by Jake Meyer>
At ISLAT we’ve done studies on the legal issues surrounding nanotechnology for both the Department of Energy and the National Science Foundation, but the issue of nanotechnology has not reached the general public so it is refreshing to see an in depth analysis as part of an AOL News Special Report. The AOL News Special Report is a three part series written by Andrew Schneider that explores the health risks nanotechnology introduce and the current regulatory efforts to protect workers, consumers, and the environment from these risks.
The first article in the series is titled “Amid Nanotech’s Dazzling Promise, Health Risks Grow.” This title is apt for the entire series as the issues that are continually raised are the great possibilities that nanotechnology promises weighed against the health risks nanotechnology contains. The worry is that too much regulation of nanotechnology will impede the development of amazing new technologies (along with it the economic boost new technologies provide). But too little regulation might lead to widespread harm.
The article describes some of the nanotechnology products, such as the creation of nano-sized delivery systems that can be injected into the body to seek out cancer cells and deliver cancer-fighting drugs. I previously wrote about other medical innovations that nanotechnology could enable such as nano robots that clean arteries of cholesterol and biosensors that allow a person with diabetes to monitor their glucose level without using a lancet. Carbon nanotubes are stronger than steel and lightweight. I previously wrote a blog about how carbon nanotubes could be the answer for the creation of space elevators.
Schneider reveals that there is no shortage of products using nanotechnology available for the consumer. Over ten-thousand products that can be bought over the counter contain the nanoparticle titanium dioxide. Nano-titanium dioxide can be found in “everything from medicine capsules and nutritional supplements, to food icing and additives, to skin creams, oils and toothpaste.” However the AOL series points out, though, despite the widespread use of nano-titanium dioxide, research suggests that these nanoparticles could be harmful to humans. Research by Bénédicte Trouiller at UCLA found that nano-titanium dioxide mixed in with the drinking water of rats was damaging or destroying the rats’ DNA and chromosomes. The DNA damage Trouiller observed can be “linked to all the big killers of man, namely cancer, heart disease, neurological disease and aging.” And its not just nano-titanium dioxide – more than 170 studies by the National Institute for Occupational Safety and Health have shown different nanoparticles to be potentially harmful.
The size of a nanoparticle is what makes it so useful, but size is also what makes a nanoparticle potentially dangerous. At nanoscale sizes, materials exhibit very different characteristics, such as mechanical, optical, electrical, chemical, or magnetic properties not present outside the nanoscale. These characteristics exist largely for two reasons. First, nanomaterials have an unusually high surface-to-volume ratio which leads to significantly increased chemical reactivity. For example, gold is inert at the macroscale, but at the nanoscale it is highly reactive and therefore potentially valuable as a catalyst for chemical manufacturing. Second, materials exhibit quantum mechanical effects at the nanoscale. These quantum mechanical effects lead to unusual electrical, optical, mechanical and magnetic phenomena. For example, opaque substances become transparent (copper); inert materials become catalysts (platinum); stable materials turn combustible (aluminum); solids turn into liquids at room temperature (gold); and insulators become conductors (silicon). Nanotechnology capitalizes on these new characteristics, but it also means that nanoscale-sized versions of familiar particles present new challenges and potential for harm to the human body. The small size of nanoparticles also means that they can enter the body in numerous ways: they can be inhaled, ingested, absorbed through the skin or eyes, or pass to the brain through the olfactory nerves in the nose. The nanoparticles can also enter cells within the body, pass between organs, get into the bloodstream, bone marrow, nerves, muscles, lymph nodes, and pass the blood-brain barrier.
Considering the ease at which nanoparticles move throughout our body and the studies indicating that some of these particles could have negative long term effects on the human body, you would think that companies would be slow to feed them to us. Schneider, in his second article “Regulated or Not, Nano-Foods Coming to a Store Near You,” points out that nanoparticles are being put into our food and the practice is going to become more and more commonplace.
The Food and Drug Administration claims that there are not currently food products sold in the U.S. that contain nanoparticles, but even the agency’s own safety experts recognize that food is available containing nanoparticles. Latin American packers spray U.S. bound produce with a nanocoating to extend the shelf-life and, according to a U.S. Department of Agriculture scientist interviewed for the AOL Special Report, there is “no indication” that this nanocoating has ever been tested for health effects. Apples, pears, peppers, cucumbers and other fruit and vegetables are being coated with a wax nanocoating to protect the color and flavor of the fruit and vegetables. Nanoparticles are being added to upgrade the texture of ice cream. Bread makers are spraying their loaves with nanomaterials to make them shinier and protect them from microbes. A science committee of the British House of Lords found that nanoparticles were being sold in salad dressings, sauces, diet beverages, and boxed cake, muffin and pancake mixes. In Germany, nonstick coatings are being added to ketchup bottles to make it easier to get all of the ketchup out of the bottle.
