At this year’s J.B. and Maurice C. Shapiro Environmental Law Conference on March 23-24, 2011, the symposium focused on the intersection between new technologies and governmental regulations.[1] On Monday, March 23, a panel was assembled to discuss “The Strengths and Limitations of Existing Governance Structure.”  Panelists included:

• Robin L. Juni, (Moderator), Assistant Dean for Student Affairs and Professorial Lecturer, The George Washington University Law School

• Mark Greenwood, Partner, Ropes & Gray, LLP and former director of the Office of Pollution Prevention and Toxics and attorney in the Office of General Counsel at the Environmental Protection Agency

• Lynn Bergeson, Founding Member of Bergeson & Campbell, P.C., a Washington, D.C. firm concentrating on chemical product approval, regulation, litigation, and associated chemical product business issues

• John C. Monica, Jr., Partner, Porter Wright, LLP and author of the legal treatise Nanotechnology Law (West/Thompson/Reuters 2009)

The panelists addressed the limitations, gaps, and redundancies that currently exist within various levels of governmental regulation (i.e. federal, state, and/or local) regarding the oversight of emerging nanotechnologies.[2]

Mr. Greenwood began the discussion with a comparative analysis of the varied existing federal oversight of new technologies.  Mr. Greenwood compared the differences between regulatory jurisdictions, standards of acceptance, implementation standards, and information collection mechanisms used in FDA’s approach to new drugs and EPA’s regulation of new pesticides and chemicals.  He began by noting jurisdictional differences: the FDA regulates with the intention to diagnose and treat diseases and regulates the risks associated with the designated, specific use of the drug; EPA regulates pesticides regarding the substances’ claims to prevent, repel, and destroy pests with a primary focus on food safety; EPA regulates new chemicals and new uses of existing chemicals, primarily through statutory authorities rendered under the Toxic Substances Control Act (TSCA), and focusing on worker safety.

Similarly, the information-collecting structure varies, with FDA requiring exhaustive upfront documentation, adverse effects reporting and post-market surveillance studies, while EPA’s chemicals’ regulation only necessitates post-review information collection orders with a “substantial risk” reporting threshold.   Despite these differences, all divisions’ regulation involves a balancing of risks and benefits (with the exception of the food safety standard required for pesticides) and none examines the full life cycle of the chemical.  Moreover, Greenwood noted how the agencies’ information-gathering obligations and the rigorousness of the analysis is inversely proportional to the program’s scope: FDA has roughly 20 new drugs to regulate per year while EPA has more than 500 new chemical substances to analyze.  Ultimately, Greenwood concluded, there is a tension in agencies’ regulation of these new technologies and substances because there is the desire to perpetuate flexibility (and encourage innovation) but also provide reliability and consistency in regulation.

Ms. Bergeson began by echoing Mr. Greenwood’s sentiments that the federal government is attempting to integrate nanotechnology into existing regulations and to consider applying new regulatory authorities to nanotechnology only as necessary.  However, these governmental initiatives are substantially lagging behind the pace of innovation.  In response to this regulatory uncertainty, the private sector has spearheaded stewardship initiatives (e.g., the EDF/DuPont Nanotechnology Risk Framework, International Council of Nanotechnology, and the Nanoparticle Occupational Safety and Health Consortium) to generate voluntary codes of conduct and design risk abatement strategies for those parties that are currently dealing with federally unregulated nanotechnologies and cannot wait for the promulgation of new federal regulations.  Similarly, there are many intergovernmental initiatives such as the Working Parties on Manufactured Nanomaterials/Nanotechnologies within the Organization for Economic Cooperation and Development (OECD) which also attempt to develop standardized terminology, best industry practices, and health and safety standards of care.  Ms. Bergeson contended that in the absence of clear, governmentally-backed legal standards, the private sector’s evolving codes of conduct are becoming the de facto legal standards against which corporate behavior is being measured.  She concluded by advising that until governmental regulations are established for new nanotechnologies, private businesses should defend themselves against future liabilities by being proactive, observing the highest standards of business practices, being risk-adverse, and staying engaged in conversations about nanotechnology regulation.

Mr. Monica agreed with Ms. Bergeson’s characterization of the void that the current federal (non)regulation of nanotechnology is creating.  In addition to international initiatives, Mr. Monica highlighted the voluntary efforts of states and localities like Berkley, California and Cambridge, Massachussetts.  Efforts include amending hazardous material ordinances to include nanoscale materials, disclosure guidelines for nanomaterials, establishing offices for technical assistance for nanotechnologies, and initiating investigative studies in legislative committees.  States and localities are choosing to get involved in regulation of nanotechnology because it enables them to be trendsetters, address legitimate nano-related environmental, health, and safety concerns, and alleviate frustrations and the uncertainty associated with the slow pace of federal efforts.

Ultimately, there was a sense among the panel that while this patchwork approach to nanotech regulation is imperfect, given the limitations of existing federal regulations and the incremental pace associated with creating new federal legislation, states and private industries are to be applauded for their efforts to engage early, educate themselves and the public, disclose mistakes and potential mishaps, attempt to learn from each other, and adhere to any currently-recognized best practices.

-Lauren Ziegler, Associate