News Room
Publications
Nanotechnology and the Dilemmas Facing Business and Government
Nanotechnology and the Dilemmas Facing Business and Government
James R. Brindell, Esq.
Gunster, Attorneys At Law
Human beings have been obsessed over the course of history with building larger and larger structures; for example Stonehenge, the Great Pyramids of Egypt, the Empire State Building, the Sears Tower. Today, that obsession continues in China and Dubai. In December of 1959, however, Dr. Richard Feynman, a recipient of a Nobel Prize in physics and a former scientist on the Manhattan Project, challenged the scientific community to think small. When he delivered a lecture entitled “Plenty of Room at the Bottom,” he suggested, among other things, that by “maneuvering things atom by atom” the twenty-four volumes of the Encyclopedia Britannica could be written on the head of one pin. He noted that biology was already aware of the ability of a single cell to carry DNA molecules containing complex information. Dr. Feynman observed that “atoms on a small scale behave like nothing on a large scale, for they satisfy the laws of quantum mechanics.”1 In 1986, Dr. Eric Drexler, who popularized the term “nanotechnology,” introduced in a book entitled Engines of Creation, the scientific concepts by which molecules can be assembled at the nano level to make usable items.2
The Essentials of Nanotechnology
Nanotechnology (molecular manufacturing) is part of a triad of parallel technological advances known as “GNR” (i.e., genetics, nanotechnology, and robotics) which are accelerating exponentially. For example, the computing capacity of computers nearly doubles every year.3 It is estimated that the twenty-first century will produce technological advances, equivalent to that of the past 20,000 years,4 that by the 2020’s, nanotechnology will enable us to “create almost any physical product from inexpensive raw materials and information,”5 and that within a few decades artificial intelligence will exceed that of humans.6 These advances are expected to create a merger of biological and technological evolution.
What are nanomaterials? They are not a specific material, but rather are particles of any material with a least one dimension in the range of 1 to 100 nanometers. A nanometer is 1 one-billionth of a meter (i.e. 39.4 inches divided into a billion increments.) For example, a single strand of hair is approximately 75,000 nanometers in diameter; and a molecule of DNA is 2 nanometers wide. Ten hydrogen atoms lined up end to end equal one nanometer, and the smallest object which an eye can see is 10,000 nanometers, or about one seventh the width of a hair.7
To understand the level at which nanotechnology works, we need to recall some of what we learned in school about atoms and molecules. This is the level at which the construction of materials occurs in this new age technology. Atoms are comprised of a nucleus of positively charged protons and neutral, non-charged neutrons orbited by negatively charged electrons. The balance achieved between the attractive force between an atom’s protons and electrons and the repulsive force between that same atom’s electrons keeps the atom together. Molecules are comprised of atoms held together by chemical bonds and can be comprised of a few or thousands of atoms. Collections of molecules held together by electrostatic force make up the materials we use.8
The National Science and Technology Council’s Committee on Technology issued a report in 2000 in which it touted nanotechnology as the “Next Industrial Revolution.”9 What raises nanotechnology to the level of a new Industrial Revolution is its extraordinary reach across the world’s societies, its economies, and the environment and the potentials for good and bad presented by these materials. The impacts on human culture will be unprecedented, and the potential for catastrophic effects has some people suggesting that the world powers and scientists should agree to relinquish research in certain areas of GNR. A thoughtful discussion of these concerns can be found in an article by Bill Joy, a co-founder and former chief scientist for Sun Microsystems, entitled “Why The Future Doesn’t Need Us.”10
Some fifty years after Dr. Feynman’s challenge, the development and use of nanomaterials is occurring at a far more rapid rate than is the research on the effects of those materials on manufacturing personnel, consumers, and the environment. That presents challenges to business and government. Despite this rapid proliferation of nanomaterials, there are no state, national, or international requirements for the manufacturers and users of nanomaterials to report to a central data base the nanoproducts manufactured or used. Nor is there any regulatory requirement to notify consumers through product labeling.
