Task Force on the Safety Assessment of Protein in the Context of Agricultural Biotechnology
The Task Force and Its Work
In 2003, the ILSI International Food Biotechnology Committee convened a task force to develop a framework and scientific underpinnings for the safety assessment of proteins produced from genes introduced into biotechnology-derived products.
The Task Force on Safety Assessment of Protein in the Context of Agricultural Biotechnology developed a manuscript describing such a framework. Reviewed by 15 international experts from government, academia and industry, the final document was published as a supplement to Food and Chemical Toxicology1. Key features include:
- The characteristics of proteins and how they drive 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 assess protein safety, including: expression level and pattern; history of safe use; bioinformatics; mode of action; protein stability; and toxicological testing.
- Descriptions of six case studies of protein safety assessments: Cry1Ab; PMI; PAT; Y coat protein; CP4 EPSPS; and anti-fungal protein.
Impacts
The Task Force publication gathers a considerable body of science underlying protein safety assessment not been previously assembled. It provides guidance on how to weigh important factors to consider throughout the safety assessment process and serves as a state-of-the-science reference for scientific and regulatory decision-making. Future ILSI activities will disseminate the conclusions to international audiences.
Task Force Expert Consultant
Sue MacIntosh, MacIntosh & Associates
Task Force Members
BASF
Bayer CropScience
Cargill
Dow AgroSciences
Pioneer, A DuPont Company
Monsanto Company
Renessen (through 2006)
Syngenta Biotechnology Inc.
Task Force Leadership
Robin Eichen Conn (Chair)
1. Delaney, B. et al., Evaluation of protein safety in the context of agricultural biotechnology. Food Chem. Toxicol. (2008), doi:10.1016/j.fct.2008.01.045.