Who Regulates Nanotechnology And How?
One of Winston's Rules is: every time something new happens, someone in the federal government has to regulate it. Something new is happening-nanotechnology-and now federal agencies, primarily FDA and EPA, are trying to decide what to do about it. So far, they don't know but they are still working on it. The agencies' uncertainty should be pardoned. This really is weird science.

Nanotechnology is the science of building things from common substances like carbon on an incredibly small scale: one billionth of a meter or less. Winston is still trying to understand the metric system, but even he knows that this is construction work on an atomic level or molecular level only dreamt of before. Those dreams are fast becoming reality.

The Government predicts that nanotech will be a trillion dollar per year industry in the next ten years. In December, 2003, President Bush signed into law the 21st Century Nanotechnology Research and Development Act, which will pour 3.7 billion dollars over four years into nanotech research. One of the most prominent research areas is defense. This fiscal year the Pentagon plans to spend 315 million dollars on nanotech research. There is now an Army Institute for Soldier Nanotechnologies and a Naval Research Laboratory Nanotech Institute. The spending is expected to continue at higher levels in the future. For security reasons, the general public will never know some of the Defense Department's nanotech research and applications. Private investment is now estimated to be in the billions of dollars, with venture capitalists contributing $500 million in 2002 alone.

Some of this research has already borne fruit. Some products in development or already on the market include stain-resistant, winkle-free pants; ultra-violet light blocking sunscreens; scratch-free, transparent coatings; and high-brightness displays. Expect further startling developments, especially in information processing and medicine.

Are nano-devices hazardous? Is Michael Crichton a prophet, and will man-made nano-devices escape into the environment, reproduce themselves, and prey on humans and other animals? The honest answer is no one knows yet, but FDA and EPA are trying to set up regulatory regimes that ensure we don't drown in a sea of gray nano-particle goo, while at the same time encouraging rather than choking a new industry that could improve life greatly.

The FDA is primarily in charge of nanotech public health issues. The agency is already regulating broad categories of nanotechnology research, including biological assembly of nanostructures; using DNA molecules to construct nanoscale devices; development of genetic nanotech systems; and modeling and simulation of biological ion channels to cure diseases. The FDA is also trying to establish a safe but efficient review and registration process for commercial nanotech products. The agency would greatly appreciate any help the public can give it in developing the guidance and rules for this process.

EPA, if anyone, is in charge of nanotech environmental issues. The "if anyone" caveat is necessary because EPA's regulatory authority is unclear under existing statutes. The most obvious statute is TSCA, which authorizes EPA control over "new chemicals" introduced into commerce. The problem is that nanotechnologies just rearrange common elements like carbon, and do not usually involve new chemical reactions. Consequently, they may not come under EPA's current TSCA definition of a "new chemical." EPA is planning on issuing a policy statement that explains how TSCA applies to nano-devices and gives EPA regulatory authority over them. Word is that this policy statement is not imminent.

Nanotechnology will pose difficult and important federal regulatory questions during the next decade. All stakeholders, who in this case are all of us, should be involved in answering those questions. Winston will be there because he does not like gray goo. He rolled in some black goo once, but that's another story.