by Andrew Schneider

Andrew Schneider Senior Public Health Correspondent

March 24, 2010
from AOLNews Website

First in a Three-Part Series
Amid Nanotech's Dazzling Promise, Health Risks Grow
 

For almost two years, molecular biologist Bénédicte Trouiller doused the drinking water of scores of lab mice with nano-titanium dioxide, the most common nanomaterial used in consumer products today.

She knew that earlier studies conducted in test tubes and petri dishes had shown the same particle could cause disease. But her tests at a lab at UCLA's School of Public Health were in vivo - conducted in living organisms - and thus regarded by some scientists as more relevant in assessing potential human harm.

Halfway through, Trouiller became alarmed: Consuming the nano-titanium dioxide was damaging or destroying the animals' DNA and chromosomes. The biological havoc continued as she repeated the studies again and again.

It was a significant finding: The degrees of DNA damage and genetic instability that the 32-year-old investigator documented can be,

"linked to all the big killers of man, namely cancer, heart disease, neurological disease and aging," says Professor Robert Schiestl, a genetic toxicologist who ran the lab at UCLA's School of Public Health where Trouiller did her research.

Benedicte Trouiller in an undated photo
Courtesy Benedicte Trouiller

UCLA molecular biologist Bénédicte Trouiller found that nano-titanium dioxide - the nanomaterial most commonly used in consumer products today - can damage or destroy DNA and chromosomes at degrees that can be linked to "all the big killers of man," a colleague says.

Nano-titanium dioxide is so pervasive that the Environmental Working Group says it has calculated that close to 10,000 over-the-counter products use it in one form or another.

Other public health specialists put the number even higher.

It's "in everything from medicine capsules and nutritional supplements, to food icing and additives, to skin creams, oils and toothpaste," Schiestl says.

He adds that at least 2 million pounds of nanosized titanium dioxide are produced and used in the U.S. each year.

What's more, the particles Trouiller gave the mice to drink are just one of an endless number of engineered, atom-size structures that have been or can be made. And a number of those nanomaterials have also been shown in published, peer-reviewed studies (more than 170 from the National Institute for Occupational Safety and Health alone) to potentially cause harm as well.

Researchers have found, for instance, that carbon nanotubes - widely used in many industrial applications - can penetrate the lungs more deeply than asbestos and appear to cause asbestos-like, often-fatal damage more rapidly.

Other nanoparticles, especially those composed of metal-chemical combinations, can cause cancer and birth defects; lead to harmful buildups in the circulatory system; and damage the heart, liver and other organs of lab animals.

Yet despite those findings, most federal agencies are doing little to nothing to ensure public safety. Consumers have virtually no way of knowing whether the products they purchase contain nanomaterials, as under current U.S. laws it is completely up to manufacturers what to put on their labels.

And hundreds of interviews conducted by AOL News' senior public health correspondent over the past 15 months make it clear that movement in the government's efforts to institute safety rules and regulations for use of nanomaterials is often as flat as the read-out on a snowman's heart monitor.

"How long should the public have to wait before the government takes protective action?" says Jaydee Hanson, senior policy analyst for the Center for Food Safety. "Must the bodies stack up first?"

Big Promise Comes With Potential Perils

"Nano" comes from the Greek word for dwarf, though that falls short of conveying the true scale of this new world: Draw a line 1 inch long, and 25 million nanoparticles can fit between its beginning and end.

Apart from the materials' size, everything about nanotechnology is huge. According to the federal government and investment analysts, more than 1,300 U.S. businesses and universities are involved in related research and development.

The National Science Foundation says that $60 billion to $70 billion of nano-containing products are sold in this country annually, with the majority going to the energy and electronics industries.

Both the promise and the potential peril of nanomaterials come from their staggeringly small size, which is highlighted by the chart above.

(Note, for example, how it shows that the periods on this page are equal to 1 million nanometers.)

Despite the speed bump of the recession, a global market for nano-containing products that stood at $254 billion in 2005 is projected to grow to $2.5 trillion over the next four years, says Michael Holman, research director of Boston-based Lux Research.

Another projection, this one from National Science Foundation senior nanotechnology adviser Mihail Roco, says that nanotech will create at least 1 million jobs worldwide by 2015.

By deconstructing and then reassembling atoms into previously unknown material - the delicate process at the heart of nanotechnology - scientists have achieved medical advancements that even staunch critics admit are miraculous. Think of a medical smart bomb: payloads of cancer-fighting drugs loaded into nanoscale delivery systems and targeted against a specific tumor.

Carbon nanotubes, rod-shaped and rigid with a strength that surpasses steel at a mere fraction of the weight, were touted by commentators at the Vancouver Olympics as helmets, skis and bobsleds made from nanocomposites flashed by. Those innovations follow ultralight bicycles used in the Tour de France, longer-lasting tennis balls, and golf balls touted to fly straighter and roll farther.

Food scientists, meanwhile, are almost gleeful over the ability to create nanostructures that can enhance food's flavor, shelf life and appearance - and to one day potentially use the engineered particles to craft food without ever involving a farm or ranch.

Yet for all the technology's promise and relentless progress, major questions remain about nanomaterials' effects on human health.

A bumper sticker spotted near the sprawling Food and Drug Administration complex in Rockville, Md., puts it well:

"Nanotech - wondrous, horrendous, and unknown."

Adds Jim Alwood, nanotechnology coordinator in the Environmental Protection Agency's Office of Pollution Prevention and Toxics:

"There is so much uncertainty about the questions of safety. We can't tell you how safe or unsafe nanomaterials are. There is just too much that we don't yet know."

