1. STEPS IN DEVELOPMENT OF TRANSGENIC
2. REGULATORY APPROVAL SYSTEM OF
Presentation by: Guru P N 2015-16
What is a transgenic?
Transgene – the genetically engineered gene added to a species
Example: – modified EPSP synthase gene (encodes a
protein that functions even when plant is treated with
Transgenic – an organism containing a transgene introduced
by technological (not breeding) methods
Example:– Roundup Ready Crops
Concept Based on the Term Transgene
We can develop organisms that express a “novel” trait
not normally found in the species
Why are transgenics important?
Extended shelf-life tomato (Flavr-Savr)
Herbicide resistant soybean (Roundup Ready)
Insect resistant transgenics
Insect resistant cotton – Bt toxin kills the
cotton boll worm
• transgene = Bt protein
Insect resistant corn – Bt toxin kills the
European corn borer
• transgene = Bt protein
Plant Transformation Methods
Physical Chemical Biological
Biolistics - gene gun/
Important Plant Improvement Methods
Crossing two individuals from the same species;
produces a new, improved variety;
not a biotechnology procedure
Adding a gene from another species; the
essential biotechnology procedure to produce
Introducing the Gene
1. Create transformation cassette
2. Introduce and select for transformants
1. Gene of interest
• The coding region and its controlling elements
2. Selectable marker
• Distinguishes transformed/untransformed plants
3. Insertion sequences
• Aids Agrobacterium insertion
Prepare tissue for transformation
Culture plant tissue
• Develop shoots
• Root the shoots
Field test the plants
• Leaf, germinating seed, immature embryos
• Tissue must be capable of developing into normal plants
• Agrobacterium or gene gun
• Multiple sites, multiple years
• Transformation cassettes are developed in the lab
• They are then introduced into a plant
• Two major delivery methods
Delivering the Gene
to the Plant
• Gene Gun
required to generate
Production of transgenic plants
Isolate and clone gene of interest
Add DNA segments to initiate or enhance
Add selectable markers
Introduce gene construct into plant cells
Select transformed cells or tissues
Regenerate whole plants
Regulation of GM Foods in India
Under Environment Protection Act (1986), MoEf rules
formulated in 1989 which created six competent authorities
namely RDAC, RCGM, GEAC, IBSC, SBCC, DLC;
MEC for field trials under RCGM and GEAC
Recombinant DNA Safety Guidelines 1990, modified 1994
DBT Revised Guidelines for research on Transgenic Plants –
1998, also includes guidelines for Toxicity & Allergenecity
evaluation of transgenic seeds, plants & plant parts
Safety assessment of GM Food Crops –2007, modified 2009
Guidelines for the safety assessment of foods derived from
GE plants -2008
Guidelines & SOPs for Confined Field Trials of Regulated
Genetically Engineered Plants –2008
Indian Regulatory System
Aims to ensure that GM crops pose no risk to food safety,
environmental safety and agriculture productivity
To demonstrate potential benefits over the conventional
variety/hybrid in terms of economic benefit to the farmer and /or
To generate quantitative biological, ecological and agronomic
Rules and guidelines formulated to achieve above objectives
Bt as part of IPM Agricultural practices to integrate
Improved Nutrition & Abiotic Stress
GOVERNMENT RULES FOR GMOs
The regulatory framework for transgenic crops in India
consists of the following rules and guidelines.
Rules and policies Rules 1989 under Environment Protection
Seed Policy 2002 Guidelines
Recombinant DNA guidelines, 1990
Guidelines for research in transgenic crops, 1998
There are six competent authorities as per the rules:
Recombinant DNA Advisory Committee (RDAC)
Review Committee on Genetic Manipulation (RCGM)
Genetic Engineering Approval Committee (GEAC)
Institutional Biosafety Committees (IBSC)
State Biosafety Coordination Committees (SBCC)
District Level Committees (DLC).
Out of these, the three agencies that are involved in approval
of new transgenic crops are:
IBSC set-up at each institution for monitoring institute level
research in genetically modiﬁed organ- isms.
RCGM functioning in the DBT to monitor ongoing research
activities in GMOs and small scale ﬁeld trials.
GEAC functioning in the MoEF to authorize large-scale trials
and environmental release of GMOs.
The approvals and prohibitions under Rules 1989 are summarized
No person shall import, export, transport, manufacture, process, use or
sell any GMOs, substances or cells except with the approval of the
Use of pathogenic organisms or GMOs or cells for research purpose
shall be allowed under the Notiﬁcation, 1989 of the EPA, 1986.
Any person operating or using GMOs for scale up or pilot operations
shall have to obtain permission from GEAC.
For purpose of education, experiments on GMOs IBSC can look after,
as per the guidelines of the Government of India.
Deliberate or unintentional release of GMOs not allowed.
