Nanotechnology: A Policy Primer (PDF)
Source: Congressional Research Service (via Federation of American Scientists)
Nanoscale science, engineering, and technology—commonly referred to collectively as nanotechnology—is believed by many to offer extraordinary economic and societal benefits. Congress has demonstrated continuing support for nanotechnology and has directed its attention primarily to three topics that may affect the realization of this hoped for potential: federal research and development (R&D) in nanotechnology; U.S. competitiveness; and environmental, health, and safety (EHS) concerns. This report provides an overview of these topics—which are discussed in more detail in other CRS reports—and two others: nanomanufacturing and public understanding of and attitudes toward nanotechnology.
The development of this emerging field has been fostered by significant and sustained public investments in nanotechnology R&D. Nanotechnology R&D is directed toward the understanding and control of matter at dimensions of roughly 1 to 100 nanometers. At this size, the properties of matter can differ in fundamental and potentially useful ways from the properties of individual atoms and molecules and of bulk matter. Since the launch of the National Nanotechnology Initiative (NNI) in 2000 through FY2012, Congress has appropriated approximately $15.6 billion for nanotechnology R&D, including approximately $1.7 billion in FY2012 funding under the Consolidated and Further Continuing Appropriations Act, 2012 (P.L. 112-55) and the Consolidated Appropriations Act, FY2012 (P.L. 112-74). President Obama has requested $1.8 billion in NNI funding for FY2013. More than 60 nations have established similar programs. In 2010, total global public R&D investments reached an estimated $8.2 billion, complemented by an estimated private sector investment of $9.6 billion. Data on economic outputs used to assess competitiveness in mature technologies and industries, such as revenues and market share, are not available for assessing nanotechnology. Alternatively, data on inputs (e.g., R&D expenditures) and non-financial outputs (e.g., scientific papers, patents) may provide insight into the current U.S. position and serve as bellwethers of future competitiveness. By these criteria, the United States appears to be the overall global leader in nanotechnology, though some believe the U.S. lead may not be as large as it was for previous emerging technologies.
Some research has raised concerns about the safety of nanoscale materials. There is general agreement that more information on EHS implications is needed to protect the public and the environment; to assess and manage risks; and to create a regulatory environment that fosters prudent investment in nanotechnology-related innovation. Nanomanufacturing—the bridge between nanoscience and nanotechnology products—may require the development of new technologies, tools, instruments, measurement science, and standards to enable safe, effective, and affordable commercial-scale production of nanotechnology products. Public understanding and attitudes may also affect the environment for R&D, regulation, and market acceptance of products incorporating nanotechnology.
In 2003, Congress enacted the 21st Century Nanotechnology Research and Development Act providing a legislative foundation for some of the activities of the NNI, addressing concerns, establishing programs, assigning agency responsibilities, and setting authorization levels. Legislation was introduced in the 110th Congress and 111th Congress to amend and reauthorize the act.
Health and Environmental Effects of Nanomaterials Remain Uncertain; Cohesive Research Plan Needed to Help Avoid Potential Risks From Rapidly Evolving Technology
Despite extensive investment in nanotechnology and increasing commercialization over the last decade, insufficient understanding remains about the environmental, health, and safety aspects of nanomaterials. Without a coordinated research plan to help guide efforts to manage and avoid potential risks, the future of safe and sustainable nanotechnology is uncertain, says a new report from the National Research Council. The report presents a strategic approach for developing research and a scientific infrastructure needed to address potential health and environmental risks of nanomaterials. Its effective implementation would require sufficient management and budgetary authority to direct research across federal agencies.Nanoscale engineering manipulates materials at the molecular level to create structures with unique and useful properties — materials that are both very strong and very light, for example. Many of the products containing nanomaterials on the market now are for skin care and cosmetics, but nanomaterials are also increasingly being used in products ranging from medical therapies to food additives to electronics. In 2009, developers generated $1 billion from the sale of nanomaterials, and the market for products that rely on these materials is expected to grow to $3 trillion by 2015.The committee that wrote the report found that over the last seven years there has been considerable effort internationally to identify research needs for the development and safe use of nanotechnology, including those of the National Nanotechnology Initiative (NNI), which coordinates U.S. federal investments in nanoscale research and development. However, there has not been sufficient linkage between research and research findings and the creation of strategies to prevent and manage any risks. For instance, little progress has been made on the effects of ingested nanomaterials on human health and other potential health and environmental effects of complex nanomaterials that are expected to enter the market over the next decade. Therefore, there is the need for a research strategy that is independent of any one stakeholder group, has human and environmental health as its primary focus, builds on past efforts, and is flexible in anticipating and adjusting to emerging challenges, the committee said.
