Safety evaluations of food and feed derived from crops produced via modern biotechnology focus on a variety of considerations, including the nature of the trait, the expected and potential unexpected effects owing to the introduction and/or presence of the new trait, and the anticipated conditions of use of the product. Most traits result from the expression of one or more newly introduced proteins. Therefore, the safety of food and feed derived from genetically modified crops includes the examination of the properties of these introduced proteins. A robust safety evaluation process has evolved in the regulatory and international scientific communities to address the potential safety concerns of these proteins.
The objective of this project is to conduct a scientific review of the approach to safety assessment of proteins in order to develop scientific consensus on this topic. The resulting document, drafted by Task Force members, describes:
- The characteristics of proteins and how that drives safety assessment
- A tiered, weight of evidence approach to the safety assessment of proteins
- A detailed description (including applicability, best practices for use and limitations) of the assessments currently done to demonstrate protein safety, including expression level and pattern, history of safe use, bioinformatics, mode of action, protein stability, and toxicological testing.
- Four examples of protein safety assessments are described in the manuscript: PMI, PAT, Y coat protein, and CP4 EPSPS.
The document brings together a considerable body of information about the science underlying protein safety assessment that has not previously been brought together in one place, and includes information from experts responsible for assessment of products currently on the market. This document is designed to describe the scientific underpinnings of protein safety assessment to a scientific audience, and is intended to serve as a key reference for scientific and regulatory considerations.
After peer review by scientific and regulatory experts worldwide, it is anticipated that the document will be submitted for publication in Food and Chemical Toxicology by the end of 2006.