ABSTRACT
Development Phase ..................................................................................... 238 10.3 Production of Proteins to Support the Comprehensive Protein
Safety Testing .............................................................................................. 239 10.3.1 Limitations of Target Protein Quantities from Plant Sources ....... 239 10.3.2 Heterologous Protein Production ................................................... 239
10.4 Safety Evaluation of the Introduced Protein ............................................... 241 10.4.1 Establishing the Identity of the Purified Proteins of Interest ........ 241 10.4.2 Tests to Confirm Equivalence of Protein Produced
in Heterologous Systems versus Protein Expressed in Plants .......242 10.4.3 Bioinformatic Analysis .................................................................. 243 10.4.4 Protein Stability in In Vitro Digestibility Assays .......................... 243 10.4.5 Role of the Acute Mouse Gavage Study to Assess
Protein Safety ................................................................................244 10.4.6 Other Components of a Protein’s Safety Evaluation ...................... 247
10.5 Case Studies for the Safety Assessment of Proteins with Different Modes of Action ..................................................................248 10.5.1 Safety Evaluation of the Cry3Bb1 Protein .....................................248 10.5.2 Safety Assessment of the CP4 EPSPS Protein ..............................249 10.5.3 Safety Assessment of Antifungal Proteins ....................................250 10.5.4 Safety Assessment of the PLRVrep Protein Present
in NewLeaf Plus Potatoes ............................................................ 251 References .............................................................................................................. 253
All foods derived through biotechnology must undergo a comprehensive safety evaluation as part of the regulatory approval process prior to entering the market and becoming part of the food supply. The general principles underpinning the safety assessment of biotechnology-derived foods have been developed over time with help from governmental regulatory agencies, academics, international organizations such as The Organization for Economic Co-operation and Development (OECD),1 the International Life Science Institute (ILSI),2 the Food and Agriculture Organization of the United Nations/World Health Organization (FAO/WHO),3,4 and many companies involved in the production of biotechnology-derived crops. Consequently, an integrated, globally harmonized, stepwise approach to safety evaluation has been developed that is utilized in different countries to assess the safety of biotechnologyderived foods.5
