Small concerns: nanotech regulations and risk management

Nanomaterials have become a hot topic in the past decade, both for their advantages and hazards. Now The National Science Foundation says the nanotechnology industry could be worth $1 trillion by 2015, and would employ two million workers directly. Both governments and industry are looking at and addressing safety concerns, and determining the next steps for nanomaterial manufacturers and handlers.

Nanomaterials have been used to create drugs that could cure cancer and radiation poisoning, and make miniature pollutant filters resulting in healthier air. Carbon nanotubes may help regrow nerve tissue or ferry drugs used to repair damaged neurons, offering possible treatment options for neurological disorders such as epilepsy, Parkinson's disease, and perhaps even paralysis.

At the same time, data has also shown that exposure to certain nanomaterials may pose health risks to consumers, wildlife, or those working with nanomaterials. Manipulated to 1/100,000 of the width of a human hair, nanoparticles can act differently when operating at the quantum level. Animal studies, including one with rats at the University of Rochester, have shown that some nanoparticles can cross the blood-brain barrier, which protects the brain from toxins in the bloodstream. A 2005 study in Environmental Science and Technology Journal showed that zinc oxide particles, found in some sunscreens, were toxic to human lung cells. A study by University of Toledo researchers found that microbes that play vital roles in ecosystems and help treat wastewater were damaged by nano-titanium dioxide after less than an hour of exposure.

Nanotech oversight

This mixed information initially resulted in a polarized reaction to the use of nanomaterials. The polarization also stemmed from an overall lack of information and communication between consumers, scientists, and government institutions.

Nanomaterials have been incorporated into everyday consumer products ranging from aerosols to topical creams like sunscreen and ointments to tennis rackets. Many companies released these products without proper testing. Until recently, government or industry regulations on testing and researching the effects of nanomaterials have been spotty to non-existent.

Government entities like the EPA and FDA have been struggling to define what nanoscale materials are exactly, "whether they are new chemicals or whether they are just new forms of existing chemicals," says Kristen Kulinowski, executive director of the Center for Biological and Environmental Nanotechnology (CBEN) at Rice University. "That has an impact on how many hoops a company has to jump through," in order to get their product to market.

Arsenate ions. (Rice University)

There can also be some confusion as to where exposure is the most dangerous. "Production might not be the most hazardous step in the process, it might be the transferring of that material to the shipping package. It might be the cleaning out of the reactor chamber," says Kulinowski.

This lack of oversight over the nanotechnology industry is a serious concern. A report from the U.S. National Research Council released in December 2008 found that federal research on nanotechnology had failed to adequately address health, safety, and environmental concerns, and called for a plan of action.

"Those of us that are trying to understand the possible risks that nanomaterials might pose are challenged to keep up with the pace of scientific progress," says Mark Wiesner, director of the Center for Environmental Implications of Nanotechnology (CEINT).

Gold nanoshells under UV light. (Rice University)

Governments around the globe have now begun to create regulations and standards for researching and the use of nanomaterials. "We've seen a growing awareness and concern by workers and companies as to whether work-related exposures to nanoparticles bring a risk of occupational illness or injury," says Fred Blosser, public affairs officer of the U.S. National Institute for Occupation Safety and Health (NIOSH).

Britain's Royal Society recommended in 2004 that nanoparticles be viewed as brand new substances. In February 2009, the European Food Safety Authority concluded that each new nanomaterial needs to be examined on a case-by-case basis.

The U.S. Environmental Protection Agency (EPA) detailed its plans in September for research into the possible health and environmental risks of nanomaterials, expanding on a draft document originally released in June 2009. The document calls for identifying sources of nanomaterials, how they move in the environment, the problems they might cause for people, animals and plants, and how these problems could be avoided or mitigated. Failure to register a product advertised as "anti-microbial" with the EPA has resulted in at least two fines.

The U.S. Food and Drug Administration (FDA) regulates products, not the materials the product is made from. "FDA sets the bar pretty high" for all products, says Kulinowski. "Whether it's a nanoscale material-based device or drug FDA treats it the same, and that means there's a long, involved process to get that product to the marketplace."

