Nanotechnology policy experts are urging that food additives that contain nanoscale materials be subject to new safety testing to ensure that their use does not pose unintended risks.
The call comes as nanotechnology emerges as a major regulatory challenge facing the incoming Obama administration. It also takes place amid debate over how to restructure the Food and Drug Administration (FDA) and possibly create a separate government food safety agency.
Policy experts at the Project on Emerging Nanotechnologies (PEN), a project funded by the Pew Charitable Trusts, urge the FDA to issue guidance on how existing listings for food additives and "generally recognized as safe" (GRAS) substances apply to nanoscale materials. This action by FDA would help increase consumer confidence and private-sector investment in new technologies. According to companies that use nanoscale materials in foods, the technology can be used to improve food taste, quality, and safety.
"Failure by FDA to issue any guidance for nano food-additives leaves the door open to manufacturers to make their own judgments and enter the market without FDA clearance, despite having a material with novel properties," says David Rejeski, the director of PEN. "Clear FDA guidance for nanoscale food-additives combined with a pre-market safety evaluation would provide a level playing field and rules of the road for industry developing new applications based on nanoscale materials."
Congress created the GRAS concept to build some flexibility into the oversight system by exempting additives that truly were considered safe from the pre-market approval requirement. FDA and industry have used this authority over the years to avoid the food additive approval process for well-tested substances whose safety is recognized by experts.
"The time may come, when the body of scientific evidence demonstrating the safety of a nanoscale food additive is sufficient to meet the GRAS standard. But the science is not close to meeting that level of confidence now," says Andrew Maynard, chief science advisor for PEN.