U.S. Issues Guidance for Regulating Nanotechnology

Document recommends future regulation and oversight not inhibit trade or innovation.

By Lynn Bergeson, Regulatory Editor

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On June 9, 2011, the Office of Science and Technology Policy (OSTP) released principles specific to the regulation and oversight of nanotechnology applications. The principles are intended to guide the development and implementation of policies, as described in “U.S. Decision-Making Concerning Regulation and Oversight of Application of Nanotechnology and Nanomaterials.” This column discusses the principles and outlines their role in the governance of nanotechnology in the United States.

Background
The White House issued overarching principles for the regulation and oversight of emerging technologies on March 11, 2011. The new principles reinforce those made in March, and reflect recommendations from a report on nanotechnology prepared by the President’s Council of Advisors on Science and Technology, and the results of a multi-agency, consensus-based process led by the National Economic Council (NEC), the Office of Management and Budget (OMB), OSTP, and the Office of the U.S. Trade Representative (USTR). The principles are available here. The document summarizes applicable principles for promoting a balanced, science-based approach to regulating nanomaterials and other nanotechnology applications in a manner that protects human health and the environment without prejudging new technologies or creating unnecessary barriers to trade or innovation.

According to the document, agencies will adhere to the Principles for Regulation and Oversight of Emerging Technologies. Specifically, to the extent permitted by law, federal agencies will:

• Base their decisions on the best available scientific evidence, separating purely scientific judgments from judgments of policy to the extent feasible;
• Seek and develop adequate information on the potential effects of nanomaterials on human health and the environment and take into account new knowledge when it becomes available;
• To the extent feasible and subject to valid constraints (involving, for example, national security and confidential business information), develop relevant information in an open and transparent manner, with ample opportunities for stakeholder involvement and public participation;
• Actively communicate information to the public regarding the potential benefits and risks associated with specific uses of nanomaterials;
• Base decisions on potential benefits and costs of such regulation and oversight, including the role of limited information and risk in decision-making;
• Provide, where practicable, sufficient flexibility in their oversight and regulation to accommodate new evidence and learning of nanomaterials;
• Consistent with current statutes and regulations, strive to reach an appropriate level of consistency in risk assessment and risk management across the federal government, using standard oversight approaches to assess risks and benefits and manage risks, considering safety, health and environmental impacts, and exposure mitigation;
• Mandate risk management actions appropriate to, and commensurate with, the degree of risk identified in an assessment;
• Seek to coordinate with one another, with state authorities and stakeholders to address issues, including health and safety, economic, environmental, and ethical issues (where applicable) associated with nanomaterials; and

• Encourage coordinated and collaborative research across the international community and clearly communicate the regulatory approaches of the U.S. to other nations.

Agencies are to use the authority provided by their existing statutes to gather information. If statutory frameworks limit mandatory reporting or other information gathering systems to those circumstances where a risk or harm has already been identified, however, and an insufficient basis exists to establish such risk of harm, “agencies should explore other legally available means to obtain the information necessary to assess risk and possible harms.”

Discussion
The document provides a balanced discussion of policy principles for regulatory oversight of nanotechnology. The principles represent an important development regarding future oversight of nanomaterials. As such, the principles may provide additional, but measured, constraints on the actions taken by regulatory agencies.



Lynn L. Bergeson is Chemical Processing's Regulatory Editor. You can e-mail her at Lbergeson@putman.net.

Lynn is managing director of Bergeson & Campbell, P.C., a Washington, D.C.-based law firm that concentrates on chemical industry issues. The views expressed herein are solely those of the author. This column is not intended to provide, nor should be construed as, legal advice.

 

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