GMO Risk Assessment and Communication of Evidence: Results from the Eur 6 Million EU-funded project

ICGEB's Biosafety Group
took part in the EUR6 million project funded under the EU European Commission 7th Framework programme on GMO Risk Assessment and Communication of Evidence (GRACE). The project was implemented between June 2012 and November 2015, with over 20 partners, a consortium of EU research institutes, worldwide.

The Conclusions and Recommendations on animal feeding trials and alternative approaches, and on the use of systematic reviews and evidence maps for GMO impact assessment was published on the dedicated web site of the European Commission in December 2015.

The project had two key objectives: i) To provide systematic reviews of the evidence on the health, environmental and socio-economic impacts of GM plants –considering both risks and possible benefits, and ii) the design, execution and interpretation of results from various types of animal feeding trials and alternative in vitro methods for assessing the safety of GM food and feed.

The Biosafety Group was involved in the construction of the central portal and database, CADIMA; Central Access Database for Impact Assessment of Crop Genetic Improvement Technologies,  that manages the information gathered in the pursuit of the two objectives and in the dissemination of information.

See full conclusions and recommendations provided.

Excerpts include:

(A) Feeding trials

GRACE scientists did not find any indication that a routine performance of 90-day feeding studies with whole food/feed would provide additional information on the safety of genetically modified (GM) maize MON810 when compared to the compositional comparison of the GM variety and its closest conventional comparator in terms of an initial safety assessment. Moreover, the 90-day feeding trials performed did not reveal any scientific trigger for an extension of the feeding period. Data gathered in the course of an additional 1-year feeding trial are in accordance with the conclusions made in the 90-day trials, i.e. that the feeding of maize MON810 to rats did not lead to adverse effects. Consequently, the 1-year study conducted in GRACE did not provide relevant additional information when compared to the 90-day studies.

The data generated by GRACE showed that non-targeted feeding studies may lead to randomly generated significant differences between animal feds with the GM test material and animal fed with a control diet. Such results are not informative for risk assessment. GRACE data support the scientific reasoning that only in case a trigger is available from the initial molecular, compositional, phenotypic and/or agronomic analyses, feeding trials with whole food/feed may provide an added scientific value for the risk assessment of GM crops. Thus, feeding trials might be considered, provided that the study design can be tailored to the posed safety concern.

Due to these limitations of rat feeding trials with GM whole food/feed, a mandatory performance in the course of GMO risk assessment cannot be justified in the light of the European goal to replace and reduce animal tests.

With respect to alternative studies it was concluded that available methods are very promising but cannot yet replace animal feeding trials in routine GMO risk assessment. In the future, they might help to decide whether an animal feeding trial is necessary and what should be the focus of this feeding study. Two different approaches were tested in the context

The so called omics approaches may detect unintended compositional differences (proteins, metabolites etc.) of GM crops in comparison with non-GM plants. Thereby omics may contribute to scientifically justify rat feeding trials with whole food/feed and to target the study design to the posed safety concern. In vitro studies such as the exposure of GM plant extracts to cell cultures provided promising results but will have to be validated.

(B) Improved methods for evidence synthesis

The project established new and more comprehensive methods for systematically collecting and assessing existing scientific evidence on environmental, health and socio-economic effects (risks and benefits) of GM plants: systematic reviews and evidence maps. These methods make it possible to draw more robust conclusions on these effects, systematically reflecting the entire body of research available.

In testing these methods for the purpose of GMO risk research and assessment it was confirmed that the conclusions of previous risk assessments on GM insect resistant Bt crops are still valid. Bt maize showed no effects on populations of non-target organisms such as beetles and butterflies or to soil microorganisms compared to conventional maize.

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