4.3 Assessing GM foods: substantial equivalence is introduced
In the early 1990s, biotechnology companies were preparing to market the first food products derived from GM crops. This provided a challenge to legislators. There were no precedents to guide them as to how to approve or ban novel food products. The methods used to approve pharmaceuticals, summarised above (Section 3.1), did not seem to transfer easily to whole food products.
Why might this have been the case?
Determining the NOAEL and hence the ADI of a whole food could prove exceptionally difficult; force-feeding laboratory animals large quantities of a single foodstuff would be impractical and ethically unacceptable.
In order to meet this challenge, the Organisation for Economic Cooperation and Development (OECD, see Table 1) gathered a group of 60 regulatory scientists nominated by its member governments. In 1993, after two years of deliberation, they published a 74-page report, which concluded that:
For foods and food components from organisms developed by the application of modern biotechnology, the most practical approach to the determination of safety is to consider whether they are substantially equivalent to analogous conventional food product(s), if such exist.
If a new food or food component is found to be substantially equivalent to an existing food or food component, it can be treated in the same manner with respect to safety. No additional safety concerns would be expected.
Where substantial equivalence is more difficult to establish because the food or food component is either less well-known or totally new, then the identified differences, or the new characteristics, should be the focus of further safety considerations.
This was the point at which the so-called 'principle of substantial equivalence' became firmly established.
The report identifies two distinct classes of food or food components derived from genetically modified organisms. What are they?
The report made a clear distinction between GM foods that could be considered substantially equivalent and therefore safe, and those where the identified differences or new characteristics should be the focus of further safety assessment.
An increasingly complex system of international regulatory institutions plays an important part in international decision making. You will come across a number of these organisations. Table 1 should provide a useful point of reference.
Table 1 International decision makers.
|—||Codex Alimentarius Commission||Created in 1963 by the FAO and WHO to develop food standards, guidelines and related texts, such as codes of practice.|
|FAO||Food and Agriculture Organisation||Part of the United Nations, leading international effortsto defeat hunger. FAO aims to act as a neutral forum where all nations meet as equals to negotiate agreements and debate policy|
|OECD||Organisation for Economic Cooperation and Development||Representing 30 developed nations, part of its remit is to produce internationally agreed instruments, decisions and recommendations to provide guidelines in areas where multilateral agreement is necessary|
|UN||United Nations||The UN's remit includes the development of international law - conventions, treaties and standards - that are intended to play a central role in promoting economic and social development, as well as international peace and security|
|WHO||World Health Organisation||The UN's specialised agency for health. Its objective is the attainment by all peoples of the highest possible level of health.|
|WTO||World Trade Organisation||An international organisation dealing with the rules of trade between nations.|