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BIOSAFETY CONCERNS IN THE
CONTEXT OF BIOTECHNOLOGY.
Presentation for Training Workshop for Regional Advisors
Bangkok, Thailand
15-27 May 2006.
STARTING POINT
• Conference on the Environment and
Development
• Convention on Biological Diversity
• Cartagena Protocol on Biosafety
WHAT IS
BIOTECHNOLOGY?
Processing of substances by biological agents to
produce goods and services.
• Biological agents: mainly microbes, animal and plant cells and
enzymes.
• Substances: renewable materials as well as those produced
by microbes.
• Goods and services: food, beverages, pharmaceuticals, etc.
EARLY
BIOTECHNOLOGY
• Exploited microbes capable of producing
useful substances by fermentation
• Gave rise to industries associated with
manufacture of wine, cheese, etc.
FIRST WAVE OF
BIOTECHNOLOGY
• Fermentation process deciphered and manipulated
to produce useful substances
• Substances include industrial chemicals: acetone,
glycerol, citric acid, etc.
• Production of industrial chemicals represents first
wave of biotechnology
SECOND WAVE OF
BIOTECHNOLOGY
• Production of antibiotics (also
fermentation products) ushered in the
second wave of biotechnology
• Use of antibiotics became the
cornerstone of infectious disease control
THIRD WAVE OF
BIOTECHNOLOGY
• Brought about by the advent of genetic
engineering
• Made possible by discovery of DNA-modifying
enzymes
• Basis of genetic engineering is gene transfer, gene
alteration and gene regulation
• Gave rise to GMOs, LMOs or transgenic organisms
DRIVERS OF
BIOTECHNOLOGY
• Fermentation technology
• Plant and animal cell culture
• Enzyme technology
• Genetic engineering
REVIEW: BIOSAFETY
PROTOCOL
• Concerns about potential negative impact
of development on the environment
• Concerns about GMOs (LMOs)
• UN System for managing trade in GMOs
WHAT ARE THESE
CONCERNS?
• Environmental concerns
• Animal and public health
concerns
ROOT OF CONCERNS
• New technology
• Status of knowledge on effects
• Complexity of GMOs and their products
• Uniqueness of each GMO
ENVIRONMENTAL
CONCERNS
• Spreading of transgenes by GMOs to
closely related domesticated or wild
relatives
• Spreading and invasion into natural
ecosystems by GMOs
• Spreading of transgenes from GMOs to
unrelated species
ENVIRONMENTAL
CONCERNS
• Development of herbicide-resistant
weeds
• Development of insecticide-resistant
pests
• Damage to non-target organisms
interacting with GMOs
Spreading of GMO
transgenes to relatives
• GMOs targeted
• Possible effects on biodiversity
• Potential contamination of conventional
crops by GMOs
• Potential for development of herbicideresistant weeds
Transgene spread to
unrelated species
Spreading of transgenes by plants to
microbes with potential implications for:
 Infectious diseases controlled by antibiotics
 Potential for resistance to antibiotics
 Increases in the number of antibiotic resistance
genes
Potential for development of
insecticide-resistant pests of plant
crops
Transgene effects on
non-target species
• GMOs targeted
• Potential for toxicants
• Potential effects on nontargets and biodiversity
ANIMAL AND PUBLIC
HEALTH CONCERNS
Effects of DNA, food and feed
derived from GMOs
• Possible pathological effects
ANIMAL AND PUBLIC
HEALTH CONCERNS
Differences between transgene
sequences in notification and in
actual insert
• Rearrangements of transgene in genome
• Appropriateness of risk assessment data
based on notifications
ANIMAL AND PUBLIC
HEALTH CONCERNS
Persistence and uptake of foreign
DNA and protein in gut of mammals
• DNA and protein escaping digestion
• DNA fragments [ for example the
cry1(A) gene] shed in faeces and
incorporated in manure
ANIMAL AND PUBLIC
HEALTH
Transgenic or altered proteins
• Difficulty in predicting plant gene
expression due to environmental control,
insertion sites and stability of inserts
• Possibility of producing allergens,
toxicants, biologically active
compounds, etc
ANIMAL AND PUBLIC
HEALTH
Production of chemicals and
pharmaceuticals by plants
• Potential for producing harmful
substances
• Plant species selected
• Unintended mixture of GMO crops and
conventional ones
RESPONSE
ADVOCATED
Proactive action encouraged
before GMOs are placed on the
market
• Case by case risk assessment
• Notification procedures( for example,
the Advanced Informed Agreement)
BIOSAFETY AND THE
BCH
The BCH is the Information System of the
Biosafety Protocol and caters for biosafety as
follows:
• Source of information on biosafety laws
• Contact information on administrators of biosafety
regime
• Source of information on GMOs ( types, uses, risk
assessment, risk management, decisions taken, etc ).
• Roster of experts