Consumers today have high expectations about the content of theproducts they use. A “natural” or “green” label means so much toconsumers that it is liberally used, subjecting companies to claimsof “green washing.” At the other end of the spectrum is the endlessuse of warnings. Some would argue that product warnings have becomeso ubiquitous in society that they have lost their effectiveness.Nanotechnology is one emerging market that seems to contradictthese trends. Products containing nanomaterials tend to use nocontent label either touting the benefits of the new technology oradvising consumers of their presence.

Developments in Nanotechnology

Nanotechnology is a cutting-edge manufacturing technology thatinvolves the manipulation of materials on such a small scale thatthey are essentially invisible to the naked eye. Nanotechnology hasimproved many of the products that are part of everyday life,including technology, food, clothing, healthcare, office productsand even sporting equipment. Increasingly, scientific literatureshows that some applications of nanotechnology may have detrimentalhealth and environmental impacts. Industry and government haveacknowledged nanotechnology's tremendous benefit to society andhave pursued product development while simultaneously fundingresearch into the safety of these products.

The issue of what to communicate to consumers about theinclusion of nanotechnology in products is complicated.Nanotechnology involves molecules of well-known materials such asgold, silver, carbon or zinc broken down into their smallest atomicform, with possibly rearranged molecular structures. In thissmaller size, particles may display different properties than theydo in their typical form. In the nanoscale, gold is red and notyellow. In reducing a substance to the nanoscale, its surface areamultiplies exponentially, resulting in increased reaction as air orother substances interact with the surface of the nanoparticle. Forexample silver, which has known antibacterial properties, is usedin the nanoscale for sanitary cleaning purposes. While theincreased surface area of the nanocompound may radically increaseits potency and create other characteristics, because the materialis “well known” the nanocompound is likely to fall below anyregulatory threshold. All of these factors raise serious questionsabout consumers' right to know of nanotechnology in their productsand what manufacturers' strategies should be for productlabeling.

Nanotechnology's Impact on Daily Life

According to The Project on Emerging Nanotechnologies, thousandsof unregulated and unlabeled consumer products containingnanocompounds are currently being marketed.¹ This numberwill continue to grow as promising new applications ofnanotechnology are developed. Presently, nanotechnology is beingincorporated into products with “new and improved formulas,”without any information that the use of nanomaterials is theimprovement being touted. The market for nano-enabled active andsmart packaging for the food and beverage industry is estimated toexceed $20 million by 2015, according to a March 2, 2014, industrygroup report.²

While nanotechnology is generally more accepted in inertproducts such as smart phones, many people are skeptical aboutnanotechnology in products that they ingest or use on their bodies,such as food or sunscreen. The Project on Emerging Nanotechnologieslists 96 leading consumer food products that it found includednanoparticles not advertised by the manufacturer.³Leading food brands such as Betty Crocker, Coca Cola, GeneralMills, Hershey's, Keebler, Kraft, M&M Mars, Nabisco, and Nestleincorporate nanoscale titanium dioxide in products as diverse asbreakfast tarts, cheese, candy bars, dressings, frostings, mashedpotatoes, sandwich crackers and sports beverages. On the otherhand, some food products and nutritional supplements, includingmineral waters marketed as containing nanosilver or nanogold, toutthe health benefits of nanomaterials. In reality, there is noeffective way for consumers to verify these claims, and the actualhealth impacts of these materials is currently unknown.

Nanomaterials used in food packaging include nanoscale clays inbeer bottle plastics, carbon and zinc oxide in food wrappers, andnanosilver in food storage containers designed to increase productfreshness.⁴ While the use of nanotechnology in foodpackaging increases freshness, protects from moisture and bacteria,and provides spoliation sensors, there are health and environmentalconcerns that nanoparticles will migrate into food or theenvironment via landfills.⁵ These nanocompounds couldcycle through the environment into other living organisms, maketheir 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 chainadvise purchasers and end-users of the presence of nanotechnologyin their products because of the chance for potentiallyharmful effects in the future? A jury research study conducted byGoverno Law Firm evaluated prospective jurors' attitudes aboutfailure to warn claims involving nanoparticle-based sunscreens andclothing designed with nanotechnology. The study indicated thatjurors are critical of any lack of notice or warning on a productcontaining potentially harmful ingredients, regardless of whetherthe jurors were generationally categorized as baby boomers (born1946-1964), Generation Xers (born 1965-1984), or millennials (born1985-1999).⁶

Another recent study by researchers at North Carolina StateUniversity and the University of Minnesota indicated that UnitedStates consumers want labels on food products that usenanotechnology, whether the nanotechnology is incorporated intofood or food packaging. The study, which involved multiple focusgroups, found that 60 percent of food consumers responding to afollow-up survey desired nanotechnology labeling even if the costof such labeling would increase the cost of the food by 5 to 25percent. However, the study also demonstrated that people are opento applications of nanotechnology in food, particularly those whichwill make food safer, more nutritious or promote increasedshelf-life.⁷