Production in which GMOs are generated or used shall not be
commenced except with the approval of GEAC supervises the
implementation of rules and guidelines.
GEAC carries out supervision through SBCC, DLC or any authorized
If orders are not complied, SBCC/DLC may take suitable
measures at the expenses of the person who is responsible.
In case of immediate interventions to prevent any damage,
SBCC and DLC can take suitable measures and the expenses
incurred will be recovered from the person responsible.
All approvals shall be for a period of 4 years at ﬁ rst instance
renewable for 2 years at a time. GEAC shall have powers to
revoke approvals in case of: Any new information on harmful
e ects of GMOs. GMOs cause such damage to theﬀ
environment as could not be envisaged when approval was
given. Non-compliance of any conditions stipulated by GEAC.
Genetic engineering experiments on plants have been grouped under three
Category I includes routine cloning of deﬁned genes, deﬁned non-coding
stretches of DNA and open reading frames in deﬁned genes in E. coli or
other bacterial/fungal hosts which are generally considered as safe to human,
animals and plants.
Category II experiments include experiments carried out in lab and green
house/net house using deﬁned DNA fragments non-pathogenic to human and
animals for genetic transformation of plants, both model species and crop
Category III includes experiments having high risk where the escape of
transgenic traits into the open environment could cause signiﬁcant alterations
in the biosphere, the ecosystem, plants and animals by dispersing new
genetic traits the e ects of which cannot be judged precisely. This alsoﬀ
includes experiments having risks mentioned above conducted in green
houses and open ﬁeld conditions. 28
OVERVIEW OF MINISTRIES AND
DEPARTMENTS INVOLVED IN REGULATION
OF GM FOOD
1. Ministry of Environment and Forest:
This ministry holds the Secretariat of the Genetic
Engineering Approval Committee, the apex body that gives approval for
manufacture, sale, import and export of all GMOs and products thereof
including foodstu , ingredients in foodstu and additives using geneticallyﬀ ﬀ
modiﬁ ed (GM) organisms or cells.
2. Department of Biotechnology:
This department holds the Secretariat of the Review
Committee on Genetically Modiﬁ cation that gives approval for research and
small scale ﬁ eld trials involving GMOs and products thereof. It also interacts
with the Institutional Biosafety Committees (IBSCs) set up in all organizations
undertaking activities involves GMOs.
3. Department of Health in the Ministry of Health and Family
Department of Health is responsible for
implementation of the PFA Act under which the quality and safety of
food is regulated. The Directorate General of Health Services has also
been designed as the nodal Ministry with the Codex Alimentarious
4. The Indian Council of Medical Research (ICMR)
It is the apex body in India for the formulation, coordination
and promotion of biomedical research under the Ministry of Health and Family
Welfare. ICMR acts as an advisory body for MoHFW on various issues
including GM foods.
5. Ministry of Agriculture:
Ministry of Agriculture is the nodal ministry for agriculture
growth in the country. It comprises of three Departments viz. Department of
Agriculture and Cooperation, Department of Agricultural Research &
Education/ Indian Council of Agricultural Research (ICAR) and Department of
Animal Husbandry & Dairying. Th e o cials from ICAR and Ministry ofﬃ
Agriculture have an important role to play in the approval of GM crops as per
Seed Policy, 2002.
6. Ministry of Commerce and Industry:
This ministry is responsible for the formulation of the
Export and Import (EXIM) Policy in the country. It implements a legislation
prescribing a system of quality control and inspection for both export/import.
7. Ministry of Food Processing Industries:
This ministry is responsible for the formulation of policy for
the healthy growth of the food processing industries and provides
developmental support to these industries. It encourages research and
developmental activities and assists the industries in active participation in the
laying down of food standards as well as their harmonization with inter-
national standards. Th is ministry is also the licensing authority for processed
fruits and vegetable industries.
India, along with a number of other countries, has supported the
mandatory labeling of GM food by Codex.
Limitations of the Regulatory System in India
I.Lack of adequate standards for risk assessment
II.The procedure and information required for a full environment
risk assessment and appropriate safety and emergency responses not
III.Instructions and conditions for use on labeling and packaging of
products containing GMOs yet to be specified.
IV.Detailed safeguards as embodied in the Cartagena Protocol yet to
V.Lack of infrastructure for risk assessment.
VI.Shortage of skilled personnel from laboratory researchers to
extension service officers. 34
(vii) Although food safety studies are fairly rigorous as prescribed
by the RCGM, there are always uncertainties in the risk
assessment process because this is a novel technology. Also
there needs to be special considerations when the food forms a
major portion of the diet (for e.g. cereals) and the special
sociocultural habits of the population need the consumption of
parts of the plant which are unconventional for other
civilisations (e.g mustard leaves). In such a scenario special
studies may have to be undertaken even on human volunteers.