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Summary
Scientists and engineers are rapidly learning how to examine, design, and manipulate materials at the molecular level, termed "nanoscale," between 1 and 100 billionths of a meter. The U.S. government has invested billions of dollars to ensure that American industry remains a global leader in the field, because the products of nanotechnology are seen to have great economic potential and offer possible solutions to national problems ranging from energy efficiency to detection of agents of biological warfare. Optimism about nanotechnology is tempered, however, by concerns about the unknown potential of nanoscale materials to harm the environment and human health. Some have called for federal regulation of potential environmental, human health, and safety (EHS) risks, arguing that the lack of federal EHS regulations increases the risks of unanticipated adverse consequences due to human or environmental exposure to engineered nanomaterials. The cost of such consequences would depend on their actual, as well as publically perceived, severity, frequency, and reversibility. The cost to the nanotechnology industry could be great, if consumers responded to a potential threat of harm by indiscriminately rejecting all products of nanotechnology, rather than the offending nanomaterial or an individual application. Others oppose federal regulatory requirements, arguing that they might unnecessarily delay the environmental, health, and economic rewards expected from nanotechnology. Questions about the need for, and ideal form of, nanotechnology regulations are exceedingly difficult to address, given the current state of scientific understanding of engineered nanoscale materials. The purpose of this report is to consider certain challenges faced by scientists, entrepreneurs, and government officials in the 25 agencies involved in the National Nanotechnology Program, as they strive to define the characteristics of nanomaterials, the EHS risks they might pose, and how any potential risks should be addressed. Challenges include the wide variety of nanomaterials and applications; lack of basic information about their properties; lack of conventions for naming, measuring and identifying nanomaterials; the proprietary nature of some critical information; the need to prioritize federal resource needs; and a possible lack of clear statutory authority or appropriate regulatory framework to anticipate or respond to any identified risks. These difficulties may be surmounted over time without significant legislative action, or Congress may choose to intervene. If it does, it might choose any of several approaches. Possible approaches include increasing funding for workshops in standardization or other research relevant to identifying and possibly ameliorating any environmental or human health and safety concerns associated with nanomaterials; changing the allocation of research money among agencies or the interagency research management structure; adopting a national or international research strategy; or enacting legislation that authorizes, mandates, or constrains agency actions to require information collection or to restrict production, sale, use, or disposal of nanomaterials. Each risk management approach has potential positive and negative consequences that Congress may want to consider.





