This document discusses biosafety issues related to genetically modified crops. It provides background on GM crops and their history. It then outlines several biosafety concerns including the safety of inserted genes and proteins, ecological impacts such as increased weediness and effects on biodiversity, environmental concerns like secondary pest problems and insect resistance, and socioeconomic issues. The regulatory mechanisms in place in India to evaluate GM crops are also described, including the various competent authorities. International regulations like the Cartagena Protocol are also mentioned.
2. Genetically Modified Organisms (GMOs)
GMOs are organisms (microbe, plant or animal) produced by gene transfer
techniques.
This technology is called ‘gene technology’, or ‘rDNA technology’ or
‘genetic engineering’ and the resulting organism is ‘genetically modified’,
‘genetically engineered’ or ‘transgenic’.
Major producers of transgenic crops - USA, Argentina, Brazil, India, Canada,
China, Paraguay, South Africa.
Bt cotton is grown in six states, i.e., Madhya Pradesh, Gujarat,
Maharashtra, Andhra Pradesh, Karnataka and Tamil Nadu.
3. Brief History of GM Crops
Years Pioneer workers Discovery
1972 Paul Berg First rDNA molecule (DNA from a monkey virus with that of
the lambda virus)
1973 Herbert
Boyer & Stanley
Cohen
First genetically modified organism (GMO)
1973 Rudolf Jaenisch Transgenic mouse by introducing foreign DNA into its embryo
(world’s first transgenic animal)
1978 Genentech Announced the production of genetically engineered
human insulin.
1983 Michael W.
Bevan, Richard B.
Flavell & Mary-Dell
Chilton.
First GE plant (Tobacco-Agrobacterium transformed with an
antibiotic resistance gene - tissue culture techniques)
1987 Insect-resistant (tobacco) plants by incorporating genes that
produced insecticidal proteins from Bacillus thuringiensis
1992 China was the first country to commercialize transgenic plants,
introducing a virus-resistant tobacco.
2000 Ingo Potrykus Vitamin A-enriched golden rice - first plant developed with
increased nutrient value
4. Years Discovery
1990 Virus resistant papaya developed in response to a Papaya ringspot virus (PRV)
1994 Calgene approved for commercial release of Flavr Savr tomato (first GM food)
1994 E. U. approved tobacco engineered resistant to herbicide bromoxynil, (first GE crop
commercialized in Europe)
1995 Insect resistant Potato approved for release in USA
1996 Approval granted to commercially grow 8 transgenic crops and one flower crop
(carnation) in 6 countries plus the EU.
2002 Commercial cultivation of Bt cotton (Cry1Ac) - first transgenic crop in the country
was approved by GOI (MECH-12, MECH-162 & MECH-184)-MAHYCO).
2005 Golden Rice 2
India - area under GM crops were 11.0 million hectares (Cotton) in 2013
5. BIOTECH CONSORTIUM INDIA LIMITED, NEW DELHI: Transgenic crops approved for commercial use
Crop Uses Countries
Argentine canola Herbicide tolerance & improved protection against weeds Canada, Us, Japan, Australia
Carnation Increased shelf life by delayed ripening, modified flower colour & herbicide
tolerance
Australia, European Union
Chicory Herbicide tolerance, improved protection against weeds & higher yields EU
Cotton Improved insect protection, herbicide tolerance & improved protection against
weeds
Japan, Australia, US, China, Mexico,
South Africa, Argentina, India,
Indonesia.
Flax Herbicide tolerance, antibiotic resistance & improved weed protection Canada, US
Green pepper Virus resistance China
Maize Herbicide tolerance, improved weed protection, resistance against insects &
restored fertility of seeds.
