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

The report discusses possible options for states and localities to oversee the environmental, health, and worker safety impacts of nanotechnology. According to the report, the following existing state authorities and experiences could be applied to nanotech oversight:

• Air: At least 15 state agencies have adopted stringent air quality laws or regulations to fill a gap in federal standards, and at least 29 local air agencies are authorized to adopt more stringent air quality controls;
• Waste: Several states have imposed standards for regulating metals in waste that are not covered by U.S. Environmental Protection Agency (EPA) regulations;
• Water: State laws often offer substantial flexibility for regulating and controlling water discharges that may contain pollutants;
• Labeling: States are free to adopt their own product labeling requirements, similar to those provided for toxic chemicals by California’s Proposition 65; and
• Worker Safety: The Occupational Health and Safety Administration (OSHA) has approved plans for 21 states that enable them to adopt federal safety standards for workers in private industry.

The report identifies California, Michigan, Massachusetts, New York, and New Jersey as “the states that appear most able to launch initiatives for overseeing safe and responsible development of nanotechnology.” 

The report identifies the following four scenarios for potential action by states or localities to fill gaps in federal oversight and thereby initiate their own oversight of nanotechnology’s health, safety, and environmental impacts:

1. Localities could require disclosure of potential health, safety, or environmental hazards;
2. States or localities may choose to adopt standards that are expert-driven, such as the nanotechnology workplace standards being developed by ASTM International, the International Organization for Standardization, or other standards bodies;
3. Stakeholders -- such as state or local regulators in other programs, consumers, workers, and even nearby businesses -- may play an important role in nanotechnology oversight when they exert pressure on states to control or prevent releases of nanomaterials; or
4. One or more states may choose to collaborate to establish joint regional standards or approaches for overseeing the safe development of nanotechnology.

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).

To determine the extent to which federal agencies have undertaken EHS research and how they are prioritizing and managing this research, the Committee and Caucus ask GAO to:

•  Review the extent to which NNI-related resources have been devoted to study the EHS risks of nanomaterials;
• Identify the key areas of research for which this EHS funding has been used;
• Determine what processes the Nanotechnology Environmental and Health Implications Working Group uses to prioritize and coordinate these various EHS research efforts; and
• Review and identify any EHS-related research and regulatory activities, independent of the NNI, that EPA, FDA, CPCS, and OSHA have undertaken, the amount of funding made available for these efforts, and the extent to which information about these efforts has been communicated to the Working Group to ensure that they are considered in the overall research planning processes for the NNI.