What is known is by turns fascinating and sobering.

Vial of carbon nanotubes

The carbon nanotubes in this vial are part of a booming industry. According to one consulting firm, the global market for nano-containing products is projected to grow to $2.5 trillion by 2014.

Nanoparticles can heal, but they can also kill.

Thanks to their size, researchers have found, they can enter the body by almost every pathway. They can be inhaled, ingested, absorbed through skin and eyes. They can invade the brain through the olfactory nerves in the nose.

After penetrating the body, nanoparticles can enter cells, move from organ to organ and even cross the protective blood-brain barrier. They can also get into the bloodstream, bone marrow, nerves, ovaries, muscles and lymph nodes.

The toxicity of a specific nanoparticle depends, in part, on its shape and chemical composition. Many are shaped roughly like a soccer ball, with multiple panels that can increase reactivity, thus exacerbating their potential hazards.

Some nanoparticles can cause a condition called oxidative stress, which can inflame and eventually kill cells.

A potential blessing in controlled clinical applications, this ability also carries potentially disastrous consequences.

"Scientists have engineered nanoparticles to target some types of cancer cells, and this is truly wonderful," says Dr. Michael Harbut, director of the Environmental Cancer Initiative at Michigan's Karmanos Cancer Institute.

 

"But until we have sufficient knowledge of, and experience with, this 21st-century version of the surgical scalpel, we run a very real risk of simultaneously destroying healthy cells."

When incorporated into food products, nanomaterials raise other troubling vagaries.

In a report issued in January, the science committee of the British House of Lords, following a lengthy review, concluded that there was too little research looking at the toxicological impact of eating nanomaterials.

The committee recommended that such "products will simply be denied regulatory approval until further information is available," and also raised the concern that while the amount of nanomaterial in food may be small, the particles can accumulate from repeated consumption.

"It is chronic exposure to nanomaterials that is arguably more relevant to food science applications," says Bernadene Magnuson, a food scientist and toxicologist with Cantox Health Sciences International.

 

"Prolonged exposure studies must be conducted."

Given the potential hazards, public health advocates are calling for greater restraint on the part of those rushing nano-products to market.

"The danger is there today in the hundreds of nano-containing consumer products being sold," says Jennifer Sass, senior scientist and nano expert for the nonpartisan Natural Resources Defense Council.

 

"Things that are in the nanoscale that are intentionally designed to be put into consumer products should be instantly required to be tested, and until proper risk assessments are done, they shouldn't be allowed to be sold."

David Hobson, chief scientific officer for international risk assessment firm nanoTox, adds that the questions raised by the growing body of research,

"are significant enough that we should begin to be concerned. We should not wait until we see visible health effects in humans before we take steps to protect ourselves or to redesign these particles so that they're safer."

Hobson says that when he talks to university and industry nano scientists, he sometimes feels as if he's talking with Marie Curie when she first was playing around with radium.

"It's an exciting advancement they're working with," he says. "But no one even thinks that it could be harmful."

More on Why Size Matters

At a weeklong Knight Foundation Science Workshop on nanotechnology at the Massachusetts Institute of Technology in June, five professors - four from the Cambridge school and one from Cornell University - dazzled their fellow participants with extensive show-and-tells on the amazing innovations coming out of their labs.

At one point, one played a video of a mouse with a severed spine dragging his lifeless rear legs around his cage.

A scaffolding made of nanomaterial was later implanted across the mouse's injury. Further footage showed the same rodent, 100 days later, racing around his enclosure, all four legs churning like mad.

When the five nanotech pioneers were asked about hazards from the particles they were creating, only one said she was watching new health studies closely. The others said size had no impact on risk: No problems were expected, since the same chemicals they had nano-ized had been used safely for years.

It's an argument echoed by researchers and nano-manufacturers around the globe. But those assumptions are challenged by the many research efforts presenting strong evidence to the contrary, among them Trouiller's study, which was published in November.

"The difference in size is vital to understanding the risk from the same chemical," says Schiestl, who was a co-author on the UCLA study.

 

"Titanium dioxide is chemically inert and has been safely used in the body for decades for joint replacements and other surgical applications. But when the very same chemical is nanosized, it can cause illness and lead to death."

Regulators Take a 'Wait-and-See' Approach

Many public health groups and environmental activists fear the government's lethargy on nanotechnology will be a repeat of earlier regulatory snafus where deadly errors were made in assessing the risk of new substances.

"The unsettling track record of other technological breakthroughs - like asbestos, DDT, PCBs and radiation - should give regulators pause as they consider the growing commercial presence of nanotech products," says Patty Lovera, assistant director of Food & Water Watch.

 

"This wait-and-see approach puts consumers and the environment at risk."

While the agency has many critics, the EPA, for its part, is pursuing an aggressive strategy on nanotechnology.

Among nano-titanium dioxide's other uses, the particle is deployed as an agent for removing arsenic from drinking water, and last year, the EPA handed out 500-page books of health studies on the particles to a panel of scientists asked to advise the agency on the possible risk of that practice.

(Another EPA science advisory board held hearings into the hazards from nanosilver used in hundreds of products, from pants, socks and underwear to teething rings.)

Dr. Jesse Goodman, the FDA's chief scientist and deputy commissioner for science and public health, says that "there is a most definite requirement that manufacturers ensure that the products be safe." But he adds that compliance is essentially voluntary. The FDA takes action only after an unsafe product is reported.

