ABSTRACT
The food safety evaluation for recombinant protein hormone products is similar to that performed for other protein products approved as animal drugs. On the other hand, the toxicology studies conducted to demonstrate the human food safety of protein products are considerably different from those just described for more traditional animal drug products. Transgenic animals modified specifically to improve the economics of producing them for food or to improve their desirability as food are expected to ultimately be the common situation. The animal drug approval process is primarily designed for drug sponsors seeking agency approval to market drugs in interstate commerce. The human food safety concern for animal drug residues focuses on the assessment of the effect of chronic low level exposure to drug residues in edible tissues. If the human food safety determination can be made on purely scientific grounds, it should not be a major barrier to approval.
