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.H0! 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 Nanotechnology

Some 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 Agencies

The 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."™ 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 Agencies

For 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.™ The Occupational Safety and Health Act of 1970 (administered by the Occupational Safety and Health Administration, or OSHA, within

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