BIOSAFETY

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

2. 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.

3. 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.

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

5. 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.

7. Genetic engineering:Recombinant DNA technology

8.  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?

9.  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?

10.  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?

11.  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

12.  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

13. 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
-

14. 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
-

15. 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

16. 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

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

18. 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

19. 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

20. 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?

21. …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

22. ..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

23.  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

24. 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

25. ….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

26. ….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

27. 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

28. What are GM’s?
• are a result of technology that has altered the
DNA of living organisms (animals, plants or
bacteria)
Other terms that mean the same thing:
• Genetically engineered
• Transgenic
• Recombinant DNA (rDNA) technology

29. How does this differ from Mendel and his
peas?
GM vs. Selective breading
Selective breeding
-slow
-imprecise
-modification of genes that naturally occur in the organism
GM
-very fast
-precise
-can introduce genes into an organism that would not occur
naturally!

30. Why do it?
• Rice- not high in essential nutrients
Modification:
– + daffodil genes and a bacterium = beta-carotene
content drastically increased
– + genes from a french bean = double the iron
content.
• Tomatoes- Introduce genes to increase shelf
life.

31. How is this done?: Transgenic tomatoes

32. Other applications
• Potato - modified to produce a beetle killing
toxin
• Yellow squash – modified to contain to viral
genes that resistant the most common viral
diseases
• Develop foods that contain vaccines and
antibodies that offer valuable protection
against diseases such as cholera, hepatitis,
and malaria
• Canola – modified to resist one type of
herbicide or pesticide

33. Benefits of Genetic Engineering
and Modifying
1. Higher yielding crops, more efficient use of
land
2. Can save money and promote higher profits
3. Longer shelf life, less waste
Example// Tomatoes from genetically
modified seeds stay fresh
longer.
4. Enhanced taste and quality
5. Reduced maturation time

34. Benefits of Genetic Engineering and
Modifying
6. Increased and improved nutrients and stress tolerance
- A single gene genetically engineered into cauliflower can increase
production of beta-carotene 100 times.
- A gene can be implanted into a soybean upgrading the soy protein
to a quality equal to that of milk.
- Corn can be modified to contain its two limiting amino acids,
lysine or tryptophan
7. Improved resistance to disease or illness
- Foods can be enhanced with phytochemicals that help maintain
health and reduce the risks of chronic disease.
8. Improved crop resistance to disease, pests, weeds and herbicides
9. New products and growing techniques
- “Individuals allergic to milk may be able to buy milk that has been
treated with the lactase enzyme” (Whiney, 2002).
- Creating decaffeinated coffee beans are in a process of research.

35. Benefits of Genetic Engineering and
Modifying
• Society
– Increased food
security for growing
populations and
growth challenges
(Human Genome Project Information (2003),
http://www.ornl.gov/sci/techresources/Human
_Genome/elsi/gmfood.shtml)

36. Risks associated with Genetic Modification
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.

37. Risks associated with Genetic Modification
– cont.
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.
(Human Genome Project Information (2003), http://www.ornl.gov/sci/techresources/Human_Genome/elsi/gmfood.shtml)

38. Risks with GM continued:
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
Draper, D. (2002). Our Environment: A Canadian Perspective 2nd Ed. Scarborough: Thompson Canada Lmt.

39. 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

40. Socio-economic concerns of GMOs

41. Technology and society

42. Socio-economic?
• Socio-economic is the way in which economic
activity affects and is shaped by social processes
• It has to do with societies progress, stagnation, or
regression because of their local or regional
economy, or the global economy

43. GMOs socio-economic considerations
• There is not yet a clear and agreed definition on what socio-economic
considerations entail in the context of biosafety regulations
• Socio-economic considerations related to GMOs could be defined as the set of the
intertwined social and economic consequences resulting from the changes arising
from the introduction of GMOs into the environment, which need to be taken into
account in the biosafety decision-making processes
Sadler and McCabe (2002)

