Skin cancer is reaching epidemic proportions in Australia. A combination of long, blistering summers and increased exposure to ultraviolet radiation from the depletion of the ozone layer has pushed up the number of sufferers. Health-care providers delivered over 412,000 treatments for non-melanoma cancer in 1997. In 2010, that figure hit 767,000, the Australian Medical Journal reported last year. By 2015, treatments are likely to top 900,000. The graphs for melanoma cancer are also trending upwards.
Not surprisingly, sunscreens are high on the list of defenses among a nation that prides itself on an outdoor lifestyle. But now some Australians would prefer to go without that protection because of a novel ingredient manufacturers are adding to their creams: nanotechnology.
Industry studies say replacing traditional “bulk” zinc oxide products, which filter UV radiation, with their nano counterparts makes sunscreen both transparent and more effective. The health risk is negligible, they say. In fact, well-publicized research conducted in 2010 by Australia’s science agency CSIRO said that sunbathers using nano-enhanced sunscreens might even enjoy health benefits from marginally increased zinc levels.
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But Australians have been hard to convince. And many non-governmental organizations (NGOs) have sided with the skeptics. Last year, for example, Friends of the Earth, an international network of environmental activist groups, called for stronger regulation, clear product labelling and other measures that would effectively ban the use of nano applications from sunscreens. The document (“Nano ingredients in sunscreen, the need for regulation”) cited research that suggested nano zinc oxide could increase cancer risk for users and, worse still, cause damage to DNA.
“Until risk assessment for nanomaterials is validated and fit-for-purpose detection methods are developed, we do not support the commercial sale of nano-sunscreens,” said Georgia Miller, the author of the report.
There have been similar arguments about nanotechnology in other fields. Five years ago, it was nanosilver. In 2008, an alliance of health and environmental campaigners filed a petition with the U.S. Environmental Protection Agency (EPA) against manufacturers of nanosilver products. It argued that the substance, which is used in washing machines, among other things, could increase the toxicity of waterways.
Before that, it was carbon nanotubes, which are used in medical equipment, building materials, sporting goods and vehicles but may also have the potential to cause cancer. And in 2003, the U.S. Congress became embroiled in a bitter fight about the definition, uses and risks associated with such technologies. Everywhere it is found, this tiny technology seems to cause trouble.
New Risks, New Rules
Nanotechnology refers to the study and application of materials at the atomic and molecular level, specifically anything smaller than 100 nanometers. (A nanometer is one-billionth of a meter—to put this in perspective, a sheet of paper is about 100,000 nanometers thick.) One of the reasons that the risks and benefits of nanotechnology are so hard to pin down is that it does not exist as a single thing. Calling them “nanotechnologies” would be more accurate.
Modern engineering techniques often work at the atomic level, so when products hit the supermarket shelves or enter the industrial supply chain, they are nanotechnologies by default. Those manufacturing processes cut across all sectors—from medicine, computing and cosmetics to energy, plastics and electronics. Sometimes, scientists working on the same product call it by different names because the processes are so new that they may be working in ignorance of each other’s research.
Risk is also difficult to assess because many nanomaterials act in unique ways. Nanosilver, for example, has a much higher surface area than traditional forms of the metal. That makes it excellent as an anti-viral material, and some hospital surfaces have nanosilver particles built into them to help fight superbugs. But the bigger surface area increases its toxicity when it comes into contact with the environment.
Scientists often have to rip up the rule book on toxicology when dealing with nanotech. Only recently have they begun to develop more standardized ways of assessing their potential risks.
In the middle of last year, the standard-setting International Organization for Standardization (ISO) published voluntary guidance for researchers on this issue (ISO/TR 13014:2012). The publication aimed to help experts “understand, plan, identify and address relevant physicochemical characteristics of nano-objects before conducting toxicological tests on them.”
The document is an admission that the traditional approaches did not work because they took no account of the physical aspects of materials. “The old way in toxicology is to think of how much mass there is and work out how harmful it might be,” said Richard Pleus, chair for the report and a member of the ISO technical group that oversees standards on nanotechnologies. “Nanotechnology helped us understand that the surface area of a substance could also influence its toxicity.”
Pleus expects the standard to help with the overall quality of scientific research on hazards, which he admits still needs improvement. That is because more information on each nanomaterial should help to make experiments on them comparable. But these in-depth tests are time-consuming and expensive, and the number of toxicologists in the world is finite. The UK’s Royal Commission on Environmental Pollution warned in 2008 that it would take decades to carry out enough research to produce reliable data that could inform effective regulation.
But industry does not wait. The global market for nanotechnology is growing at almost 20% per year. In 2011, it was worth just over $20 billion, according to the forecasting firm BCC Research. It expects total sales to reach almost $50 billion by 2017.
Lux Research puts global sales even higher. It estimates that if the figures are adjusted to include the sales from so-called composite products, in which nanoscale and larger materials are mixed, the value of the market will reach almost $2.4 trillion in 2015. These are big figures for such small particles.
Regulating in a Vacuum
Given the speed of this growth, regulators initially have had to act in a relative data vacuum regarding potential risks. Different countries have taken different routes. U.S. authorities, for example, do not recognize nanotechnology as a distinctive substance that needs its own definition and separate regulator.
Instead, existing bodies manage applications. The EPA, for example, deals with nanosilver when used as a pesticide; the U.S. Food and Drug Administration deals with nanosilver when it is used as a wound dressing.
