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Nanotechnology: Big Problems Come in Small Packages
   by Kevin Murch, SZD
   Strategies   Spring  2011
  
Although the advantages nanotechnology brings to manufacturing are not often disputed, the risk the proliferation of nanotechnology may pose to human health is still very much in question. Like anything else, the risks associated with nanotechnology will lead to increased regulation and with that, increased litigation. Thus, there is a business risk that comes along with nanotechnology as well. Companies will need to do their best to prepare themselves to comply with new regulations and to limit their exposure to the inevitable lawsuits to follow.

A. What is Nanotechnology? How Does it Apply to Plastics?
In its most simplistic definition, it is really small stuff used to make bigger stuff. Perhaps a better definition is the one used by the National Nanotechnology Initiative (NNI):

A nanometer is one-billionth of a meter. A sheet of paper is about 100,000 nanometers thick; a single gold atom is about a third of a nanometer in diameter. Dimensions between approximately 1 and 100 nanometers are known as the nanoscale. Unusual physical, chemical and biological properties can emerge in materials at the nanoscale. These properties may differ in important ways from the properties of bulk materials and single atoms or molecules.
Nanotechnology is used in manufacturing where nanoparticles can be manipulated to make products such as tennis rackets, baseball bats, bicycles and similar products lightweight but at the same time, stronger. Nanotechnology is used in pharmaceuticals to simplify the administering of medication. It is used to make clothing stain resistant. Nanotechnology can be applied to make space-saving products. According to the NNI, almost all electronic devices manufactured in the last decade use some sort of nanomaterials.

The plastics industry uses nanotechnology in a variety of ways. Materials reinforced through nanotechnology are used in thermoplastics because they are capable of resisting heat, provide dimensional stability and are capable of conducting electricity. Plastic nanotubes also are being created with nanotechnology. These nanotubes are flexible, lightweight and durable, and are being used in the automotive, aerospace and chemical industries. Finally, special nanocomposite foams have been created and are expected to replace solid plastic because they are much lighter.

The impact of nanotechnology in the future seems immeasurable. The hope is that by using nanotechnology, companies will be able to make safer and stronger products. It will allow for energy efficiency in homes, offices and vehicles. Better medical devices. Better medicine. Could there be a downside? Of course.

B. Risks and Concerns (in other words, the downside)
How prevalent is the use of nanotechnology? Researchers estimate that by 2015, nanomaterials will be incorporated in over $1 trillion worth of products. The NNI reports that in 2001, federal funding for nanotechnology was approximately $464 million. Presently, that amount has risen to $1.5 billion. The increased reliability on nanomaterials comes with increased concerns.

Concerns involve predictability, the impact on the health of employees and consumers and the impact on the environment. Predictability is an issue because no one really knows how these nanomaterials will behave over time. The behavior of materials at the nanoscale is not the same as those observed at larger scales. George Kimbrell from the International Center for Technology Assessment explained the “scientific consensus on nanomaterials is that nano does not mean merely tiny, but rather materials that have the capacity to act in fundamentally different ways.”

Of special concern is the health of employees involved in manufacturing products incorporating nanomaterials. For the manufacturing employees who will have the most extensive exposure to nanomaterials, there is a real health risk in handling such small materials. Due to their extremely small size, nanomaterials have the ability to move throughout the environment unnoticed. Inhaled nanomaterials can flow through the body undeterred by the human body’s natural defenses that would usually serve to block larger particles.

There is simply no way of knowing how each and every nanomaterial will behave once inside the body or what long-term effects it may have. Many have equated the potential risk of nanomaterials to human health to those created by asbestos. The study of the potential health risks of nanomaterials has its own name – nanotoxicology.

C. Regulation of Nanotechnology
Given the uncertainty associated with nanotechnology, a major focus has been shifted to the regulation of nanotechnology and nanomaterials. Debates exist with respect to whether existing regulation is sufficient or whether nanomaterials merit individual government attention. As recently as 2007, the Bush administration held the collective opinion there was no need for special regulation of nanomaterials. However, the following year, other opinions arose. In Nanotechnology Oversight: An Agenda for the New Administration, J. Clarence Davies explored the need for special regulation. Davies focused on four federal regulatory bodies – the Food and Drug Administration (FDA), the Environmental Protection Agency (EPA), the Consumer Product Safety Commission (CPSC) and the Occupational Safety and Health Administration (OSHA) – all of which have some authority to regulate nanomaterials.

Davies suggested actions the regulatory bodies could take, both together and independent of one another, to assist in regulation. For example, the EPA, which administers the existing Toxic Substances Control Act (TSCA), could define nanomaterials as “new” chemical substances. Treating the materials as “new” rather than simply smaller versions of existing chemicals would subject the nanomaterials to many TSCA regulatory authorities. The EPA also could explore the application of other existing laws under its authority to nanomaterials and push for revisions of those laws to give them teeth in the face of potential risks.

Similarly, the FDA could determine which nanomaterials are “new” for regulatory purposes. In other words, when already approved products begin to incorporate nanomaterials, will the product then be considered “new”? If so, additional testing and approval may be required. Davies suggested OSHA should require education and training concerning the use of nanomaterials. OSHA could use its existing regulations to monitor and review safety standards related to nanomaterials. As this shows, opinions are moving toward greater regulation of nanotechnology.

D. What Steps Should You Take Now?
It is likely just a matter of time before the first large class-action cases are filed asserting a connection between the use and exposure of certain nanomaterials and personal injury. Some commentators warn that the risk and danger of overexposure to nanomaterials will result in the same type of mass tort litigation that arose from the undisclosed risks associated with asbestos. While there is no way for manufacturers and other employers to avoid a determined plaintiff’s attorney, there are steps they can take to limit their litigation risk and exposure. First, manufactures and employers must stay informed with regard to new regulations and proposed regulations. Business owners do not want to end up in litigation over something as simple as posting a warning on its products or properly training its employees. The regulatory landscape may be quickly changing and businesses need to keep up or suffer the consequences.

Second, companies should review their insurance policies with their carriers to determine whether existing policies are sufficient or if additional coverage will be necessary. If there is a concern about the use of nanomaterials in the workplace or in products, it is much better to address the issues with the insurance companies now rather than after a lawsuit is filed.

Third, businesses may want to consult with experts in the field of nanomaterials. Such experts may be able to identify potential risks not readily apparent to the everyday business owner or employee. Additionally, in the two birds with one stone category, an expert will likely be familiar with all existing regulations and potential regulations that could impact the business and its employees.

The one certainty that can be taken away is that nanotechnology is here to stay. Although nanotechnology serves to benefit us all greatly, there are, like with everything else, risks that must be weighed as well. Companies must be diligent in monitoring their use of nanomaterials and its effects on employees and products. No one can completely avoid a lawsuit, but everyone can take affirmative actions to lessen the impact of litigation on their bottom line.

Kevin Murch is a partner in Schottenstein Zox & Dunn’s Litigation and Trial Law Practice Group. He can be reached at 614.462.2217 or kmurch@szd.com.