As all of these products enter the marketplace, who is ensuring the public’s safety? FDA and U.S. Department of Agriculture food specialists interviewed for Schneider’s article stated that industry cannot be relied on to ensure safety. Only a few companies are disclosing what they’re doing and collaborating with the FDA and USDA. Companies submit little information voluntarily and when they do, information critical to determining health risks, such as the chemicals used and the results of health studies performed by the company, is often withheld.
And rules in place at the FDA leave a hole for nanoparticles to pass through directly to our dinner table. The FDA considers titanium dioxide a food additive that is “generally recognized as safe.” Additives with this designation can bypass costly health testing. The food safety agencies of Canada and the European Union require all ingredients to be submitted for testing before they can be sold in a grocery store. This seems to be the appropriate measure when you consider that a nanosized material is going to have different properties and could be damaging to human health – nano-titanium dioxide is getting a pass in the U.S. on health testing before its put in our food and researchers at UCLA have shown that it’s causing cancer in rats.
Schneider’s third article, titled “Obsession With Nanotech Growth Stymies Regulators,” details the federal agencies approaches to regulating nanotechnology. Four agencies are primarily in charge of protecting the public, workers, and environment from the risks of nanomaterials: the Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA) and the Occupational Safety Health Administration (OSHA).
Schnieder is particularly critical of the FDA’s handling of nanomaterial, describing the agency’s approach as “mostly AWOL in its handling of nanomaterial in food,” and “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 the store shelves.”
The EPA has been attempting to impose some controls on carbon nanotubes. The EPA had made progress in issuing a final notice on its “Significant New Use Rules,” which would require companies to notify the EPA 90 days before manufacture, import, or processing of carbon nanotubes. I had previously blogged about the Significant New Use Rules here. Studies have shown that carbon nanotubes are capable of damaging or destroying the immune system, creating lung disease and causing cancer or mutations in various cells. The EPA believes the reporting requirements for carbon nanotubes will be mandatory by the end of the year.
EPA Administrator Lisa Jackson is proposing to make it mandatory that all companies report the use of nanomaterials. The change from a voluntary to a mandatory reporting system would drastically improve the reporting rates – currently 90 percent of the nanoscale materials used commercially were never reported to the government. This would be a big change from the past, where the EPA has had a difficult time regulating materials. In the last 30 years, the EPA has only been able to require testing on 200 of more than 80,000 chemical produced in the United States. By requiring companies to report all use of nanomaterials the EPA will be more aware of the various nanomaterials available commercially, which could result in more success in requiring testing of potentially harmful nanomaterials that are commercially available.
The article commends the National Institute for Occupational Safety and Health (NIOSH) as the “front-runner in efforts to institute meaningful safety regulations for nanomaterial.” NIOSH cannot pass laws but only makes recommendations to the Occupational Safety and Health Administration. NIOSH has recommended that the exposure limit for workers handling nano-titanium dioxide should be 15 times lower than that for the normal sized chemical. NIOSH is also working on recommendations for carbon nanotubes and is testing the toxicity of two dozen other nanoparticles.
Overall, Schneider’s three part series is a great wake-up call for many that were likely unaware of the pervasiveness of nanoparticles in our life and a call to arms for the agencies that regulate these industries. The lack of a regulatory response from federal agencies seems familiar in the wake of the economic meltdown that was prompted by a lack of regulatory oversight of banks that sold poorly understood financial products. The argument for less regulation among the banks is that more regulation will slow economic growth – in the case of nanotechnology the concern is that regulation will slow innovation, and possibly the country misses out on the economic boost something like a breakthrough in quantum computing would provide. However, if regulation had prevented consumption of the financial innovation the Collateralized Debt Obligation (CDO), millions would be better off. And millions will also be better off if regulation prevents the consumption, inhalation, or absorption of nano-titanium dioxide or other nanoparticles that later cause cancer, heart disease, and neurological diseases. And for me, the most ridiculous part is that we’re subjecting our citizens to the experiment of ingesting untested nanoparticles all in the name of a shiny loaf of bread or a rich textured bowl of ice cream.