Abstract
It's high time for the United States to get nanotech regulations–and it needs to get them right.
The evidence is mounting. Despite the incredible potential of engineered nano-materials, there are serious questions about the risks–and the U.S. government is fast falling behind in any effort to abate the danger.
Nanoscale materials (measured in units the width of approximately 10 hydrogen atoms), could one day be used to make cleaner fuels; stronger yet lighter building materials; and life-saving drug delivery systems. But there's a big caveat with these tiny particles–exposure to some of them could harm the nervous, pulmonary, cardiovascular, and/or immune systems. Research conducted by the National Institute for Occupational Safety and Health (NIOSH) shows that some nano-sized carbon particles induce pulmonary inflammation and fibrosis in mice, and are capable of crossing the blood-brain barrier. In fish, they caused nerve-cell damage by lipid peroxidation, according to Duke University scientists.
Researchers from NIOSH and the University of Rochester, respectively, also found that polystyrene nanoparticles induced inflammation and vascular thrombosis in mouse lung tissue, and that nano-Teflon fumes are much more acutely toxic than their normal-sized counterparts when inhaled by test rats. Most recently, environmental scientists at the New Jersey Institute of Technology found that certain nanoparticles can stunt plant growth.
Despite these early warnings, government response to potential risks has been woefully inadequate. Only 4 percent of federal nanotechnology funding is earmarked for research on health and environmental effects, and another 4 percent on social implications and education, according to the Project on Emerging Nanotechnologies at the Woodrow Wilson International Center for Scholars. More importantly, federal agencies have failed to enact the necessary, comprehensive regulations to protect the public from unforeseen risks.
The private sector response has been mixed. Some corporations seem concerned only about the public perception of health risks and hope to disavow actual risk by avoiding safety testing, keeping safety data confidential, and reassuring the public. Fearing actual or perceived risks, insurance companies, such as Swiss Re, and financial investment advisers, such as Innovest and Allianz, have called for safety testing and regulatory oversight of the commercial use of nanomaterials. Other large corporations and many small start-ups would also welcome safety testing and regulations, if they were not overly costly or burdensome. Yet little has been done, and existing environmental laws render federal agencies essentially impotent to regulate the nanotech industry.
The Toxic Substances Control Act, enacted by Congress in 1976 to gather information about chemical substances and to control those deemed dangerous to the public or environment, is the most obvious candidate for regulating nanomaterials. But the act lacks an effective means of requiring companies to provide risk data, and it places the burden on the government to demonstrate unacceptable risk–if the government does not respond to evidence of harm within months of a new product application, a company may market its product freely. Other laws are also inadequate. The Food, Drug, and Cosmetic Act, enforced by the FDA, leaves all cosmetics (which could be a big field for nano-use) essentially unregulated, and the underfunded, under-enforced Occupational Safety and Health Act does not satisfactorily protect worker health.
Nanoscale materials could one day be used to create an array of amazing products, such as stronger, but lighter, building materials. But there's a big caveat with these tiny particles–exposure to them might be physically dangerous.
In response to the lack of ready-made regulations, the EPA is developing a voluntary program that will ask nanomaterial producers to submit basic information on material characterization, toxicity, exposure potential, and risk-management practices. In exchange, a company would be able to advertise its participation as a means of dispelling public fears about its product. A more in-depth level of participation would generate more detailed risk information.
While this program fills a gap in the absence of real regulations, it is severely limited in several important ways. It only captures companies that volunteer to participate, and only those products that companies choose to disclose. Companies with the riskiest products, as well as those with poor business ethics, are unlikely to participate. The program also lacks punitive measures; it will do little more than gather data–primarily industry-generated data, which experience has shown are less likely than data from government or independent studies to report products' harmful effects.
In the past, industries have simply downplayed the health risks of such materials as asbestos, lead, vinyl chloride, and other toxics, only to have those materials lead to devastating occupational and public health consequences. For example, in December 2005, the EPA slapped chemical manufacturer DuPont with the largest administrative penalty in the EPA's 3 5-year history for failing to make public more than 20 years of data on birth defects and other harmful effects from its Teflon-related perfluorochemicals. What then is the public to think of DuPont's commitment, two months earlier, to “an early and open examination of the potential risks” of nanotechnology?
An array of good stewardship approaches to nanotechnology development would increase public confidence and market stability. Such measures include increased safety testing conducted by independent or government laboratories subject to “sunshine laws” that allow public access; public disclosure about potential risks; labeling consumer products that contain nanomaterials; and full life-cycle assessments that examine the production, use, and disposal of nanotech products. Unfortunately, the development of new laws to enforce these types of practices are not likely to be forthcoming in the antiregulatory environment fostered by the Bush administration.
In the absence of such laws, many public interest advocacy groups, including the Natural Resources Defense Council, have insisted on immediate action to restrict uses of nanomaterials that may result in human exposures or environmental releases, unless the safety of these uses can be demonstrated beforehand, and to require labeling of consumer products that contain nanomaterials. The federal government, state regulators, and nanotech industry have an opportunity to develop this exciting new technology openly, with public participation and government oversight, but we must demand assurance that our families and the environment are safe. Empty assurances will not win over a wary public.
“Something's up—we've gone to DEFCON 1.”
Supplementary Material
Toxic Substances Control Act: Legislative Changes Could Make the Act More Effective
Supplementary Material
Overview of Issues for Public Discussion and Consideration by NPPTAC