Regulation of nanotechnology

Because of the ongoing controversy on the implications of nanotechnology, there is significant debate concerning whether nanotechnology or nanotechnology-based products merit special government regulation. This mainly relates to when to assess new substances prior to their release into the market, community and environment.

Nanotechnology refers to an increasing number of commercially available products – from socks and trousers to tennis racquets and cleaning cloths. Such nanotechnologies and their accompanying industries have triggered calls for increased community participation and effective regulatory arrangements. However, these calls have presently not led to such comprehensive regulation to oversee research and the commercial application of nanotechnologies, or any comprehensive labeling for products that contain nanoparticles or are derived from nano-processes.

Regulatory bodies such as the United States Environmental Protection Agency and the Food and Drug Administration in the U.S. or the Health and Consumer Protection Directorate of the European Commission have started dealing with the potential risks posed by nanoparticles. So far, neither engineered nanoparticles nor the products and materials that contain them are subject to any special regulation regarding production, handling or labelling.

Managing risks: human and environmental health and safety

Further information: Implications of nanotechnology and Nanotoxicology

Scientists are studying how tiny particles used in nanotechnology might affect our health and the environment. They have found that smaller particles can sometimes be more harmful than larger ones because there are more of them. Current methods for checking if something is safe are not always good for these tiny particles, and special tools are needed to detect and measure them.

Regulatory groups in the United States and the European Union believe that nanoparticles may pose new risks and need careful testing. The International Council on Nanotechnology keeps a large collection of research papers on this topic, and the Project on Emerging Nanotechnologies lists many products that use nanotechnology, though this is only a small part of all such products. Safety information for these materials does not always clearly show if they are in their tiny form, making it harder to know exactly how safe they are.

Democratic governance

Many believe that governments should give people chances to help shape new science and technology, like nanotechnology. This can happen through public meetings, voting, or including community members on special committees. These steps help make sure everyone’s voice is heard when new technologies are developed.

Some argue that without strong rules, nanotechnology could bring health and safety risks for people and the environment. Good regulation helps balance these risks with the benefits of new technology. It also makes sure the public’s interests are considered as these technologies grow and change.

Arguments against regulation

Many people worry that new rules are needed for nanotechnology because it seems so different. But in fact, most countries already check new products for safety before they go on sale. They have been doing this for many years, even for tiny particles that have been used for decades, like carbon black, titanium dioxide, and zinc oxide.

Some think we don’t need special rules just for tiny particles. They say that most important uses of nanotechnology are still a long way off, and it’s hard to make rules for things that might not even work yet. For now, they believe we can handle new nanomaterials with small changes to the rules we already have.

Response from governments

United Kingdom

In 2004, the United Kingdom's Royal Society published a report about nanotechnologies. The report explained that many nanotechnologies do not pose new health risks, but it encouraged careful handling of nanoparticles and nanotubes. It suggested that these materials should be treated as new chemicals and undergo safety testing before being sold.

The report also recommended that the public be included in discussions about the risks of nanotechnology and that decisions be made openly.

United States

In the United States, the Food and Drug Administration (FDA) works with different agencies to coordinate the regulation of nanotechnology products. In 2009, the FDA asked for more information about how nanomaterials move in the environment and how they might affect people, animals, and plants.

Some critics felt that the government did not require enough labeling or special rules for these products.

California

In 2006, California passed a law allowing the state to request information about the health and environmental effects of chemicals, including nanomaterials. In 2008, the state asked manufacturers of carbon nanotubes for more details about these materials. This helped the state understand how these tiny materials might affect the environment and health.

European Union

The European Union created a group to study the risks of nanotechnology. Countries like France, Belgium, Sweden, and Denmark have set up their own lists of nanomaterials. The European Union also plans to create a central place to collect information about the safety and use of nanomaterials.

Response from advocacy groups

In January 2008, many civil society groups worked together to call for careful oversight of nanotechnology. They pointed out that many everyday products, like sunscreen and clothing, now include tiny materials that might pose health and environmental risks. They emphasized the need for clear rules to protect both people and the planet.

These groups suggested eight key ideas for managing nanotechnology safely, including better rules for workers, more public information, and holding manufacturers responsible. Some organizations, such as [Friends of the Earth](, suggested creating special agencies to oversee nanotechnology rules. This would help make sure all products are checked properly and safely.

Technical aspects

Regulation of nanotechnology needs clear rules about the size of tiny particles involved. Scientists debate what size should count as "nano," but most agree it involves particles from about 1 to 300 nanometers—so small that they can behave differently from larger materials and may affect living cells.

Traditional rules for chemicals often focus on how much of a substance is present. However, because nanoparticles are so tiny, they often don’t reach these amounts. Experts suggest that rules for nanotechnology should consider more than just size or weight, such as how the surface area of these particles might affect their effects.