GMO issue and regulation

GMOs RELATED ISSUE(Risk and Regulation & Biosafety Issue)

Presented by- Vivek YadavRoll No- ------------- Department of Horticulture Sikkim University

Course- GP 501(BIOTECHNOLOGY FOR CROP IMPROVEMENT)

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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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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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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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Myths • Foods produced using biotechnology has not been  established as safe

and are not adequately regulated.

• Crops produced using biotechnology will negatively impact the environment.

• The long-term effects of foods developed using biotechnology are unknown.

Controversies

The possibility

that genes might spread from modified crops to wild relatives might

pose health risks to consumers.

The development of GM products which have been found to cause allergic reactions in many

ways.

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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

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Risk to Biodiversity

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

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

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

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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 cauliflowerTraits include insect resistance, herbicide tolerance, virus resistance,

nutritional enhancement, salt tolerance, fungal resistance

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

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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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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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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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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.

THANK YOU

“Terminator” Seeds