NIOSH is a non-regulatory government organization working with public- and private-sector colleagues from the United States and abroad to conduct strategic planning and research, and make information available. "As an occupational safety and health research agency, NIOSH has worked with partners over the past several years to investigate the occupational safety and health implications of nanotechnology," says Blosser.

Several agencies will be increasing spending specifically on nanotechnology-risk research in 2010. The National Institute of Standards and Testing (NIST) will be investing $90.5 million, and the National Institutes of Health (NIH) an additional $7 million. Overall, the projected budget specifically dedicated to nanotechnology risk research for 2010 is $88 million -- up $16 million from 2009. 

Independent Guidelines

Still, government regulations do not always provide clarity in some areas, making many companies and universities nervous. Therefore, many organizations have already developed their own standards and guidelines for the development and handling of nanomaterials.

"Any major research institution working with nanomaterials should have protocols and guidelines in place for handling and working with nanomaterials. We are continually in the process of updating our procedures as new information becomes available," says Wiesner. CEINT performs fundamental research on the behavior of nanoscale materials in ecosystems that will provide guidance in assessing existing and future concerns surrounding the environmental implications of nanomaterials.

Kulinowski is also the director of the International Council on Nanotechnology (ICON). ICON is a multi-stakeholder organization dedicated to the safe, responsible, and beneficial development of nanotechnology. (Kulinowski wrote an article for SPIE Professional on nanosafety, and has served as an SPIE conference chair and OSA/SPIE congressional fellow).

If companies are concerned, they can contact NIOSH for a free assessment of their workplace. Blosser explains the NIOSH field evaluation is probably most useful as an assessment for the safety of companies' and workers' practices, and is "designed to address the unique aspects of nanomaterials. In turn, NIOSH's research is enhanced and furthered through first-hand observation of actual processes in which nanomaterials are made or used."

"It's not like we have to completely change the way that we do business, we just have to be aware and not complacent," Kulinowski adds. "We have the tools, we just need to use them, and use them the right way."

As these regulations begin to take effect, the polarized reaction to nanomaterials may soon wane. Wiesner says the discussion over nanotechnology seems to have become less polarized over the past decade as more research has come out about nanomaterials and more people have been educated about nanotechnology.

"The reality concerning possible risks associated with nanomaterials remains somewhat obscured by our need to develop new methodologies and new ways of thinking about how to categorize materials and resultant technologies," says Wiesner. However, he adds, "I think that most people understand that we are not allowed to not ask the question anymore."

Resources for Good Guidelines

ICON has developed a site http://goodnanoguide.org, in an effort to fill the need for up-to-date information about current good workplace practices, highlighting new practices as they develop.

Mark Wiesner of CIENT also recommends the following site for good samples of best practices put in place by different organizations: http://www.nanoceo.net/nanorisks/OHS-Protocols-Best-Practices.

Fred Blosser of NIOSH says, "Our recommendations for designing, establishing, and evaluating such programs are described in 'Approaches to Safe Nanotechnology in the Workplace,' (http://www.cdc.gov/niosh/docs/2009-125/), originally issued in 2005 and regularly updated since then."

Richard A. Liroff, founder and director of the Investor Environmental Health Network, suggests key questions companies need to ask themselves while performing due diligence, including covering supplier issues, life-cycle considerations and real-world safety assessments:

• Has your supplier provided robust environmental, health, and safety data about their product, including disclosure of whether they use or incorporate nanomaterials? If the product does involve nanomaterials, do such data take account of the unique properties of these nanomaterials, and have these data been developed at or verified by trusted independent sources or by your own company's technical experts?
• How well do you know the supplier? Are they new or are they a long-term trusted participant in your supply chain?
• Have you carefully scrutinized your supplier's materials policies and the reliability and consistency of their manufacturing processes?
• Have lifecycle considerations been taken into account, so as to address occupational exposures at the front end and end of life fate at the back?
• Do environmental, health, and safety assessments take into account real-world and worst-case applications of the materials?

Beth Kelley is an editor at SPIE.