BERGESON & CAMPBELL, P.C.
Nanotechnology Practice

It is presumptuous for any firm to claim that it has a well defined nanotechnology practice because the practice is so young. What B&C offers is an experienced group of professionals with unique skills, capabilities, and strong relationships with the U.S. Environmental Protection Agency (EPA), the National Institute for Occupational Safety and Health (NIOSH), and the Occupational Safety and Health Administration (OSHA) decision-makers, all of which are essential for the chemical community to navigate around the challenges and benefits posed by current uses of engineered nanoscale materials and the emerging commercialization of nanotechnology.

B&C has made a concerted effort to be in the forefront of the science policy debate involving nanotechnology and other emerging technologies. B&C professionals have participated in all Foresight and Governance Project Dialogues on nanotechnology. Presently, Lynn Bergeson serves on the Steering Committee of the American National Standards Institute Nanotechnology Standards Panel (ANSI-NSP), which is seeking to coordinate the development of voluntary consensus standards relating to nanotechnology. As long-time sponsors of the American Chemistry Council (ACC) Global Chemical Regulations Conference, B&C is presenting in March 2005 a panel discussion on nanotechnology and regulatory review initiatives. Ms. Bergeson is also a member of the Converging Technologies Bar Association (CTBA), which is very active in developing legal and policy issues pertinent to emerging technologies. Finally, B&C’s article, “Reading the Small Print,” which appeared in the March/April 2004 issue of the Environmental Law Institute’s The Environmental Forum, has received praise for flagging significant regulatory and policy issues pertinent to nanotechnology and nanoscale materials.

Our attorneys are well versed in the legal authorities, administrative programs, and regulatory options that EPA and other government agencies, including NIOSH, OSHA, and the Food and Drug Administration (FDA), are now exploring to address the potential risks posed by the use of engineered nanomaterials, the commercialization of nanotechnology, and the convergence of other emerging technologies.

Experience with other legal authorities is also needed, however, and B&C is uniquely qualified to offer these diverse skills. For example, B&C professionals have long worked with EPA’s Office of Pollution Prevention and Toxics staff on Toxic Substances Control Act (TSCA) Inventory and nomenclature issues. We are now working with clients on precisely these issues and on EPA’s continuing revisions of the TSCA regulatory framework, as it relates to nanomaterials and nanostructures that consist of chemical substances. B&C professionals have also long worked with NIOSH on a wide range of issues. Presently, B&C is working with NIOSH on its review of titanium dioxide (TiO2) and, in particular, its hazard assessment of TiO2 in pigment grade and ultra fine particle form. NIOSH intends to release soon a Comprehensive Intelligence Bulletin on TiO2 which, in part, is expected to be pertinent to its broader review of hazards posed by nanoscale materials.

B&C professionals also work closely with several FDA offices. Michael F. Cole is a distinguished FDA practitioner with three decades of experience with FDA obtaining FDA approval for substances used in packaging materials and food processing equipment, preparing Drug Master Files, counseling on the need to submit, and the strategy for, obtaining clearances for device Premarket Notification and Premarket Approval Applications, counseling on medical device classification matters, defending cosmetic ingredient use, and related topics.

Similarly, B&C has significant experience in counseling clients and conducting advocacy initiatives with the National Toxicology Program (NTP) and has worked for years with scientists inside and outside of NTP on science policy issues involving testing protocols, the development of analytical methods, and related topics. B&C represents many companies and trade organizations that have disputed or are in the process of disputing the findings of an NTP study. Our assistance in this regard has consisted of marshaling the technical resources necessary to launch a comprehensive review of the findings, drafting the advocacy documents necessary to support such an effort, and representing our clients in discussions with NTP staff. Given NTP’s current research initiatives involving nanoscale materials, this experience is invaluable.

We also work closely with companies and chemical testing consortia to ensure that NTP’s selection of chemicals, protocols used once a chemical has been nominated for chemical testing, and the technical conclusions and inferences drawn from the test results are presented in a fair and technically defensible way. B&C offers clients an NTP tracking system that advises clients of the status of NTP’s chemical testing initiatives with respect to particular chemical compounds. This tracking system allows companies an opportunity proactively to participate in the chemical testing process. Doing so helps blunt the possibility for erroneous test results, and hence minimizes the possibility that ill-conceived conclusions will be drawn with respect to test chemicals.

B&C routinely counsels clients on a wide variety of matters under the Occupational Safety and Health Act. B&C’s representations include assisting many chemical consortia in the development of American Conference of Governmental Industrial Hygienists’ threshold limit values applicable to, among other chemicals, carbon disulfide, phenol, ethylene glycol, and certain nickel compounds. We have worked on the development of many permissible exposure limits and routinely offer regulatory counseling and enforcement defense services.