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Nanotechnology and Its Impact on Consumers

Report to the Consumer Council of Canada

Elizabeth Nielsen Ph.D. EBN Consulting February 26, 2008

Nanotechnology and Its Impact on Consumers February 26, 2008

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Financial support from Industry Canada to conduct the research on which this report is based is gratefully acknowledged. The views expressed in this report are not necessarily those of Industry Canada or of the Government of Canada. . Contact Information: Dr. Elizabeth Nielsen EBN Consulting Box 44, Richmond Ontario, Canada K0A 2Z0 [email protected]

Cover photograph provided by Alex Parlinig of the Woodrow Wilson International Center for Scholars, Project on Nanotechnologies, C2007.


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Contents Acknowledgements 4 Foreword 4 Executive Summary 5 Chapter 1: Introduction 9

1.1. What is Nanotechnology? 9 1.2. Why is it Different? 11 1.3. Definitions 12 1.4. Materials Produced by Nanotechnology 14

Chapter 2 Nanotechnology and Consumer Products 18 2.1. What Consumer Products Contain Nanoscale Materials? 18 2.2. Automotive 21 2.3. Cosmetics and Personal Care Products 22 2.4. Food and Food Packaging 24 2.5. Health and Nano Medical Products 26 2.6. General Consumer Products 29 2.7. Products to Protect the Environment 31 Chapter 3 Do Products of Nanotechnology Pose Any Risks? 34 3.1. What is the Impact on Humans? 35 3.2. What is the Impact on the Environment? 40 3.3. State of Scientific Knowledge on Nanotechnology 42 Chapter 4 Oversight Mechanisms 48 4.1. What are Governments Doing? 50 4.1.1. Regulatory Challenges 50 4.1.2. Nationally 53 4.1.3. Internationally 57 4.1.4. Managing Nanotechnology with Regulations 61 4.2. Standards 62 4.3. Responsible Industry Development 63 4.4. Insurance Industry 65 4.5. Regulatory Concerns of Consumers and Advocacy Groups 65 Chapter 5 Consumers‘ Knowledge and Views on Nanotechnology 68 5.1. Knowledge of Consumers about Nanotechnology 70 5.2. Ethical, Legal and Social Issues 73 5.3. Involvement of Consumers in Decisions 74 Chapter 6 Conclusions and Key Findings 78 Appendix 1 Products Identified in the Nanotechnology Consumer 83 Products Inventory, October 2nd 2007. Appendix 2 Nanomaterials in Consumer Products: 85 Study by European Parliament Appendix 3 Telephone Survey of Consumers 87 Appendix 4 Public Interest Network Survey 95 Appendix 5 Sources of Information 104


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Acknowledgements The author would like to thank the Consumers Council of Canada and Industry Canada‘s Office of Consumer Affairs Contributions Program for Non-profit Consumer and Voluntary Organizations for their support. These organizations made it possible to carry out this study. Also, the input of Dr. Anne Wilcock and the members of the Consumers Council of Canada‘s Steering Committee (Patricia Jensen, Agni Shah, Susan Winter and Durhane Wong-Rieger) is very much appreciated.

Foreword The Consumers Council of Canada investigated the impact of nanotechnology, a rapidly emerging technology, on consumers due to its wide spread use in consumer products and its potential beneficial and adverse impacts on human health, safety and the environment. The purpose of the investigation and this report is to improve the capacity of consumers and consumer organizations to inform and effectively represent consumers in decisions being made by governments, industry and standards organizations. It is intended to provide them with objective background information on nanotechnology. This is in keeping with the mission of the Consumers Council of Canada to provide credible, fact-based representation of the consumer interest to government and business to enhance policy development and programming. In addition, the Council‘s goal is to work collaboratively with consumers, business and government to solve marketplace problems. By providing consumers and consumer representatives with the balanced information they need, it is anticipated that they will be able to work with business and government to ensure that the potential benefits for consumers and society associated with this technology will not be lost while the concerns of consumers are addressed and any potential risks to humans or the environment are managed effectively or eliminated.


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Executive Summary

Nanotechnology, one of the key emerging technologies of this century, has the potential to provide consumers with a number of significant benefits and profoundly affect all aspects of their lives. These include energy efficiency, pollution prevention and clean up, diagnosis and treatment of disease and safe food and water. Nano enhanced products may also play a major role in reducing risks such as injury in car crashes, fire and earthquake damage due to their increased strength, flame resistance and flexibility. While the benefits of these technologies appear almost limitless, they will only be realized if consumers are confident that any potential adverse effects of nanotechnologies are identified, studied and managed. Against this background of rapid development, commercialization and uncertainty, a number of issues have been identified and questions raised that need to be investigated and resolved.

What are its impacts on human health over the short term and long term?

What will be its impact on the environment?

Can any adverse effects be minimized or repaired?

What can be done to manage the technologies while regulatory oversight is being developed?

How will it affect society in Canada and globally?

Will those most in need of the new technology be able to access it? The main challenge facing society is how to realize the societal benefits of nanotechnology while minimizing adverse impacts. This report explains for consumers what nanotechnology is, why the materials produced by the technology are different, what products contain nanomaterials, what is known about the benefits and risks associated with the materials, what gaps exist in the scientific knowledge, what is being done by governments, industry and the standards community to manage the new technology, and the concerns and knowledge of consumers about the new technology. The study is limited to nanotechnology and manmade nanomaterials used in products intended for consumers and the general public. It draws on a wide range of references and sources of information in an attempt to present a balanced overview of nanotechnology and the challenges to be faced by consumers and other interested parties. Key Findings.

1. Properties of Nanomaterials: Nanoscale materials due to their small size, relatively larger surface area and a greater proportion of atoms on the surface can be more chemically reactive and exhibit very different electrical, physical, optical and/or magnetic properties than their larger counterparts. In addition, the nanomaterial may be more toxic and has the potential of dispersing readily through the body or the air, water and soil in the environment.

2. Application in Consumer Products: Nanomaterials are being used or being considered for use to improve a wide variety of consumer products because of their superior and novel properties. Currently, over 585 consumer products utilizing nanomaterials have been identified on the American market and it is estimated that most of these are available to Canadians through retail outlets or


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the internet. The products include improved breast cancer therapies, stain resistant clothes, prolonged shelf life of foods, self- cleaning window glass, transparent sunscreens, scratch resistant car paint, more efficient and smaller electronic devices, and lighter and stronger sports equipment Future applications of nanotechnology could possibly result in computers with increased speed and storage capacity, food packaging that warns of contaminated food, improved drug delivery, energy efficient lighting, water purification devices and matter to rebuild bones and nerves.

3. Impact on Human Health: From the literature reviewed, it appears that any adverse impact on human health will be caused by the tiny scale of these materials, their increased reactivity, and their ability to penetrate the body by various routes and cross cell membranes. Exposure to nanomaterials can vary significantly depending on how the material is incorporated into a product and its behaviour over the lifecycle of the product. It is unlikely that many uses of nanomaterials in products intended for consumers will pose health or safety risks since the nanomaterials are encapsulated in stable matrices and exposure is not anticipated (e.g. sports equipment or computers). Potential risks to human health will primarily be related to products where the nanomaterials exist in a free form and exposure is more likely (E.g. cosmetics, personal care products or cleaning products). It was also shown that the route of exposure can affect any adverse impact on humans. There is considerable uncertainty about the actual

risk posed since limited information is available on the potential toxicity of nanomaterials and the actual exposure over the life cycle of the product.

4. Impact on the Environment: The release of nanomaterials into the environment could occur potentially during manufacture, production of nano-enhanced products, use of the nano-enhanced product, disposal or recycling of the nano-enhanced product, or as a result of direct release to clean-up the environment. There appears to be almost no scientific evidence available to evaluate the potential impact of nanomaterials on the environment or life in the environment. Questions about the behaviour of nanomaterials in air, water and soil, their persistence or accumulation in the environment, the unintentional release of nanomaterials from disposed products or the intentional release for remediation purposes have not been answered.

5. Gaps in Research: The main research emphasis to date has been on the development and commercialization of the technology and not on it affects human health or the environment. A number of significant gaps in key areas have been identified and include:

Lack of definitions and nomenclature/classification systems;

Test procedures and instrumentation to measure, characterize and evaluate nanomaterials;

Identification of the potential impact of nanomaterials on the body at the cellular level, their toxicity and the resulting risks to human health;

Knowledge about the effect of nanomaterials on all types of biological species in the environment, how they are transported through the environment, and their potential persistence and accumulation in the environment; and


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A determination of whether or not existing risk assessment tools are appropriate for nanomaterials.

6. Regulation and Oversight: Regulatory and oversight policies and practices in

Canada are very much in their early stages. Regulators are facing many challenges that make it difficult to draft appropriate regulations – lack of scientific data, definitions, test procedures and instrumentation to identify and assess the materials, the number and diversity of products being developed, and the difficulty in keeping up with the rapid development of products. Currently, most Canadian regulation is carried out using existing regulations that were not designed for products of nanotechnology. The development of nanomaterials and nano-enhanced products is expected to impact on a wide range of regulations relating to the safety of products, environmental protection and worker safety. Concerns have been raised about the adequacy of existing regulations where the regulatory frameworks do not :

Require pre-market evaluation or safety testing (e.g., cosmetics, general consumer products) before the product is marketed;

Treat nanomaterials as new substances or classes of materials requiring review and oversight different from the same substance in its larger form;

Follow a lifecycle approach that manages nanomaterials during disposal, destruction or recycling as well as production and use;

Require labelling of products containing nanomaterials; and

Require third party certification or proof of safety of product. Industry has developed or is in the process of developing a number of codes of practices to ensure the responsible development of nanotechnology. Although Canadian consumers do not think that government exercises adequate regulatory oversight over nanotechnology, they do not trust industry to regulate itself and believe that regulatory oversight is critical to managing the technology. The confidence of consumers in this new technology will in the end very much depend on the effectiveness of governments in providing oversight.

7. Social and Ethical Issues: As nanotechnology develops, significant social and ethical concerns are emerging. Concerns have arisen about who will control the development of the technology and who will benefit from it, how it will affect an individual‘s privacy, and how it will be used to enhance human capabilities. These concerns are very similar to those raised about other new technologies and need to be taken seriously and investigated if the technology is to receive wide acceptance by consumers in the long term.

8. Knowledge of Consumers: The knowledge of consumers about nanotechnology is very low in Canada as it is around the world. The surveys of the Canadian public and consumer representatives commissioned as part of this study found a lack of awareness among 70% of those surveyed. Despite the lack of information received and their knowledge of the technology, the majority of Canadians are optimistic about it and 58% of them have no concerns. To maintain this positive attitude much will depend on the information they receive in the future about the associated risks and benefits and their experience with nano-enhanced products. This suggests that a concerted effort needs to be made by


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the federal and provincial governments to inform and to engage consumers on the subject. Also, since most Canadians reported that they obtain information about nanotechnology from the media, the attitude of Canadians will also depend on the direction that the media takes in presenting the technology. Efforts to work with and provide balanced information to the media will be crucial in ensuring that the information received by consumers is accurate and balanced.

In a survey of Canadian consumers conducted for this study, it was found that consumers were not aware of the nano-enabled consumer products on the market. When told about them, they indicated that the greatest benefits would come from the use of nanomaterials to improve medical devices, drugs, energy efficiency and general consumer products. The greatest risks would occur in products that were ingested such as food and drugs or applied to the skin.

9. Involvement of the Public: The involvement of Canadian consumers in the issue of nanotechnology is very limited, if not nonexistent. A wide range of novel processes that have been used in Europe and the United States to inform and involve consumers. Such processes may also be suitable for use with Canadian consumers.

10. Consumer Attitudes and Identified Needs: From the studies and initiatives that have been carried out it would appear that Canadians and citizens in many countries have a common set of attitudes about the technology and opinions about what is needed. These include:

The need for greater transparency and disclosure about which products contain nanomaterials and how industry is using and plans to use the technology;

Limited trust in government or industry to manage any potential risks associated with nanotechnologies and the materials produced;

The need for pre-market testing to ensure that the nanomaterials do not pose a risk to human health or the environment;

A requirement for third party testing by an independent certifying agency to verify the safety of the products;

The need for research to be carried out to determine the longer term risks and impacts on human health and the environment;

Greater engagement of the public in shaping how the technology is developed, managed and regulated;

Public wariness of potentially negative, unintended and long-term consequences of new technologies; and

Less support for the use of nanomaterials in high exposure applications such as cosmetics and food or in nanosensors that could affect their privacy.

As consumers become more aware of the nano enhanced products being sold, it is expected that they will demand that government identify, consider and weigh any associated risks and benefits in some meaningful way before the products are marketed. Taking advantage of technological progress and preventing adverse side effects requires careful consideration and guidance to ensure the technology is developed in ways that benefit society and the environment.


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Chapter 1: Introduction

Claims are being made that nanotechnology could clean up the environment, destroy cancer cells, produce clean energy, enable a digital camera to work in the dark, make the food supply safe and produce clothes that do not stain or wrinkle. Nanotechnology also could be the new asbestos. These are all phrases and claims that appear in the media and scientific literature. What exactly are consumers to make of this contradictory list of benefits and warnings? What are the specific concerns that should occupy consumers interested in this issue? The purpose of this study is to provide consumers and consumer organizations with the critical information that they need about nanotechnology and its application so that they can effectively represent the interests of consumers in the decisions being made by governments, standard developers and industry. The findings will also inform government, standards bodies and industry decision makers about consumer concerns and the importance of involving and engaging consumers in this issue. The study is limited to nanotechnologies and their application in products intended to be used by consumers and the general public.

1.1. What is nanotechnology?

Nanotechnology is perceived to be one of the key emerging technologies of this century that has the potential to profoundly affect virtually every sphere of Canadian life.1 It could fundamentally restructure every conceivable technological discipline - medicine, defence, energy production, environmental management, transportation, communication, computation, and education.2,3 Like the steam engine and the industrial revolution of the late 19th century, nanotechnology has the potential of revolutionizing manufacturing and consumption by creating materials, devices and systems with new and unusual properties. Other foundation technologies, such as the internet, the internal combustion engine, or electricity have had impacts on society that were broad and often unanticipated4. Clearly, the implications for industry and societies that do not adapt are significant and could result in obsolescence for certain industrial sectors, widening the gap between the rich and the poor and a shift in the global balance of energy and global power. The possibility of working at the nanoscale was first envisioned by the Nobel Laureate Richard Feynman in 19595 when he presented the idea that the ability to manipulate atoms and molecules would result in new avenues of technology. At the time, he did not have the tools or equipment available to make his theory a reality. It was not until 20

1 Bergeron S and E Archambault, Report prepared for Environment Canada, Canadian

Stewardship Practices for Environmental Nanotechnology, March 2005, www.science-metrix.com/eng/reports_2005_t.htm 2 Rejeski David, Testimony to United States House of Representatives Committee on Science‟s

Hearing on: “Environmental and Safety Impacts of Nanotechnology: What Research is Needed?”, November 2005. 3 CMP Científica, Nanotechnology the tiny revolution, November 2001,

www.infoedge.com/samples/CM-0001free.pdf 4 Born P. et al, The potential risks of nanomaterials: a review carried out for ECETOC, Particle

and Fibre Toxicology, 2006, 3:11, www.particleandfibretoxicology.com/content/3/1/11 5 Feynman Richard, There is Plenty of Room at the Bottom, Presentation at the Annual Meeting

of the American Physical Society, California Institute of Technology, December 1959.

http://www.science-metrix.com/eng/reports_2005_t.htm


http://www.infoedge.com/samples/CM-0001free.pdf

http://www.particleandfibretoxicology.com/content/3/1/11


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years later with advancements in scientific equipment such as improved electron microscopes that manipulation of matter at the nano scale was actually able to take place. Even today, the instruments available are at an early stage of development. As a result, the ability of scientists to overcome certain roadblocks such as learning what is happening as a nanomaterial forms or the extent to which humans are exposed is limited. Scientists have suggested that they need better tools to see things at a nanoscale, to characterize the properties of the materials, to put atoms where they want them to go and to assess human exposure and the toxicity of nanomaterials6. Currently, over 585 consumer products7 utilizing nanomaterials are being marketed in the United States and it is estimated that over 80% of these are also sold in Canada8. The products include among others improved therapy for breast cancer, clothes that repel stains, self- cleaning window glass, transparent sunscreens, car paints that resist scratching and tennis rackets that are lighter and stronger. Future applications of nanotechnology could possibly result in computers with increased speed and storage capacity, food packaging that kills micro-organisms, more improved cancer therapies, energy efficient lighting, water purification devices and matter to rebuild bones and nerves9. While the benefits appear almost limitless, they will only be realized if the public is confident that any potential adverse effects of nanotechnology are identified, studied and managed. Against this background of rapid development and commercialization, several scientists10, 11,12 government agencies13,14 and nongovernmental organizations (NGOs)15, 16, 17 have expressed concerns regarding the lack of knowledge about the potential risks to human health, the environment, the structure of society and the impact

6 Schmidt Karen, Visions for the Future of Nanotechnology, PEN 6, March 2007,

www.nanotechproject.org 7 Woodrow Wilson International Center for Scholars, A Nanotechnology Consumer Product

Inventory, www.nanotechproject.org/consumerproducts 8 Senik D.R. & Associates Inc., A Study for Industry Canada, Analysis of Databases on Nano

Products Entering Canada from the United States, March 2007. 9 The Royal Society and Royal Academy of Engineering, Nanoscience and nanotechnologies:

opportunities and uncertainties, July 2004. www.nanotec.org.uk/final/Report.htm 10

Rejeski David, Testimony to United States House of Representatives Committee on Science Hearing on: “Environmental and Safety Impacts of Nanotechnology: What Research is Needed?”, November 2005. 11

Warheit David B. Human Health Impacts of Nanomaterials, Conference on Nanotechnology and the Environment, August 16, 2004. 12

The Royal Society and Royal Academy of Engineering, Nanoscience and nanotechnologies: opportunities and uncertainties, July 2004, www.nanotec.org.uk/final/Report.htm 13

European Commission, Scientific Committee on Consumer Products, Preliminary Opinion on Safety of Nanomaterials in Cosmetic Products, June 19, 2007 http://ec.europa.eu/health/ph_risk/committees/04_sccp/sccp_cons_04_en.htm 14

Environmental Protection Agency Nanotechnology Workgroup, Nanotechnology White Paper, Washington, DC, February 2007, www.epa.gov/ncer/nano/publications/whitepaper12022005.pdf 15

ETC Group, Tiny Primer on Nano-scale Technologies and the Little Bang Theory, June 2005, www.etcgroup.org 16

Cairns Carolyn, Consumers Union, Food and Drug Administration, Nanotechnology Task Force, Pubic Meeting on Nanotechnology Material in FDA Regulated Products, October 10, 2006, pp 62-69, www.fda.gov/nanotechnology/agenda1010.html 17

Balbus John, Environmental Defense, Food and Drug Administration, Nanotechnology Task Force, Pubic Meeting on Nanotechnology Material in FDA Regulated Products, October 10, 2006, Pp 50 – 56, www.fda.gov/nanotechnology/agenda1010.html

http://www.nanotechproject.org/

http://www.nanotechproject.org/consumerproducts

http://www.nanotec.org.uk/final/Report.htm


http://ec.europa.eu/health/ph_risk/committees/04_sccp/sccp_cons_04_en.htm

http://www.epa.gov/ncer/nano/publications/whitepaper12022005.pdf

http://www.etcgroup.org/

http://www.fda.gov/nanotechnology/agenda1010.html



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on the developing world. They also questioned the adequacy of current oversight mechanisms such as regulatory frameworks and policies to deal with these new materials.18,19 ,20 As consumers become more aware of the nano enhanced products being sold, it is expected that they will demand that government identify, consider and weigh any associated risks and benefits in some meaningful way before the products are marketed.21 Taking advantage of technological progress and preventing adverse side effects requires careful consideration and guidance to ensure the technology is developed in ways that benefit society and the environment.

