Emerging Legal and Product Stewardship Implications of Products of Nanotechnology

L.L. Bergeson
Bergeson & Campbell, P.C.,
United States

Keywords: product stewardship, nanotechnology

Summary:

While the pace of technological innovation is furious, the unambiguous application of law, regulation, and policy, and the implications of nanotechnology for effective product stewardship are moving at far lesser speeds, creating uncertainty and potential commercial, legal, and business risk. It is, for example, far from clear what standards apply to various phases of a product’s development, use, and end of life if the product contains nanoscale materials that are intended to enhance the product’s efficacy and are expected to remain in the product after its useful life. While a host of private standards could apply, the precise application of legally enforceable standards is sometimes fluid, leaving product manufacturers and stewards in a quandary. In addition, because the commercial value chain can be complicated, it is not always known when a product or process involves elements of nanotechnology. Suppliers often harbor legitimate expectations of confidentiality with regard to product composition or process engineering. Such expectations, however, are sometimes difficult to align with a purchaser’s desire to address all aspects of product stewardship, both actual and implied. Reconciling these expectations with meaningful and thorough product stewardship can be challenging. This presentation will focus on the emerging legal and private product stewardship implications of products of nanotechnology. While the focus will favor U.S. law and policy, foreign legal programs will be included because some, including the European Union’s Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program, are too influential to omit. In addition, a growing number of notification requirements derivative of European “nanomaterial product inventories” will be featured. Significant emphasis will be placed on the growing number of international and domestic voluntary and quasi-regulatory standards/reference materials that, while not enforceable, are nonetheless influential in developing a “code of conduct” against which prudent and reasonable business practices increasingly are measured. Such standards are relevant in court cases and thus in defining the judicial parameters of business codes of conduct that are increasingly becoming the “norm” regardless of what legal standard may apply under more traditional U.S. environmental laws. An essential component of the legal, regulatory, and policy implications of nanoscale materials and their varied applications is the concept of sustainability. While the term is generally well understood as an aspirational goal, the meaning of sustainability in a legal and policy context is less clear and less developed as a governance parameter. This presentation will also focus on the legal, regulatory, and policy implications of sustainable nanotechnology.