A set of core studies including molecular characterization, expression and characterization of the newly expressed proteins (or other expression product), and safety assessment of the introduced protein, are appropriate to characterize the product and assess safety. Using data from core studies and employing a “problem formulation” approach, the need for supplementary hypothesis-driven or case-by-case studies can be determined. Employing this approach for the evaluation of GM plants will remove regulatory data requirements that do not provide value to the safety assessment, and provide a consistent framework for global regulation.
Stephen Watersa, Adela Ramosb, Angela Hendrickson Cullerc, Penny Hunstd, Lawrence Zephe, Rachel Gaste, Debbie Mahadeoc, Jordan Sottosantod, Scott Hubere, Guomin Shanb, Suma Chakravarthyf,∗, Laurie Goodwinf,∗∗
aWaters International Consulting, Bousval, Belgium bCorteva Agriscience TM, Johnston, IA
cBayer, Crop Science Division, Chesterfield, MO dBASF Corporation, Research Triangle Park, NC eSyngenta, Crop Protection, LLC., Research Triangle Park, NC fCropLife International, Washington, DC