1.2. Why is it Different? When the dimensions of a substance become very small, the substance can behave very differently than its larger counterpart. It not only can be more chemically reactive and display different electrical, optical and mechanical properties22,23 but it also can move more easily through the body, air and water. Sometimes materials that are inert on a macro scale become reactive at the nano-level or exhibit different properties. For example, nanoscale zinc oxide can absorb and remove arsenic from water even though bulk-scale zinc oxide cannot absorb arsenic.24

Researchers attribute the unique properties of nanoscale materials to two main factors.25,26 First, the nanomaterials have a relatively greater surface area than the same material in its larger form. The result is proportionately more atoms on the surface of the material. The greater number of atoms on the surface means that the material can interact readily with other materials and can have a greater catalytic efficiency necessary to the development of fuel cells and batteries.27,28 In other words, the smaller the matter the more reactive it can be. This leads to implications both in terms of benefits but also in terms of harmful consequences if the nanomaterials enter the body or the

18

Macoubrie Jane, Informed Public Opinions and Trust in Government, Woodrow Wilson International Centre for Scholars, 2005. http://www.nanotechproject.org/8/who-do-you-trust-public-attitudes-towards-nanotechnology-government-and-industry 19

Davies Clarence J., Managing the Effects of Nanotechnology, Woodrow Wilson International Center for Scholars, Project on Emerging Nanotechnologies, 2005 20

Holtz Susan, Canadian Institute for Environmental Law and Policy, Discussion Paper on a Policy Framework for Nanotechnology, March 2007, www.cielap.org 21

Macoubrie Jane, Informed Public Opinions and Trust in Government, Woodrow Wilson International Centre for Scholars, 2005. http://www.nanotechproject.org/8/who-do-you-trust-public-attitudes-towards-nanotechnology-government-and-industry 22

Environmental Protection Agency Nanotechnology Workgroup, Nanotechnology White Paper , Washington, DC, February 2007, www.epa.gov/ncer/nano/publications/whitepaper12022005.pdfwww.epa.gov/ncer/nano/publications/whitepaper12022005.pdf 23

Swiss Re. Nanotechnology. Small matter, many unknowns, 2005, Zurich 24

NanotechWeb, Nanoparticles Clean Up Arsenic, May 25, 2004, http://www.nanotechweb.org/articles/news/3/5/15/1. 25

Swiss Re, Nanotechnology. Small matter, many unknowns, 2005. Zurich. 26


Gleiche Michael et al, Nanoforum Report, Nanotechnology in Consumer Products, October 2006, www.nanoforum.org 28

Born Paul et al, The potential risks of nanomaterials: a review carried out for ECETOC, Particle and Fibre Toxicology, 2006, 3:11, www.particleandfibretoxicology.com/content/3/1/11

http://www.nanotechproject.org/8/who-do-you-trust-public-attitudes-towards-nanotechnology-government-and-industry


http://www.cielap.org/





http://www.nanotechweb.org/articles/news/3/5/15/1


http://www.nanoforum.org/



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Nanoparticles, nanotubes, fullerenes, etc

Coatings, fabrics, optical components, orthopaedic materials, etc

Cars, clothing, cosmetics, pharmaceuticals, food, food containers, appliances, bedding, etc.

environment.29 Second, any nanomaterials smaller than 50 nm no longer behave according to the classical laws of physics but are subject to quantum physics. Nanomaterials, as a result, can have optical, magnetic or electrical properties that are different from the same substance on a larger scale. The change in size related properties may not occur until a critical size is reached. For example, reducing the size of a material to 75 nm may not have any effect on its properties but moving to 20 nm might. The consequence is that the 75 nm nanomaterial can be treated in the same way as its larger counterpart while the 20 nm nanomaterial will need further evaluation to understand its properties. In addition to effect of size, consideration is now being given to the effect of shape on the properties of the material.30

1.3. Definitions

There are many different definitions of nanotechnology and there is not one that everyone agrees upon. The term nanotechnology can also be misleading since it refers not to one technology but many diverse technologies that bring together chemistry, physics, biology and engineering used to improve a wide range of consumer and industrial products. The reality is that there is no nanotechnology market instead it is a chain from the production of the nanomaterial, to its incorporation into an interim product than to the finished product as illustrated in Figure 1 below. Figure 1; Chain in the production of a nano-enabled consumer product.31

This emerging technology involves the study and manipulation of matter on a scale from 1 to 100 nanometers (1 meter = 1 billion nanometers) which can only be seen or worked on using special microscopes and equipment. For consumers, the size can pose a challenge since it is difficult to imagine anything that small. To put the size into perspective, a hair is 80,000 nanometers in diameter while a sheet of regular paper is 100,000 nanometers thick.

29

European Commission's Scientific Committee on Emerging and Newly Identified Health Risks, The appropriateness of existing methodologies to assess the potential risks associated with engineered and adventitious products of nanotechnologies, 10 March 2006, http://ec.europa.eu/health/ph_risk/documents/synth_report.pdf 30

Oberdorster G et al, Principles for characterizing the potential human health effects from exposure to nanomaterials: elements of a screening strategy, Particle & Fibre Toxicology, 2005, Vol 2, 8. www.particleandfibretoxicology.com/content/2/1/8 31

Holman Michael Holman, Senior Analyst Lux Research, Nanotechnology‟s Impact on Consumer Products, Presented at EU,, October 25, 2007, www.luxresearchinc.com

Nanoscale structures in unprocessed form

Intermediate products with nanoscale features

Finished products incorporating nanotechnology

http://ec.europa.eu/health/ph_risk/documents/synth_report.pdf


http://www.luxresearchinc.com/


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Even though, nanotechnologies can be very different, they all have certain characteristics in common as described in this definition of nanotechnology used by the US Environmental Protection Agency (EPA).

― Nanotechnology is research and technology at the atomic, molecular or macromolecular levels using a length of scale approximately 1 to 100 nanometers, in any direction; the creation and use of structures, devices and systems that have novel properties and functions because of their small size; and the ability to control and manipulate matter on an atomic scale.‖32

Although the literature indicates that there is no consensus on the international definition of nanotechnology, the basic concepts of size in the range of 1 to 100 nanometers in one direction and the creation of materials with unique properties are also found in definitions developed by the United Kingdom‘s (UK) Royal Society and the Royal Academy of Engineering33, the United States‘ (US) National Nanotechnology Initiative (NNI)34, the Organization of Economic Development (OECD)35 and the definitions being drafted by the International Standards Organization (ISO) and the International Electro technical Commission (IEC). ISO and IEC have taken on the task of developing internationally accepted terminology for nanotechnologies. The purpose of developing such an international standard is to eliminate the confusing set of definitions that are being developed by various organizations36. The development of internationally accepted definitions is crucial to industry, government and consumers so that everyone can understand what is being talked about whether drafting commercial contracts, developing government regulations or making purchasing decisions. Definitions for various terms and products related to nanotechnology have been generated but are not consistent. Generally, the following definitions have been used.37

Nanoscale: having one or more dimensions in the size range of 1 - 100 nanometres. Nanoscience: the study of phenomena and manipulation of materials at atomic, molecular, and macromolecular scales where properties differ significantly from those at a larger scale. Nanomaterial: material with one, two or three dimensions in the range 1-100 nm, which could exhibit novel characteristics compared to the same material without nanoscale features.

32

Environmental Protection Agency Nanotechnology Workgroup, Nanotechnology White Paper, Washington, DC, February 2007, www.epa.gov/ncer/nano/publications/whitepaper12022005.pdf 33


National Nanotechnology Initiative, What is Nanotechnology, http://nano.gov/html/facts/whatIsNano.html 35

OECD and Allianz, Editor: Dr. Christoph Lauterwasser Allianz Center for Technology, Small size matters: Opportunities and risks of Nanotechnologies Report in co-operation with the OECD International Futures Programme 36

Willis Clive, Nanotechnology: The Terminology Challenge, ISO Focus, April 2007, Vol. 4, No. 4, pp 26-28. 37

The Royal Society and Royal Academy of Engineering, Nanoscience and nanotechnologies: opportunities and uncertainties, July 2004, www.nanotec.org.uk/final/Report.htm



http://nano.gov/html/facts/whatIsNano.html



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1.4. Materials Produced by Nanotechnology Materials on the nanoscale are not new but have existed around us for hundreds if not thousands of years. They exist in the smoke from forest fires, salt crystals in ocean air, car exhaust fumes, and ceramics. Moreover, humans have benefited from the properties of nanomaterials for centuries. For example, gold and silver on a nanoscale have been used as coloured pigments for stained glass and ceramics since the 10th century.38.

Materials on a nanoscale can be made from nearly any substance and their properties are not only dependent on their chemistry but also their size and structure.39 Manufactured nanoscale materials are typically not products in their own right, but generally serve as raw materials, ingredients or additives in other products such as cosmetics, textile finishes, drugs, foods or sports equipment. The most common of these are manufactured or engineered from silver, carbon-based materials, silicon, silicate, titanium and various metals or metal oxides.40,41 Experts also feel that it is important to differentiate between ―free nanomaterials‖ that can enter and move about the human body or disperse through the environment and ―fixed nanomaterials‖ that are embedded in a matrix and cannot move. This differentiation becomes extremely important when assessing exposure to nanomaterials.42 There are a number of different types of nano scale materials produced through nanotechnology including.43

Nanoparticle: material with all three dimensions in the range of 1-100 nm. Quantum dots are semiconducting crystalline nanoparticles.

Nanocomposite: composite in which at least one of the phases has one dimension on the nanoscale.

Nanoplate: material with one dimension at in the range of 1-100 nm and the other two dimensions can be extended to make a thin film or surface coating.

Nanorod: material with two dimensions in the range of 1-100 nm and extended in the third dimension. Examples include nanotubes which are hollow nanorods, nanowires which are conducting nanorods and nanofibres which are flexible nanorods.

Major categories of nanoscale materials are described below.

38

Wellcome Trust, Big Picture on Nanoscience, Big picture, Issue 2, June 2005. 39

Maynard Andrew, Nanotechnology: The Next Big Thing, or Much Ado about Nothing? Ann. Occup. Hyg., Oct. 14, 2006, pp 1-12. 40

OECD and Allianz, Editor: Dr. Christoph Lauterwasser Allianz Center for Technology, Small size matters: Opportunities and risks of Nanotechnologies, Report in co-operation with the OECD International Futures Programme 41

Powell Maria C and Marty S. Kanarek, Nanomaterial Health Effects - Part 1: Background and Current Knowledge, Wisconsin Medical Journal, 2006, Vol. 105(2). 42

European Commission, Nanotechnologies: A Preliminary Risk Analysis on the Basis of a Workshop Organized in Brussels on 1-2 March 2004 by the Health and Consumer Protection Directorate General of the European Commission, 2004. http://europa.eu.int/comm/health/ph_risk/events_risk_en.htm. 43


http://europa.eu.int/comm/health/ph_risk/events_risk_en.htm



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a) Carbon-based Materials: These are materials primarily composed of carbon in the form of hollow spheres, ellipsoids, or rods. Spherical and ellipsoidal carbon nanoscale materials are commonly referred to as fullerenes, while cylindrical rods are called nanotubes. Fullerenes are composed of carbon atoms (28 to 100) arranged in a spherical shape similar in appearance to a soccer ball44. For this reason, they are often referred to as buckyballs after the geodesic domes designed by Buckminister Fuller. 45 The sphere is hollow and can be single walled or multi-walled displaying many unique properties. Physically, they are very strong and can withstand extreme pressures and then bounce back to their original shape when the pressure is released. When added to polymer matrices, they can impart their strength and low density to the material. Fullerenes also have the potential of acting as a catalyst to enhance a reaction without being consumed themselves and, as a result, they are being investigated for use in batteries and fuel cells. Moreover, their unusual electrical properties are being considered for use in a

Figure 2: Fullerene46 Figure 3: Nanotubes number of electronics related areas. These rigid hollow spheres can be filled by substances and it is thought that they could be effective in delivering drugs. In the area of cosmetics, they are being used to mop up free radicals which can damage tissue and to deliver substances to moisturize the skin.47

Carbon nanotubes are one atom thick sheets wrapped into tubes about 1 nm in diameter and several microns long, and they often pack tightly together to form rods or ropes of microscopic sizes. Basically, they are a form of carbon atoms aligned either in a single sheet then wrapped into a tube or multi-walled where there are cylinders within cylinders. They can be extended to various lengths in one direction. According to many

44

www.nanoword.com 45


http://en.Wikipedia.org/wiki/fullerene 47

Holister Paul, Cristina Roman Vas, Tim Harper, Fullerenes, Cientifica Technology White Papers nr.7, Oct. 2003.

http://www.nanoword.com/


http://en.wikipedia.org/wiki/fullerene


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experts48, single walled carbon nanotubes are the best known of the new nanoscale materials and the most important material in nanotechnology today. To ensure that the nanotubes connect to a polymer matrix, chemical groups can be added to the surface to establish strong bonds that are stable.

The unique atomic configuration of carbon nanotubes leads to a material with exceptionally high strength, light weight, and excellent electrical and thermal conductivity49. For example, it has been claimed that nanotube based material will be 50-100 times stronger than steel with one-sixth its weight. The unique electrical, mechanical and thermal properties that carbon nanotubes possess have many potential applications in the electronics, sports equipment, and aerospace industries.50,51 The hollow nature of nanotubes also allows them to act as pipes for transporting and moulding atoms and molecules. Since the manufacturing process normally involves the presence of metals, carbon nanotubes often contain metal content that depends on how they were synthesized and purified. Carbon nanotubes can be difficult to make uniformly in large quantities.

b) Metal-based materials: Nanogold, nanosilver and nanoscale metal oxides, such as titanium dioxide make up these types of nanoscale materials. Unique properties result due mainly to the increased surface area to volume. For example, titanium dioxide and zinc oxide become transparent at the nanoscale. Yet, they still remain capable of absorbing and reflecting UV light which makes them very desirable in sunscreens. Silicon dioxide (glass) nanoparticles can be used to reduce the scratch sensitivity of surfaces such as finishes on cars and nanosilver is being used extensively as an anti-microbial agent.52 Metals or metal oxides can be made into spheres or rods for fullerene or nanorod type structures to produce lubricants, catalysts and energy storage. Titanium dioxide nanotubes, for example, are being considered for such purposes.53 Conductive metal nanowires based on copper or cobalt are being considered for nano electric devices. c) Nanoscale Polymers: Dendrimers consist of nanosized polymers built from branched atomic units. On the surface of a dendrimer are many chain ends, as illustrated in Figure 41, which can be designed to perform certain chemical functions. Their reactivity makes makes them useful as catalysts and, because they can be produced in three-dimensional configurations with interior cavities into which other molecules could be placed, they may be useful for drug delivery. It has also been suggested that dendrimers could assist with environmental clean-up since they can trap and therefore filter metal ions out of water metal ions.54

48

Maynard Andrew, Nanotechnology: The Next Big Thing, or Much Ado about Nothing? Ann. Occup. Hyg., Oct. 14, 2006, pp 1-12. 49


Ichimura S, Carbon nanotubes and fullerenes in nanotechnologies: Applications and standardization, ISO Focus, April 2007, Vol. 4, No. 4, pp 11-13 51

Nanoforum Report, Michael Gleiche, Holger Hoffschulz, Steve Lenhert, Nanotechnology in Consumer Products, October 2006, 52

Nanoforum Report, Michael Gleiche, Holger Hoffschulz, Steve Lenhert, Nanotechnology in Consumer Products, October 2006, 53 The Royal Society and Royal Academy of Engineering, Nanoscience and nanotechnologies: opportunities and uncertainties, July 2004, www.nanotec.org.uk/final/Report.htm 54

The Royal Society and Royal Academy of Engineering, Nanoscience and nanotechnologies:




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Fibres at the nanoscale can be made from a variety of polymers through an electro-spinning process. They are being incorporated into textile yarns to provide wrinkle and stain resistance properties. Other types of nanoscale polymers are being used in textile finishes as well to provide similar properties. It is anticipated that in the future nanoscale polymers will be used as scaffolds to repair tissue or to control the release of drugs55.

d) Nanocomposites: These are materials created by combining nanomaterials into a matrix. In general, the nanosubstance is dispersed into the matrix during processing. After adding nanomaterials to the matrix, the nanocomposite that results may exhibit very different properties. For example, nanosized clays are being added to products ranging from auto parts to packaging materials, to enhance mechanical, thermal, barrier, and flame-retardant properties. Nano carbon tubes are added into the matrix of hockey sticks and tennis rackets to increase their strength while reducing their weight.

e) Nanocrystals: A nanocrystal is a crystalline material with the three dimensions measured in nanometers. As the size of a crystalline solid decreases, the interface within the material changes affecting its strength, and thermal, mechanical and electrical properties. For example, nanocrystalline nickel is as strong as hardened steel.56 Nanocrystals made with zeolite are used as a filter to turn crude oil onto diesel fuel, a method cheaper than the conventional way. A layer of nanocrystals is used in a new type of solar panel named SolarPly made by Nanosolar. It is cheaper than other solar panels, more flexible, and claims 12% efficiency. (Conventionally inexpensive organic solar panels convert 9% of the sun's energy into electricity.). (Source: National Geographic June 2006)

f) Nanolayers: A nanolayer which has one dimension less than 100 nm and is stretched into a thin layer or film can be used as a semiconductor to reduce screen thickness and electricity consumption for use in LCD screens. g) Quantum Dots: A quantum dot is a closely packed semiconductor crystal comprised of hundreds or thousands of atoms, and whose size is on the order of a few nanometers to a few hundred nanometers. Changing the size of quantum dots changes their optical properties.

opportunities and uncertainties, July 2004, www.nanotec.org.uk/final/Report.htm 55

Canadian Nanobusiness Alliance, Neil Gordon & Uri Sagman, Nanomedicine Taxonomy Briefing Paper, February 2003, www.nanobusiness.ca/documents.php 56


Figure 4: Dendrimer


http://www.nanobusiness.ca/documents.php



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Chapter 2: Nanotechnology and Consumer Products The improved consumer products and processes that potentially will result from the application of nanotechnologies promise to make major contributions to the quality of life, human health and the environment. It is alleged that they will help resolve urgent issues such as the provision of clean water, efficient energy production, safe and efficient food supply and new ways to monitor and treat disease. There are a number of critical questions to be answered with respect to the use of nanomaterials in consumer products.

Does the consumer really benefit from the inclusion of these materials in the products they buy?

Do the added nanomaterials actually add value to the products? and

Does the use or disposal of the consumer products containing these materials pose a risk to consumers or the environment?

2.1. What Consumer Products Contain Nanoscale Materials? More and more consumer products incorporating nanomaterials and using the term ―nano‖ are being placed on the market. Everything from paints, cosmetics, sporting goods, textiles, construction materials, computer and cell phone components to food additives and children‘s toys are being marketed.57, 58. As can be seen in Figure 559 below, the number of consumer products registered in the Nanotechnology Consumer Products Inventory has more than doubled in just over 18 months.

Figure 5: Number of Consumer Products Registered from March 2006 to Oct. 2007

57

Maynard Andrew, The Nanotechnology Consumer Products Inventory, Woodrow Wilson International Center for Scholars, Project on Emerging Nanotechologies 58

Swiss Re. Nanotechnology. Small matter, many unknowns, 2004. Zurich 59

Source: Nanotechnology Consumer Products Inventory, Woodrow Wilson International Center for Scholars. www.nanotechproject.org/consumerproducts



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There are a number of inventories of nanotechnology consumer products that contain information on products that are available globally and may or may not be available in Canada. For example, the Friends of the Earth in a report published in 2006 identified over 100 cosmetic and personal care products that claim to include nanoscale materials.60 The products identified included toothpaste, skin creams, sunscreens for adults and children, and anti aging creams among others. The Royal Society of the United Kingdom noted61 that the majority of nanotech products were cosmetics. In the inventory of Nanotechnology Consumer Products62, 585 products containing nano-materials were voluntarily listed by manufacturers as of October 17, 2007 and the numbers and types of consumer products in each category are presented in Appendix 1. A random sampling of these products over the internet found that the majority are available to Canadian consumers either in retail outlets or over the internet. The Woodrow Wilson International Center for Scholars also has inventories for medical products and foods. According to a report on nanotechnology in consumer products from Europe63, the products that include the term ―nano‖ on their labels make up only a small number of the consumer products that actually contain nanoscale materials. It has been suggested that some companies aware of the fears caused by Genetically Modified Organisms in food are wary of labelling new products as nanotechnology based. To add to the confusion, a study by the European Parliament found that some products that claim to be ―nano‖ did not actually contain nanoscale materials.64 Since no standards or guidelines for labelling have been developed and since there is no legal obligation to inform consumers, it is difficult to determine the exact number of consumer products containing nano scale matter that are on the market65. Nano-silver is the most common of the nanoscale materials reported in the Nanotechnology Consumer Products Inventory and is used mainly for its anti-microbial properties. Carbon nanoscale material including nanotubes and fullerenes was found to be the second most common material cited followed by silica, zinc, titanium dioxide and gold. 66 The European Parliament in its report on Nanoscale materials in Consumer Products complied a detailed listing from different inventories and reports of nanoscale materials in consumer products. The table that was created as part of the study can be found in Appendix 2. In Table 1, the consumer products based on nanotechnology identified by a number of organizations67,68,69,70 are presented.

