Public's Understanding, Perceptions, and Acceptance of Nanotechnology through the Lens of Consumer Products

CHAPTER 2.1

Public’s Understanding, Perceptions, and Acceptance of Nanotechnology through the Lens of Consumer Products Todd Kuiken, Marina E. Quadros, Sean McGinnis, Mathew Hull Woodrow Wilson International Center for Scholars, Washington, DC, USA

1. BACKGROUND/HISTORY OF THE PROJECT ON EMERGING NANOTECHNOLOGIES CONSUMER PRODUCTS INVENTORY The Project on Emerging Nanotechnologies (PEN), established in 2005 with a grant from the PEW Charitable Trust, had widespread exposure in industry, government, and with the general public until 2010 when the project was significantly ramped down at the conclusion of the PEW grant cycle. The mission was “to help ensure that as nanotechnologies advance, possible risks are minimized, public and consumer engagement remains strong, and the potential benefits of these new technologies are realized.” Researchers, government, industry, NGOs, policymakers, and others collaborated on the project to provide independent, objective knowledge and analysis that could inform critical decisions affecting the development and commercialization of nanotechnologies. In 2008, PEN’s Consumer Products Inventory (CPI) [1] was launched and was the first online inventory to compile consumer products which claimed to contain nanomaterials. Since its inception, it has compiled information from over 1800 consumer products claiming to contain nanoscale materials (Figure 1). More than 40 publications have cited the CPI and there have been more than 2 million unique page views of the inventory since 2008. But one of the shortfalls of the inventory has always been its inability to verify the nano claims beyond information provided by the manufacturer or others. Som et al. [2] observe that the data held within the CPI should be used with caution as “the database suffers from the problem of insufficient available information.” In addition, they argue that the uncertainties over the effects and impacts of nanomaterials in relation to environmental health and safety are unlikely to be solved in the short term. To address some of these shortfalls [3], in 2011, PEN and the Woodrow Wilson Center began a partnership with Virginia Tech University (VT) to update the CPI to

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Figure 1 Total number of products both active and archived found within the consumer products inventory.

incorporate more detailed research on products found within the inventory. In addition to both PEN and VT incorporating data, the CPI now has a crowdsourcing component in order to expand the experts contributing information contained in the inventory. By crowdsourcing expertise our goal is to create a “living” inventory for the exchange of accurate information on nano-enabled consumer products. Registered users are encouraged to submit relevant data pertaining to nanoparticle function, location, properties, potential exposure pathways, toxicity, and life cycle assessment (LCA) data. Registered users can also update product information and add/remove products. The overall benefit of the inventory for both consumers and regulatory agencies would be improved with the ability to provide more detailed, independently verified information about the nanomaterials found within the products and the environmental health and safety data associated with those products. A good example of this type of analysis is provided in Section 6. Studies such as these are based on trends extrapolated from the CPI which is able to show shifts in nanomaterials being used in consumer products (Figure 2).

2. PUBLIC UNDERSTANDING OF NANOTECHNOLOGY IN THE US HAS NOT CHANGED PEN has been conducting US-based national surveys to better understand the public’s understanding and awareness of nanotechnology since 2006. Despite outreach efforts

Public’s Understanding, Perceptions, and Acceptance of Nanotechnology through the Lens of Consumer Products

Figure 2 Nanomaterials identified within products.

started in 2005 from the Nanoscale Informal Science Education Network [4], a National Science Foundation sponsored “national community of researchers and informal science educators dedicated to fostering public awareness, engagement, and understanding of nanoscale science, engineering, and technology,” there has only been a minor shift in public awareness of nanotechnology [5] (Figure 3). There has been only a minor shift in public awareness of nanotechnology. How much have you heard about nanotechnology? Heard a lot Heard some Heard just a little Heard nothing at all 49% 42%

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Figure 3 U.S. public awareness of nanotechnology from 2006e2013.