The Food and Drug Administration's (FDA) handling of nano-titanium dioxide provides a more emblematic example of the government's overall approach.

Public health advocates and some of the FDA's own risk assessors are frustrated by what they perceive as the agency's "don't look, don't tell" philosophy. The FDA doesn't even make a pretense of evaluating nanoparticles in the thousands of cosmetics, facial products or food supplements that have already flooded the market, even those that boast the presence of engineered particles.

Nano Gold Energizing Cream ($420 a jar) and Cyclic nano-cleanser ($80 a bar) are among the many similar products unevaluated by the agency.

Dr. Jesse Goodman, the FDA's chief scientist and deputy commissioner for science and public health, says the exclusion of cosmetics and nutritional supplements from its regulations is what Congress wants.

Goodman adds that,

"there is a most definite requirement that manufacturers ensure that the products be safe",

...but says that compliance is essentially voluntary, with the FDA taking action only after an unsafe product is reported.

AOL News repeatedly asked what steps the FDA was taking regarding nano-titanium dioxide, whose risks are acknowledged by other regulatory bodies, including the EPA and the NIOSH.

The slow-to-arrive answer from spokeswoman Rita Chappelle:

"If information were to indicate that additional safety evaluation or other regulatory action is warranted, we would work with all parties to take the steps appropriate to ensure the safety of marketed products."

Chappelle says FDA scientists are conducting research that focuses on nano-titanium dioxide, but declines to offer any details.

Several of the agency's own safety experts say they specifically have urged that the engineered structures not be used in any products they do regulate without appropriate safety testing.

 

Why Nano-Optimists Hold the Upper Hand

Many government investigators join civilian public health specialists in denouncing the scant money that goes to exploring nanomaterials' possibly wicked side effects.

The 2011 federal budget proposes spending $1.8 billion on nanotechnology, but just $117 million, or 6.6 percent, of that total was earmarked for the study of safety issues.

The Obama administration says it is being appropriately vigilant about nanotech.

"This administration takes nanotechnology-related environment, health and safety very seriously. It is a significant priority," says Travis Earles, assistant director for nanotechnology in the White House Office of Science and Technology Policy.

After taking office, he adds,

"We were able to immediately increase the spending in those areas."

But Earles, in what has become standard federal practice, is more fixated on nanotech's upsides.

"We are talking about new jobs, new markets, economic and societal benefits so broad they stretch the imagination," he says. Yes, "absolutely," there are reasons for caution, he says.

 

"But you can't refer to nanotechnology as a monolithic entity. Risk assessment depends fundamentally on context - it depends on the specific application and the specific material."

There's some scientific basis for this emphasize-the-positive position.

"Every time you find a hazardous response in a test tube, that should not necessarily be construed as a guarantee of a real-life adverse outcome," notes Dr. Andre Nel, chief of the division of nanomedicine at the California Nanosystems Institute at UCLA.

But there are two ways to proceed in the face of such uncertainty.

One is to forge ahead, assuming the best - that this will be one of those times where the lab results don't correlate to real-world experiences. Another is to hit pause and do the additional testing necessary to be sure that sickened lab animals do not portend human harm.

For advocates of more precautions for nanotech, the latter is the only responsible course.

"From cosmetics to cookware to food, nanoparticles are making their way into every facet of consumer life with little to no oversight from government regulators," says Lovera from Food & Water Watch.

 

"There are too many unanswered questions and common-sense demands that these products be kept off the market until their safety is assured."

With a moratorium not a realistic option, the U.S. government, along with its counterparts abroad, is left to tread gingerly in responding to the emerging evidence of nanotechnology's potential hazards.

"They don't want to cause either a collapse in the industry or generate any kind of public backlash of any sort," says Pat Mooney, executive director of ETC Group, an international safety and environmental watchdog.

 

"So they're in the background talking about how they're going to tweak regulations - where in fact a lot more than tweaking is required.

"They've got literally thousands of [nano] products in the marketplace, and they don't have any safety regulations in place," Mooney continues.

 

"These are things that we're rubbing in our skin, spraying in our fields, eating and wearing. And that's a mistake, and they're trying to figure out what to do about it all."

Second in a Three-Part Series
Regulated or Not, Nano-Foods Coming to A Store Near You
 

For centuries, it was the cook and the heat of the fire that cajoled taste, texture, flavor and aroma from the pot.

Today, that culinary voodoo is being crafted by white-coated scientists toiling in pristine labs, rearranging atoms into chemical particles never before seen.

At last year's Institute of Food Technologists international conference, nanotechnology was the topic that generated the most buzz among the 14,000 food-scientists, chefs and manufacturers crammed into an Anaheim, Calif., hall. Though it's a word that has probably never been printed on any menu, and probably never will, there was so much interest in the potential uses of nanotechnology for food that a separate daylong session focused just on that subject was packed to overflowing.

In one corner of the convention center, a chemist, a flavorist and two food-marketing specialists clustered around a large chart of the Periodic Table of Elements (think back to high school science class).

The food chemist, from China, ran her hands over the chart, pausing at different chemicals just long enough to say how a nano-ized version of each would improve existing flavors or create new ones.

One of the marketing guys questioned what would happen if the consumer found out.

The flavorist asked whether the Food and Drug Administration would even allow nanoingredients.