60

Friends of the Earth, Nanomaterials, sunscreens and cosmetics: Small Ingredients Big Risks, Report, May 2006, www.foe.org 61


The Nanotechnology Consumer Products Inventory, Woodrow Wilson International Center for Scholars, Project on Emerging Nanotechologies 63


European Parliament's Committee on the Environment, Public Health and Food Safety, Nanomaterials in Consumer Products: Availability on the European market and adequacy of the regulatory framework, RIVM/SIR Advisory report 11014 (IP/A/ENVI/IC/2006-193), April 2007 65

Swiss Re, Nanotechnology. Small matter, many unknowns.2004, Zurich. 66

Nanotechnology Consumer Product Inventory, Project on Emerging Nanotechnologies, Analysis, www.nanotechproject.org/consumerproducts 67

Senik D.R. & Associates Inc, A Study for Industry Canada, Analysis of Databases on Nano Products Entering Canada from the United States, March 2007

http://www.foe.org/




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Table 1: Nanotechnology Based Consumer Products on the Global Market

Automotive

Air and Oil Filters

Waxes, engine oil

Anti-scratch finishes

Car wax

Air purifiers

Catalysts to improve fuel consumption

Tires

Clothing and Textiles

Wrinkle and stain resistant apparel

Anti-bacterial and anti odour clothing

Anti-bacterial fabrics

UV resistant and protective clothing

Flame retardant fabrics

Cosmetics

Skin creams and moisturizers

Skin cleansers

Sunscreens

Lipstick, mascara, make-up foundations

Make up removal

Electronics

Batteries

Displays-electronics

Organic Light Emitting Diodes (OLED) and LEDs

Data memory

Anti-bacterial and anti static coatings on keyboards, mouse, cell phones

DVD coatings

MP3 players

Computer processors and chips

Food and Food Additives

Energy drinks

Nutritional supplements

Food storage containers

Anti-bacterial utensils

Cutting boards

Plastic wrap

Nano-tea, chocolate shakes, canola active oil

Household

Anti-bacterial furniture and mattresses

Anti-bacterial coatings in appliances

Filters

Air purifiers

Self cleaning glass

Anti-bacterial, UV resistant paints

Irons, vacuums

Solar cells

Cleaning products

Disinfectant sprays

Fabric softeners

Personal Care/Health

Hearing aids

Contact Lenses

Body wash

Cellulite treatment

Tooth powder

Shampoos, hair gels

Deodorants

Insect repellents

Anti-bacterial creams

Bandages

Home pregnancy tests

Drug delivery patches

Man-made skin

Sports Equipment

Golf balls and clubs

Tennis rackets and balls

Baseball bats

Hockey sticks

Skis and snowboards

Ski wax

Bicycle parts

Wet suits

Shoe insoles

Anti fogging coatings

Toys and Children’s Goods

Stain resistant plush toys

Anti-bacterial baby pacifiers, mugs and bottles

X-boxes and play stations

Anti-bacterial stuffed toys

68

Nanotechnology Consumer Products Inventory, Woodrow Wilson International Center for Scholars, Project on Emerging Nanotechologies, www.nanotechproject.org/consumerproducts 69

Australian Government, Nanotechnology Australia, Australian Nanotechnology Consumer Products: backing tomorrow's consumer innovations, 2005 70

European Parliament's Committee on the Environment, Public Health and Food Safety, Nanomaterials in Consumer Products: Availability on the European market and adequacy of the regulatory framework, RIVM/SIR Advisory report 11014 (IP/A/ENVI/IC/2006-193), April 2007



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In an effort to identify products based on nanotechnology that appear on the Canadian market, Industry Canada commissioned a study to be carried out to determine which US companies producing nanotechnology products also shipped them to Canada. The study included 132 US companies and the researchers found that 81.9% of the companies shipped their products to Canada71. The companies surveyed produced approximately 709 nanotech products of which 634 were shipped to Canada. It was reported that the largest concentration of products shipped were in the ‗Cosmetics & Personal Products‘ sector followed by ‗Nanoscale materials‘ (e.g. carbon nanotubes, nanofibres, nano-silver) and ‗Biomedical/Life Sciences‘ (e.g. anti-microbials, diagnostic systems, drug delivery). Products in the construction sector did not appear to be shipped to Canada and the authors of the study speculated that this may be due to concerns that these products are not able to withstand the colder climate and heavier snow loads. The consumer products identified as being shipped to Canada are presented in Table 2. Table 2. Consumer Products Shipped to Canada Identified by Industry Canada Survey

Sector Consumer Products Shipped to Canada

Automotive Air and Oil filters, inner tire liners, car air purifiers, anti scratch finishes

Clothing and textiles Fibres and fabrics, apparel, home furnishings,

Cosmetics Anti aging cream, hair treatments, skin creams, anti-oxidant moisturizer, face make-up

Electronics Batteries, coated CDs and DVDs, mini fuel cells, lithium ion batteries,

Food and Food Additives Energy drink, anti-oxidant, nutritional supplements, Ca & Mg supplement, B-12 Supplement, frying oil refiner, polypropylene food storage containers

Personal Care Contact lenses, body wash, pain relief cream, cellulite treatment, skin powder, dermabrasive for exfoliation, tooth powder, immune system agent, insoles,

Sunscreens For adults and children

Sporting Goods Golf balls, baseball bats, golf clubs, nanowax

Specialities Coated glassware,

2.2. Automotive

According to those involved in the automotive industry, the use of nanotechnology focuses on better materials, reduced fuel consumption, improved driving safety and the longevity of the vehicle. Self cleaning car windows, nano lubricants that reduce friction, fuel additives to increase engine efficiency, anti-fog, anti-rain, anti-ice coatings for windshields to improve visibility, operational fuel cells and more efficient batteries are all being used now or are under development. It is claimed that the car of the future will respond intelligently to stimulants from the environment and to driver behavior. Screens and mirrors will adapt to external light conditions, tires will have better traction on

71

Senik D.R. & Associates Inc, A Study for Industry Canada, Analysis of Databases on Nano Products Entering Canada from the United States, March 2007, pp 28-32.


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different road surfaces and numerous sensors will plan ahead to regulate the driving state under changing weather conditions or to prevent crashes.72

Nano scale ceramic particles are currently used in a variety of ways as coatings to improve the scratch resistance of lacquers and automotive paints.73

For example in 2003, engineers at Mercedes-Benz added tiny, microscopic ceramic particles to the paint which when heated in paint shop ovens cross-linked into a dense network that enhances scratch resistance.74 Scratch and abrasive resistant coatings for safety glass, car finishes and flooring have also been developed using antimony-tin oxide, silicon dioxides, aluminum and aluminum oxide nanoparticles. Nanocomposites have been used by GM in the step assists of their vans since 2002 to reinforce components and in bumpers. The nanocomposites are not only stronger and lighter but do not become brittle when exposed to the elements. In the future, it is planned to use these materials in interior parts and trim and eventually in molding the auto body itself to give a lighter cars that use less fuel.

2.3. Cosmetics and Personal Care Products

It is very difficult to estimate the number of cosmetic and personal care products commercially available that incorporate substances produced through nanotechnology. Manufacturers do not always make public information about the ingredients or nanomaterials in their products. In the Nanotechnology Consumer Products Inventory, which

only contains data provided voluntarily by manufacturers, 116 cosmetic and 85 personal care products are listed. The photograph75 above illustrates some of these products. The Friends of the Earth in a recent report identified116 personal care and cosmetic products containing nanomaterials.76 The European Commission‘s Scientific Committee on Consumer Products indicated that nanomaterials are used in almost all

72

German Federal Ministry of Education and Research, Nanotechnology – a Future Technology with Vision: Nanomobile, www.bmbf.de/en/nanotechnologie.php 73

Thomas Treye et al, Research Strategies for Safety Evaluation of Nanomaterials, Part VII: Evaluating Consumer Exposure to Nanoscale Materials, Toxicological Sciences, 91 (1), 2006, pp 15-19 74

Nikkel Cathy, Nanotechnology: The Itty Bitty Auto Revolution, autoMedia.com 75

Courtesy of the Woodrow Wilson International Center for Scholars, Project on Emerging Nanotechnologies, , www.nanotechproject.org 76

Friends of the Earth, Nanomaterials, sunscreens and cosmetics: Small Ingredients Big Risks, Report, May 2006, www.foe.org

http://www.bmbf.de/en/nanotechnologie.php


http://www.foe.org/


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types of cosmetics and personal care products such as anti-aging creams, eye makeup, lipsticks, foundation makeup, nail treatment, and body washes.77 One of the most common uses for nanomaterials is in sunscreens. Titanium dioxide and zinc dioxide are excellent absorbers of ultra-violet (UV) radiation which is the reason that for many years they have been used as sunscreens. Nanoscale titanium dioxide and zinc dioxide are used because these normally white substances become transparent when the materials are nano-sized. This transparency is more acceptable to end users and it is alleged that it could result in greater use of sunscreens. However, most sunscreens containing these materials are not labeled leaving the public to guess.78, 79 Nanoscale systems for localized delivery, controlled release and stabilization of cosmetic ingredients are being developed by a number of companies. A variety of terms are being used to describe them such as liposomes80 nanoemulsions and nanoencapsulations. They act as small containers or capsules able to hold and deliver an aqueous content. Their deliveries may vary from therapeutic drugs to vitamins or

cosmetic materials in body lotions. These nano systems allegedly improve the depth of penetration into the skin of the cosmetic substance and stabilize ingredients that are not stable in air by encapsulating them. It is also possible using this system to release the ingredients over a period of time81. For example, Vitamin A molecules in a polymer ―capsule‖ are being used to introduce the vitamin into the underlying base layers of skin.82 Nanoscale materials can even be found in toothpastes for sensitive teeth. Tooth sensitivity problems normally can occur when the gum recedes. The exposed neck of the tooth can cause an increase in tooth sensitivity. Toothpastes containing nanoscopic crystals of hydroxyl apatite, the main ingredient in natural dentin, act to seal the dentin cells, stopping the pain. The toothpaste induces the formation of a protective layer of tooth like material through the crystallization of calcium phosphate from saliva.83

77

European Commission, Scientific Committee on Consumer Products, Preliminary Opinion on Safety of Nanomaterials in Cosmetic Products, 19 June 2007, http://ec.europa.eu/health/ph_risk/committees/04_sccp/sccp_cons_04_en.htmhttp://ec.europa.eu/health/ph_risk/committees/04_sccp/sccp_cons_04_en.htm 78



Nanoforum Report, Michael Gleiche, Holger Hoffschulz, Steve Lenhert, Nanotechnology in Consumer Products, October 2006. 81


Nanotechnology Consumer Products Inventory, Woodrow Wilson International Center for Scholars, Project on Emerging Nanotechologies, www.nanotechproject.org/consumerproducts 83

http://www.nanit-active.com

Figure 5: Liposome





http://www.nanit-active.com/


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The use of nanomaterials in cosmetics is an application that has caused a great deal of concern in the scientific community for a number of reasons. Unlike drugs and natural health products regulated by Health Canada, cosmetics are not subject to premarket health assessment and Health Canada does not receive safety data on the product before it is marketed. This is the same in other jurisdictions as well. Furthermore, there are no post-market reporting requirements for adverse events associated with cosmetics. Secondly, this is a product where the user is directly exposed to the nano material since it is applied on the skin. The questions that need to be answered are

Can they penetrate the skin in any appreciable way?

If they can, where do they go in the body? and Are there any systemic effects?

84

A non-governmental organization, Friends of the Earth, released a report in May of 2006 characterizing the level of regulation of cosmetics and sun screens as one of the most striking failures since asbestos. This September, the Cosmetic, Toiletry and Fragrance Association, the CTFA, a trade association, released a statement claiming, "The general scientific consensus is that there is no risk to human health". The statements from both these organizations are examples of the selective use of scientific literature and how the stage is being set for ineffective and polarized public debates on the risks and benefits of nanotechnologies.85

2.4. Food and Food Packaging In recent years, nanotechnology has rapidly become a major ingredient and/or component of food and food packaging. The safety of food and its quality promise to improved as a result of the application of nanotechnology now and in the future. The first generation of nano food products are now hitting the market which is alleged to be only the beginning. Food is an area where it is anticipated that nanotech is going to take hold in a big way to create better packaging and safer and healthier foods. Experts estimate that there are over 600 nanofood products being sold worldwide. In 2003, the nanofood market was approximately $2.6 billion dollars; it grew to $5.3 billion in 2005 and is expected to grow to $ 20.4 billion in 201086. The food packaging market is also expected to increase in value from $1.1 billion in 2005 to $3.7 billion in 2010. Helmut Kaiser Consultancy has predicted a change of 40-60% in the food industry by 2015 due to nanotechnology. Food or food related products that are being marketed now and are listed in the Nanotechnology Consumer Products Inventory include antibacterial coatings on kitchenware and baby bottles, anti-microbial nanosilver in food storage containers and

84

Balbus John, Environmental Defense, Presentation at the Food and Drug Administration, Nanotechnology Task Force, Pubic Meeting on Nanotechnology Material in FDA Regulated Products, October 10, 2006, Pp 50 - 56, www.fda.gov/nanotechnology/agenda1010.html 85

Balbus John, Environmental Defense, Presentation at the Food and Drug Administration, Nanotechnology Task Force, Pubic Meeting on Nanotechnology Material in FDA Regulated Products, October 10, 2006, Pp 50 – 56, , www.fda.gov/nanotechnology/agenda1010.html 86

Helmut Kaiser Consultancy, Strong increase in nanofood and molecular food markets in 2007 worldwide, www.hkc22.com/Nanotfoodconference.html.



http://www.hkc22.com/Nanotfoodconference.html


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plastic wrap, cholesterol blocking canola oil, supplements such as colloidal silver, nano calcium and magnesium and slimming chocolate milk shakes.

Applications ranging from smart packaging to foods personalized to meet the needs of individual consumers are being researched for potential development by every major food company. The applications that promise to improve food safety and quality now and in the future87 are listed below.

Nano scale additives to improve the consistency of chocolate or ice cream or to add nutrients such as tuna oil to bread are under development or being used.

Nanosensors embedded in packaging that respond by changing colour to the release of particular chemicals produced when food spoils or to changes in temperature or pH will alert the consumer to the fact the food is no longer safe to eat.

Silver nanomaterials are being added to food packaging, refrigerators and containers to give them anti-bacterial characteristics that increase the shelf life of food products. 88

Nano composites are used in food and beer packaging to increase shelf life by reducing the permeability of plastics to oxygen.89

The creation of nanomaterials to deliver powerful nutrients to human cells where they previously could not reach is underway.

The design of nanomaterials to block certain substances in food, such as harmful cholesterol or food allergens, from reaching certain parts of the body is being commercialized. For example, canola cooking oil uses the technology to reduce the body‘s absorption of cholesterol in the blood by up to 14%.

Interactive foods are being designed to allow the consumer to modify food based on their nutritional needs or tastes.90

Packaging that incorporates nanomaterials can be ―smart,‖ which means that it can respond to environmental conditions or repair itself.

Nanomaterials are being developed that more efficiently and safely administer pesticides, herbicides, and fertilizers by controlling precisely when and where they are released. One such environmentally friendly nano based pesticide under development releases its pest killing properties only when it is inside the targeted insect.

There are also nanomaterials under development that can detect and neutralize animal pathogens in livestock before they reach consumers.91

Nanotechnology has found applications in monitoring and tagging of food items. Radio Frequency Identification (RFID) technology which consists of microprocessors and an antenna that can transmit data to a wireless receiver, can

87

Scott Norman, Nanoscale Science and Engineering for Agriculture and Food Systems, presented at the USDA Planning Workshop, November 18 – 19, 2002 88 Nanoforum Report, Tiju Joseph and Mark Morrison (2006), Nanotechnology in Agriculture and Food, www.nanoforum.org 89


Nanoforum Report, Tiju Joseph and Mark Morrison, Nanotechnology in Agriculture and Food, May 2006. 91

Kuzma Jennifer and Peter Verhage (Sept. 2006), Nanotechnology in Agriculture and Food Production: Anticipated Applications, Woodrow Wilson International Center for Scholars, Project on Emerging Nanotechnologies, www.nanotechproject.org




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be used to monitor an item from the animal or warehouse to the consumer‘s hands. Unlike bar codes, which need to be scanned manually and read individually, RFID tags do not require line-of-sight for reading and it is possible to automatically read hundreds of tags a second.

2.5. Health and Medical Nano Products Nanotechnology is alleged to have the potential of curbing viruses and other infectious diseases, reversing the odds against cancer, repairing wounds, restoring functions to damaged tissue and nerves, replacing tissue and ultimately significantly impacting on the efficiency and accessibility of healthcare92. The possibilities seem to be limitless mainly due to the fact that nanoscale materials are small enough to interact with cells and tissues at the molecular level and have the potential of targeting specific cells.93 Although many of these potential applications may take years before they are available, some of the first generation nano products in the area of medicine are being marketed now. In fact, according to research carried out by Lux Research,94, the pharmaceutical industry sells over $1 billion worth of drugs coated with nanoparticles or encapsulated in nano structures. The US Food and Drug Administration (FDA), in 2005, approved the first drug based on a new nanotechnology delivery system. This involved incorporating the drug Taxol into a protein found in human serum; the result being a drug that appeared to have fewer side effects while being more effective in treating one type of breast cancer95. Other drugs currently on the market are designed to treat ovarian cancer, nausea from chemotherapy, suppress the immune response so transplanted organs are not rejected, lower cholesterol, stimulate appetite, replace hormones after menopause and replace bones.96 Nano-silver is being widely used as an anti-microbial agent in many types of clothing, bedding (particularly for hospitals), paints, cleaning products, food storage containers, creams, bandages, upholstered furniture, mattresses, coatings on baby‘s pacifiers, computer equipment and cell phones, air purifiers and conditioning devices, refrigerators and washing machines.97,98 Silver has been used for the treatment of medical ailments for many years due to its natural antibacterial and antifungal properties. Examples of such products advertised by Canadian retailers are illustrated below.

92

Nanofrontiers Newsletter (1), Horizons of Medicine and Health care, May 2007 93

Silva G.A. Introduction to nanotechnology and its applications to medicine. Surg Neurol 2004; 61:216–20. 94 Michael Holman, Nanomaterial “Forecast: Volumes and “Applications, Presented ―at the ICON Nano-material Environmental ―Health and Safety ―Research Needs ―Assessment, Jan. 9, 2007. Lux Research. 95

Karen Schmidt, Visions for the Future of Nanotechnology, PEN 6, March 2007, www.nanotechproject.org 96

The Nanotechnology and Medicine Inventory, Woodrow Wilson International Center for Scholars, Project on Emerging Nanotechologies. www.nanotechproject.org 97

Consumer Product Inventory, Project on Emerging Nanotechnologies, Analysis, www.nanotechproject.org/consumerproducts 98

Gleiche Michael, Holger Hoffschulz, and Steve Lenhert, Nanotechnology in Consumer Products, Nanoforum Report, October 2006





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Figure 7: Advertisement for anti microbial socks99 and mattress.100

Nano-silver particles typically measure 25 nanometres, which means that a relatively small volume of silver provides an extremely large surface area and increases the contact area between the nanosilver particles and bacteria or fungi. When bacteria and fungi come into contact with the nano-silver, their cellular metabolism and growth is adversely affected reducing infection, odor, itchiness sores and smelly feet.101

The unique optical properties of gold in the size range of less than 50 nm is being used in home pregnancy tests. One such test results in a pink colour when exposed to certain hormones produced by pregnant women. In addition, hearing aids based on nano technology are being sold that collect and transform data into precise electrical signals that are delivered directly to the human nervous system. Some of these new aids are

99

Mark‘s Work Wearhouse Advertisement Supplement in the Ottawa Citizen October 10, 2007. 100

Canadian Tire Advertisement Supplement in the Ottawa Citizen, Dec 1, 2007. 101

http://www.agactive.co.uk/index.cfm/fuseaction/page.display/page_id/24/.htm

http://www.agactive.co.uk/index.cfm/fuseaction/page.display/page_id/24/.htm


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currently being marketed and are listed in the Nanotechnology Consumer Product Inventory.102 In a briefing103 to a workshop on the future of nano-medicine organized by the Canadian Institutes of Health Research, it was reported that considerable research is being carried out on the use of nanotechnology in this sector. Some of the potential beneficial applications identified as being under development are outlined below.

