31 Brazil nano paper - Silbergeld 5/21/2010 8:48 AM
Ethical perspectives on nanotechnology
“NANOTECHNOLOGY could become the most influential force to take hold of the technology
industry since the rise of the Internet. Nanotechnology could increase the speed of memory
chips, remove pollution particles in water and air and find cancer cells quicker. Nanotechnology could prove beyond our control, and spell the end of our very existence as human beings. Nanotechnology could alleviate world hunger, clean the environment, cure cancer, guarantee biblical life spans or concoct super-weapons of untold horror. Nanotechnology could be the new asbestos. Nanotechnology could spur economic development through spin-offs of the research. Nanotechnology could harm the opportunities of the poor in developing countries. Nanotechnology could make the molecules in ice cream more uniform in size. Nanotechnology could enable a digital camera to work in the dark. Nanotechnology could clean up toxic waste on the atomic level. Nanotechnology could change the world from the bottom up. Nanotechnology could become an instrument of terrorism. Nanotechnology could lead to the next industrial revolution. Nanotechnology could transform the food industry. Nanotechnology
could repair the ozone layer. Nanotechnology could change everything.” UNESCO 2008
Introduction
Nanotechnology is the emerging technology of the 21st century. It has been called the “science of the very small.” To many people, it may seem inconceivable that humans are able to manipulate matter at the atomic level, utilizing elements and compounds to form new materials with size and structure not found in nature and with remarkable new properties. From the domain of research to application in consumer products, this technology has moved with remarkable speed enhanced by substantial government subsidies to the private sector and academia.
The ethics of new technologies involve multiple considerations, including the social utility of innovation, impacts on individuals and society, and the political economy of the state. Failures to acknowledge the importance of engaging these ethical concerns are considered to have contributed to major economic failures for the biotech industry as well as negative impacts on US agricultural exports of the products of genetically modified organisms to several countries, including the EU (Cameron 2006).
There are also ethical concerns about the rights of less developed countries and populations within countries to access and share in the potential benefits (including economic growth) of a new technology, which involve but are not limited to legal issues of intellectual property (UNESCO 2008). The proposect of unequal access to the benefits of nanotechnology is a real issue, since investments and intellectual production have been dominated by the US, the EU, China and Japan (see figure 1, from OECD). However, there is evidence that in contrast to biotechnology, other countries have more rapidly participated in research community through “early adoption” of nanotechnology in national programs explicitly linking research to economic growth. In Brazil, nanotechnology policy began in 2001 with a CNPq program to support “Redes nacionais de nanotecnologia” with support at the level of US$5 million increasing to US$58.9 million in 2004 for a for year program of development towards production (Kay ND).
Fig 1. Dominance of US, Japan, and China: publications per year by country of lead author. Data from OECD (http://www.oecd.org/dataoecd/36/17/42326281.pdf).
I am certainly no expert in bioethics, and it is daunting to enter a field that has its own journal (Nanoethics). In this paper, I will focus more narrowly on an issue of relevance to my training and experience in toxicology: the ethical aspects of nanotechnology in the context of understanding health and environmental impacts. Arguably, this is the responsibility of those countries in which new technologies are developed, since these are the locations of the largest economic and human capital resources required for generating a knowledge base for both technology development and assessment.
A reasonable question at the outset is whether nanotechnology raises novel ethical issues, or whether an informative ethical analysis can be built upon experience in areas such as applied biotechnology (Cameron 2006). Nanotechnology is clearly a convergent technology (Roco 2006), in that it is a transformative methodology rather than simply an application. That is, the ability to synthesize and manipulate matter at the atomic scale is being utilized to serve many applied and research purposes, including medicine, engineering, materials analysis, electronics, energy generation and storage, agriculture, biological and chemical sensing, etc. In this way it resembles genetic engineering, which is the transformative technology driving applications in medicine to agriculture. Issues of convergence are of importance in ethics but as Ellul (1968) has argued, it is difficult if not impossible for any sector in civil society to prevent convergence due to the force of technology within modern society.
At some level, many issues in new technologies involve the balance between innovation and caution, which has been a concern in societies since the industrial revolution and of heightened concern following the chemical revolution of the 1880s and the technical revolutions following the Second World War. Rosner and Markowitz (1985) illuminated this tension in their history of the introduction of tetraethyl lead into automotive fuels in the US in the 1920s; the chairman of Standard Oil referred to this innovation as a “gift of God” in response to concerns voiced by public health experts. This event is arguably one of the technological innovations that had the broadest adverse impacts on worker and community health around the world (Silbergeld 1997). The history of TEL also illuminates some aspects common to the introduction of new technology, which characterize the development of nanotechnology as well (Table 1).
Table 1 THE TAXONOMY OF NEW TECHNOLOGIES – 20th AND 21st CENTURYGovernment-industrial-academic partnerships in research
Government subsidies for developing new technology
Promises of major social benefits from technology
Economic benefits (jobs, national economy) promoted by government and industry
Assertions that benefits will outweigh any reasonably anticipated risks or impacts
Applications introduced with minimal assessment of risks
Early applications have marginal social utility or benefits
Concealment of the presence of new technological products in consumer goods
The strategic engagement of academia in the development of new technologies over the past 60 years began in the US with the development of nuclear weapons during the Second World War, and has been critical to the subsequent development of microelectronics, biotechnology, and nanotechnology. In the US the origins of this national strategy goes farther back, to the so-called land grant state university system, established by federal and state government to support institutions of higher education with the goal of strengthening American agriculture. The modern era of massive investments in higher education and academic research in the US began after the Second World War, based upon the vision of Vannevar Bush, who connected support for education and research with economic growth. This not only fostered the growth of the modern American research universities, such as Johns Hopkins, but, as argued by Krimsky (1999) and many others, compromised the independence of academic scholars as critics of technology. This compromise can be lessened when governments also invest in the production of knowledge relevant to the safe development and application of technology, but this rarely happens on a scale or time course sufficient to provide relevant and timely information to government, industry, and the public on the risks and benefits of a new technology.
