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					Environmental and Biosafety issues
    in modern Biotechnology

          Dr Veena Chhotray, IAS
           Senior Fellow, TERI

            6th February, 2006

„Biosafety‟ means the need to
protect human and animal health
and environment from the possible
adverse effects of the products of
modern biotechnology
    International Evolution
   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
      The Rio Earth Summit (1992)
      Convention on Biodiversity (CBD) [1992]
      Cartagena Protocol on Biosafety (CPB) [1993]
Convention of Biodiversity (CBD) [1992]
      Focus: conservation and sustainable use of
      Recognized the potential of modern biotechnology
       for human well being
      Took cognizance that modern biotechnology
       could have serious effects on environment and
      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.
The Cartagena Protocol on Biosafety (CPB)
      Entered into force on 29th December 1993
      Focus on transboundary movement of the
      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.
Basic Premises of CPB
      “Advance Informed Agreement” between Parties
      Decision on the basis of scientific risk
      Precautionary Principle
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
      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.
Genetic engineering:Recombinant DNA technology
    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
…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
    ….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.
….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
Biosafety issues in transgenic crops
     Relate to environmental, human and animal health
     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

      Known Probability                 Unknown Probability

                •Rigorous Scientific Assessment
                       •Risk Mitigation
                   •Precautionary Principle
..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
..Biosafety issues in transgenic crops
- 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
   GE venturing into an unknown biological
   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
    Two main stages:

    1.   Laboratory/green house stage
    2.   Confined Trial Stage

  Prevention of the spread of genetically
   engineered material outside lab/field
Laboratory/green house stage

  Different biosafety levels as per the
  degree of risk involved
  Two methods of containment
    Confined Trial Stage
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
            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
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?
…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
..Bio-pharmaceutical therapeutics
 Environmental risks
  Outcrossing between GMOs and pathogens
  Negative effects on populations of non target
 Risk assessment
  Access
  Expression
  Damage
 Risk management and communication
  Physical
  Biological
    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
.. 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
    ….GM foods: Allergenicity; Toxicity
    It is a hypersensitive reaction initiated by immunologic
    mechanisms caused by specific substances called
      Is the gene source allergenic?
      Expression level of introduced gene
      Unintended effect
      Digestibility and heat stability
   New proteins as a result of intended modification
   Unintended new proteins as a result of the modification
   Natural constituents beyond their level of normal
    ….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
         Concluding Note……
   Biosafety is integral to modern biotechnology
   The adoption of modern biotech products
    needs to be balanced with adequate biosafety
   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
Thank you

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