For the past several years, nanotechnology has been hyped as the next big thing. It's clear some forms of nanotechnology are here, and this requires thinking about how the technology should be regulated. Nanotech visionaries talk about machines and robots built on a molecular scale. It can be difficult to determine how much of this is science fiction and how much of it is right around the corner.
Defining what is meant by nanotechnology is the first challenge. The National Nanotechnology Initiative (NNI) has proposed that something qualifies as nanotechnology only if it involves all three of the following:
- Research and technology development at the atomic, molecular or macromolecular levels, in the length scale of approximately 1 - 100 nanometer range;
- Creating and using structures, devices and systems that have novel properties and functions because of their small and/or intermediate size; and
- Ability to control or manipulate on the atomic scale.
In common usage, it's likely that the term nanotechnology will be used more loosely to refer to anything having a very small particle size measured in nanometers.
What applications of nanotechnology are we likely to see in food technology? Microencapsulated flavors, antioxidants, nutrients and other types of ingredients are probably the most immediate examples. Very small, microencapsulated particles can allow for better dispersion and solubility. They also may enhance the stability of some food ingredients and allow for their use at lower concentrations in food.
More interesting applications are envisioned. Nano-machines could be used to kill pathogenic microorganisms, making food safer. Nano-machines could be used to manufacture food ingredients, similar to the manner in which microorganisms are used today to produce enzymes and other food ingredients.
At first blush, it does not appear the FDA requires a whole new regulatory framework to handle these developments. In the case of food ingredients that come in nanotech particle sizes, FDA and the food industry must consider on a case-by-case basis whether smaller particle sizes present any special risk to the consumer. This can be done as part of the normal safety evaluation to which any new food ingredient or technology is subjected. It only requires a toxicological understanding of the behavior and fate of the small particles after ingestion.
If a food or food ingredient will be newly produced using nanotechnology, FDA would be in a position to evaluate this new production method, in the same way that it currently evaluates new routes of chemical synthesis or the use of biotechnology to produce food ingredients. And, as always, the proponent of the technology would have the burden of demonstrating safety.
It also may be necessary in some cases to define permitted food ingredients in terms of particle size. Currently, food additives generally are described by their chemical identities. Purity specifications are established, and the method by which a food additive is manufactured often is specified. If nano-particle versions of existing food additives are developed, and if they have different safety profiles, FDA may find it necessary to clarify at some point that existing food additive clearances do not necessarily apply to nano-particle versions.
In addition to these questions about how FDA will address food nanotechnology, there is the question of consumer acceptance. Hopefully, we will not see a repeat of the war against genetically modified foods. But there certainly are many voices expressing concern about nanotechnology.
Some fear a "gray goo" scenario in which nano-robots reproduce like viruses and eventually consume the planet. It seems safe to put this in the science fiction category. Why would man-made nano-machines be likely to do this while no other machine and no living organism has yet done so?
There are plenty of reasons that the gray goo theory will not stop nanotechnology dead in its tracks. Unlike genetically modified foods, nanotechnology does not threaten to revolutionize agriculture … nor food processing. Thus, there may not be reasons related to international trade for some countries to oppose foods produced using nanotechnology.
Nanotechnology may be able to avoid the stigma attached to genetically modified foods, and the best way to do that will be for the industry to adopt rigorous safety standards, communicate effectively and partner with regulatory authorities.David Joy is a partner in the Washington, D.C., office of Keller and Heckman LLP. He specializes in food and drug law with emphasis on the domestic and international regulation of food, food additives, food labeling, antimicrobial pesticides and medical devices. He is a member of the District of Columbia Bar and holds a bachelor's degree in chemistry. For more information about Keller and Heckman, visit the firm's web site at www.khlaw.com.