This document discusses biosafety issues related to modern biotechnology. It provides background on the emergence of environmentalism and key international agreements related to biosafety, such as the Convention on Biodiversity and the Cartagena Protocol on Biosafety. The document then discusses differences between genetic engineering and conventional breeding. It examines debates around whether genetic engineering is inherently unsafe and notes that case-by-case scientific risk assessments are needed. The document outlines biosafety concerns for transgenic crops and bio-pharmaceuticals. It emphasizes that rigorous scientific assessment and risk mitigation are important to ensure biosafety.

1. Assignment
Subject : Breeding Designer Crops (GPB822)
Presented by: Mr. Indranil Bhattacharjee
Student I.D. No.: 17PHGPB102
Presented to : Prof. (Dr.) B.G.Suresh
Sam Higginbottom University of Agriculture, Technology &
Sciences
Allahabad-211007
Environmental and Biosafety issues
in modern Biotechnology

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

3.  Environmentalism emerged as a distinct
development in the last forty years.
 Emergence of “pressure groups” in the sixties
 First Earth Day (1970)
 The United Nations Conference on the Human
Environment and Development (1972)
 The Brundtland Report: our Common Future
(1987)
 The Rio Earth Summit (1992)
 Convention on Biodiversity (CBD) [1992]
 Cartagena Protocol on Biosafety (CPB) [1993]
International Evolution

4. Convention of Biodiversity (CBD) [1992]
 Focus: conservation and sustainable use of
biodiversity
 Recognized the potential of modern biotechnology
for human well being
 Took cognizance that modern biotechnology
could have serious effects on environment and
health
 Article 8(g) emphasized the need to regulate the
risks associated with the use of LMOS.
 Article 19(3) set the stage for a legally binding
international instrument about biosafety.

5. The Cartagena Protocol on Biosafety (CPB)
 Entered into force on 29th December 1993
 Focus on transboundary movement of the
LMOS.
 Seeks to lay down an internationally acceptable
framework to provide for an adequate level of
protection against the possible adverse affects of
LMOS on biodiversity and human health.

6. Basic Premises of CPB
 “Advance Informed Agreement” between Parties
(AIA)
 Decision on the basis of scientific risk
assessment
 Precautionary Principle

7. How is Genetic Engineering (GE) different
from conventional breeding (CB)?
 Combining DNA in new combinations and
introducing it into a new organism are the GE
tools.
 Main differences between CB and GE
 Ability to move across sexual barriers
 Amount of change: a specific gene embodying a
particular trait or thousands of genes embodying
desirable and undesirable traits
 Occurrence of change in one or several generations.

9. Genetic engineering:Recombinant DNA technology

10.  Two diametrically opposite trends of thought
 US-Canada
 No new risks associated with GM crops
 New regulations not considered necessary
 Safety assessments
 ‘Product’rather than ‘process’ based
 In comparison and contrast to their ‘familiarity’ and
‘substantial’equivalence to conventional crops
Is GE inherently unsafe?

11.  EU
 GE crops considered new and special
 Existing legislation not considered sufficient
 Safety assessment
 Process based
 Principle of ‘substantial equivalence’ beginning rather than
the end
 Adoption of ‘Precautionary Principle’ as guide
…Is GE inherently unsafe?

12.  GE technology carries certain inherent unpredictability
 Some facts
 Isolation of a gene from its natural environment and
integration into entirely different organism
 Possible transgenic instability due to triggering of the
inbuilt defense mechanisms of the host organism
leading to inactivation or silencing of foreign genes.
….Is GE inherently unsafe?

13.  Possibilities of integration of foreign gene at a site
predisposed to silencing of genes (position effect).
Variance in the levels of expression of the
transgene in different environmental conditions
(heat, humidity, light…..)
Possibilities of silencing of genes arising in
subsequent generations
….Is GE inherently unsafe?
Case by case sound scientific
assessment is of utmost significance

14.  Relate to environmental, human and animal health
consequences
 Both can have short and long term implications
 Biosafety risks involve the entire spectrum of biodiversity
 A universal ‘true for all’ approach may not be applicable
Biosafety issues in transgenic crops
Known Probability Unknown Probability
Risks
•Rigorous Scientific Assessment
•Risk Mitigation
•Precautionary Principle

