Guideline for the Conduct of Food Safety Assessment of Foods Produced Using Recombinant-dna Microorganisms

1. This Guideline supports the Principles for the Risk Analysis of Foods Derived from Modern Biotechnology and addresses safety and nutritional aspects of foods produced through the actions of recombinant-DNA microorganisms. The recombinant-DNA microorganisms that are used to produce these foods are typically derived using the techniques of modern biotechnology from strains that have a history of safe, purposeful use in food production. However, in instances where the recipient strains do not have a history of safe use their safety will have to be established. Such food and food ingredients may contain viable or non-viable recombinant-DNA microorganisms or may be produced by fermentation using recombinant-DNA microorganisms from which the recombinant-DNA microorganisms may have been removed.