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Size v. substance: consumer expectations and nanomaterials in products.

Consumers today have high expectations about the content of the products they use. A "natural" or "green" label means so much to consumers that it is liberally used, subjecting companies to claims of "green washing." At the other end of the spectrum is the endless use of warnings. Some would argue that product warnings have become so ubiquitous in society that they have lost their effectiveness. Nanotechnology is one emerging market that seems to contradict these trends. Products containing nanomaterials tend to use no content label either touting the benefits of the new technology or advising consumers of their presence.

Developments in Nanotechnology

Nanotechnology is a cutting-edge manufacturing technology that involves the manipulation of materials on such a small scale that they are essentially invisible to the naked eye. Nanotechnology has improved many of the products that are part of everyday life, including technology, food, clothing, healthcare, office products and even sporting equipment. Increasingly, scientific literature shows that some applications of nanotechnology may have detrimental health and environmental impacts. Industry and government have acknowledged nanotechnology's tremendous benefit to society and have pursued product development while simultaneously funding research into the safety of these products.

The issue of what to communicate to consumers about the inclusion of nanotechnology in products is complicated. Nanotechnology involves molecules of well-known materials such as gold, silver, carbon or zinc broken down into their smallest atomic form, with possibly rearranged molecular structures. In this smaller size, particles may display different properties than they do in their typical form. In the nanoscale, gold is red and not yellow. In reducing a substance to the nanoscale, its surface area multiplies exponentially, resulting in increased reaction as air or other substances interact with the surface of the nanoparticle. For example silver, which has known antibacterial properties, is used in the nanoscale for sanitary cleaning purposes. While the increased surface area of the nanocompound may radically increase its potency and create other characteristics, because the material is "well known" the nanocompound is likely to fall below any regulatory threshold. All of these factors raise serious questions about consumers' right to know of nanotechnology in their products and what manufacturers' strategies should be for product labeling.

Nanotechnology's Impact on Daily Life

According to The Project on Emerging Nanotechnologies, thousands of unregulated and unlabeled consumer products containing nanocompounds are currently being marketed. This number will continue to grow as promising new applications of nanotechnology are developed. Presently, nanotechnology is being incorporated into products with "new and improved formulas," without any information that the use of nanomaterials is the improvement being touted. The market for nano-enabled active and smart packaging for the food and beverage industry is estimated to exceed $20 million by 2015, according to a March 2, 2014, industry group report.

While nanotechnology is generally more accepted in inert products such as smart phones, many people are skeptical about nanotechnology in products that they ingest or use on their bodies, such as food or sunscreen. The Project on Emerging Nanotechnologies lists 96 leading consumer food products that it found included nanoparticles not advertised by the manufacturer. Leading food brands such as Betty Crocker, Coca Cola, General Mills, Hershey's, Keebler, Kraft, M&M Mars, Nabisco, and Nestle incorporate nanoscale titanium dioxide in products as diverse as breakfast tarts, cheese, candy bars, dressings, frostings, mashed potatoes, sandwich crackers and sports beverages. On the other hand, some food products and nutritional supplements, including mineral waters marketed as containing nanosilver or nanogold, tout the health benefits of nanomaterials. In reality, there is no effective way for consumers to verify these claims, and the actual health impacts of these materials is currently unknown.

Nanomaterials used in food packaging include nanoscale clays in beer bottle plastics, carbon and zinc oxide in food wrappers, and nanosilver in food storage containers designed to increase product freshness. While the use of nanotechnology in food packaging increases freshness, protects from moisture and bacteria, and provides spoliation sensors, there are health and environmental concerns that nanoparticles will migrate into food or the environment via landfills. These nanocompounds could cycle through the environment into other living organisms, make their way through the food chain again, and be consumed by people, potentially causing harm.

Consumer Expectations on Disclosure

Should manufacturers, and others in the distribution chain advise purchasers and end-users of the presence of nanotechnology in their products because of the chance for potentially harmful effects in the future? A jury research study conducted by Governo Law Firm evaluated prospective jurors' attitudes about failure to warn claims involving nanoparticle-based sunscreens and clothing designed with nanotechnology. The study indicated that jurors are critical of any lack of notice or warning on a product containing potentially harmful ingredients, regardless of whether the jurors were generationally categorized as baby boomers (born 1946-1964), Generation Xers (born 1965-1984), or millennials (born 1985-1999).

Another recent study by researchers at North Carolina State University and the University of Minnesota indicated that United States consumers want labels on food products that use nanotechnology, whether the nanotechnology is incorporated into food or food packaging. The study, which involved multiple focus groups, found that 60 percent of food consumers responding to a follow-up survey desired nanotechnology labeling even if the cost of such labeling would increase the cost of the food by 5 to 25 percent. However, the study also demonstrated that people are open to applications of nanotechnology in food, particularly those which will make food safer, more nutritious or promote increased shelf-life.

Health and Environmental Impacts

As commercial use and development of nanotechnology has increased, researchers are beginning to better understand the potential health and environmental risks of products containing these components. Concerns initially arose following a 2008 research study that found carbon nanotubes may behave similarly in the body to asbestos and cause mesothelioma.

Several new studies are beginning to cast doubt on the safety of nanocompounds that already have been widely disseminated in consumer products. A recent government funded European study showed that titanium dioxide nanoparticles, similar to those used in foods, medications, sunscreens and toothpaste can have carcinogenic effects on the gastric epithelial cells in the human stomach.

