Gluten-free is now defined. GMO labeling is still controversial, but is getting more industry and regulatory attention. Is nano next?
We believe that nano, with its nanotechnology and the resulting nanomaterials, is the next big thing in foods and their packaging. But, with all the questions that remain about this evolving technology, we also believe that it is crucial that science and the industry work to ensure that the excitement of developing new uses of nanotechnology not overwhelm the research on and understanding of the effects of those nanomaterials in the body.
I’m not sure I’d call it a revolution, but there certainly is an evolution in this technology that is crossing all borders and industries, and carrying just as many questions along with it:
- Is nanotechnology safe? How do we know?
- Do nanomaterials pose greater risk than their larger counterparts?
- Who should regulate nano?
- Is there a difference between engineered and natural nanomaterials?
- And … what does it mean to the food industry?
With estimates that the global market for nanotechnology will exceed $3 trillion by 2015, these questions are becoming exceedingly important. Unfortunately, the growth of the use of nanotechnology in products seems to be exceeding the growth of a general understanding of “nano” or the decisions on regulation – around the world.
So before we get too far into discussion, let’s take a moment to provide some definition and background.
As defined by USDA, nanotechnology is “the science of studying and producing materials and devices of nanometer size – about the size of a small molecule or individual atom.” USDA’s National Institute of Food and Agriculture agency manages grant programs that fund nanotechnology research projects, some of which are being conducted by USDA’s Agricultural Research Service (ARS) itself.
FDA is just as involved in nano, with its own explanation that: “Nanomaterials, developed using nanotechnology, are measured in nanometers – equal to about one-billionth of a meter. … These nanomaterials can have different chemical, physical or biological properties than their conventionally scaled counterpart materials used in many products regulated by FDA.”
It is important to note, however, that the agencies don’t profess to completely understand nano themselves. Rather, the FDA Fact Sheet continues, “Understanding nanotechnology remains a top FDA priority. FDA is monitoring the evolving science and has a robust research agenda to help assess the safety and effectiveness of products using nanotechnology.”
With the work they are doing in the area, both FDA and USDA are part of the National Nanotechnology Initiative (NNI), a U.S. government R&D initiative of 27 department and agency units with the vision of "a future in which the ability to understand and control matter at the nanoscale leads to a revolution in technology and industry that benefits society."
However, the 27-way split in focus is now being questioned. Last year, a report was issued by The National Academies on this very topic. The report, “Research Progress on Environmental, Health, and Safety Aspects of Engineered Nanomaterials,” makes a case that national nano research progress could be accelerated if a single agency were designated to direct all research efforts.
Whether this is a good idea remains to be seen, but given the numerous applications of nanotechnology, from cosmetics to bicycles to food, we believe there could be risks with the use of nanomaterials in foods that may or may not be of concern in other areas. Because nano particles are so small, I fear that they could cross cell membranes, and we have no idea what the effect of that could be.
If food were made a priority by the National Academies’ recommended “single” agency, it could be beneficial, but there is also distinct advantage in allowing the scientists who best understand an area (i.e., food scientists) to be the ones focused on it.
On the other hand, FDA is not currently viewing nano differently than other technologies. In April 2012, FDA issued a draft guidance describing the factors that manufacturers should consider when determining whether a significant change in manufacturing process – including that of nanotechnology – for a food substance already in the market affects the identity, safety of use or regulatory status of use of the food substance -- thus whether it warrants a regulatory submission to FDA.
“FDA considers food manufacturing processes that involve nanotechnology in the same manner as any other food manufacturing technology,” the guidance states. Thus, there is no specific testing required for its use. Rather, if there is no significant change in manufacturing process with the use of nanotechnology, the agency sees it as not affecting food safety.
One of the greatest dangers for the food industry is that consumers will develop their own conclusions about the safety of nano before the science is there. As we all know, once that train leaves the station, it is impossible to turn it around. So there is some sense of urgency on this one to push forward fast and better understand the science and risks behind the technology.