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3. METHODOLOGY BEHIND THE CPI The information contained within the CPI is solely based on information that can be readily found on the Internet; non-Internet based sources have not been used. By taking this approach, all entries can be validated by anyone with the Internet access. Products have been identified for inclusion in the inventory following systematic web-based searches. These have ranged from exploratory searches through searches on specific categories of goods to following up leads from multiple sources (including media articles). Information from relevant list serves and RSS feeds were also used. All identified products have been tested against the selection procedures outlined below, before being listed in the inventory. Listed products include information on the manufacturer, country of origin, product category, claims supporting the application of nanotechnology, and the date on which the entry was last updated. In addition, the nanomaterial, nanomaterial function, nanomaterial location/characterization, potential exposure pathway, and coatings information are provided when identified by the manufacturer, supported by supplemental data or can be reasonably assumed. Hyperlinks are also provided to the manufacturer’s Web site. Some products may be marked “Archive,” indicating that the availability or the “nano” claim of the product can no longer be ascertained. For these products we have attempted to locate a cached version of the original product Web site using the Internet Archive. Most products in this inventory satisfy three criteria: 1. They can be readily purchased by consumers, 2. They are identified as nano-based by the manufacturer or another source, and 3. The nano-based claims for the product appear reasonable; meaning the inclusion of some form of nanotechnology or nanomaterial would enhance the product or provide some new property unlikely to appear without it. In every instance, we have tried to identify specific products from specific producers. However, since nanotechnology has broad applications in a variety of fields, we have included a number of “generic” products that you can find in many places on the market such as computer processor chips. These are clearly labeled in the inventory. In some cases, companies offer several similar nanotechnology-based products and product lines. To avoid redundancy, we have just included a few samples in this inventory and hope that they will provide an initial baseline for understanding how nanotechnology is being commercialized. There are probably some products in the inventory which producers allege are “nano,” but which may not be. We have made no initial attempts to verify manufacturer claims about the use of nanotechnology in these products, nor have we

Public’s Understanding, Perceptions, and Acceptance of Nanotechnology through the Lens of Consumer Products

conducted any independent testing of the products. We have tried to avoid including products that clearly do not use nanotechnology, but some have undoubtedly slipped through. In order to address these deficiencies and ascertain higher quality data, registered users are encouraged to submit relevant data pertaining to nanoparticle function, location, properties, potential exposure pathways, toxicity, and LCA. Registered users can also update basic product information as well as add new products.

3.1 Product Categories Entries have been placed within generally accepted consumer product categories and subcategories: • Appliances (heating, cooling, and air; large kitchen appliances; laundry and clothing care) • Automotive (exterior, maintenance and accessories) • Goods for Children (basics, toys and games) • Electronics and Computers (audio, cameras and film, computer hardware, display, mobile devices and communications, television, video) • Food and Beverage (cooking, food, storage, supplements) • Health and Fitness (clothing, cosmetics, filtration, personal care, sporting goods, sunscreen) • Home and Garden (cleaning, construction materials, home furnishings, luxury, paint) • Cross-cutting (Coatings) As new products are entered, new categories and subcategories will be added as needed.

3.2 How Much We Know The following classification system was developed to provide a confidence level in the “nano” claims gathered for each product (Figure 4). • Category 1 (Extensively verified claim) The manufacturer has provided information supporting the nanotechnology claim and this claim was verified by an independent source. The actual product has been tested for nanomaterials or supporting documentation references a similar product that was described in more than one published scientific document (such as research studies, patents, or reports). For example: The manufacturer website lists a datasheet with nanomaterial characteristics plus a scientific research paper or patent also describing the product. • Category 2 (Verified claim) The manufacturer has provided information supporting the nanotechnology claim and this claim was verified by additional supporting documentation about

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Figure 4 Number of products found within each classification system that was developed to provide a confidence level in the nano claims gathered for each product. Category 1dextensively verified claim to Category 5dlowest confidence level.

the specific nanomaterial that is claimed to be in the product. For example: The manufacturer website lists a datasheet with nanomaterial characteristics plus a scientific research paper or patent also describes the nanomaterials used in this product. • Category 3 (Manufacturer-supported claim) The manufacturer has provided information supporting the nanotechnology claim. For example: The manufacturer provides a datasheet with nanomaterial characteristics, electron microscopy images, etc. • Category 4 (Unsupported claim) The manufacturer claims that the product contains nanotechnology, but no specific information is provided to support this claim. For example: The manufacturer website mentions the use of “nanotechnology” and provides no additional information. • Category 5 (Not advertised by manufacturer) Nanotechnology claim is provided by source other than manufacturer. Typically a news story or third-party stores selling the product.

