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POLICY: Nanotechnology and the Regulation of New Technologies by Bart Mongoven

Bart Mongoven is a senior analyst with Austin based strategic intelligence consultancy  Stratfor.com, where he tracks public policy. This piece first appeared in the Stratfor Public Policy Intelligence Report. If you find his analysis interesting, you may want to take a look at his earlier analysis of the issues facing California Gov. Arnold Schwarzenegger’s health reform plan. You also may want to consider signing up for their free email reports, which I find very useful and well-informed.  — John 

Researchers from the Woods Hole Oceanographic Institution and Massachusetts Institute of Technology on Aug. 16 released a study stating that the production of carbon nanotubes gives rise to the creation of a slew of dangerous chemicals known as polycyclic aromatic hydrocarbons, including some that are toxic.
Discussion of a new regulatory regime for nanotechnology has been ongoing among think tanks, advocacy groups and industry for years, and findings that suggest the sector could generate public health risks will add to the growing pressure on regulators or legislators to decide how to regulate it.

The debate over the regulation of nanotechnology has taken place on two levels. The first is over the public health risks nanotechnology poses and ways to determine and measure those risks. This is mainly the familiar risk-assessment process applied to the products of a technology that acts slightly differently than previous technologies do.
At the center of a second debate over public policies governing nanotechnology is an older, more contentious issue: the politicization of science and technology.

At issue is the point at which government is justified in stepping into the realm of science to stop or slow scientific research, regardless of whether harm has been done. This concern lay at the center of the early debate over biotechnology, and also played a role in the debate over federal funding of stem cells and bans on human cloning.

A number of efforts are currently under way to determine the answers to the first question. The most impressive of these efforts are occurring in a number of partnerships between corporations and advocacy groups or think tanks. By contrast, the debate over the second question is largely being ignored. Where it is taking place, the discussion is occurring by implication.

What ultimately happens with the risk-centered regulatory debate will impact this larger philosophical debate, and will be crucial to the rules governing the coming wave of new technologies. This new wave will include even more controversial issues, including human cloning and synthetic forms of life. These issues will challenge the public to accommodate technological progress in their world views.

Nanotechnology

Nanotechnology was defined by one of its founders, Nobel Prize winner Rick Smalley, as "the art and the science of building stuff that does stuff on a nanometer scale." Essentially, nanotechnology is the manipulation of atoms and small molecules at a level that is slightly different from chemistry. While nanoparticles generally behave like traditional chemicals do, in some cases they can be very different. In these slight differences lies the technology’s promise — namely, what is possible through chemistry has been studied for centuries, while nanotechnology mostly remains an open field. Still, as one observer has put it, to say that we should regulate nanotechnology is the equivalent of saying we should regulate a hammer — nanotechnology is a tool, and its creations will emerge as the subject of regulatory debate.

Nanotechnology is currently used in commercial applications, most famously sunscreens and stain-resistant pants. The next five years will see a boom in the use of nanotechnology in applications ranging from greatly improved batteries to stronger, lighter materials to improved military weapons. At the base of nanotechnology are some prevalent building blocks, most importantly carbon nanotubes, fullerenes and buckminsterfullerenes or "buckyballs." (Fullerenes and buckyballs were named after Buckminster Fuller, considered the godfather of nanotechnology, because their shape is similar to his geodesic dome.)

The major players in nanotechnology include all of the large research-based chemistry companies, including DuPont, Dow Chemical Co., Corning Inc., General Electric Co. and a number of smaller research companies that cluster around universities in the Northeastern United States. The way these companies currently use nanotechnology has given rise to the first set of regulatory concerns surrounding nanotech. The questions raised by this use will be answered by rules regarding what these manufacturers must guard against in production, use and disposal of nanotechnologies. In June, DuPont and the environmental group Environmental Defense provided a preview of the likely framework for nanotechnology regulation.

Most of the larger corporate players view nanotechnology as an important addition to a new generation of chemistry and to biotechnology. It is in the combination of chemistry, biotechnology, electronics and nanotechnology — specifically the combining of nanoscale devices with specially engineered living organisms — that a real revolution in materials, devices and medicine lies. It is also here that the controversy surrounding nanotechnology is strongest, as it raises questions about the foreseeablity of risks and the desirability of certain technological advances.

When to Regulate?

Modern chemistry is regulated in industrialized countries by a process known as risk assessment, which is a complex scientific assessment that determines whether the potential risks posed to health and the environment of a certain chemical outweighs its value in commerce. In the United States, chemicals are regulated by the 1976 Toxic Substances Control Act (TSCA). In Europe, they are regulated by a new process known as the Registration, Evaluation and Authorization of Chemicals (REACH).

As the framework created by Environmental Defense and DuPont shows, nanotechnology probably can piggyback on chemical regulation, but it will require a slightly different set of standards than chemical regulations do. Important differences include measuring exposure and dose-response relationships. For example, Andrew Maynard of the Woodrow Wilson International Center for Scholars points out that for some nanoscale materials, such as titanium dioxide, toxicity is based on the surface area to which sensitive tissue — lung tissue in the case of titanium dioxide — is exposed, rather than simply the mass of the material. The dose still makes the poison, but the dose needs to be measured differently than in traditional chemistry. In addition, the current regulatory framework needs additional tools to anticipate harm, a controversial but largely successful element of chemical regulation far more difficult to apply in the new field of nanotechnology.

These regulatory questions have come at an interesting point. The European Union is only now beginning to implement REACH, and its coming into force has triggered changes in the marketplace and accelerated efforts to change U.S. chemical regulation. For some in the United States, the imminent commercial boom in nanotechnology calls for the widening of TSCA to cover nanotechnology.