Posed a variation of the latter question, Dr. Jesse Goodman, the agency's chief scientist and deputy commissioner for science and public health, gave a revealing answer. He said he wasn't involved enough with how the FDA was handling nanomaterials in food to discuss that issue. And the agency wouldn't provide anyone else to talk about it.

This despite the fact that hundreds of peer-reviewed studies have shown that nanoparticles pose potential risks to human health - and, more specifically, that when ingested can cause DNA damage that can prefigure cancer and heart and brain disease.
 

Despite Denials, Nano-Food Is Here

Officially, the FDA says there aren't any nano-containing food products currently sold in the U.S.

Not true, say some of the agency's own safety experts, pointing to scientific studies published in food science journals, reports from foreign safety agencies and discussions in gatherings like the Institute of Food Technologists conference.

In fact, the arrival of nanomaterial onto the food scene is already causing some big-chain safety managers to demand greater scrutiny of what they're being offered, especially with imported food and beverages.

At a conference in Seattle last year hosted by leading food safety attorney Bill Marler, presenters raised the issue of how hard it is for large supermarket companies to know precisely what they are purchasing, especially with nanomaterials, because of the volume and variety they deal in.

According to a USDA scientist, some Latin American packers spray U.S.-bound produce with a wax-like nanocoating to extend shelf-life.

"We found no indication that the nanocoating... has ever been tested for health effects," the researcher says.

Craig Wilson, assistant vice president for safety for Costco, says his chain does not test for nanomaterial in the food products it is offered by manufacturers.

But, he adds, Costco is looking,

"far more carefully at everything we buy... We have to rely on the accuracy of the labels and the integrity of our vendors. Our buyers know that if they find nanomaterial or anything else they might consider unsafe, the vendors either remove it, or we don't buy it."

Another government scientist says nanoparticles can be found today in produce sections in some large grocery chains and vegetable wholesalers.

This scientist, a researcher with the USDA's Agricultural Research Service, was part of a group that examined Central and South American farms and packers that ship fruits and vegetables into the U.S. and Canada.

According to the USDA researcher - who asked that his name not be used because he's not authorized to speak for the agency - apples, pears, peppers, cucumbers and other fruit and vegetables are being coated with a thin, wax-like nanocoating to extend shelf-life.

The edible nanomaterial skin will also protect the color and flavor of the fruit longer.

"We found no indication that the nanocoating, which is manufactured in Asia, has ever been tested for health effects," said the researcher.

A science committee of the British House of Lords has found that nanomaterials are already appearing in numerous products, among them salad dressings and sauces.

Jaydee Hanson, policy analyst for the Center for Food Safety, says that they're also being added to ice cream to make it "look richer and better textured."

Some foreign governments, apparently more worried about the influx of nano-related products to their grocery shelves, are gathering their own research. In January, a science committee of the British House of Lords issued a lengthy study on nanotechnology and food.

Scores of scientific groups and consumer activists and even several international food manufactures told the committee investigators that engineered particles were already being sold in,

• salad dressings

• sauces

• diet beverages

• boxed cake, muffin and pancakes mixes,

...to which they're added to ensure easy pouring.

Other researchers responding to the committee's request for information talked about hundreds more items that could be in stores by year's end.

For example, a team in Munich has used nano-nonstick coatings to end the worldwide frustration of having to endlessly shake an upturned mustard or ketchup bottle to get at the last bit clinging to the bottom.

Another person told the investigators that Nestlé and Unilever have about completed developing a nano-emulsion-based ice cream that has a lower fat content but retains its texture and flavor.

 

The Ultimate Secret Ingredient

Nearly 20 of the world's largest food manufacturers, among them,

• Nestlé

• Hershey

• Cargill

• Campbell Soup

• Sara Lee

• H.J. Heinz,

...have their own in-house nano-labs, or have contracted with major universities to do nano-related food product development.

But they are not eager to broadcast those efforts.

[UPDATE: Campbell's spokesman Anthony Sanzio says his company does not have a nanotechnology program, but adds "We would be irresponsible to ignore it."]
 

A team in Munich, the House of Lords investigators also learned, is using nano-nonstick coatings to make it easier to get the last drops of ketchup out of the bottle.

Kraft was the first major food company to hoist the banner of nanotechnology.

Spokesman Richard Buino, however, now says that while,

"we have sponsored nanotech research at various universities and research institutions in the past," Kraft has no labs focusing on it today.

The stance is in stark contrast to the one Kraft struck in late 2000, when it loudly and repeatedly proclaimed that it had formed the Nanotek Consortium with engineers, molecular chemists and physicists from 15 universities in the U.S. and abroad.

The mission of the team was to show how nanotechnology would completely revolutionize the food manufacturing industry, or so said its then-director, Kraft research chemist Manuel Marquez.

But by the end of 2004, the much-touted operation seemed to vanish.

All mentions of Nanotek Consortium disappeared from Kraft's news releases and corporate reports.

"We have not nor are we currently using nanotechnology in our products or packaging," Buino added in another e-mail.

Industry Tactics Thwart Risk Awareness

The British government investigation into nanofood strongly criticized the U.K.'s food industry for,

"failing to be transparent about its research into the uses of nanotechnologies and nanomaterials."

On this side of the Atlantic, corporate secrecy isn't a problem, as some FDA officials tell it.

Investigators on Capitol Hill say the FDA's congressional liaisons have repeatedly assured them - from George W. Bush's administration through President Barack Obama's first year - that the big U.S. food companies have been upfront and open about their plans and progress in using nanomaterial in food.

