AAAS Policy Brief: Nanotechnology

Issue Summary | Resources

 

---

Background
Environmental, Health, and Safety Risk
Policy and Regulation
Commercialization
Future Insights

Background

One of the newest multidisciplinary frontiers on the scientific horizon is nanotechnology, the science that involves the engineering of matter at the atomic and molecular scale.  Materials at this size fall in the “nanoscale,” meaning that they are 100 nanometers or smaller—one nanometer is 10-9 (one billionth) meter, about half the width of a DNA molecule.  “Nanotechnology” is shorthand for “nanoscale science, engineering, and technology,” and while “nanoscience” refers to the general study of materials at the nanoscale, “nanotechnology” involves the manipulation and creation of structures of this size.  Scientists are interested in nanoscale particles because at such small sizes, materials display properties much different than their macroscale counterparts.  Those properties, such as low surface area-to-volume ratio and dependence on quantum mechanics, can be applied across all scientific disciplines—scientists foresee nanomaterials performing such diverse feats as penetrating DNA, filtering tiny toxins, and splitting water molecules.

Though research is still in its infancy, nanotechnology’s promise to revolutionize science has already attracted corporate investors as well as the federal government, which is interested not only in investing in research and development (R&D), but in examining its economic and societal implications.  The Congressional Research Service (CRS) recently identified several key applications to which nanotechnology could contribute, including detection and treatment of deadly diseases, low-cost renewable energy, sensing and filtration of environmental chemicals, and improvements in digital memory storage.  Not only would advances in these areas impact the daily lives of Americans, they would also contribute to national interests such as space exploration, national security, and defense.

Back to top

Environmental, Health, and Safety Risks

As nanotechnology research surges forward, scientific experts warn that unknown environmental, health and safety (EHS) risks may accompany these advances.  Nanotechnology research is heavily focused on innovation and development, while hazards for humans and the environment are, by comparison, very much understudied—a concern expressed by many experts and echoed by the White House’s National Science and Technology Council (NSTC).  Concerned scientists and international organizations such as the International Risk Governance Council (IRGC) maintain that nanomaterials’ unique characteristics— precisely what make them so novel and valuable— may also make them dangerously toxic to humans and the environment.  The IRGC, which is concerned with global health and environmental risk management, warned in a 2007 white paper that nanostructures, with their ability to pass easily through biological systems, could bioaccumulate and persist in those systems, whereupon they might induce toxic responses or interact with other chemicals.

For example, scientists raised doubt about the chemical safety of nanostructures in a 2008 Nature-published study that revealed the carcinogenic, asbestos-like effects of carbon nanotube exposure in rodents.  The study found that the tiny, needle-like molecules injected into mice accumulated in the thin epithelial tissues surrounding the body cavity, causing inflammation and precancerous lesions.  Nanotube technology, one of the most-studied and promising subjects of nanotechnology research, is also likely to become one of the most commercially valuable, as nanotubes are used as lightweight reinforcements in hard metal structures.  Until this study’s release, many believed that carbon nanotubes were no more toxic than graphite, their corresponding macro-material. Thus, some scientists believe that their potential EHS risks need to be analyzed further.

Back to top

Policy and Regulation

The struggle between nanotechnology innovation and regulation has been a challenge for policymakers and regulatory groups, who are faced with the task of promoting technological advances while simultaneously protecting the public.  Since the new millennium, the United States has invested federal funds in nanotechnology R&D through the National Nanotechnology Initiative (NNI), a multi-agency program designed to coordinate federal research efforts and ensure U.S. competitiveness on the global nanotechnology front.

The National Nanotechnology Initiative (NNI)

Founded in 2000 by President Clinton, the NNI is funded through 13 federal agencies and incorporates 12 others for regulatory responsibilities, making it the first integrated nanotechnology-focused national program in the world.  It is directed through the NSTC subcommittee on Nanoscale Science, Engineering, and Technology (NSET), and its activities are framed in the 2003 Nanotechnology Advancement and New Opportunities Act (PL 103-153).  To date, since its initial funding in FY 2001, the NNI has received $8.4 billion in appropriations from agencies such as the Department of Defense (DOD), the National Science Foundation (NSF), and the Department of Energy (DOE), and it has received more each year since its creation.  According to its Strategic Plan, NNI was designed as a multi-agency funding effort due to the diverse sectors to which nanotechnology is relevant and its potential to affect all agencies involved.  Despite nanotechnology’s potential for civilian applications, DOD continues to be NNI’s primary sponsor, with about 29 percent of NNI’s proposed FY09 budget going to defense applications.

Despite eight years of funding, some watchdog and interest groups say that given nanotechnology’s potential economic and social contributions, the government is not investing enough in federal R&D for nanotechnologies.  They call for increased, sustained funding of the NNI, which has also been criticized for failing to coordinate innovation efforts with EHS regulations and standardizations.^{1, 2}  Advisory groups such as the President’s Council of Advisors on Science and Technology (PCAST) echo these concerns, recommending that the NNI develop clear standards for identification and regulation of nanomaterials.  Other reports, such as the National Research Council’s review of the NNI, also suggest reorganization and revision of NSET’s strategic plan, as well as increasing multi-agency investment in research.  PCAST has also called for a renewed focus on public communication and outreach efforts and expressed concern for our nation’s global technology leadership.  Their concern points to the fact that though the NNI was the first group of its kind in the world, 60 other countries have created similar initiatives since 2000, and programs in China and the European Union are likely to quickly outstrip U.S. efforts.³

In response to these growing concerns, members of Congress have introduced a number of bills to reform the NNI and address nanotechnology stewardship, competitiveness, and regulatory issues.