Health and Environmental Impacts

As commercial use and development of nanotechnology hasincreased, researchers are beginning to better understand thepotential health and environmental risks of products containingthese components. Concerns initially arose following a 2008research study that found carbon nanotubes may behave similarly inthe body to asbestos and cause mesothelioma.⁸

Several new studies are beginning to cast doubt on the safety ofnanocompounds that already have been widely disseminated inconsumer products. A recent government funded European study showedthat titanium dioxide nanoparticles, similar to those used infoods, medications, sunscreens and toothpaste can have carcinogeniceffects on the gastric epithelial cells in the humanstomach.⁹

An in-depth review study found evidence to support a range ofmedical and environmental concerns associated with titanium dioxide(TiO2) nanoparticles, including cellular toxicity in the heart,circulatory system and lungs. The researchers also concluded thatthe titanium dioxide nanoparticles may have a synergistic effectpromoting increased cellular toxicity from metal compounds andBisphenol A (BPA) in the bloodstream. The study also raisedconcerns about the toxicity of nanoTiO2 in the aquatic environmentafter being flushed from the body.¹⁰ In April 2014,researchers at the Harvard School of Public Health andMassachusetts Institute of Technology released research findingsthat nanoscale zinc oxide and nanosilver produced statisticallysignificant DNA damage which could lead to genome damage andpromote the development of cancer. Conversely, their researchindicated that silicon dioxide, iron oxide and cerium oxidenanoparticles showed low genotoxicity.¹¹

There is a growing collection of research indicating thatcertain nanocompounds may be detrimental to plants and wildlife. Awidely 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.¹² A2005 study suggests that aluminum oxide, a nanocompound used insunscreen and automobile scratch proof paints, may inhibit plantgrowth.¹³

The health effects of nanoparticles generally create moreconcern than those of standard size materials because ofnanoparticles' increased ability to migrate into organisms and bodytissues. Given the current scale of nanotechnology development andits promising commercial applications in medicine, technology, foodpackaging and transportation, ongoing research into the safety ofthese compounds is vital to minimize and control medical,biological and environmental health risks. This research may helpmanufacturers determine whether a health warning is necessary or ifsafer product formulations need to be designed.

Emerging Regulation of Nano Manufacturing

Currently, the Food and Drug Administration (FDA) does notrequire the disclosure or testing of nanomaterials used in food.However, upon inquiry from the FDA, manufacturers are required toprovide proof that foods using nanotechnology are safe. The FDA hasalso issued guidelines with non-binding recommendations concerningthe safety assessment of manufacturing processes includingnanotechnology. It does not categorically judge all productscontaining nanomaterials as intrinsically benign or harmful as it“considers…the characteristics of the finished product and thesafety of its intended use.”¹⁴ The FDA recommends thatsafety assessments be as rigorous as possible and based on relevantdata. However, the guidelines make it clear that the industryremains responsible for ensuring that products meet safetystandards and that the FDA will continue post-market monitoring.Although these guidelines are currently non-binding, the FDA hassignaled that it is likely to increase its oversight ofnanotechnology-enabled products. In a September 13, 2013, speech atthe Global Summit on Regulatory Science Research, FDA CommissionerMargaret Hamburg announced that FDA scientists are studying thepotential risks of increased dermal penetration of nanoparticlesused in sunscreens, and indicated that the methods developed forthe work may also be relevant to evaluating similar nanotechnologyproducts.¹⁵

In addition, the United States Department of Agriculture (USDA)is exploring the increasing impact of nanotechnology on the foodand forestry industries. Industry experts gathered at a workshop inFebruary, “Nanotechnology in the Future of Agriculture andForestry,” to discuss the emerging uses for nanotechnology, such aswaxes that coat fruits and vegetables to avoid spoliation, andlighter and more compact food packaging which could reduce foodtransportation costs.¹⁶ However, Norman R. Scott, Ph.D.,a preeminent biological and agricultural engineer at CornellUniversity, stated that consumer concerns about nanotechnology,questions about the effectiveness of regulatory oversight, and theresistance of food companies to communicate about research andproducts could be problematic for consumer acceptance of thetechnology.¹⁷ The combination of consumer interest inthe disclosure of nanotechnology ingredients along with theincreased confidence which may occur as a result of governmentregulation, presents a potential incentive for manufacturers toidentify the use of nanotechnology-based products.

Another sign that increased regulatory oversight is here to stayis the EPA's February 12, 2014, significant new use rule (SNUR)regulating four varieties of single-walled carbon nanotubes andinfused carbon nanostructures. The final rule, which took effect onApril 14, 2014: (1) requires health studies when certainmulti-walled carbon nanotubes are incorporated in a product over anestablished use threshold, (2) requires the use of personalprotective equipment, and (3) bans surface water releases as aresult of manufacturing.¹⁸

The National Institute for Occupational Safety and Health(NIOSH) recommends, but does not require, exposure limits of 0.3mg/m3 for engineered nanoscale titanium dioxide, a commonly usednanocompound.¹⁹ However, due to lack of knowledge andmonitoring, manufacturers, retailers and food service companies mayinadvertently and unknowingly expose their employees and customersto this substance in excess of the exposure guideline. NIOSH'srecommendations are focused on the safety of manufacturing workersexposed to titanium dioxide and do not apply to users of consumerproducts.