But FDA and USDA food safety specialists interviewed over the past three months stressed that based on past performance, industry cannot be relied on to voluntarily advance safety efforts.

These government scientists, who are actively attempting to evaluate the risk of introducing nanotechnology to food, say that only a handful of corporations are candid about what they're doing and collaborating with the FDA and USDA to help develop regulations that will both protect the public and permit their products to reach market.

Most companies, the government scientists add, submit little or no information unless forced.

Even then, much of the information crucial to evaluating hazards - such as the chemicals used and results of company health studies - is withheld, with corporate lawyers claiming it constitutes confidential business information.

Both regulators and some industry consultants say the evasiveness from food manufacturers could blow up in their faces.

As precedent, they point to what happened in the mid-'90s with genetically modified food, the last major scientific innovation that was, in many cases, force-fed to consumers.

"There was a lack of transparency on what companies were doing. So promoting genetically modified foods was perceived by some of the public as being just profit-driven," says Professor Rickey Yada of the Department of Food Science at the University of Guelph in Ontario, Canada.

"In retrospect, food manufacturers should have highlighted the benefits that the technology could bring as well as discussing the potential concerns."
 

Eating Nanomaterials Could Increase Underlying Risks

The House of Lords' study identified "severe shortfalls" in research into the dangers of nanotechnology in food.

Its authors called for funding studies that address the behavior of nanomaterials within the digestive system.

Similar recommendations are being made in the U.S., where the majority of research on nanomaterial focuses on it entering the body via inhalation and absorption.

The food industry is very competitive, with thin profit margins.

And safety evaluations are very expensive, notes Bernadene Magnuson, senior scientific and regulatory consultant with risk-assessment firm Cantox Health Sciences International.

"You need to be pretty sure you've got something that's likely to benefit you and your product in some way before you're going to start launching into safety evaluations," she explains.

Magnuson believes that additional studies must be done on chronic exposure to and ingestion of nanomaterials.

One of the few ingestion studies recently completed was a two-year-long examination of nano-titanium dioxide at UCLA, which showed that the compound caused DNA and chromosome damage after lab animals drank large quantities of the particles in their water.
 

Meat cooler at grocery store

Sono-Tek, a company based in Milton, N.Y., employs nanotechnology in its industrial sprayers.

"One new application for us is spraying nanomaterial suspensions onto biodegradable plastic food wrapping materials to preserve the freshness of food products," says its chairman and CEO.

It is widely known that nano-titanium dioxide is used as filler in hundreds of medicines and cosmetics and as a blocking agent in sunscreens.

But Jaydee Hanson, policy analyst for the Center for Food Safety, worries that the danger is greater,

"when the nano-titanium dioxide is used in food."

Ice cream companies, Hanson says, are using nanomaterials to make their products "look richer and better textured."

Bread makers are spraying nanomaterials on their loaves,

"to make them shinier and help them keep microbe-free longer."

While AOL News was unable to identify a company pursuing the latter practice, it did find Sono-Tek of Milton, N.Y., which uses nanotechnology in its industrial sprayers.

"One new application for us is spraying nanomaterial suspensions onto biodegradable plastic food wrapping materials to preserve the freshness of food products," says Christopher Coccio, chairman and CEO.

He said the development of this nano-wrap was partially funded by New York State's Energy Research and Development Authority.

"This is happening," Hanson says.

He calls on the FDA to,

"immediately seek a ban on any products that contain these nanoparticles, especially those in products that are likely to be ingested by children."

"The UCLA study means we need to research the health effects of these products before people get sick, not after," Hanson says.

There is nothing to mandate that such safety research take place.

 

The FDA's Blind Spot

The FDA includes titanium dioxide among the food additives it classifies under the designation "generally recognized as safe," or GRAS.

New additives with that label can bypass extensive and costly health testing that is otherwise required of items bound for grocery shelves.

A report issued last month by the Government Accountability Office (GAO) denounced the enormous loophole that the FDA has permitted through the GRAS classification. And the GAO investigators also echoed the concerns of consumer and food safety activists who argue that giving nanomaterials the GRAS free pass is perilous.

Food safety agencies in Canada and the European Union require all ingredients that incorporate engineered nanomaterials to be submitted to regulators before they can be put on the market, the GAO noted.

No so with the FDA.

"Because GRAS notification is voluntary and companies are not required to identify nanomaterials in their GRAS substances, FDA has no way of knowing the full extent to which engineered nanomaterials have entered the U.S. food supply," the GAO told Congress.

Amid that uncertainty, calls for safety analysis are growing.

"Testing must always be done," says food regulatory consultant George Burdock, a toxicologist and the head of the Burdock Group. "Because if it's nanosized, its chemical properties will most assuredly be different and so might the biological impact."

Will Consumers Swallow What Science Serves Up Next?

Interviews with more than a dozen food scientists revealed strikingly similar predictions on how the food industry will employ nanoscale technology.

They say firms are creating nanostructures to enhance flavor, shelf life and appearance. They even foresee using encapsulated or engineered nanoscale particles to create foods from scratch.

Experts agreed that the first widespread use of nanotechnology to hit the U.S. food market would be nanoscale packing materials and nanosensors for food safety, bacteria detection and traceability.

While acknowledging that many more nano-related food products are on the way, Magnuson, the industry risk consultant, says the greatest degree of research right now is directed at food safety and quality.

"Using nanotechnology to improve the sensitivity and speed of detection of food-borne pathogens in the food itself or in the supply chain or in the processing equipment could be lifesaving," she says.

