Import Requirements for Genetically Engineered Organisms Proposed for Update
The Department of Agriculture’s Animal and Plant Health Inspection Service is proposing to update its regulations regarding the importation, interstate movement, and environmental release of certain genetically engineered organisms in response to advances in genetic engineering and understanding of the plant pest and noxious weed risk posed by genetically engineered organisms. APHIS states that its goals for this proposal, which would be the first comprehensive revision of the regulations since they were established in 1987, are to ensure a high level of plant health protection based on the best available science; improve regulatory processes so that they are more transparent, efficient, and predictable for stakeholders and the public; and provide regulatory relief that will stimulate innovation and competitiveness. Comments on this rule are due no later than May 19.
APHIS states that its evaluations over the past 29 years have provided evidence that most genetic engineering techniques, even those that use a plant pest as a vector, vector agent, or donor, do not result in a GE organism that presents a plant pest risk. On the other hand, genetic engineering techniques have been developed that do not employ plant pests as donor organisms, recipient organisms, vectors, or vector agents and could be used to produce GE organisms with plant pest risks without falling within the scope of regulated articles.
Under the proposed rule APHIS would first assess GE organisms to determine if they pose plant pest or noxious weed risks. If they do not, APHIS would not require a permit for the importation, interstate movement, and environmental release (outdoor use) of the GE organism. On the other hand, if APHIS determines that controls on imports, interstate movements, or environmental releases (regulated controlled outdoor use such as in field trials) are needed it will work with the requestor to establish appropriate permit conditions to manage identified risks.