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Biosafety & Regulatory Requirements For GMOs
K.K. Tripathi
Department of Biotechnology,
Ministry of Science and Technology,
Outline of Presentation
• Why we need Biotech crops?• Biosafety issues• Regulatory aspects• IBSC Checklist• Transgenics in Agriculture• Harmonisation of Regulatory Process
The first hope
for food
based approach
through GM
Various Insect & Herbicide tolerant crops etcVarious Insect & Herbicide tolerant crops etc
GM to combat GM to combat malnutritionmalnutrition
Biotechnology contributing in Agriculture
Pest managementTrait improvementIncreased productivityFortificationGolden rice (vitamin A rich rice)Iron and Zinc rich riceQuality Protein maizeAmA1 gene in Potato
BIOSAFETYBIOSAFETY
PUBLICRisk CommunicationNavigation in perpetual
space
POLICY MAKERSRisk Management
Navigation in decision space
SCIENTISTSRisk Assessment
Navigation in physical space
Biosafety Information sought from GMO trials
Laboratory and Green House TrailsBack crossing methods
Seed setting characteristics
Germination rates
Phenotypic characteristics
Target gene efficacy tests
Toxicity and allergenicity implications if any during handling
Biosafety Information sought from GMO trailsRational for the developmentEconomic, agronomic and other benefits, and rationale of developmentDetails of the molecular biology of GMOs
Description of the host plantSource and sequence of transgenicCloning strategyCharacteristic of expression vectorsCharacteristic of inserted genes with details of
sequencesCharacteristic of promotersTransformation/cloning methods of target organismGenetic analysis including copy number of inserts,
stability, level of expression of transgenes, biochemistry of expressed gene products etc.
contd…...
Biosafety Information sought from GMO trailsField Trial
Comparison of germination rates and phenotypic characteristics
Study of gene flowInvasiveness studiesPossibility of weed formationPossibility of transfer of transgenes to near relatives through
out crossing Implications of out crossing Susceptibility to diseases and pests Toxicity and allergenicity implication of plants/fruits, seeds
and animals studies food/feed safety evaluation
Handling procedures for allergenic substancesAgronomic evaluation
Regulatory Aspects for GMOs
Why Regulations are Necessary for Using GMOs andProducts Thereof?
GMOs) and and their products are to play important role including human and animal health care system, agriculture, industrial products, environment management
Concurrently, there could be unintended hazards and risks from the use of GMOs and products thereof, if the new technology was not properly assessed before use
A GMO can be safe but this can be unsafe too depending upon the trans-genes, the host organism and the environment where the GMO is being tested
GMOs can be microorganisms, plants, and animals
A case-by-case analysis of the safety of each GMOsand products thereof need to be conducted to assess their safety
Whenever GMOs are released in environment they require safety evaluation for humans and animals; due to this
Indian Government enacted the Environment (Protection) Act in 1986 and thereafter, notified Rules & Procedures (Rules) for handling GMOs and hazardous organisms through a Gazette Notification from the Union Ministry of Environment & Forests
The Rules cover all kinds of GMOs and products thereof
Steps to be followed for developing Transgenic Crops with new gene in new gene cassette
Proposal
Institutional Biosafety Committee with DBT Nominee
RCGM’s approval for Lab & Green House Experiments & Generation of relevant data
RCGM’s approval for Contained open field trials& Generation of biosafety data
RCGM’s approval for Multi-location trials under RCGM for generation of biosafety and agronomic data
Large scale field trials under GEAC & ICARTrials for generation of biosafety and agronomic data
Commercialization of seeds as per the relevant Acts & Rules
IN ORDER TO EVALUATE PROPOSALS, DBT HAS ISSUED FOLLOWING GUIDELINES
Recombinant DNA Safety Guidelines, 1990
Recombinant DNA Safety Guidelines and Regulations, 1994
Revised Guidelines for Safety in Biotechnology, 1994
Revised Guidelines for Research in Transgenic Plants, 1998
Guidelines for generating pre-clinical and clinical data for rDNA vaccines, diagnostics and other Biologicals, 1999.
EPA 1986Authorities & Administrative structure
STATUTORY BODIESSTATUTORY BODIES1. 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)
RESPONSIBILITIES OF IBSC
• REGISTRATION OF BIOSAFETY COMMITTEE MEMBERSHIP COMPOSITION WITH RCGM
• REGULAR MEETINGS AND SUBMISSION OF REPORTS
• REVIEW AND CLEARANCE OF PROJECT PROPOSALS FALLING UNDER RESTRICTED CATEGORY THAT MEETS THE REQUIREMENTS UNDER THE GUIDELINES
• TAILORING BIOSAFETY PROGRAMME TO THE LEVEL OF RISK ASSESSMENT
• ENSURE TRAINING OF PERSONNEL ON BIOSAFETY
• INSTITUTING HEALTH-MONITORING PROGRAMME FOR LABORATORY PERSONNEL
• ADOPTING EMERGENCY PLANS
ASPECTS TO BE REVIEWED
• GENERAL CONSIDERATIONS
• SCIENTIFIC CONSIDERATIONS
• CONTAINMENT FACILITIES
GENERAL CONSIDERATIONS
• STATUS OF THE ORGANIZATION
• ORGANIZATIONAL CAPABILITIES (SKILLED / TRAINING REQUIREMENTS)
• PROJECT DETAILS
• REQUIREMENT OF OTHER APPROVALS
• DOCUMENTATION
• ETHICAL ISSUES
STATUS OF THE ORGANIZATION
• CONSTITUTION• AFFILIATION• BRANCHES / SUBSIDIARIES• YEAR OF ESTABLISHMENT• YEAR OF INITIATING rDNA ACTIVITIES• YEAR OF SETTING UP IBSC
ORGANIZATIONAL CAPABILITIES
• AVAILABILITY OF EXPERTISE (TECHNICAL & REGULATORY)
• CHAIN / HEIRARCHY IN COMMAND OF MONITORING• DISTINCT ALLOCATION OF RESPONSIBILITIES• SPECIALISTS IN LINE WITH COMPLEXITY OF THE
PROJECT• REGULATION OF STAFF MOVEMENT AND
UNAUTHORISED ENTRY• ACCREDIATION IF ANY (GLP, GMP, DSIR, FDA, WHO etc.
