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20 years ‘Blue Book’, ISBGMO, Jeju Island
Basic framework for risk assessment of
transgenic plants developed by OECD:
history and evolution of OECD’s
risk/safety assessment framework
Hans Bergmans
National Institute for Public Health
and the Environment
The Netherlands
20 years ‘Blue Book’, ISBGMO, Jeju Island
1983: Biotechnology:
international trends and perspectives
‘Blue Book’: Recombinant DNA Safety
Considerations, OECD 1986
Authors
 scientists, academia, advisory committees
 scientists, regulators
 representatives of governments
 representatives of industry
20 years ‘Blue Book’, ISBGMO, Jeju Island
‘Blue Book’: Recombinant DNA Safety
Considerations, OECD 1986
Focus on new developments
 Large scale industrial applications
 Agricultural and environmental applications
 Micro-organisms, and plants
Input from experience
 GMOs
‘contained use’
 Non-GMOs
large scale industrial applications
environmental applications (plant protection, breeding)
20 years ‘Blue Book’, ISBGMO, Jeju Island
‘Blue Book’: Safety considerations
Science-based risk assessment:
Hazards/risks identified on basis of:
properties of the recipient organism
technique of modification
properties of the GMO
Conjectured hazards vs. evidence for safety
• change in pathogenic effects e.g. host range
• toxicity
• weediness
20 years ‘Blue Book’, ISBGMO, Jeju Island
‘Blue Book’: Safety considerations
Appendices: ‘parameters’
 General scientific considerations (characterization)
 Human health considerations
 Environmental and agronomic considerations
Ecological Traits Relating to the Donor and Recipient
Application of the Engineered Organism in the Environment
Survival, Multiplication and Dissemination in the Environment
Interactions of Engineered Organism(s) with Biological Systems
Potential Environmental Impacts
 Potential risks to humans, plants and animals
(of microorganisms)
20 years ‘Blue Book’, ISBGMO, Jeju Island
‘Blue Book’: Recommendations
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Use existing data on environmental and human health
effects of living organisms to guide risk assessments
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Ensure that recombinant DNA organisms are evaluated for
potential risk, prior to applications in agriculture and the
environment …
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… by means of an independent review of potential risks on
a case-by-case basis
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Conduct the development of rDNA organisms … in a
stepwise fashion
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Encourage further research to improve the prediction,
evaluation and monitoring of applications of rDNA
organisms
20 years ‘Blue Book’, ISBGMO, Jeju Island
Risk/safety assessment framework
Case-by-case
Step-by-step
Further discussions
step-by-step: safe way for GM plant development
case-by-case: yes, but there is a common approach
20 years ‘Blue Book’, ISBGMO, Jeju Island
step-by-step
lab, greenhouse  small scale field  scale-up
‘Good developmental principles’ (GDP)
Safety considerations for biotechnology 1992
scientific guidance to the performance of
low or negligible risk small-scale field research,
including basic and applied research
confinement
‘trap of GDP’:
there are no other lessons from such ‘safe’ experiments
than that the approach is indeed safe
20 years ‘Blue Book’, ISBGMO, Jeju Island
step-by-step
lab, greenhouse  small scale field  scale-up
Safety considerations for biotechnology:
‘Scale-up of crop plants’ (1993)
The concept of Familiarity:
‘knowledge and experience’ that can be used for
 Risk/safety analysis
 Applying risk management
 Indicating where more knowledge is needed
20 years ‘Blue Book’, ISBGMO, Jeju Island
Common approach to risk/safety evaluation
‘Preamble’ (1993)
in: Safety considerations for biotechnology: Scale-up of crop plants
Risk/safety analysis
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hazard identification and, if hazard identified:
risk/safety assessment
based on knowledge and experience: familiarity
familiarity is not the same as safety
Based on
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characteristics of the recipient organism,
the introduced trait,
the environment into which the organism is introduced,
the interaction between these, and
the intended application
20 years ‘Blue Book’, ISBGMO, Jeju Island
‘Preamble’
in: Safety considerations for biotechnology: Scale-up of crop plants
Risk/safety analysis
 is based on ‘familiarity’
 is typically an ongoing component of research,
development and testing of new organisms
 is a scientific procedure; does not imply or exclude
regulatory oversight
Operational principles
 step-by-step: next step is determined by risk/safety analysis:
the steps are not fixed
20 years ‘Blue Book’, ISBGMO, Jeju Island
Familiarity:
For risk/safety evaluation: baseline information
‘Traditional crop breeding practices’ (1993)
A historical review to serve as a baseline
for assessing the role of modern biotechnology
Soybean, Wheat, Rice, Cucurbits, Cotton,
Tobacco, Sunflower, Maize, Sugar beet, Alfalfa,
Oilseed rape, Onion, Cassava, Potato, Prunus
20 years ‘Blue Book’, ISBGMO, Jeju Island
Working Group for Harmonisation of Biotechnology
Consensus Documents
Biology documents
Crop plants, trees, microorganisms
Trait documents
Virus resistance, herbicide tolerance
Guidance documents
Use of bacterial taxonomy in risk assessment
20 years ‘Blue Book’, ISBGMO, Jeju Island
Consensus Documents
“snapshots” of current information, for use during the
regulatory assessment of products of biotechnology
‘An Introduction to the Biosafety Consensus Documents of
OECD’s Working Group for Harmonisation in Biotechnology’
‘Points to Consider for Consensus Documents on the Biology of
Cultivated Plants’ (2006)
20 years ‘Blue Book’, ISBGMO, Jeju Island
Developments
Blue Book
thought starter:
science-based risk assessment
familiarity, baseline for risk/safety evaluation
Risk assessment
‘Preamble’
Familiarity
GDP, Scale up document
Baseline
Traditional crop breeding practices
Consolidation
Consensus documents
New developments
Biology documents: Points to consider
Trait documents
Environmental risk parameters
Molecular characterisation
20 years ‘Blue Book’, ISBGMO, Jeju Island
These documents are not written in stone, they are
snapshots in time of a developing framework
Blue Book: http://www.oecd.org/dataoecd/45/54/1943773.pdf
GDP: http://www.oecd.org/dataoecd/8/3/2375496.pdf
Scale-up: http://www.oecd.org/dataoecd/26/26/1958527.pdf
Traditional breeding and other guidance:
http://www.oecd.org/document/17/0,2340,en_264_34385_1891281_1_1_1_1,00.h
tml
Consensus documents
http://www.oecd.org/document/51/0,2340,en_2649_34385_1889395_1_1_1_1,00.
html