4. PITFALLS OF THE INVENTORY Obtaining detailed characterization data about the nanomaterials used in products has been difficult, yet is critically important in order to develop risk scenarios. Hansen

Public’s Understanding, Perceptions, and Acceptance of Nanotechnology through the Lens of Consumer Products

et al. [6] argue that developing risk scenarios is more complex than simply saying increased consumer products lead to increased exposure. They suggest that determining the location of the nanomaterial in the product will be a key parameter to identifying exposure pathways. According to our classification in the CPI and others [6], there is little information in terms of the location of nanomaterials in consumer products. As evidenced in the CPI and suggested by Hansen et al. [6], very few manufacturers/producers of products provide information about the specific characteristics, location, and concentrations of nanomaterials in a particular consumer product. Only 9 of the 1880 products (as of April 2014) are classified as Category 1. According to Nazarenko et al. [7], consumer products containing nanomaterials can release both nanoparticles incorporated into the product itself as well as nanoparticles within the products’ matrix (solvent) presenting exposure pathways during product handling, application, and disposal. They also found that during the use of nanotechnology-based sprays and sprays which do not purport incorporating nanomaterials, particles ranging from 13 nm to 20 mm were released. Both Maynard and Lioy et al. [7,8] discussed how difficult it is to predict with any certainty the exposure and related health effects of a consumer product solely based on the characteristics of the nanomaterial within the product. Studies have shown that not only do products which claim to incorporate nanomaterials contain them, but other products do as well [7]. According to Lorenz et al. [9] consumer exposure depends on two main components: (1) Characteristics associated with the consumer, such as body weight and amount of product an individual uses per use and (2) properties associated with the product in combination with the product-specific application, such as pH. In their study they found that exposure levels vary significantly according to consumer behavior. In order to design “safer” products, Morose [47] suggested that there are three challenges that need to be addressed: (1) How should manufacturers characterize the nanomaterials used in their products? (2) What are the key attributes that should be included in the characterization? and (3) How do the hazards identified in research papers based on nanomaterial translate to the nanomaterials in the actual product? In addition, Morose also suggests that there is a lack of comprehensive data on nanoparticles of different shapes, sizes, surfaces, structures, and functionalization.

5. A NEED FOR LCA OF NANO-ENABLED CONSUMER PRODUCTS A future goal of the CPI is to scientifically assess and quantify the potential human health and environmental risks associated with nanomaterials. To this end, one must determine how these nanomaterials enter the environment via the manufacturing process, their use or their disposal, as well as the fate and transport mechanisms of the specific nanomaterial in the air, water, and soil. All of this information can be compiled using a methodology known as life cycle assessment (LCA), which quantifies environmental risks using the best

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current scientific information. VT plays a critical and unique role in this area given their expertise in the areas of nanomaterial characterization as well as fate and transport research. LCA is a systematic methodology for quantifying the environmental impacts of a product, process, or system. This assessment method is governed by various standards including ISO 14040 and ISO 14044. LCA ideally considers all phases of the life cycle from extraction to manufacturing to use to disposal. However, for some products, one or more of these phases may not be significant relative to the others. LCA requires a well-defined system boundary as well as a functional unit which defines the specific function of the product for accurate comparisons. Increasingly, Environmental Product Declarations (EPDs) are being used to set a standard comparison basis for products which fulfill the same basic function. An EPD reports verified environmental data in predetermined impact categories based on LCA methods and in accordance with ISO 14025. LCA compiles an inventory of the inputs and outputs within the system boundary and then multiplies this inventory by characterization factors which estimate the level of associated environmental damage. Various impact assessment models exist but they generally include models which consider the fate, transfer, and exposure of materials to humans and the environment. While energy, carbon dioxide emissions, and toxicity tend to dominate discussions today, a broader range of environmental impacts can be considered using LCA. The impacts include, but are not limited to, climate change, ozone depletion, photochemical smog, eutrophication, acidification, human health, ecosystem damage, and resource depletion. For decision-making across the spectrum of environmental impacts, LCA results may also be normalized and weighted in order to compare different environmental impacts. While LCA can provide very useful information for decision-making with nanomaterials and the products containing them, very few characterization factors have been determined for environmental issues uniquely related to nanomaterials. This means that current nanomaterial LCAs typically do not include environmental issues which depend on the size and chemical behavior of these materials. Such considerations, like nanomaterial toxicity to humans and other species, are under investigation and can be added to the LCA framework as they are completed and confirmed. For nanomaterials, LCA can currently be used either to assess the production of the raw material itself or a product containing nanomaterials. In the former case, the LCA would be considered a cradle-to-gate analysis with system boundaries from extraction of the natural materials to refining or processing these materials up to the point of a raw material such as nanopowder or nanomaterials in solution. In this case, LCA results could be used to compare the environmental impacts for nanomaterial production. Such LCA information is also useful for LCA inventory databases which compile all the inputs and outputs for materials so they can be used in more extensive LCA.

