I would like to thank Lynn Bergeson, Bergeson & Campbell, P.C., Richard Canady, PhD DABT, Senior Advisor, McKenna, Long & Aldridge, LLP, and Philip Lippel, PhD for their contributions to this summary.

I would like to share the following nanotechnology articles with our community:

What’s up with nanotech?

U.S. lead in nanotech eroding, report finds

NanoBusiness Alliance to Present 3rd Annual Nano Renewable Energy Summit in Denver, CO, May 24-25, 2010

Forbes Wolfe Emerging Tech

The NanoBusiness Alliance’s (NbA) Washington, DC Roundtable on March 15-17, 2010, was a huge success. Below is a summary of the NbA Federal Roundtable on March 17, 2010.

Convened in Foley & Lardner LLP’s http://www.foley.com/home.aspx lovely conference room overlooking the Potomac River from the office’s Georgetown perch, the day-long Federal Roundtable was intended to familiarize NbA members and supporters with a detailed and informative overview of all aspects of federal oversight of nanotechnology. Specifically, the NbA identified three meeting objectives: stimulate dialogue between NbA members and federal agencies; brief members on the latest regulatory policy/impending regulatory actions and federal research initiatives; and familiarize NbA members with federal product approval authorities and processes and innovation strategies, with an emphasis on pending developments. The agenda is available online http://www.enobis.com/pdfdocs/NbAagenda.pdf.

I www.vincentcaprio.org, Executive Director of the NanoBusiness Alliance, introduced the first substantive panel, moderated by Richard Canady, PhD DABT, Senior Advisor, McKenna, Long & Aldridge, LLP. The session, titled Regulatory Policy Movement for Nano – Cross-Agency and International Perspectives, featured presentations by Travis Earles, Assistant Director for Nanotechnology, Office of Science and Technology Policy (OSTP), Executive Office of the President. Travis reviewed the state of the National Nanotechnology Initiative, noting that continued growth in both overall funding (projected at $1.7 B for 2011) and environmental, safety and health research ($117 M). He told the audience to keep an eye out for more details on the newly announced NNI Signature Initiatives. Travis noted that the Administration is working hard to ensure clear regulatory pathways for innovators. A new high-level interagency task force on emerging technologies will look at this and other issues affecting commercialization. Dr. Shaun Clancy presented a PowerPoint presentation available online, http://www.enobis.com/pdfdocs/clancy.pdf titled the Importance of Policy and International Activities to NbA Companies. The presentation reviewed key domestic and international policy, standard-setting, and regulatory initiatives pertinent to NbA members, and explained the reasons why early and consistent engagement in these activities is essential for sound policy setting and effective product stewardship.

Next Dr. Celia I. Merzbacher, Vice President for Innovative Partnerships, Semiconductor Research Corporation, provided a very informative PowerPoint presentation, available online, http://www.enobis.com/pdfdocs/merzbacher.pdf titled Nanoelectronics Research Initiative: How Public Private Partnerships Add Value. Dr. Merzbacher described how SRC member companies and federal agencies cooperate, through the NRI, on long-range research to ensure that Moore’s Law will continue. Given Dr. Merzbacher’s current industry role and former position with OSTP, her insights into what makes for successful public-private partnerships were targeted, informative, and very useful.

The next panel was moderated by Charles M. Auer, Charles Auer & Associates, LLC, titled Chemical and Consumer Product Risk Management Policy and Regulatory Actions. Charlie was Director of the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics until early 2009, and was responsible for managing EPA’s regulatory initiatives pertinent to nanoscale materials, among many other chemical regulatory initiatives. Charlie was also deeply engaged in Organization for Economic Cooperation and Development (OECD) initiatives dealing with nanotechnology and other chemical management initiatives, and continues to engage in OECD matters in private practice. Charlie’s first two speakers discussed current regulatory approaches. First up was Bill Jordan, from EPA’s Office of Pesticide Programs, who spoke about how the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) applies to nanomaterials with pesticidal or antimicrobial properties. Next, Jim Alwood, EPA Chemical Control Division, gave a presentation, available online, http://www.enobis.com/pdfdocs/alwood.pdf titled TSCA Nanotechnology Regulations at EPA. The presentation provided an up-to-the-minute review of regulatory initiatives under the Toxic Substances Control Act (TSCA) pertinent to most other nanoscale materials. Finally, Dr. Jeff Morris, EPA Office of Research and Development, described EPA’s long-term research program to develop new methods for integrating safety and environmental impact studies of nanomaterials into a full lifecycle assessment, covering design, development, use, and disposal. He emphasized the collaborative nature of this process, stating that everyone in the room needed to work on it together, and noted that EPA has commissioned a National Acadamies study to help plan the effort. Dr. Morris’ excellent PowerPoint presentation, Future Considerations for Nanotechnology EHS: Informing Policy and Regulatory Decisions, is available online http://www.enobis.com/pdfdocs/morris.pdf. It provides a compelling basis for understanding EPA’s need for data to inform the Agency’s risk management decision-making efforts.

