Guidelines developed by international agencies for safety assessment of GM crops are usually adapted by countries to meet their own regional regulatory frameworks. Consequently, problem formulation and safety data to support risk assessments are tailored to a country's specific needs, and data transportability is not always feasible. Although data transportability challenges are well referenced for field trials; data requirements for laboratory experiments such as molecular and biochemical characterization of GM crops can also vary regionally. The data transportability status for molecular and biochemical characterization data for GM crops is described along with benefits and limitations of harmonization. While standardization and harmonization offer potential benefits including minimizing redundancies leading to inefficiencies and additional resource investments for both developers and regulators, along with facilitation of global trade, the autonomy of regulatory authorities in decision making must be recognized. The delivery of high quality, science-based risk assessments is the goal.

Data transportability status for molecular and biochemical characterization data for genetically modified crops

248th National Meeting (2014)

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