CTScientificdecisions RCGM Biosafety Research Level Screen House Event 2 (BRL 2) Trials DLC SBCC Selection Trials Biosafety Research Level 1 (BRL 1) Trials Environmental Release for commercial agriculture (??)Where is the release & notification under Seed Act 1966?
  • 7. BRL1 and BRL 2 Compliance Team* To undertake field visits at the experimental site(s).* To review the design of experiments / trials and collection of data during limited open field trials* To collect information on the comparative agronomic advantages of transgenic crop* To assess and advise on the risks and benefits from the use of transgenic plants* To assist in collecting, consolidating and analyzing the field data for evaluating the environmental risks emanating from the transgenic plants* To recommend those transgenic crops which would be found to be environmentally safe and economically viable to RCGM and to GEAC for consideration to release into the environment
  • 8. Purpose of Biosafety Research Trials• To evaluate the performance of the GM events• To collect biosafety data needed to meet regulatory requirements for commercial release and• To produce material needed for food, feed and environment safety assessments
  • 9. Confined Field Trial for Biosafety Testing• Confined field trial option employed for biosafety testing of GM crop• A confined field trial is a field experiment under terms and conditions that are intended to mitigate the establishment and spread of the plant
  • 10. No Mateiral Goes Out of Trial Site • The confined field trial system is not intended to support other activities such as, • commercial seed multiplication or • No seed can be harvested from BRL trials • For seed production, a separate regulatory authorization needs to be obtained at a different site • Entire biological produce has to be destroyed after the data generation is completed
  • 11. Types of Biosafety Trials for GM Crops• RCGM is the regulatory authority for Event Selection Trial (with the approval of GEAC)• Mandatory Trials: BRL I (2 years); BRL II (1 Year)• RCGM is the regulatory authority for Bioafety Research Level I (BRL I) trials (with the approval of GEAC)• GEAC is the regulatory authority for Biosafety Research Level II.(BRL II) trials (recommendation of RCGM)• Minimum off three years BRL trials are required for
  • 12. Trial Size and Number of LocationsI. Biosafety Research Level I (BRL I)trials are limited in size to A. No more than 1 acre (0.4 ha) per trial site location and B. Cumulative total of 20 acres (8.1 ha) for all locationsfor each plant species/construct combination, per Applicant,per crop season. C. No more than two events (single or stacked) per trial, 2-3 genotypes per event D. Each event genotype should have its non-transgenic counterpart E. Appropriate checks (national and regional)
  • 13. Trial Size and Number of LocationsBiosafety Research Level II trialsA. no more than 2.5 acres (1 ha) per trial site location andB. no more than eight (8) locations within India for each plant species/construct combination (e.g., one or more events originating from transformation of a plant species with the same genetic construct) per Applicant, per crop season
  • 14. Composition of BRL 2 TrialsA. No more than two genotypes per GE event if more than one event was tried in the BRL I trial andB. If only one GE plant genotype was evaluated in the BRL I, the same composition with the same number of treatments as in BRL I need to be maintainedC. The selection of the GE plant genotype/genotypes should be strictly based on the performance evaluation conducted in the BRL I, approved for advancing to BRL II, by the regulatory body.D. The plot size should be a minimum of twice the size of the plot adopted in the BRL I
  • 15. Locked gate with Hazard authorized Minimum isolation distance sign entry (5 mts to 500 mts.: (cropwise) recordExperimentdetail withauthorization Rep1 Fencing TRIAL Rep2 50m security 500m Rep3 LIMITED FIELD TRIAL LAY-OUT
  • 16. North Ranjitnagar N eFIELD u en Av en avTRIAL ue 1 ainSITE M Av West Patelnagar en ue 2 Av en ue 3 Av en ue 4 IARI Lib rar y Av en ue LOCATION OF SITE OF FIELD TRIAL
  • 17. Field Trial of Transgenic Tomato and Mustard
  • 18. BRL 1 Trial
  • 19. NEW SET OF GUIDELINES AND SOPs FOR GE CROPS• Guidelines and Standard Operating Procedures (SOPs) for Confined Field Trials of Regulated, Genetically Engineered (GE) Plants - 2008• Guidelines for the Safety Assessment of Foods Derived from Genetically Engineered Plants - 2008• Protocols for Food and Feed Safety Assessment of GE crops - 2008
  • 20. Studies and Information Required Before BRL I Trial• Description of the GM Plant• Description of the Biology of the Non- Transgenic Host Plant• Description of the Genetic Modification(s)• Assessment of Possible Toxicity and Allergenicity• Conformation of Inheritance of the New Trait(s) Over Multiple Generations
  • 21. Studies that need to be completed during BRL Trials• Include both in-field experiments and Studies that require plant material collected from field trials 1. Confirmation of expression levels of new proteins 2. Data about reproductive and survival biology as compared to non transformed counterpart 3. Impact on non target organisms 4. Compositional analysis of key components 5. Live stock feeding performance studies
