Nanotechnology - the ability to manipulate and control matter in the size range of approximately 1 to 100 nanometers to harness new properties –has enormous potential for the development of new materials and products and the improvement of many others. However, this promising technology raises questions about potential health and environmental effects, and even how to determine those effects. Regulators at the local, state, federal, and international levels are engaged in determining how to apply existing regulatory requirements to these new materials and products and whether and to what extent new regulatory requirements are needed. Meanwhile, investors, manufacturers, non-governmental organizations, and others are exploring data needs, product stewardship issues, potential tort liability, and related concerns associated with the development, manufacturing, commercialization, and disposal of nanoscale materials and nanotechnology-based products.
Many of our clients are working to identify and manage the various risks that the development and commercialization of nanoscale materials and nanotechnology-based products pose, including the risk of regulatory noncompliance, market rejection, and tort liability. Our attorneys have assisted with the evaluation of these risks and the establishment of cost-effective strategies for addressing them in a manner that is consistent with client business objectives.
Among other things, we advise clients with respect to their obligations under EPA’s product approval regulations, including TSCA and FIFRA, and their responsibilities to employees under the Occupational Safety and Health Act, including the hazard communication standard and the General Duty Clause. Our attorneys have also helped to evaluate client participation in voluntary programs, including EPA’s Nanoscale Materials Stewardship Program and proposed industry codes of conduct. The Firm has assisted clients tracking foreign and international initiatives in the Asia-Pacific Region, the European Union, Canada, the OECD, and ISO TC 229, and with evaluating the potential impact of these initiatives on client operations both in the United States and abroad. With the increasing level of scrutiny that nanotechnology is receiving, we also have assisted our clients in assessing potential tort and other liability considerations that may arise.
For the American Bar Association, our attorneys have led or worked on teams preparing white papers on how EPA and FDA may regulate nanoscale materials under the Toxic Substances Control Act, the Federal Insecticide, Fungicide, and Rodenticide Act, the Clean Air Act, and the Federal Food, Drug, and Cosmetic Act. We have also participated in case studies on regulation of nanoscale indirect food additives under FFDCA. Our knowledge of these issues, combined with our experience advising companies developing other emerging technologies, has served us well in counseling clients in various industrial sectors on emerging nanotechnology regulatory issues and liability concerns.
Representative examples of our recent experience include the following: