Safety assessment strategy for proteins introduced into foodfeed crops

In Chapter 10, a safety testing approach was outlined for proteins introduced into biotechnology-derived crops. This strategy was based on guidelines provided by the Organisation for Economic Co-operation and Development (OECD), the World Health Organization (WHO), the European Food Safety Authority (EFSA), etc. The basic elements of this testing strategy are:

History of Safe Use (HOSU): Proteins introduced into biotechnology-derived crops that have a history of safe use/consumption in food, or are structurally and functionally related to proteins with a HOSU, are generally considered safe to consume. The HOSU concept is widely used in a regulatory context to provide guidance on the level of familiarity with respect to probable safety of chemicals or proteins in food. Safety testing guidelines developed by EFSA state, "The studies required to investigate the toxic-ity of a newly expressed protein should be selected on a case-by-case basis, depending on the knowledge available with respect to the protein's source, function/activity and history of human/animal consumption. In the case of proteins expressed in the GM plant where both the plant and the new proteins have a history of safe consumption by humans and animals, specific toxicity testing might not be required."81

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