Nanostructures to deliver drugs directly to where they are needed without causing harsh side effects in the patient. It will also be possible to release the drug over a prolonged period of time by encapsulating the drug in a nano scale material that degrades in the body at a predetermined rate.

Nanotechnology has the potential of producing a range of materials with large surface areas that can increase the adhesion, durability and lifespan of implants. The larger surface provides the maximum possible contact area between the implants and the bone surface to improve the potential for in-growth in the host bone. Ceramic materials such as calcium phosphate are being investigated for this purpose.

Nanoscale polymers of polyvinyl alcohol are being investigated as potential scaffolds to assist in tissue regeneration. For example, the possibility of molding the polymer into heart valves and providing a structure for seeding corneal epithelia cells into the cornea are being researched. .

Nanotechnology potentially can offer new implantable and/or wearable sensing technologies that provide continuous and extremely accurate medical information. One such example is a microchip implanted under the skin that can continuously monitor key body functions including pulse, temperature and blood glucose.

Several new technologies are being developed to improve the ability to identify, label and detect unknown target genes. Gold nanoparticle probes are being treated with chemicals that cling to target genetic materials and illuminate when the sample is exposed to light. These types of improvements in imaging technologies could provide higher quality images to identify cancer tumors, for example, that are not possible with current devices.

Nano technologies are being used to develop a new generation of smaller and potentially more powerful devices to restore lost vision and hearing functions. The devices collect and transform data into precise electrical signals that are delivered directly to the human nervous system.

As a number of authors have noted104,105 much of the research into nanomedicine is at an early stage and many of the clinical applications under development that potentially could benefit the public may take years to reach the market if at all.

102

Nanotechnology Consumer Product Inventory, Project on Emerging Nanotechnologies, Analysis, www.nanotechproject.org/consumerproducts 103

Canadian Nanobusiness Alliance, Neil Gordon & Uri Sagman, Nanomedicine Taxonomy Briefing Paper, February 2003, www.nanobusiness.ca/documents.php 104

Canadian Nanobusiness Alliance, Neil Gordon & Uri Sagman, Nanomedicine Taxonomy Briefing Paper, February 2003, www.nanobusiness.ca/documents.phpwww.nanobusiness.ca/documents.php 105

Silva G.A., Introduction to nanotechnology and its applications to medicine. Surg Neurol 2004;61:216–20.






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2.6. General Consumer Products

More and more general consumer products containing nanoscale materials are emerging. In fact, the number of products containing nanomaterials that were self-identified by manufacturers has risen from 212 to 580 in 18 months106. Nanoscale materials are being used in everything from household, garden and sports equipment, to clothing and children‘s products as illustrated in the photo above provided courtesy of the Project on Nanotechnology at the Woodrow Wilson Center for International Scholars. Although the number of consumer products on the market is growing very quickly very few Canadian consumers actually know that the technology is being used in products they purchase.

To improve the strength of sports equipment while reducing its weight, carbon nanotubes have been embedded in various polymers or matrices found in racquets, baseball bats, hockey sticks, skis or snowboards107. The weakest areas in a traditional carbon-fiber bat or a snowboard are the tiny spaces between the fibers that contain only resin. To improve the strength of these areas, carbon nanotubes, which are sixteen times stronger than steel, are dispersed throughout the resin making it tougher and stronger108. Since the nanomaterials are embedded in a stable polymer, it is unlikely that a consumer will be exposed to them during use. Nanomaterials are also being used in other sports products including ski wax to produce hard, fast gliding surfaces or tennis

106

Woodrow Wilson Center for International Scholars, Nanotechnology Consumer Product Inventory, November 19, 200, www.nanotechproject/consumerproducts 107

Woodrow Wilson Center for International Scholars, Nanotechnology Consumer Product Inventory, November 19, 2007, www.nanotechproject/consumerproducts 108

Easton Sports, http://baseball.eastonsports.com/adultbaseball/index.php?PHPSESSID=d938393701ba3515afbdedcf21b850cb

http://www.nanotechproject/consumerproducts

http://www.nanotechproject/consumerproducts

http://baseball.eastonsports.com/adultbaseball/index.php?PHPSESSID=d938393701ba3515afbdedcf21b850cb

http://baseball.eastonsports.com/adultbaseball/index.php?PHPSESSID=d938393701ba3515afbdedcf21b850cb


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balls where nano-silicates are added to the rubber lining of the balls to give a more consistent bounce and longer life span.

As is the case for many health products, nanosilver is being used extensively in consumer products. The anti-microbial properties of this material are being utilized in to coat everything from the interiors of refrigerators, washing machines and vacuum cleaners to door handles, baby pacifiers and baby bottles. Manufacturers have identified plush teddy bears, sheets, socks, slippers, mattresses containing fabrics incorporating nano-silver particles. These ultra-fine silver nanoparticles cannot be seen or felt but they enhance these products by killing or reducing the growth of bacteria and fungi. Currently, there are only a few products of nanotechnology found in hardware or building supply retail outlets. One such product is self-cleaning sheet glass based on a layer of titanium dioxide nanoscale particles. The self-cleaning layer is activated when exposed to ultra-violet light, and results in the breakdown of any organic compounds on the glass. Rain is then needed to wash away the loosely bonded decomposed dirt. The batteries in some cordless power tools109 are using phosphate nanocrystals so that they can be used for longer time periods. Nanoparticles can also be found in paints not only to lend the paint improved adhesion and anti-mildew properties, but also to allow users to forgo the normal two-step priming and coating process. In one brand of paint, ―NanoGuard‖ additives help create a harder, more durable film when the paint dries that is resistant to water, mildew, stains and grease.110 Many more products appear to be under development, including self-healing concrete, materials to block ultraviolet and infrared radiation, smog-eating coatings and light-emitting walls and ceilings. Nanotech is also starting to make the ―smart home‖ a reality. Nanotech-enabled sensors are available today to monitor temperature, humidity, and airborne toxins. Soon it is alleged that inexpensive sensors will be available to monitor vibration, decay and other performance concerns in building components from structural members to appliances.111

Nanoscale additives have been found to work as flame retardants in polymers or to improve the function of existing flame retardants. The nanoparticles influence the formation of a crust that works as a barrier to the gases involved in the combustion process. Both are critical factors for fire extinction. In addition, it inhibits the dripping of burning polymers112. The textile and clothing industry is currently a significant user of nanotechnology. The industry uses the new technology to produce fabrics that are highly resistant to water, stains and wrinkles. One well known disadvantage of textile fabrics is their tendency to soak up liquids and become stained. This property can be overcome by increasing the water repellency of the fabric using fluorinated carbon chains that make the cloth more hydrophobic or water hating. Teflon (polytetrafluorethylen) is a well known hydrophobic material with which most consumers are familiar. This material has been used for many years to produce waterproof clothing such as Gore-Tex, which consists of several

109

Woodrow Wilson Center for International Scholars, Nanotechnology Consumer Product Inventory, DeWalt Cordless Power-tool Set by Black & Decker®. 110

Behr® PREMIUM PLUS® Kitchen & Bath Paint, www.forbes.com/home/investmentnewsletters/2006/01/09/in_jw_0109soapboxslide_8.html 111

Elvin George, Risks in architectural applications of nanotechnology, Nanobuzz.co, November 9, 2006 112

Nanoforum Report, Michael Gleiche, Holger Hoffschulz, Steve Lenhert, Nanotechnology in Consumer Products, October 2006,

http://www.dewalt.com/us/cordless/

http://www.nanotechproject.org/index.php?id=44&action=view&product_id=1024

http://www.forbes.com/home/investmentnewsletters/2006/01/09/in_jw_0109soapboxslide_8.html


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laminated layers surrounding a thin Teflon membrane. More recent approaches are based on the use of nanoparticles and dendrimers that are alleged to enhance water repellency by increasing the fluorine content of the outmost fabric layer. Terms such as ―nanotex‖, ―nano‖ and ―nanotech‖ have been used with various textile articles from sheets to pants. In some cases, the terms refer to finishes on the fabrics which incorporate nanomaterials to provide the properties desired; in other cases nanofibres created through specialized spinning processes are attached to natural fibres such as cotton or to manmade fibres such as polyester. These fibres can be designed to provide the fabrics with different stain, wrinkle resistant, antibacterial, and ultra violet radiation absorbency properties. In addition to nano-silver, titanium and zinc dioxide at a nano scale are being added to textile fibres to provide protection against ultra violet radiation.113,114 In electronic consumer products, the benefit of nanotechnology largely results from being able to make things smaller. There has been a steady improvement of processor speed and memory density through miniaturization of the components. The industry was basically facing a size barrier using the existing technology. The use of nanoscale materials is anticipated to allow the industry to overcome this barrier and manufacture computers with unbelievable levels of power.

2.7. Products to Protect the Environment. This section will describe the materials and products that nanotechnology has the potential to create not only to advance the ability to detect, monitor, and clean-up environmental contaminants, but also to prevent pollution in the first place. One of nanotechnology‘s most immediate and compelling promises from an environmental perspective may be in the area of access to safe drinking water. Waterborne diseases and water-related illnesses have been identified by the World Health Organization as a major health problem which kills more than five million people a year worldwide, 85% being children. Most of the deaths are caused by diarrhea due to fecal contamination of drinking water. Some 1.1 billion people were still using water from ―unimproved‖ sources in 2002115, and 42% of the population of sub-Saharan Africa remained without safe drinking water.116 At a workshop of nanotech scientists117, it was argued that nanotechnology had the potential of revolutionizing clean water technologies through purifying water, preventing water pollution and cleaning up contaminated water. Similar observations were made by the Meridian Institute about water purification systems based on nanotechnology that have been developed and their importance to society particularly in the third world. For

113



World Health Organization, http://www.who.int/water_sanitation_health/dwq/wsh0207/en/index2.html 116

Meridian Institute, Nanotechnology and the Poor: Opportunities and Risks, Closing the gaps within and between Sectors of Society, January 2005, www.nanoandthepoor.org 117

Schmidt Karen, Visions for the Future of Nanotechnology, PEN 6, March 2007, www.nanotechproject

http://www.who.int/water_sanitation_health/dwq/wsh0207/en/index2.html

http://www.nanoandthepoor.org/

http://www.nanotechproject/


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example, one system is alleged to filter out of the water all types of micro-organisms, not by forcing the water through tiny holes in a filter but by using a positive charge to attract the negatively charged viruses and bacteria, measuring 20 to 100 nm. Another development involves a ―nanomesh‖ fabric made of fused carbon nanotubes. The manufacturers claim that it filters out all bacteria, viruses, and other waterborne pathogens to the extent that the water meets US Environmental Protection Agency (EPA) potable water standards. The company also claims that the mesh removes lead, arsenic, and uranium.118 Nanotechnology has the potential of both purifying water and increasing the supply of water by desalination of sea water. 119 It is claimed that products of nanotechnology have the potential to help clean-up the environment due to their enhanced surface area and reactivity, and their ability to segregate containments from the environment or de-segregate them from soil so they can be degraded by other mechanisms. According to the EPA, nanosized cerium oxide has been developed to decrease diesel emissions; iron nanoparticles can remove contaminants from soil and ground water by precipitating them and making them less mobile; and nanosized sensors could improve the detection and tracking of contaminants.120 In these and other ways, nanotechnology presents an opportunity to improve how we measure, monitor, manage, and reduce contaminants in the environment.

Nanotechnology offers the potential to measure exposure more accurately by improving the ability to collect large amounts of data in real time and accessing it remotely. It soon should be possible to develop nanoscale sensor arrays that can identify specific contaminants in the environment. The potential also exists to extend the monitoring systems for use by individuals to detect personal exposures. Some of the developments being researched are sensors to detect biological and chemical contaminants in soil, water and air. Nanoparticles such as titanium dioxide, zinc oxide and metal nanoparticles are being investigated for these purposes. For example, nanoscale zinc oxide appears to be able to not only sense the presence of toxic chemicals but also to destroy them121. One of the most important challenges facing the world today is providing a clean, affordable and sustainable supply of energy in response to growing development around the globe and climate change. Three ways of addressing this problem have been identified including reducing energy consumption, increasing the efficiency of energy production and developing and using environmentally friendly alternate energy sources. Nanotechnologies are expected to improve the production, conversion, storage, distribution and use of energy.122,123 For example, under development are cheap

118


Schmidt Karen, Visions for the Future of Nanotechnology, PEN 6, March 2007 120

Environmental Protection Agency Nanotechnology Workgroup, Nanotechnology White Paper, Washington, DC, February 2007 121

Bergeron S. and E. Archambault, Report for Environment Canada, Canadian Stewardship Practices for Environmental Nanotechnology, March 2005, www.science-metrix.com/eng/reports_2005_t.htm 122

Volker Türk, Claudia Kaiser, Christa Liedtke, Hugh Knowles, Vicky Murray, Stephan Schaller, Holger Wallbaum and Hans Kastenholz, Andreas R. Köhler, Nanologue, Opinions on the Ethical, Legal and Social Aspects of Nanotechnologies- Results from a Consultation with Representatives from Research, Business and Civil Society, Sept 2005. www.Nanologue.net.




http://www.nanologue.net/


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systems to produce electricity from solar power, including films that can be unrolled across roofs or painted on surfaces and high efficiency solar cells. The higher strength and lighter weight of materials for vehicles is expected to result in a reduction in fuel consumption. It is claimed that nano-clusters, nanoporous membranes and nanotubes will improve hydrogen storage, artificial photosynthesis and lead to more efficient batteries and fuel cells. Nanoparticles and nanotubes in batteries and fuel cells are being used to improve the performance of rechargeable batteries so that they recharge 10-100 times faster.

123

Schmidt Karen, Visions for the Future of Nanotechnology, PEN 6, March 2007, , www.nanotechproject



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Chapter 3: Do Products of Nanotechnology Pose Any Risks?

In order to assess a new technology fairly, attention must be paid not only to the benefits of that technology but also to the potential risks to human health or the environment. Many promising benefits of nanotechnology when used in consumer products have been identified and were presented in Chapter 2. The research community and other organizations claim that the technology should lead to a better and healthier life for consumers. Greenpeace, for example, stated that new technologies like nanotechnologies can provide a solution to many environmental problems through the production of more efficient renewable energy and waste treatment systems.124 On the other hand, many scientists125, governments126 and NGOs127 have raised questions about whether nanoscale materials in products can cause adverse health or environmental effects. The short answer is that nobody really knows. Dr. Andrew Maynard an international expert in nanotechnology stated in a recent interview, ―we have to realize that if something is going to behave in unusual ways, there‘s got to be the possibility of unusual risk with it.‖128 The Royal Society expressed the same concern that the properties being exploited by industry such as high surface reactivity and ability to cross cell membranes might also result in more toxic materials.129 Both Health Canada and Environment Canada in their consultation on a regulatory framework for nanomaterials stated that

―The novel properties of nanomaterials, however, may also give rise to new exposures and effects which need to be assessed for their potential impacts on human health and the environment. It is incumbent on Environment Canada and Health Canada to develop a regulatory framework under the Canadian Environmental Protection Act, 1999 which enables the responsible introduction of nanomaterials to

124

Aarnail Alexander Huw, Future Technologies, Today's Choices, Nanotechnology, Artificial Intelligence and Robotics,; A technical, political and institutional map of emerging technologies. A Report for the Greenpeace Environmental Trust, July 2002, www.greenpeace.org.uk 125

Maynard Andrew D, Nanotechnology: A Research Strategy for Addressing Risk, Woodrow Wilson International Centre for Scholars, July 2006, http://www.nanotechproject.org/80/nanotechnology-development-suffers-from-lack-of-risk-research-plan 126


ETC Group, Tiny Primer on Nano-scale Technologies and the Little Bang Theory, June 2005, www.etcgroup.org 128

Maynard Andrew, Nanotech Watcher, Andrew Maynard Assesses its Risks, ISTHMUS The Daily Page, Nathan J. Comp, July 7, 2007 129


―One of the biggest challenges facing firms commercialising nanotechnology innovations today is managing environmental health and safety risks‖ Lux Research

http://www.greenpeace.org.uk/

http://www.nanotechproject.org/80/nanotechnology-development-suffers-from-lack-of-risk-research-plan





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Canada through the scientific assessment and appropriate management of the potential risks.‖130

A number of major reports examining the potential problems and benefits related to nanotechnology concluded that, although there is little scientific evidence of potential harm inherent in nanotechnology, there is reason to believe that in addition to the positive benefits that may result, real, inherent dangers could arise to harm human health and the environment.131, 132 The main concern raised is that the unregulated use of nanoscale materials may result in the same unintended consequences and harm to humans and the environment that were seen in the past, with other new substances – pesticides, flame retardants and asbestos. Such a concern is not necessarily incorrect due to the rapid advancements in products of nanotechnologies which are not matched by research into the possible hazards and risks associated with working, living and disposing of them.133,134 As is often the case, standards and/or regulations to assess and manage risks in new technologies lag years behind their entry into commerce. This can result in long, difficult and sometimes unsuccessful processes to remove them from commerce and the environment at a later date. According to the testimony of the Consumer Union at a FDA public meeting that is exactly what consumers do not want to see happen with engineered nanomaterials.135

3.1. What is the Impact on Humans? When potential risks to the humans are being considered, it must be recognized that risk is assessed by considering three main elements:

the basic hazard that exists such as toxicity, flammability or explosive properties of a material or product;

the probability of exposure of the public to the material during production, use or after release of the material into the environment; and

the consequences of exposure such as whether or not it causes a minor or major acute or chronic health problem.

130 Environment Canada and Health Canada, Proposed Regulatory Framework for Nanomaterials Under the Canadian Environmental Protection Act, 1999, Workshop on a Proposed Regulatory Framework for Nanomaterials under CEPA 1999, September 27, 2007. www.ec.gc.ca/substances/nsb/eng/nanoproposition_e.shtml 131


Swiss Re. Nanotechnology. Small matter, many unknowns, 2004. Zurich., 133

Tetley TD, Health Effects of Nanomaterials, Biochemical Society Transactions, (2007) Volume 35, part 3, pp 527-531 134

Balbus John, Richard Denison, Karen Florini, Scott Walsh, Getting Nanotechnology Right the First Time, Position of Environmental Defense, Summer 2005, www.environmentaldefense.org/go/nano 135

Cairns Carolyn, Consumer Union, Presentation at the Food and Drug Administration, Nanotechnology Task Force, Public Meeting on Nanotechnology Material in FDA Regulated Products, October 10, 2006, Pp 62-69

http://www.ec.gc.ca/substances/nsb/eng/nanoproposition_e.shtml


http://www.environmentaldefense.org/go/nano


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Production of

Nanomaterials

Manufacture of

Consumer Products

Use of Consumer

Products

Disposal of

Consumer Product

Release of

Nanomaterials into

the Environment

Occupational

Exposure

Exposure of

General Public

Inhalation

(air)

Dermal

(sunscreen)

Ingestion

(Food)

Soil

Water

Air

Exposure of

living species

in the environment

Human Exposure

Environmental Exposure

Figure 8: Potential Exposure During Life Cycle Stages of Nanomaterials Used in Consumer Products

As can be seen in Figure 8, modified from the study carried out on behalf of the European Parliament on consumer products136, human and environmental exposure to nanoscale materials in consumer products can take place throughout the life cycle of the product. The primary lifecycle stages of concern include the production of the nanoscale materials, the manufacture and use of consumer products containing nanoscale materials and the release of nanoscale materials into the environment (through industrial emissions, leakage, recycling or disposal of consumer products). The main routes of exposure of humans to nanomaterials include:

Inhalation of nanoparticles emitted or released into the air from products during manufacture, use or disposal such as occurs with aerosol sprays or decomposition of the materials after disposal;

Dermal route of exposure through the skin involving nanoparticles present in such products as cosmetics and sunscreens;

Oral route of exposure by intentional ingestion of food, drugs or oral hygiene products or unintentional ingestion of nanomaterials used in food packaging;

Injection of a drug or implantation of a device for medical purposes; or

Release of nanomaterials in the environment leading to human exposure through the air, water or food.

