Department of Environmental Engineering, Technical University of Denmark, Kgs. Lyngby 2800, Denmark.
Wiley Interdiscip Rev Nanomed Nanobiotechnol. 2010 Sep-Oct;2(5):441-9. doi: 10.1002/wnan.99.
The 2000s have been characterized by an unprecedented exploration into research and development of nanotechnology and nanomaterials. Despite a slow start, new regulatory initiatives are popping up like mushrooms internationally. Many of these initiatives have yet to materialize themselves or are soft law initiatives, and their impact on the development of more authoritative and prescriptive regulatory measures is most likely to be limited. This is due to a number of transnational regulatory challenges that include: (1) whether to adapt existing legislation or develop a new regulatory framework, (2) whether nanomaterials should be considered as different from their bulk counterparts, (3) how to define nanotechnology and nanomaterials, and (4) how to deal with the profound limitations of risk assessment when it comes to nanomaterials. In this opinion, I discuss these and related issues and conclude that the development of a new authoritative and prescriptive regulatory framework might be the only way to effectively address these challenges while ensuring a transparent and informed decision-making process.
21 世纪见证了纳米技术和纳米材料研发的空前探索。尽管起步缓慢，但新的监管举措如雨后春笋般在国际上涌现。其中许多举措尚未落实或属于软性法规倡议，它们对更权威和规范性监管措施的发展的影响很可能是有限的。这是由于存在一些跨国监管挑战，包括：（1）是调整现有立法还是制定新的监管框架；（2）是否应将纳米材料视为与大块材料不同；（3）如何定义纳米技术和纳米材料；以及（4）如何应对纳米材料风险评估的巨大局限性。在本意见中，我讨论了这些和相关问题，并得出结论，制定新的权威和规范性监管框架可能是有效应对这些挑战的唯一途径，同时确保透明和知情的决策过程。
