Nanotechnology Regulation Slowly Beginning to Appear

Date: April 09, 2008

What is Nanotechnology?

Although there is no universally accepted definition, nanotechnology can be described as the science of manipulating materials at the nanoscale level to produce unique or enhanced materials, products and devices. When materials are manipulated at the nanoscale level (one to 100 nanometers, with a nanometer equaling one billionth of a meter), the characteristics of the materials can change. For example, carbon may become 100 times stronger than steel, aluminum turns highly explosive and gold melts at room temperature. There are already more than 300 consumer products that contain engineered nanomaterials, with some estimates much higher. Some examples include Behr Premium Plus Exterior and Kitchen and Bath paints, Dockers? Go Khaki? slacks, Flex-Power? Joint and Muscle Pain Relief Cream, Intel? computer processors, Turtle Wax? F21" Super Protectant Wax, and many more. By 2014, approximately $2.6 trillion worth of goods worldwide are expected to use nanotechnology. Additionally, the United States National Science Foundation estimates that by 2015, nanotechnology industries will employ 2 million workers globally.

Concern Voiced About Nanomaterials

Tempering the enthusiasm surrounding nanotechnology, however, is concern voiced by some that there is still very little known about the potential environmental and health effects of nanomaterials. Some of the same properties of nanomaterials that make them so useful - large relative surface area and the propensity to enter cells and translocate to remote target organs - may also cause them to have increased toxic potential. A survey of recent inhalation toxicology studies reveals that some animals exposed to different types of nanomaterials exhibited evidence of pulmonary toxicity, lung inflammation, decreased lung function and other vascular effects. Some scientists report evidence of nanoparticles translocating from the lungs of laboratory animals to other organs, including the liver, kidney, brain and heart.

The rapid proliferation of products containing engineered nanomaterials, despite their known physical properties and the results of these toxicology studies, has led some public interest groups and consumer advocates to compare nanotechnology to the asbestos and tobacco industries. Currently, the National Institute for Occupational Safety and Health (NIOSH) is focusing tremendous effort and resources on the research needed to bridge these knowledge gaps, determine whether nanomaterials pose risks to workers and develop guidelines for the safe handling of nanomaterials.

Some Governments and Agencies Beginning to Regulate Use of Engineered Nanomaterials

In December 2006, Berkeley, California, amended its hazardous-material reporting requirement to include all facilities that manufacture or use engineered nanomaterials. Companies subject to the ordinance are required to annually report, among other information, the average and maximum daily amount of nanomaterials stored on-site at any time during the year, the use of the nanomaterial within the site, and available information on the toxicity of the nanomaterial. Critics of the ordinance contend that it is unworkable because it is too vague and provides little guidance regarding thresholds that trigger reporting requirements. Despite these criticisms, however, Cambridge, Massachusetts, is studying the Berkeley ordinance to determine whether it should pass a similar regulation.

More recently, in January 2008, the Environmental Protection Agency (EPA) published in the Federal Register its plan for a Nanoscale Materials Stewardship Program under the Toxic Substances Control Act. This plan offers industry, non-governmental organizations and other groups the opportunity to voluntarily submit safety data on engineered nanoscale materials that they use. The EPA took a stronger stance in March 2008, when it fined IOGEAR $208,000, pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), for marketing its wireless mouse and keyboard products as containing "anti-microbial nano-coatings" without properly registering and obtaining approval for the coatings.

Foreign countries are also beginning to regulate engineered nanomaterials. China, for example, has classified approximately 10 medical products containing engineered nanomaterials as Class II medical devices. This means that manufacturers or importers of those products must provide the Chinese government with certain information about the devices, including the results of safety tests. France is attempting to include nanoscale chemicals in the European Union's Registration, Evaluation, Authorization and Restriction of Chemical Substances (REACH) law that went into effect June 1, 2007. The United Kingdom recently published nine documents providing UK companies with guidance and standard terminology for nanotechnology, including a document on guidance for the labeling of engineered nanomaterials and products containing engineered nanomaterials. As a result, companies that operate outside of the United States must also pay attention to emerging regulations in foreign countries.

Don't Get Caught Unprepared

In order to protect workers while information about the potential environmental and health effects of nanomaterials is being developed, NIOSH recommends that manufacturers and users of nanomaterials evaluate available toxicology data, assess their processes to determine areas of potential exposure for workers, educate their workers on the proper handling of nanomaterials, install and implement appropriate equipment and engineering controls, identify appropriate personal protective equipment for their workers, and use safety measures for fine and ultrafine particles (which serve as the closest comparison to nanoparticles) that have proven to be effective in the past (NIOSH Nanotechnology Research Center, "Progress Toward Safe Nanotechnology in the Workplace," DHHS (NIOSH) Publication No. 2007-123, Feb. 2007, pp. 172-77).

Performing such an evaluation, however, is time-consuming and difficult. It may require the coordinated involvement of experts across a number of different disciplines:

  • Toxicologists to help determine whether and to what extent the results of animal studies can be extrapolated to the human condition;
  • Industrial hygienists to determine the levels of worker and/or consumer exposure, and to develop safety procedures to prevent exposures;
  • Warnings experts to determine what, and the form in which, information should be provided to users and consumers of engineered nanomaterials; and
  • Medical doctors, such as cardiologists, pulmonary specialists, oncologists and others to assess the human health hazards of potential exposures.

As a result, the earlier that companies start such an evaluation and coordinate with the appropriate experts, the easier it will be to develop a comprehensive risk management program.