Regulatory and biosafety considerations for bioengineered crop plants

Since the mid-1990s, more than 1 billion hectares of genetically modified (GM) crops have been planted by millions of farmers in 28 countries worldwide. The vast majority of these plantings comprised commodity food and fiber crops that have been modified to increase productivity through improved insect resistance and/or herbicide tolerance. Prior to commercial deployment, these crops undergo rigorous biosafety assessments to identify potential harms and risks associated with the new traits to human and animal health, and to the environment. Two decades have passed without a single, validated adverse effect. Even so, in recent years, the biosafety assessment scheme applied to these crops has become increasingly burdensome and costly, potentially excluding all but the large multinational technology companies from GM crop product development. In contrast to focusing the risk assessment process on identified harms and the potential for exposure, some national regulators now require additional experimental data that have little bearing on the actual risk assessment. Horticultural crop trait improvement via the tools of modern biotechnology has particularly suffered from this regulatory burden, as the same regulatory framework applied to large hectare food and fiber crops is also applied to horticultural crops. This presentation will examine the underlying concepts that frame the current GM crop regulatory scheme and options to design a fit-for-purpose process for horticultural crops.