Environmental and Biosafety issues

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Environmental and Biosafety issues in modern
Biotechnology Dr Veena Chhotray, IAS Senior
Fellow, TERI 6th February, 2006
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BIOSAFETY

• 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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• 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
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• 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.

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• 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.

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• Basic Premises of CPB
• Advance Informed Agreement between Parties
  (AIA)
• Decision on the basis of scientific risk
  assessment
• Precautionary Principle

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• 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.

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Genetic engineeringRecombinant DNA technology
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Is GE inherently unsafe?

• 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

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Is GE inherently unsafe?

• 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

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.Is GE inherently unsafe?

• 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.

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.Is GE inherently unsafe?

• 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

Case by case sound scientific assessment is of
utmost significance
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• 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
Risks
Known Probability
Unknown Probability

• Rigorous Scientific Assessment
• Risk Mitigation
• Precautionary Principle

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..Biosafety issues in transgenic crops -

• 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

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• 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 -
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..Biosafety issues in transgenic crops

• 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

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..Biosafety issues in transgenic crops

• Two main stages
• Laboratory/green house stage
• Confined Trial Stage

IMPORTANT Prevention of the spread of
genetically engineered material outside lab/field
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• Laboratory/green house stage
• Different biosafety levels as per the degree of
  risk involved
• Two methods of containment
• Physical
• Biological

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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
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Focus on Risk Mitigation

• 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

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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?

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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

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..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

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GM foods need for safety assessment

• 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

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.. Safety assessment of GM foods comprise

• Guidelines by Codex Alimentarius Commission
• Assessment of possible allergenicity
• Assessment of possible toxicity
• Compositional analysis of key components
• Food processing
• Nutritional modification

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.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

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.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
• Phenotype Metabolites
• Enzymes Toxins
• Genotype

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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

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Thank you