WEL COMETransgenics: handling, protocols to be followed, infrastructure needed and

regulatory issues

Anilkumar, C.PALB 5062

Transgenics

Handling of GM crops

Biosafety guide lines

Regulatory issues

Public and private role

Infrastructure required

In this hour............

Introduction

• Increasing population• Impediments in traditional agriculture• Specific problems

Opportunities

• Break Yield Barriers• Improve productivity –output/input ratio• Improve quality of foods and grains• Minimize chemical inputs – pesticides and

fertilizers• Integrated Management - Insect pests and

diseases

JUDICIOUS COMBINATION OF PLANT BREEDING AND BIOTECHNOLOGY

GM CROPS-THE PROMISE

More foodBetter quality foodSafer foodHealthy foodsDesigner foods

Transgenics:

an organism containing a transgene introduced by technological (not breeding) methods

Transgenics are those which carry additional stably integrated and expressed foreign gene(s), usually transferred from unrelated organisms.

Transgenic Plant

Term. Promoter

Binary Vector

Hypocotyl InoculationCallus Induction

Embryogenesis

Shooting

SuspensionCulture

Rooting

Coding Sequence

Transformation systems currently in place for all crop species

MAKING A TRANSGENIC PLANT

Agrobacterium

GM CROPS – status - 1996-2013ECONOMICNet gain US$ 116.6 billion

SOCIALAlleviation of poverty by enhancing the income of resource-poorReduction of drudgery- Farm labour and women

ENVIRONMENTALReduced pesticide usageProtection of water, soil, biodiversity, animal and human health

James, 2013

INDIAN STATUS Only one crop approved 14 crops under various stages of contained

field trials Include brinjal, cotton, cabbage, groundnut,

pigeon pea, mustard, potato, sorghum, tomato, tobacco, rice, okra and cauliflower

Traits include insect resistance, herbicide tolerance, virus resistance, nutritional enhancement, salt tolerance, fungal resistance

Handling of transgenics:

Information to be provided:

Rationale of development:

economic, agronomic and other benefits

Details of molecular biology of GMOs:

• Description of host plant • Source and sequence of

transgene• Cloning strategy• Characteristics of

expression vector• Characteristics of

inserted gene• Promoter characteristics• Cloning method

Laboratory and green house trials

• Germination rates • Phenotypic characters• Organism challenging tests• Chemical challenge tests• Toxicity and allergenecity tests

Field trails • Study of gene flow • Invasiveness study • Possibility of weed formation• Possibility of transfer of

transgenes to near relatives through out crossing

• Susceptibility to pest and diseases

• Toxicity and allergenicity implications

• Agronomic evaluation

Presently it is banned in India (supreme court order dated 22nd April 2006)

However, Supreme Court on 13th Oct 2006 permitted Delhi University as exception to conduct field trial on GM Mustard (DMH-11).

However, on 7th Nov. 2006 one of the Member of Parliament Mr. Aruna Rodrigues filed petition against the decision on Field trial of GM mustard by DU, based on potential toxic/allergic and environmental impact of gene

Main ConcernsDevelopment of aggressive weeds/ wild

relatives by transfer of transgenic traitsErosion of land races/wild relatives by genetic

pollution in centres of origin/ diversityHarm to the non-target organismsDevelopment of pest resistance by prolonged

useMonoculture and limitations to farmers’ choice

in crop managementHazard to human and animal health by transfer

of toxins and allergens and by creation of new toxins and allergenic compounds

Biosafety issues in transgenic crops

INSTITUTIONAL MECHANISM GOI

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GEAC

SBCC

RDAC

RCGM

DBT

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IBSC

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ROLE AND JURISDICTION OF COMPETENT AUTHORITIES IN INDIA

Competent authority underthe EPA Rules 1989 of the EPAAct 1996

Implementing ministry/agency and jurisdiction

Guideline/protocol Function

Recombinant DNA Advisory Committee (RDAC)

DBT in consultationwith all relevantministries and stakeholders

– Overall advisory role, to oversee global biotech development and recommend technologies/processes for revisionof safety regulations.

Genetic Engineering, ApprovalCommittee (GEAC)

Ministry of Environment and Forest (MoEF)

Revised Guidelines for Research in Transgenic Plants and Guidelines for Toxicity and Allergenicity Evaluation of Transgenic Seeds, Plants and Plant parts-1998 (revised in 1990, 1994 and 1998)

Responsible for approval of R&D safety assessment, field trials and environmental release of GM crops and import/export of GM food.

