Introduction
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Describe the potential benefits of nanotechnology-utilizing commercial products.
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Identify and describe what is known about the environmental and human health risks of nanomaterials and the approaches to assess their safety.
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Assess the suitability of multicriteria decision analysis for reconciling the benefits and risks of nanomaterials and nanotechnology.
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Provide direction for future research in nanotechnology and environmental science to address issues associated with emerging nanomaterial-containing consumer products.
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Identify strategies for users in developing countries to best manage this rapidly developing technology and its associated risks, and to realize its benefits.
Nanotechnology, its applications, consumer products, and benefits
State of the field
Nanomedicine
Environment
Energy
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Hydrogen production from sunlight and water,
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Solar cells with 20% power efficiency and 100 times lower cost than current cells,
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Solid-state lighting requiring half the power consumption of current technologies, and
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Super-strong, light-weight materials to improve the fuel efficiency of the transportation sector.
Consumer products
Benefits and implications
Ways to overcome problem
Human health risk and implications
State of the field
Impediments to risk assessment
Strategies for addressing risk assessment needs
Ecological risk
State of the field
Main problem
Ways to overcome problem
Considerations for implementation of manufactured nanomaterial policy and governance
State of the field
Science and research aspects | Legal and regulatory aspects | Social engagement and partnerships | Leadership and governance | |||||||||||||
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1 | 2 | 3 | 4 | 1 | 2 | 3 | 4 | 1 | 2 | 3 | 4 | 1 | 2 | 3 | 4 | |
USEPA 2007
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US FDA 2007
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Davies 2006
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ED-DuPont 2007 | ■ | ■ | ■ | ■ | ■ | ▪ | ▪ | ▪ | ■ | ▪ | ■ | ▪ | ||||
Québec Commission 2006
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UK Royal Society | ■ | ■ | ■ | ■ | ▪ | ■ | ■ | ▪ | ■ | ■ | ▪ | ■ | ▪ | ■ | ▪ | ▪ |
UK DEFRA 2006
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Responsible NanoCode 2006
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EC SCENIHR 2007
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EC Action Plan 2005
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▪ | ■ | ■ | ■ | ■ | ▪ | ■ | ■ | ■ | ■ | ■ | ■ | ■ | ■ | |||
US NNI 2008
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REACH 2006 | ■ | ■ | ■ | ■ | ▪ | ▪ | ■ | ■ | ■ | ■ | ■ | ■ | ▪ | ■ | ■ | ▪ |
Sub-criteria for the table are as follows | |||
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Science and research aspects
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Social engagement and partnerships
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1. | Development of methods for detection/characterization/data collection | 1. | Promotion of education and distribution of information/use of risk communication tools |
2. | Assessment of environmental fate & transport/impacts | 2. | Use of stakeholder engagement tools |
3. | Assessment of toxicology/human health impacts | 3. | Development of partnerships with academia, industry, public organizations, provinces, and international regulators |
4. | Assessment of health and environmental exposure | 4. | Emphasis of ethical conduct |
Legal and regulatory aspects
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Leadership and governance
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1. | Voluntary regulatory and best-practices measures | 1. | Transparency in nanotechnology-related decisions |
2. | Information-based regulatory tools (e.g., labeling) | 2. | Consideration of benefits of nanotechnology |
3. | Economic-based regulatory tools (e.g., tax or fee for safety testing) | 3. | Adaptive modification of existing or development of new legislation |
4. | Liability-based regulatory tools (e.g., penalty for pollution) | 4. | Consideration of precautionary principle |
Challenges
Strategies for addressing policy needs
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A “regulatory pyramid” (with self-regulation at the pyramid’s base and prescriptive legislation at the apex) is needed. However, some members of the WG noted that the huge diversity of possible nanomaterials makes the pyramid approach very challenging, and that it would be impossible to develop a “one-way-to-go” methodology to support the development of policies. This is especially true in countries where more than one regulatory agency is involved in the regulatory process for manufactured nanomaterials.
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An adaptive management approach should be utilized to respond to new developments and gain additional information through policy.
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The framework should employ multiple tools at different levels of the regulatory pyramid, with specific tools chosen on a case-by-case basis.
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Information- or economics-based tools would help both bottom-up (i.e., self-regulation) and top-down approaches (i.e., prescriptive regulation) for the assessment, management, and regulation of nanomaterials.
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Multicriteria decision analysis, including stakeholder engagement, can be used to prioritize regulatory knowledge gaps, select specific regulatory tools, and also to allocate limited resources and focus follow-up activities.
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An adaptive, tiered integration of risk management with decision support would thus be ideal.
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A common, standardized taxonomy and terminology for nanomaterials, including the capturing of key aspects of their physical and chemical characteristics, together with the establishment of standardized use categories, should be the global goal. This would facilitate the development of information resources (e.g., publications and other documents, and databases) that provide easy access and sharing across countries as regulators attempt to understand and assess the properties of new materials compared to similar materials. Attempts could be made to have a leading global organization(s) for key aspects of this effort.
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The differences between the sources and intended uses of nanoscaled particles (naturally occurring versus manufactured) need to be acknowledged and considered when developing policies and frameworks.
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Interactions and collaborations among regulators, scientists, and other stakeholders should continue and be further encouraged to develop coherent, adequate policies to address such a dynamic field.
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The ideal policy should take a holistic viewpoint, considering the entire lifecycle of a nanomaterial, in addition to the production, transport, and disposal/recycling.
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The main exposure considerations for policy development include occupational, consumer, and general population exposures of humans, and environmental exposures of ecological receptors.
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Ecological and human health effects should be considered for all reasonably foreseeable exposures in multiple media.
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Attempts should continue to be made by both companies and regulatory agencies to communicate information about manufactured nanomaterials to the public. The WG noted the efforts of the not-for-profit organization GreenFacts (www.greenfacts.org) to provide information. See: http://copublications.greenfacts.org/en/nanotechnologies/index.htm
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Development of a crisis-/catastrophe plan for manufactured nanomaterials should be considered by both companies and regulatory agencies. The recent case of the Magic Nano consumer products in Germany being associated with respiratory problems was discussed by the WG as both a good and bad example of how such a crisis should be addressed by material suppliers, consumer product companies, and regulatory agencies (e.g., see http://www.smalltimes.com/Articles/Article_Display.cfm?ARTICLE_ID=270664&p=109 and http://www.bfr.bund.de/cm/279/frequently_asked_questions_on_nanotechnology.pdf).