Start of stakeholder consultation on draft study plans for chronic and sub-chronic toxicity studies with GM maize

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Start of stakeholder consultation on draft study plans for chronic and sub-chronic toxicity studies with GM maize

On 6 Dec 2013 the FP7 project GRACE project announces the start of a written stakeholder consultation procedure on the draft study plans of two animal feeding studies conducted with GM maize MON810:

Comments to these plans can be provided via e-mail to

The deadline for comments is 20 Dec 2013.



The consultation is closed. The consultation report and revised study plans are published.

Stakeholder consultation:

Revised Study Plans:

Note: Due to the privacy policy of the Julius Kühn-Institute the names of team members had to be blackened if they have not been published before.

The design, conduct and interpretation of whole food animal feeding studies in the context of GMO risk assessment have been highly debated over recent years and are presently again in the focus of a controversy in scientific media and among stakeholders. The aim of this consultation is to receive feed-back from stakeholder groups and experts in order to improve the draft plans for the design, conduct and analysis these animal studies. The plans will then be reconsidered based on the comments received. The animal studies are scheduled to start in the beginning of 2014 and will be conducted based on the revised plans. Once the results of these studies will be available another stakeholder consultation will be organised in 2015 in order to discuss results and draft interpretations.

GRACE already held one stakeholder/expert workshop including a written consultation on the design of 90-day animal studies with GM maize and on the plans for in-vitro, in-silico, and analytical studies in Dec 2012. The detailed consultation report, the revised study plans, and a response from GRACE team members to the questions and comments received in the course of the consultation are already available.

Information on the GRACE approach to stakeholder involvement can be found here.

Contact: Gloria Adduci at

*Background information:

A specific study (based on the 90-day feeding study design) to consider whether (additional) metabolic endpoints improve the evaluation of toxic effects through transgenic crops. Since the collection of samples of blood and urine throughout the (longitudinal) study means additional disturbance for the rats a separate study was launched using the same plant material as for previous 90-day feeding studies. This study will take into account OECD TG408 and the EFSA standard protocol on conducting repeated-dose 90-day oral toxicity study in rodents on whole food/feed.

Consultation Reports

Stakeholder consultation

Stakeholder consultation on animal feeding studies and in vitro studies for assessment of GMO impacts on human health.


3-4 December 2012, Vienna


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