WP1: Subchronic toxicity studies on rodents
Feeding trials for testing GM food and feed safety are described and standardised in several international guidance documents (e.g. EFSA guidance; the French Agency for Food, Environmental and Occupational Health & Safety (ANSES); the OECD; the Codex Alimentarius).
However, there is no adopted protocol for conducting 90-day feeding studies on whole food and feed. The European Food Safety Authority (EFSA) has developed draft guidance for carrying out such feeding studies in rodents (EFSA Scientific Committee, 2011). However, the scientific value of such 90-day feeding trials for whole GM food and feed is being questioned. Therefore, GRACE (WP1) will perform feeding trials with whole GM and non-GM plant material to validate and refine these suggested approaches.
As a starting point, the team of experts will survey the current evidence in the literature on the performance of 90-day feeding trials and gather viewpoints from relevant regulators and scientists throughout Europe. This information will form a baseline for establishing a detailed experimental design appropriate to the test animals and a clear definition of the GM crops and components tested. Certified test laboratories will conduct 90-day feeding trials on rodents with different maize and potato cultivars (MON810 maize and three potato events with altered glycoalkaloid metabolism). The internal evaluation of all data will be followed by an evaluation by external experts to recommend future implementations for safety evaluations of GM food and feed in the EU.
Based on the results, WP1 will draw conclusions and advise on:
- the need for 90-day feeding trials in all cases (single event GMOs);
- the design of 90-day feeding trials on the basis of whole GM food/feed;
- extended (long-term) feeding trials of up to two years.
Test results and recommended guidelines will be available on the GRACE project website and in the open-access database (WP6).
The database CADIMA (Central Access Database for Impact Assessment of Crop Genetic Improvement Technologies) contains quality assessed studies and conclusions on the health effects, socio-economic consequences and environmental impacts of GM plants as well as raw data of animal feeding studies and alternative in vitro approaches.