Post on 13-Apr-2018
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Biosafety & Regulatory Requirements
For GMOs
K.K. Tripathi
Department of Biotechnology,
Ministry of Science and Technology,
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Outline of Presentation
• Why we need Biotech crops?
• Biosafety issues• Regulatory aspects
• IBSC Checklist
• Transgenics in Agriculture
• Harmonisation of Regulatory Process
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T h e f i r s t h o p e
f o r f o o d
b a s e d a p p r o a c h
t h r o u g h G M
Various Insect & Herbicide tolerant crops etcVarious Insect & Herbicide tolerant crops etc
GM to combatGM to combat
malnutritionmalnutrition
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Biotechnology contributing inAgriculture
Pest management
Trait improvementIncreased productivity
Fortification
Golden rice (vitamin A rich rice) Iron and Zinc rich rice
Quality Protein maize
AmA1 gene in Potato
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BIOSAFETYBIOSAFETY
PUBLICRisk Communication
Navigation in perpetual
space
POLICY MAKERSRisk Management
Navigation indecision space
SCIENTISTSRisk Assessment
Navigation in
physical space
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Biosafety Information sought from GMO trials
Laboratory and Green House Trails
Back crossing methods
Seed setting characteristics
Germination rates
Phenotypic characteristics
Target gene efficacy tests
Toxicity and allergenicity implications if
any during handling
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Biosafety Information sought from GMO trails
Rational for the development
Economic, agronomic and other benefits, and rationale ofdevelopment
Details of the molecular biology of GMOs
Description of the host plantSource and sequence of transgenic
Cloning strategy
Characteristic of expression vectorsCharacteristic of inserted genes with details of
sequences
Characteristic of promotersTransformation/cloning methods of target organism
Genetic analysis including copy number of inserts,
stability, level of expression of transgenes, biochemistryof expressed gene products etc.contd…...
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Biosafety Information sought from GMO trails
Field TrialComparison of germination rates and phenotypic
characteristics
Study of gene flow
Invasiveness studies
Possibil ity of weed formation
Possibility of transfer of transgenes to near relatives through
out crossingImplications of out crossing
Susceptibili ty to diseases and pests
Toxicity and allergenicity implication of plants/fruits, seeds
and animals
studies food/feed safety evaluation
Handling procedures for allergenic substances
Agronomic evaluation
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Regulatory Aspects for GMOs
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Why Regulations are Necessary for Using GMOs and
Products 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 thenew 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 andthe environment where the GMO is being tested
GMOs can be microorganisms, plants, and animals
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A case-by-case analysis of the safety of each GMOs
and 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 tothis
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 UnionMinistry of Environment & Forests
The Rules cover all kinds of GMOs and products thereof
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Steps to be followed for developing Transgenic Cropswith new gene in new gene cassette
Proposal
Institutional Biosafety Committee with DBT Nominee
RCGM’s approval for Lab & Green House Experiments & Generation ofrelevant 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 & ICAR
Trials for generation of biosafety and agronomic data
Commercialization of seeds as per the relevant Acts & Rules
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IN ORDER TO EVALUATE PROPOSALS, DBT HASISSUED 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.
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EPA 1986 Authorities & 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)
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RESPONSIBILITIES OF IBSC
• REGISTRATION OF BIOSAFETY COMMITTEE MEMBERSHIPCOMPOSITION WITH RCGM
• REGULAR MEETINGS AND SUBMISSION OF REPORTS
• REVIEW AND CLEARANCE OF PROJECT PROPOSALSFALLING UNDER RESTRICTED CATEGORY THAT MEETSTHE REQUIREMENTS UNDER THE GUIDELINES
• TAILORING BIOSAFETY PROGRAMME TO THE LEVEL OFRISK ASSESSMENT
• ENSURE TRAINING OF PERSONNEL ON BIOSAFETY
• INSTITUTING HEALTH-MONITORING PROGRAMME FORLABORATORY PERSONNEL
• ADOPTING EMERGENCY PLANS
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ASPECTS TO BE REVIEWED
• GENERAL CONSIDERATIONS
• SCIENTIFIC CONSIDERATIONS
• CONTAINMENT FACILITIES
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GENERAL CONSIDERATIONS
• STATUS OF THE ORGANIZATION• ORGANIZATIONAL CAPABILITIES (SKILLED /
TRAINING REQUIREMENTS)
• PROJECT DETAILS
• REQUIREMENT OF OTHER APPROVALS
• DOCUMENTATION
• ETHICAL ISSUES
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STATUS OF THEORGANIZATION
• CONSTITUTION
• AFFILIATION
• BRANCHES / SUBSIDIARIES
• YEAR OF ESTABLISHMENT
• YEAR OF INITIATING rDNA ACTIVITIES
• YEAR OF SETTING UP IBSC
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ORGANIZATIONAL
CAPABILITIES• AVAILABILITY OF EXPERTISE (TECHNICAL &
REGULATORY)• CHAIN / HEIRARCHY IN COMMAND OF MONITORING
• DISTINCT ALLOCATION OF RESPONSIBILITIES
• SPECIALISTS IN LINE WITH COMPLEXITY OF THEPROJECT
• REGULATION OF STAFF MOVEMENT ANDUNAUTHORISED ENTRY
• ACCREDIATION IF ANY (GLP, GMP, DSIR, FDA, WHO etc.