15. Biosafety concerns arise from:
 Horizontal gene transfer
 Genetic contamination
 Transfer of allergens and toxins from one
life form to another and creation of new
toxins and allergenic compounds
..Biosafety issues in transgenic crops
-

16. Main Concerns
Development of aggressive weeds/ wild relatives by
transfer of transgenic traits
Erosion of land races/wild relatives by genetic
pollution in centres of origin/ diversity
Harm to the non-target organisms
Development of pest resistance by prolonged use
Monoculture and limitations to farmers’ choice in
crop management
Hazard 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
-

17. Assessment
 GE venturing into an unknown biological
territory
 ASILOMAR Conference (1975): No research till
safety guidelines in place
 Initially, focus on laboratory safety procedures
 Wider definition of biosafety with possibilities of
commercialization of GM products
 The broad format of biosafety parametres
essentially the same in all regulations
..Biosafety issues in transgenic crops

18. Two main stages:
1. Laboratory/green house stage
2. Confined Trial Stage
IMPORTANT
Prevention of the spread of genetically
engineered material outside lab/field
..Biosafety issues in transgenic crops

19. Laboratory/green house stage
Different biosafety levels as per the
degree of risk involved
Two methods of containment
Physical
Biological

20. A confined trial is a small scale release of a
transgenic plant species for research purposes
conducted under conditions that prevent spread
of the organism and mitigate its impact on the
surrounding environment
Objective is to collect data to evaluate the
crops’performance
Confined Trial Stage

21. Risk mitigation – the terms and conditions that are
necessary to conduct the trial safely.
 Prevent Gene Flow
 Prevent entry of GMOs into food chain
 Prevent Persistence of GMOs in the field
Focus on Risk Mitigation

22. Bio-pharmaceutical therapeutics
Biosafety risk
 Survival, multiplication and dissemination of
GMOs in contained/ open environment
 Interaction of GMOs with biological systems
 Routes of dissemination: physical; biological
Risk depends upon
 Nature of organism invovled
 Extent of use of LMOs
 End product LMO or not?

23. …Bio-pharmaceutical therapeutics
Risk categorization of micro organisms:
determining factors
 Capability to cause disease
 Hazard to laboratory workers
 Risk of spread to community
 Availability of effective treatment
Health risks
 Toxigenicity Pathogenicity
 Allergenicity Antibiotic resistance

24. ..Bio-pharmaceutical therapeutics
Environmental risks
 Outcrossing between GMOs and pathogens
 Negative effects on populations of non target
organisms
Risk assessment
 Access
 Expression
 Damage
Risk management and communication
 Physical
 Biological

25.  Expressed proteins generally not a part of regular
food supply
 Food complex mixtures e.g. nutrients, anti-
nutrients and natural toxins
 Directly enter human system
 Assume different forms
 Involve storage, processing, transportation
GM foods: need for safety assessment

26. Guidelines by Codex Alimentarius Commission
 Assessment of possible allergenicity
 Assessment of possible toxicity
 Compositional analysis of key components
 Food processing
 Nutritional modification
.. Safety assessment of GM foods comprise

27. ….GM foods: Allergenicity; Toxicity
Allergy
It is a hypersensitive reaction initiated by immunologic
mechanisms caused by specific substances called
allergens.
Assessment
 Is the gene source allergenic?
 Expression level of introduced gene
 Unintended effect
 Digestibility and heat stability
Toxicity
 New proteins as a result of intended modification
 Unintended new proteins as a result of the modification
 Natural constituents beyond their level of normal
variation

28. ….GM foods: nutritional aspects;
unintended effects
 Intended and unintended changes in nutrient levels
 Bioavailability of nutrients, stability and processing
 Presence and effect of anti-nutrients
 Impact of individual changes on overall nutritional profile
Unintended effects
Random integration of transgenes
 Insertional mutagenesis
 Disruption of gene functions
 Production of new proteins
 Changes in
o Phenotype Metabolites
o Enzymes Toxins
o Genotype

29. Concluding Note……
 Biosafety is integral to modern biotechnology
 The adoption of modern biotech products
needs to be balanced with adequate biosafety
safeguards
 Case by case scientific risk assessment and
cost benefit analysis
 Greater acceptance of health care applications
 Need based adoption in GM crops and foods
 Participation of various stakeholders
 Dissemination of knowledge and information

30. Thank you