Because of the importance of timely and accessible information about new technologies, I propose to examine the ethical aspects of nanotechnology in the context of the control of knowledge, that is, the ethics of ensuring adequate knowledge on risks and benefits prior to introducing innovations in the workplace, marketplace, and environment. The generation of information and access to that information are the first ethical requirements for an informed social debate among parties at interest, for governments to make decisions and for the public to participate in the process. Among others, William Ruckelshaus (twice administrator of the US EPA) noted the adverse impact of complicated decision making tools (such as risk assessment) because of their impact on the ability of the public to participate in democratic processes (1983). It is relevant that the proposed Safe Chemicals Act of 2010, introduced in the US Senate, requires that risk assessments be “understandable.” NGOs and others have challenged its efficacy as a regulatory tool as well as the increasing suspicion of the public that it is a malleable tool for political and economic purposes (Silbergeld 1993).
Barriers to information on technological risks in the US
Before discussing the problem of information as an ethical issue in nanotechnology, it is important to recognize that there are general impediments to information on technological risks in many countries. These include barriers to accessing information when it exists and the obstacles to requiring the generation of new information. The former set of barriers are embedded in economic policy and law in many countries, establishing the concept of “confidential business information” or the right of industry to keep information away from the public on the grounds of its economic value to competitors. Ethically, adoption of such policies places a higher value on the interests of the private sector than on the value of an informed public. This deference is not restricted to capitalist economies: in many countries, as catalogued by the OECD Environment Program, even state-owned industries enjoy protection from public disclosure of information on health and safety. With the rise of regulatory agencies with mandates to register (approve) chemicals and technologies, this deference has been reduced to some extent, but these agencies accede to claims of confidential business information in terms of the extent of data collection and public access to this information (in the case of pharmaceuticals and pesticides in the US, for example). Confidential business information will be maintained in the new REACH legislation in the EU.
The second set of barriers are more complex and in many ways raise more systematic problems as they prevent the generation of information ab initio, and without information, the right of access is irrelevant. For chemicals there are major barriers in current laws and regulations in the US to requiring the production of information on the products of new technology. Unlike drugs and pesticides, new industrial chemicals (which are how nanomaterials may be defined; see below), are not required to be tested prior to their production and use. Under the current Toxic Substances Control Act (TSCA) for existing chemicals the procedural obstacles to government requesting information are difficult to surmount, such that it is now universally accepted that chemicals are assumed to enjoy the Anglo-Saxon right of innocence until proven guilty. As a result, the majority of existing chemicals (even high production volume chemicals) have little or no information to support an assumption of safety about their presence in the environment or their use by workers and consumers. For new chemicals, the burden is placed on the EPA to demonstrate a need for information, rather than on the producer to supply this information. This has resulted in a policy of “don’t tell, don’t ask” in the US, in which industry is not required to tell and government is unable to ask.
In the US, there is argument as to whether current laws could empower agencies to act on nanomaterials as new chemicals. The US chemicals law defines existing chemicals based on chemical composition nomenclature from the Chemical Abstracts Service (CAS); as titanium dioxide or carbon are already listed on the TSCA inventory, these substances in nanoform would have to be regulated as an existing chemical. The newly proposed Safe Chemicals Act redefines the scope of regulation to include “chemical substances and materials,” which is recognition of the issues involved in defining nanomaterials. TSCA does provide EPA with the powers to initiate new regulations under conditions of a “significant new use”, but this has in the past been interpreted as a mass-based criterion of significance. Since the total mass of any nano-based use of titanium or carbon would be very small, “significant new use” would need to be interpreted as a use involving a different form, properties, and purpose. Those countries that have adopted principles of chemical regulation from US law and practice have similar barriers.
Recent advances in regulation and law, starting in the EU with the REACH legislation, have dramatically shifted the burden to producers to provide evidence of safety for existing and new chemicals, rather than governments having to justify a request for information. The feasibility of implementing REACH remains hotly debated in terms of the resources ot time, expertise, and animals that will be required (e.g. Hartung et al 2009; Williams et al 2009). Moreover, it is not yet clear if REACH can “reach” nanomaterials; as with TSCA its requirements for information are based upon volume (mass) of production and use. Even for carbon nanotubes, a nanomaterial with increasing uses in consumer products and industrial processes, growth in production is still below the threshold that triggers submission of comprehensive information on health and ecological impacts.
Other regulatory agencies in the US are similarly limited when information is lacking. The Consumer Product Safety Commission, which has the power to regulate products (under current US law the EPA only regulates chemicals), is not able to undertake independent analysis of constituents in products; it acts upon findings from EPA or other agencies with respect to risk assessment. At the FDA, nanomaterials have so far fallen into the large loophole for evaluation and action related to the concept of GRAS (generally recognized as safe), a designation created decades ago on the basis of expert judgment that results in an assumption of safety without the need for additional data or de novo hazard or risk evaluation. Discussions at the FDA have centered on whether a substance that has been considered GRAS, or safe at the macroscale should also be considered safe at the nanoscale. Michael Taylor, newly appointed deputy director of the Center for Food Safety at FDA has stated that nanoparticles with novel properties should be deemed to be new substances for purposes of safety evaluation but up to the present, FDA has undertaken no actions to restrict use of nanomaterials or to require safety evaluations.