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November 1, 2004
Guest Editorial: Regulatory Issues in Nanotechnology

Nanotechnology presents a unique opportunity for regulators to apply existing regulations and common law in a way that doesn”t stifle important innovation.
The limitless potential of nanotechnology is not without risks. Under some circumstances, nanoparticles can aggregate, accumulate, self-replicate, or engage in other molecular self assembly. They may be engineered to be dynamic, that is, to change character.
Nanoparticles of different sizes may affect different parts of human anatomy. Faced with such challenges, the government”s normal response is regulation, usually in the form of numerical concentration standards relating to anticipated handling and use of the product. Sometimes government regulation allows a variance from numerical standards in favor of risk-based criteria. To date, the government has shown admirable restraint by not rushing to regulate nanotechnology.
It may not be necessary for the government to expressly regulate nanotechnology. Existing regulation and common law may be sufficient. Should nanotechnology create an exceedance of an existing numeric standard, regulatory and enforcement mechanisms already exist. Violations of common law obligations (negligence, nuisance, trespass, and strict liability) can result in financial compensation and possible punitive damages to victims of those violations.
Negligence is "the omission to do something which a reasonable man . . . would do or the doing of something which a reasonable and prudent man would not do."
A nuisance is "anything which essentially interferes with enjoyment of life or property" and a nuisance per se is "an act, occupation, or structure which is a nuisance at all times and under all circumstances, regardless of location or surroundings."
A trespass is the "doing of an unlawful act or of lawful act in an unlawful manner to the injury of another”s person or property." Strict liability is "liability without fault," commonly employed when there is a circumstance which is inherently dangerous, that is, a condition which at all times requires special precautions to prevent injury.
In the context of nanotechnology, these common law remedies speak loudly. Negligently producing or using nanoproducts, creating a nuisance with nanoproducts, allowing nanoproducts to trespass onto others” property or into others” bodies, or creating nanoproducts which are inherently dangerous, all subject the actor(s) to harsh financial sanctions.
There are ample standards to avoid liability. The U.S. EPA has "Prioritization Criteria for Risks to Human Exposure" (http://www.epa.gov/superfund/programs/nrbpp/criteria.htm). The Foresight Institute has a set of "ethical standards" for developing safe nanotechnology. The National Toxicity Program of the NIH and The International Counsel on Nanotechnology are studying the issues and will offer guidance.
It is important that the government regulate only if necessary. Other nations are developing nanotechnology without constraint. The United States” leadership in nanotechnology could be lost to a regulatory bureaucracy. Bureaucracy is capable of turning pure energy into solid waste.
Producers and users of nanoproducts are obligated to use reasonable care to protect the public. If they violate the common law and cause injury to people, they will be accountable at law for such injuries, thus putting their entrepreneurial venture at risk.
Published in Gradient Trends – Gradient Corporation’s newsletter for Risk Science and Application  http://www.gradientcorp.com/coinfo/trends.html.