Public’s Understanding, Perceptions, and Acceptance of Nanotechnology through the Lens of Consumer Products

A cradle-to-cradle analysis for nanomaterials would include the cradle-to-gate analysis as well as an analysis of the manufacturing, use, and disposal of a specific product containing nanomaterials. This type of LCA is more informative for decisions regarding specific products but also necessarily depends on the cradle-to-gate LCA information to define the inventory for the extraction and manufacturing phases. To date there has been limited studies examining nano-enabled products from cradle to cradle. One problem with conducting LCA on consumer products containing nanomaterials is that manufacturers are reluctant to share information relating to the nanomaterials they are incorporating into products (size, quantity, functionalization) for fear that competitors may be able to deduce proprietary information based on such reporting. Typical LCA analysis involves the use of mass-based equivalents. However, because the volume of nanomaterials being used are substantially less, based on their size and the amount needed in a product, mass-based equivalents may be an inappropriate measurement for nanomaterials, as Theis et al. [10] suggest, and characterizing them in terms of their principal functional property may be a better measure. As consumer products utilizing nanomaterials become increasingly popular, environmental releases of nanomaterials are expected to escalate. There are multiple potential release scenarios for nanomaterials that can be divided into the same phases that comprise the life cycle of any consumer product: production, use, and disposal. Studies are needed to characterize nanomaterial emissions across the entire life cycle of consumer products. Results from these LCA studies could provide information on the environmental and human exposure to nanomaterials. Som et al. [2] suggest that combining life cycle concepts and the increasing understanding of the effect that engineered nanomaterials could have on human health and the environment could provide the basis for adaptive risk assessment and informed decision-making by both industry and regulators in order to enable environmentally sustainable nanoproducts. The updated CPI is designed to foster this type of data sharing in order to provide better data points and product evaluations to feed into studies which combine both life cycle and risk assessment and address issues around communication among actors throughout the life cycle of a product.

6. NANOSILVERdEXCERPT FROM “RELEASE OF SILVER FROM NANOTECHNOLOGY CONSUMER PRODUCTS AND POTENTIAL FOR HUMAN EXPOSURE” [11] NOTE: This section and all references are taken directly from Nina Quadros’ dissertation work conducted at Virginia Tech [11]. Dr. Quadros is now a contributing partner with PEN on the CPI. This section provides an example of the type of data and analysis needed in order to provide better information on products containing nanomaterials. Silver nanoparticles (nanosilver) are gaining significant attention from the academic and regulatory communities, not only because of their antimicrobial effects and

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subsequent product applications, but also because of their potential environmental and human health impacts. Silver nanotechnology appears in a multitude of applications, such as paints, soaps and laundry detergents, refrigerators, laundry machines, cooking utensils, antibacterial sprays and ointments, medical instruments (dressings, catheters, pacemakers) and drug delivery devices, water purifiers, air filters, clothing, and personal care products (toothpaste, shampoo, cosmetics). Numerous in vitro studies have shown that silver nanoparticles are toxic to certain organisms such as phytoplankton [12], bacteria [13,14], algae [15], and fish [16e19] and also to human cells [20e23]. In vivo studies have also been performed with silver nanoparticles and they were proven to be toxic to rats and to translocate between organs [24e28]. Luoma [16] reports that silver can be absorbed by the lungs, skin, and gastrointestinal and urogenital tracts, but it is not thought to be toxic to the nervous, cardiovascular, or reproductive systems in humans. So, general knowledge on the potential health impacts of silver nanotechnology is still under dispute. Although there have been studies on the toxic effects of silver nanoparticles to human cells and the environment, there still exists a gap in knowledge about realistic human exposure scenarios during the use of nanosilver consumer products, with few published works that only partially cover this subject [29e32]. The mechanisms, forms, and amount of silver released from consumer products containing nanosilver are poorly understood and at present, cannot be predicted on the basis of product type and physical and chemical characteristics[8,16]. Therefore, new data are needed to describe the size, morphology, chemical composition, and other physicochemical properties of silver contained in and released from consumer products. Whether silver is in the ionic or nanoparticle form is of special interest because the distinction likely has implications for toxicity [16]. There is a large gap in knowledge regarding human and environmental exposure associated with nanotechnology, including silver nanoparticles. Hundreds of new products containing silver nanoparticles have been introduced, and laboratory studies have shown that silver nanoparticles can be toxic, but the potential for human exposure has not been assessed [6,7,9,16,17,33e37]. Therefore, new data are needed to answer fundamental questions about the physico-chemical properties and dose metrics of silver that may be released during the use of products containing silver nanoparticles. Guney and Zagury [38] call for the development of regulations concerning toxic substances in toys and children’s products based on risk assessment rather than on total contaminant content. Quadros et al. [29] assessed the potential human exposure associated with the use of silver nanotechnology products. They found that the characteristics of silver to which humans may be exposed depend on a combination of the product’s properties and how it is used. Furthermore, exposure may occur through multiple routes. Consumer spray products emit silver-containing particles capable of depositing throughout the

