biosafety tripathi

7/27/2019 Biosafety Tripathi

http://slidepdf.com/reader/full/biosafety-tripathi 1/32

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



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



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



BIOSAFETYBIOSAFETY

PUBLICRisk Communication

Navigation in perpetual

space

POLICY MAKERSRisk Management

Navigation indecision space

SCIENTISTSRisk Assessment

Navigation in

physical space



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



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…...



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



Regulatory Aspects for GMOs



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



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



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



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.



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)



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



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 THEORGANIZATION

• 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 THEPROJECT

• REGULATION OF STAFF MOVEMENT ANDUNAUTHORISED ENTRY

• ACCREDIATION IF ANY (GLP, GMP, DSIR, FDA, WHO etc.



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



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.



Harmonization Process

Swaminathan Committee

Regulatory Approvals in Agriculture

Mashelkar Committee

Regulatory Approvals in rDNA Pharma

Protocol-I: For New Transgenic Event



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 trialsby Company/ Institution(s)

ICAR trials for VCU

involving SAUs andother State Agencies



NATIONAL BIOTECHNOLOGY

REGULATORY AUTHORITY/COMMISSION

In consonance with the recommendations

of

Both the Committees

CHAIRMAN



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



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



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



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



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.



Thank you

biosafety tripathi

Documents