It is predicted that nanotechnology could lead to less invasive surgery; elimination of hunger, homelessness, and pollution; more targeted drug delivery; lighter, stronger materials that make transportation safer and more energy efficient; extended life spans of hundreds of years by enabling cellular repair which might slow, halt, or reverse the aging process. Yet, the potential for vast and historic negative impacts on central aspects of world culture create a heightened concern around the development and use of nanomaterials. For example, the potential to: extend dramatically life expectancy through damaged cell repair or replacement raises issues of population sustainability; create consumer products at minimal costs raises concerns about adverse impacts on jobs and the world economy; create extraordinarily small and inexpensive surveillance devices which could be embedded everywhere raises concerns for privacy; replicate all types of weaponry at little cost raises concerns for more effective terrorist groups, rogue states, and worldwide conflict; cause respiratory, dermal, and inter-organ damage; create end-of-life product damage to the environment. Discussions about these potential impacts are occurring across the world, but without much notice by the general public.11 These concerns have even spurred a debate among ethicists about whether nanotechnology has such potential for impacts on human life that it has created a separate niche of nanoethics.12
Nanomaterials and nanotechnology are currently used in cosmetics, food, clothing, sports equipment, medical treatments, electronic sensors, and environmental remediation.13 The Woodrow Wilson International Center for Scholars maintains an inventory of products using nanomaterials which are currently on the market. The Center reports that there are some 807 such products manufactured by 420 companies in 21 countries. Examples of such consumer products are: Bianchi 928 carbon road bike; Acticoat Wound Dressings; Kara Vita Everyday Skin Penetrating Cream; First Response Home Pregnancy Test; Apple iPod Nano; Elmer’s Nano Glue; Summitek Nano-silver Toothpaste; Eddie Bauer Nano-Tex Shirt; Nanoceuticals Artichoke Nanoclusters; Samsung washing machine; Nano Pacifier; Silver Nano Baby Milk Bottle; Zellers Fullerene C-60 Eye Cream; Toshiba Lithium-Ion Battery.14
When materials are assembled at the nanoscale, they have the capability to behave in ways which are not characteristic of their behavioral traits on the macroscale. At the nanoscale, their physical, biological, and chemical properties may be different. Those altered properties may include color, solubility, material strength, electrical conductivity, and magnetic behavior. At the nanoscale, there is such a large increase of surface area to volume that the materials can become much more highly reactive to other materials. These altered properties increase their ability to be inhaled and ingested, to react with human tissue and cells in a toxic manner, and to cross between normal structural barriers in the body.15
The Challenges of Nanotechnology
The basic problem confronting governments and regulators is the lack of data on the pathways and possible effects on people, animals, and the environment in general, and the lack of generally accepted best practices and standards for handling these materials. Meanwhile, the great potential of nanomaterials to improve all facets of our lives is accelerating the use of these materials in the world’s marketplaces. The result is a reluctance by government to impose testing-first or other regulatory requirements. At the same time, there is anxiety over the risks of unknown negative impacts. For example, to work effectively and efficiently, nanobots need to be programmed to self-replicate. Without adequate controls on, or defenses against, runaway self-replication, assaults on earth’s ecosystems and humans could be unleashed inadvertently or intentionally. This information void is filled by fictional works such as the 2002 novel Prey by Michael Crichton, in which a swarm of air-borne nanobots escape from the lab where they were produced as a result of filters improperly installed in air vents. The nanobots are solar-powered, reproduce, have enough intelligence to adapt and, of course, kill human beings.16 More recently, the escape of nanobots in San Francisco is the background for a mystery novel entitled Tiny Little Troubles.17 Preventing such catastrophic results will require strong international conventions with supporting national laws and an effective network of detection and enforcement systems.
These risk issues are the subject of an extensive report issued by the British Royal Commission on Environmental Pollution in November of 2008. The report describes the problem confronted by government as the “control dilemma” which is compounded by the “condition of ubiquity.” The Royal Commission explains the problem this way:
In the early stages of development of a technology we do not know enough about its future implications to establish the most appropriate management regime. But by the time problems emerge, the technology is likely to have become too embedded to change without significant social or economic disruption…
The challenge of controlling novel materials is exacerbated by the fact that they are seldom encountered as discrete entities, but are likely to be contained within products. This introduces two further implications, making them very difficult to control. First, it means that they will not necessarily be recognizable and may, therefore, escape regulatory attention. Second, in the context of a globalized economy and world trade, they are likely to become ubiquitous. Controls established in one country or region may not be observed by producers of goods which are likely to be circulated worldwide.18
Efforts to Address the Challenges
The U.S. National Nanotechnology Initiative (NNI) was established in January of 2000. Congress enacted the 21st Century Nanotechnology Research and Development Act in 2003, which authorized $849 million for fiscal year 2004 in support of the National Nanotechnology Initiative. It required the President to implement a national nanotechnology program to be overseen by the National Science and Technology Council. Section 9 of the Act requires the establishment of an American Nanotechnology Preparedness Center to: (1) conduct, coordinate, collect, and disseminate studies on the societal, ethical, environmental, educational, legal, and workforce implications of nanotechnology; and (2) identify anticipated issues related to the responsible research, development, and application of nanotechnology and make recommendations to address such issues.19 A December 2008 report by the National Research Council criticized the Initiative for not providing an adequate strategy to evaluate the health and environmental risks of nanomaterials.20 NNI rejected the Council’s criticism in a January, 2009 rebuttal.21
The Environmental Protection Agency (EPA) described its Nanoscale Materials Stewardship Program in the Federal Register on January 28, 2008. This program addresses nanoscale materials under the Toxic Substances Control Act (TSCA). It is a voluntary program and does not relieve a participant from any requirements under TSCA. The purposes of the program are to assist EPA in acquiring existing information, developing new data, identifying risk management practices pertinent to nanoscale materials, and encouraging responsible development of nanoscale materials. With respect to this last purpose, EPA cites to the description of “responsible development” by the National Research Council: the balancing of efforts to maximize the technology’s positive contributions and minimize its negative consequences. Thus, responsible development involves an examination both of applications and of potential implications.