Canada, Japan, US, Argentina, EU,
South Africa, Philippines
Melon Delayed ripening
Polish Canola Herbicide tolerance & improved weed control Canada
Potato Improved protection from insect &leaf roll virus US, Canada
Rice Herbicide resistance US
Soybean Improved weed control & herbicide tolerance, increased cooking quality US, Argentina, Japan, Canada,
Uruguay, Mexico, Brazil and South
Africa
Squash Resistance against watermelon mosaic virus & zucchini yellow mosaic virus US
Sugar beet Herbicide tolerance US, Canada
Sunflower Herbicide tolerance Canada
Tobacco Herbicide tolerance US
Tomato Improved shelf life, taste, colour & texture, improved insect resistance, virus
resistance
US, Mexico, Japan, China
Source: http://www.agbios.com/
6. Bt cotton hybrids approved for commercial cultivation in India
Zone Company Hybrid
North Mahyco, Mumbai
Rasi seeds, Attur, Tamil Nadu
Ankur seeds, Nagpur
Naziveedu seeds, Hyderabad
J.K. Agri seeds, Hyderabad
Nath seeds, Aurangabad
MRC-6304, MRC-6026, MRC-6029
RCH-134, RCH-317, RCH-308, RCH-314
Ankur-2534
NCS-913, NCS-138
JKCH-1947
NCEH-6R
North and Central Mahyco, Mumbai
Ankur seeds, Nagpur
MRC-6301
Ankur-661
Central Rasi seeds, Attur, Tamil Nadu
Ankur seeds, Nagpur
Mahyco, Mumbai,
Ajeet seeds, Aurangabad
Krishidhan seeds, Jalna
RCH-144, RCH-138, RCH-118
Ankur-09
MRC-7301, BGII and MRC-7326BGII
ACH-11-2BGII
KDCHH-441 BGII
Central and South Mahyco, Mumbai,
Rasi seeds, Attur, Tamil Nadu
Naziveedu seeds, Hyderabad
MECH-12, MECH-162, MECH-184
RCH-2
NCS-145 Bunny, NCH-207 Mallika
South Mahyco, Mumbai,
Rasi seeds, Attur, Tamil Nadu
Ganga Kaveri, Hyderabad
Emergent seeds Ltd., Hyderabad
Naziveedu seeds, Hyderabad
Nath seeds, Aurangabad
J.K. Agri sedds, Hyderabad
Ajeet seeds, Aurangabad
Prabhat Seeds Ltd., Hyderabad
MRC-6322, MRC-6918, MRC-7351 BGII, MRC-720BGII, MRC-
7347BGII
RCH-20, RCH-368, RCH-111 BGI, RCH-371BGI, RCH-708 BG1
G-209, GK-207
Brahma Bt, NCS-913
NCEH-3R
JK-Durga, JKCH-99
ACH-33-1Bt
PCH-2270
KDCHH-9632, VICH5
Source: DBT, Govt. of India
7. Transgenic crops developed in public sector in regulatory field trials
Crop Organization Trait
Brinjal IARI, New Delhi Insect Resistance
Castor Directorate of Oilseeds Research (DOR),
Rajendranagar, Hyderabad
Insect Resistance
Sorghum National Research Centre for Sorghum
(NRCS),Hyderbad
Insect Resistance
Groundnut ICRISAT, Hyderabad Fungal disease resistance
Potato Central Potato Research Institute (CPRI), Shimla Leaf blight disease resistance
Rice IARI, New Delhi
Tamil Nadu Agricultural University
Mahyco, Mumbai
Fungal diseases resistance and
drought tolerance
Tomato IARI, New Delhi Virus disease resistance
10. Why Bio-safety Concerns ?
Due to Horizontal gene transfer (HGT) in the development of GMOs there
have been conflicting reports on the benefits of GMOs, risks, apprehensions,
environmental concerns and social concerns for the release of GMOs.
Transgenic crop contains a gene or genes of a different species artificially
inserted in its genome, which may come from an unrelated plant or from a
completed different species.
11. A. Bio-safety of human and animal health
1. Safety of source organism and genes
a. safety of inserted DNA (danger from eating of foreign DNA in GM foods)
c. safety of antibiotic resistance marker [selectable markers – neomycin
phosphotransferase (npt II) and Hygromycin (hpt).
