Clara Rubinstein

What´s in a name: the issue with regulatory definitions

The title refers to a line from William Shakespeare’s Romeo and Juliet to suggest that names are unimportant 1 . While this may hold true in the context of human equality, clear terminology and definitions are essential for legal and regulatory purposes. Clear, unambiguous definitions reduce discretionary interpretations, make regulatory requirements more predictable and transparent, and facilitate compliance. The rise of gene-editing techniques and the renewed interest in agricultural biologicals call for a revision of the criteria used to define a GMO, particularly for microorganisms.