The White House’s Emerging Technologies Interagency Policy Coordination Committee published a memorandum on regulating nanotechnology in 2011. The document lists a set of principles for regulators to consider and calls for more coordination between agencies. But it does not specifically define nanotechnology and argues that any judgement on whether nanomaterials are benign or harmful needs to be based on scientific evidence. Gathering data has become a major focus.
Chemical manufacturing in Europe, on the other hand, is regulated under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), an EU regulation that has been in force since June 2007. Now, any chemical imported into, or manufactured in, the European Union in quantities of more than one ton per year must be registered with REACH. If they aren’t, they may not be made or sold within EU borders. While REACH only talks of chemical substances, the European Commission adopted a definition of nanotechnology in 2011 that will underpin all of its regulation of nanomaterials.
Industry experts generally believe that the U.S. system will be more resilient in managing existing and emerging risks in the field. “I think the U.S. regulators are able to handle any risk issues that arise on nanotechnologies,” said Martha Marrapese, partner at the U.S. law firm Keller and Heckman and founder of the practice’s special interest group in nanotechnology. She says that they have a track record in reviewing materials and have chosen to regulate nanomaterials based on whatever scientific evidence they have seen.
U.S. regulators have powers to request more data and deny the release of materials about which they have concerns. They can also fine companies for infringements, such as using false descriptions on their products. Beyond the field of pesticides, however, there has been very little enforcement from the regulators in terms of fines. “Agencies have used those few cases to send out a clear message,” said Marrapese. “Be aware of the programs, and register your products.”
Searching for an Advocate
Andrew Maynard says that Europe’s more-prescriptive view could see some risky, novel materials, which may be larger than 100 nanometers, fall outside of its regulatory framework. And on the whole, Maynard, international chair of environmental health sciences at the University of Michigan, believes that regulators are behind the game when it comes to the more-complex materials now emerging.
Despite the recent ISO standard, he says that U.S. administrators still view risk from the old chemical paradigm and pay much less attention to the potential hazards created by the physical properties of sophisticated materials. These issues have been compounded, he argues, by the way that the industry has been “slow off the mark” to deal with risk and in devising suitable toxicology tests.
“There is an explosion of research in this area,” he said, “and we are beginning to piece together parts of the puzzle. But it is painfully slow and it doesn’t tell us exactly what we need to know.” He also worries that no one seems willing to champion the benefits of nanotechnologies, which allows public debate to be dominated by cries of their potential harms.
Hilary Sutcliffe, director of Matter, a self-styled emerging technologies “action tank,” lays much of the blame for this at the doorstep of big business. She says companies have failed to sell the benefits of nanotechnologies to the public.
In 2008, Sutcliffe set up the Responsible Nano Forum and, prior to that, was a member of the secretariat for the Responsible Nano Code, a multi-stakeholder initiative that developed a principles-based code of conduct for companies involved with nanotechnologies. The code was intended to act as a benchmark for investors, she says, but it failed to get adequate funding from global corporations. It is now used mainly by the Brussels-based trade body, the Nanotechnologies Industry Association (NIA), help to certify product quality and safety.
“We felt, with the Nano Code, that we were communicating into a vacuum, and ultimately people got too frightened to identify themselves with nanotechnology,” she said.
Instead of being driven by the debates around risk and harm, Sutcliffe argues that corporations need to build trust with the public by being open and talking in a measured way about the benefits and risks associated with their products. “You can’t do research all the time because it leads to analysis-paralysis,” she said. “You need to get your products in front of people and talk about them.”
Opening a Nanotech Dialogue
There are few takers. But one of them is the world’s largest chemicals company, BASF. The German-based corporation has been running its Dialog Forum Nano since 2008. It says it has found the process useful.
The project gets a wide range of stakeholders together, including representatives from science, labor unions, commercial and business interests, churches, and environmental and consumer groups, to discuss the company’s products in specific sectors. Policymakers are specifically excluded so that no one attending the sessions is tempted to turn meetings into a soapbox for political advocacy.
“The initiative is part of the company’s risk management of nanotechnology,” said Carolin Kranz, BASF’s senior manager of communications and government relations. Other strands of its risk processes include safety research and political communication, but the Dialog is high on the company’s list of priorities. “Without social acceptance, we can’t sell our products,” she said.
The program does not deal directly with the public but relies on the participants to communicate with their own stakeholders, including the wider population. “Of course, we cannot know what the stakeholders will make of it,” she said.
But it is a risk the company believes is worth taking. Not only does BASF have the opportunity to get its message across and educate the participants, the process acts as an early-warning system. Kranz says that if anyone in the group does not accept nanotechnology in a particular product, that information is fed back into the company and informs its decision making.
While the Dialog initiative has been successful in Kranz’s view, it has also been a challenge. She feels that the company has too many audiences to persuade, each with its own level of technical competence. On top of that, each audience is likely to have its own interests and agendas that it wants to communicate to the corporation. That can be a lot for the company to take on board.
More Government Action Required
Given the prevailing public ignorance and uncertainty about nanotechnologies and the over-riding focus on hazards in some products, the industry trade body NIA wants to see more government action.
“While industries always take the lion’s share of responsibility for communicating the benefits of their products on the market,” said Steffi Friedrichs, NIA’s managing director, “the current risk-centric debates on nanomaterials have also created a strong responsibility for governments to wade in and support nanotechnology’s innovative power. It should ultimately provide an unbiased environment, in which the benefits can be openly communicated.”
For Australians facing more scorching summers, an unbiased assessment of the sunscreen products they use cannot come soon enough. But with the continuing lack of clarity over the risks and benefits of nanotechnologies in so many areas, it could be a long wait. Until then, the threat of uncertain hazards will continue to hover over the entire industry.
Fonte: Risk Management