The National Research Council (NRC) issued a report in December critiquing the federal government’s strategic plan for nanotechnology, the understanding and control of matter at dimensions between one and 100 nanometers. Among numerous concerns, the NRC was especially troubled that the plan does not address potential health risks posed by nanomaterials, which are increasingly being used by consumers who are often unaware of their presence. At the same time, experts are calling on the government to regulate the industry.
The National Nanotechnology Initiative (NNI), a collaboration of 25 federal agencies with the goal of coordinating federal nanotechnology research and development, prepared the strategic plan. The plan has four main goals: to (1) advance a world-class research and development program; (2) foster the transfer of new technologies into products for commercial and public benefit; (3) develop and sustain educational resources, a skilled workforce, and the supporting infrastructure and tools to advance nanotechnology; and (4) support responsible development of nanotechnology. The National Nanotechnology Initiative: Strategic Plan December 2007, NNI (Dec. 2007), available at http://www.nano.gov/.
Describing the plan as “inadequate,” the NRC report says it does not provide a clear picture of the current understanding of “nano-risk research” or offer goals to ensure that nanotechnologies are as safe as possible. Press Release, Federal Research Plan Inadequate to Shed Light on Health and Environmental Risks Posed by Nanomaterials, Natl. Acads. (Dec. 10, 2008), available at http://www.nationalacademies.org/. David Rejeski, director of the Project on Emerging Nanotechnologies (PEN), calls the NRC report a “clear sign” that the government must revamp its research strategy. Press Release, Panel Blasts Federal Nanotech Risk Research Strategy: Long-Awaited Report Gives Obama Adminstration Direction for Change, PEN (Dec. 10, 2008), available at http://www.nanotechproject.org/.
Nanotechnology concerns matter at incredibly small dimensions. One nanometer is one billionth of one meter; there are 25.4 million nanometers in one inch; and a sheet of paper is about 100,000 nanometers thick. At such small scales, the properties of nanomaterials differ from their larger counterparts. They have far larger surface areas than similar volumes of larger scale materials, so that more surface is available for reactions with surrounding materials. As an example, gold is an excellent conductor of heat and electricity, but not of light. Gold nanoparticles, however, can absorb light and turn it into so much heat that they act like “thermal scalpels” that can kill unwanted cells such as cancer cells. “Nanosizing” certain molecules can also improve their effectiveness. Sunscreen with nanoscale titanium dioxide, for example, reflects ultraviolet light to prevent sunburns. What Is Nanotechnology?, NNI, available at http://www.nano.gov/.
In addition to sunscreen, there are numerous consumer products containing nanomaterials. Categories of products include batteries, computer hardware, sporting goods, luggage, and even children’s toys. Microsoft Corporation’s Xbox 360 contains nanoscale silicon to reduce heat and improve performance. Some foods also contain nanoparticles. For example, RBC Life Sciences, a company that makes products for people who want to “live longer, healthier lives,” has created an ingredient for some of its products called NanoClusters, a nanosize powder that allegedly “reduces the surface tension of foods and supplements to increase wetness and absorption of nutrients.” Foods using nanotechnology include canola oil and tea.
The issue of nanomaterials in products, especially foods, raises many questions, including how they should be regulated. Whether the FDA subjects products to premarket approval depends on the type of product. In general, any substance that is intentionally added to food is subject to approval unless it is generally recognized as safe (GRAS) under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301 et seq. The FDA does not currently have a regulatory category for products containing nanomaterials and concedes that nanoscale materials will present new regulatory challenges.
A report issued by the FDA’s nanotechnology task force stated that “the very nature of nanoscale materials—their dynamic quality as the size of nanoscale features change, for example, and their potential for diverse applications—may permit the development of highly integrated combinations of drugs, biological products, and/or devices, having multiple types of uses, such as combined diagnostic and therapeutic intended uses.” As a consequence, the report says, the agency needs to assess the process for regulating “combination products” to ensure it is the best way to regulate highly integrated combination products. Nanotechnology: A Report of the U.S. Food and Drug Administration Nanotechnology Task Force, FDA (July 25, 2007), available at http://www.fda.gov.
