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Risk Assessment for Biotechnology Products - In U.S.A., foods and additives developed by biotechnology are subject to the same rigorous safety standards as are conventional foods and additives, and there are no special requirements for such products.

The foods and additives obtained from genetically modified organisms are called genetically modified food (GM food). Assessment of risk from GM food takes into consideration the following:

(1) the food crop that has been modified,

(2) the potential for any introduced DNA to encode harmful substances,

3) the safety of proteins encoded by Tran’s genes, and

(4) proof that known plant toxicants and important nutrients are within acceptable levels in the new variety.

There is some chance that proteins encoded by transgenes may cause allergies in some individuals; this is particularly so for proteins derived from such foods as milk, eggs, wheat, fish, tree nuts and legumes. There are some instances where a transgenic variety had to be withdrawn due to severe allergic reactions in some people, e.g., a soybean transgenic variety in Mexico.

Information on the following four aspects of the production process and the product would help in evaluation of the safety of a product generated by recombinant DNA technology.

I. Genetic backgrounds of the host and the donor organisms.

2. The technical procedures used for developing the products.

3. Composition of the food, including any potential toxicants and significant nutrients.

4. Relevant toxicological data on the host organism.

Japan has decided to 'label' those GM foods that are found to be 'safe'.

Similarly, European Union has adopted legislation requiring mandatory labelling of all GM food. In contrast, U.S. Food and Drug Administration (FDA) requires the food to be labelled as genetically modified only if the changes introduced through genetic engineering have an impact on the safety or nutrition of the food itself.

Labelling is considered desirable because it gives the consumer the choice of deciding if he wishes to have GM food, but companies fear that labelling may frighten the consumers.