Regulating Nano: Tiny Particles, Huge Questions

By: Dennis Draeger

It is a difficult time for regulators trying to make sense of nanotechnologies, the engineering of super-small particles to utilize their size and unusual properties. While environmental, health, and safety (EHS) concerns abound, so too do the technological and economic benefits which extend particularly to the electronics, green tech, and health industries. As regulators seek to protect the populace, they also need to avoid undue public backlash which could damage these huge benefits because of poor communication and limited scientific research.

What is changing?

The number of products enabled by nanotechnologies has risen from 212 in 2006 to more than 1,300 today with advances ranging from smell-resistant clothing to less expensive water filters to antibacterial goods. However, regulators are still taking baby steps to significant regulation. In June, two US government agencies and the White House released statements about nanotechnologies and their regulation, but even these statements did little more than reinforce what had already been said. The White House iterated a need for a scientific approach to regulating nanomaterials to avoid knee-jerk reactions to speculative concerns. The EPA (Environmental Protection Agency) called for responses to its proposed policy for information gathering from manufacturers, and the FDA (Food and Drugs Administration) reinforced its policy of regulating nanomaterials on a case-by-case basis.

The USA’s attempt to develop an adaptive and responsive regulation strategy seems to be prevailing with the European Union as well even though individual European nations still express a desire for stricter, more overt regulations like the labeling of products. Other countries like Australia resist the notion of mandatory labeling worrying that such labels would send the wrong message to consumers who may throw the baby out with the bathwater.

Another contentious area is a viable definition of nanotechnologies for regulatory purposes. Some researchers argue that safety concerns of nanomaterials would best be addressed without a specific definition, but regulators feel they need a standardized vocabulary. The European Commission received a great deal of criticism when they released their working definition of nanotechnology recently especially over questions of the deciding body’s political integrity. The US FDA is also flooded with comments and requests which mostly surround the vagaries of their proposed definition. If regulators make the definition too specific, they risk allowing dangerous materials to slip through the cracks, but if they define nanotechnology too broadly, products may be gridlocked delaying important innovations such as lighter, more efficient aircraft and better treatments for addiction.

Why is this important?

Nanotechnologies have the potential to revolutionize virtually every industry—from philanthropy and sports to fashion and communications. The health industry alone could see targeted cures for cancer with minimal side-effects, more effective tests and drugs for sexually transmitted diseases (STDs), and treatments for patients with spinal cord injuries to enable them to walk again. Along with the medical potential come promises to boost the electronics industry and accelerate some much needed clean tech advances like economically viable solar cells.

Too many questions remain unanswered. Many environmental, health, and safety concerns have been raised over nanotechnologies, and research suggests these concerns may be valid. Just because a material is inert in its standard size does not mean it is safe when engineered at the nanoscale because nanoparticles behave differently. However, other research suggests humans have long been exposed to nanoparticles from silver, copper, and other substances. Ultimately, no fatalities or environmental degradation has been directly attributed to nanoparticle exposure, and swift, harsh regulation of nanotechnologies could needlessly postpone the myriad of innovations they promise.

By Dennis Draeger