  • 22. Specific information and data requirements for the safety assessment of GM Crops Food & Feed Safety Environmental Risk Assessment Assessment Field Non-field Field Non-fieldSTUDIES TO BE COMPLETED studies studies* studies studies*Acute oral safety limit studyPepsin digestibility assayProtein thermal stabilitySubchronic feeding study in rodents (if required)Livestock feeding study (if required)Molecular characterizationInheritance of introduced traitStability of introduced traitExpression of introduced protein(s)Compositional analysisReproductive and survival biologyImpact on non-target organisms: Tier I testingImpact on non-target organisms: Tier 2 testing*run concurrently with field trials
  • 23. Compliance RecordsRecords of all confined field trials to be maintained by the PermittedParty to be made available to RCGM/GEAC including •pre- and post-harvest site monitoring •activities related to trial site compliance (including subcontracts) •cleaning of equipment •transportation •disposition and •storage of all surplus and harvested seed and plant materialMandatory recording formats for Confined Field Trials of GeneticallyEngineered Crops : Transport, Storage, Management, Harvest orTermination and Post Harvest Management and can bedownloaded from http://igmoris.nic.in
  • 24. Mandatory Information Submissions by ApplicantI. Planting Information Submission:RCGM/GEAC shall be informed in writing within 7 working daysof planting at a trial site:•Record of Planting shall be submitted and must reference the confined trial permit number and document, •document the amount of material planted •the planting date •the transportation of plant material to the trial site •the cleaning of any equipment used during planting, and •the disposition of any surplus plant material remaining after planting•If it was not provided with the application, this notification mustalso include a detailed map of the trial site along with experimentalfield layout plan
  • 25. II. Harvest Information Submission:A Record of Harvest/Termination shall be prepared for each confinedfield trial site and shall document•the date and method of harvest,•the amount of harvested material,•the disposition of any harvested materials,•the cleaning of any equipment used during harvest, and•the method of destruction of any residual plant material on the trial site. This record must be verified and signed by a member of theMonitoring Agency or any nominee of RCGM /GEAC /SBCC /DLC/SAU authorized by RCGM/GEAC during the conduct of a trial siteinspection during harvest, or within 15 days of the completion of harvest
  • 26. III. Accidental Release Information :The Permitted Party shall notify RCGM/GEAC immediately upondiscovery by telephone but positively within 24 hours in writing ofany incident involving an accidental or unauthorized escape like, •Spillage, •Theft or encroachment by unauthorized persons, •vandalization etc. of regulated GE plant material during transportation, storage within a contained facility, or during any other activity associated with the conduct of a confined field trialAny breach of the authorized terms and conditions ofreproductive isolation shall be considered an accidental release andsubject to risk assessment and management if any at the cost of theapplicant or Permitted Party
  • 27. Other Submissions :In the event that the plants undergoing confined field trialtesting exhibit any characteristics substantially different from•those known for the host plant species,• anticipated and listed in the application,•or suffers any unusual occurrence,the Permitted Party shall notify RCGM/GEAC in writingwithin five (5) days of such observations
  • 28. Reproductive Isolation of Confined Field Trials•To prevent their establishment and spread within theenvironment, regulated GM plants within a confined trialmust be reproductively isolated from sexually compatibleplant species in proximity to the trial site, and any progenyplants that arise on the trial site after completion of the trialmust be eliminated•It is the responsibility of the Permitted Party to ensure thatthe conditions for reproductive isolation of all trial plants aremet during growing season and the post-harvest period
  • 29. Spatial Isolation•The primary means of achieving reproductive isolation is through theimposition of a spatial isolation distance between the trial plants andany neighbouring sexually compatible plants•Minimum spatial isolation distances vary depending on thereproductive biology of the plant species•The spatial isolation area defined by the isolation distance must becontinuous and completely surround the confined trial site•Any prohibited plants found growing within the isolation area shall beremoved prior to flowering, otherwise, a breach of reproductiveisolation shall be deemed to have occurred•In the event of any breach of reproductive isolation, the post-harvestland use restrictions and requirements for post-harvest monitoringshall apply to both the trial area and the surrounding isolation area
  • 30. Alternative Methods of Reproductive IsolationApplicants should refer to the crop-specific RCGM/GEAC SOPs todetermine if alternative methods of reproductive isolation will bepermitted:1. Removal of floral parts before pollen maturity2. Bagging of flowers/tassels to prevent open pollination3. Termination of the trial prior to flowering4. Temporal isolation of pollination (i.e., planting earlier or later thanany nearby sexually compatible plants so that flowering isasynchronous)5. Planting of border rows of non-regulated plants of similar variety asthe trial plants to act as a pollen trap (This is only applicable to insect-pollinated crops and only when experimental studies havedemonstrated that pollen traps are as effective as spatial isolation forthe purpose of reproductively isolating a field trial site)