136

European Parliament's Committee on the Environment, Public Health and Food Safety, Nanomaterials in Consumer Products: Availability on the European market and adequacy of the regulatory framework, RIVM/SIR Advisory report 11014(IP/A/ENVI/IC/2006-193), April 2007


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It also must be remembered that once identified, a risk can be managed or minimized through a number of different ways, such as preventing or reducing the likelihood of exposure by enclosing the production process, installing devices to prevent leakage into water or air, labeling products with accurate handling and disposal instructions and binding the particles into stable matrices. Unique problems of exposure are related to the small size of the nanoscale particles. The small size means that the particles could penetrate deep into the lungs if inhaled137, be absorbed through the skin if there is dermal contact or enter the blood stream if ingested and then circulate throughout the body.138 In addition, the following potential problem with respect to food was identified by Kuzma:

―using nano materials to improve the body‘s ability to absorb nutrients by making them small enough to cross the cell wall that ordinarily would prohibit their passage. While there may be benefits to breaking down these barriers such as quicker and efficient uptake of nutrients, there could be unintended consequences.‖139

The chances of actually being exposed to nanoscale materials vary significantly depending on the product and how the nanomaterials are used within the product. In many consumer applications such as sports equipment, textiles or self-cleaning glass, the nanoscale materials are fixed and embedded in stable matrices. Under these circumstances, consumers are at a low risk of being exposed to the materials during use. However, free engineered nanoscale materials are a major concern from a health and safety perspective since potentially high exposures may be expected from any consumer products which may contain free nanomaterials like cosmetics and aerosols140. The free nanomaterials are not immobilized in a matrix and can unintentionally escape into the air or water during production, use or degradation as a result of disposal. If inhaled, free nanomaterials can deposit in the lungs, cause damage to the lungs, cross over into the circulatory system and travel to the brain.141,142 Under the situation where free nanomaterials occur in products applied to the skin, it becomes very important to determine whether the nanoscale materials are capable of penetrating human skin, whether they can cause harm once inside the human body and what the fate and impact of these novel materials will be in the environment once washed off the skin or as a result of disposal. The concerns about exposure are not theoretical as many of the current commercial applications of nanotechnology are high-exposure uses

137

Warheit David, Human Health Impacts of Nanomaterials, Nanotechnology and the Environment, August 16, 2004 138

Oberdorster G et al, Principles for characterizing the potential human health effects from exposure to nanomaterials: elements of a screening strategy, Particle & Fibre Toxicology, 2005, Vol 2, 8, www.particleandfibretoxicology.com/content/2/1/8 139

Kuzma Jennifer and Peter Verhage, Nanotechnology in Agriculture and Food Production: Anticipated Applications, Woodrow Wilson International Center for Scholars, Project on Emerging Nanotechnologies, Sept. 2006, www.nanotechproject 140

European Parliament's Committee on the Environment, Public Health and Food Safety, Nanomaterials in Consumer Products: Availability on the European market and adequacy of the regulatory framework, RIVM/SIR Advisory report 11014 141

Lam Chiu-Wing, John T James, Richard McCluskey and Robert L. Hunter, Pulmonary Toxicity of Single-Wall Carbon Nanotubes in Mice 7 and 90 Days After Intratracheal Instillation, Toxicological Sciences, Vol 77, pp 126-134, 2004. 142

Warheit David, Human Health Impacts of Nanomaterials, Nanotechnology and the Environment, August 16, 2004




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such as cosmetics, food and drugs.143 There is no reason to conclude that individuals will not be exposed to nanomaterials. As Andrew Maynard indicated144, the magnitude and significance of exposure will depend on the nanomaterial, the production process and how it is handled. In the future, as nanomaterials are developed to interact with biological systems in new and novel ways, new risks to human health and the environment could emerge. The group that is at the greatest risk are the workers who carry out research on nanoscale materials, produce them, incorporate them into other products or clean the manufacturing plant. It is anticipated that as new nano enhanced products enter the market, exposure of consumers will increase both directly through using the products and indirectly from disposal of the products into the environment.145 Scientific studies to determine what happens when large quantities of nanoscale materials are absorbed by the body are just starting. Scientists at the EPA146 , the Institut de recherche Robert-Sauvé en santé et en sécurité du travail (IRSST)147 and other organizations determined or suggested that some nanoscale materials may be able to enter the body, cross biological membranes and access cells, tissues and vital organs via the blood stream. According to Brom et al148 who reviewed the research on risks, the inhalation of nanomaterials may have an effect on the cardiovascular system either through material entering the blood or by inflammatory reactions in the lungs causing tissue damage. Although it was suggested that nanomaterials can enter the brain via the nerves in the nose or via the blood, the potential impact on the brain or nervous system is not clear. Oberdorster et al (2005) noted, ―The biologic activity and biokinetics of nanoscale articles are dependent on many parameters: size, shape, chemistry, crystallinity, surface properties (area, porosity, charge, surface modifications, weathering of coating), agglomeration state, bio-persistence, and dose.‖ These parameters are very different from the two or three parameters that are normally needed to evaluate the toxicity of materials149. Other studies reached the same conclusion that certain nanomaterials demonstrated toxic effects and the toxicity seems to be linked to their size, shape, surface area and surface activity rather than mass and composition as occurs with the same substance at a macro level 150, 151. Researchers152 who examined the

143

Davies Clarence J., Managing the Effects of Nanotechnology, Woodrow Wilson International Center for Scholars, Project on Emerging Nanotechnologies, 2005, www.nanotechproject 144

Maynard Andrew, Is Engineered Nanomaterial Exposure a Myth?, October 2, 2007, www.safenano.org 145

OECD and Allianz, Editor: Dr. Christoph Lauterwasser Allianz Center for Technology, Small size matters: Opportunities and risks of Nanotechnologies, Report in co-operation with the OECD International Futures Programme 146


Institut de recherche Robert- Sauvé en santé et en sécurité du travail (IRSST), Health Effects of Nanoparticles, August 2006, www.irsst.qc.ca 148

Borm PJA et al, The potential risks of nanomaterials: a review carried out for ECETOC, Particle and Fibre Toxicology, 2006, 3:11, www.particleandfibretoxicology.com/content/3/1/11 149

Oberdorster G et al, Principles for characterizing the potential human health effects from exposure to nanomaterials: elements of a screening strategy, Particle & Fibre Toxicology, 2005, Vol 2, 8, www.particleandfibretoxicology.com/content/2/1/8 150

Maynard Andrew, Smart Science The challenges and benefits of getting


http://www.safenano.org/

http://www.irsst.qc.ca/




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characteristics of nanoscale materials that pose a clear risk proposed criteria that could be used to identify such nanoscale materials. These included exposure, biological accessibility of the material after exposure and the potential for a biological response different from that of the material on a macroscale. As a result, risk assessment data on bulk materials does not appear to be applicable to the same material at a nanoscale. The route of entry into the body also appears to have an impact on the risk posed by a nanomaterial like a carbon nanotube. Initial work carried out at Rice University showed that carbon nanotubes injected directly into the blood stream of animals caused no immediate adverse health effects and after one hour were removed by the liver.153 However, scientists from the toxicology group at NASA‘s Johnson Space Center found that when inhaled carbon nanotubes were capable of producing inflammation, fibrosis and biochemical changes in the lungs154. Other health concerns focus on the largely unknown effects of using nanoscale materials in pharmaceutical products to deliver drugs or diagnose diseases. John Balbus of the Environmental Defense League in a presentation before the FDA155 raised a number of issues that need to be addressed for medical applications. The durability of the materials, their persistence in the body and elimination of the materials are questions to be answered in order to understand the potential risks that may be associated with them. The effect of nanomaterials on the human body has been explored for a number of years by the pharmaceutical industry in their effort to develop novel drug delivery systems. The major portion of the research involved exposure by injection due to the barriers presented by other potential routes of exposure. Although the particles are mainly excreted through urine and breath, some were deposited in organs and it very much depended on the surface coating used. The surface coating may also impact on the toxicity of these particles. According to the authors, less desirable nanomaterials may penetrate into cells or cross natural barriers, such as those between the blood and the brain, that serve as important defences against harm156. Due to the limited research, the lack of data on long exposures, the inconsistent composition of the nanomaterials tested (diameter, length and agglomeration), and other factors, the toxicological data specific to the impact of nanomaterials on human health is not sufficient to draw conclusions. Moreover, the evidence about the potential risks associated with nanomaterials comes primarily from studies evaluating inhalation of ultrafine particles. The results of these studies may not predict toxicity for other routes of

nanotech right in the laboratory, Midwest Nanotechnology Safety Workshop, University of Wisconsin, May 20-22, 2007, http://www2.fpm.wisc.edu/safety/nano/agenda.htm 151

Institut de recherche Robert- Sauvé en santé et en sécurité du travail (IRSST), Health Effects of Nanoparticles, August 2006, www.irsst.qc.ca 152

Maynard A, and E D Kuempel, Airborne nanostructured particles and occupational health. J. Nanoparticle Res: 7, 587-614, 2005 153

Weisman Bruce and Richard Smalley, Nanotubes Cleared by the Liver, Proceedings of the National Academy of Sciences, Nov. 29, 2007. 154

Lam Chiu-Wing, John T James, Richard McCluskey and Robert L. Hunter, Pulmonary Toxicity of Single-Wall Carbon Nanotubes in Mice 7 and 90 Days After Intratracheal Instillation, Toxicological Sciences, 2004, Vol. 77, pp 126-134. 155

Balbus John, Environmental Defense, Presentation at the Food and Drug Administration, Nanotechnology Task Force, Public Meeting on Nanotechnology Material in FDA Regulated Products, October 10, 2006, Pp 50 - 56 156


http://www2.fpm.wisc.edu/safety/nano/agenda.htm




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exposure such as dermal, ingestion or injection directly into the body for medical purposes. The wide range of applications will make it difficult to develop one approach in assessing risk and distinguishing between those nanoscale materials that present a clear risk to health versus those that do not. At the present time, a good understanding of what materials present a hazard and exposure of the public to them does not exist. Still less is known about how we might predict and manage the risks from new applications in the future.157 These gaps in our knowledge need to be filled to ensure the confidence of consumers in the safety of nanoscale materials. In light of these knowledge gaps, the ETC Group158 and Friends of the Earth159 urged governments to establish a moratorium on the commercialization of new products containing novel, engineered nanomaterials until test procedures could be established and regulations were in place to protect consumers and the environment In a recent web dialogue related to consumer products that involved scientists and consumers, a number of critical questions were raised that have been missing from the debates on risks related to nano materials.

―Do we really need nanotechnologies in food and consumer products?

Who gets to decide whether or not nano food and consumer products are necessary, which ones are allowed on the market, and what alternatives are considered?

Who benefits and who is most at risk from the decisions? 160‖

3.2. What is the Impact on the Environment? Inevitably the increased production of man-made nanomaterials will result in more and more of them finding their way into the environment. Potential direct or indirect release of nanomaterials into the environment could be due to the manufacture and processing of nanomaterials, activities to clean-up chemical contaminants such as the remediation of contaminated sites, the release of nanomaterials incorporated into materials used to fabricate products for consumer use including drugs and releases from the use, recycling and disposal of consumer products containing nanoscale materials (e.g., disposal of screen monitors, computer boards, automobile tires, clothing and cosmetics).

Very little is currently known about the impact of nanomaterials, some of which are chemically or biologically reactive, on the environment and species other than humans. It is also not known how they are transported through the environment and what their fate is.161 In fact, the Royal Society stated ―There remains virtually no data on the potential negative impacts of nanomaterials on the environment. Research into ecotoxicology is

157

Maynard Andrew, Nanotechnology: The Next Big Thing, or Much Ado about Nothing? Ann. Occup. Hyg., pp 1-12, Oct 14, 2006, 158

ETC Group, Presentation to FDA Nanotechnology Public Meeting, October 10, 2006 159


Powell Maria, Comment: Nano in food and consumer products are they necessary?, Web Dialogue on Nanotechnology and the Consumer; A public dialogue, www.webdialogues.net/pen-consumer-discussion/view/dm/4019 161

Aarnail Alexander Huw, Future Technologies, Today‟s Choices, Nanotechnology, Artificial Intelligence and Robotics; A technical, political and institutional map of emerging technologies. A Report for the Greenpeace Environmental Trust, July 2002, www.greenpeace.org.uk

http://www.foe.org/

http://www.webdialogues.net/pen-consumer-discussion/view/dm/4019

http://www.webdialogues.net/pen-consumer-discussion/view/dm/4019



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urgently required.‖ This view was supported by Friends of the Earth who stated that there was no body of knowledge about the potential of nanomaterials to cause harm to the environment. Although the organization cautioned against extrapolating results from the limited research that does exist, it pointed out that the preliminary findings indicate a need for further study.162

Research is starting in this area, and particles such as nano-silver and nano-copper have been shown to be harmful to aquatic life. This could have adverse environmental consequences if large amounts were released into the environment. Carbon fullerenes in one study were found to cause brain damage in largemouth bass.163 Nanoparticles and quantum dots could make up new classes of pollutants that are not biodegradable and will be difficult to remove from the environment164. Scientists from the Center for Biological and Environmental Nanotechnology of Rice University have shown that nanoscale materials can absorb contaminants such as cadmium and organics and have postulated that they could carry such contaminants rapidly through underground water.165 The release of nanomaterials will very much depend on the resistance to wear and tear, the solubility or the degradability of the material in which they are incorporated. Once released, different types of micro-organisms, plants and species may be exposed to the nanomaterials and the impact on them is unknown. Moreover, removing nanomaterials from the environment would present a significant challenge due to their small size and the fact that they could be taken up by plants or soil or transported long distances through air or water. According to the ETC Group166, many new and existing products involving the use of nanomaterials and/or nanotech-enabled processes could result in large-scale release of these materials into the environment. The following are a few examples of products under development cited by ETC.

• Researchers are experimenting with turning silicates into glass at ambient temperatures in order to encapsulate oil spills, radioactive materials and other wastes. Research funded by the US Department of Energy demonstrates that this process can be used to solidify soil around waste spills and to turn toxic or radioactive liquids into a hard ceramic.

• Researchers at Lehigh University are investigating ways to inject iron nanoparticles into groundwater channels of contaminated sites. The nano-sized iron is highly reactive and will, in effect, "rust" dangerous heavy metals like lead and mercury. Researchers say any remaining unused nano-scale iron will continue its way through groundwater paths until it is completely dissolved.

• A nanotech company filed a patent application last year on a water cleaning substance dubbed ―NanoCheck‖ intended for use in swimming pools, fountains and fish farms. Nanocheck uses 40 nm particles of lanthanum to absorb phosphates from the water and to prevent growth of algae.

162


Oberdorster E, Manufactured nanomaterials (fullerenes C60) induce oxidative stress in largemouth bass, Environmental Perspectives, 2004, 112;1058-1062 164

Swiss Re, Nanotechnology Small matter, many unknowns. 2004, Zurich. 165

Colvin Vicki, Responsible Nanotechnology: Looking Beyond the Good News, EurekAlert In Context, November 2002. 166

ETC Group, Mulch ado about nothing? … Or the “Sand Witch?”, ETC Communique, Issue 81, Sept/Oct 2003, www.etcgroup.org.

http://www.foe.org/



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• Trials are being conducted on a new method of delivering DNA vaccines to fish by attaching them to nanomaterials released into fish ponds. The vaccines are intended to immunize fish en masse when exposed to ultrasound.

• Agrochemical companies are formulating new pesticides composed of nano-liposomes that encapsulated particles which can be used to deliver bioactive chemical substances into crops as pesticides.

In the absence of regulatory oversight and transparency on the part of industry, ETC was very uncertain of the environmental appropriateness or safety of such products. The US EPA in its white paper on nanotechnology stated that ―at this point not enough information exists to assess environmental exposure for most engineered nanomaterials.‖167 Generating this scientific data is important because governments need sound scientific evidence in order to assess and manage any unforeseen future impacts resulting from the introduction of nanomaterials into the environment. Environment Canada and Health Canada expressed the same need for further research due to the limited understanding that exists about the potential impacts of this technology.168

3.3. State of Scientific Knowledge on Nanotechnology Recent reports169,170, 171 on research needs for nanotechnology, the results of a workshop172 on assessing nanomaterial toxicity and a recent Canadian Workshop on Multidisciplinary Research on Nanotechnology173 identified a number of significant gaps in the scientific knowledge on nanotechnology. The research needed to fill these gaps is described below and falls into a number of key areas.

3.3.1. Terminology and Nomenclature. There is a lack of commonly accepted definitions and nomenclature systems for nanotechnology and nanomaterials. Nomenclature refers to a naming convention that can be used to name and classify things in a particular discipline. Without such a system, it is extremely difficult to develop appropriate definitions essential to the

167

Environmental Protection Agency Nanotechnology Workgroup, Nanotechnology White Paper, Washington, DC, February 2007. 168 Environment Canada and Health Canada, Proposed Regulatory Framework for Nanomaterials Under the Canadian Environmental Protection Act, 1999, Workshop on a Proposed Regulatory Framework for Nanomaterials under CEPA 1999, September 27, 2007, www.ec.gc.ca/substances/nsb/eng/nanoproposition_e.shtml 169

Maynard Andrew D, Nanotechnology: A Research Strategy for Addressing Risk, Woodrow Wilson International Center for Scholars, July 2006, http://www.nanotechproject.org/80/nanotechnology-development-suffers-from-lack-of-risk-research-plan 170


National Science and Technology Council, Environmental, Health and Safety Research Needs for Engineered Nanoscale Materials, Sept 2006. 172

Balbus John et al, Meeting Report: Hazard Assessment for Nanoparticles - Report from an Interdisciplinary Workshop, Environmental Health Perspectives, Vol. 115, No. 11, Nov. 2007, 1654-1659 173

Canadian Institutes of Health Research, Canadian Workshop on Multidisciplinary Research on Nanotechnology: Gaps, Opportunities and Priorities, Edmonton, January 22-24, 2008.






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development of regulations or labelling schemes, to carry out rational commercial activities, to allow for the sharing of research information or for rational public discussion.174 As discussed in a recent consumer web dialogue175, the lack of definitions impacts on the awareness and understanding of consumers. 3.3.2. Instrumentation and Test Protocols

The evaluation of current test procedures and the development of alternative methods that are suitable and practical to detect, to characterize, to measure and to monitor nanomaterials in biological systems and the environment are essential in order to:

quantify the hazard;

assess material size and size distribution;

determine the properties of nanomaterials;

understand the effect of variations in size, shape, surface area and structure on the properties of nanomaterials;

develop reference materials to validate tests and exploratory research;

obtain reliable and reproducible information;

assess the purity of the material;

determine the potential accumulation and persistence of nanomaterials in the body and the environment;

identify the routes of exposure; and

determine the exposure of individuals and the ecosystem to nanomaterials.

