Three documents released since July 26, and a recent public hearing, highlighted the difficulties of promoting promising new nanotechnologies, protecting public health and safety, and safely disposing of waste products from their use and manufacturing. Nanotechnology involves manipulating matter the size of one-billionth of a meter or 100,000 times smaller than the width of a human hair. In 2005, more than $30 billion in nanotechnology products were sold globally, according to the Project on Emerging Nanotechnologies (PEN) at the Woodrow Wilson International Center for Scholars.

Nanotechnologies have been called the "next industrial revolution" with the potential to affect future products, from clothes to cars to medicine, according to Pew Trusts. However, if early studies are accurate, this promise comes with health, safety and environmental risks that should be considered.

First, the U.S. Food and Drug Administration's (FDA) Nanotechnologies Task Force issued a report July 25 urging the agency to issue guidance documents to clarify what information is necessary to ensure effective oversight of drugs, medical devices and other products. The report emphasizes the need for guidance to manufacturers and researchers because "the potential use of nanoscale materials includes most product types regulated by FDA and that those materials present regulatory challenges similar to other emerging technologies," according to a press release announcing the report.

BNA ($) reported July 26 that FDA's report brought both praise and criticism. The Director of PEN, Michael Wilson, a former FDA deputy commissioner, thought it was an important, positive step for the agency. The report's long list of required tasks, however, means that Congress "needs to fix the problem of FDA's chronic underfunding."

At the same time, the report's call for issuing guidance documents instead of regulations and for not recommending labeling of nanotechnology products drew criticism from the International Center for Technology Assessment (ICTA). ICTA and a coalition of consumer and environmental groups petitioned FDA in 2006 to develop regulations for nanomaterial products.

Second, PEN released a report July 26 that focused on the critical issue of managing wastes from the manufacture and use of nanomaterials.

Today, with over 500 nano-enabled products already on the market, one of the questions in greatest need of attention is how various forms of nanomaterials will be disposed of and treated at the end of their use. They may find their way into landfills or incinerators, and, eventually, into the air, soil, or water bodies. As we are learning, when we throw something away, there really is no "away."

The authors analyze the two primary U.S. statutes for regulating waste products, the Resource Conservation and Recovery Act (RCRA) and the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), or Superfund. Both laws give authority to regulate waste materials to the U.S. Environmental Protection Agency (EPA). The report concludes with recommendations for EPA such as encouraging "the development of data on human health and eco-toxicity and on the fate and transport of nanomaterials in the environment." It also contains recommendations for businesses and the investment community.

Third, on July 31, an international coalition of more than 40 groups from nearly every continent released a statement of principles for the oversight and regulation of nanotechnologies. The statement, released through ICTA, calls on governments, universities and businesses to adopt eight principles the coalition believes provides "the foundation for adequate oversight and assessment of the emerging field."

The principles include adopting a precautionary approach to approving products with nanomaterials and holding manufacturers liable for harm resulting from products and their production; protecting the environment through life cycle costing and protection of workers exposed to nanomaterials; labeling products and disclosing product safety data; and developing mandatory regulations for specific product classifications.

EPA held a public hearing Aug. 2 on its strategy for managing nanotechnology, a proposed Nanoscale Materials Stewardship Program (NMSP). The agenda included speakers from the public and private sectors and from government. Former EPA official and advisor to PEN, Terry Davies, stressed a sense of urgency that EPA's voluntary strategy does not recognize. He also criticized EPA's policy of using the Toxic Substances Control Act (TSCA) as the framework for its strategy, which treats nanomaterials as chemical substances. The size of nano-engineered substances means that their molecular structure is different from larger-scale particles and, therefore, poses different risks because their properties are different, according to Davies. He urged EPA to begin a regulatory program in addition to the voluntary one.

Congress was not silent during this time. Rep. Mike Honda (D-CA) introduced H.R. 3235 July 31, which would establish a $100 million nanomanufacturing investment partnership to assist in the development of a research strategy. The research is to address the uncertainties hindering the commercialization of nanotechnologies. The bill has been referred to four House committees for action.