On January 10, 2011, Environmental Science & Technology posted a peer-reviewed pre-publication article entitled “120 Years of Nanosilver History: Implications for Policy Makers,” which shows that nanosilver in the form of colloidal silver has been used for more than 100 years and, according to the authors, has been registered as a biocidal material in the U.S. since 1954. The article states that 53 percent of the U.S. Environmental Protection Agency (EPA)-registered biocidal silver products likely contain nanosilver and most of the applications are silver-impregnated water filters, algicides, and antimicrobial additives that do not claim to contain nanoparticles. The authors state: “The implications of this analysis for policy of nanosilver is that it would be a mistake for regulators to ignore the accumulated knowledge of our scientific and regulatory heritage in a bid to declare nanosilver materials as new chemicals, with unknown properties and automatically harmful simply on the basis of a change in nomenclature to the term ‘nano.’”
On September 22, 2010, the California Department of Toxic Substances Control (CDTSC) and the U.S. Environmental Protection Agency (EPA) held a public workshop on state and federal nanomaterial activities. During the workshop, CDTSC and EPA discussed the results of California’s data call-in (DCI) for carbon nanotubes (CNT), its plans for future DCIs, and EPA’s efforts related to CNTs. The candidate chemicals for CDTSC’s second DCI, which it intends to issue this Fall, include nanosilver, nano zero valent iron, nano titanium dioxide, nano zinc oxide, nano cerium oxide, and quantum dots. CDTSC may also include in the DCI a request for more information concerning CNTs incorporated in nanometals. According to CDTSC, the DCI will focus its initial questions on analytical test methods for the respective nanomaterial chemical, as well as its metabolites and breakdown products, in various matrices. The meeting presentations for each of the DCI candidates include more specific information regarding applications, production, human health and environmental concerns, why CDTSC is interested, and possible DCI questions.
Bush Administration Releases Principles for Nanotechnology Environmental, Health, and Safety Oversight
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).