Responsible Development
| Given the breadth of the expected applications of nanotechnology and their likely revolutionary impact on industry and society, another important role for the Government is to support research and other activities that address the broad social implications of nanotechnology, including benefits and risks. Responsible development of nanotechnology comprises one of the four principal goals outlined in the 2004 NNI Strategic Plan, and it is also one of the principal components of the NNI research and education program. Activities supported by the NNI consistent with this role include support for research on the environmental, health, and safety impacts of nanotechnology, education-related activities, and research directed at identifying and quantifying the broad implications of nanotechnology for society, including social, economic, workforce, educational, ethical, and legal implications. Perhaps the most pervasive concern that has been raised in the popular press about potential negative impacts of nanotechnology relates to its potential for adverse environmental, health, or safety implications. The NSET Subcommittee has formed a formal interagency working group to exchange information among regulatory and R&D agencies on this subject, including participation by several agencies within the Executive Office of the President.[10] This group also seeks to help prioritize and implement research required for the responsible development and oversight of nanotechnology, and to promote communication of information related to the responsible handling and use of nanotechnology-enabled products. Some industry groups have expressed the view that the government needs to provide a clear regulatory path for industry to follow for the safe and responsible commercialization of nanotechnology, as a key government role necessary to successful industrial development. Existing Laws and Regulations and the Responsible Development of NanotechnologySome people have asked whether there is a need for new regulations or even statutes governing the development of nanotechnology to avoid any possible adverse consequences to the environment, public health, worker safety, or even economic stability. Although research on the environmental, health, safety, and societal impacts of nanotechnology is in its infancy, this may remain an open question. However, with the information available to date, it is difficult to imagine a scenario in which the existing legal and regulatory framework that has evolved over the past century to address such concerns would need to be changed significantly. The following discussion outlines some of the existing laws, regulations, and procedures that are in place to protect public health and safety that might apply to nanotechnology. These should obviate the need for any major legal or regulatory changes. Research AgenciesThe U.S. government agencies that fund scientific research already have in place various policies to address ethical, health, and safety considerations related to the research they are funding or performing in their laboratories. Applicants for NSF research funding are required to certify in writing that they are in compliance with various NSF policies and relevant sections of the U.S. Code of Federal Regulations with respect to, for example, recombinant DNA, human subjects, and the use of animals in research. NSF has broad authority to suspend or terminate ongoing research grants if grantees fail to comply with grant regulations, or for "other reasonable cause."[11] NSF program officers conduct regular site visits to review ongoing research, where they have an opportunity to see whether there are any problems that might justify such actions. Other research agencies have comparable mechanisms. Regulatory AgenciesFor research and product development not funded by the government, other statutory and practical controls apply. The many existing statutes and regulations addressing commercial products also apply to nanotechnology-based products and materials. For example, the Consumer Products Safety Act of 1972 (administered by the Consumer Products Safety Commission) requires that manufacturers of consumer products ensure that their products are safe and holds them liable if they are not; CPSC can require the recall of products in cases where it has evidence that they are not safe.[12] The Occupational Safety and Health Act of 1970 (administered by the Occupational Safety and Health Administration, or OSHA, within the Department of Labor) provides for federal regulation of safety in the workplace, including public as well as private research laboratories.[13] The National Institute of Occupational Safety and Health (NIOSH), within the Centers for Disease Control, conducts research and training to inform OSHA regulatory decisions.[14] NIOSH is leading an effort within the government to develop a set of recommended safe handling practices for nanomaterials, for research as well as commercial production facilities. The Toxic Substances Control Act of 1976 (administered by the Environmental Protection Agency) regulates the manufacture, importation, and use of new and existing chemical substances.[15] Several other statutes administered by the EPA (such as the Clean Air Act and the Clean Water Act) also may come into play with respect to nanotechnology. The National Institute of Environmental Health Sciences, within the National Institutes of Health, also conducts health-related research that informs regulatory decisions by other agencies.[16] The Federal Food, Drug and Cosmetic Act (originally enacted as the Pure Food and Drug Act in 1906 and administered by the Food and Drug Administration within the Department of Health and Human Services) requires prior testing and review of pharmaceutical and medical products under strictly controlled conditions.[17] Under most of these statutes, any adverse effects of new products or processes that are uncovered as a result of privately funded research must be reported to the government. These and many other statutes and accompanying regulations provide an ample basis for both criminal and civil legal action against any private organizations that produce or import products or services that may be deemed hazardous to the public. All of the agencies and institutes listed here are coordinating their nanotechnology-related activities through their participation in the NSET Subcommittee and its NEHI Working Group. To clarify how these existing statutes and regulatory structures apply to nanotechnology, scientific as well as legal research efforts are under way. For example, NSET member agencies are working with universities, industry, and standards organizations to develop a clear system of nomenclature for classifying new nanomaterials. This nomenclature standard is needed to facilitate both appropriate regulation of nanotechnology and its commercial development. In another example, EPA will be holding a public hearing in 2005 to inform discussion of how the Toxic Substances Control Act should be applied to nanomaterials, starting with a voluntary pilot program.[18] For nanotechnology R&D specifically, the 21st Century Nanotechnology Research and Development Act includes a number of additional measures to ensure adequate oversight of the interagency NNI activity. One of the stated purposes of the Act is to ensure that "ethical, legal, environmental, and other appropriate societal concerns" are properly addressed. Specific measures include oversight of the NNI by the President's National Science and Technology Council, a separate National Nanotechnology Advisory Panel, and a triennial review of the NNI by the National Academy of Sciences. All three of these oversight bodies are charged with addressing the responsible development of nanotechnology. The NNCO and the Office of Science and Technology Policy (part of the Executive Office of the President) also play coordinating and oversight roles, respectively, in the responsible management of the NNI research portfolio. In short, within the United States, not only are the mechanisms for minimizing any misuses of nanotechnology in place, but also they are working to ensure the responsible and safe development of nanotechnology.
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EAN: 2147483647
Pages: 204