It's a quantum leap in materials science, revolutionizing manufacturing, food production and health care. Objects as small as a few dozen atoms across can be manipulated in size and shape, and function. But as nanotechnology rapidly worms its way into commerce, there has been very little government oversight addressing the risks that may accompany the breakthroughs.
Experts say this is because the technology is so new and, in part, regulators are reluctant to hamper innovation. Meanwhile, manufacturers have, quietly, begun incorporating nanomaterials into all sorts of consumer products. These include products that hit close to home, such as cosmetics, medicines and even food. But there is very little definitive information about where these nanotech products are to be found.
The House of Representatives Science and Technology Committee recently introduced legislation to strengthen federal efforts to understand and address the environmental safety and health risks posed by engineered nanomaterials. Although a similar bill passed the House on a 407-6 vote last year, lawmakers in the Senate ran out of time in the legislative session before mark-up could be completed.
The bill, sponsored by Science and Technology Committee chair Rep. Gordon Bart, D-Tenn., comes on the heels of a report from the National Research Council, which was highly critical of the Bush administration's hands-off approach in addressing the risks posed by these new technologies.
It also follows a lead set by Canada, which this month is likely to become the first nation to require companies to list which engineered nanomaterials they use.
While President Barack Obama and the new Congress will likely have to face major regulatory decisions regarding nanotechnology, nanomaterials experts say the risk-assessment process requires ongoing dialogue to keep pace with new product developments and emerging scientific information.
The Woodrow Wilson Center's Project on Emerging Nanotechnologies has issued a series of recommendations for the new administration, penned by environmental policy expert J. Clarence Davis, a former Environmental Protection Agency official.
"Scientists have given and will continue to give us vast marvels, capable of producing technologies of great power," Davis writes in the report's conclusion. "Each of these marvels, including nanotechnology, comes in a treasure chest of riches and a Pandora's box of evils. The challenge of the new century and to the new administration is to use the treasure while keeping shut the lid on the Pandora's box. It is a daunting challenge, but one that can be met."
Not surprisingly, there are conflicting opinions on the correct path to keeping the lid shut, said Frank Torti, the Food and Drug Administration's deputy commissioner and chief scientist.
"There is a school of thought that says nanotechnology can be viewed just like any other type of product. Does it work? —Efficacy. Does it make people sick? — Toxicity," he demonstrated.
But Torti cautioned that with items increasingly small, nanotech complications grow increasingly large.
"Surface structures of nanomaterials are extremely complex," he explained while giving the keynote address last fall at the Nanotechnology Task Force. "There are issues related to nanomaterials that go well beyond their chemical structures that need to be characterized, experimented with and understood in order to reach firm and reasonable regulatory decisions."
The former Wake Forest cancer researcher noted that the FDA would begin to collect input from producers, advocates and other concerned parties to help shape health and safety policy for this budding and promising new technology.
Perhaps the most comprehensive nanotech consumer product inventory is a Web-based survey compiled by the Project on Emerging Nanotechnologies. Andrew Maynard, chief science adviser to the project, said the list, which "relies solely on information the manufacturer has put out into the public domain," has expanded rapidly within three years to include more than 800 products. Of these, he says about 100 are characterized by their manufacturers as cosmetics, including anti-aging creams, conditioners and other hair and skin treatments — products intended for direct application to the human body.
Maynard cites one product on the inventory, a hair treatment, infused with nanoscale gold particles. In its promotional material, the product claims to offer the benefits of penetrating the hair shafts with tiny bits of gold attached to fine strands of silk. Observing that the gold particles sparkle in the familiar hue "behaving in the way one would normally expect," not in some novel way. And considering that "human hair is made up of dead tissue," Maynard said, "I probably wouldn't be too concerned about this product."
Of greater concern, he said, is a growing list of products claiming to encapsulate "therapeutic" agents within nanoscale capsules designed to survive skin penetration and deliver these materials to various sites in the body.
Ian Illuminato, health and environment campaigner for Friends of the Earth, said in the absence of oversight, nanoscale materials are also being incorporated into consumer goods intended for direct ingestion as well, with "a sort of wild west" fervor. Some of these products, he said, are being marketed as wholesome, citing a dietary supplement directed at children that touts the benefits of nanoscale iron particles.