The next panel focused on nanotechnology policy and guidance developments pertinent to the U.S. Food and Drug Administration (FDA). Foley & Lardner’s David Rosen, Co-Chair of the Life Sciences Industry Team at the firm, moderated the session. David introduced Dr. Mitchell A. Cheeseman, Deputy Director of the Office of Food Additive Safety, Center for Food Safety and Applied Nutrition, who discussed FDA’s efforts in this area. Mitch’s PowerPoint presentation, available online, http://www.enobis.com/pdfdocs/cheeseman.pdf titled Regulatory Hurdles for Nanotechnology, provided a useful outline of the challenges regulated entities face in obtaining approvals for food-related products. Joining Mitch on the panel was Dr. Subhas G. Malghan, Deputy Director for Program Policy and Evaluation, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health. Subhas walked through a PowerPoint presentation, available online, http://www.enobis.com/pdfdocs/malghan.pdf titled Science and Regulatory Issues Relevant to Devices Containing Nanoscale Materials, which reviewed issues pertinent to medical devices approvals. The third panelist was Larry Tamarkin, CEO of CytImmune. Larry described his company’s anticancer therapeutics. CytImmune has worked closely with the National Cancer Institute’s Nanotechnology Characterization Laboratory to develop data supporting FDA product approval, and has completed Phase I clinical trials for their lead product.

Following a luncheon break, the Federal Roundtable reconvened with a panel discussion on workplace and worker protection issues moderated by Dr. Sam Brauer. Sam introduced David O’Connor, Director, Office of Chemical Hazards, Occupational Safety and Health Administration (OSHA). David’s PowerPoint presentation, available online, http://www.enobis.com/pdfdocs/oconnor.pdf titled Nanomaterials: OSHA’s Approach to Protecting Workers from Potential Hazards, provides a useful overview of OSHA’s approach to nano workplace safety. Dr. O’Connor noted that OSHA’s general mandate is to ensure that workplaces are free from recognized hazards that could cause death or serious harm. Nanotech manufacturers are certainly included in this charge, but there have been no nano-specific actions to date. OSHA enforces Permissible Exposure Limits for many materials; in the absence of specific information about the hazards of nanoscale versions of a material, these are legally applicable although it is not generally known if they are protective. General requirements for the use of personal protective equipment, including respirators, should of course be followed. Dr. Charles A. Geraci, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention (NIOSH/CDC) spoke next. Chuck gave a PowerPoint presentation, available online, http://www.enobis.com/pdfdocs/geraci.pdf titled Nanotechnology: Collaboration Opportunities for Workplace Safety. Chuck noted that NIOSH has a long history of working in the “gray zone”, using experience-based approaches which adapt existing frameworks to new situations by focusing on what may be unique. He emphasized that regulators and industry share responsibility for occupational safety and health, and provided a thorough review of opportunities to collaborate with NIOSH on worker health and safety issues. Next, Dr. Kristen M. Kulinowski, Center for Biological and Environmental Nanotechnology, International Council on Nanotechnology, Rice University, walked through a PowerPoint presentation, available online, http://www.enobis.com/pdfdocs/kulinowski.pdf titled Collaboration on Nanotechnology Workplace Safety: Tools for Nano Businesses. Kristen’s presentation summarized key issues with respect to collecting reliable information on workplace nano hazards, and explained an extremely useful tool for business – the GoodNanoGuide, http://GoodNanoGuide.org – an Internet site which presents specific practices for safe handling of nanomaterials by workers or researchers. This is a community-generated site, and NbA members are encouraged to become both users and contributors.

Next, Lynn L. Bergeson, Bergeson & Campbell, P.C., a Washington, D.C. law firm, provided a PowerPoint presentation, available online, http://www.enobis.com/pdfdocs/bergeson.pdf titled Effectively Navigating Your Business around Uncertainties: Making the Most from Careful Planning, Regulatory Awareness, and Smart Planning. The presentation expressed the reasons why NbA members must engage early and often with regulators, legislators, and health and environment public interest groups to ensure businesses’ message is clear, its commitment to stewardship is known, and its science is understood.

