The 2016 Nobel Prize for Chemistry was recently awarded to three researchers for their work on the design of tiny molecular machines. Though this is the first time that nanotechnology has captured a Nobel, it is not surprising.
But with great promises come great pitfalls. The critical question is whether this new science harbors destructive powers which, if fully understood, would call for legal restrictions or a ban on the use of nanoparticles.
The public and scientists alike have thus far viewed nanotechnology as a tremendous advance in the quest for lighter materials, more effective pharmaceuticals and better medicine. Exceedingly small nanoparticles are already used in a wide range of consumer products, such as food and food contact items, cosmetics and skin care, varnishes and paints, cleaning products and communication devices.
Silver nanoparticles are inserted into fabrics to function as antimicrobials. Carbon nanotubes are used to strengthen materials. Titanium dioxide nanoparticles make sunscreens clear.
The next generation of nanotechnology may involve nanoscale structures that change when exposed to light, magnetic or electric fields, or the presence of specific molecules. New applications may include targeted drug and gene delivery mechanisms, diagnostic devices, “smart” packaging, cloaking devices and weapons capable of autonomous firing decisions.
New technologies that are initially seen as great advances are sometimes later viewed as exceedingly dangerous. There are many examples. Chlorofluorocarbons made refrigeration, air conditioning and aerosols possible but seriously damaged Earth’s protective ozone layer. Lead additives made paint durable but poisoned children generations later. Asbestos insulated products but destroyed human respiratory systems. Fossil fuels catalyzed industry and transportation but also sped destructive climate change.
The health, safety and environmental risks associated with nanotechnology are largely unknown because the relevant science continues to evolve. Significant knowledge gaps remain.
Research has suggested that some carbon nanotubes may cause serious health problems because they exhibit toxic properties similar to asbestos. However, not all nanotubes are equally hazardous.
It is unclear how law should respond to uncertain-but-potentially-devastating risks. Most consumers have no ability to intelligently evaluative the dangers posed by products containing nanotechnology. Tort litigation is unlikely to provide remedies because of the difficulties of proving causation.
There are regulations in the United States and Europe that cover chemicals that may be produced in nanoform. However, those regimes are not designed to detect the risks posed by nanotechnology because they often fail to appreciate what is unique about nanomaterials.
Nanoparticles can pass through membranes and enter the body via unexpected paths. Because of their tube-like or wafer shape, which results in increased surface area in comparison to mass or weight, nanomaterials may have greater toxicity. Nanoparticles sometimes display radically different physical or chemical properties than their bulk counterparts, and may exhibit special optical, electrical and magnetic behavior.
It seems unlikely that the administration of President-elect Donald Trump or other countries will act in the near future to effectively address nanotechnology risks because those risks are uncertain and the potential costs of regulation are high. Every major industrialized country has invested heavily in the development of nanotechnologies. Because scientific developments move at a rapid pace, any regulatory interruption has the potential to seriously impede innovation and profitability.
Logically, nanotechnology risks should be addressed at the international level because nanomaterials cross borders and pose issues worldwide. Internationally consistent standards would prevent a “race to the bottom” in which countries sacrifice health, safety and environmental interests in an effort to attract nanotechnology enterprises.
Yet, there is little precedent for such regulation. The difficulties of creating of a global agreement to address climate change suggests that it will be a long time before any treaty effectively grapples with nanotechnology.
At present, the best course is to develop the “soft law” predicate for later “hard law” regulation. Soft law refers to nonbinding international norms or agreements that can gradually acquire legal value. Soft-law instruments include codes of conduct, aspirational guidelines, statements of best practices, voluntary reporting, risk management systems, and licensing, accreditation or certification schemes.
The basic role of soft law is to create expectations that, once widely endorsed, can be translated into binding legal obligations.
Minimizing the health, safety and environmental risks related to nanotechnology requires raising the visibility of the issue, collecting reliable data, establishing prudent practices, building an international consensus and eventually enacting and enforcing binding obligations.
Great strides in the development of nanotechnology must reflect a prudent balance between economic progress and hazard prevention.
Johnson is professor of law at St. Mary’s University in San Antonio.