This document discusses GMOs and related issues including risks and regulations. It outlines both the advantages and disadvantages of GMOs, such as increased crop yields but also potential risks to human health and the environment. The document examines myths around GMOs and discusses controversies including safety, intellectual property access, ethics, and labeling. It also reviews principles of risk analysis for GMOs and biosafety guidelines and regulations in India and internationally. In conclusion, the author notes the field of biosafety is controversial but proponents see benefits while critics see risks that may be unacceptable without sufficient scientific certainty and precautions.

1. GMOs RELATED ISSUE
(Risk and Regulation & Biosafety Issue)
Presented by- Vivek Yadav
Roll No- -------------
Department of Horticulture
Sikkim University
Course- GP 501
(BIOTECHNOLOGY FOR CROP IMPROVEMENT)

2. Aspects
Advantage/disadvantage and myths
Risk and regulation
International regulation
Biosafety issue
Regulatory in India and major country
Ethical issue
Legal Issue
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3. Advantage
• Improved nutritional quality
• Increased crop yield
• Insect resistance
• Disease resistance
• Herbicide resistance
• Salt tolerance
• Biopharmaceuticals
• Saving valuable topsoil
• Ability to grow plants in harsh environments
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6. Disadvantage
• Damage to human health
• Allergies
• Horizontal transfer and antibiotic resistance
• Eating foreign DNA
• Changed nutrient levels
• damage to the natural environment
• Crop-to-weed gene flow
• Leakage of GM proteins into soil
• Reductions in pesticide spraying: are they real?
• Disruption of current practices of farming and food production in developed countries
• Crop-to-crop gene flow
• Disruption of traditional practices and economies in less developed countries.
• Lack of research on consequences of transgenic crops.
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8. Myths
• Foods produced using biotechnology has not been established as safe
and are not adequately regulated.
• Crops produced using biotechnology will negatively impact the environme
nt.
• The long-term effects of foods developed using biotechnology are
unknown.
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9. Controversies

10. Risk factor
1. Safety
• Potential human health
implications.
• Potential environmental impact.
• Out-crossing
• Inevitable out-crossing of transgenic
plants with naturally occurring ones.
• Creation of super-weeds
• Creation of biological weapons.
2. Access and Intellectual
Property
• Domination of world food
production by a few companies and
developing countries.
3.Ethics
• “Playing God”
• Tampering with nature by mixing genes
among species.
4. Labeling
• Not mandatory in some countries (e.g., Canada
and the United States).
• Mixing GM crops with non-GM confounds
labeling attempts.
5. Society
• New advances may be skewed to the interests
of rich countries.
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Unknown Probability
•Rigorous Scientific Assessment
•Risk Mitigation
•Precautionary Principle
Known Probability
Risks

12. Risk to Biodiversity
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Biodiversity
 Addition of Bt gene into plants including corn, potatoes and cotton to increase
resistance to plants
 Bt gene obtained from Bacillus thuringiensis (a soil bacterium that produces a
natural insecticide)
 Problem: plants producing Bt toxin are releasing toxin in pollen.
 Pollen from a Bt plant was dusted on to milkweed:
• only 56% of young monarch butterfly larvae lived
whereas pollen from organic plants dusted on the milkweed produced a survival rate
of 100%.
• Approximately half of the monarch butterfly population live in the “corn belt” of the
USA
• this new gene could have serious repercussions for this organism

13. Environmental risk
assessment
Hazard
identification
Likelihood
estimation
Consequence
evaluation,
including a
baseline
assessment
Risk
estimation
Phase 1: Consideration of each of the inserted genes and
sequences individually
Phase 2: Consideration of the whole plant, including potential
synergistic and of possible

14. Principles in Risk
Analysis
Know the audience
Involve the scientific experts
Establish expertise in communication
Be a credible source of information
Share responsibility
Assure transparency.
Put the risk in perspective

15. Biosafety (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
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‘Biosafety’ means the need to protect human and animal
health and environment from the possible adverse effects of
the products of modern biotechnology

16. Biosafety guideline in India
• All products obtained using recombinant DNA technology shall be subject
to general regulation normally applicable for such product .
• Pre-release tests of GMOs in agriculture should include elucidation of
requirements for veg. growth.
• The controlled release of GMOs should be done under appropriate
containment facilities to ensure safety.
• The DBT has a RCGM which reviews all the approval of ongoing on GMOs
and Several other issue.
• Physical containments to limit the spread of dangerous Ms by good
laboratory practices safety eqipements.
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17. Regulatory Framework
1. GOVERNMENT RULES FOR GMos
2. Recombinant DNA guidelines, 1990
3. Guidelines for research in transgenic
plants, 1998
4. Seed policy, 2002
5. Prevention of food adulteration act
6. The food safety and standards bill, 2005
7. Plant quarantine order 2003
8. Task force on application of agricultural
9. Biotechnology
10. Draft national environment policy, 2004
11. Draft national biotechnology strategy 2005
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18. Codex Alimentarius commission (CAC)
• CAC is an inter governmental body concerned with implementation of the
joint FAO/WHO food standards programme in order to protect the health
of consumers and the promote food trade by setting international
standards on food called Codex Standard.
• The task force :
• Principles of risk analysis of food Derived from modern biotechnology.
• Guideline for the conduct of food safety Assessment for food produced
• Guideline for the conduct food safety Assessment of foods derived from
DNA plants.
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19. Conclusion
In sum, the field of biosafety is, above all else, area in which much activity is
ongoing, even though it is extremely controversial. Proponents identify possible
benefits of GMOs that are enormous, including possibilities such as hunger
alleviation, and universally available medical care, within our lifetimes.
Counter-arguments identify a level of possible risks well beyond anything that
has ever been deemed “acceptable” in the past.67 It is essential that decision-
makers and others seeking to progress beyond the current stalemate demonstrate
a strong commitment to the position that, in the absence of sufficient scientific
certainty surrounding the commercial application of modern biotechnology,
preventive and precautionary measures based on risk assessment and
management are called for at all international and national levels.
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20. THANK YOU
“Terminator” Seeds