Research and regulations on the environmental and safety issues of nanomaterials: a global approach.
By Janice Kleinschmidt
Nanotechnology data is growing exponentially as universities and industries around the world research and develop products with specific performance attributes (liquid, dirt and odor repellence, antimicrobial properties and insulating capabilities) by manipulating substances at the one-billionth-of-a-meter scale. But questions about regulating nanomaterials have grown as well.
In November 2009, the U.S. Environmental Protection Agency (EPA) held a four-day meeting with a scientific advisory panel to review issues related to nanometals, particularly nanosilver. “We are going to need new guidelines for nanoparticle characterization,” senior policy adviser William Jordan said in a Chemical & Engineering News article .
“If you really look at what we know about small particles, there’s a huge amount of data out there,” says James Delattre, Ph.D., a chemist and vice president of marketing for NanoHorizons Inc. of Bellefonte, Pa. Though NanoHorizons’ antimicrobial SmartSilver™ is on the cutting edge of textile additives, silver nanoparticles have been used for antimicrobial properties since the early 1900s, Delattre says.
Schoeller Technologies AG of Sevelen, Switzerland, likewise puts a new spin on nanoscale inorganic particles that have been used in dental fillings and hip replacements to create its NanoSphere® finish for water- and dirt-repelling textiles. While NanoSphere is bluesign® certified, Schoeller still must consider government regulations.
“Nanotechnology sounds really cool and wonderful,” says Mark Banash, vice president of quality and regulatory affairs for Nanocomp Technologies of Concord, N.H. “People have a lot of expectations in that it sounds very futuristic and very advanced. But it’s like any other technology, and what you have to think about is whether it’s going to have a practical benefit and whether it can be used in the industrial environment.”
Nanocomp, which makes sheets and spun yarns with long carbon nanotubes used in performance fabrics for electromagnetic shielding and ballistics protection, created the regulatory affairs position last summer. “Customers were already starting to express concerns to us,” Banash says. “They said we needed to take not only a proactive role, but a leading role in these issues.” To do so, Nanocomp works with the National Institute for Occupational Safety and Health, EPA, National Nanotechnology Initiative, Occupational Safety and Health Administration (OSHA) and academics at the forefront of assessing the environmental and biological effects of nanotechnology. “We strive to be objective and data-driven,” Banash says.
“We are interested in setting the standards as far as worker safety, environmental discharge safety and customer safety. Our facility has been profiled every month by an outside testing lab,” says President and CEO Peter Antoinette. “We have found that we have a highly clean environment.”
BASF–The Chemical Co., headquartered in Ludwigshafen, Germany, similarly takes a leading role in issues surrounding nanotechnology, not only with regulatory and research entities, but also with the general public through an extensive “dialogue” section on its website. Additionally, BASF organizes and participates in stakeholder forums, including the German government’s NanoDialog. In 2006, the company, which uses amorphous silicon dioxide nanoparticles in its dirt-repelling Mincor® treatment for textiles, even established a Code of Conduct Nanotechnology.
“Nanoparticles in products based on nanotechnology are usually permanently incorporated in a matrix. That is why free nanoparticles are unlikely to be released into the environment from consumer products,” says Rüdiger Iden, BASF’s senior vice president, polymer physics. “However, targeted, interdisciplinary research is necessary to investigate the long-term environmental behavior of products containing nanoparticles. We are involved in continuously developing the scientific basis for the evaluation of possible risks. This includes our own research in the fields of toxicology and ecotoxicology, as well as participation in national and international projects, such as NanoCare of the German Federal Ministry of Education and Research or the EU-sponsored NanoSafe project.”
“Almost all agencies and governments with regulatory authority are considering how current regulations apply to nanoscale materials or if those regulations need to be modified,” says Jim Alwood, EPA environmental protection specialist. “Agencies and governments are awaiting development of data to make better-informed decisions.”
While he acknowledges that nanomaterials demonstrate benefits such as using less energy and fewer chemicals, Alwood says, “The single most important issue is the lack of environmental health and safety data for nanoscale materials. As long as this information gap exists, companies should expect regulators to be cautious.”
Under the system in place in the United States, companies may be required to register their products with the EPA or the Food and Drug Administration. “It’s just a matter of where that material you are making fits in and whatever law or regulation is in place,” Alwood says. “There seems to be some question whether we need to update regulations.” The Toxic Substances Control Act, enacted in 1976, has never been updated. According to Alwood, what may change is not to whom companies will submit data, but the type of information required. When in doubt, “Just call the EPA,” he says
“We have seen top people, scientists, in the EPA interested in doing proper types of regulations to create a safe environment, but also ensure business can, in fact, take place, and I think that’s very important,” Antoinette says. “One could create regulations where you make it impossible for businesses to get going or proceed.”
With a global marketplace, regulations governing nanomaterials need to be as consistent as possible. The EPA coordinates efforts through the Organisation for Economic Co-operation and Development based in Paris, France. “In some cases, EPA will also coordinate with specific governments bilaterally,” Alwood says.
“We need planning certainty and a legal framework that allow us to be successful in global competition,” Iden says. “In the political arena, international harmonization of activities is always desirable.”
The proactive approach
Antoinette cautions that companies should maintain a proactive approach to nanotechnology. “I think by the time you are waiting for someone to tell you what to do, you are not doing the right thing,” he says. “Regulations are fine when applied efficiently, but I think that 21st century management compels one to be ahead of the regulatory agencies.”
Researchers don’t necessarily see regulations as stifling innovation. Rather, says Juan Hinestroza, an assistant professor of fiber science at Cornell University in Ithaca, N.Y., “I think that smart regulation implies an evidence- and fact-driven process that can enable innovation while addressing potential hazards.”
As Todd Kuiken, a research associate for The Project on Emerging Nanotechnologies at Woodrow Wilson International Center for Scholars in Washington, D.C., points out, regulations ultimately may be a saving grace. “Let’s say you put out some material and it turns out it has hazardous properties,” he says. “That’s not just going to be damaging for that specific product, because of the way the word ‘nanotechnology’ is used. It has the potential to derail the entire industry. You want to pre-empt those types of situations from happening so [a product] can advance safely and the public accepts it.
“There’s going to be hazards and risks to everything in life,” he adds. “That’s why the studies need to be done so we can reap the benefits and minimize the risks.”
“I don’t subscribe to the theory that [nanotechnology] is creating the great goo of a Michael Crichton novel that is going to take over the world,” Antoinette says. “But anything not appropriately looked at by people who care could end up being hazardous.”