The nation's science and engineering workforce, education, and innovation system were discussed during the morning session of a March 30 meeting of the President's Council of Advisers on Science and Technology (PCAST), as reported in FYI #48. After lunch, the Council members heard about current research on the health and environmental impacts of nanomaterials, and the efforts of federal agencies to regulate them.
There is "no consensus" within the scientific community about the safety of purposely-engineered nanomaterials, reported Vicki Colvin of Rice University. She explained that little is known about their impacts on biological systems, and that consistent terminology to discuss them does not even exist yet. She urged the U.S. to support credible basic research, use the multi-agency National Nanotechnology Initiative (NNI) to develop terminology and standards, establish global leadership in defining the risks as a basis for labeling and regulation, and learn from social scientists about communicating risk to the public. "It will all come down to public acceptance," she predicted. David Diehl of PPG Industries, an industrial coatings company, described the potential for widespread use of nanomaterials in many products: "we see nanotechnology impacting everything we do," he said. Until proven otherwise, he added, manufacturers should handle nanomaterials "as unknown risks" and "take every precaution."
Marburger reported that, under the auspices of the NNI, an interagency working group is helping coordinate research on health, safety and environmental issues, and another group is looking into future regulation of nanomaterials. Clayton Teague of the National Nanotechnology Coordination Office said that nearly 12 percent of NNI funding annually goes to federal agency efforts for basic research into interactions between nanotechnologies, the environment, and the human body, and to the applications and implications of this research. (In FY 2004, this amount was $105.8 million, or 11 percent of total NNI funding of $961 million.)
According to representatives of both the FDA and the EPA, it is still unclear what nanomaterials and nanotechnologies might require federal approval before going on the market. Norris Alderson warned that the FDA only regulates sponsors' claims for products, and may not even know that certain products contain nanomaterials unless the sponsor includes that information as part of the claim. Charles Auer of the EPA said his agency is exploring whether certain nanomaterials would fall under the Toxic Substances Control Act. Some nanotechnologies might be considered new uses of technologies already on the market, while others might be treated as new chemicals requiring submission for EPA approval before manufacture. In the latter case, the manufacturer would be obligated to provide any test and health data that is available, but Auer pointed out that nearly 85 percent of new chemicals submitted for approval have no such health data. Asked about the potential for a product to show negative effects after FDA approval, Alderson replied that the FDA tries to minimize such situations, but can never assure consumers that there will be no adverse effects. Both he and Alderson reiterated the need for consistent nomenclature to facilitate the regulatory process. There was also discussion about the need for more research, better computer models, new regulatory tools, and international discussion and coordination as more nanotechnologies come on the market.