The investment made by the federal government via the National Nanotechnology Initiative (NNI) to spawn growth of emerging nano-enabled products and maintain global leadership by the U.S. in fundamental nanoscale science and technology has been effective in meeting specified goals and objectives over the first decade. According to conclusions from the recent report by the President’s Council of Advisors on Science and Technology (PCAST) the $12B NNI investment in nanotechnology since 2001 has provided a “catalytic and substantial impact.” Yet, with this positive assessment, significant challenges remain in order to stimulate sustainable economic impact and growth through commercialization of nanotechnologies. These challenges include workforce training and education while further balancing key issues of societal impact and worker safety through regulatory oversight. Several issues have recently been cited by industry groups, government organizations, and the PCAST report regarding regulation, workforce training, and effective commercialization of nanoscience breakthroughs that suggest a critical balance must be struck during the second decade of the NNI in order to optimally reap the benefits of federal investments.
The top recommendations of the PCAST report include increasing investments in nanomanufacturing and product commercialization to facilitate the entrance of novel nanotech products into the marketplace, while also growing the workforce with expertise in nanofabrication and strengthening commitments to environmental, health, and safety (EHS) research. Additional recommendations included an increase in the NNI investment in nanomanufacturing by 100% over the next five years. In 2011, government funding for nanomanufacturing is proposed to make up only 5.8% of the total NNI budget.
Along with nanomanufacturing comes responsible product development and an understanding of product impacts. The report recommends a more rationalized approach to identifying the risks of nanotechnology and developing a cross-agency strategic research plan to fill EHS knowledge gaps. This becomes critical in order to ensure safety while providing a clear path to market for new companies and emerging products. Further challenges are presented as the EHS knowledge base expands and regulation of the industry takes hold. One of the key issues is how to protect workers and the public while fostering the growth of a new industry, something for which regulatory agencies are keenly aware. In a recent workshop in Washington D.C., members of the NanoBusiness Alliance also met with federal regulators to stimulate dialogue and find out the latest on regulatory actions regarding nanotechnology. During these discussions, industry representatives expressed frustration with the current regulatory system because various offices within a single agency regulate nanotechnology differently and one office doesn’t seem to know what another is doing. This issue may be further exacerbated by the introduction of H.R. 5820, the Toxic Chemicals Safety Act by Representatives Henry Waxman (D-CA) and Bobby Rush (D-IL). In its current form, the bill hurts manufacturers' ability to innovate and remain competitive in a global marketplace. The legislation in its present form dramatically expands the scope of the Environmental Protection Agency’s authority over every sector of our nation’s economy, sets unrealistic standards and timeframes and puts unnecessary burdens on manufacturers with new and inconsistent statutory requirements. Potential nanotechnology manufacturers support a U.S. nanomaterials regulatory and management system that is risk-based and uses the best science to ensure nanomaterials are safe for their intended use. Manufacturers’ position is that federal regulation should protect human health and the environment, promote innovation, restore public confidence, and avoid unnecessarily adverse economic impacts on small and large businesses. If enacted, the new bill will potentially create even more uncertainty for manufacturers and will hurt their ability to create jobs and grow our economy at a critical time in our nation.
To resolve this, industry wants government agencies to create a more streamlined approach to regulating nanotechnology that would be easier to navigate than the current system. A clear and robust regulatory process will also reduce the uncertainty around nano-enabled products. The concern is that the longer it takes for regulatory agencies to harmonize their processes, the more the industry will move offshore because investors are hesitant to fund the development of products with such high uncertainty. Regulation aside, nanomanufacturing stakeholders seem to take the position that it is in their best interests to proactively address the risks of nanotechnology.
Assessing the risks of nanotechnology is difficult, however, because in most cases toxicity data on nanomaterials are insufficient. Although government investment in EHS research has grown from $35 million in 2005 to a proposed $117 million in 2011, several knowledge gaps still remain. And, although there are calls like the one in the PCAST report for more investment in this area, funding for EHS research still only makes up a small percentage (6.6% in 2011) of the total NNI budget. To help identify those knowledge gaps and prioritize nanotech EHS research needs, NNI convened a series of four workshops over the past year focusing on exposure assessment, environmental impacts, human health effects, and risk management methods along with the ethical, social, and legal implications of nanotechnology. The information gathered during the workshops will be used to develop a new strategic plan for EHS research. Its current strategy, released in February 2008, was heavily criticized by stakeholders, including industry trade groups, nanomaterial manufacturers, and environmental organizations. Future workshops being planned, such as the Nanoinformatics 2010 sponsored by the National Nanomanufacturing Network in cooperation with several partners, will address related issues including accessibility of nanomaterials information and federation of materials and process databases. All of these activities will facilitate a robust, efficient approach to the regulation of emerging nanotechnologies, further sustaining effective growth and commercialization of nano-enabled products.