For example, researchers at Clemson University, according to USDA, have used nanoparticles to identify campylobacter, a sometimes-lethal food-borne pathogen, in poultry intestinal tracts prior to processing.

At the University of Massachusetts Amherst, food scientist Julian McClements and his colleagues have developed time-release nanolaminated coatings to add bioactive components to food to enhance delivery of ingredients to help prevent diseases such as cancer, osteoporosis, heart disease and hypertension.

But if the medical benefits of such an application are something to cheer, the prospect of eating them in the first place isn't viewed as enthusiastically.

Advertising and marketing consultants for food and beverage makers are still apprehensive about a study done two years ago by the German Federal Institute of Risk Assessment, which commissioned pollsters to measure public acceptance of nanomaterials in food.

The study showed that only 20 percent of respondents would buy nanotechnology-enhanced food products.

Third in a Three-Part Series

Obsession With Nanotech Growth Stymies Regulators
 

When the United States government formally acknowledged the world-changing potential of nanotechnology a decade ago, it was decided that America should lead the way.

Almost immediately, 25 different federal agencies began scrambling to find uses for the engineered particles in medicine, energy, transport, weapons, protective devices and food, as well as thousands more real and dreamed-about applications.

Today, the U.S. is at the fore of worldwide nano-innovation.

But when it comes to regulations and laws that will protect consumers and workers from the potential hazards, the country lags badly behind many other nations.

"The government agencies responsible for protecting the public from the adverse effects of these technologies seem worn and tattered," former Environmental Protection Agency assistant administrator Clarence Davies wrote in a study for the Woodrow Wilson International Center for Scholars' Project on Emerging Nanotechnologies, where he is now a senior adviser.

Davies, who while at the EPA authored what became its all-important Toxic Substances Control Act, adds that the gap between the capabilities of nanotechnology and those of the regulatory system,

"is likely to widen as the new technologies advance."

Andrew Maynard in an undated photo

Andrew Maynard, chief science adviser for the Woodrow Wilson International Center for Scholars, is among those advocating guidelines for nano-safety.

"Get these rules wrong - and we're not sure what they are yet - or ignore them, and we may cause unnecessary harm to people and the environment," he says.

Advocates say the importance of establishing effective nano-safety guidance is difficult to overstate.

But that effort is also dauntingly difficult.

"Get these rules wrong - and we're not sure what they are yet - or ignore them, and we may cause unnecessary harm to people and the environment," says Andrew Maynard, chief science adviser for the Wilson Center.

 

"I don't think it will be the end of the world as we know it. But it will be a lost opportunity to get an exciting new technology right."

No One's in Charge

The U.S. government has no nano czar, no single entity responsible for setting priorities and doling out billions in research funds. But on paper, the National Nanotechnology Initiative (NNI) comes closest to fitting that role.

Launched by the Clinton administration's 2001 budget, the NNI was tasked with coordinating federal investment in nanotechnology research and development.

The official description of its mission mandates it to "advance a world-class nanotechnology research and development program, foster the transfer of new technologies into products for commercial and public benefit, and support responsible development of nanotechnology."

While that sounds somewhat czar-like, the reality is that who's in charge of America's nanotech policy is murky.

"Final authority resides in the [White House's] Office of Science and Technology Policy, the Office of Management and Budget, and with the president," says NNI Director Clayton Teague.

At the same time, Teague's position is that there's no need for a central, government-wide coordinating entity on nanotechnology.

"There is no nuclear 'czar,' no independent authority over information technology, electronic technology, or biotechnology for health and medicine," he says, adding that nanotechnology activities "claim less than 1 percent of the federal research and development budget" and therefore "simply don't require the special focus you are suggesting."

NNI's biggest shortcoming, say even the agency's supporters, is its failure to adequately fund basic research on the safety hazards of nanomaterial.

"The NNI has never effectively addressed environmental, health and safety issues surrounding nanotech with a comprehensive, interagency plan," Matthew Nordan, president of technology forecasting firm Lux Research, told the Senate Committee on Commerce, Science and Transportation.

Although his statement was made almost two years ago, committee investigators say there has been little or no improvement since.

The Obama administration's 2011 budget illustrates the scant federal resources devoted to nano-safety.

It proposes spending $1.8 billion on nanotechnology overall, but just $117 million - or 6.6 percent - of that was earmarked for the study of health-related issues surrounding the engineered particles.

"It's not a small amount," says Travis Earles, a nanotech adviser to the White House, defending the allotment.

Without a single office leading the charge, the task of guarding against potential nanotech risks falls to the four agencies most involved in protecting the public, workers and the environment:

• the EPA

• the Food and Drug Administration

• the U.S. Department of Agriculture

• the Occupational Safety Health Administration

Many of the safety experts in those agencies told AOL News that the vital regulations for the use, production, labeling, sale and ultimate disposal of nanomaterial are not keeping pace with the rush of new products entering the marketplace.

"Consumers want to know what they buy, retailers have to know what they sell, and processors and recyclers need to know what they handle," Christoph Meili, of the Innovation Society Ltd., said in a report on international nano regulations funded in part by the Swiss Federal Office for the Environment.

Some of the scientists involved in turning nanoparticles into new business opportunities, however, argue that such protocols would be premature.

"I don't think we have the scientific basis on which to establish regulations. And I think that right now a lot of the materials that are being produced are absolutely benign," says Stacey Harper, assistant professor of nanotoxicology at Oregon State University.