Illuminato is concerned that, under current law, the FDA's has very little authority over these dietary supplements, and untested products including those that contain nanomaterials can reach the market without going through any official FDA approval process.
As Davis wrote for the Project on Emerging Nanotechnologies, "under the (Federal Food, Drug, and Cosmetic Act), two major high exposure applications of nanotechnology, cosmetics and dietary supplements, are essentially unregulated. In fact, the current language in the law serves primarily to assure that there will not be adequate oversight."
Equally troubling, Illuminato said, is the lack of disclosure. "Manufacturers are not required to inform consumers of the presence of nanoscale materials in their products," he said. Adding to the uncertainty, researchers have little information with which to target safety and efficacy studies.
"The number of studies examining the routes of exposure," a critical measure of risk, Illuminato said, "can be counted on the fingers of the hand."
In light of this knowledge gap, Illuminato said Friends of the Earth has issued a call for "a moratorium on incorporating nanomaterials into consumer goods" until sufficient scientific evidence of their safety can be ascertained.
Sunshine and Clouds
Nanomaterials are increasingly prevalent in sunscreen products.
Because the FDA classifies sunscreens and sun blocks as drugs, they undergo a higher level of scrutiny than dietary supplements or cosmetics, but that does not prevent questions from being raised.
At last fall's task force meeting, Francis Quinn, a physicist for L'Oreal Cosmetics, took the podium to offer an exuberant defense of his company's ventures in nanomaterial sunscreens. He presented findings that, he said, demonstrate few novel risks or concerns from these products.
Titanium dioxide, the nanoscale component used by L'Oreal, is one of the most abundant minerals on the Earth's surface, he noted. He added that titanium dioxide has been used as a pigment in cosmetics for generations with no cause for alarm.
But more importantly, he said, preventing melanoma is of vital public health interest, and L'Oreal's sunscreen products help do that.
When added to sunscreen in nanoscale formulations, he said titanium dioxide provides a highly effective barrier to skin-damaging ultraviolet radiation. And when applied to the skin, it vanishes in an almost transparent sheen — and that, Quinn explained, makes the product attractive to beachgoers.
Using nanotech particles "enhances consumer acceptance" compared to ordinary oil-based sunscreens, he said, encouraging vacationers to comply with the recommended practice of using sunscreen when outdoors. Though Quinn points out that the product is obviously not intended for ingestion, he added that healthy skin has multiple layers of tissue that prevent any of the particles penetrating the dermis.
Capping his argument, he displayed slides showing that nanoscale particles in finished sunscreens tend to congeal into "larger clumps," reducing any risks of subdermal exposure to titanium dioxide particles.
Not All Vacationers Are Equal
Maynard of The Wilson Center, however, said in the real world things don't always conform to the norm. For instance, he said not all vacationers have healthy skin. In August, researchers at the University of Rochester released a study showing that, in mice, "nanoscale particles can penetrate through UV damaged skin more easily than normal skin."
Carolyn Cairns, project leader with Consumers Union, said there could be unforeseen risks from mixing incompatible outdoor formulations. She said consumers often use sunscreens in combination insecticides such as DEET, and cites findings indicating that the presence of incompatible chemicals might facilitate a higher absorption rate of co-mingling substances — a risk that she says, in the case of nanomaterials, has not been adequately studied. There are also concerns that even "friendly" substances may have unexpected behavior at the nano level.
She conceded that aesthetic considerations might be important criteria for many consumers. But, she said, "Consumers must be given the opportunity to make an informed choice."
Illuminato acknowledges that in the current atmosphere, few close observers see much prospect for a moratorium, but he told Miller-McCune.com that he believes a bad event arising from a product with nano features could result in a crippling consumer backlash against the technology as a whole. "A rush to place these products on the shelves prematurely, without adequate information, in pursuit of short-term profits could be counterproductive in the long term."
Maynard said there is another compelling reason to develop a better understanding of the risks posed by nanomaterials in consumer goods. He told Miller-McCune.com that the materials can be manipulated with such precision that — armed with the accurate information — manufacturers should be able to avoid known risks by "fine-tuning the engineering of their products before they reach the market."
The public should be included in the decision-making on nanomaterials, Illuminato said. "Not as unwitting guinea pigs," but as knowledgeable, informed consumers. "It is to the advantage of consumers as well as industry to have clear regulatory guidance."
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