The Animal and Plant Health Inspection Service (APHIS) within the US Department of Agriculture seeks public comment on its proposed rule that would revise the regulations regarding the movement (importation, interstate movement, and environmental release) of certain genetically engineered (GE) organisms in response to advances in genetic engineering and our understanding of the plant pest risk posed by them, thereby reducing regulatory burden for developers of organisms that are unlikely to pose plant pest risks. This proposed rule, which would mark the first comprehensive revision of the regulations since they were established in 1987, would provide a clear, predictable, and efficient regulatory pathway for innovators, facilitating the development of new and novel genetically engineered organisms that are unlikely to pose plant pest risks.
While the current regulations have been effective in ensuring the safe introduction of GE organisms during the past 30 years, advances in genetic engineering have occurred since they were promulgated. APHIS has now accumulated three decades of experience in evaluating GE organisms for plant pest risk. The Agency's evaluations to date have provided evidence that genetically engineering a plant with a plant pest as a vector, vector agent, or donor does not in and of itself result in a GE plant that presents a plant pest risk. Additionally, GE techniques have been developed that do not employ plant pests as donor organisms, recipient organisms, vectors, or vector agents yet may result in GE organisms that pose a plant pest risk. Given these developments, as well as legal and policy issues discussed below, it has become necessary, in our view, to update our regulations accordingly.