"The Holy Grail," she says, "is figuring out what are those [hazardous] features that we need to avoid in engineering these newer materials."

'Do Nothing to Prevent Innovation'

The FDA makes stringent demands for safety information on nanomaterial used in medicine and medical devices, says Jesse Goodman, its chief scientist and deputy commissioner for science and public health.

But the agency takes no specific measures to ensure the safety of the many costly cosmetics and dietary supplements boasting the benefits of the nanoingredients they claim to include, even though its own investigators say the public submits a constant stream of questions and complaints.

"Nanotechnology products present challenges similar to those the [FDA] faces for products of other emerging technologies," says an agency press officer, and "our existing regulations can pretty much handle these advancements."

FDA headquarters in Rockville, Md.
Getty Images

 

The FDA (whose Rockville, Md., headquarters are shown here) has drawn fire from activists for its approach to nanomaterials.

The agency, says the Center for Food Safety's Jaydee Hanson, is "like ostriches with their heads in the ground, not looking for a problem so they do not see one."

That stated approach terrifies public health advocates, as well as some of the agency's own risk assessors.

"FDA is like ostriches with their heads in the ground, not looking for a problem so they do not see one. If they don't see one, they don't have to respond to a problem," says Jaydee Hanson, senior policy analyst for the Center for Food Safety.

The FDA does need better tools and expertise to predict the behavior of nanomaterial, Goodman concedes.

But, he adds,

"to get information needed to assess the safety of nano-products, we do that in a way that doesn't cause a problem in terms of preventing innovation."

"Do nothing to prevent innovation" was former Vice President Dick Cheney's marching orders to the Office of Management and Budget during President George W. Bush's administration.

 

"For years OMB acted as industry's protector," says Celeste Monforton, assistant research professor at George Washington University's School of Public Health.

She is among the public health activists who cringe to hear the phrase still being used by President Barack Obama's regulators.

For all that, however, the FDA appears mostly AWOL in its handling of nanomaterial in food. Food safety experts in the agency say it is doing little more than paying bureaucratic lip service to developing criteria for handling the anticipated avalanche of food, beverages and related packaging that is heading to store shelves.

(The agency declined repeated requests to interview any of its food scientists or regulators.)

With the FDA largely punting, responsibility for ensuring the safety of the nanomaterial in the marketplace falls to the Consumer Product Safety Commission - which raises additional problems.

"If you take the nano-products that we know are out there and divide them up among the safety agencies, the CPSC is actually responsible for a majority of those," says David Rejeski, science director for the Technology Innovation Program at the Woodrow Wilson International Center for Scholars.

In an analysis of CPSC's ability to handle nanomaterial, Rejeski - who has worked in the White House Office of Science and Technology Policy - and his team identified many limitations.

The CPSC has no method of collecting information on nano-products, and limited ability to inform the public about health hazards.

"Even if they find a product," Rejeski says, "they don't have much ability to do any research to determine whether it's dangerous."

Finding a Way Around the Roadblocks

Since 2008, the EPA has been attempting to impose some controls on carbon nanotubes, whose myriad industrial applications make them one of the most heavily used engineered particles.

In June, it seemed to have made significant progress toward that goal, issuing a final notice on a process called "Significant New Use Rules," which would have required companies to notify the agency at least 90 days prior to the manufacture, importing or processing of carbon nanotubes.

The move was cheered by the public health community:

Studies have shown that multiwalled nanotubes are among the nanomaterials posing potential risks to humans, capable of damaging or destroying the immune system, creating asbestos-like lung disease and causing cancer or mutations in various cells.

The advocates heralded the measure as the first clear sign that EPA was going to hold nano developers and users accountable.

Almost immediately, the Washington law firm of Wilmer Hale, while declining to say whom it represented, threw up procedural roadblocks, notifying the EPA that it planned,

"to submit adverse and/or critical comments on behalf of one or more clients."

That was enough to force the EPA to withdraw the new rules.

The EPA resubmitted its proposal. But on December 1, in an unprecedented move, the European Commission's Directorate-General for Enterprise and Industry raised concerns on behalf of a British nanotube maker. Action on the new rule was put off for another three months, with the public comment period running through March.

Nevertheless, the EPA believes that by year's end, its new nanotube requirements will be mandatory.
 

EPA Administrator Lisa Jackson in December 2009

EPA Administrator Lisa Jackson is pushing for reforms that would make it mandatory for companies to report the use of nanomaterials.

Industry players are pushing back.

Efforts such as those undertaken by Wilmer Hale's client to stall or thwart new or enhanced safety regulations are legal.

So is another practice used by many corporations to deny EPA access to health studies and other information crucial to assessing the risk of a new chemical or product: declaring that the data is confidential business information.

EPA Administrator Lisa Jackson has said she wants to put an end to the corporate maneuvering, especially as it applies to the new nanomaterial. While testifying before a Senate committee in December attempting to add teeth to the Toxic Substances Control Act, Jackson explained the obstacles EPA risk assessors confront in trying to do their jobs.

Due to the legal and procedural hurdles in the law, over the past 30 years, the administrator said, EPA has only been able to require testing on about 200 of the more than 80,000 chemicals produced and used in the United States.

"EPA should have the clear authority to establish safety standards that reflect the best available science... without the delays and obstacles currently in place, or excessive claims of confidential business information," Jackson told the lawmakers.

In February, the agency's assistant inspector general, Wade Najjum, issued a report that said,

"EPA's procedures for handling confidential business information requests are predisposed to protect industry information rather than to provide public access to health and safety studies."

