Nanotechnology in Food Products: Workshop Summary (2009)

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4 Educating and Informing Consumers About Applications of Nanotechnology to Food Products This chapter summarizes the presentations and discussions that oc- curred during the third and final session of the workshop. The first pre- senter, Julia Moore of the Woodrow Wilson International Center for Scholars, used polling data and results from four years of focus group work to argue that public opinion about nanotechnology being applied in the food industry is essentially “up for grabs.” A large majority of Americans know little about nanotechnology and have yet to form an opinion about its use. She identified several key lessons learned from past “ag-biotech” experience about public engagement with new tech- nologies. The second presenter, Carl Batt of Cornell University, spent most of his time describing how he and his collaborators designed the Too Small to See: Zoom into Nanotechnology museum exhibition. He discussed the challenges faced when trying to communicate ideas about size and scale to the public and how Too Small to See overcomes some of these chal- lenges. He briefly described production of Nanooze, a nanoscience magazine for children that is available in print and online. The third and final presenter of the session, Jean Halloran of Con- sumers Union, provided consumer perspective insights and responses to several of the ideas and issues that other workshop presenters and atten- dees had raised up until that point. She commented on the difference be- tween knowing about a technology and accepting that technology; gaps in knowledge about the safety of nanotechnologies in food; consumers’ fear of the unknown, particularly in foods; the importance of regulation and how consumers need to know that they are being protected; and the importance of consumer choice. The session ended with a lengthy panel discussion with all 10 presenters of the day participating on the panel. Most of the questions 85 

86 NANTECHNOLOGY IN FOOD PRODUCTS and comments revolved around issues related to consumer behavior and public engagement, although the issue of regulatory uncertainty re-emerged as well. NANOTECHNOLOGY AND FOOD: THE PUBLIC KNOWS “NANO” 1 Presenter: Julia A. Moore 2 Moore began her talk by remarking that the public knows very little about nanotechnology in food. Within her organization, the Woodrow Wilson International Center for Scholars, the Project on Emerging Nanotechnologies, has probably done more focus group and public opin- ion polling on public attitudes and perceptions, as well as how to influ- ence those attitudes and perceptions, than any other organization. That said, it was actually the National Science Foundation (NSF) that sup- ported the first public opinion polls on nanotechnology in 2004. One of the questions posed in that initial NSF poll was: How much have you heard about nanotechnology? The question was posed again in a 2008 study conducted by Peter D. Hart Research Associates (on behalf of the Project on Emerging Nanotechnologies), and the numbers were basically the same (Moore presented the 2008 data, which involved surveying 1,003 adults nationwide 3 ): • 49 percent replied that they had “heard nothing at all”; • 26 percent said they had “heard just a little”; • 17 percent had “heard some”; • 7 percent had “heard a lot”; and • 1 percent were “unsure.” Moore remarked that most of the 17 percent who said that they “heard some” probably in fact knew nothing about nanotechnology. She said that it is easy to imagine somebody getting a phone call and being told, 1 This section is a paraphrased summary of Julia Moore’s presentation. 2 Julia A. Moore is Deputy Director of the Project on Emerging Nanotechnologies, an initiative of the Woodrow Wilson International Center for Scholars & The Pew Charita- ble Trusts. 3 SOURCE: Peter D. Hart Research, Inc. 2008. “Awareness of and Attitudes Toward Nano- technology and Federal Regulatory Agencies.” Available online at http://www. pewtrusts.org/our_work_report_detail.aspx?id=30539. Accessed January 26, 2009. 

EDUCATING AND INFORMING CONSUMERS 87 “Hey, I’m going to talk to you about nanotechnology …” and the person saying, “Yeah, I’ve heard something about nano….” According to the same 2008 poll, when asked what their initial impressions were about the benefits and risks of nanotechnology (i.e., whether the benefits will outweigh the risks or vice versa), many people were unsure: • 48 percent replied “not sure”; • 25 percent replied “the benefits and risks will be about equal”; • 20 percent replied “benefits will outweigh risks”; and • 7 percent replied “risks will outweigh benefits.” Although, as shown in Figure 4-1, the percentage of people that were unsure decreases as familiarity with nanotechnology increases (i.e., 65 percent of people who had “heard nothing” were “not sure” about the benefits and risks, whereas only 10 percent of those had heard “a lot” said that they were “not sure”). Benefits will Which will outweigh: Not outweigh Risks sure benefits, risks, or equal? 20% 48% Benefits and Risks will be Impact of Familiarity Prior to Survey about equal Heard Heard Heard Heard a lot Some a little nothing 25% Benefits 49 41 24 8 outweigh Benefits/risks 33 26 29 22 equal Risks outweigh 8 8 8 5 Not sure 10 25 39 65 Risks will outweigh 7% Benefits FIGURE 4-1 How people perceive the risks and benefits of nanotechnology without being told anything about nanotechnology prior to being surveyed. The table on the lower left breaks the responses down according to how familiar with nanotechnology respondents said they were prior to the survey. Image courtesy of Peter D. Hart Research Associates, Inc., on behalf of the Project on Emerging Technologies. 

88 NANTECHNOLOGY IN FOOD PRODUCTS When people were provided with some information about nanotech- nology prior to the survey (i.e., the pollster read some sentences about what nanotechnology and its applications are), the percentage of people who were unsure dropped from 48 to 9 percent (see Figure 4-2): • 38 percent replied “benefits and risks will be about equal”; • 30 percent replied “benefits will outweigh risks”; • 23 percent replied “risks will outweigh benefits”; and • 9 percent replied “not sure.” Which will outweigh: Benefits will benefits, risks, or equal? Not outweigh Risks sure 30% 9% Impact of Familiarity Prior to Survey Heard Heard Heard Heard a lot Some a little nothing Benefits 55 45 32 19 outweigh Benefits/risks 26 28 44 40 equal Risks outweigh 16 18 17 29 Not sure 3 9 7 12 38% 23% Benefits and Risks will outweigh Risks will be Benefits about equal FIGURE 4-2 How people perceive the risks and benefits of nanotechnology after being informed about the potential risks and benefits of nanotechnology. The table on the lower left breaks the responses down according to how familiar with nanotechnology respondents said they were prior to the survey. Image courtesy of Peter D. Hart Research Associates, Inc., on behalf of the Project on Emerging Nanotechnologies. The take-home message from these survey data, Moore said, is that “public opinion is really up for grabs when it comes to nanotechnology. The public really doesn’t know very much to have an opinion.” When asked about the benefits that they would like to see derived from nanotechnology, indeed from any new technology, Americans con- sider the potential medical applications to be the most important (e.g., “a 

