1. While the limitation of animal study methodology when used on whole food has been pointed out, the Consultation was of the view that in specific cases animal testing may be useful. It is recommended that further research and standardization should be initiated in this area.
2. The detection methods for unintended effects based on the analysis of specific components could be supplemented with alternative strategies, such as profiling techniques. These techniques are under development; it is recommended that these methods are further developed and validated. This will be especially important for more complex genetic modifications perhaps involving multiple between-species gene transfers.
3. It will be important to monitor changes in nutrient levels in foods from plants derived by conventional breeding and by genetic modification, and assess their effect on the nutritional status of the population. A number of future food products with specific nutritional changes will be especially relevant to the needs of developing countries, and efforts should be made to improve the dissemination of appropriate methodologies and capacity building in the developing world.
4. It is recommended that integration of nutritional and toxicological expertise needed for the evaluation of genetically modified foods be encouraged and facilitated. This will facilitate R&D in the area of genetic modification of plants and lead to an early identification of relevant safety and nutritional issues.
5. The Consultation encourages the use of alternative transformation technologies, if available and demonstrated to be safe, that do not result in antibiotic resistance genes in genetically modified foods. If further development of technology is required, additional research should be strongly encouraged.
6. It is recommended that consensus documents are developed to facilitate uniform application of the concept of substantial equivalence. These should include guidelines for appropriate design of field trials and the use of appropriate statistical methods to generate and analyse comparative data on genetically modified plants and their conventional counterparts.
7. Communication of the principles involved in the safety assessment of genetically modified foods should be improved. The Consultation concluded that the key message to be conveyed is that substantial equivalence is a concept used to identify similarities and differences between the genetically modified food and a comparator with a history of safe food use which in turn guides the safety assessment process.
8. WHO/FAO should be encouraged to convene an Expert Consultation on the assessment of the allergenicity of genetically modified foods and the novel proteins contained therein. The Consultation should focus on the development of an improved decision-tree approach for the assessment of the allergenicity of genetically modified foods and on the standardization/validation of specific criteria, such as optimal methods for assessment of digestive stability.
9. The Consultation identified the following as the additional issues to be addressed in future FAO and WHO Consultations.
Safety assessment specific to genetically modified micro-organisms
Safety assessment specific to genetically modified animals (including fish)
Safety assessment of functional food, including the nutritional aspects of the genetically modified foods
Improved methodologies for the safety study of whole foods.
The use of antibiotic resistance genes in plants and microorganisms for food production in relation to possible medical problems