Public’s Understanding, Perceptions, and Acceptance of Nanotechnology through the Lens of Consumer Products

respiratory system, especially in the nasopharyngeal region. On the other hand, exposure to nanosilver via biologically relevant liquid media occurs in ionic form and is facilitated in media with high concentrations of chloride and low pH. The release of silver cannot be predicted solely on the basis of silver concentration in the product. How and where the silver nanoparticles are incorporated into the product also control the potential for exposure. Consumer products composed of similar materials (e.g., polyester fibers in a blanket versus polyurethane foam inside a plush toy) may release silver at very different rates, even if those products contain similar amounts of nanosilver. Silver release is also controlled by the location of particles within the product (surface versus interior of fibers or plastic matrix) and by how easily the product’s surface is abraded during use. Exposure levels for individual consumer products are expected to be low but rarely zero. If silver nanotechnology becomes widespread and multiple consumer products are unknowingly used in combination, the minimal dose for argyria (a condition caused by exposure to silver typically associated with skin that has turned blue) may be reached within the lifetime of a consumer, especially for children.

7. US REGULATORY SYSTEM As Beaudrie et al. [39] found, there are various agencies that are “charged with enforcing regulations to control risks from specific types or uses of substances.” These include: Environmental Protection Agency, the Food and Drug Administration (FDA), the Occupational Safety and Health Administration (OSHA), the Consumer Product Safety Commission, and in some instances the Department of Agriculture. Currently, the US does not have a coordinated governance strategy to evaluate nanomaterials that are entering the market across these various agencies. In addition, there are various definitions that agencies use to identify what a nanomaterial is, thresholds that trigger certain regulations, and data requirements to evaluate toxicity, safety, and other environmental parameters. Beaudrie et al. [39] found that “under the current system a number of nanoproducts will be exempt from regulations, will not trigger thresholds for applicability, and may not be managed until they are categorized to be hazardous, determined to be unsafe, or can be specifically monitored and controlled.” They go on to say that there is the potential for a large number of products containing engineered nanomaterials to go through their entire life cycle with “minimal regulatory oversight” (Figure 5).

7.1 FDA’s New Nano Approach In June 2014, the FDA released guidance for industry regarding the use of nanomaterials in cosmetic products [40] and other FDA-regulated products. While these guidance documents represent FDA’s “current thinking on this topic” and “does not create or confer any rights for or on any person and does not operate to bind FDA or the public,” it represents a significant shift in how a US regulatory agency views nanomaterials in relation

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Product Category ENMs as "New" Chemical Substances, or a "new use" of an exisng substance ENMs based on "EXISTING" Chemical Substances ENM Pescide

Product Fabricaon (Pre-Market)

Life Cycle Stages Product Use (Post-Market) End-of-Life

Environment

Occupaonal

TSCA - Risk review considers implicaons for human health and environment across the life cycle of an ENM chemical substance. Significant New Use Rule (SNUR) ulized on a case by case basis, resource intensive. Low Volume Exempon (LVE) for substance produced <10 tonnes/year may limit review of ENMs TSCA - No risk review for ENMs based on substances currently on the TSCA inventory ("Exisng Substances") FIFRA - Risk review considers implicaons for human health and environment across the life cycle of a ENM pescide. Regulaons apply only to substances "claimed" to be pescides