Many see REACH as more protective of public health and the environment than TSCA. As such, there is a growing movement in the United States for the adoption of REACH-like chemical regulations. For those calling for a complete reassessment of TSCA, the revolution in nanotechnology has come at the right time. They argue that TSCA cannot cope with the challenges of nanotechnology, so therefore the law should be revamped to prepare for the next wave of technology. A number of states are currently considering their own REACH-like laws, and the "opening" of TSCA (Capitol Hill-speak for rewriting the law) seems increasingly likely in the coming years.Politics and Technology

Ultimately, REACH and REACH-like laws deal only with the risks posed by the substance. They do not address the moral or social questions relating to whether society wants certain technologies to advance, or even whether the government has a right to stop the development of new technologies.

In the Western conception — strongest in the United States — individuals, groups and companies are allowed to do whatever they want until or unless that activity is proven harmful to others. Attendant social, cultural or economic changes have seldom been allowed to stand as a reason not to allow a technology. The classic example is the fate of the buggy whip manufacturer of the early 20th century driven out of business by the advent of the automobile. The manufacturers certainly experienced economic losses, but this cost was accepted as the price of technological advance. Similarly, the manufacturers of black-and-white televisions, vacuum tube amplifiers and film all have seen their businesses decimated by technological advances.

Still, the introduction of biotechnology to Europe sparked a protectionist reaction. The food that has been served to millions of Americans daily without incident was made, and largely remains, illegal for European consumers. Europeans have justified their bans on biotechnology using various scientific and ecological arguments, but with a few exceptions, their assertions are considered scientifically tenuous. This is not to say justifiable reasons for Europe to ban genetically modified organisms (GMOs) do not exist, just that the reasons the European Union has given for bolstering their laws are flimsy by almost any scientific account.

Instead, Europe approached biotechnology by banning products on social and cultural grounds. To do this, they appealed to the precautionary principle, which more or less states that in the presence of fear but the absence of hard data, a product should be proven not to be harmful before being allowed on the market. With the act of proving a negative still being impossible, when the principle is used in a regulatory context, it becomes a tool to ban a product or activity without proof that the thing is actually dangerous — a clear reversal of the traditional process of letting people and companies do what they want to do as long as it harms no one.

The European Union saw biotechnology as bringing change to the economics of farming, reducing the margins for farmers, encouraging larger, corporate-owned farms and placing multinational seed companies that double as chemical companies in a powerful position on the farm. Such a shift was unacceptable to many EU countries, especially France. Making matters worse, the biotechnology companies argued that their products were materially no different than traditional products and should not be labeled as being different in any way. To Europeans (and also to the Japanese), bringing technology to food is suspicious to begin with. And saying it should not be labeled is akin to demanding the ability to foist a technology in a very personal place — food — on a helpless public. The EU bans on GMOs came for these reasons.Products and Morality

World Trade Organization (WTO) rules contain prohibitions against the use of safety or health regulations as barriers to free trade. Under WTO rules, to avoid claims that product bans or prohibitions are protectionist, countries’ regulations (or those of groupings like the EU) must reflect the standards set by the International Organization for Standardization (for products) or Codex Alimentarius (for food). Stricter standards can be judged to be trade barriers rather than legitimate protective regulations. While fighting in venues like WTO and Codex on behalf of the precautionary principle — arguing that it is only sane to look before you leap and better to be safe than sorry — the European Union has been forced to develop scientific arguments that meet the WTO’s requirements. These have failed generally, and the union is under sanction for these regulations.

Nanotechnology (along with the coming combination of nanotech with other new technologies) has the potential to bring the precautionary principle back in a new, more coherent form. This would be marked by the public, regulators and legislators arguing over whether advances in science and technology should be political, rather than scientific.

American business expresses exasperation at the European Union’s use of the precautionary principle, the bans on GMOs, hormone-fed beef and certain other products, and other such issues. At the same time, the United States has a number of regulations and policies applying the brakes to technology that do not solely rely on risk assessment and the assertion that the individual or corporate behavior is risky to others. The ban on human cloning and the federal government’s decision not to fund stem cell research are examples of U.S. government decisions that certain technology is not desirable, regardless of the long-term potential benefit to society and assertions that by law these practices do no harm and therefore should be legal.

Nanotechnology in most applications does not rise to the level of controversy associated with human cloning or even stem cell research, but in some envisioned applications it does raise serious moral questions, especially when tied to emerging biotechnologies. Among the most intriguing of these is the development of synthetic life. A recent patent application was submitted for an organism composed of cells whose genetic makeup has been limited only to the genes necessary to maintain life. These synthetic organisms, combined with nanotechnologies that can provide structure and even potentially movement, create essentially programmable living things. The applications for medicine, remediation and manufacturing are legion. The moral questions to some are just as vast. In an attempt to raise concerns, one activist group has nicknamed the patented synthetic organism "Synthia."

Stopping Synthia’s creation could prove difficult. Its creation, life and disposal will not hurt anyone. Like Dolly and the dozens of cloned animals that came after, it is not human. Those who want to stop Synthia’s creators can argue they do not want this technology to advance, but in the strictest regulatory sense, what is happening is legal. Still, there probably will be potent debates in Washington, Brussels and other capitals over the limits society wants placed on biotechnology and nanotechnology, and politics will be playing a role in the future of technology. The question facing nanotechnology’s champions — both in the short term and in the long term — will be whether they want to press this to a crisis and force regulators to draw a line defining where politics does and does not have a place in technology, or whether they want to stay clear of that line for as long as possible.

Copyright 2007 Strategic Forecasting Inc. All rights reserved.

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