Competent authority under the EPA Rules 1989of the EPA Act 1996

Implementing ministry/agency and jurisdiction

Guideline/protocol Function

Review Committee on Genetic Manipulation (RCGM)

DBT Ministry of Science& Technology

Guidelines and SOP for Confined Field Trials of Genetically Engineered Plants (2008)

Draft and bring out guidelines and protocols, issue import permit ,Review projects, guide and overseebiosafety and food safety regulations and environmental assessments.

Protocols for Food andFeed Safety Assessmentof GE crops (2008)ICMR, MoH&FW Guidelines for the Safety

Assessment of Foods Derived from Genetically Engineered Plants (2008)

Evaluation of food safety concerns addressing risk assessment, risk management and communication and ensure safety of GM foods to human health.

Monitoring and Evaluation Committee (MEC)

DBT in collaboration with ICAR

Guidelines for the Monitoring of Confined Field Trials of Regulated, Genetically Engineered Plants, 2008

Monitoring of field trials, storage facility and documentation of records and check compliance with the terms and conditions of field trial permit.

Competent authority underthe EPA Rules 1989 of the EPAAct 1996

Implementing ministry/agency and jurisdiction

Guideline/protocol

Function

IBSC DBT and institute undertaking rDNA research

Handbook for IBSC members

A nodal point for interaction with the institutions for implementation of biosafety regulatory framework

State Biotechnology Coordination Committee (SBCC)

State Government – Inspect, investigate, asses damage if any and take punitive action in case of violation of statuary provisions at state level

District level committee (DLC) State Government - Monitor the safety regulations, inspect on-site control measures, assess damage if any, and report to SBCC in case of non-compliance at district level

Biosafety Information Kit, 2013. Regulatory Framework for GMOs in India, Project Coordinatingand Monitoring Unit (PCMU), Ministry of Environment and Forest (MoEF).

CATEGORIES OF GENETIC ENGINEERING EXPERIMENT

Routine cloning of defined DNA fragments of microbial, animal and plant origin

Transfer of defined cloned genes into Agrobacterium Use of defined genes to study transient expression in

plant cells to study genetic transformation conditions Molecular analysis of transgenic plants grown in vitro

Category IInvolves experiment in the lab in containment environment

Category I experiment need only intimation to the IBSC

Transgenic with constitutive, tissue specific and chimeric promoters used for experimenting expression of defined DNA fragments

Marker genes extensively used in genetic transformation of plants in lab and green house/ net house experiments

Lab and green house/net house experiments with plants with herbicide resistance conferring genes

Lab and green house experiments with plants using heterologous genes which confer resistance to biotic and abiotic stresses.

Lab and green house experiments on transgenics with genes for production of antibodies

Category IIInclude lab and green house/net house experiments in containment environment where non-pathogenic DNA fragment used for genetic transformation

Category II experiment requires intimation to RCGM prior to initiation of execution

This category pertains to high risk experiments where the escape of transgenic traits into the open environment could cause significant alterations in the biosphere, the ecosystem, the plants and animals by dispersing new genetic traits, the effect of which can not be judged precisely.

Toxin gene cloning, cloning of genes for active production, genes coding for antibiotic in pathogenic organism which do not naturally posses such resistance, DNA from cancer causing organism, gene with known toxicity to plants, field testing and release of engineered microorganism and plants etc.

Category III experiments requires clearance from RCGM and notification by Department of Biotechnology before execution

Category III

  Public sector Private sectorPerformance

measureSocial benefits including share to poor

producers and consumersProfits

National-level organizations

Public NARS Local seed companies

Key assets Local diverse germplasmLocal knowledge

Breeding and evaluation programmes and associated infrastructure

Upstream capacity in Type I NARSAccess to delivery system including

extensionPositive public image

Local knowledgeBreeding programmes and

infrastructureSeed delivery system

Marketing network

Global organizations

CGIAR International Centres Global life science companies

Key assets Diverse germplasmBreeding programmes and associated

infrastructureGlobal germplasm exchange and

evaluation networksEconomies of market size

Upstream capacity in a few centresGenerally positive public image

Biotechnology tools, genes, knowledge

Access to capital marketsEconomies of market size

Skills in dealing with regulatory agencies

Possible negative public image

Source: Byerlee and Fischer, 2002.

Public and private sectors in Agri-biotechnology research

Infrastructure required

•Laboratory facility•Green house facility•Field facility

Laboratory facility

Standard laboratory equipments

Maintenance controlled conditions

Availability of resources and

transportation

Maintenance of hygiene

Availability of skilled assistants

Green house facility

Green house should be well protected

It should avoid the gene flow

Pathogen and vector free

Good water facility and transport

Well maintenance

Field facility

It should be in isolationThere should be good irrigation facilityProtected from diseases and pest Protected from insect vectorsGood transport systemThere should not be harm to natural habitat