- reduce the effectiveness of antibiotic to fight disease when these
antibiotics are taken with the meal
2. Safety issue of newly developed product
a. potential for toxicity and allergenicity
c. changes in nutritional level
Major Concerns Of GM food & GM crops -
12. Toxic and allergenic effects of some compounds.
Compounds Role in plant defense Toxic effects Allergenicity
Lectins Fungus and insect resistance Weight loss and hyper growth of
small intestine in rats
Allergenic
Proteinase
inhibitors
Insect resistance Pancreas enlargement, hyperplasia
and adenoma
Allergenic
Thionins Antifungal Toxic on intravenous injection,
nontoxic orally
-
Phytoalexins Fungus and insect resistance Toxicity problem -
Virus coat
protein
Virus resistance Toxicity not reported -
Cry protein
(Starlink corn),
2002
Insect resistance - Allergenic
13. B. Labeling of GM and non GM Food
With concerns among the public, keeping GM and non GM
products separately with appropriate labeling, also through
colour codes for illiterate people.
14. C. Ecological concerns
1. Creation of weediness: Gene flow due to cross pollination for the traits
involving resistance can result in development of tolerant/resistant weeds
that are difficult to eradicate.
2. Effect on Biodiversity:
GM crops could lead to erosion of biodiversity and 'pollute' gene pools of
endangered plant species.
Genetic erosion has occurred as the farmers have replaced the use of
traditional varieties with monocultures.
15. D. Environmental Concerns
Effect of transgenic plants on population dynamics of target and non
target pests
Secondary pest problems
Insect sensitivity
Evolution of new insect biotypes
Environmental influence on gene expression
Development of resistance in insect population
Development of resistance to herbicide
16. Gene Escape into the Environment
Accidental cross breeding between GMO plants and traditional varieties
through pollen transfer can contaminate the traditional local varieties with
GMO genes resulting in the loss of traditional varieties of the farmers.
Transgenic herbicide-tolerant rapeseed (Brassica napus) in the UK, showed
that the gene flow rates through cross pollination ranged between 0.0156%
and 0.0038% at 200 m and 400 m, respectively.
17. E. Public Attitude
Consumer response depends on perceptions about risks and benefits of
genetically modified foods.
In order to maximize the trust, it is essential that relevant and reliable
information about the genetically modified food is communicated to the
consumers and stake holders.
The media, individuals, scientists and administrators, politicians and NGO
have the responsibility to educate the people about the benefits of GM foods.
18. F. Socio economic and ethical consideration
Potential benefits to the consumers and farmers
Due to increasing seed market, the developing countries may get
dependent on few suppliers.
GURT: Genetic Use Restriction Technologies.
India has totally banned the use of GURT in plant variety for registration
under PPV & FRA, 2001.
19. Regulatory Mechanism:
Department of Biotechnology (DBT) and Ministry of Environment & Forests
(MoEF) are two apex regulatory bodies.
Rules have been notified by MoEF in 1989 under Environmental Protection Act,
1986 (EPA).
Guidelines for safety have been issued by the DBT in 1990 covering research in
biotechnology, field trials and commercial applications.
20. Presently, there are six competent authorities for implementation of
regulations and guidelines in the country:
i. Recombinant DNA Advisory Committee (RDAC)
ii. Review Committee of Genetic Manipulation (RCGM)
iii. Genetic Engineering Approval Committee (GEAC), (apex bodies)
iv. Institutional Biosafety Committees (IBSC) attached to every organization
engaged in rDNA research
v. State Biosafety Coordination Committees (SBCC) and
vi. District Level Committees (DLC)
21. Bio-safety and Cartagena Protocol:
The Cartagena Protocol on Bio-safety is the first international regulatory
framework for bio-safety, negotiated under the aegis of the Convention on
Biological Diversity (CBD).
The Protocol was adopted on 29th January 2000 and entered into force
from September 11, 2003.
22. What happens when GM foods are traded internationally?
Codex Alimentarius Commission (Codex) - FAO/WHO intergovernmental body
responsible for developing the standards, codes of practice, guidelines and
recommendations that constitute the Codex Alimentarius, meaning the
international food code.
Codex developed principles for the human health risk analysis of GM foods in 2003.
23. Conclusions
GMOs are emerging as very important tools to solve several current
problems; however bio-safety is an equally important concern.
Bio-safety is important not only from the safe product development
point of view but also for safe utilization of the technology.
No technology is 100% risk free.