In December 2013, the International Organization forStandardization (ISO) published a new technical specification toprovide for consistency in labeling practices for productsincorporating nanotechnology.²⁰ The ISO standard doesnot include a standardized warning label and a universalnano-hazard warning symbol has not yet been developed.

Labeling Decisions are Fact Specific

Size may trump substance when it comes to labelingnanotechnology. While the health and environmental impacts areunproven and uncertain, consumers expect to know what is in theirproducts. This expectation will only be satisfied by a broaderdisclosure of the presence of nanotechnology. Trade-secrets andother business interests may provide incentives to follow currentregulations that encourage manufacturers to avoid making anyvoluntary disclosure about nanotechnology in their products.Subject to these considerations, product manufacturers mightevaluate the scope and substance of their product labeling.Insurance professionals may want to explore these issues as theyevaluate underwriting risks. One thing is certain, in thecomplicated and fast-paced nanotechnology environment, businessesshould stay informed of regulatory developments and continuouslyevaluate their strategy regarding nanotechnology labeling and thepotential benefit of warnings to avoid regulatory and legalproblems.

Footnotes:

¹ http://www.nanotechproject.org/cpi/

² “Global Active, Smart and IntelligentPackaging Market By Products, Applications, Trends and Forecasts(2010-2015)”,http://www.marketsandmarkets.com/Market-Reports/smart-packaging-324.html

³ http://www.nanotechproject.org/cpi/browse/categories/food-and-beverage/food/

⁴ http://www.nanotechproject.org/cpi/browse/categories/food-and-beverage/storage/

⁵ Ortiz, Christina, Wait, There'sNanotechnology in My Food?, Popular Mechanics,http://www.popularmechanics.com/science/health/wait-theres-nanotechnology-in-my-food-16510737

⁶ Delany, J.; Governo, D.; Noffsinger, M.For The Defense.http://dritoday.org/ftd/2013-01F.pdf. 

⁷ Brown, J. and Kuzma J. (2013) Hungry forInformation: Public Attitudes Toward Food Nanotechnology andLabeling, Review of Policy Research, 30: 512–548.doi: 10.1111/ropr.12035

⁸ Poland, C.; Duffin R.; Kinloch, I. (2008)Carbon nanotubes introduced into the Abdominal Cavity of Mice ShowAsbestos-like Pathogenicity in a Pilot Study, NatureNanotechnology, 3: 423-428. 

⁹ Botelho, MC.; Costa, C.; Silva, S. Effectsof Titanium Dioxide Nanoparticles in Human Gastric Epithelial Cellsin Vitro, Biomed Pharmacother. 23 Aug. 2013.

¹⁰ Liu, K.; Lin, X.; Zaho, J. Review: ToxicEffects of the Interaction of Nanoparticles With Chemicals orPhysical Factors, International Journal of Nanomedicine,2013:8; 2509-2520.

¹¹ Watson, C.; Ge, J.; Cohen, J.High-Throughput Screening Platform for EngineeredNanoparticle-Medicated Genotoxicity Using CometChip Technology,ACS Nano, 2014, 8 (3): 2118-2133.

¹² Oberdörster, Eva. “Manufacturednanomaterials (fullerenes, C60) induce oxidative stress in thebrain of juvenile largemouth bass.” EnvironmentalHealth perspectives (Jul 2004); 112(10)1058-1062.

¹³ Yang, Ling, and Watts D, “Particlesurface characteristics may play an important role in phytotoxicityof alumina nanoparticles.” ToxicologyLetters 158, no. 2 (2005): 122-132.

¹⁴ Draft Guidance for Industry: Assessingthe Effects of Significant Manufacturing Process Changes, IncludingEmerging Technologies, on the Safety and Regulatory Status of FoodIngredients and Food Contact Substances, Including Food Ingredientsthat Are Color Additives, April 2012.

¹⁵ http://www.fda.gov/newsevents/speeches/ucm367930.htm

¹⁶ Karst, T., Nanotechnology Offers Promisefor Ag, The Packer, Everything Produce (March 5, 2014),http://www.thepacker.com/fruit-vegetable-news/Nanotechnology-offers-promise-for-ag-248654281.html

¹⁷ Id.

¹⁸ Significant New Use Rules of CertainSubstances, Environmental Protection Agency, February 12, 2014.

¹⁹ Current Intelligence Bulletin 63,Occupational Exposure to Titanium Dioxide, National Institute forOccupational Safety and Health (April 2011).

²⁰ “Nanotechnologies – Guidance on voluntarylabeling for consumer products containing manufacturednano-objects” (ISO/TS 13830:2013).