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Title: Basic%20framework%20for%20risk%20assessment%20of%20transgenic%20plants%20developed%20by%20OECD:%20history%20and%20evolution%20of%20OECD

Basic framework for risk assessment of transgenic
plants developed by OECDhistory and evolution
of OECDs risk/safety assessment
frameworkHans BergmansNational Institute for
Public Health and the EnvironmentThe Netherlands
1983 Biotechnology international trends and
Blue Book Recombinant DNA Safety
Considerations, OECD 1986
  • Authors
  • scientists, academia, advisory committees
  • scientists, regulators
  • representatives of governments
  • representatives of industry

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)

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

Blue Book Safety considerations
  • Appendices parameters
  • General scientific considerations
  • Human health considerations
  • Environmental and agronomic considerations
    Ecological Traits Relating to the Donor and
  • 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)

Use existing data on environmental and human
health effects of living organisms to guide risk
Blue Book Recommendations
  • Ensure that recombinant DNA organisms are
    evaluated for potential risk, prior to
    applications in agriculture and the environment
  • by means of an independent review of potential
    risks on a case-by-case basis
  • Conduct the development of rDNA organisms in a
    stepwise fashion
  • Encourage further research to improve the
    prediction, evaluation and monitoring of
    applications of rDNA organisms

Risk/safety assessment frameworkCase-by-caseSt
ep-by-stepFurther discussions step-by-step
safe way for GM plant development case-by-case
yes, but there is a common approach
step-by-steplab, greenhouse ? small scale field
? scale-upGood developmental principles
(GDP)Safety considerations for biotechnology
1992scientific guidance to the performance
oflow or negligible risk small-scale field
research,including basic and applied
researchconfinementtrap of GDP there are
no other lessons from such safe
experimentsthan that the approach is indeed safe
step-by-steplab, greenhouse ? small scale field
? scale-upSafety 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

Common approach to risk/safety evaluation Preambl
e (1993) in Safety considerations for
biotechnology Scale-up of crop plants
  • Risk/safety analysis
  • hazard identification and, if hazard
  • risk/safety assessment
  • based on knowledge and experience familiarity
  • familiarity is not the same as safety
  • Based on
  • characteristics of the recipient organism,
  • the introduced trait,
  • the environment into which the organism is
  • the interaction between these, and
  • the intended application

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
  • regulatory oversight
  • Operational principles
  • step-by-step next step is determined by
    risk/safety analysis
  • the steps are not fixed

  • 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

  • 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

  • Consensus Documents
  • snapshots of current information, for use
    during the regulatory assessment of products of
  • An Introduction to the Biosafety Consensus
    Documents of OECDs Working Group for
    Harmonisation in Biotechnology
  • Points to Consider for Consensus Documents on
    the Biology of Cultivated Plants (2006)

Developments thought starter Blue
Book 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 Environme
ntal risk parameters Molecular
  • These documents are not written in stone, they
    are snapshots in time of a developing framework
  • Blue Book http//
  • GDP http//
  • Scale-up http//
  • Traditional breeding and other guidance
  • Consensus documents
  • http//,2340,en_2649_34