11.

Bioethics and biosafety

At the end of this chapter
 Discuss Ethical, legal and social implications, Issues around
GMOs,,
 Discuss Ethics and safety of GM food,
 Discuss Labelling of GMO products, colclusion

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 issues in transgenic crops
 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

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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..Biosafety issues in transgenic crops
-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 extensive 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
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..Biosafety issues in transgenic crops
Two main stages:

1. Laboratory/green house stage

2. 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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 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

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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 involved
 Extent of use of GMOs
 End product GMO 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
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variation
 ….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 15
 Labeling
• Generally, the purpose of labeling is to provide
enough information and advice accurately and
clearly to allow consumers to select products
according to their needs.
• labeling is all about consumer choice and
usually nothing to do with safety as far as the
GMO is concerned (tobacco issue).

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 Conclusion
 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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