Regulatory Challenges

Under the NNI, four regulatory groups—the Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), the Consumer Product Safety Commission (CPSC), and the Occupational Safety and Health Administration (OSHA)—have authority to enact safety protocols and regulations for nanomaterials.  However, due to funding restraints and lack of resources, only EPA and FDA have introduced nanotechnology-specific oversight measures.⁴ One of the biggest challenges these groups face is how to classify nanomaterials, which are often chemically identical to other compounds—the only difference being their smaller particle size (as in the case of nanotubules and graphite, both of which are made solely of carbon).  Should the nanomaterial be classified as a new chemical, thus requiring its own set of regulations and protocols?  This question was raised when EPA fined a California technology company for claiming to use antibacterial nanotechnology. EPA said that any substance, including nanomaterials, claiming to exhibit antimicrobial properties must be registered with EPA under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).  In the absence of nanotechnology-specific legislation, current legislation must suffice in order for EPA to conduct oversight on nanomaterials.

In addition to FIFRA, another law under which EPA can exercise nanotechnology oversight is the Toxic Substances Control Act (TSCA), which requires that all “new” chemicals and all known EHS data be reported to EPA.  Currently, however, EPA does not define nanomaterials as “new chemicals” under this law, meaning they are exempt from these stringent regulations.  EPA addressed this issue with the January 2008 enactment of the Nanoscale Materials Stewardship Program (NMSP) under TSCA, which is a program that seeks to identify how and where companies are using nanotechnology.  The NMSP requests that companies submit information about privately engineered nanostructures—including information about their chemical properties, production and use, and known hazards.  EPA hopes to use this existing information to inform future policy decisions and encourage company stewardship.  However, compliance with NMSP is only voluntary, and currently, only four companies have submitted information under NMSP’s basic program.

FDA, too, struggles with nanotechnology regulation.  It created its Nanotechnology Task Force (NTF) in 2006 to regulate the use of nanomaterials in food packaging and drug delivery methods, but NTF says it cannot create effective standards without more information about how nanomaterials interact with biological systems.  For now it says it must make the best use of existing knowledge and develop new approaches as nanotechnologies are introduced under its jurisdiction.⁵ The FDA has also suffered from insufficient funding and a growing list of responsibilities, and critics say that the FDA currently does not view nanotechnology safety as a pressing public health issue.⁶

Back to top

Commercialization

With scant regulation and tapering federal support for public projects, private corporations have found it easy to conduct their own nanotechnology R&D activities for use in commercial products.  The CRS estimates that nearly half of nanotechnology research is privately funded—in 2006, $6 billion were invested in private sector R&D, compared with $6.4 billion in federal R&D.   The Wilson Center also has compiled a “Consumer Products Inventory,” which lists more than 600 consumer products incorporating nanotechnology, with three to four new products appearing per week.  Such heavy private sector investment in nanotechnology is worrisome to NNI proponents, who say that with new technologies appearing in the private sector, federally-funded efforts are undercut and progress becomes difficult.  The EU recently addressed this problem with its “Public Dialogue on Nanotechnologies,” which is a push to improve and pool knowledge among private European companies and governments.  Other countries will likely establish similar initiatives, and groups such as the CRS warn that, though the science is in its infancy, such efforts might undermine U.S. leadership in nanotechnology.

Future Insights

With the country’s science and technology global leadership at stake, many see the growing field of nanotechnology as an opportunity in which the United States can solidify its place at the forefront of technological competitiveness.  However, the federal government finds itself struggling to promote innovation while facing the increased privatization of knowledge, funding restraints, lagging oversight, and unknown EHS risks.  As nanotechnology’s promises become greater and as the country prepares for a new administration, U.S. nanotechnology policy will continue to be a debated and important issue for Congress, private investors, and independent groups.

Back to top

---

Endnotes

1. Keiner, Suellen.  “Room at the Bottom?  Potential State and Local Strategies for Managing the Risks and Benefits of Nanotechnology.”  Project on Emerging Nanotechnologies, March 2008.
2. Lane, Neal and Kalil, Thomas.  “The National Nanotechnology Initiative: Present at the Creation.”  
3. Sargent, John F.  “Nanotechnology: A Policy Primer.”  Congressional Research Service, May 2008.
4. Davies, J. Clarence.  “Nanotechnology Oversight: An Agenda for the New Administration.”  Project on Emerging Nanotechnologies, July 2008.
5. Taylor, Michael R.  Keynote address, “1st Annual Conference on Nanotechnology Law, Regulation, and Policy,” February 2008.
6. Davies, J. Clarence.  “Nanotechnology Oversight: An Agenda for the New Administration.”  Project on Emerging Nanotechnologies, July 2008.

Updated October 9, 2008