Nano, Nano: The Next Regulatory Wave?

Date: Oct 01, 2006

Nanotechnology has the capacity to change our lives in many and varied ways. Everything from the way that drugs are delivered, pesticides are applied, data is sent over the internet and cars are made has the potential to be affected by nanotechnology advances.

Needless to say, packaging will not miss (escape?) the revolution. The question is whether the federal regulatory agencies are ready to assess and regulate such products under existing statutory authority, or if new laws and new regulations will be needed. At least for packaging, it appears that the Food and Drug Administration has everything it needs.

One difficulty with nanotechnology is understanding what the term means and what products that it covers. The FDA has not developed its own definition for nanotechnology. It did, however, participate in a federal research program known as the National Nanotechnology Initiative (NNI), which developed the following definition (see "FDA and Nanotechnology Products: Facts and Questions," www.fda.gov/nanotechnology/faqs.html):

  1. Research and technology development at the atomic, molecular or macromolecular levels, in the length scale of approximately 1 to 100 nanometer (nm) range.
  2. Creating and using structures, devices and systems that have novel properties and functions because of their small and/or intermediate size.
  3. Ability to control or manipulate on the atomic scale.

NNI's definition resulted from the collaboration of 23 agencies, including the FDA and the Environmental Protection Agency; it has coordinated an inter-agency dialogue on nano-scale science, engineering and technology. The FDA has accepted this definition informally with a slight development of the size component, noting that a particle may qualify as a nanoparticle "where at least one dimension that affects the functional behavior of the product" is 1 to 100 nm.

The FDA has thus far declined to regulate nanotechnology-based products outside of its existing regulatory framework, largely because few FDA-regulated products have made nano­technology claims and also because the FDA believes that it has a great deal of experience evaluating substances at the molecular level. This latter point is particularly true in the food packaging program at the FDA where agency staff regularly reviews data for substances that are migrating on a molecular scale.

The FDA is confident that its present regulatory framework is sufficiently comprehensive to effectively protect the public health without separately regulating nanotechnology. Nevertheless, all the FDA centers now participate in a Nanotechnology Interest Group that discusses how the FDA should approach regulation of nanotechnology. And just this month of October, the FDA held a public meeting to help further its understanding of emerging issues in nanotechnology.

Of particular importance here is determining whether the nano size and manipulation of the substance changes the physical and chemical properties of the substance such that it can be expected to behave differently-either in its capability of transferring to a packaging material to food or in being more bioavailable once it enters the digestive tract.

Equally important is to assess whether the nano particle may present a different toxicology profile than its natural cousin. This analysis should ensure that use of the substance with food will not result in a harmful or deleterious effect on human health regardless of its size.

Used with permission. Copyright FOOD & DRUG PACKAGING, October, 2006.

For further information about this article, please contact George G. Misko at 202-434-4170 or by email at misko@khlaw.com.