An in-depth review study found evidence to support a range of medical and environmental concerns associated with titanium dioxide (TiO2) nanoparticles, including cellular toxicity in the heart, circulatory system and lungs. The researchers also concluded that the titanium dioxide nanoparticles may have a synergistic effect promoting increased cellular toxic

ity from metal compounds and Bisphenol A (BPA) in the bloodstream. The study also raised concerns about the toxicity of nanoTi[O.sub.2] in the aquatic environment after being flushed from the body. In April 2014, researchers at the Harvard School of Public Health and Massachusetts Institute of Technology released research findings that nanoscale zinc oxide and nanosilver produced statistically significant DNA damage which could lead to genome damage and promote the development of cancer. Conversely, their research indicated that silicon dioxide, iron oxide and cerium oxide nanoparticles showed low genotoxicity.

There is a growing collection of research indicating that certain nanocompounds may be detrimental to plants and wildlife. A widely cited 2004 study suggests that Fullerenes (a/k/a Buckyballs) enter the brains of bass fish embryos and cause oxidative stress, which is associated with the development of cancer. A 2005 study suggests that aluminum oxide, a nanocompound used in sunscreen and automobile scratch proof paints, may inhibit plant growth.

The health effects of nanoparticles generally create more concern than those of standard size materials because of nanoparticles' increased ability to migrate into organisms and body tissues. Given the current scale of nanotechnology development and its promising commercial applications in medicine, technology, food packaging and transportation,

ongoing research into the safety of these compounds is vital to minimize and control medical, biological and environmental health risks. This research may help manufacturers determine whether a health warning is necessary or if safer product formulations need to be designed.

Emerging Regulation of Nano Manufacturing

Currently, the Food and Drug Administration (FDA) does not require the disclosure or testing of nanomaterials used in food. However, upon inquiry from the FDA, manufacturers are required to provide proof that foods using nanotechnology are safe. The FDA has also issued guidelines with non-binding recommendations concerning the safety assessment of manufacturing processes including nanotechnology. It does not categorically judge all products containing nanomaterials as intrinsically benign or harmful as it "considers...the characteristics of the finished product and the safety of its intended use." The FDA recommends that safety assessments be as rigorous as possible and based on relevant data. However, the guidelines make it clear that the industry remains responsible for ensuring that products meet safety standards and that the FDA will continue post-market monitoring. Although these guidelines are currently non-binding, the FDA has signaled that it is likely to increase its oversight of nanotechnology-enabled products. In a September 13, 2013, speech at the Global Summit on Regulatory Science Research, FDA Commissioner Margaret Hamburg announced that FDA scientists are studying the potential risks of increased dermal penetration of nanoparticles used in sunscreens, and indicated that the methods developed for the work may also be relevant to evaluating similar nanotechnology products.

In addition, the United States Department of Agriculture (USDA) is exploring the increasing impact of nanotechnology on the food and forestry industries. Industry experts gathered at a workshop in February, "Nanotechnology in the Future of Agriculture and Forestry," to discuss the emerging uses for nanotechnology, such as waxes that coat fruits and vegetables to avoid spoliation, and lighter

and more compact food packaging which could reduce food transportation costs. However, Norman R. Scott, Ph.D., a preeminent biological and agricultural engineer at Cornell University, stated that consumer concerns about nanotechnology, questions about the effectiveness of regulatory oversight, and the resistance of food companies to communicate about research and products could be problematic for consumer acceptance of the technology. The combination of consumer interest in the disclosure of nanotechnology ingredients along with the increased confidence which may occur as a result of government regulation, presents a potential incentive for manufacturers to identify the use of nanotechnology-based products.

Another sign that increased regulatory oversight is here to stay is the EPA's February 12, 2014, significant new use rule (SNUR) regulating four varieties of single-walled carbon nanotubes and infused carbon nanostructures. The final rule, which took effect on April 14, 2014: (1) requires health studies when certain multi-walled carbon nanotubes are incorporated in a product over an established use threshold, (2) requires the use of personal protective equipment, and (3) bans surface water releases as a result of manufacturing.

The National Institute for Occupational Safety and Health (NIOSH) recommends, but does not require, exposure limits of 0.3 mg/m3 for engineered nanoscale titanium dioxide, a commonly used nanocompound. However, due to lack of knowledge and monitoring, manufacturers, retailers and food service companies may inadvertently and unknowingly expose their employees and customers to this substance in excess of the exposure guideline. NIOSH's recommendations are focused on the safety of manufacturing workers exposed to titanium dioxide and do not apply to users of consumer products.

In December 2013, the International Organization for Standardization (ISO) published a new technical specification to provide for consistency in labeling practices for products incorporating nanotechnology. The ISO standard does not include a standardized warning label and a universal nano-hazard warning symbol has not yet been developed.

Labeling Decisions are Fact Specific

Size may trump substance when it comes to labeling nanotechnology. While the health and environmental impacts are unproven and uncertain, consumers expect to know what is in their products. This expectation will only be satisfied by a broader disclosure of the presence of nanotechnology. Trade-secrets and other business interests may provide incentives to follow current regulations that encourage manufacturers to avoid making any voluntary disclosure about nanotechnology in their products. Subject to these considerations, product manufacturers might evaluate the scope and substance of their product labeling. Insurance professionals may want to explore these issues as they evaluate underwriting risks. One thing is certain, in the complicated and fast-paced nanotechnology environment, businesses should stay informed of regulatory developments and continuously evaluate their strategy regarding nanotechnology labeling and the potential benefit of warnings to avoid regulatory and legal problems.

Sarah E. O'Leary and David M. Governo are with Governo Law Firm, LLC in Boston, Mass. O'Leary can be reached at and Governo at
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Author:O'Leary, Sarah E.; Governo, David M.
Date:Jun 1, 2014
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