Principles for regulating nanotech

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Courtesy of Bergeson & Campbell, P.C.

On June 9, 2011, the Office of Science and Technology Policy (OSTP) announced that the White House Emerging Technologies Interagency Policy Coordination Committee (ETIPC) has developed a set of principles specific to the regulation and oversight of applications of nanotechnology. The principles are intended to guide the development and implementation of policies, as described in the title 'U.S. decision-making concerning regulation and oversight of nanotechnology and nanomaterials' that occur at the agency level.

According to OSTP, the principles reinforce the overarching principles for the regulation and oversight of emerging technologies released on March 11, 2011. The principles also reflect recommendations from a report on nanotechnology prepared by the President's Council of Advisors on Science and Technology and, importantly, reflect the results of a multi-agency, consensus-based process lead by the National Economic Council (NEC), the Office of Management and Budget (OMB), OSTP and the Office of the U.S. Trade Representative (USTR).

OSTP states that the goals of all of these documents 'are to achieve consistent approaches across different emerging technologies and to ensure the protection of public health and the environment while avoiding unjustifiably inhibiting innovation, stigmatizing new technologies, or creating trade barriers.' The principles concerning regulation and oversight of applications of nanotechnology and nanomaterials are available online.

According to the ETIPC, the principles are intended to guide development and implementation of policies for the oversight of nanotechnology applications and nanomaterials. The document summarizes generally applicable principles relevant to promoting a balanced, science-based approach to regulating nanomaterials and other applications of nanotechnology in a manner that protects human health, safety and the environment without prejudging new technologies, creating unnecessary barriers to trade or hampering innovation.

The principles, according to the ETIPC, build on the 'firm foundation' provided by current regulatory statutes and do not supersede existing legal authorities or hinder federal agencies from enforcing or applying their existing statutory and regulatory authority as mandated by law. ETIPC notes that federal agencies that have regulatory responsibilities, such as the U.S. Environmental Protection Agency, the U.S. Food and Drug Administration and the Occupational Safety and Health Administration, 'must continue to implement sound policies to protect public health, safety, and the environment.'

ETIPC states that, for oversight and regulation, the critical issue in describing nanomaterials 'is whether and how such new or altered properties and phenomena emerging at the nanoscale create or alter the risks and benefits of a specific application.' According to ETIPC, a focus on novel properties and phenomena observed in nanomaterials 'may ultimately be more useful than a categorical definition based on size alone.'

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