The changes to the Toxic Substances Control Act that Jackson is advocating would require mandatory reporting of the use of nanomaterials.

EPA lawyers have told Senate investigators that the overhaul is vital due to the industry pressure spawned by the big business opportunities new nano-products can generate. Meanwhile, some nanotechnology players are pushing hard to get a resistant EPA to grandfather in nanomaterial already on the market.

It's a significant point of dispute:

One of the reasons the EPA is seeking the mandatory reporting requirement in the first place is that the agency is convinced the current voluntary system of submitting safety data doesn't work.

In the fall, EPA assistant administrator Steve Owens told an international conference on regulating nanomaterial that about 90 percent of the various nanoscale materials already being used commercially, or thought to be used, were never reported to the government.

"EPA has determined that regulating existing nanoscale materials," explains press officer Dale Kemery, "is needed to ensure protection of human health and the environment."

A spokesman for the Senate Committee on Environment and Public Works says two more hearings need to be held on revising the Toxic Substances Control Act, but they have yet to be scheduled.

 

Workers Require Extra Protections

If there is a front-runner in the effort to institute meaningful safety regulations for nanomaterial, it is the National Institute for Occupational Safety and Health (NIOSH), the worker safety research arm of the Centers for Disease Control and Prevention.

Physicians and scientists there have been scrambling to identify the risks that the nanotechnology industry's employees are encountering on the job.

"Workers and employers can't wait for us to come up with all the answers before they unleash this technology. It's unleashed already," says Paul Schulte, manager of the NIOSH Nanotechnology Research Center.

Having published more than 170 peer-reviewed studies on the health effects from nano exposure, the agency has established exposure limits for nano-titanium dioxide - the heavily used material shown to damage and destroy DNA and chromosomes in studies at UCLA.

The division has recommended that to ensure safety, the exposure limit for workers handling nano-titanium dioxide should be 15 times lower than that for the normal size of the chemical, says Vincent Castranova, the agency's chief of the Pathology and Physiology Research Branch.

The particles are believed to be used in more than 100 different manufacturing sites across the country. That's a lot of workers.

NIOSH cannot pass laws, only make recommendations to the Occupational Safety and Health Administration (OSHA). And because of all the tortuous, bureaucratic steps that still must be completed, as well as the anticipated blocking efforts from some industry interests, it could be two years before any regulations are instituted.

OSHA leaders refused to respond to questions on what the agency will do in the meantime. NIOSH has also almost completed recommendations for the handling of carbon nanotubes.

And scientists at NIOSH's animal labs in Morgantown, W.Va., are now testing the toxicity of almost two dozen other nanoparticles, including,

• the diesel additive cerium oxide

• the metal hardening mixture of tungsten carbide and cobalt

• the anti-microbial agent nanosilver

• the sunblocker zinc oxide

Vial of nanotubes

Since 2008, the EPA has also been seeking to impose some controls on carbon nanotubes. That effort has been made more difficult by corporate maneuvering.

Most significantly, NIOSH scientists have identified health risks from nanomaterials not previously documented by other researchers.

For example, says Castranova, when studying the potential impact of nano-titanium dioxide exposure on workers' lungs, they also found cardiovascular effects - damage to the heart muscle.

Separately, the NIOSH team discovered that beyond the well-documented lung damage that comes from inhalation of carbon nanotubes, those heavily used carbon structures were causing inflammation of the brain in the test animals.

"Everything we say could apply to a consumer. The big difference is that the consumer will likely see much lower concentrations, for much shorter periods of time," Castranova says, adding that the findings need to be viewed with the proper perspective.

Nanomaterials, Castranova says, are not anthrax, but they aren't Kool-Aid, either.

 

Other Countries Exercise Greater Caution

Consumer and safety watchdogs say Canada, the U.K. and the rest of the European Union are far ahead of the U.S. when it comes to nano safety requirements.

Canada became the first country to demand stringent reporting requirements of corporations and universities that import, manufacture or use more than 2 pounds of nanomaterial a year. The regulations - necessary for proper risk assessment, the Canadian government said - were crafted and are enforced by Health Canada and Environment Canada.

They require the reporting of the nanomaterial's chemical composition and physical description, toxicity and proposed use, along with other data.

French lawmakers have drafted legislation with similar stipulations. And the European Parliament voted last year that its 27 member states should consider nanomaterials as new substances, and not cover them under existing laws that do not take into account the risks associated with the technology.

It also demanded that consumer products containing nanomaterials be clearly labeled as such, and that the manufacturers of new cosmetic products containing nanomaterials provide specific information to regulators six months before the product is placed on the European market.

In the U.K., the battle cry of nano-regulators is "No data, no market," especially with food products.

"Products will simply be denied regulatory approval until further [safety] information is available," the British House of Lords' science committee said in December.

It concluded that there was too little research into the toxicological impact of eating nanomaterials, and too much secrecy on the part of the food industry.

"It's obvious that in some cases the U.S. has been a bit lax, though you could make the case that in some cases the EU requirements are a little bit too stringent," says Michael Holman, research director of Lux Research.

 

"There's no regulatory regime that can give you 100 percent certainty that everything that comes to market is going to be perfectly safe."

But to Patty Lovera, assistant director of Food & Water Watch, that doesn't leave the U.S. government off the hook.

The failure of the U.S. regulatory system to keep up with nanotechnology, she states simply,

"puts consumers and the environment at risk."