Richard Canady, PhD DABT, Senior Advisor, McKenna, Long & Aldridge, LLP, next went through a PowerPoint presentation, available online, http://www.enobis.com/pdfdocs/canady.pdf titled The Evolving Regulatory Landscape for Nanomaterials. The presentation summarized the preceding presentations, pointed out that both legal requirements and regulatory philosophies vary both across and within agencies, reiterated that NbA members need to engage with government officials and present businesses’ views on responsible commercialization of nanotechnology. For example, he noted most nanomaterials safety studies to date have looked at hazards but not assessed exposure risks. Businesses could advocate for safety studies which more accurately reflect actual or proposed uses.

The final panel, moderated by Philip Lippel, PhD, was titled Advising the NNI-NGO Input to Research Priorities and Regulatory Issues: The Roles of the National Nanotechnology Advisory Panel and the National Academies of Sciences. Terry L. Medley, Global Director, Corporate Regulatory Affairs, DuPont, provided a PowerPoint presentation, available online, http://www.enobis.com/pdfdocs/medley.pdf on the recently concluded Third Assessment of the National Nanotechnology Initiative by the President’s Council of Advisors on Science and Technology. Terry offered his insights on the PCAST review process, discussed the summary recommendations, and speculated about their impact on future directions of the National Nanotechnology Initiative. (The full Report to the President and Congress… http://www.whitehouse.gov/sites/default/files/microsites/ostp/pcast-nano-report.pdf is now available from the Office of Science and Technology Policy.) Terry serves as a member of the Nanotechnology Working Group of the President’s Council of Advisors on Science and Technology (PCAST), which authored the report.

Next, NbA was pleased to hear the remarks of Dr. Jennifer Sass, Senior Scientist, Natural Resources Defense Council (NRDC), and also a member of the PCAST Nanotechnology Working Group. Dr. Sass provided an overview of NRDC’s interest in nanotechnology and its perspective as a very large non-governmental organization (NGO).

Following Dr. Sass, Ray Wassel, Senior Program Officer, Board of Environmental Studies and Toxicology, National Research Council (NRC), described work just getting underway, under EPA sponsorship, to develop a research strategy for environmental, health, and safety aspects of engineered nanomaterials. Further information on this 4-year project, with an interim report due late next year, is available on the National Academies’ website. http://www8.nationalacademies.org/cp/projectview.aspx?key=49173

The afternoon keynote slot featured Anne Meagher Northup, Commissioner, Consumer Product Safety Commission (CPSC),who offered her perspective of the CPSC’s role in ensuring consumer products are safe. She discussed the Commission’s challenges given the scope of its mandate, and its plans for discharging its responsibilities.

Following Commissioner Northup’s remarks, Lloyd Whitman, Deputy Director, Center for Nanoscale Science & Technology, National Institute of Standards and Technology (NIST), U.S. Department of Commerce, gave a PowerPoint presentation, available online, http://www.enobis.com/pdfdocs/whitman.pdf titled Supporting the Nanotechnology Enterprise from Discovery to Production. The presentation emphasized that industry receives high priority in using CNST’s advance resources for fabricating and characterizing nanomaterials, in line with NIST’s mission to support U.S. innovation and industrial competitiveness.

The final presentation of the day, available online, http://www.enobis.com/pdfdocs/murday.pdf was given by Dr. James S. Murday, Director of Physical Sciences, University of Southern California. Jim reported on an NSF Sponsored Workshop: Partnership for Nanotechnology Education at the University of Southern California. His presentation provided an overview of why creating partnerships for nanotechnology education is an excellent way to promote nanotechnology and ensure its sustainability. Jim urged the nanotechnology community to become involved in efforts to develop uniform science education standards, noting that due to current reform efforts, we may have a unique opportunity over the next year to make students better prepared for careers in nanotechnology.

The Federal Roundtable provided an invaluable opportunity to meet many of the key government and other stakeholder representatives engaged in policy and regulatory initiatives directly relevant to NbA members, to hear about these critically important developments, and to engage with these stakeholders in a casual business setting. The Federal Roundtable accomplished our goals set for the NbA, and we look forward to another roundtable in 2011.


Vincent Caprio “It’s Green, It’s Clean, It’s Never Seen – That’s Nanotechnology”
Executive Director
NanoBusiness Alliance