44. Concerns with GMOs
• Scientific
– Environment
• Is it natural, ‘crossing the
species barrier
• Can the plants spread
uncontrollably
– Health safety
• Does the food contains
bacterial genes
• Are the crops regulated;
well scrutinized
• Non-scientific
– Ethical
• Is it ethical
• Is it natural
– Socio-economic
• Whose interest does it represent
• Income security
• Rural labor
• Intellectual Property Rights (IPRs)
– Religious
– Political
• Food security

45. International biosafety context
• Initial scope of biosafety expanded to include food and feed safety
• Proposal to expand it further to include socio-economics, ethical, religious,
philosophical and other considerations
• Socio-economics has little to do with the safety profile
• Two contrasting points of view
• Oppose:
• Decisions should be left to end-users
• Open for blanket (no need to show real proof ) rejections of technology
• Favor
• Critical to ensure that GM crops will not harm communities and producers
IFPRI

46. SOCIO-ECONOMIC CONSIDERATIONS in
Cartagena Protocol
• Article 26 SOCIO-ECONOMIC CONSIDERATIONS
1. The Parties, in reaching a decision on import under this
Protocol or under its domestic measures implementing the
Protocol, may take into account, consistent with their
international obligations, socio-economic considerations
arising from the impact of living modified organisms on the
conservation and sustainable use of biological diversity,
especially with regard to the value of biological diversity to
indigenous and local communities.
2. The Parties are encouraged to cooperate on research and
information exchange on any socio-economic impacts of
living modified organisms, especially on indigenous and local
communities.

47. Socio-economic consideration NBMA ACT, 2015
• Anticipated changes in the existing social and economic patterns
resulting from the introduction of the genetically modified organism
or products
• Possible treats to biological diversity, traditional crops or other
products and in particular, farmers’ varieties and sustainable
agriculture
• impacts likely to be posed by the possibility of substituting traditional
crops, products and indigenous technologies through modern
biotechnology outside of their agro-climatic zones.

48. Socio-economic consideration NBMA ACT, 2015
• Anticipated social and economic costs due to loss of genetic diversity,
employment, market opportunities and in general, means of
livelihood of the communities likely to be affected by the
introduction of the genetically modified organisms or products
• Possible countries and communities to be affected in terms of
disruptions to their social and economic welfare
• Possible effects which are contrary to the social, cultural, ethical and
religious values of communities arising from the use of release of the
genetically modified organism or the product

49. Issues and roles for Socio Economic
Considerations in Biosafety
• Socio economic assessments for biosafety purposes are ex ante
• Technical know how to do “feasible” Ex ante studies is available in the Nigeria
• Methods to answer many of the questions posed by some stakeholder in an ex
ante framework
• Question of timing
• Not all the technologies that enter the biosafety regulatory process will be released into the
environment
• The earlier assessments are required in the regulatory process, the more assumptions one has to
make
IFPRI

50. Some countries approach to socio-economic
assessments
• Large variation in terms of approaches
• Argentina requires SEA, but limited to impacts on Argentinean exports
• South Africa limits scope to impacts on surrounding communities
• India not formally required in regulations yet regulatory authority required a
baseline impact study
• USA, Canada, and probably the EU, still voluntary information that may be included
with dossiers
IFPRI

51. Biotech and African Agriculture
• Food security is still an
issue in SSA
• Millions of people are
starving
• Therefore, Africa needs
all the appropriate tools
in science & technology
to increase productivity
& enhance food security

52. Genetic Modification & Medicine
• Europe is over producing food, thus enhancing
agricultural productivity is no priority
• But Health and Longevity are very important to the
West
• Hence, acceptance of GM medicine

53. Final comments
• Socio-economic impacts (positive or negative, predicted or unforeseen) are
inherent part of technology introduction and adoption.
• This points out the need of including socio-economic considerations in the
biosafety decision-making related to GMOs.
• In order to carry out these socio-economic assessments relevant to sustainability,
precautionary or anticipatory (also called ex-ante) assessments are needed,
complemented with regular monitoring (or ex-post).
• The Socio-economic consideration is already domesticated in the NBMA ACT, 2015

54. Thank you