A New Soft Law Approach to Nanotechnology Oversight: A Voluntary Product Certification Scheme

G. Marchant, Douglas J. Sylvester, Kenneth W. Abbott
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引用次数: 19

Abstract

Regulatory oversight of nanotechnology is necessary yet problematic. The necessity of regulation, now or later, is driven by two related concerns. First, some nanotechnologies, if left unregulated, are likely to pose very real if currently unknowable risks of significant health or environmental damage. Second, public confidence in new technologies and in the regulatory agencies that govern them may be permanently damaged if injurious nanomaterials are released without adequate, or at least the perception of adequate, oversight. Of late, we have seen numerous proposals for “soft law” solutions, at least in the short term, as well as the implementation of some soft law mechanisms. None are based on the traditional command–and-control approach, under which government agencies enact detailed regulatory requirements enforced by the threat of penalty. Instead, all reflect a variety of voluntary, cooperative or partnership approaches. However, although these approaches have many advantages, none of the currently operational regimes has fully achieved two obvious and oft-cited goals of nanotechnology regulation: (1) broad industry participation, with sufficient data submission to aid regulators in risk assessments; and (2) reassurance of public stakeholders as to government’s role in regulating emerging technologies. This article therefore proposes another soft law option that may better achieve these goals. We propose a voluntary certification scheme under which companies that produce nanotechnology products may obtain a government-supervised certification for specific products if the firms subject those products to specified safety testing, data disclosure and risk management measures. Given differing national regulatory approaches, our proposal is designed primarily for the United States. However, there is nothing in the proposal that could not be adapted for use in other jurisdictions, indeed, nothing to prevent creation of an equivalent international scheme. Part II sets up the need for new approaches by explaining why regulation of nanotechnology is largely infeasible under traditional approaches. Part III summarizes the experience and promise of current soft law regimes, as well as some of their limitations. This Part also identifies some features of successful certification systems and discusses their relevance to a nanotechnology certification system. Part IV introduces our proposal for a voluntary safety testing certification scheme, and discusses the ways in which such a scheme might gain the trust of consumers and other relevant audiences. Part V considers the elements of the scheme in greater detail. The final section is a brief conclusion.
纳米技术监管的软法律新途径:自愿性产品认证计划
对纳米技术的监管是必要的,但也存在问题。不管是现在还是以后,监管的必要性是由两个相关的担忧驱动的。首先,一些纳米技术如果不加以管制,可能会造成非常真实的、但目前尚不可知的重大健康或环境损害风险。其次,如果有害的纳米材料在没有足够的监督,或者至少没有足够的监督的情况下被释放,公众对新技术和管理它们的监管机构的信心可能会永久受损。最近,我们看到了许多“软法”解决方案的建议,至少在短期内是这样,以及一些软法机制的实施。没有一个是基于传统的命令和控制方式,在这种方式下,政府机构通过惩罚的威胁来制定详细的监管要求。相反,它们都反映了各种自愿、合作或伙伴关系的方法。然而,尽管这些方法有很多优点,目前的运作机制都没有完全实现纳米技术监管的两个明显和经常被引用的目标:(1)广泛的行业参与,有足够的数据提交,以帮助监管机构进行风险评估;(2)向公众利益相关者保证政府在监管新兴技术方面的作用。因此,本文提出了另一种可能更好地实现这些目标的软法律选择。我们建议推行自愿性认证计划,让生产纳米科技产品的公司,在特定产品进行指定的安全测试、数据披露和风险管理措施后,可获得政府监督下的认证。鉴于各国的监管方法不同,我们的建议主要针对美国。但是,该建议中没有任何不能加以修改以供其他司法管辖区使用的地方,事实上,没有任何地方可以防止建立一个等效的国际办法。第二部分通过解释为什么在传统方法下纳米技术的管理在很大程度上是不可行的,建立了对新方法的需要。第三部分总结了当前软法律制度的经验和前景,以及它们的一些局限性。本部分还确定了成功的认证体系的一些特征,并讨论了它们与纳米技术认证体系的相关性。第四部分介绍了我们对自愿安全测试认证计划的建议,并讨论了该计划可能获得消费者和其他相关受众信任的方式。第五部分更详细地讨论了该方案的要素。最后一部分是一个简短的结论。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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