Nanotechnology poses greatest challenge for regulatory agencies

Big issues with tiny tech

03 September 2007 00:00  [Source: ICB]

Nanotechnology is seeping into the global consumer market. Are current regulations sufficient for dealingwith the potential risks?

Doris De Guzman/New York

REMEMBER MAGIC Nano, the glass and tile sealant recalled by its German manufacturer last year when almost 100 people reported health problems after using the new aerosol? Although nanotechnology was immediately suspected, leading activists to call for tighter regulations, it turned out that there was no more nanotechnology in the product than there was magic.

However, hundreds of other consumer products do employ genuine nanotechnology - clothing, air purifiers and sunblocks to pharmaceuticals, tennis rackets and car wax. Are these products safe?

The absence of regulations specifically addressing nanotechnology is at the center of growing worldwide debate.

There are at least two major reasons why regulating nanotechnology has been difficult for government agencies. One has been settling on a definition. A loose, popular definition of nanotechnology is the ability to measure and manipulate materials at a scale between 1 and 100 nanometers. Second is a lack of data and testing procedures for assessing the safety of nanoscale materials.

In the US, the Environmental Protection Agency (EPA) regulates most nanomaterials like any other existing or new chemical under the Toxic Substances Control Act (TSCA). The Food and Drug Administration (FDA) also regulates nanotechnology-based food, drugs and cosmetics under its existing requirements.

Both agencies acknowledge the potential health and environmental risks posed by the unique properties of nanomaterials, but they hold that additional regulatory actions will require more research.

"At this point, not enough information exists to assess environmental exposure for most engineered nanomaterials," the EPA said in its recent nanotechnology report. "Information is important to have a sound scientific basis for assessing and managing any unforeseen future impacts resulting from the introduction of nanoparticles and nanomaterials in the environment."

For now, EPA is proposing a Nanoscale Materials Stewardship Program (NMSP) that will call upon manufacturers to voluntarily evaluate nanomaterial production and use and provide the results to the EPA. The agency recently invited public comment on the program's approach. The NMSP proposes to cover existing chemical nanoscale materials manufactured or imported for commercial purposes. The EPA is also seeking comment for determining whether a nanoscale material is a new or existing chemical substance under TSCA.

Like the EPA, the FDA is also approaching nanotechnology-based materials on case-by-case basis. According to a recent report by the FDA's Nanotechnology Task Force, existing FDA regulation is comprehensive enough to accommodate nanoscale materials, especially products that undergo premarket authorization, such as drugs, biological products and devices.

"The report does not change procedures or recommend the development of regulations," says FDA spokeswoman Crystal Rice. "It lays out areas where there is a need to seek and, in some cases, develop additional information as FDA reviews nano-based products using existing regulations and approaches."

For products not subjected to the FDA's premarket authorizations, such as cosmetics and dietary supplements, the FDA says it will work with manufacturers to identify data substantiating the safety of products containing nanomaterials.

DEMANDS FOR PREEMPTIVE ACTION

Advocacy groups unhappy with the agencies' failure to issue new regulations assert that there is an urgent need to address the hazards of nanotechnology.

Beth Burrows of the Edmonds Institute says: "Given our past mistakes with wonder technologies like pesticides, asbestos and ozone-depleting chemicals, the rapid commercialization of nanomaterials without full testing or oversight is shocking."

Terry Davies, former EPA administrator and current senior advisor for Project on Emerging Nanotechnologies, gave testimony at EPA's recent public hearing on the NMSP. "A new commercial product that claims to contain nanomaterial is marketed every day, and the pace is accelerating," he said. "Every day that EPA is not exercising some kind of oversight on nanomaterials is another day when the American public is involuntarily participating in a huge experiment to see whether nanotechnology poses any threat to health or environment."

Activists have strongly criticized the EPA's proposed NMSP program, saying it hinders the implementation of an adequate regulatory system.

SET BACK THE CLOCK

Testifying at the EPA hearing, Richard Denison, senior scientist for Environmental Defense, said: "We supported the original proposal for a voluntary program two years ago because it included regulatory steps intended to provide a backstop and it was to be launched and completed quickly.

"Two years in the making, EPA's tepid proposals have actually set back the clock. As a government response to addressing the possible downsides of the nanotechnology revolution, it's simply too little, too late."