The FDA is now in the process of gathering information about nanotechnology and identifying the regulatory challenges nanoproducts pose. The agency held a public meeting last September to discuss the issue. The meeting’s primary purpose was to determine what factors the FDA should consider when providing guidance on information and data that may be needed to show the safety and efficacy of FDA-regulated products containing nanomaterials and what circumstances might cause a product’s regulatory status to change due to the presence of nanoscale materials. 73 Fed. Reg. 46022 (Aug. 7, 2008). The agency held break-out sessions for specific product categories for which it might need guidance, in which it asked participants to consider several questions, including what assessment tools exist to evaluate the characteristics of nanoscale materials and what characteristics of the materials in FDA-regulated products should be identified and evaluated to ensure their safety and effectiveness.
“Food and color additives” was one of the products categories. Michael R. Taylor, professor of health policy at the George Washington University School of Public Health and Health Services, voiced concern that “the GRAS concept, if not applied in the rigorous way intended by Congress, opens the door to independent decisionmaking by technology providers and food companies to market truly new food technologies without a pre-market safety evaluation and approval by FDA.” Taylor called on the FDA to provide clear guidance to the industry on its position on how the GRAS concept applies to nanotechnology and food. Michael R. Taylor, State., Food-Related Applications of Nanotechnology: Regulatory Issues (Sept. 8, 2008), available at http://www.fda.gov.
Another participant was Michael Hansen, senior scientist for Consumers Union. Like Taylor, Hansen called for more transparency regarding the regulatory status and safety of food ingredients derived from nanotechnology. Michael Hansen, State., Comments of Consumers Union at FDA Nanotechnology Public Meeting Public Breakout Session on Food and Color Additives, Including Food Contact Substances, (Sept. 8, 2008), available at www.fda.gov. He added that nanoparticles raise potential toxicity issues because of their greater reactivity potential stemming from their larger surface area, and the FDA should thus find them ineligible for GRAS classification and require food additive petitions for them. “Just because something is safe at the macro level, doesn’t mean it’s safe at the nano size. All scientists agree that size matters,” said Hansen. Barbara Liston, Nano-Foods: The Next Consumer Scare?, Reuters (July 30, 2008), available at http://www.reuters.com.
One such nanoparticle that has great potential but that also has some scientists concerned is the buckminsterfullerene carbon-60 molecule, also known as the “buckyball.” This molecule generally contains carbon-60 atoms, which form interlocking pentagons or hexagons. It is incredibly strong and heat resistant and has the potential to be used in the manufacture of industrial materials and drug delivery systems, among other uses. Buckyballs are also believed to be capable of dissolving in cell membranes, passing into the cells, and reforming on the other side. This raises the possibility that they could damage cells. Some buckyballs, also known as fullerenes, have been shown to cause brain damage in fish. Nanotechnology Risks: How Buckyballs Hurt Cells, Sci. Daily (May 27, 2008), available at http://www.sciencedaily.com.
Additionally, inhaling carbon nanotubes, hollow fibers produced by buckyballs, can cause lung damage comparable to that caused by asbestos. According to Peter Tieleman, a biochemist at the University of Calgary, “[t]here are studies showing that they can cross the blood-brain barrier and alter cell functions, which raises a lot of questions about their toxicity and what impact they may have if released into the environment.”
Given nanotechnology’s potential, there is huge demand for more research and development as well as the manufacture of products containing nanomaterials. It is estimated that by 2014, about $2.6 trillion worth of goods worldwide will use nanotechnology, compared to $50 billion in 2006. While the unique properties of nanomaterials can confer a variety of benefits, ranging from improving the treatment of diseases to making healthier foods, Andrew Maynard, a science advisor with PEN, says that “[t]he more we know about nanomaterials’ risks, the more we worry about what we don’t know.” Nanotechnology: Untold Promise, Unknown Risk, Consumer Rpts. (July 2007), available at http://www.consumerreports.org/.