The program has two parts. The Basic Program involves participants reporting to EPA all known or reasonably ascertainable information on specific nanoscale materials and on risk management practices. The In-Depth Program invites participants to sponsor by themselves, or with a group, the development of data on the physical and chemical characterization of materials, health and environmental hazards, use, exposure and releases of materials and risk management and safety practices. Both of these parts of the program are subject to claims of confidential business information (CBI) under TSCA. EPA asserts that the benefits to participants include the sharing of data which would enhance a stakeholder’s ability to make informed decisions and would help them in identifying and developing appropriate health and safety plans for their work places and throughout the supply chain of nanoscale materials.22 EPA reports that as of December 8, 2008, only twenty-nine companies and trade associations made submissions under the Basic Program covering 123 different nanoscale materials. By that same date, only four companies had agreed to participate in the In-Depth Program. Materials submitted have provided information on physical and chemical properties, uses, manufacturing processes, and risk management practices, but have provided little information on toxicity or fate studies.23
On October 31, 2008, EPA issued a notice stating that it “generally considers CNT’s (carbon nanotubes) to be chemical substances distinct from graphite or other allotropes of carbon listed on the TSCA Inventory. Many CNT’s may, therefore, be new chemicals under TSCA section 5.”24 The effect of this notice is that anyone who intends to manufacture or import a CNT which is not on the TSCA Inventory must submit a pre-manufacturing notice (PMN), or exemption, at least 90 days before starting the manufacturing of the CNT. Then, on November 5, 2008, EPA announced a Direct Final Rule promulgating significant new use rules (SNUR’s) for two nanomaterials: Siloxane modified silicon nanoparticles and Siloxane modified alumina nanoparticles. With regard to the modified silica, EPA stated it has concerns for lung effects and for potential systemic effects from dermal exposure. It also indicated that the use of the material should be with impervious gloves or NIOSH-approved respirators. EPA stated that based on the physical properties of modified alumina it has concerns for potential systemic effects from inhalation and dermal exposure and made the same statement about using gloves or a respirator as it did for modified silica.25
EPA also issued a guidance paper in January 2008 describing its general approach to determining whether a nanoscale substance constitutes a new chemical substance under TSCA. It is clear that EPA will not use particle size as a determining factor. Rather, the determination will be based on whether a particular nanoparticle of a material has the same molecular identity as a macroparticle of that material. If the identity is different, then the nanoparticle will be considered a new chemical substance even if the macro form of the material is on the TSCA Inventory. EPA considers substances to have different molecular identities when they: have different molecular formulas; have the same molecular formulas, but have different atom connectivities; have the same molecular formulas and atom connectivities, but have different spatial arrangements of atoms; have the same type of atoms, but have different crystal lattices,26 are different allotropes27 of the same element, or have different isotopes28 of the same elements.29
The Foresight Nanotech Institute, a nanotechnology think tank, and Battelle, the world’s largest non-profit independent research and development organization, released a detailed report in January 2008, a detailed report identifying the multi-disciplinary research and development collaborations between academia, government, and industry which are necessary to achieve atomically precise manufacturing (ATM). The report was the result of three years of effort by 70 research scientists, nanotechnology theorists, and business leaders. It includes 39 working group papers.30 The report does not include a discussion of whether or how the collaborating groups should address research on the potential negative impacts of ATM or its products. Yet, it observes that nanotechnology “…characteristics of scale, cost, and performance point to far-reaching, disruptive change that spans multiple industries.”31
Currently, the State of Florida has no state statutes or rules expressly regulating the health or environmental impacts of nanotechnology. Yet, there is a considerable amount of activity involving the development and use of nanomaterials by businesses, research centers, and universities in Florida. It should be noted that local governments in Florida are not precluded from regulating nanomaterials and that some local governments in other states are beginning to engage in such activities. In doing so, they might look toward the City of Berkeley, California which has adopted an ordinance which requires that all manufactured nanoparticles be reported in a disclosure plan as well as a disclosure of the “current toxicology of those materials to the extent known and how the facility will safely handle, monitor, contain, dispose, track inventory, prevent releases and mitigate such materials.”32