  • 31. Disposition of Material from Confined Field Trial•No harvested material or byproduct from a confined field trial may beused as human food or livestock feed•Seed or other plant material harvested from confined trials (includingborder rows) that has not been previously authorized by RCGM/GEACto be retained for future research work, must be disposed off by amethod approved by RCGM/GEAC (e.g., dry heat, steam heat,incineration, deep burial, chemical treatment, or crushing or burying onthe trial site)•Composting is not an acceptable method for the disposal of plantmaterial especially in open pit with any organic animal waste•Progeny from any confined field trial cannot be retained for futureplanting without prior written authorization from RCGM/GEAC, andthis must be specifically requested in the field trial application
  • 32. Post-Harvest Land Use Restrictions and Post-Harvest MonitoringIt is also necessary to prevent the establishment of any progeny plantsat the field trial site during subsequent growing season. Therefore, apost-harvest period for various plant species on a case-by-case basisis established and requires following precautions to be implemented:1. The area under restriction must be monitored during the post-harvest period to ensure that any prohibited plants (volunteers or sexually compatible species) are destroyed prior to flowering2. No plants of the same or a sexually compatible species may be planted in the restricted area during the post-harvest period3. Land use of the restricted area must be compatible with requirements for monitoring and removal of prohibited plants. No plants that could interfere with monitoring for prohibited plants can be plantedThe restricted area is normally limited to the area of the trial site, anddoes not include the surrounding isolation area unless a breach ofreproductive isolation occurred
  • 33. Field Trial Report•The Permitted Party shall submit a field trial report toRCGM/GEAC within 3 months after termination/harvest of a confined field trial•The field trial report must summarize the completed trial,including methods, observations, data and analysis of anyeffects of the trial plants on other plants, non-targetorganisms, or the environment
  • 34. Detailed information to be made available to theMonitoring Agency/ies* As per designed proforma* As truthfully as can be perceived* Any item not included in the proforma but the experimenter perceives as a potentially unsafe trait/effect
  • 35. Proposed Combined Trials for Biosafety and Productivity• BRL 1 (I & II Year) can be aligned with field experimentation in line with IVT 1 and AVT 1• BRL 2 (I year) can be aligned with field experimentation in line with AVT II along with ancillary data sets generation (Agronomy, quality, pathology, physiology, etc.)• The BRL and AICCIP trial combine as “ IVT/AVT-GM” Trials following EPA 1986 and SA 1966
  • 36. DBT, MoEF ICAR, DAC GEAC BRL II GEAC RCGM Verification by AVT I-GM Evaluation by CT BRL I ( II year) AICCIP RCGM AICCIP CT Evaluation by Verification by AVT II-GM IVT-GM BRL I (I year) IdentificationEnvironmental PD/PC (AICCIP) release (EPA 1986) RCGM DAC Field release (SA 1966)
  • 37. An integrated approach• Eliminates extremely diverse, unreliable and vulnerable evaluation at non-descript fields without proper data generation and evaluation of performance• Makes direct connection to improving farmer level productivity of the value added crop• Increases public confidence and acceptability of data by regulators for reliable decision making• Increases credibility of the decisions and seed distribution/production of both private and public agencies
  • 38. BRAI Bill 2009Biotechnology Regulatory Authority of India Bill Nodal Ministry : Ministry of S & T
  • 39. BRAIInterministerial (Chairman and 2 Members) BiotechnologyAdvisory Board Advisory Council(Chair : Secy, DST, 17 (Chair : Chair, BRAI,Officers as Members) Regulatory Divisions (Min 3) 11 Expert Members) (Chief Regulatory Officers) 1. Agric., 2. Human and 3. Industrial and Forestry & Veterinary Environmental Fisheries Health Applications Risk Assessment Unit Enforcement Unit (Scientific Officers) (Monitoring Officers)
  • 40. Functional/Decision Making/Supporting Bodies of BRAI Products Ruling Committee (Member, BRAI + CROs + at least 3 experts nominated by Chairman) State Biotechnology Regulatory Advisory Committees (Each State) •Chaired by Secretary/Head/Commissioner of State Dept of Biotech / Biotech Commission/Dept of S & T • Director or equivalent officer, Health • Director or equivalent officer, Environment • Director or equivalent officer , Agriculture • Director or equivalent officer, Industry • Two members – Experts in healthcare/ agriculture/ environment/ industry • Two members - Biotechnology
  • 41. Notified Labs and Research Institutes (Accredited for modern biotech and lab equipment based data generation) Designated organization/organizations as Auditors (toaudit the notified labs/research institutes to ensure compliance relating to safety of biotech as specified) Biotechnology Regulatory Appellate Tribunal•One full time Chairperson – Judge in SC or CJ HC• Five part-time expert members – Eminent Scientists withminimum 20 years experience
  • 42. Applicant BRAI Regulatory Division/sRisk Assessment Product RulingUnit Committee
  • 43. Acknowledgement• DG, ICAR and DDG (CS)• Dr V. Ahuja, BCIL Thank You