FDA takes ‘first step’ toward greater regulatory certainty around nanotechnology
Source: U.S Food & Drug Administration
The U.S. Food and Drug Administration today released draft guidance to provide regulated industries with greater certainty about the use of nanotechnology, which generally involves materials made up of particles that are one billionth of a meter in size. The guidance outlines the agency’s view on whether regulated products contain nanomaterials or involve the application of nanotechnology.
Nanotechnology, the science involving manipulation of materials on an atomic or molecular scale, is an emerging technology with a broad range of potential applications, such as increasing bioavailability of a drug, improving food packaging and in cosmetics.
The draft guidance, “Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology,” is available online and open for public comment. It represents the first step toward providing regulatory clarity on the FDA’s approach to nanotechnology.
Specifically, the agency named certain characteristics – such as the size of nanomaterials used and the exhibited properties of those materials – that may be considered when attempting to identify applications of nanotechnology in regulated products.
“With this guidance, we are not announcing a regulatory definition of nanotechnology,” said Margaret A. Hamburg, MD, Commissioner of Food and Drugs. “However, as a first step, we want to narrow the discussion to these points and work with industry to determine if this focus is an appropriate starting place.”
See also: Policy Principles for the U.S. Decision-Making Concerning Regulation and Oversight of Applications of Nanotechnology and Nanomaterials (PDF; Office of Science and Technology Policy, Office of Management and Budget, United States Trade Representative)
Federal Research and Development Funding: FY2012 (PDF)
Source: Congressional Research Service (via OpenCRS)
President Obama has requested $147.911 billion for research and development (R&D) in FY2012, a $772 million (0.5%) increase from the FY2010 actual R&D funding level of $147.139 billion. Congress will play a central role in defining the nation’s R&D priorities, especially with respect to two overarching issues: the extent to which the federal R&D investment can grow in the context of increased pressure on discretionary spending and how available funding will be prioritized and allocated. Low or negative growth in the overall R&D investment may require movement of resources across disciplines, programs, or agencies to address priorities. As year- long funding for FY2011 appropriations has not yet been completed, this report compares the President’s FY2012 request to FY2010 appropriations. Analysis of federal R&D funding is complicated by several factors, including the Obama Administration’s omission of congressionally directed spending from the FY2012 budget request. This report will be updated as Congress acts on FY2012 appropriations bills.
Under the President’s request, six federal agencies would receive 94.8% of total federal R&D spending: the Department of Defense (DOD, 51.8%), Department of Health and Human Services (largely the National Institutes of Health, 21.9%), National Aeronautics and Space Administration (6.6%), Department of Energy (DOE, 8.8%), National Science Foundation (NSF, 4.3%), and Department of Agriculture (1.5%). The Department of Energy would receive the largest R&D dollar increase for FY2012 of any agency, $2.153 billion (19.9%) above its FY2010 funding level. The DOD would receive the largest reduction in R&D funding, $3.969 billion (-4.9%) less than its FY2010 level.
President Obama’s request includes increases in the R&D budgets of the three agencies that were targeted for doubling over 7 years by the America COMPETES Act, and over 10 years by the America COMPETES Reauthorization Act of 2010 and by President Bush under his American Competitiveness Initiative, as measured using FY2006 R&D funding as the baseline. Under President Obama’s FY2012 budget, the DOE Office of Science would receive an increase of $512 million (10.4%) over its FY2010 funding level, the NSF budget would rise by $795 million (11.4%), and the National Institute of Standards and Technology’s core research and facilities construction funding would grow by $111.1 million (17.0%).
President Obama continues support for three multi-agency R&D initiatives. The President’s FY2012 request includes $2.132 billion in funding for the National Nanotechnology Initiative, $201 million (10.4%) above the FY2010 funding level. The Networking and Information Technology Research and Development program would receive $3.868 billion in FY2012 funding under the President’s request, an increase of $74 million (2.0%) from the FY2010 level. The President’s request proposes $2.633 billion for the U.S. Global Change Research Program in FY2012, $446 million (20.4%) above the FY2010 level.
For the past five years, federal R&D funding and execution has been affected by mechanisms used to complete the annual appropriations process—multiple short-term continuing resolutions for FY2011, the year-long continuing resolution for FY2007 (P.L. 110-5), and the combining of multiple regular appropriations bills into the Consolidated Appropriations Act, 2008 for FY2008 (P.L. 110-161), the Omnibus Appropriations Act, 2009 (P.L. 111-8), and the Consolidated Appropriations Act, 2010 (P.L. 111-117). Completion of appropriations after the beginning of each fiscal year may cause agencies to delay or cancel some planned R&D and equipment acquisition.