The International Center for Technology Assessment (ICTA) rebuked the FDA. "The FDA report recognizes the challenges and uncertainty that nanomaterials present but then dismisses potential oversight actions or requiring labeling for another day," says George Kimbrell, staff attorney for ICTA. "The result is that FDA will, at least for now, continue to treat the radical new products of nanotechnology as nothing more than business as usual."

According to the Project on Emerging Nanotechnologies, the number of consumer products using nanotechnology more than doubled within 14 months, from 212 to 475. Nanoscale silver, already found in 95 products on the group's ­inventory, is said to be the nanomaterial most used. Carbon, including carbon ­nanotubes and fullerenes, is the second-most-used nanomaterial.

Many in the chemical industry view existing regulations as sufficiently flexible in tackling currently commercialized nano-based products and materials.

The number of nanoscale chemicals in the marketplace is said to be very small, and most of these chemicals have already been regulated for years, notes Jim Cooper, senior manager for government relations at the Synthetic Organic Chemical Manufacturers Association (SOCMA).

"The misconception out there is that nanoscale materials are all brand new chemistries," says Cooper. "The EPA is doing the right thing in establishing the NMSP program and collect valuable risk-related information before the markets really start to expand. We just hope everybody will allow the program a chance to work before they start hammering about regulations."

SOCMA recently formed a Nanotech SME (small and medium-sized enterprises) Manufacturers Coalition to provide SME perspectives to various regulatory agencies regarding the health, safety and environmental aspects of nanotechnology.

"With the change in attitudes in Washington, it is even more important that companies seeking to create a nanotechnology business interface with the agencies," Cooper says.

DuPont, meanwhile, has actually partnered with activist group Environmental Defense, recently launching a "nano risk framework" designed to develop a systematic and disciplined process for the responsible development and use of nanomaterials. DuPont says the framework augments and supplements its existing product stewardship procedures.

RATIONAL AND RESPONSIBLE

"We have adopted the framework, and it is now a mandatory part of our product commercialization process for nanoscale materials," says Terry Medley, DuPont's global regulatory affairs director. "We've received a number of favorable comments from individuals that read or maybe adopted the framework. We think that this is the rational and responsible way to proceed in order to aid regulatory agencies in developing policies," he adds.

BASF and Degussa both note hundreds of millions of dollars in nanotechnology investment not only for product research and development (R&D) but also including risk-assessment projects.

BASF says it is participating in safety research projects at national and international level, including the EU's Nanosafe 2 and the NanoCare project sponsored by the German Ministry of Education and Research. The company is investing €180m ($248.3m) this year until 2008 in R&D alone, says BASF spokeswoman Melanie Steigelmann.

"In our own projects, and by participating in various research networks, we are generating a scientifically well-founded database for the assessment of potential risks of exposure-free nanoparticles not incorporated in a matrix," says Steigelmann.

Degussa says it has invested more than €100m over the past five years in R&D and marketing new nanomaterials and nanotechnology-based systems alone. The company is also involved in the EU's NanoCare and Nanoderm projects.

For Bayer, safety issues and the acceptance of nanotechnology and nano-based products at the end of the value chain by the final customers are considered the key for the industry's future success.

"In addition to the assessment of the impact of nanoparticles on health and environment, the standardization of definitions, nomenclature and validation of characterization methods are important," says Frank Rothbart, spokesman for Bayer MaterialScience. He adds that the company has been involved in several EU nanotechnology projects including NanoCare and Tracer. Bayer also implemented a product-stewardship program for its carbon nanotube (CNT) product.

This year, the firm completed its 60 short ton/year CNT pilot production plant in Laufenburg, Germany. An additional 200 ton/year plant in Leverkusen is expected to start by 2009.

"Further plant capacity will be created according to market needs, and from today's point of view, we hope to have our planned 3,000 ton/year plant at our disposal no later than 2012," says Rothbart.

Product development using nanotechnology is surging. Estimated worldwide public funding for R&D in 2006 was €5bn, says the European Commission, while a 2004 Lux Research study projects that nanotechnology's global economic impact will reach $2.6 trillion by 2014.

"The implementation of nanotechnology for product development has just started and we expect the number of nano-based products to be amplified in the coming years," says BASF's Steigelmann. "Still, nanotechnology will only be successful if it gains the trust and acceptance of society. Hence, we inform the public about our activities, take part in the public debate and seek dialogue with various ­interest groups."

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