ENM Food Addivie or Drugs

FFDCA - Risk review considers implicaons for human health only. Food addives considered "GRAS" exempt from review. Exempons available under a Food Contact Noficaon (FCN)

FFDCA - Risk review does not consider environmental or human health implicaons from discarded products. NEPA manufacturers may be required to submit an Environmental Assessment for end of life and environmental implicaons of discarded products

ENM Dietary Supplements

FFDCA - Authority to recall FFDCA - No risk review or authority to unsafe products. Reporng of restrict supplements at the "preingredients is voluntary except for "new dietary ingredients" market" stage and adverse effect reports

FFDCA - Does not consider environmental or human health implicaons from product manufacturing, environmental releases, or discarded supplements

ENM Cosmecs

FFDCA - No risk review or authority to FFDCA - Reporng of restrict cosmecs at the "pre-market" ingredients and product recalls stage are voluntary

FFDCA - Does not consider environmental or human health implicaons from product manufacturing, environmental releases, or discarded cosmecs

CPSA - Does not CPSA - No risk review or authority to consider occupaonal CPSA - Case by case risk review and product recalls, limited by agency ENM Consumer Products restrict consumer products at the health and safety resources "pre-market" stage implicaons from consumer products

Regulaons applicable to All ENM Product Categories

See TSCA, FFDCA, and FIFRA above

CWA/CAA - ENMs RCRA - Limited to must first be ENMs classified as classified as a "hazardous". Does pollutant. not apply to CPSA - Risk review and recalls Monitoring and household for consumer products Control containing ENMs is limited by hazardous waste, technologies or to small scale agency resources necessary for industrial regulaons to be generators enforced, but not (<100kg ENMs/yr) currently adequate for ENMs

OSHA - Currently no substance specific stnadards for ENMs. General Respiratory Protecon Standards may not be appropriate. Resource constraints, and challenges for regulang substances under high uncertainty.

Figure 5 U.S. regulatory pathways for product categories containing engineered nanomaterials. Color coding indicates the adequacy of current regulations according to Beaudrie et al. for assessing risk. Green (light gray in print versions) indicates that the regulation is adequate and few exemptions or gaps exist. Yellow (white in print versions) indicates the regulation is adequate but exemptions and other gaps limit their effectiveness. Red (dark gray in print versions) indicates the regulation is inadequate. ENM, engineered nanomaterial; TSCA, toxic substances control act; FIFRA, federal insecticide, fungicide, and rodenticide act; FFDCA, federal food, drug, and cosmetic act; NEPA, national environmental policy act; CPSA, consumer product safety act; RCRA, resource conservation and recovery act; CWA, clean water act; CAA, clean air act. (Adapted from Ref. [39].)

to the properties that nanomaterials can impart on products. This same shift also highlights the lack of any coordinated strategy/definition among the US regulatory agencies on what an engineered nanomaterial is and whether they deserve additional analysis

Public’s Understanding, Perceptions, and Acceptance of Nanotechnology through the Lens of Consumer Products

when evaluating the safety of a product. The major shift is in the FDA’s interpretation of what properties a nanomaterial exhibits in a product, as explained below: While the FDA has not established regulatory definitions of nanotechnology, nanomaterial, nanoscale, or other related terms, according to the June 2014 guidance documents: “At this time, when considering whether an FDA-regulated product involves the application of nanotechnology, FDA will ask: 1. Whether a material or end product is engineered to have at least one external dimension, or an internal or surface structure, in the nanoscale range (approximately 1e100 nm); In addition, as we explain in more detail below, because materials or end products can also exhibit related properties or phenomena attributable to a dimension(s) outside the nanoscale range of approximately 1e100 nm that are relevant to evaluations of safety, effectiveness, performance, quality, public health impact, or regulatory status of products, we will also ask: 2. Whether a material or end product is engineered to exhibit properties or phenomena, including physical or chemical properties or biological effects, that are attributable to its dimension(s), even if these dimensions fall outside the nanoscale range, up to 1 mm (1000 nm).” More importantly the FDA is “particularly interested in the deliberate and purposeful manipulation and control of dimensions to produce specific properties, because the emergence of these new properties or phenomena may raise questions about the safety, effectiveness, performance, quality or public health impact that may warrant further evaluation.” The FDA appears to be focusing more on the properties that the nanomaterials are exhibiting in a particular product and moving away from a strictly size-based evaluation paradigm. This would enable the FDA to evaluate products in which the nanomaterials have agglomerated and no longer fit within the typical 1e100 nm range, are not present in the final product, or have changed along the course of the product’s life cycle; despite the desired properties of those nanomaterials still persisting in the product. Using a strict size-based regulatory definition could enable products to escape review, while evaluating the properties those nanomaterials are designed to exhibit, such as the FDA is suggesting, would capture more of the products utilizing nanotechnology.

8. EUROPEAN REGULATORY SYSTEM Most European Union (EU) laws apply to nanomaterials regardless of their size parameters. In addition, there has been recent sector-specific regulations put in place to capture nanomaterials. Figure 6 describes the various laws and regulations that govern nanotechnology within the EU. Similar to the US, the EU has not adopted a universal definition for nanotechnology; however a recent report [41] stated that the “Identification of products containing nanomaterials and market transparency requires a harmonized definition of the term ‘nanomaterial.’” While most of the definitions refer to similar size

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Figure 6 Overview of European Union legislation with regard to specific reporting or labelling requirements for nanomaterials. NM, nanomaterials; REACH, registration, evaluation, authorisation and restriction of chemicals; CSR, chemical safety report; SVHC, substance of very high concern; SDS, safety data sheet; CLP, classification, labelling, packaging; PBT, persistent, bioaccumulative and toxic; vPvB, very persistent and very bioaccumulative; tpa, tonnes per annum. (Adapted from Ref. [41].)

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Figure 6 Continued

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ranges (1e100 nm), some definitions allow for other parameters like the origin or the persistence of the nanomaterial. A list of the various EU definitions is given below: Regulation (EU) No 1223/2009 of the European Parliament and of the Council of November 30, 2009 on cosmetic products “Nanomaterial” means an insoluble or biopersistant and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm;

Regulation (EU) No 1169/2011 of the European Parliament and of the Council of October 25, 2011 on the provision of food information to consumers “Engineered nanomaterial” means any intentionally produced material that has one or more dimensions of the order of 100 nm or less or that is composed of discrete functional parts, either internally or at the surface, many of which have one or more dimensions of the order of 100 nm or less, including structures, agglomerates, or aggregates, which may have a size above the order of 100 nm but retain properties that are characteristic of the nanoscale.

Regulation (EU) No 528/2012 of the European Parliament and of the Council of May 22, 2012 concerning the making available on the market and use of biocidal products “Nanomaterial” means a natural or manufactured active substance or nonactive substance containing particles in an unbound state or as an aggregate or agglomerate, and where for 50% or more of the particles in the number size distribution, one or more external dimensions are in the size range 1–100 nm. Fullerenes, graphene flakes, and single-wall carbon nanotubes with one or more external dimensions below 1 nm shall be considered as nanomaterials. For the purposes of the definition of nanomaterial, “particle,” “agglomerate,” and “aggregate” are defined as follows: • “particle” means a minute piece of matter with defined physical boundaries; • “agglomerate” means a collection of weakly bound particles or aggregates where the resulting external surface area is similar to the sum of the surface areas of the individual components; • “aggregate” means a particle comprising strongly bound or fused particles.

Public’s Understanding, Perceptions, and Acceptance of Nanotechnology through the Lens of Consumer Products

9. PUBLIC ENGAGEMENT WITH INSUFFICIENT AND COMPLICATED DATA As recently as May 2014, the CPI continues to be utilized as a source in inappropriate and misleading ways. Based on the study, “Titanium Dioxide Nanoparticles in Food and Personal Care Products” [42] we incorporated a list of products that had been analyzed for the presence of titanium dioxide and subsequently inferred that they also contain a nanoscale component of titanium dioxide. The Weir et al. [42] study analyzed food-grade titanium dioxide which is commonly used in the food and personal care products industry for its particle size distribution. The study showed that approximately 36% of the particles are less than 100 nm in at least one dimension. The study went on to analyze 89 food products and a host of other personal care products for the concentration of titanium dioxide. They did not, however, analyze each product for its size distribution of titanium dioxide. The study infers that if titanium dioxide is present in the product, its size distribution will be proportional to the distribution found in the food grade titanium dioxide distribution tested separately. The addition of this study’s results into our inventory increased the number of food products percentage significantly (Figure 7). However, since the study did not analyze the specific products for their nanoscale components we classified all of those products in the CPI as Category 5, which is our lowest confidence level, despite having a peer-reviewed journal article with supplemental data showing the specific products tested.

Figure 7 Number of products in the various product categories within the consumer price index (CPI).

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Despite this classification and without contacting PEN for comment or explanation of the data, Friends of the Earth (FOE) released a report entitled, “Tiny Ingredients Big Risks: Nanomaterials Rapidly Entering Food and Farming” [43] where in their press release they state, “Major food companies have rapidly introduced nanomaterials into our food with no labels and scant evidence of their safety, within a regulatory vacuum,” and “The report documents 85 food and beverage products on the market known to contain nanomaterials.” Within the report they do not mention that the data were given our lowest confidence level, nor do they discuss the actual Weir et al. study in which the products were tested. There were subsequent news stories [44] based on the FOE report which amplified their misleading results and attributed those results to PEN, again without ever contacting PEN for comment or explanation of the data.

9.1 Nano-Labels Brown and Kuzma [45] found that the vast majority of participants in focus groups examining the public’s attitude toward nanotechnology utilized in food wanted labels identifying the use of nanotechnology and that they were willing to pay a premium for such labels. Similarly, a study conducted by the United Kingdom’s Food Standards Agency [46] found that despite mixed views on efficacy, the public wanted labels on products identifying nanotechnology along with a registry of approved products that was managed by an independent body. The issue of what goes on a label and how consumers might use that information is complicated when placed alongside the public’s understanding of nanotechnology (Figure 7). As Brown and Kuzma [45] found, “most participants desire a label for the purpose of an informational device, triggering them to seek more information and allowing them to make their own choice about risk tolerance.” Where consumers get this additional information and whether they trust the information available to them will have a significant impact on how widespread the adoption of nanotechnologyenabled products will be among consumers. As both of these studies found, participants called for an independent and trusted institution to provide information on nano-enabled products. The CPI has attempted to provide such information, but as discussed above, has its pitfalls and requires consistent and long-term funding in order to provide the information to the public that he appears to be asking for, particularly when trying to categorize risk exposure. The Danish Nanodatabase (http://nanodb.dk) which is maintained and updated by the Danish government, Technical University of Denmark, and two Danish NGOs provides a description of the nanomaterials utilized in each product in addition to a risk categorization profile for the product. These two examples showcase the potential databases could have if proper funding were provided to maintain them. Communicating complicated data such as the nano component of a food ingredient to a wide audience of varying understanding of nanotechnology has always been a source

Public’s Understanding, Perceptions, and Acceptance of Nanotechnology through the Lens of Consumer Products

of consternation for PEN and the CPI in particular. Full transparency should always be the goal of any public engagement exercise, yet that transparency can also cause confusion and fear when not presented in the proper context along with a detailed explanation of the uncertainties. More often than not the nuances within the methods section of a scientific study convey those uncertainties and explain important details about what the data do and do not show. Unfortunately those nuances are often overlooked and/ or ignored when presenting data such as the Weir et al. study to the general public. The updated CPI attempts to address some of those nuances by developing a classification system for the products entered into the database in order to provide an easy qualitative way for the public to make a judgment on the reliability of the data. And when possible, the CPI provides links to data sheets and scientific studies in which the products are linked to.

10. LOOKING FORWARD Nanotechnology, as a field, is rapidly moving out of the lab and into the public domain. Scanning the nanotechnology landscape through the lens of consumer products shows that the path of governance which evaluates, regulates, and engages the public on nanotechnology is foggy. The vast array of regulations, definitions and lack of clarity, primarily within the US regulatory system, has the potential to disrupt nanotechnology innovation. One lesson learned from our experience managing the CPI is that absent LCA studies, clear and identifiable governance systems, transparency from companies and improved public understanding about the nanomaterials being utilized in consumer products will continue to breed misinformation, confusion, and potential backlash toward nanotechnology. Governments who have invested billions of dollars toward nanotechnology research are risking that investment by not investing in public engagement and developing a clear and precise governance strategy. Any strategy that is developed should be adaptive as the technology develops, and also clear in terms of what is being evaluated and why. Regulatory definitions should focus on the properties that a nanomaterial is expressing in a product and not based solely on its specific size range.

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