Cambridge, Massachusetts published a report in July of 2008 based upon a year of work by the City’s Public Health Department and a Nanomaterials Advisory Committee appointed by the City Manager. Members of the Advisory Committee included representatives of businesses developing nanomaterials, MIT, Harvard, Carnegie-Mellon, and the Woodrow Wilson International Center for Scholars. The report recommended that the City not adopt a regulatory ordinance “at this time…in recognition of the limited health effects data and the absence of a clear consensus on best practices and standards for these engineered nanomaterials.”33 Instead, the Advisory Committee recommended that a survey be sent to over 100 facilities where nanomaterials are believed to be present (not including consumer materials) collecting sufficient materials to identify potential risks, exposures, and exposure mitigation strategies. They would establish a voluntary technical assistance program to share information and to develop best management practices for health and safety, would establish a public information program, and report to the City Council every two years.34
The National Science Foundation and EPA provided grants in September of 2008 for the establishment of two Centers for the Environmental Implications of Nanotechnology (CEIN). One center is located at the California Nanosystems Institute at UCLA and the other one is located at Duke University. They “will study how nanomaterials interact with the environment and with living systems, and will translate this knowledge into risk assessment and mitigation strategies…”. Each of these centers will collaborate with a number of other national and international science and engineering laboratories.35
Though they have entered the arena of regulation, it is clear that U.S. federal and state governments have been disinclined to establish a comprehensive notification of use or regulatory program for nanomaterials, or to require proof of no harm to human health or the environment before allowing a particular nanomaterial to be used.36 While the government does not want to stymie the research and development of nanomaterials, that places an added burden on the scientific community and businesses. They must use particular care to anticipate the potential health and environmental problems which might occur along the pathways of development, use, and disposal of these materials. Transparency will be especially important to head off unfounded, reactionary concerns by the public and special interest groups.
The Task Ahead
There is a strong need for the nanoscience community to communicate effectively with the public and policy makers. In line with EPA’s Stewardship Program, the research labs and manufacturing sectors which are developing and using nanomaterials could employ a proactive course of action in an effort to avoid an event which evokes a harsh public outcry and stringent and overly broad regulatory reaction. After all, these labs and manufacturers are in the best position to identify the potential pathways along which the specific materials may travel and the likely risk points to health and the environment. These groups could develop in cooperation with each other the impact assessment methods and protocols to measure such impacts and risks, and then share that information with each other and the government. There is sufficient experience to know that hiding such information, or not generating it, ultimately results in reactionary regulatory and judicial sanctions.
The nanotechnology industries should consider encouraging federal pre-emption and the placing of regulatory control within one federal agency in exchange for mandatory reporting of the development and use of nanomaterials, the development and disclosure of test data, and the labeling of consumer products. Focusing the data collection and regulation within one federal agency would preclude subjecting the nanomaterials industry to potentially overlapping and conflicting regulations, would minimize the possibility that an issue of concern might fall unattended between agency programs, would enhance public’s confidence that their health and safety are being protected, would produce more comprehensive and fact-based public policy, and would reduce the likelihood that the government would be an unnecessary obstacle to the advancement of nanotechnology.
Until a legal framework evolves, individual businesses developing, importing, using, or selling nanomaterials will have to chart their own courses with respect to potential liability for nuisance, negligence, strict liability, and environmental damage. Good starting points might be Nano Risk Framework developed by the Environmental Defense Fund and the Dupont corporation37 and the International Organization for Standardization’s environmental management systems requirements and guidelines under ISO14001:2004 and 14004:2004.38
The limited scientific data on adverse impacts when coupled with the industry knowledge that nanoscale materials may not behave in the same ways that they would be expected to do at the conventional scale and the general lack of public awareness create a serious obligation on the parts of R&D laboratories and manufacturers to conduct sound research on the effects of the nanomaterials they develop or use in products. Consequently, those manufacturing and selling nanomaterials need to evaluate their potential exposure to liability and develop a risk reduction plan. This brings into play the conflict driven by the manufacturers’ obligation not to cause harm to employees, consumers, and the environment and the pressure to be competitive by getting products to the marketplace.
Industry may look to their existing liability insurance as a protection, but their policies may have specific exclusions for such coverage or the insurer’s may take that position. New policies covering damage and harm from nanomaterials may be difficult, or impossible, to obtain. Industry developers and users of such materials may need to fund industry group self-insurance pools. That could lead to cooperative R&D on effects and standardized protocols for the development, use, and disposal of nanomaterials. That would be a better course than government regulation based on little knowledge or requirements established by the judiciary.
Originally published in the Environmental & Land Use Law Journal of the Florida Bar - July/August 2009