These test methods are particularly crucial to understand and assess the toxicity of the nanomaterials and their impact on human health. They are also of particular concern in the regulation of certain consumer products containing nanomaterials where exposure is potentially very high - drugs, medical devices, cosmetics and food - and for quality control by industry. Currently, scientific equipment and tools are being used at the limits of their resolution176 to investigate nanoscale materials and this can result in large measurement errors. The lack of more precise tools and methods to accurately characterize the materials and their properties could hinder the further development of products of nanotechnology and the management of any associated risks.177 It is not only researchers who need these tools but also industry that is required to produce consistent products and government authorities who are responsible for providing oversight on behalf of the public. In addition, there is a need to develop affordable and portable measurement instruments that can be used in various locations to measure nanomaterials in air, water or soil. Nanoparticles and nanotubes are too small to be measured by most

174

Willis Clive, Nanotechnology the Terminology Challenge, ISO Focus, Vol. 4, No. 4, April 2007. 175

Woodrow Wilson International Center for Scholars and the Consumers Union, Consumers Talk Nanoweb Dialogue, http://www.webdialogues.net/pen/consumer 176

Schmidt Karen, Visions for the Future of Nanotechnology, PEN 6, March 2007, www.nanotechproject.org 177 Siegel R. W. et al, Nanostructure Science and Technology: R&D Status and Trends in Nanoparticles, Nanostructured Materials, and Nanodevices, Final Report prepared for the National Science and Technology Council, September 1999, http://itri.loyola.edu/nano/final/.

http://www.webdialogues.net/pen/consumer


http://itri.loyola.edu/nano/final/


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standard instruments currently available. The instruments that are capable of carrying out such measurements (e.g. electron microscopes) are very expensive and require a high level of expertise to use. 3.3.3. Impact on Human Health

The identification of potential risks to human health requires that knowledge gaps related to the response of the body and its components to engineered nanoscale materials be filled. These include understanding:

The interactions between nanomaterials and the body at the cellular level and which characteristics of nanomaterials are responsible for them;

Whether potential changes in characteristics such as material size, size distribution, shape, surface area, purity, and catalytic behaviour over the lifecycle of the material will affect the level of risk posed;

The ability of nanomaterials to avoid detection by macrophages in the lungs and to cross cell membranes into the blood stream;

The solubility of the materials which determines whether they will be absorbed by the body or excreted;

The factors that determine the safety and toxicity of nanomaterials so that models can be developed to assess any new nanomaterials likely to go into large-scale production and how they could impact people;

The absorption and transport of nanomaterials throughout the body for different routes of exposure;

The role of surfaces and interfaces in influencing the properties of nanoscale materials; and

The impact of implantable medical devices or materials to rebuild bones and nerves that contain nanomaterials on the body over long periods.

The results of this research will enable governments and industry to establish appropriate mechanisms to identify and manage any risks and support the development of safer products.

3.3.4. Impact on the Environment

Knowledge about the potential effects of nanotechnology on all types of biological species in the environment is limited. It is needed to identify, to understand and to manage any risks to the environment posed by nanomaterials. The results of research on the fate and transport of nanomaterials is also essential to improve our knowledge of how these materials enter, remain, degrade and are transported through the environment. The significant physiological differences between classes of animals living in the water and on land will lead to a wide range of unique issues that cannot be addressed through studies being carried out only on mammals. The type of research that has been identified178 as necessary includes the following;

Research to explore the effect of nanomaterials or changes to these materials on both biological and non-biological environmental conditions;

178

National Science and Technology Council, Environmental, Health and Safety Research Needs for Engineered Nanoscale Materials, Sept 2006.


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Studies to understand the exposure of aquatic organisms to various types of nanomaterials;

The identification of factors that affect the transport of nanomaterials through air, water and soil and the identification of new methods to evaluate this aspect;

The degree to which nanoparticles can act as a carrier for toxic substances and transport them over long distances in air, water and soil also needs to be investigated;

One of the major gaps is the understanding of how nanomaterials change if and when exposed to the environment and conditions such as sunlight, moisture, or oxygen; and

New models to assess environmental fate and exposure that are applicable to intentionally produced nanomaterials.

The Royal Society and the Royal Academy of Engineering in their report recommended that ―until more is known about environmental impacts of nanoparticles nanotubes, that the use of free (that is not fixed in a matrix) manufactured nanoparticles in environmental applications such as remediation is prohibited until appropriate research has been undertaken179‖. The same conclusion was reached by environmental groups such as Greenpeace180 and ETC181. 3.3.5. The Assessment and Management of Risks.

The authors of the reports on research needs182,183 stressed that the assessment of risks should focus on the safety of nanoparticles that have been commercialized and on the development of methods to assess any risks. However, it is not clear whether the existing risk assessment and management tools are appropriate to evaluate the new uses and properties of engineered nanomaterials. The research needs identified included:

The evaluation of the ability of existing risk assessment and management tools to identify those nano materials that pose the greatest risk;

The identification of ways to reduce any risks by minimizing the hazard or exposure to nanomaterials; and

Work to better understand the impact of nanomaterials over the full life cycle of the product so that the stages in the life cycle that pose the greatest risk can be identified.

179 The Royal Society and Royal Academy of Engineering, Nanoscience and nanotechnologies: opportunities and uncertainties, July 2004, www.nanotec.org.uk/final/Report.htm 180

Aarnail Alexander Huw, Future Technologies, Today's Choices, Nanotechnology, Artificial Intelligence and Robotics; A technical, political and institutional map of emerging technologies. A Report for the Greenpeace Environmental Trust, July 2002, www.greenpeace.org.uk 181

ETC Group, Mulch ado about nothing? … Or the “Sand Witch?”, ETC Communique, Issue 81, Sept/Oct 2003, www.etcgroup.org 182

Maynard Andrew D, Nanotechnology: A Research Strategy for Addressing Risk, Woodrow Wilson International Centre for Scholars, July 2006, http://www.nanotechproject.org/80/nanotechnology-development-suffers-from-lack-of-risk-research-plan. 183

Balbus John et al, Meeting Report: Hazard Assessment for Nanoparticles - Report from an Interdisciplinary Workshop, Environmental Health Perspectives, Vol. 115, No. 11, Nov. 2007, 1654-1659







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The limited scientific knowledge available about nanomaterials often prevents assessments going much further than the identification of the hazard - the first step in the assessment of risks. Contributing to this inability to complete the risk assessment is the lack of data on exposure and the dose response to engineered nanomaterials. According to Environmental Defense, studies performed to date are inadequate to provide a full picture of the risks of engineered nanoscale materials and raise even more questions about engineered nanoscale materials.184 In an effort to address the lack of assessment methodology and the need to develop a process to help in the responsible development of nanotechnology Environmental Defense and DuPont185 worked together to develop a framework to assess the risks that may be associated with nanoscale materials. The Framework offers guidance on the key questions an organization should consider in developing applications of such materials, and on the critical information needed to make sound risk evaluations and

risk management decisions. Although not without critics, it goes a long way to moving the development of a risk assessment methodology suitable for nanotechnology forward. It will be a challenge for industry, regulators and those assessing risks to fill the knowledge gaps and establish appropriate test protocols and risk assessment methodologies for the multitude of applications under development, the potential changes that may take place over the life cycle of the materials and the influence that changes in shape or size can have on the properties of the materials.

3.3.6. Nanotechnology Environmental, Ethical, Economic, Legal and Social

(NE3LS) Issues

At the 2008 Canadian Workshop on Multidisciplinary Research on Nanotechnology, it was identified that research is required into the ethical, economic, legal and social impacts of nanotechnology186,187 in addition to research in the fundamental sciences. The research that is needed includes investigating how the technology will affect individuals and society and determining the economic value of new materials and new industries, as well as economic dislocations caused by the decline of industries tied to displaced technologies particularly in the developing world creating a nano-divide. Other implications might include increased life spans made possible through nano-based medicines or diagnostic techniques, leading to greater numbers of active senior citizens seeking employment.

184

Balbus John, Richard Denison, Karen Florini, and Scott Walsh, Getting Nanotechnology Right the First Time, Position of Environmental Defense, Summer 2005 185

Environmental Defense – DuPont Nano Partnership, Environmental Defense- Dupont Nano Risk Framework Draft, February 26, 2007, www.NanoRiskFramework.com 186

Coates Ken, Building Bridges: Engaging the Social Sciences, Humanities and Fine Arts in the Debate about the Future of Nanotechnology, Canadian Workshop on Multidisciplinary Research on Nanotechnology: Gaps, Opportunities and Priorities, Edmonton, January 22-24, 2008. 187

Sheremeta Lorraine, Nanotechnology: Technological Development & the Significance of NELS Issues, Canadian Workshop on Multidisciplinary Research on Nanotechnology: Gaps, Opportunities and Priorities, Edmonton, January 22-24, 2008.

http://www.nanoriskframework.com/


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The list of social, ethical, legal, and cultural implications also includes such issues as privacy, potential conflicts of interest, and research ethics.188 The convergence of nanotechnology and information technology to develop smaller and smaller sensors and surveillance devices is a major ethical concern. These developments provide the

capability to track individuals without their knowledge. Nanotechnology could also help enhance certain physical and cognitive characteristics of humans. It is hard to define what is a medical therapy to heal or restore a body to normal function and when does it become a technology that maximizes human performance beyond what is the norm. This is a very controversial issue. It is widely recognized that since the applications of nanotechnology are not yet clear, neither are the ethical issues that may arise. And yet, as identified at the Canadian Workshop on Nanotechnology, these issues must begin to be addressed now, before they overwhelm nanotechnology and derail potential benefits.

188

Commission of de l‘ Éthique de la Science et de la Technologie, Gouvernement du Québec, Position Statement, Ethics and Nanotechnology, A basis for Action, 2006,


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Chapter 4: Oversight Mechanisms The rapid development and commercialization of materials produced by nanotechnology

or incorporated into consumer products have outpaced any efforts to understand their impact on human health, safety or the environment. It is actually in the best interests of not only the public but the private sector to identify and manage the potential risks up front rather than have to deal with them after problems have arisen. As the commercialization of products of nanotechnology continues to expand into the mainstream, it is anticipated that more and more consumers will show an interest in them and expect adequate oversight and regulation of the technology similar to the issue of Genetically Modified Organisms. Oversight mechanisms could include a broad spectrum, ranging from:

a complete ban or moratorium on their use until full scientific evidence is available;

the use of nanomaterials only under certain circumstances or in certain situations like the military;

the development of regulations;

the use of voluntary consensus standards; or

a dependence on industry codes of practice. From the perspective of the public, government regulation of nanotechnology is essential. The growth in the industry led Richard Denison189 senior scientist with the advocacy group Environmental Defense, to point out ―the urgency of action has only increased.‖ Surveys and focus groups carried out on this subject indicate that the public does not trust industry to regulate itself and does not think governments exercise adequate regulatory

oversight over nanotechnology.190,191 However, effective oversight whether voluntary or mandatory is critical to maintaining the confidence of the consumer in new technologies. From the perspective of industry, effective oversight contributes to the establishment of a

189

Denison Richard A, No Small Thing: Getting Nanotechnology Right the First Time, Environmental Defense, Position of Environmental Defense, Summer 2005 190

Macoubrie Jane (2005), Informed Public Opinions and Trust in Government, Woodrow Wilson International Centre for Scholars, http://www.nanotechproject.org/8/who-do-you-trust-public-attitudes-towards-nanotechnology-government-and-industry 191

Genome Prairie GELS team, University of Calgary, First Impressions: Understanding the public's views on emerging technologies. http://www.biostrategy.gc.ca/CMFiles/CBS_Report_FINAL_ENGLISH249SFD-9222005-5696.pdf

.

If nothing specific is done to manage nanotechnology‟s possible adverse effects, a range of undesirable developments could emerge. The public potentially would be left unprotected, the government would struggle to apply existing laws to a technology for which they were not designed, and industry would be exposed to the possibility of public backlash, loss of markets, and potential financial liabilities. If nanotechnology is to fulfill its promise, society must openly face the issues of whether the technology has or could have adverse effects, what these effects are and how to prevent them in the future.

Clarence Davies – Woodrow Wilson International Center for Scholars, Project on Nanotechnologies



http://biostrategy.gc.ca/english/LinkSearch.asp?x=1&formAction=gotourl&url=http%3A%2F%2Fwww%2Ebiostrategy%2Egc%2Eca%2FCMFiles%2FCBS%5FReport%5FFINAL%5FENGLISH249SFD%2D9222005%2D5696%2Epdf


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level playing field essential to fair competition and clear guidelines about what practices and areas of development will be permitted. In many ways, the industry is already regulated since many products containing nanomaterials fall under existing regulations and statutes. However, these legal mechanisms were never designed to address the types of novel materials produced through nanotechnology and the concerns of consumers about the adequacy of these regulations192. It has been claimed 193 that ―existing laws either suffer from major shortcomings of legal authority or from a gross lack of resources or both. They provide a weak basis for identifying and protecting the public from potential risk‖. For example, fullerenes or carbon nanotubes, which are made entirely of carbon, are regulated as graphite although their behavior may be quite different. Many experts194 and advocacy groups195,196,197 have argued that, in order to deal with the potential health and environmental risks of nanotechnologies, they need to be considered as a class on their own. Some have suggested that new regulatory frameworks need to be developed and implemented198 preferably internationally;199 that they need to be treated as new substances under existing regulatory frameworks;200 or that a moratorium be placed on the use201 or release of nanomaterials into the environment202 until it is clear that the materials are safe. One approach that may be considered is the development of an international framework convention on nanotechnologies similar to the Convention on Biological Diversity. All of these experts concluded that the danger of these emerging technologies should be considered to be real until proven false. The Royal Society in its report recommended that nanomaterials be clearly identified and assessed as new chemicals since the associated risks were potentially serious enough to require them being assessed as new chemicals. The Society based the latter

192

Genome Prairie GELS team, University of Calgary, First Impressions: Understanding the public's views on emerging technologies, http://www.biostrategy.gc.ca/CMFiles/CBS_Report_FINAL_ENGLISH249SFD-9222005-5696.pdf 193


Davies J. Clarence, EPA and Nanotechnology: Oversight for the 21st Century, PEN 9, May 2007, http://www.nanotechproject.org/124/ 195

ETC Group, Mulch ado about nothing? … Or the “Sand Witch?‖, ETC Communique, Issue 81, Sept/Oct 2003. 196

Cairns Carolyn, Consumer Union, Presentation at the Food and Drug Administration, Nanotechnology Task Force, Pubic Meeting on Nanotechnology Material in FDA Regulated Products, October 10, 2006, pp 62-69 197


Swiss Re. Nanotechnology. Small matter, many unknowns. Zurich, 2004. 199

Marchant Gary and Douglas Sylvester , Transnational Models for Regulation of Nanotechnology, J of Law, Medicine and Ethics, 2006, Vol 34 (4), p 714-725. 200


ETC Group, Mulch ado about nothing? … Or the “Sand Witch?”, ETC Communique, Issue 81, Sept/Oct 2003. 202

Aarnail Alexander Huw, Future Technologies, Today's Choices, Nanotechnology, Artificial Intelligence and Robotics,; A technical, political and institutional map of emerging technologies. A Report for the Greenpeace Environmental Trust, July 2002, www.greenpeace.org.uk


http://www.nanotechproject.org/124/




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recommendation on the fact that the toxicity of the particles cannot be predicted from the properties of the same materials on a larger size203. This is very similar to the argument being put forward by many consumers and advocacy groups who have stated that ―Government and industry should be working to identify and manage possible health and environmental risks before new products are widely used‖204. They also recommended that:

―a new government organization be established which would be responsible for regulation of public and private nanoscale research and development

researchers and organizations involved in product development must prove the safety of the materials with which they work and the products they develop;

research must always be contingent on an assessment of associated risk.‖205 Like most other countries, the regulatory oversight of consumer products being sold to Canadians requires under existing laws that certain products be assessed for their safety and efficacy before entering the market. These products include drugs, biological health products, natural health products, medical devices, pesticides and novel foods. While other products including children‘s toys, cosmetics, textiles, sporting goods, paints and household chemicals do not require such premarket evaluation. No requirements for labeling of products that contain nanoscale materials exist in Canada or other countries. The Royal Society and the Royal Academy of Engineering recommended that ―the ingredients list of consumer products should identify the fact that manufactured nanoparticulate material has been added‖.206 In the policy framework for nanotechnology drafted at a Canadian Institute for Environmental Law and Policy‘s workshop, it was also recommended that ―in the absence of a regulatory regime, ways to legally require labelling of consumer products with nanomaterials that can come in contact with humans, other animals, or enter the environment directly should be found‖.207 The regulatory and oversight policies and practices are very much in their early stages and very few government or organizations nationally or internationally offer concrete solutions to known or anticipated problems, nor practical foundations for establishing effective regulation. There are very divergent views on how this should be carried out. They vary from those who believe that no regulation is needed to those who believe that the lack of regulation could prove to be harmful to human health and the environment and to industry. If nothing is done to adequately manage the possible risks posed by these products, it is anticipated that consumers would be left unprotected, regulators would struggle to apply existing legislation to substances and products for which they

203

The Royal Society and Royal Academy of Engineering, Nanoscience and nanotechnologies: opportunities and uncertainties, July 2004, p 95, www.nanotec.org.uk/final/Report.htm 204

Balbus John, Richard Denison, Karen Florini, and Scott Walsh, Getting Nanotechnology Right the First Time, Position of Environmental Defense, Summer 2005 205 Report of the Madison Area Citizen Consensus Conference on Nanotechnology, April 24,

2005 206

The Royal Society and Royal Academy of Engineering Nanotechnology Working Group Prepared by: BMRB Social Research, Nanotechnology: Views of the General Public Quantitative and qualitative research carried out as part of the Nanotechnology study, Jan 2004, www.nanotec.org.uk/Market%20Research.pdf 207 Holtz Susan, Canadian Institute for Environmental Law and Policy, Discussion Paper on a Policy Framework for Nanotechnology, March 2007.


http://www.nanotec.org.uk/Market%20Research.pdf


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were never designed and a public backlash would result in lost markets and loss of the benefits nanotechnology could provide208.

4.1. What are governments doing?

4.1.1. Regulatory Challenges Regulating or developing policies to oversee any new technology at its beginning is very difficult. With the emergence of a new technology, regulatory agencies face a number of challenges to identify and determine how best to manage any risks or potential risks that may adversely affect the public or the environment. The situation is no different with nanotechnologies and the complex challenges that governments face are outlined below.

Lack of a Basic Understanding of Properties and Risks: According to Environment Canada and Health Canada, the main regulatory challenges facing governments involve gaining a better understanding of the properties, behaviour and effects of nanomaterials, and developing a system of nomenclature to classify them.209 These deficiencies make it difficult to develop appropriate options to manage the technology, to determine whether existing regulatory frameworks can manage nanotechnology or whether new frameworks specific to nanotechnology need to be developed.

Lack of Tools to Evaluate Products: As has been pointed out previously in this report, many of the test methods, protocols, and tools needed to detect nanomaterials or characterize and measure their properties in a variety of settings are still at a very early stage of development. It is difficult if not impossible to regulate materials that cannot be detected or their properties measured.

Number and Diversity of Materials and Products: A major challenge facing government agencies responsible for the management of nanotechnologies is the number of diverse nanomaterials and nano enhanced products that are being produced or developed. As John Balbus from Environmental Defense pointed out ―nanotechnology entails many fundamentally different types of materials (and hundreds or thousands of potential variants of each); many novel properties that are potentially relevant to risk; many potential types of applications; and multiple sources and routes of and exposure over the full life cycle of a given material or application‖.210 As a result, it will be very difficult for governments to assess the risks in all these products and applications. Contributing to the problem is the perception among the public that nanotechnology is one technology and any problems related to one application will apply to other products and applications.

208

Davies Clarence J., Managing the Effects of Nanotechnology, Woodrow Wilson International Center for Scholars, Project on Emerging Nanotechnologies, 2005 209 Environment Canada and Health Canada, Proposed Regulatory Framework for Nanomaterials Under the Canadian Environmental Protection Act, 1999, Workshop on a Proposed Regulatory Framework for Nanomaterials under CEPA 1999, September 27, 2007. 210

Balbus John, Richard Denison, Karen Florini, and Scott Walsh, Getting Nanotechnology Right the First Time, Position of Environmental Defense, Summer 2005


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Route of Exposure: The fact that the risk posed by nanomaterials may be different depending on the route of exposure adds to the complexity for those making regulatory or policy decisions.

The Rapid Development of Nanotechnology: The anticipated rapid growth of nanomaterials brings significant regulatory challenges. Government regulators are operating in a catch up mode with scientific information and evidence lagging behind the commercialization of the products. Society has moved into a world that as David Rejeski states ―is dominated by rapid improvements in products, processes, and organizations, all moving at rates that exceed the ability of our traditional governing institutions to adapt or shape outcomes.‖ He warns, ―If you think that any existing regulatory framework can keep pace with this rate of change, think again‖.211

Suitability of Existing Regulatory Frameworks to Manage Nanotechnology: None of the legislation or regulations to manage adverse impacts on health or the environment was drafted with nanotechnology in mind. The question that arises is whether or not products of nanotechnology will fit under the existing statutory frameworks. For example, existing regulations for substances are based on their chemical properties and the assumption that there is a direct relationship between quantity or volume of the substance and degree of risk. In the case of nanomaterials, their properties appear also to be based to a great degree on physics and physical structure such as size, shape and surface structure.

