Mode of Action and Functionality

Understanding the mode of action and/or biological function of the introduced protein will inform the safety assessment so that appropriate testing can be undertaken to address any safety concerns that may exist. If the mode of action is specific for a certain biological function (for example, enzymatic conversion of substrate A to product B) and the products of the enzymatic reaction pose no safety concerns, then no additional safety testing may be warranted beyond the bioinformatics and digestibility assessments previously discussed in Chapter 10.

If the mode of action is not established (control insect pests by an unknown mechanism) or the function is related to the mode of action of known mammalian protein toxins or pharmacologically active proteins [antifungal protein (AFP) example, Chapter 10], then additional safety testing is warranted to assess whether the protein can be safely used.


The protein introduced into biotechnology-derived crops should not show amino acid sequence similarity to known mammalian toxins, allergens, or pharmacologically active proteins. If similarity to those proteins is found, additional safety evaluations will be needed to determine whether these proteins can be safely consumed in the diet.

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