EDUCATING AND INFORMING CONSUMERS 89 cure for cancer”). More specifically, in a 2006 study, surveyed members of the U.S. public identified the following as the most important potential benefits of nanotechnology 4 : • Medical applications (31 percent) • Better consumer products (27 percent) • General progress, better life (12 percent) • Environmental protection (8 percent) • Food and nutrition (6 percent) • Economy, jobs (4 percent) Moore remarked that, interestingly, when the same question is asked in Europe, respondents generally indicate that they are much more con- cerned with environmental issues (e.g., environmental clean-up methods) than U.S. residents are. Of note, only 6 percent of respondents indicated that “food and nutrition” benefits are one of the most important potential benefits of nanotechnology. This is consistent with most other new tech- nologies. While people are generally delighted to have new technologies put to use in computers, telephones, etc., even tennis racquets, the idea of having a new technology applied to a food is often viewed as “yucky.” That is something to keep in mind, Moore said, when considering or try- ing to project what public perceptions of this new technology (i.e., nanotechnology) will be. While one might expect most people to learn about nanotechnology in the classroom, through government education programs, or from sci- ence societies, such as the National Academy of Sciences, Moore said that this is not the case. Most people learn about nanotechnology in gro- cery, clothing, and drug stores. Moore encouraged workshop attendees to visit http://www.nanotechproject.org/inventories/consumer and browse the 800+ consumer products, particularly products in the “food and bev- erage” category that are self-identified as “nano” or nanotechnology- based. As Philbert had remarked earlier, being self-identified as nano does not mean that a product is in fact nanotechnology based. It means only that the manufacturer is making that claim. In addition to the fact that only a small percentage of people identify food and beverage benefits as an important potential benefit of nanotech- nology, Moore said “another piece of bad news” is that many people are 4 J Macoubried. 2006. Nanotechnology: Public concerns, reasoning and trust in govern- ment. Public Understanding of Science 15:221-241. 

90 NANTECHNOLOGY IN FOOD PRODUCTS worried about the overall safety of the U.S. food supply. When asked how the food supply has changed over the last five years (as part of the same 2008 survey cited previously): • 39 percent replied that it “has become somewhat less safe”; • 22 percent replied that it “has become much less safe”; • 22 percent replied that it “has become somewhat more safe”; • 7 percent replied that it “has become much more safe”; • 6 percent replied that it “has been unchanged”; and • 4 percent replied that they were “not sure.” Moore emphasized that even though these responses reflect perceptions, not necessarily reality, the results are consistent with other polling data. This concern about safety raises the question, who does the American public trust, and where does it place its confidence with respect to maxi- mizing the benefits and minimizing the risks of scientific and technologi- cal advancements? Other polling data show that the public trusts the U.S. government (i.e., the USDA, FDA, and EPA), independent scientists, and independent agencies much more than they trust businesses and compa- nies. Basically, Moore said, the public wants to know that the FDA is taking care of the safety of the food supply. Moore emphasized that the public is not averse to nanotechnology. For example, according to the same survey data collected by Peter D. Hart Research Associates, Inc. (on behalf of the Project on Emerging Nanotechnologies), when asked if they would use food storage products enhanced with nanotechnology, 12 percent said yes, 73 percent said that they need more information about the health risks and benefits, and 13 percent said no. When asked if they would purchase food enhanced with nanotechnology, 7 percent said yes, 62 percent said that they need more information about the health risks and benefits, and 29 percent said no. But they do need more information. In summary: • A large majority of Americans still have heard little or noth- ing about nanotechnology. • A large portion of the public does not have an opinion on the trade-offs between the risks and benefits of nanotechnology. • The U.S. public is more comfortable with government or independent oversight than industry self-regulation of new technologies. Moore noted that this is an important point to 

EDUCATING AND INFORMING CONSUMERS 91 consider because the U.S. public relies on industry to provide safe products (i.e., because too much regulation would stifle innovation). • The current lack of awareness presents an opportunity for the government and industry to establish confidence in nanotechnology. Moore said that if those involved in the food sector think that nanotechnology is going to provide strong benefits for consumers, then they really need to get out there and start shaping that still unformed perception of nanotechnology. • The U.S. public values nanotechnology medical benefits over food and nutrition. Moore remarked that a single highly beneficial application of nanotechnology, not necessarily in food but more likely in medicine, would cause people to “immediately identify” with nanotechonology. Moore listed four lessons to be learned from the “ag-biotech experi- ence”: 1. Build public trust in a strong, credible U.S. and international oversight process. The American public is much more likely to accept a new technology if they think someone is looking after their interest. If they don’t think that anyone is looking after their interest, they will reject the new technology. 2. Make sure nanotechnology’s environmental and health benefits and safety are confirmed by independent research. 3. Demonstrate concern for consumer choice and provide good consumer information. Focus group and polling studies have shown that consumers like choice. For example, people do not like being told that they have to use sunscreen with nanotechnol- ogy and that they don’t really have a choice. Consumers become upset when they find out that a product that they have been using all along has nanotechnology in it without their knowledge (i.e., there is no mention of nanomaterials in the labeling). In order to build confidence in a new technology, it is important to provide consumers with information and to make sure that they have a choice about whether to use the new technology or not. This is true even though people do not necessarily actually look at the information. But they want somebody to have the information. They want it to be transparent and available. 

92 NANTECHNOLOGY IN FOOD PRODUCTS 4. Offer opportunities for public input into the technology’s devel- opment and regulation. A key issue with respect to engaging the public is that the engagement does not involve just telling people that nanotechnology is “all about controlling matter on a 1–100 nm scale.” That is not the type of communication they want. Fo- cus group studies have shown that people want to have input into whether or not the new technology is going to be used in ways that they think are important, and they want to feel that they are being heard. Moore concluded by encouraging people to visit the Project on Emerging Nanotechnologies website, where more information on the focus group and polling studies that she discussed is posted: http://www.nanotechproject.org. Moore also provided a hand-out for workshop attendees that contained some of the same data she presented. 5 CHALLENGES IN EDUCATING CONSUMERS ABOUT EMERGING TECHNOLOGIES 6 Presenter: Carl Batt 7 Batt began with a few comments about his scientific research on biodegradable plastics. His research team has developed a process that involves coupling a particular enzyme to a magnetic bead and growing large masses of bacterial polyester. The polymer masses stay in place in situ and are being used for cancer therapy and other therapeutic applications. Batt and his students are also doing what Batt refers to as “nanostructured prospecting,” or “reverse food science,” and they are investigating the use of chemically modified particles in pesticide detection. But the focus of his talk was not his scientific research, rather his participation in development of Too Small to See: Zoom into Nanotech- nology, a 5,000-square foot traveling museum exhibition supported by 5 Awareness of and Attitudes Toward Nanotechnology and Federal Regulatory Agencies: A Report of Findings, available online at http://www.pewtrusts.org/uploadedFiles/www. pewtrustsorg/Reports/Nanotechnologies/Hart_NanoPoll_2007.pdf. Accessed February 11, 2009. 6 This section is a paraphrased summary of Carl Batt’s presentation. 7 Carl A. Batt, PhD, is Liberty Hyde Bailey Professor of Food Science and co-founder and former director of the Nanobiotechnology Center, Cornell University, Ithaca, NY. 

EDUCATING AND INFORMING CONSUMERS 93 the NSF, and the magazine Nanooze. Batt remarked that, for the remain- der of his presentation, while describing these two programs, he would try to convey what he and his colleagues think are the “underlying foun- dations” of what people know and how they think about size and scale. Too Small to See When Batt and his colleagues began developing Too Small to See, rather than trying to get a sense of what the public knows about nanotechnology, which is essentially nothing, they formulated a set of questions designed to get a sense of what people know and how they think about size and scale. Initially, they did ask, “Have you heard of nano?” The responses, Batt said, were based largely on the fact that peo- ple would get kind of embarrassed if they had not heard of it, and so they’d say, “yeah, yeah, I’ve heard of it.” Slightly less than 30 percent (in the 18–22-year-old age range) to more than 70 percent (in the <8 years old age range) of respondents said that they had heard of nano. But when probed further and asked “What is nano?” most people referred to the iPod nano (or “that iPod thing”), an answer Batt said was “sort of meaningless.” So Batt and his team changed the focus of the questioning. Instead, they asked people, “What is the smallest thing that you can see?” But the answers were often dependent on the respondents’ environments. If someone saw a bug crawling, that would be the answer. Or if they had crumbs all over them, that would be the answer. So again, the answers were sort of meaningless. Instead, as their first line of questioning in their effort to find out what people know about size and scale and how they know it, they asked, “What is the smallest thing that you can think of?” The answers, Batt said, were interesting. Some people identified a visible organism, like a bug, as the smallest thing they could think of; others identified something cellular as the smallest thing they could think of; and then there were people who identified either something atomic or something subatomic, like a quark or proton, as the smallest thing they could think of. Batt referred to people in one of the latter two groups as “post-atomic.” The answer to this question allowed the researchers to define populations of people who thought on a macroscopic vs. micro- scopic vs. nanoscopic scale. The exhibitors developed a scoring system to measure people’s thinking about scale, with post-atomic people earn- ing higher “think scores.” Specifically, people that identified a visible organism as the smallest thing they could think of were assigned a score 

94 NANTECHNOLOGY IN FOOD PRODUCTS of 1; people that identified something cellular were assigned a score of 2; people that identified something atomic received a 3; and people that identified something subatomic received a 4. The highest scores were among teenagers (age 16–18; see Figure 4-3). Generally, only a small fraction of people actually thinks about things “on a nanoscale world.” FIGURE 4-3 The range of “think scores,” by age, when respondents were asked to identify the smallest thing they could think of. A higher score indicates more “sub-atomic,” or nanoscopic, thinking. See text for more details. SOURCE: Reprinted from Springer, Journal of Nanoparticle Research, Volume 10, Issue 7, 2008, pp. 1141-1148, Numbers, scale and symbols: the public un- derstanding of nanotechnology, CA Batt, AM Waldron, N Broadwater, adapted from Figure 1, Copyright © (2008), with kind permission from Springer Science and Business Media. The finding that only a small percentage of people actually think about things on a nanoscale level, combined with the reality that the average visitor to a science museum spends less than one minute in front of any individual exhibit, became the basis for Too Small to See. The challenge was to distill all of the information that Batt and his team wanted to convey into something that could be communicated in less 

EDUCATING AND INFORMING CONSUMERS 95 than a minute (or, as Batt noted, 60,000,000,000 nanoseconds). In order to do that, they developed what they termed the “Four Concepts,” or “Carl’s Commandments”: • All things are made of atoms. • Molecules have size and shape. • At the nanometer scale, atoms are in constant motion. • Molecules in their nanometer scale environment have unex- pected properties. Batt said the fourth point—that unexpected things happen—is what makes nanotechnology so interesting. The exhibitors decided that they wanted to hammer these four concepts at every opportunity. The four concepts also serve as a basis for every issue of Nanooze. Scale and Perspective Before describing the Four Concepts in more detail, Batt discussed how difficult it is for people to understand the concept of scale. It is hard enough to imagine a billion of something, let alone one billionth of something. Also, people have a difficult time with numbers, often inter- preting “billion” and “1,000,000,000” differently. As an example, Batt referred to the widespread email scam whereby somebody claiming to be from Nigeria informs the recipient that “the sum of $1,000,000,000 USD (One Million Dollars Only)” awaits him or her. $1,000,000,000 is not a million dollars—it’s a billion dollars. So figuring out 109 is hard, 10−9 even harder. Thinking small is difficult, and many people, “including probably all of us,” Batt said, “can’t think on those terms.” Physicist Richard Feynman developed a helpful analogy: if an atom were the size of an apple, then an apple would be the size of the earth. Still, even that analogy would be difficult for most people to interpret while walking through a science exhibit. In Too Small to See, everything is 100,000,000 (one hundred million) times larger than it actually is. So atoms, for example, are represented as objects that are 100,000,000 times larger than actual atoms are. Batt said that many people might wonder, “Why one hundred million? Why not a million?” As it turns out, objects smaller than 1.3 inches are considered choking hazards and cannot be included. And if the scale had been made larger, then the atoms would have been very large. A human hair at 100,000,000-fold, for example, would be the width of a river. Even at 

96 NANTECHNOLOGY IN FOOD PRODUCTS 100,000,000-fold, people have a difficult time. For example, when told what a golf ball would look like when enlarged 100,000,000 times and then asked what a pinhead would look like when enlarged to the same extent, less than 20 percent of people with lower “think scores” (i.e., below 3) answered correctly when given a choice of answers separated by two orders of magnitude. About 25 percent of people with think scores of 3 and 60 percent of people with think scores of 4 answered correctly. In addition to their difficulty with scale, many people also have a dif- ficult time with perspective. For example, Batt showed an image of two spheres, one in the foreground and one in the background; although the spheres are the same size, the one in the background looks larger (see Figure 4-4). When designing Too Small to See, the exhibitors tried to avoid these problems with scale and perspective. FIGURE 4-4 Images depicting the types of scale and perspective problems that the creators of Too Small to See tried to avoid when developing their exhibition. In the image on the right, even though the spheres are the same size, many peo- ple think that the sphere in the background is larger. In the image on the left, the orders of magnitude difference in size between the moon in the background and the tree in the foreground is not immediately apparent. SOURCE: With permission from Caro1 Batt. available online at http:// www.moillusions.com/2008/12/moon-optical-illusion.html. Accessed March 24, 2009. 

EDUCATING AND INFORMING CONSUMERS 97 The Four Concepts Batt described in more detail how the museum exhibit was built around the four concepts, based on interviews conducted at the New York State Fair: 1. All things are made of atoms. The researchers asked interview- ees to draw an atom, a molecule, and a piece of DNA. Interest- ingly, Batt said, when people tended to get DNA right, they drew the iconic double-stranded helix. Yet, they couldn’t identify any of the atoms on the double helix. Most people, when they drew molecules, drew ball-and-stick figures. When drawing atoms, most people drew the Bohr model. And then there were the chil- dren that drew things that looked nothing like an atom, molecule, or piece of DNA (see Figure 4-5). The exhibitors decided that since most people that could associate with the post-atomic, or nanoscale world, did so through use of the iconic ball-and-stick image, they would use the ball-and-stick model in the exhibit. They also tried to use iconic coloration of the balls and sticks as much as possible. So when people walk into the exhibit, every time they see a ball, they recognize that ball as an atom. And again, every atom, including every digital representation, is enlarged 100,000,000 times. 2. Molecules have size and shape. The scientists showed interview- ees images of a ball-and-stick model, a space-filling model, and a domain model of a molecule and then asked the interviewees to identify components of each model (see Figure 4-6). Again, peo- ple were able to identify atoms in the ball-and-stick model and, to a lesser extent, bonds in the same model. The highest “think score” was among the 13–15 years old age group, where more than 70 percent of those surveyed correctly identified atoms in the ball-and-stick model. Many people identified the domain model image as “moldy popcorn.” 3. At the nanometer scale, molecules are in constant motion. This is a very important concept and one that is also very difficult to portray. With the help of artist Zack Simpson, Austin, Texas, the exhibitors developed an animated display where museum visitors could reach out and, on a screen, fold and stretch molecules (see Figure 4-7). 4. Molecules in their nanometer scale environment have unex- pected properties. The greatest challenge in developing this ex- 

98 NANTECHNOLOGY IN FOOD PRODUCTS hibit was in designing a way to show these unexpected proper- ties, since nanoscale phenomena do not scale up. For example, the scientists built a prototype exhibit using neodymium super- magnet spheres (available online at http://www.amasci.com/ amateur/beads.html), but too many visitors walked away think- ing that atoms are like little magnets. Gianinna, Age 10 Cliva, Age 11 Kelly, Age 12 Anthony, Age 13 aw an atom: w a molecule: Draw DNA: FIGURE 4-5 When asked to draw an atom, molecule, and piece of DNA, some children drew iconic ball-and-stick depictions of molecules and DNA (e.g., Cliva and Kelly), while others drew objects that bore no resemblance at all to how these materials are typically represented (e.g., Anthony). SOURCE: Reprinted from Springer, Journal of Nanoparticle Research, Volume 10, Issue 7, 2008, pages 1141-1148, Numbers, scale and symbols: the public understanding of nanotechnology, CA Batt, AM Waldron, and N Broadwater, from Figure 3, Copyright © 2008, with kind permission from Springer Science and Business Media. 

EDUCATING AND INFORMING CONSUMERS 99 FIGURE 4-6 Interviewees were asked to identify components of each of these models of a molecule: ball-and-stick (on the left), space-filling (in the middle), and domain (on the right). SOURCE: Reprinted from Springer, Journal of Nanoparticle Research Volume 10, Issue 7, 2008, pp 1141-1148, Numbers, scale and symbols: the public under- standing of nanotechnology, CA Batt, AM Waldron, and N Broadwater, Copy- right © 2008, with kind permission from Springer Science and Business Media. Reprinted with permission from David Goodsell, available online at http://www.rcsb.org/pdb/static.do?p=education_discussion/molecule_of_the_mo nth/pdb14_1.html. Accessed May 4, 2009. FIGURE 4-7 An exhibit in Too Small to See that was designed to communicate the concept that molecules are in constant motion. Visitors can reach out and fold and stretch the molecule on the screen. Source: Reprinted with permission from Z. B. Simpson and Mine Control, Inc.; Reprinted with permission from A. Strickland. 

100 NANTECHNOLOGY IN FOOD PRODUCTS Batt showed a picture of the exhibit when it was at Epcot Theme Park, Orlando, Florida, where 5,000 to 10,000 people toured the exhibi- tion daily. He then showed some pictures of the various exhibits, includ- ing the following: • Magnification Station, where visitors could see different size scales, including atomic scales (i.e., ball-and-stick molecular models), of some common objects, like an oyster shell, a butterfly wing and a salt crystal. • Zoom into Nation, where visitors would turn a wheel to zoom in and out from the macroscopic to nanoscopic worlds. Batt said, “We had people just standing there for hours on end.” • Build a Molecule, where visitors would create their own mo- lecular models. Batt said that kids would play at this station for 20–30 minutes at a time. • Atom Transporter, where visitors would play an arcade-like game that involves arranging moving atoms into a pattern. Kids would spend abut 5–10 minutes at this station. Batt and colleagues also built a smaller, bilingual version of the exhibit, Too Small to See-2, which is available for tour. Nanooze and Other Nanotechnology Education Projects Batt then briefly described Nanooze, which started as a webzine in 2006 (www.nanooze.org) and is now available in print as well. About 50,000 print copies of each issue are distributed across the United States. The webzine gets about 10,000 hits a month. The webzine is available in English, Spanish, Portuguese, and Swahili; it has primary articles, a blog, games, and interviews, and people can send questions, with a return time of about 90 minutes. Batt described Nanooze as “very cool” and pointed out that the last issue contains an interview with Don Eigler, a “gem of resources.” Batt also mentioned a partnership he and his group have with Earth- Sky (www.earthsky.org). Funded by the National Science Foundation (NSF); they are producing what they call “Chronicles of a Science Ex- periment,” a series of 8-minute podcasts on nanotechnology and other science topics. In the first episode (September 8, 2008), Cornell Univer- 

EDUCATING AND INFORMING CONSUMERS 101 sity postdoctoral scientist Aaron Strickland talked about his daily life, not just in the lab but also at home. Batt said, “We’re trying to give peo- ple this impression that science is back … it actually involves pretty normal people … pursuing interesting things.” In conclusion, Batt said that Too Small to See has been seen by about 5,000,000 visitors; Nanooze in print is seen by about 50,000 children, and Nanooze online gets about 10,000 hits a month; and EarthSky pod- casts are heard 14 million times daily. He mentioned that the U.S. De- partment of Agriculture (USDA) would be sponsoring six EarthSky epi- sodes on nanotechnology and food beginning in March 2009. A special issue of Nanooze will be produced to complement the podcasts. CONSUMER INTEREST IN AND CONCERNS WITH EMERGING TECHNOLOGIES 8 Presenter: Jean Halloran 9 Scientific Knowledge Versus Acceptance of Technology Halloran agreed with Moore and Batt that “consumers really don’t know anything about nanotechnology,” and she praised Batt’s science education work, saying “If only it could be distributed everywhere be- cause the sorry state of science education in a lot of the country is a real problem for the Nation.” She expressed hope, however, that it wasn’t being distributed with the expectation that, if people really understand nanotechnology, they will automatically accept its use in food. She em- phasized that the two are “entirely separate questions.” In fact, while not okay from an educational perspective, it may be okay from a “marketing perspective” if two-thirds of the public never really understand nanotechnology since they don’t really need to learn about it unless it is causing some sort of problem. Consumers can become educated and tend to learn about new scientific entities or concepts very quickly when prob- lems arise and something has them worried. For example, Halloran imag- ined that if people were polled two years ago about their knowledge of melamine, probably less than one percent of the population would have 8 This section is a paraphrased summary of Jean Halloran’s remarks. Unlike the other prepared presentations, Halloran shared thoughts and reactions to some of the key ideas and themes of the other presentations and discussions held throughout the day. 9 Jean Halloran is Director of the Food Policies Initiative at the Consumers Union (pub- lisher of Consumer Reports). 

102 NANTECHNOLOGY IN FOOD PRODUCTS known what melamine was; today the majority of people probably know what melamine is. Gaps in Scientific Knowledge About Safety Halloran remarked that scientists involved with nanotechnology have been expressing a lot of enthusiasm about what they are doing with this new technology and where nanoscience is headed. This is an “absolutely natural thing for scientists to feel,” she said. Unfortunately, however, we tend to hear only in passing that there are some safety issues. In fact, as Philbert stated, there is a huge gap in our scientific understanding of the safety of nanotechnology. For example, where exactly do nanoparticles go when they enter the human body? Halloran suspects that grants are not being awarded for the scientific study of the safety of nanotechnology to nearly the same extent that they are being awarded for the investigation of “all the nifty new things you can do with nanotechnology.” If such funding were available, Halloran said that scientists would probably be just as happy to address these safety questions. But now, without the funding, the attitude among nanoscientists is that addressing safety is not their job. They think it is someone else’s responsibility. Consumers’ Fear of the Unknown Halloran elaborated on a comment that Yada made during his over- view presentation: that consumers fear the unknown. As a result of this fear of the unknown, one of the fastest-growing segments of the food market today is natural and organic food. Halloran said that this is not an unreasonable fear, for a couple of reasons. First, consumers tend to be conservative, or traditional, with foods. In other words, in scientific par- lance, people have coevolved with their food supplies and without the benefit of what we can do with our food today because of science. People instinctively do things the “old way” or “the way that Grandma did things.” People don’t feel that innovation in food is really necessary. Second, consumers fear the unknown because of the way scientific inno- vations have been introduced over the past half-century. Consider, for example, synthetic chemicals: while they may do “incredible things” and have “probably brought us half the things in this room,” they have also created all sorts of difficulties. We are in a situation now, for example, 

EDUCATING AND INFORMING CONSUMERS 103 where we can’t eat striped bass from the Hudson River because of poly- chlorinated biphenyl (PCB) contamination, and nobody knows how to fix the problem. The river itself has been cleaned, but cleaning the river bot- tom would cost billions and billions of dollars. So PCBs remain. Hal- loran pointed to the current debate about bisphenol A (BPA) as another example of the problems still emerging from our use of synthetic chemi- cals, with many people questioning how federal regulatory agencies are handling some of the issues. Halloran argued that it is not “really fruitful” to have a discussion about whether consumers and the public are for or against nanotechnol- ogy. Rather, the issue is the safety and effectiveness of nanotechnology. The application of nanotechnology to the food supply needs to actually provide benefits to consumers and not be frivolous, and it needs to be safe. Of course, she said, there may be some consumers who would actu- ally still appreciate having a “better Twinkie,” so it may have some frivolous applications as well. Either way, it must be safe. Regulating Nanotechnology in Food: Who Is Going to Do It and How? This concern about safety raises the issue of regulation. Consumers want to know who is protecting them. Halloran remarked that, obviously, scientists are not going to ensure the safety of the applications they are developing, unless they receive the funding to do so. Nor, Halloran said, does FDA send a very reassuring message for consumers. She said, “It kind of feels like the FDA is sitting there waiting for the phone to ring.” While some of the 800-plus products out there that are self-identified as “nano” may not even have nanoparticles in them, who is out there trying to figure out which ones do contain nanoparticles and, of those that do, whether they are safe? She agreed with Degnan’s advice that written guidance needs to be provided so that at least sponsors know when they need to pick up the phone and call FDA. Halloran also noted that the Consumers Union, which she represents, has called for a mandatory safety review for the use of nanoparticles in all cosmetic and food prod- ucts. At this point, it falls on industry to ensure that products entering the market are safe, which raises another set of concerns. Experience has shown that industry has a difficult time regulating itself, even when it comes to its own long-term self-interest. There is such a premium on short-term gain that many products are pushed into the market without 

104 NANTECHNOLOGY IN FOOD PRODUCTS adequate self-assessment. Halloran argued that this is why FDA needs to be taking a more active role. Halloran referred to an earlier question (in the previous session) about companies that are developing products but for whom the cost of animal testing is prohibitive. So what are they doing? Are they moving forward with development anyway, without ani- mal testing? Consumer Choice Halloran referred to the issue of choice that Moore brought up during her presentation. Consumers Union recognized the importance of this issue after some Consumer Reports testing with big commercial brand sunscreens revealed that the active ingredient in all sunscreens is either a chemical recognized by the Environmental Working Group as having some safety concerns or a nano-form of titanium dioxide or zinc oxide. A second round of testing with organic sunscreen products revealed that even though the customer service departments of these companies said that the products did not contain nanoparticles, in fact all of the products did. So there is no way at this point to avoid sunscreens with nanoparti- cles; the only other choice is to purchase a brand that contains a chemical recognized by the Environmental Working Group as being even more hazardous. The situation is exacerbated by the fact that the only reason nanoparticles are used in sunscreens is to make the lotions more trans- parent. Transparent sunscreens sell better than opaque ones, even though the benefit to consumers is not really that great. Halloran questioned whether consumers would really want transparent sunscreens if they really understood what was going on. Other Safety Issues Finally, Halloran referred to an earlier comment about vitamin forti- fication and asked whether it might be possible to get too much of a cer- tain vitamin as a result of nanotechnology and, if so, how this could be prevented. She identified the presence and use of nanoparticles in foods pre- pared in other countries and imported into the United States as another important but unresolved issue: Who is evaluating that? She noted the global nature of our food supply and that we are dealing with other coun- 

EDUCATING AND INFORMING CONSUMERS 105 tries that are just as technologically advanced as the United States but with weaker regulatory and safety infrastructures. In conclusion, she advised, “go slow” and “be very, very precau- tionary to ensure it’s safe.” PANEL DISCUSSION ON CURRENT ISSUES All 10 speakers of the day were invited to participate as panelists during the final question and answer period. Much of the dialogue revolved around issues raised during this third session on consumer edu- cation and behavior, with Food Forum member Ned Groth’s comments on consumer skepticism generating the most discussion. The issue of regulatory uncertainty was also revisited at length. More specifically, discussants considered: • how consumers make new choices with new technologies; • the lack of and need for more safety data on nanomaterials with novel properties and how regulatory guidance can be provided in the absence of such data; • engaging the public in discussions about nanotechnology in food and empowering consumers; • educating the public about nanotechnology; • a comparison between consumer acceptance of nanotechnology in food and consumer acceptance of irradiation in food; • naturally occurring food nanosystems and the positive spin they give to the concept of nanotechnology in food; • second generation “nano-bio” devices being developed for the treatment of cancer and the regulatory challenges they will pose for the FDA; • the various options FDA has for providing initial guidance on nanotechnologies in food; • how other governments are dealing with these same issues; and • how the United States will handle the importation of food prod- ucts constructed with nanomaterials. 

106 NANTECHNOLOGY IN FOOD PRODUCTS Consumer Choice and Demand Doyle opened the panel discussion with a question about whether any research has been conducted to determine whether consumers would accept particular types of nanomaterials or approaches to nanotechnology in specific types of foods. Halloran replied first by stating that asking that type of question is oversimplified and would not provide a very use- ful response. If a product has been through a full safety review and the nanoscience/nanotechnology has been shown to provide some benefit that consumers could clearly identify, then yes, most consumers would almost certainly accept it. She remarked that some people draw an anal- ogy with GMOs, but in fact nanotechnology doesn’t raise the same “tampering with life” ethical issues. With nanotechnology, consumer acceptance is fundamentally a safety and usefulness matter. Moore agreed with Halloran that consumers are more likely to respond to benefits than to risks. For example, there is a body of litera- ture showing that the use of cell phones can promote brain tumors and cancers. Yet, most consumers view the benefits of cell phones as so great that the cell phone–brain tumor association will require a lot more evi- dence before people are willing to throw their cell phones away. She doesn’t anticipate that type of response with nanotechnology in food. The public is still “up for grabs” with respect to being convinced of benefits associated with nanotechnology. She described some focus group work that the Project on Emerging Nanotechnologies has done with nano “toys,” for example Tupperware that supposedly contains nano-silver particles with antimicrobial properties. When you put these “toys” in front of adults and ask them what they think, the overwhelming response is that people want more information—they want to know that the product is safe and who the authority figure is with respect to safety. But many people have a hard time identifying food safety authority fig- ures that they trust. The authoritative source mentioned most often is Consumer Reports. She emphasized the necessity of having a food safety authority figure in place—it could be the Consumers Union (publisher of Consumer Reports), or it could be an FDA that people feel has been ade- quately resourced and provided with the tools necessary for overseeing safety. Taken together, research suggests that consumers are responsive to benefit, however, even in the absence of evidence for overwhelming benefit, consumers still need to be convinced by an authoritative figure before they will accept risks from a product. 

EDUCATING AND INFORMING CONSUMERS 107 Safety Data and Regulatory Guidance Workshop attendee Scott Thurmond of the USDA remarked that there had been several calls during the course of the workshop for the FDA to promulgate guidance for nanomaterials to be submitted under their purview. The USDA is considering perhaps requesting absorption, distribution, metabolism, and excretion (ADME) data upfront for novel products, which Thurmond noted brings up another issue: while it easy to demand ADME data, it is much more difficult to demand how those data should be generated. He asked what advice the panel had for making that type of request. In response, Degnan suggested that rather than telling sponsors what they need to do, regulatory agencies could provide guid- ance in the form of questions (i.e., what type of questions the agency would ask when an actual petition for the product is submitted). That is just one suggestion, Degnan said, for dealing with “that type of knowl- edge vacuum.” He remarked further that this is an area where regulatory authorities would benefit from the expertise of those people who have been studying and thinking about the applications of nanotechnology; such experts could help the regulatory agency determine the appropriate questions and identify issues that might arise, even before an actual product is under review. Degnan again emphasized (as he had during his presentation) the value of having a written document to work with during those early stages, no matter how preliminary the guidance, particularly in cases where nanomaterials possessing novel properties have been added to products previously considered GRAS. With nanomaterials possessing novel properties, there is going to be a lot of focus on whether the GRAS exception is applicable or whether every additive with a nanomaterial with novel properties must go through the food additive approval proc- ess. “That, to me,” he said, “is a really important regulatory issue that needs to be addressed in some manner.” Engaging the Public Food Forum member Ned Groth made a couple of observations and said that he hoped his comments would stimulate some response from the panel. First, until he retired five years ago, he worked for 25 years for Consumers Union, where much of his work was in risk communication. During that time, he said, “I learned quite a bit about what consumers 

108 NANTECHNOLOGY IN FOOD PRODUCTS know and don’t know and how they react to information.” While con- sumers have a great deal of common sense, they also have enormous gaps in knowledge particularly with respect to quantitative information (as Batt elaborated during his presentation). For example, Consumers Union did some work with Alar about 20 years ago, when the pesticide was found in apple juice at parts per million (ppm) levels, exceeding EPA recommendations. When Consumers Union published that informa- tion, they received a lot of letters from concerned citizens, including a medical doctor from Rancho Cucamonga, California who asked what all the “fuss” was about, given that there “can’t be more than one molecule” of Alar in a gallon of juice. In fact, at those ppm levels, a liter of apple juice would contain an astronomical number of molecules: 1.4 × 1017. Groth said, “Even the people in this room probably couldn’t get a good grip on it intellectually.” Getting consumers to get a handle on this type of quantitative information is an enormous challenge. The second observation Groth made was that, while consumers may not be very good with quantitative information, they are good with skep- ticism. He remarked that Yada’s earlier comment about how the National Nanotechnology Initiative was designed to get kids excited about nanoscience and “all of the wonderful things that nanotechnology offers” reminded him of watching a Disney movie, Our Friend the Atom, as a kid, and then seeing 15–20 years later a pamphlet on nuclear power and electricity. The pamphlet, which was put out by a coalition of electrical utilities called Infinite Energy, claimed that nuclear power-generated electricity was going to be not only incredibly beneficial but also too cheap to meter and that the future would bring atomic cars, atomic air- planes, atomic wristwatches, etc. Then, 10–15 years later, there was an accident at Three Mile Island, and people realized that they had been hearing only part of the nuclear energy story. Generating this excitement serves a useful social purpose, Groth said, but consumers might wonder whether “sales pitches” like this are based on a balanced assessment of the public interest. Consumers are skeptical of both risks and benefits of new technologies. He referred to some of the data that Moore had pre- sented which showed that many consumers think (without really know- ing about the technology) that the risks are probably greater than the benefits or, at best, that the risks and benefits are the same. Groth argued that if participants in this stage of developing nanotechnology applica- tions want to persuade consumers that there are in fact huge benefits to nanotechnology and not very big risks, they have to do it in a way that does not resemble a sales pitch. Instead, he encouraged efforts to engage 

EDUCATING AND INFORMING CONSUMERS 109 consumers in the manner that Moore described: by inviting them to the table, finding out what they are interested in, including them in the deci- sion-making process, and respecting their views (including their igno- rance). This is very difficult and something, Groth said, “we haven’t really learned to do very well as a society.” He said that moving forward with nanotechnology “could be a big experiment in social mechanisms, as well as in new technology.” With respect to Groth’s second observation (i.e., on public engage- ment), Moore agreed that the United States has not done a good job of engaging the public on science policy issues. Europe, she said, has done a “little better.” In the United Kingdom, various government agencies have begun including interested citizens or consumers on oversight boards. One of the lessons learned in Europe is that unless people par- ticipate in a process and feel that their opinions and advice have some impact on the government decision-making, they feel like they are being given nothing more than a sales pitch and they become very angry. Moore expressed hope that, with new technology [i.e., not nanotechnol- ogy but new communication technology], society is developing “a new form of … democracy.” She stated that President Obama’s use of the Internet while campaigning is a manifestation of this new type of democ- racy, one that entails a higher level of public engagement than has been possible in the past. She said that she doesn’t think that these new ave- nues of communication have been explored enough as a way to truly en- gage the public and not just throw sales pitches. Yada was the second panelist to comment on Groth’s remarks. He commended the educational programming work that Batt is doing, but equally important will be conducting and communicating cost/benefit analyses. He remarked that the early stages of the GMO debate started with consumers stating that the technology was being imposed on them and without the public really understanding the technology. Yada followed up with a question to Moore, asking if the data she presented on consumer perception of benefit/cost might be suspect if in fact only half of those surveyed actually understood the technology. He pointed out that if he were asked about the potential benefits and costs of a new technology that he did not understand, particularly with respect to that technology being applied in food, he wasn’t sure that he could an- swer objectively. Moore confirmed that the one question pertaining to the benefits that people would like to see derived from nanotechnology was asked whether people knew about nanotechnology or not. She said its response was consistent with “virtually every finding” she is aware of 

110 NANTECHNOLOGY IN FOOD PRODUCTS with respect to the types of benefits people want from new technologies (i.e., that food and nutrition are not high priority benefits, and medical applications rank the highest). That finding is not nano-specific, she said. Moore elaborated that, in fact, most consumers don’t really make an effort to learn that much before making a decision, particularly a decision related to something scientific or technical. Sometimes they go to Con- sumer Reports, sometimes to a government or company website, but most of the time they turn to somebody they know who they consider reliable—it could be a cousin, a dentist or, for example when it comes to a cell phone, a 15-year-old boy. People turn to others who they think share the same values, are knowledgeable and accessible, and have your best interest in mind. Moore referred to a recent study reported in Nature Nanotechnology 10 concluding that most people form their attitudes and decisions about benefit/risk, for example whether nanotechnology is safe or unsafe, based on their “cultural cognition reality” and where they have “anchored” their trust. Once people have that cultural anchor, they proc- ess all other new pieces of data by turning to whomever it is they trust and processing their decisions accordingly. For example, people in some cultural groups mistrust industry declarations that products are safe be- cause they don’t think that industry has their best interest in mind. On the other hand, if you are in a different cultural group, for example if you are a 50-year-old white male businessperson, and GreenPeace declares that nanotechnology may be unsafe, you might automatically mistrust that declaration and believe that nanotechnology could provide a treatment for prostate cancer and that “those people don’t want me to have it” or that “those people don’t understand that we’ve got to make money in this country, that we’ve got to have a robust, technologically driven econ- omy.” Moore encouraged those who are trying to figure out how to en- gage the public in discussions about nanotechnology look at this re- search. Philbert was the next to respond to Groth’s comment by making an observation about some of the terms that people use when discussing nanotechnology. He said that while listening to this discussion, he keeps “bumping up against a simple cognitive dissonance and that is that we keep talking about this nanotechnology as if it’s a thing.” But it’s not a single thing; nor is nanotoxicology. He also commented on use of the word “risk” and that there needs to be a careful distinction between “risk aversion” and “hazard aversion.” Too often, when people use the word 10 DM Kahan, D Braman, P Slovic, J Gastil, and G Cohen. 2008. Cultural cognition of the risks and benefits of nanotechnology. Nature Nanotechnology 4:87-94. 

EDUCATING AND INFORMING CONSUMERS 111 “risk,” they are really referring to a “hazard.” He also commented on the fact that as more is learned about nanotechnologies and their various ap- plications, much of what has been learned to date will be supervened by new information. It is therefore very important that these discussions be open and transparent and that the public recognizes that “we’re just lift- ing the edge of the rug.” As we lift it further, much of the new informa- tion may very well reverse what will have already been said about the safety of nanomaterials up until that point. Nanotechnology is a very “sexy word,” Philbert said, and a powerful inducer of grant funding, but it’s useless for engaging the public and empowering consumers to make informed choices. Moore agreed with Philbert “from an intellectual standpoint,” but disagreed “from a practical standpoint.” She said, “There are so many people who have embraced this word over the last 20-plus years in the vernacular, that I think its wishful thinking.” She mentioned NSF award- ing its first grant with nanotechnology in the title in 1991. She predicted that nanotechology would almost certainly be a major component of the Obama administration’s economic stimulus package. Philbert agreed with Moore on the widespread use of the word but opined that the language needs to evolve and that we need to go beyond using the simple “nanotechnology” label for everything nano. His fear, he said, is that something bad will eventually happen and that all useful nanotechnology, safe and otherwise, will be lost. Moore agreed. Degnan responded next. Recognizing that biotechnology is “not the best comparator” for nanotechnology and that genetic alteration of natu- ral materials raises a host of quite different concerns, there is a very clear practical lesson to be learned from that experience. Specifically, when biotechnology emerged, there was not single biotech product that con- sumers could identify with and recognize as being beneficial for them. Instead, the new technologies were benefiting the farmers, growers, and agricultural companies. After watching the biotech industry suffer injury for 15 years because of this, it is very clear that the first nanotechnology products that enter the market, whether they are medical care products or food packaging products (or something else), must possess recognizable consumer benefits. Educating the Public About Nanotechnology Food Forum member Donna Porter, who also served on the work- shop planning committee, asked the panelists a series of questions, 

112 NANTECHNOLOGY IN FOOD PRODUCTS beginning with two questions directed at Batt. First, have Batt and his colleagues been able to test people’s knowledge after they have been through Too Small to See? Second, is there any plan to expand the exhi- bition into, for example, a school program that could be presented by teachers nationwide? Batt said the answer to both questions was “yes.” Regarding the first, because the exhibit receives NSF support, some sort of assessment is required, so he and his team have in fact done that. He referred workshop attendees to www.informalscience.org for a summary of what Batt and his team have learned about what people gain from the exhibit. Regarding the second question, the exhibit is currently on na- tional tour. It rotates from one science museum to the next about every three months. Its touring schedule is posted online at www.toosmall tosee.org. Nanoooze is being distributed nationwide as well. It is being sent mostly to teachers, although anybody can request copies. The big chal- lenge, Batt said, is that every state has their own formal education agenda/curriculum and not a single one of those curricula include nanotechnology. He said, “To try to shove that into the curriculum as a mandate is virtually impossible.” He and his team are doing what they can to distribute Nanooze as much as possible. Porter asked if it has been presented at science teacher education conferences. Batt said yes, for example the National Science Teachers Association (NSTA). He men- tioned that after Nanooze was recently reviewed in a newsletter, Neuro- science for Kids, Batt asked the newsletter editor where he had heard about Nanooze and learned that it was being distributed among various language arts programs as well. Batt said that it’s very graphically pleas- ing, with a lot of “cool stuff,” and it is not just being read in the science classroom. Comparing Consumer Acceptance of Nanotechnology to Consumer Acceptance of Irradiation Porter then directed two questions to Moore and Philbert. First, has the consumer reaction to nanotechnology been similar to what occurred when irradiation in food was first discussed? Second, when new techno- logical ideas are presented to consumers, for example in focus groups or through polling studies, are consumers led to believe that all food is go- ing to be affected by the new technology (whether it be irradiation or, today, nanotechnology), or do the respondents understand that the new technologies will be used only in selected ways, at least initially? Moore 

EDUCATING AND INFORMING CONSUMERS 113 said that, based on four years of focus group work, her informed opinion is that people generally react to nanotechnology as being something “cool.” It sounds “hip and edgy,” particularly to the younger generation. But there is not a lot of awareness about what nanotechnology is. In the first focus group she conducted (four years ago), when asked if anybody had ever heard about nanotechnology, only a few participants responded, and somewhat tentatively. In the last series of focus groups, conducted in August 2008, 10 of 12 pairs of hands shot up when the same question was asked. However, when further asked how they had heard about it, many people mentioned the iPod nano. But, Porter said, “at least they got that it was small. They got the first ‘Carl Commandment’ down.” So awareness of nanotechology remains the same (i.e., low). The reaction to synthetic biology, Moore said, has been more similar to what occurred with irradiated food. The word “synthetic” brings to mind nylon and other images of things that were “new and great and wonderful” decades ago but are not thought of that way today. Today, consumers want things that are “organic” and “natural.” When “syn- thetic” is combined with “biology,” people who know even less about synthetic biology than they know about nanotechnology don’t like it. There is a “yuck factor” associated with synthetic biology, as there was with irradiated food, that many people “are just not going to get over.” Use of the word “nanotechnology” does not elicit that same response. Just with the nomenclature, she said “you’re starting off at a better point than you might think you are.” Halloran agreed that nanotechnology is starting out with a “good rap” and that the iPod nano had done the technology a “huge favor.” Ir- radiation in food, on the other hand, started out as being associated with an effect of the atomic bomb and, as such, had to cross a huge hurdle. Either way, the public does not get enough credit for the “reasonable and rational way” they make their back-of-the-envelope risk/benefit analyses. With irradiated food, public perception was also influenced, for example, by a Consumer Reports project on irradiated food showing that irradiated meat did taste differently, that the irradiation did not kill all bacteria and potentially created a false sense of security, and that there were other ways to make meat safer. That was how Consumer Reports came to their conclusion about irradiated meat (i.e., not by associating it with effects of the atomic bomb), and that is how the average consumer forms his or her opinion as well. Halloran remarked further that not only do these tech- nologies (irradiation and nanotechnology) involve complex decisions, those decisions are often made within the context of individual applica- 

114 NANTECHNOLOGY IN FOOD PRODUCTS tions and on a case-by-case basis. This is particularly true of the use of nanotechnology in food. Not only does each nanotechnology have differ- ent benefits, those benefits depend on the (food structure) matrix and all of the other variables that must be taken into consideration when con- ducting safety analyses. We can’t make broad generalizations about whether nanotechnology is good or bad. Naturally Occurring Nanosystems Food Forum member Eric Decker interjected with a comment on the common perception that processed foods are “evil” and that the addition of synthetic nanotechnology-derived compounds to foods would make consumers even more wary of processed foods. Yet, as Aguilera dis- cussed during his presentation, many nanostructures naturally exist in foods. Not only do we consume nanostructures all the time, but also these nanostructures are often what make foods “good for us.” Casein micelles, which deliver calcium, are just one example. Decker stated that there has not been enough scientific exploration of naturally occurring nanosystems and the benefits they provide and that conducting more of that type of analysis would provide the means for telling a very positive story about a technology that “could be beneficial to everybody.” The Use of Nanotechnology to Treat Cancer Recognizing that the question was slightly off-topic, Porter then asked Philbert about the current status of using nanotechnology to treat cancer. Philbert said, “It is here.” There are at least two nanotechnology- derived formulations for anticancer therapeutics that are already FDA approved. Both are smaller reformulations of existing drugs. There is also a second wave of nanoscale approaches being applied in medicine where “nano” is no longer the “watchword” and where FDA “is going to hit the wall.” Philbert described these second-wave approaches as “nano- bio.” He and his colleagues, for example, are working on nano-bio hy- brids of polymers and bioactive peptides for use in drug and contrast agent delivery. Philbert predicted that the FDA will not only have a diffi- cult time categorizing some of these second-wave products, which fall somewhere between drugs and devices, but the agency will also have a difficult time evaluating their safety. It is very difficult to predict how the various components of many of these products break down. 

EDUCATING AND INFORMING CONSUMERS 115 The Starting Point for Regulatory Guidance The focus of the discussion shifted back to issues related to safety and regulatory guidance when Porter asked Degnan and Tarantino if the FDA would be providing initial guidance with an Advanced Notice of Proposed Rulemaking (ANPR), commenting that this is how many other issues without proposed rules were started. Degnan replied that an ANPR is more time-consuming than guidance. If the guidance is structured as preliminary but thought-provoking, it could serve the same purpose as an ANPR with respect to “attracting attention, scrutiny, comment, and a level of thoughtfulness and attention that at least I haven’t seen to date.” Tarantino agreed. She said that guidance makes more sense than an ANPR if for no other reason than it is easier to change than a regulation, at least at this point. She referred to Degnan’s earlier comments about the importance of including questions about safety in the initial guidance and suggested that some of the questions asked at the public meeting on September 8, 2008, might serve as a good starting point. If a regulation in a certain area were to become useful, however, an ANPR would be a good way to solicit maximum input and ensure transparency. The goal, Tarantino said, is to encourage as much dialogue and involvement as possible. Degnan followed up by remarking that FDA in fact has a number of options and that multiple routes could be taken. Historically, FDA has simply used notices in the Federal Register to post questions. In the late 1980s, for example, prior to passage of the Nutrition Labeling and Edu- cation Act (NLEA), FDA issued a number of questions about how to regulate nutrition (e.g., whether mandatory nutrition is necessary and what authority FDA would have). As another example, about five or six years ago, FDA issued a similar notice asking questions about over-the- counter (OTC) drugs (e.g., Is this an appropriate way to proceed?). Fi- nally, just a couple of months ago (in July/August 2008), FDA issued a notice in the Federal Register asking questions about the newly enacted section 912 of the FDC Act. So rather than taking a position one way or the other, the agency asks some “very probing questions.” Publishing a notice of this nature would be another way to initiate dialogue. 

116 NANTECHNOLOGY IN FOOD PRODUCTS How Other Governments Are Dealing with Nanotechnology Regulation Porter asked Yada and Aguilera how their governments were pro- ceeding with nanotechnology regulation in food. Aguilera said that the Chilean government is only just beginning to talk about nanotechnology and that there is no specific initiative dealing with nanotechnology appli- cations in food. It will become an important issue in the near future, however, since Chile exports more foods than most other Latin American countries. Yada replied that the situation in Canada is similar to that of the United States, with regulatory authorities still struggling with the is- sue. Many questions are being debated: Are we going to regulate the technology? Are we going to regulate the products? What guidelines will we use? Will we use the precautionary principle? Will we use substantial equivalencies? Yada noted that he had recently visited Ottawa, where he consulted with Canadian food inspection agency regulators who were “really probing” to identify the issues needing attention. Finally, Porter asked the other panelists if they knew of any other government that has moved ahead with respect to regulation of food nanotechnology. Halloran commented that the European Union (EU) had requested information on sunscreens with nanomaterials, which Halloran interpreted as an encouraging sign. More specifically, the EU requested that manufacturers provide safety data within a year (of the request). Wolf Maier of the EU commented that the UK Parliament was consider- ing a motion to regulate all foods that contain particles derived from nanotechnology as normal foods, which would mean that they are subject to pre-market authorization. While the issue is not yet decided, the ques- tioner remarked that pre-market authorization seems to be the direction headed. Tarantino offered a final remark: The EU food safety authority had issued a call for data and information to aid in its review process and also was receiving expert advice from the World Health Organization (WHO) and Food and Agriculture Organization (FAO). So agencies worldwide are gathering information in an effort to decide how best to proceed. Importing Food Products That Contain Nanomaterials Doyle noted that the first four speakers of the day were from outside of the United States and that obviously there is a lot of international ac- 

EDUCATING AND INFORMING CONSUMERS 117 tivity in the area of food nanotechnology. He asked, how will the United States address the import of nanotechnology-derived foods? Degnan re- sponded by stating that FDA’s authority over imports is its broadest au- thority and that the agency can detain a product based simply on the ap- pearance of a violation. It is a very tough standard—appearing to be a violation is very different than having been proven to be a violation. But the FDA needs to be prepared, he said, so that regulatory decisions are not being made in an enforcement context. Regulatory decisions need to be made in a deliberate, meaningful, structured way with respect to both statutory standards and available science. Tarantino said that the easy answer is that all imported foods must meet U.S. safety standards, “whatever those are.” The bigger issue is how do you do that? She agreed with Degnan that the FDA needs to be prepared. She said, “I think trying to stay abreast of what actually is hap- pening not only in this country but elsewhere is, right now, the best we can do to … anticipate what we are likely to be seeing.” The workshop was then adjourned.