PROJECT DETAILS AND STATUS
• OBJECTIVES• SOCIO-ECONOMIC BENEFITS• STAGE OF DEVELOPMENT• SOURCES OF FUNDS (In-house/government
organizations/ central ministries/state departments/ international organizations/industry collaboration/ national and international NGOs and any other donors)
• IPR AND ROYALTY ISSUES• IF COLLABORATIVE, MTA/OTHER AGREEMENTS AND
STATUTORY APPROVALS
Summary of Transgenic Research in Agriculture
Target Crops/ VegetablesCotton, Corn, Mustard, Rice, Soybean, Potato, Tobacco, Coffee, Tomato, Brinjal, Cauliflower, Pea, Cabbage, Banana, Muskmelon, Pigeonpea, Chickpea, Bell-pepper, Blackgram, Chilli, Watermelon etc.
Transgenes EmployedBt. toxin genes, Herbicide tolerant genes (CP4 EPSPS, Bar gene), Xa21, ctx-B and tcp of V.cholera, Chitinase, Glucanase, ACC synthase, RIP, Protease Inhibitor, Lectin, Ama-1, OXDC gene, Rabies glycoprotein gene, Bar, Barnase, Barstar, GNA gene, Vip-3 gene, Bacterial Blight Resistance gene, Osmotin etc.
Harmonization Process
Swaminathan Committee
Regulatory Approvals in Agriculture
Mashelkar Committee
Regulatory Approvals in rDNA Pharma
Protocol-I: For New Transgenic Event
Institutional Biosafety Committee (IBSC)
Review Committee on Genetic Manipulation (RCGM)
Monitoring-cum-Evaluation Committee (MEC)
Genetic Engineering Approval Committee (GEAC)
Approval for large scale Field Trials and Evaluation Protocol**
Concurrent
Field trials by Company/ Institutions ICAR trials for VCU
Involving SAUs and other State Agencies
GEAC
Ministry of Agriculture (DAC/ICAR )
Approval for commercial release/notification/registration of variety(ies)/hybrid(s) DAC/ICAR
Ministry of Agriculture & State Governments, Post-release monitoring
Protocol - II: For Released Event
Institutional Biosafety Committee (IBSC)
Preparation/submission of application data
RCGM
Case verification and Bio-safety clearance (Need based trials)
Genetic Engineering Approval Committee (GEAC)
GEAC
Evaluation of data Environmental clearance of the event
DAC/ICAR, Ministry of Agriculture
Approval for commercial release of variety(ies)/hybrid(s)
Ministry of Agriculture & State Governments, Post-release monitoring
Approval for large scale Field Trials and Evaluation Protocol Farmer's Field trials by Company/ Institution(s)
ICAR trials for VCU involving SAUs and other State Agencies
NATIONAL BIOTECHNOLOGY
REGULATORY AUTHORITY/COMMISSION
In consonance with the recommendations of
Both the Committees
CHAIRMAN
Apex Committee with Statutory Powers, consisting of all stakeholder Ministries/Departments
Vice-Chairman
Secretariat
Agriculture Products/ Transgenic Crops
Pharmaceutical/Drugs and Industrial Products
Transgenicfoods/feed
Transgenic Animals/aquaculture
The Secretariat will have Professionally competent and Experienced Technical Officers in relevant areas of specialization
Details of the Secretariat and their expertise
Agriculture Products/ Transgenic CropsMolecular biologistPlant biologistPlant GeneticistPlant breederAgronomistPlant EcologistEnvironment biologistAgriculture economistEnvironment biologist
Pharmaceutical/Drugs and Industrial ProductsMolecular biologistPharmacologistToxicologistEpidemiologistMicrobiologistBiochemistAnalytical ChemistPhysicistEnvironmentbiologist
Transgenic foods/feedMolecular biologistNutritionistPharmacologistToxicologistEpidemiologistMicrobiologistBiochemistAnalytical ChemistPhysicistEnvironmentbiologist
Transgenic Animals/aquacultureMolecular biologistAnimal BreederPoultry BreederNutrition ExpertAnimal PathologistFishery ExpertPharmacologistToxicologistEpidemiologistMicrobiologistBiochemistAnalytical ChemistPhysicistEnvironmentbiologist
Capacity Building Needs and its Relevance
Capacity building needs are considered to be the key milestones to be successfully crossed by the developing regions including at least some developing countries in the region to enable the confidence building exercise. In other words there should be societal acceptance of the technologies of living modified organisms (LMOs) and in this context capacity building needs become most relevant aspect in the safe use of LMOs
Institution Building
Risk assessment capacities
Involvement of stakeholders
Development and strengthening of legal and regulatory structures
Capacity Building Efforts- Indian expertise and experience that can be shared in the region
Skills in biotechnology process and applications
Human resources strengthening and development
The public should be viewed as a “partner” and a level of trust needs to be created. Developing this style will be a major challenge for business leaders as well as university scientists and government regulators.The Public perception is most important in the success/failure of rDNA product and safety aspects to environment/humans/animals etc.
Thank you