Studies on GMO Risk Assessment

 

THIRD WORLD NETWORK BIOSAFETY INFORMATION SERVICE
 
Dear Friends and colleagues,
 
RE: Studies on GMO Risk Assessment
 
We wish to highlight two recent scientific studies which critically scrutinize the practice and approach taken by the authorities in conducting risk assessments on GMOs in the European Union.
 
Recommendations are also put forward to improve the practice of assessing GMOs as well as to change regulations where necessary in order to require more comprehensive risk assessments to be carried out. 
 
Both studies can be downloaded for free at their respective links provided below.
 
 
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Item1 
 
Abstract
 
Purpose
 
The prevailing controversies on the potential environmental risks of genetically modified organisms [GMOs] still fuel ongoing discussions among European Union [EU] member states, risk assessors, applicants and scientists, even several years after the commercial introduction of GMOs. The disagreements mainly derive from the current risk assessment practice of GMOs and differences in the perceived environmental risks. Against this background, the aim of this study was to scrutinize the current practice of environmental risk assessment [ERA] of several GMO applications currently pending for authorisation in the EU.
 
Methods
 
We analysed the data presented for three assessment categories of the ERA of genetically modified [GM] maize applications for cultivation in the European Union: the agronomic evaluations and the assessments of the effects of GM maize on target organisms and of its potential adverse effects on non-target organisms.
 
Results
 
Major shortcomings causing considerable uncertainties related to the risk assessment were identified in all three categories. In addition, two principles of Directive 2001/18/EC are largely not fulfilled – the consideration of the receiving environment and the indirect effects, as mediated, e.g. by the application of the complementary herbicide in the case of herbicide-tolerant GM maize.
 
Conclusions
 
We conclude that the current practice of ERA does not comprehensively fulfil the scientific and legal requirements of Directive 2001/18/EC, and we propose improvements and needs for further guidance and development of standards. The recommendations address likewise applicants, risk assessors as well as decision makers.
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Item 2
 
Abstract
 
Purpose
 
Since more than 25 years, public dialogues, expert consultations and scientific publications have concluded that a comprehensive assessment of the implications of genetic engineering in agriculture and food production needs to include health, environmental, social and economical aspects, but only very few legal frameworks allow to assess the two latter aspects. This article aims to explain the divergence between societal debate and biosafety legislation and presents approaches to bring both together.
 
Main features
 
The article reviews the development of biosafety regulations in the USA and the EU, focussing on diverging concepts applied for assessing the risks of genetically modified organisms (GMOs).
 
Results
 
The dominant environmental risk assessment methodology has been developed to answer basic questions to enable expedient decision making. As a first step, methodologies that take into account complex environmental and landscape aspects should be applied. Expanding the scope of risk assessment, more holistic concepts have been developed, for example the Organisation for Econonomic Co-operation and Development (OECD) concept of systemic risks which includes socio-economic aspects. International bodies as the OECD, the Convention on Biological Diversity (CBD) and the European Union (EU) have developed the Strategic Environmental Assessment (SEA) as an instrument that includes the additional aspects of risk assessment as demanded by many stakeholders. Interestingly, there had been no attempts yet to link the existing frameworks of GMO risk assessment and SEA.
 
Conclusions
 
It is recommended to adapt current models of SEA to assess the systemic risks of GMOs. It is also suggested to revise the EU GMO legislation to promote the inclusion of SEA elements.
 
 
 

Studies on GMO Risk Assessment

 

Item1 
 
Abstract
 
Purpose
 
The prevailing controversies on the potential environmental risks of genetically modified organisms [GMOs] still fuel ongoing discussions among European Union [EU] member states, risk assessors, applicants and scientists, even several years after the commercial introduction of GMOs. The disagreements mainly derive from the current risk assessment practice of GMOs and differences in the perceived environmental risks. Against this background, the aim of this study was to scrutinize the current practice of environmental risk assessment [ERA] of several GMO applications currently pending for authorisation in the EU.
 
Methods
 
We analysed the data presented for three assessment categories of the ERA of genetically modified [GM] maize applications for cultivation in the European Union: the agronomic evaluations and the assessments of the effects of GM maize on target organisms and of its potential adverse effects on non-target organisms.
 
Results
 
Major shortcomings causing considerable uncertainties related to the risk assessment were identified in all three categories. In addition, two principles of Directive 2001/18/EC are largely not fulfilled – the consideration of the receiving environment and the indirect effects, as mediated, e.g. by the application of the complementary herbicide in the case of herbicide-tolerant GM maize.
 
Conclusions
 
We conclude that the current practice of ERA does not comprehensively fulfil the scientific and legal requirements of Directive 2001/18/EC, and we propose improvements and needs for further guidance and development of standards. The recommendations address likewise applicants, risk assessors as well as decision makers.
———————————————————————————————————————
 
Item 2
 
Abstract
Purpose
Since more than 25 years, public dialogues, expert consultations and scientific publications have concluded that a comprehensive assessment of the implications of genetic engineering in agriculture and food production needs to include health, environmental, social and economical aspects, but only very few legal frameworks allow to assess the two latter aspects. This article aims to explain the divergence between societal debate and biosafety legislation and presents approaches to bring both together.
Main features
The article reviews the development of biosafety regulations in the USA and the EU, focussing on diverging concepts applied for assessing the risks of genetically modified organisms (GMOs).
Results
The dominant environmental risk assessment methodology has been developed to answer basic questions to enable expedient decision making. As a first step, methodologies that take into account complex environmental and landscape aspects should be applied. Expanding the scope of risk assessment, more holistic concepts have been developed, for example the Organisation for Econonomic Co-operation and Development (OECD) concept of systemic risks which includes socio-economic aspects. International bodies as the OECD, the Convention on Biological Diversity (CBD) and the European Union (EU) have developed the Strategic Environmental Assessment (SEA) as an instrument that includes the additional aspects of risk assessment as demanded by many stakeholders. Interestingly, there had been no attempts yet to link the existing frameworks of GMO risk assessment and SEA.
Conclusions
It is recommended to adapt current models of SEA to assess the systemic risks of GMOs. It is also suggested to revise the EU GMO legislation to promote the inclusion of SEA elements.
 
 
 
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