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PROJECT DETAILS ANDSTATUS
• OBJECTIVES
• SOCIO-ECONOMIC BENEFITS
• STAGE OF DEVELOPMENT
• SOURCES OF FUNDS (In-house/governmentorganizations/ 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
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Summary of Transgenic Research inAgriculture
Target Crops/ Vegetables
Cotton, Corn, Mustard, Rice, Soybean, Potato,
Tobacco, Coffee, Tomato, Brinjal, Caulif lower, Pea,
Cabbage, Banana, Muskmelon, Pigeonpea,
Chickpea, Bell-pepper, Blackgram, Chill i,
Watermelon etc.
Transgenes Employed
Bt. 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, GNAgene, Vip-3 gene, Bacterial Blight Resistance gene,
Osmotin etc.
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Harmonization Process
Swaminathan Committee
Regulatory Approvals in Agriculture
Mashelkar Committee
Regulatory Approvals in rDNA Pharma
Protocol-I: For New Transgenic Event
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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
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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 trialsby Company/ Institution(s)
ICAR trials for VCU
involving SAUs andother State Agencies
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NATIONAL BIOTECHNOLOGY
REGULATORY AUTHORITY/COMMISSION
In consonance with the recommendations
of
Both the Committees
CHAIRMAN
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CHAIRMAN
Apex Committee with Statutory Powers, consisting of all
stakeholder Ministries/Departments
Vice-Chairman
Secretariat
Agriculture
Products/TransgenicCrops
Pharmaceutical/
Drugs andIndustrialProducts
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
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Details of the Secretariat and their expertise
AgricultureProducts/Transgenic
CropsMolecular
biologist
Plant biologist
PlantGeneticist
Plant breeder
Agronomist
Plant EcologistEnvironment
biologist
Agricultureeconomist
Environment biologist
Pharmaceutical/Drugs andIndustrialProducts
Molecular biologist
Pharmacologist
Toxicologist
Epidemiologist
Microbiologist
Biochemist
AnalyticalChemist
Physicist
Environment biologist
Transgenic foods/
feed
Molecular biologist Nutritionist
Pharmacologist
Toxicologist
EpidemiologistMicrobiologist
Biochemist
Analytical Chemist
Physicist
Environment
biologist
TransgenicAnimals/aquacultur
Molecular biologistAnimal Breeder
Poultry Breeder
Nutrition Expert
Animal PathologistFishery Expert
Pharmacologist
Toxicologist
EpidemiologistMicrobiologist
Biochemist
Analytical Chemist
PhysicistEnvironment
biologist
Capacity Building Needs and its
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Capacity Building Needs and itsRelevance
Capacity building needs are considered
to be the key milestones to be
successfully crossed by the developingregions 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 thiscontext capacity building needs become
most relevant aspect in the safe use of
LMOs
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Institution Building
Risk assessment capacities
Involvement of stakeholders
Development and strengthening of legal andregulatory 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
Th bli h ld b i d
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The public should be viewed as a
“partner” and a level of trustneeds to be created. Developing
this style will be a major challengefor business leaders as well asuniversity scientists and governmentregulators.
The Public perception is most important in thesuccess/failure of rDNA product and safetyaspects to environment/humans/animals etc.
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Thank you