New synthetic biology creations don't fit nicely into the areas that regulators have carved out to oversee, ScienceInsider reports. A new report from the Synthetic Biology Project notes that various agencies ranging from the Food and Drug Administration to the Environmental Protection Agency could potentially oversee synthetic biology products.
This situation, the report notes, could be challenging for small startups to deal with as they might not have the resources of a larger company to wade through the applicable laws.
The report's authors from the Woodrow Wilson International Center for Scholars examine how regulators would handle different synthetic biology products like the Oxitec mosquito, synthetic squalene, the PBAN moth trap, and a glowing ornamental plant.
Typically, the authors say, the Department of Agriculture's Animal and Plant Health Inspection Service would oversee genetically modified insects, but as this mosquito is intended to control human disease, it could fall under the auspices of the FDA's Center for Drug Evaluation and Research. But, they note, it's actually being evaluated by the Center for Veterinary Medicine at FDA.
In addition, the glowing ornamental cress plant would be thought to fall under the USDA Animal and Plant Health Inspection Service, but since it uses an agrobacterium-based gene transfer approach, the agency says it doesn't have jurisdiction. ScienceInsider notes that no agency has stepped up to evaluate it.
"The system is not flexible enough to address rapidly evolving technologies like synthetic biology," Todd Kuiken from the Synthetic Biology Project says in a statement. "This could make it difficult for agencies to properly evaluate the potential risks of these products, as well making it difficult for products to move to the market."