Protein Monographs

The Issue

Genetically engineered (GE) crops expressing certain proteins have been assessed and approved for food and environmental safety by regulatory authorities in a number of countries. For each of these proteins, the assessments have considered similar information to reach a conclusion that the level of risk is acceptable. The information considered and the rationale for these decisions can be very useful to regulators assessing these proteins for the first time, and it is collectively instructive regarding the common approach to risk assessment of novel proteins in GE crops. This information in different jurisdictions is often publicly available, but it is not always easy to find.

What We Are Doing

The Agriculture & Food Systems Institute has published monographs that review the global approvals of specific novel proteins in genetically engineered crops and provide links to publications, regulatory dossiers, and decision documents. These protein monographs provide a comprehensive review of environmental and food safety information and data for five novel proteins:

• Cry1Ab (Environment and Food – updated in 2026), Cry2Ab (Environment – updated in 2026, Food – published in 2026), and Cry1Ac (Environment – 2010, Food – 2016) proteins that confer insect resistance, and
• EPSPS (Environment – 2010, Food – 2016) and PAT/BAR (Environment – 2011, Food – 2016) proteins that confer herbicide tolerance.

Monographs for environmental safety information and data have also been published for five other novel proteins:

• Vip3Aa (2012), Cry1F (2013), Cry34Ab1 and Cry35Ab1 (2013), and Cry3Bb1 (2014) proteins that confer insect resistance.

*More information about our peer review policy for self-published works can be accessed at this link.