Innovation and Trade: Regulators must also consider the impact of any regulation on innovation, progress, and the establishment of technical barriers to trade.

Expectations of the Public: From a number of studies and initiatives engaging consumers that were carried out in Canada212,213, the United States214 and Britain215, there appears to be a striking similarity in what consumers expect from their governments related to managing nanotechnology‘s potential risks. They expect:

Information to be supplied about the products and any harmful effects to support informed consumer decisions;

211 Rejeski, David, The Next Small Thing, The Environmental Forum, March/April,2004 pp. 42–49 212

Genome Prairie GELS team, University of Calgary, First Impressions: Understanding the public's views on emerging technologies http://www.biostrategy.gc.ca/CMFiles/CBS_Report_FINAL_ENGLISH249SFD-9222005-5696.pdf 213

Canadian Institute for Environmental Law and Policy, Stakeholder Meeting on Nanotechnology, Friday March 16 2007, www.cielap.org 214


The Royal Society and Royal Academy of Engineering Nanotechnology Working Group Prepared by: BMRB Social Research, Nanotechnology: Views of the General Public Quantitative and qualitative research carried out as part of the Nanotechnology study, Jan 2004, www.nanotec.org.uk/Market%20Research.pdf







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Increased safety testing of products before they are marketed;

A requirement that producers are obligated to prove that their products are safe;

Manufactured nanoparticles should be assessed as new substances; and

Products containing nanomaterials intended for consumers should be clearly labelled.

A coalition of consumer, environmental, labour and public health advocacy groups from around the world recently called for strong, comprehensive oversight of the new technology and outlined eight principles that should be followed by governments. I. “A Precautionary Foundation: Product manufacturers and distributors must bear the burden of proof to demonstrate the safety of their products: if no independent health and safety data review, then no market approval. II. Mandatory Nano-specific Regulations: Nanomaterials should be classified as new substances and subject to nano-specific oversight. Voluntary initiatives are not sufficient. III. Health and Safety of the Public and Workers: The prevention of exposure to nanomaterials that have not been proven safe must be undertaken to protect the public and workers. IV. Environmental Protection: A full lifecycle analysis of environmental impacts must be completed prior to commercialization. V. Transparency: All nano-products must be labelled and safety data made publicly available. VI. Public Participation: There must be open, meaningful, and full public participation at every level. VII. Inclusion of Broader Impacts: Nanotechnology�s wide-ranging effects, including ethical and social impacts, must be considered. VIII. Manufacturer Liability: Nano-industries must be accountable for liabilities incurred from their products.‖216

4.1.2. Nationally A complex regulatory framework involving many federal and provincial government departments and agencies exists in Canada to manage the diverse consumer products containing nanomaterials. At the Federal level, Environment Canada (EC), Health Canada (HC), the Pest Management Regulatory Agency (PMRA), the Canadian Food Inspection Agency (CFIA) and Industry Canada (IC) are all involved.

216 International Center for Technology Assessment, Broad International Coalition Issues Urgent

Call For Strong Oversight of Nanotechnology, 07/31/2007


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Provincially, agencies to protect workers, human health and the environment, to ensure safe drinking water and to build research and industrial capacity are involved. The national legislation or regulations that potentially could provide oversight with respect to products used by or to which consumers are exposed are outlined below.

The Canadian Environmental Protection Act (CEPA) was put in place by parliament to prevent pollution and protect the environment and human health. CEPA provides the Ministers of the Environment and Health with the authority to assess and mange new and existing chemicals, to gather information, in order to assess and manage the risks to the environment and human health from such chemicals on the Canadian market. The New Substances Notification Regulations under CEPA require that companies submit a notification to EC and HC of any new substance to be imported into or manufactured in Canada or where there is a significant new activity and provide the information required by the regulations.

Where the application of a nano enhanced product, such as a pesticide or pharmaceutical, is addressed under other appropriate legislation (e.g. Pest Control Products Act, Food and Drugs Act) CEPA does not apply. In the case of chemicals regulated under CEPA decisions have to be made as to whether or not a nanomaterial is ―new‖ if it differs merely in size from the listed substance; or whether there should be a different low volume exemption threshold for nanomaterials. The first step toward a coherent policy on nanotechnology is to recognize that risks of the nanoscale are often size and structure dependent and uniquely different than those of their larger counterparts. In order to address the challenges to the regulatory regime under CEPA, EC and HC proposed an approach to develop a regulatory framework for nanomaterials.217 Consultations on this approach were undertaken by the two departments in the fall of 2007. It was proposed that the development of regulations consists of two phases. The first phase would involve continuing to work with international partners to develop scientific and research capacities; inform companies involved with products of nanotechnology of their regulatory responsibilities under current regulations; develop initiatives to gather information from industry on uses, properties and effects of nanomaterials; and consider where amendments would need to be made to facilitate the risk assessment and management of nanomaterials. The second phase would involve resolution of the terminology and nomenclature; consideration of the establishment of data requirements under the New Substances Notification Regulation; and investigating the use of the Significant New Activity provision of CEPA to require notification of nanoscale materials considered to already exist in Canada. Manufacturers or importers of substances that are on a list of existing substances in Canada are not normally required to provide information unless it is deemed that the substance is being used for a different purpose.

217

Environment Canada and Health Canada, Proposed Regulatory Framework for Nanomaterials Under the Canadian Environmental Protection Act, 1999, Workshop on a Proposed Regulatory Framework for Nanomaterials under CEPA 1999, September 27, 2007, www.ec.gc.ca/substances/nsb/eng/nanoproposition_e.shtml



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The Food and Drugs Act (FDA) provides HC with the authority to regulate the safety of foods and cosmetics and the safety, efficacy and quality of drugs, vaccines, medical devices, and natural health products (e.g. vitamins, herbal remedies, and homeopathic medicines).

New drugs, medical devices, vaccines, and natural health products must undergo a review to assess their safety, efficacy and quality before they can be sold in Canada. The manufacturer must provide HC with scientific evidence from both pre-clinical and clinical studies, of its therapeutic value, conditions for use and side effects. HC scientists review the evidence to determine whether the potential benefits associated with the product warrant the risks the product may present. If the risks are acceptable, and if the product has been shown to be effective, it is approved for sale in Canada. HC continues to monitor the product once it reaches the market by evaluating reports of suspected problems received from manufacturers, health care professionals and consumers and taking appropriate action if a serious health risk is identified.

In the case of food products and food packaging the assessment of these products varies considerably depending on the particular product. For example, new food additives or new uses for food additives require the manufacturer to provide detailed information about the additive for pre-market safety evaluation by HC scientists before it can be used in foods for Canada. With respect to most foods sold in Canada, HC sets policies and standards to govern the safety of food which the supplier is expected to meet and these are then enforced by CFIA. In the case of materials use to package food, the regulation places the responsibility on the seller to ensure that it meets the regulations. A manufacturer, however, may submit information about the material to HC for evaluation on a voluntary basis. No regulations to deal specifically with products of nanotechnology used in food or food packaging have been developed at this time.

Regulations for cosmetics are in place under the FDA. These regulations set standards and/or requirements for general safety, labelling and notification. Pre-market evaluation of a cosmetic is not carried out as the safety of the product when used as intended is the company‘s responsibility. The company must notify HC when it markets a cosmetic and provide information about the company, the purpose of the product, its form, ingredients and concentrations of ingredients. There are no specific requirements to identify nanoscale ingredients. The regulations are enforced by monitoring the market and addressing safety problems indentified.

HC is currently using the existing regulations under the FDA to assess the safety and efficacy of applications of nanotechnology. However, it recognizes that new approaches may be necessary and has established a Nanotechnology Working Group to gather scientific data and identify areas where additional regulations may need to be developed. Information with respect to this analysis does not appear to be available to the public.

The Hazardous Products Act (HPA) covers the safety of a wide range of consumer products and the administration and enforcement of this Act is the responsibility of HC. This act covers "any product designed for household, garden or personal use" including products used "in sports or recreational activities, as


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lifesaving equipment or as a toy, plaything or equipment used by children". However under this Act, suppliers are not required to submit safety data for pre-market evaluation or to report adverse incidents that may occur after the product has been marketed. HC also does not have the authority to prevent the marketing of these products and can only take action once the product is on the market and found to pose a safety hazard. The undertaking of a review and possible modernization of this Act was announced by the Minister of Health in the fall of 2007. A consultation on the proposed initiative218 commenced in January 2008 and any changes that may result could possibly improve the ability of HC to deal with this new technology. The Workplace Hazardous Materials Information System (WHMIS) is mandated under the Hazardous Products Act. WHMIS is a hazard communication regime designed to protect workers. It requires cautionary labelling of WHMIS controlled products, the provision of Material Safety Data Sheets (MSDS) and worker education. At the present time, most MSDSs for nanomaterials reflect the properties of these materials at a macro scale and not at the nanoscale. This means that many workers may not have the safety information on how to protect themselves when working with these materials.

The Pest Control Products Act was established by Parliament to protect human health and the environment by minimizing the risks associated with pest control products. The PMRA which reports to the Minister of Health is responsible for administering this Act. The Act requires companies that wish to sell a pest control product in Canada to submit detailed information and data about the safety of the product for evaluation by PMRA. The evaluation results either in the product being granted registration and allowed to be sold and used in Canada, or in the product being refused registration. To enforce the legislation, PMRA has the authority to investigate the use, sale and importation of products; perform on-site inspection of usage and storage of products; do soil, crop and product sampling; and educate individuals, local officials and grower groups as to regulatory requirements.

Although Canada has many regulatory programs in place that can be used to address various health and environmental risks associated with consumer products, these programs were not designed to deal with nanomaterials. Many nanoscale substances can fall through the gaps and are either not regulated or under regulated and could potentially pose risks to the public that are only discovered when adverse effects occur. Deficiencies in these regulatory programs are outlined below.

Many consumer products that contain nanoscale materials do not require assessment or pre-market approval by government prior to their entry into the Canadian market. These include cosmetics regulated under the Food and Drugs Act and consumer products such as clothing, sports equipment, products intended for children, household furnishings and household chemicals regulated under the Hazardous Products Act. HC is only able to take action against these products if they cause adverse health effects after being sold.

218

Health Canada, Strengthening and Modernizing Canada's Safety System for Food, Health and Consumer Products Discussion Paper on Canada's Food and Consumer Safety Action Plan,Jan. 10, 2008, www.healthycanadians.ca

http://www.healthycanadians.ca/


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It is not clear how socks, turtleneck shirts, watch chains, taps, cleaning sprays, kitchen ware and appliances that contain nano-silver and are being advertised for their ―anti-microbial‖ properties will be classified and dealt with. Since health and/or disinfectant type claims are being made about these general consumer products, it is not clear whether they will fall under the Food and Drugs Act, the Pest Control Products Act or the Hazardous Products Act. Depending on what claims are made and which regulatory framework is applied, the product may or may not be assessed for its impact on human health or the environment prior to sale.

It is anticipated that many of the nanotechnology products regulated by HC will be combination products (e.g. drug-medical device). Since the regulations are specific to certain types of products, combination products make the decision about which regulations to apply complex.

The New Substances Notification Regulations under CEPA establish the provisions for health and environmental assessment and management of chemicals and polymers before they enter the Canadian market. Nanoscale substances that do not have unique structures are considered to be an existing substance and are not assessed. Since it is difficult to identify and characterized the structures, nanoscale substances with novel properties could be entering Canada without any scrutiny by EC and HC. Moreover, because of their novel properties the data requirements specified in these regulations may not be adequate to assess the risks that may be associated with nanomaterials.

In many cases, an assessment under CEPA is only triggered when the weight of a substance is greater than a threshold amount determined by regulations. Unlike macro scale chemicals where mass is a major factor in toxicity, the toxicity of nano materials which are very reactive due to their large surface area to mass ratio may be based on size and shape instead of mass.

The voluntary reporting initiative being established under CEPA will prove useful in allowing EC and HC to become familiar with the firms producing nanomaterials and the materials themselves. However, if it results in delays in establishing an adequate oversight system, Canadians will not be given the protection they should have.

4.1.3. Internationally

4.1.3.1. United States

In the United States, twenty- five government agencies have been brought together under the auspices of the National Nanotechnology Initiative (NNI) in an effort to coordinate federal work. The agencies involved are responsible for carrying out or supporting nanotechnology research and development and/or regulating many products intended for consumers that contain nanomaterials. According to many experts inside and outside government, very little of the government‘s investment in research is directed towards identifying and managing the effects of nanomaterials on human health, the environment, and society.219,220

219


Bergeron Stephane and Eric Archambault, Report for Environment Canada, Canadian Stewardship Practices for Environmental Nanotechnology, March 2005, www.science-metrix.com/eng/reports_2005_t.htm




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The effectiveness of oversight of the safety of nanomaterials and consumer products containing nanomaterials varies considerably depending on the type of material or product. Chemical substances may be required to undergo a review and products such as drugs and medical devices undergo rigorous pre-market review before they can be sold in the United States similar to Canada. While other products even if they contain the same nanomaterials are not reviewed and can only be dealt with if they cause adverse health effects after sale. Moreover like Canada, there are no labelling requirements for nano enabled products in the United States. The Environmental Protection Agency (EPA) under the Toxic Substances Control Act (TSCA) has the authority to gather data on health and environmental effects and exposures to both new and existing chemicals. The purpose is to prevent new chemicals from being marketed without adequate safeguards and to fill gaps in the regulation of existing chemicals. Manufacturers of new chemicals must notify EPA before placing a substance into commerce and depending on the amount to be supplied provide data on its impact on human health and the environment. EPA scientists will review the data. Under a ―Significant New Use‖ provision, the EPA can require that an existing chemical or category of chemicals be regulated as a new chemical. It appears that most nanomaterials would be excluded from the legislation since:

chemicals produced in volumes of less than 10,000 k gms per year are exempt;

toxicity data does not exist for most of these substances;

EPA announced that it does not intend to consider nanoscale substances that have the same molecular identity as an existing chemical as a new substances221; and

EPA cannot take action unless it shows that the chemical presents an unreasonable risk.

On October 18, 2006, EPA launched a process to design, develop and implement a voluntary Nanoscale Materials Stewardship Program (NMSP) under TSCA222. The purpose of the program is to complement and support EPA's new and existing chemical programs under TSCA and to help provide the scientific evidence required to make sound regulatory decisions. Concerns were raised about limited participation of industry in such a program without a regulatory backstop as occurred in the United Kingdom, and the potential delay in developing a regulatory framework for nanomaterials that may result.223,224

In 2006, when Samsung marketed a ―nano-silver-washing-machine‖ the EPA in response to critical reactions from environmental and consumer organisations reclassified the machine‘s silver ions as a pesticide under the Federal Insecticide,

221

Environmental Protection Agency, TSCA Inventory Status of Nanoscale Substances – General Approach, July 2007. 222

Environmental Protection Agency, Nanoscale Materials Stewardship Program, www.epa.gov/oppt/nano/#stewardship 223

Davies Clarence, Testimony at EPA Public Meeting on Nanoscale Materials Stewardship Program, Aug 2, 2007 224

Environmental Protection Agency, Meeting Summary Report Nanoscale Materials Stewardship Program, (August 2, 2007 Meeting), August 8, 2007

http://www.epa.gov/oppt/nano/#stewardship


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Fungicide and Rodenticide Act . This means that the washing machine must be registered and evidence provided that the interior nano-silver coating does not damage the environment. Thus, any company wishing to sell a product that it claims will kill germs by the release of nanotech silver or related technology will also have to provide scientific evidence that the product does not pose an environmental risk. "We will be able to evaluate them and ensure that these products are not going to do damage to the aquatic environment," said Jim Jones, Director of the EPA's Office of Pesticide Programs.225

The Food and Drug Administration (FDA) like HC is responsible for regulating food, drugs, medical devices, biologics, cosmetics, and dietary supplements under the Food Drug and Cosmetic Act or the Dietary Health and Education Act. In order to identify the regulatory approaches that should be used with nanoscale materials used in products for which FDA is responsible, a Nanotechnology Task Force was formed. One of the conclusions of the Task Force was that where products are subject to pre-market evaluation the agency‘s authorities give the FDA the ability to require companies to provide the detailed scientific information needed to review the safety and efficacy of the products. Leading public interest groups working on nanotechnology policy sharply criticized the FDA task force report for its failure to propose strong protections against the risks posed by nanotechnology and nanoscale materials in consumer products.226,227 Not all products that fall under these Acts are reviewed or approved by the FDA before sale. For example, the FDA is not authorized to require producers of cosmetics to register with the FDA, provide information on ingredients, carry out and report on safety testing of their products or provide such information to the FDA for evaluation prior to sale. Since cosmetics is one of the areas where nanomaterials are being used in products that are actually on the market and since the FDA does not have the authority to require that they be evaluated prior to sale, the FDA has introduced a voluntary reporting system for cosmetics. The Voluntary Cosmetic Registration Program228 was established to obtain information from manufacturers about the production and ingredients used in cosmetic products.

The Consumer Product Safety Commission has the responsibility for the safety of a wide range of consumer products many of which contain nanomaterials. Like HC, it does not have the authority to prevent the marketing of these products and can only take action once the product is on the market and found to pose a safety hazard. It can, however, implement labelling requirements for products. Manufacturers, retailers and distributors of consumer products containing nanomaterials are obligated to report to the Commission immediately if they obtain information that the product fails to comply with a consumer product safety rule, contains a defect or causes serious injury or death.229

225

Jones Jim, Director EPA‘s Office of Pesticide Programs, Quoted in Washington Post, Thursday, November 23, 2006; Page A01 226

International Center for Technical Assessment, Press Release, FDA Nanotech Task Force Report Fails to Address Serious Risks to Health, Environment and Workers, July 25, 2007 227

Cairns Carolyn, Consumer Union, Presentation at the Food and Drug Administration, Nanotechnology Task Force, Pubic Meeting on Nanotechnology Material in FDA Regulated Products, October 10, 2006, Pp 62-69 228

www.cfsan.fda.gov/~dms/cos-regn.html, 229 Thomas Treye, Overview - Strategies for Assessing Nanomaterial Health Risks in

http://www.cfsan.fda.gov/~dms/cos-regn.html


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4.1.3.2. European Union

The European Commission in developing policies on nanotechnology has taken a different approach than most other countries. It is basically trying to create a balance between the commercial development of nanotechnology and the impacts on society. The Commission has adopted a comprehensive strategy and action plan whose overall objective is to create ―safe, integrated and responsible development of nanotechnology.‖230 In the strategy, safety is clearly indicated as one of the key conditions to the success of nanotechnologies in Europe. Public health, occupational health and safety, environmental and consumer risks of nanotech applications must be addressed at an early stage. The Commission in reviewing its regulations concluded that the existing legislation will cover the potential risks posed by nanomaterials. However, the European Union‘s Committee on the Environment, Public Health and Food Safety questioned whether new risks posed by nanomaterials would be recognized by the regulations. The main reasons for this are that none of these legislative or regulatory frameworks in Europe include specific requirements for nanomaterials and that the knowledge and the tools available to measure the safety of these products are very limited.231 Like Canada, there are a number of statues in the European Union that deal with the safety of nano enhanced products intended for consumers in the chemical, food and non-food areas. For some products or substances (e.g. drugs, medical devices, chemicals over certain tonnage) data on the safety of the product or substance must be provided for pre-market evaluation. For other products covered by the Cosmetics Directive, Toys Directive and the General Product Safety Directive, industry is responsible for the safety of the products they produce and it is expected that they would assess any risks before placing a product on the market. This is sometimes very difficult to accomplish for products including nano technological components since the data necessary to assess the risks is not always available. The directives provide member state regulators with the authority to take action if the product poses a risk once it is on the market. For chemical substances, a new regulation that will replace the current legislation has been developed and will come into force on June 1, 2008. REACH is the new regulation concerning the Registration, Evaluation, Authorisation and Restrictions of Chemicals. The provisions of REACH apply to the manufacture, import, placing on the market or use of substances on their own, in preparations or in products. The requirements will be the same for both existing and new substances. Any substance that is produced or imported in annual volumes of at least 1 tonne/year either on its own or in a product) must be registered. The registration for volumes above 10 tonnes per year requires a chemical safety report covering all aspects of the life cycle of the product. Since nanomaterials are often produced in small quantities and are of

Consumer Products, 3

rd Nanoregulation Conference, St.Gallen Switzerland, Sept 12-13 Sept

2007. 230

Coggi Paola Testori, Deputy Director-General, Directorate General Health and Consumer Protection, European Commission, Opening Remarks at the 1

st Annual Nanotechnology “Safety

for Success‖ , Dialogue Workshop, Oct 25-26, 2007, Brussels. 231



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low weight, it is not clear whether these materials will be required to even be registered. 4.1.4. Managing Nanotechnology with Regulations

In order to manage nanomaterials and consumer products containing nanomaterials within existing regulatory frameworks, a number of different approaches were

suggested by the Royal Society and the Royal Academy of Engineering232, Swiss Reinsurance Company

233, experts234 and consumer and environmental

advocates.235, 236

These include:

Separating and treating nanomaterials as classes of materials that require special review and oversight;

Requiring that ―ingredients in the form of nanoparticles undergo a full safety assessment by the relevant scientific advisory body before they are permitted for use in products‖237 so that the impact of the novel properties of nanoscale materials on health, safety and the environment for all products that are not pre- approved before they enter the market is determined;

Ensuring that products containing nanomaterials are identified or labeled;

Coordinating existing laws and regulations, clarifying the policies and responsibilities of different government departments and developing classification protocols to make sure the appropriate regulations apply to substances/products, they do not fall between the gaps and duplication is eliminated;

232 The Royal Society and Royal Academy of Engineering, Nanoscience and nanotechnologies: opportunities and uncertainties, July 2004, www.nanotec.org.uk/final/Report.htm 233

Swiss Re,. Nanotechnology. Small matter, many unknowns. Zurich., 2004. 234


Canadian Institute for Environmental Law and Policy, Stakeholder Meeting on Nanotechnology, Friday March 16 2007, Toronto. 236

Kleinman Daniel and Maria Powell, University of Wisconsin, Report of the Madison Area Citizen Consensus Conference on Nanotechnology, April 2005. 237

The Royal Society and Royal Academy of Engineering, Nanoscience and nanotechnologies: opportunities and uncertainties, July 2004, p 95, www.nanotec.org.uk/final/Report.htm

Generic Deficiencies in Regulations

- Many regulations do not adequately address size and structure dependent novel properties of nano substances.

