Nanotechnology Lawyer & Attorney : Bergeson & Campbell Law Firm : Nanotechnology Law Blog

According to NNI, in FY 2006, federal agencies devoted $37.7 million -- or three percent of the $1.3 billion total nanotechnology research funding -- to research primarily focused on the EHS risks of nanotechnology, according to the NNI. GAO found that about 20 percent of this total could not actually be attributed to this purpose, however. GAO states that 22 of the 119 projects identified as EHS in FY 2006 were not primarily related to understanding the extent to which nanotechnology may pose an EHS risk. Instead, many of the projects focused on how to use nanotechnology to remediate environmental damage or detect hazards not related to nanotechnology. GAO states that, at the time of its review, federal agencies and NNI were in the process of identifying and prioritizing EHS risk research needs, and the overall process they were using appeared reasonable. NNI also was engaged in an iterative prioritization effort through its Nanotechnology Environmental and Health Implications (NEHI) working group. NEHI identified five general research categories as a priority for federally funded research. GAO found that most of the research projects that were underway in FY 2006 were generally consistent with agency and NEHI priorities. NEHI released its new EHS research strategy on February 13, 2008. According to GAO, agency and NNI processes to coordinate activities related to potential EHS risks of nanotechnology have been generally effective. In its March 2008 report, GAO recommended better guidance to improve the accuracy of data reported by NNI. Although the Office of Science and Technology Policy (OSTP) asserted that it provides extensive guidance, it agreed to review how the agencies respond to the current guidance. Robinson made no new recommendations in his statement before the Subcommittee.

The memorandum states that these agencies should follow the following principles in developing policies for environmental, health, and safety oversight related to nanotechnology:

• Purpose:  Federal oversight approaches should be cognizant of the potential benefits of nanotechnology, including health, economic, and environmental benefits, while recognizing uncertainties surrounding the evolving science and technology.  The purpose of considering environmental, health, and safety oversight approaches in the context of nanotechnology is to protect human health and the environment.
• Current Understanding:  The federal government’s current understanding is that existing statutory authorities are adequate to address oversight of nanotechnology and its applications.  As with any developing area, as new information becomes available the federal government will adapt or develop additional oversight approaches, as necessary, to address the area of nanotechnology.
• Information Development:  Adequate information should be developed with respect to the effects of nanomaterials on human health and the environment.  To the extent practicable and respecting confidential information (e.g., Confidential Business Information (CBI)), this information should be developed in an open and transparent manner by stakeholders, including the federal government and developers of nanomaterials.
• Risk Assessment and Risk Management:  The federal government should use standard oversight approaches to assess risks and benefits, and manage risks, considering safety, health and environmental impacts, and exposure mitigation.  As experience is gained, these approaches can be refined.  The federal government should strive to reach an appropriate level of consistency in risk assessment and management approaches across the government.
• International:  Recognizing the global efforts to develop nanotechnology, the federal government should proactively promote international cooperation.  The federal government should encourage coordinated and collaborative health and environmental research and test data development across the international community.  The federal government should also promote access to information across the international community.  These efforts will allow the federal government to contribute to, and take advantage of, risk assessment and risk management approaches, as appropriate, across the international community.
• Regulatory Path Forward:  In light of the “Purpose” of oversight as described above, the federal government should consider the following, to the extent permitted by law and where applicable, in establishing environmental, health, and safety regulations for nanotechnology:
  • Regulation should focus where need exists and where scientific information supports action (e.g., targeted to specific groups and classes of materials instead of a “one-size-fits-all” approach);
  • Decisions should be based on the best reasonably obtainable scientific, technical, economic, and other information;
  • Where possible, regulatory approaches should enable rather than hinder innovation;
  • Regulatory approaches should be performance based to the extent feasible and provide predictability and flexibility in the face of evolving science and technology;
  • Benefits of regulation should justify their costs;
  • Regulations should be developed in an open and transparent manner; and
  • Regulations and guidance should consider established requirements and guidance such as the following:
    • Executive Order (EO) 12866 -- Regulatory Planning and Review (Oct. 4, 1993);
    • Information Quality Act and Information Quality Guidelines: OMB Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies (2002);
    • National Technology Transfer and Advancement Act of 1995;
    • Office of Management and Budget (OMB) Circular A-119, Transmittal Memorandum, Federal Participation in the Development and Use of Voluntary Standards (Feb. 10, 1998);
    • OMB Final Information Quality Bulletin for Peer Review (Dec. 16, 2004);
    • OMB Final Bulletin for Agency Good Guidance Practices (Jan. 18, 2007); and
    • OMB/OSTP Memorandum:  Updated Principles for Risk Analysis (Sept. 19, 2007).