Beveridge & Diamond
 

Nanotechnology

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. 

Recent Matters

Representative examples of our recent experience include the following:

  • Corporate Strategy and Policy Development.  We participate on the internal nanotechnology team of a leading member of the electronics industry to assist the company with analyzing its potential involvement with various EH&S initiatives and the development of nanotechnology-specific corporate occupational health and safety policies and product stewardship practices. 
  • Industry Counseling.  We advise industry companies and an informal group of in-house counsel for several of the major research-based pharmaceutical and medical device companies on potential environmental, health, and safety (EH&S) compliance challenges under the regulations that Occupational Safety and Health Administration, EPA, and the FDA administer, as well as the regulations of select Canadian and European counterpart agencies.  We also help them assess the regulatory implications, and the potential influence on tort liability standards of care, of various international initiatives occurring within the OECD and ISO TC 229. 
  • Trade Association Advocacy.  Beveridge & Diamond has a collaborative relationship with an international trade association, the Nanotechnology Industries Association (NIA), to analyze U.S. regulatory initiatives, as well as insurance industry initiatives and other legal developments potentially affecting the manufacture, import or marketing of nanoscale materials and nanotechnology-based products in North America, and to identify appropriate opportunities for the NIA to engage in the regulatory or legal processes or policy debates.
  • MSDS Preparation and Evaluation of Other Product-Related Requirements.  We assisted a start-up company with preparing its Material Safety Data Sheet (MSDS) and evaluating the regulatory and potential tort liability implications of marketing a product containing silver nanoparticles.  Our analysis of the company’s product and its anticipated uses, combined with our regulatory experience with FIFRA, enabled us to identify a strategy for marketing the product without undertaking a burdensome product registration process.
  • Voluntary Programs.  Our attorneys have advised clients in various industry sectors on participation in the NMSP and on development of internal product stewardship programs for nanoscale materials and nanotechnology-enabled products, and have submitted to EPA extensive comments on the NMSP.