- Mass based standards/thresholds of many regulations will not work (mass will not translate into toxicity: no adequate scientific basis for setting thresholds; not enough risk research).

- Reporting exemptions will exclude many nanotech manufacturing facilities with small production quantities.

- Technologies for pollution control are not available. David R David Rejeski, Woodrow Wilson International Center for Scholars




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Drafting regulations and regulatory process so that they are in-line with accepted international standards to avoid regulatory disputes and misunderstandings between countries;

Amending existing laws or regulations to address deficiencies and the range of nanomaterials and nano enhanced products;

Increasing regulatory and legislative oversight and applying the precautionary and life cycle approach; and

Drafting and enacting new legislation to deal with the potential health and environmental risks of nanotechnology in a comprehensive manner.

4.2. Standards The International Standards Organization (ISO) and the International Electro-technical Commission (IEC) established technical committees to develop international standards for nanotechnologies. These technical committees ISO/TC 229 and IEC SC 113 are working together to develop standards for terminology and nomenclature, measurement and instrumentation, including specifications for reference materials, test methodologies, modeling and simulation, and science-based health, safety and environmental practices. The development of these standards is absolutely crucial to identify and manage any potential risks associated with these products. In January 2008, the British Standards Institute recognizing the need for standards to provide the foundation for the development of nanotechnology published nine documents for nanotechnology guidance and terminology. The aspects covered will help support:

Safety testing, legislation and regulation,

Worker, public and environmental safety,

Commercialisation and procurement,

Patenting and intellectual property rights, and

Communication about the benefits, opportunities and potential problems associated with nanotechnologies.

One of the nine new publications specifically addresses the labelling of products containing manufactured nanomaterials. This voluntary guide will help to ensure that all kinds of users, from professionals to consumers, are aware of the nanomaterial content of products they are purchasing, selecting or handling. It will serve to reduce confusion among the public and consumers faced with a new technology by providing a standardized approach to labelling. They will help industry to select or avoid ingredients based on their nanoscale properties, comply with regulatory requirements and in drafting contracts. Two publications, will offer good practice guidance to ‗specifying nanomaterials‘ and to ‗safe handling and disposal of engineered nanoparticles‘. In addition, other documents were published dealing with terminologies for a broad spectrum of applications and for specific application of nanotechnologies in cosmetics, sunscreens and medicinal products.238

238

BSI Press Release, New Publications, Standardizing nanotechnologies, the heavyweight small science, 15 November 2007


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The Organization for Economic Development (OECD) established a working party on Manufactured Nanomaterials239 to help member countries efficiently and effectively address the safety challenges of nanomaterials by developing methods for the safety testing and assessment of chemical products. Basically, OECD wished to address the possible safety implications at the same time as research on new applications is being undertaken. Another initiative in the area of management of risks has been developed by Innovation Society Ltd. and TÜV, a certification body. They have developed a certifiable risk management and monitoring system for firms involved with nanotechnology called CENARIOS®. The process is similar in many ways to certification to the ISO 9000 quality management standard. CENARIOS®, according to those involved, provides a "State-of-the Art" hazard and risk assessment tools to reduce potential risks. It is made up of four elements:

• Risk and Hazard Assessment / Risk Evaluation by a comprehensive survey of risks related to products and processes;

• Risk Monitoring System to identify trends in science, technology and regulation; • Issues-Management and Communication which includes the tools to effectively

cope with risk; and • Certification by TUV.240

4.3. Responsible Industry Development The development and commercialization of products of nanotechnologies presents significant opportunities for industry. However, there is real uncertainty over the potential of adverse effects on human health and the environment. Due to the early stage of scientific knowledge and the lack of many basic elements to identify and to adequately evaluate nanomaterials, governments find it difficult to provide oversight quickly enough to deal with the products on the market or those entering the market. It is, therefore, in the interest of producers to manage the uncertainties surrounding this emerging technology. The Canadian public still has a positive attitude towards nanotechnology as was seen in a recent study241 and the survey carried out for the Consumers Council of Canada

239

http://www.oecd.org/env/nanosafety/ 240

Weidl Thorsten, Gerhard Klein, and Christoph Meiliz, CENARIOS® – A nano risk management system as a business and safety opportunity, 3rd International "Nano-Regulation― Conference 12. – 13. September 2007, St.Gallen (Switzerland)

An early and open examination of the potential risks of a new product or technology is not just good common sense — it's good business strategy. We need to make sure this assessment takes place now for today's "next big thing" — nanotechnology. With the right mix of voluntary corporate leadership, coordinated research, and informed regulation, we can reap the benefits of this promising technology while reducing the likelihood of unintended consequences. Fred Krupp, President of Environmental Defense, and Chad Holliday, CEO of DuPont, Wall Street Journal, June 14, 2005.

http://www.oecd.org/env/nanosafety/


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(Appendix 3). Moreover, governments have not yet established regulations. By developing responsible strategies and approaches during this transitional period, industry has the opportunity to maintain the public‘s confidence in nanotechnology and to avoid the type of backlash that occurred over Genetically Modified Organisms. One mechanism to fulfill this responsibility is to establish and implement codes of good practice or standards of care for the production, distribution and disposal of nanoscale materials. According to Environmental Defense, these codes or standards should include a framework and a process to identify and manage nanoscale materials‘ risks across a product‘s full life cycle, taking into account worker safety, manufacturing releases and wastes, product use, and product disposal. Ideally, such standards of care would help provide a model for the development of sensible regulatory policies.242 To promote the responsible development of engineered nanoscale materials, Environmental Defense in partnership with DuPont developed a framework, the Nano Risk Framework, to evaluate and address any potential risks. The framework provides guidance on the questions that an organization should consider when developing applications for such materials or when using materials provided by external suppliers; the information needed to make risk management decisions; suggestions on how to deal with situations where there is little information; and an actual output worksheet for a company to follow. Moreover, it provides guidance on how to communicate information and decisions to stakeholders.243 One example of a code of good practice is the Code of Conduct Nanotechnology developed by BSAF in 2006. It is a set of rules outlining the responsibility of BSAF to protect employees, customers and business partners, to protect the environment, to participate in safety research, to communicate openly and to strive for a public dialogue. In practical terms the code is implemented by working with closed production systems to limit exposure to workers, assessing the hazards and risks of their products, and conducting research into human health and environmental impacts.244 The Royal Society, Insight Investment, the Nanotechnology Industries Association and the Government of the United Kingdom held a workshop to explore oversight issues with industry and possible solutions245. As a result of the recommendations from the workshop, these organizations are currently in the process of developing a voluntary code entitled the Responsible Nanotechnologies Code. A consultation document was distributed in October 2007 to interested parties not only in Europe but internationally. The purpose of the initiative is to help companies identify the risks associated with nanomaterials; share information with others including consumers; and prevent

241

Gaskell George and Jonathan Jackson, A Comparative Analysis of Public Opinion: Canada, the USA and the European Union, First Impressions: Understanding Public Views on Emerging Technologies, Genome Prairies GELS Team at the University of Calgary, 242


Environmental Defense – DuPont Nano Partnership, Nano Risk Framework, June 2007. www.NanoRiskFramework.com 244

Kranz Carolin, Code of Conduct: A suitable tool for the sustainable development of nanotechnologies - the BASF experience, 3rd International „Nano-Regulation― Conference 12. – 13. September 2007, St.Gallen (Switzerland) 245

Insight Investment, the Royal Society and Nanotechnology Industries Association, Workshop Report, How can business respond to the technical, social and commercial uncertainties of nanotechnology, www.responsiblefutures.com


http://www.responsiblefutures.com/


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exposure of workers and consumers to any risks identified. It states in the document ―Our aim is to develop a voluntary, principles-based Code, which is appropriate for adoption by organisations of all sizes involved in the research, development, manufacturing and retailing of products using nanotechnologies.‖246 The code as proposed would require companies to carry out extensive health and safety testing, to examine effects on workers and consumers, and to lodge authority for nanotech matters with the board. A governance and reporting structure is also being considered.

4.4. Insurance Industry

The commercialization of nanotech products brings about the possibility of a whole range of new product liability issues for the insurance industry. With any new technology, as the gaps in scientific knowledge are filled, defects and adverse impacts are discovered. For the insurance industry, it is very difficult to calculate suitable premiums since at this stage they are unable to estimate the costs of potential claims. Therefore, they are very much involved in developing risk management tools to help

industry prevent or reduce losses.247

It appears that companies that insure commercial

and industrial enterprises have taken the position that emphasis has to be placed on determining how nanotechnology risks can be best managed. Allianz, a European Insurance Company, suggested the following elements for a successful risk management framework:

- ―sufficient funding of independent research on nanotechnology related risks with

active steering by government; - transparency and open access to the results of research activities; - ongoing dialogue between insurers and commercial clients; - international standards and nomenclature; - adequate regulation of risk issues; and - a global governance approach‖. 248

4.5. Regulatory Concerns of Consumers and Advocacy Groups The challenges for consumers and advocacy groups related to the regulation of nanomaterials are significant given their lack of knowledge about these technologies and the consumer products that are being marketed or under development. Studies carried out at the University of Calgary in 2004/5 found that almost half of those surveyed believe that the regulatory system for emerging technologies including nanotechnology is somewhat or very lax.249 Several key reasons for the views were identified and included:

246 Secretariat of the Responsible Nano Code Initiative, Responsible Nanotechnology Code Consultation Draft – 17 September 2007, www.responsiblenanocode.org. 247

Schmid Gerhard, Insuring nano – Perspective of MunichRe, 3rd International "Nano-

Regulation― Conference 12. – 13. September 2007, St.Gallen (Switzerland) 248

OECD and Allianz, Editor: Dr. Christoph Lauterwasser Allianz Center for Technology, Small size matters: Opportunities and risks of Nanotechnologies, Report in co-operation with the OECD International Futures Programme, p5. 249 Walker Jeff, Report on a Study of Emerging Technologies in Canada and the U.S.: Prevailing Views, Awareness and Familiarity Genome Prairie GELS Team, University of Calgary, First

Impressions: Understanding the public's views on emerging technologies, p.6 http://www.biostrategy.gc.ca/CMFiles/CBS_Report_FINAL_ENGLISH249SFD-9222005-5696.pdf

http://www.responsiblenanocode.org/



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―Concerns that people who work in regulatory systems are not able to ―keep up‖ with new technologies;

Concerns that corporate influence can have undue influence on decisions make by regulatory bodies; and

Concerns that not enough resources are dedicated to this function within Government‖.

The result was that only 17% of Canadians had confidence in the existing ―safety and regulatory approval systems governing nanotechnology‖.250 One of the causes of this may be the lack of information that consumers are receiving about the actions of government to manage the technology. This was confirmed by a survey carried out for this report by the Consumers Council of Canada‘s Public Interest Network where it was found that 97% of the respondents in the survey of reported that they were not aware of anything that government was doing to manage the technology (Appendix 4).

In a similar study carried out by Jane Macoubrie in the U.S.251, the participants found that no more than 50% of respondents believed that they could trust government regulators of the EPA, FDA and the Consumer Product Safety Commission to regulate nanotechnology based products accurately and successfully. This limited trust in government was also expressed in a British study carried out for the Royal Society. 252 Consumer dialogues in Germany, the United Kingdom, Switzerland253, the United

States254,255 256 and a Canadian stakeholder meeting 257 resulted in a number of recommendations regarding the management of risks related to nanoscale materials.

250

Einsiedel Edna, In the Public Eye: The early landscape of nanotechnology among Canadian and US Publics, Genome Prairie GELS Team, University of Calgary, First Impressions: Understanding the public's views on emerging technologies, p.99 http://www.biostrategy.gc.ca/CMFiles/CBS_Report_FINAL_ENGLISH249SFD-9222005-5696.pdf 251


Nanotechnology: Views of the General Public. London, U.K.: BMRB Social Research,

January 2004, BMRB/45/1001-666. Available at www.nanotec.org.U.K./Market%20Research.pdf 253

Buning Monika, Federation of German Consumer Organisations, Germany Buying Nano – What Consumers Want To Know, 3rd International "Nano-Regulation― Conference 12. – 13. September 2007, St.Gallen (Switzerland) 254

Kleinman Daniel and Maria Powell, University of Wisconsin, Report of the Madison Area Citizen Consensus Conference on Nanotechnology, April 24, 2005. 255

Cairns Carolyn, Consumer Union, Presentation at the Food and Drug Administration, Nanotechnology Task Force, Pubic Meeting on Nanotechnology Material in FDA Regulated Products, October 10, 2006, Pp 62-69 256

Woodrow Wilson International Center for Scholars and Consumers Union, Consumers talk nano, web dialogue, Oct 23 and 24, 2007. 257

Canadian Institute for Environmental Law and Policy, Stakeholder Meeting on Nanotechnology, Friday March 16 2007, www.cielap.org

“What I hear from the governments of Canada and Ontario is silence, deafening silence.”

Public Interest Network Respondent




http://www.nanotec.org.u.k./Market%20Research.pdf



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Those participating in a citizens consensus conference at the University of Wisconsin recommended that *Given the unique physical characteristics of nanoscale materials, we recommend the burden of proof of the safety of new products should be on the producers of products that have nanoscale materials in them‖. In other words, producers should be required to prove their products are safe, rather than consumers being required to prove these products are unsafe.

Consumers participating in dialogues across Europe, the US and Canada emphasized that it was critical that products containing nanomaterials be so labelled and producers declare when nanomaterials are present in a product so that consumers have the freedom to choose whether to use these products. This view was also expressed in a study258 of Canadian attitudes to new technology and by the Consumers Union259 in the United States which urged the FDA to require labelling of products that contain nanoscale ingredients.

Participants recommended that government develop a clear and precise definition of nanotechnology in order to determine which products should fall under any nanotechnology-related regulations.

It was recommended that specific health and safety testing processes for nanoscale materials be developed and that the results should include disclosure of nano substances in products and also information on the effects of interactions between all materials that make up the product.

It was recommended that civil society stakeholders should be brought into policy discussions very early in the process for the development of robust and publicly acceptable decisions on nanotechnology

From the studies that have been carried out, the common take home messages to governments from consumers nationally and internationally on what they expect in terms of oversight include:

increased safety testing of products before they are marketed,

more information and labelling of products that contain nanomaterials so consumers can make informed choices,

requiring producers to prove their products are safe,

developing and implementing mechanisms to inform public of potentially harmful effects, and

testing and regulating manufactured nanoparticles as if they were a new substance.

258

Walker Jeff, Report on a Study of Emerging Technologies in Canada and the U.S. Prevailing Views, Awareness and Familiarity, Genome Prairie GELS team, University of Calgary, First Impressions: Understanding the public's views on emerging technologies, http://www.biostrategy.gc.ca/CMFiles/CBS_Report_FINAL_ENGLISH249SFD-9222005-5696.pdf 259

Cairns Carolyn, Consumer Union, Presentation at the Food and Drug Administration, Nanotechnology Task Force, Pubic Meeting on Nanotechnology Material in FDA Regulated Products, October 10, 2006, Pp 62-69

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Chapter 5. Consumers’ Knowledge and Views on Nanotechnology

There is a wider group of social and ethical concerns relating to society‘s and consumers‘ awareness of nanotechnology and how they view the application of this technology. It involves concerns about who wins and who loses; how open and transparent are businesses and governments in conducting their affairs; to what extent is the public involved; and whether there are oversight mechanisms in place to ensure hazards are identified and products are regulated. There are also ethical issues stemming from specific applications of the technology; for instance, civil liberty issues arising from the application of nanosensor devices for surveillance and humanity issues arising from enhancing human performance capabilities. The debate around nanotechnology is becoming more public and is based on two opposing views of the technology260. There is one group which is very optimistic and believes the technology will result in a society where the costs of goods and services are substantially reduced, computers are billions of times faster than today, and medical advances have led to a virtual end to illness, aging and death. While opposing this view are those that are pessimistic about the technology and believe it will increase global inequalities261, cause social disruption and that nanorobots will take over the world. The challenge for all those involved is how to fully realize the societal benefits of nanotechnology while identifying and minimizing any adverse impacts to humans or ecosystems from exposure to nanoscale materials. The divergent views are well discussed in a report reviewing nanotechnology prepared for Greenpeace.262 Due to the diverse applications of the technology, Greenpeace has indicated that there may be some very beneficial applications of nanotechnology in the areas of medicine, the production of clean energy and pollution prevention and remediation. However at the same time, the organization has concerns about the impact on human health and the environment and whether it will increase the divide between rich and poor individuals and countries.

260

Arnall Alexander and Douglass Parr, Moving the nanoscience and technology (NST) debate forwards: Short-term impacts, long-term uncertainty and the social constitution, Contribution paper to EC Workshop on Risk Analysis, Mar 2004, http://europa.eu.int/comm/health/ph_risk/events_risk_en.htm. 261


Aarnail Alexander Huw, Future Technologies, Today's Choices, Nanotechnology, Artificial Intelligence and Robotics,; A technical, political and institutional map of emerging technologies. A Report for the Greenpeace Environmental Trust, July 2002, www.greenpeace.org.uk

―We suggest that corporations and start-ups developing nanotechnology applications have as much to lose from perceptual risks as to real ones. Real risks apply to specific materials and applications, but perceptual risk could make commercialisation of any nanomaterial unfeasible.” Lux Research Testimony to the House Committee on Science Nanotech Environmental, Health and Safety Risks and Action Needed. USA Nov 2005

http://europa.eu.int/comm/health/ph_risk/events_risk_en.htm




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Some studies263,264 have shown that Canadians and Americans are generally optimistic about nanotechnology, particularly in the areas of health and medicine. Approximately, 78% of Canadians indicated that they could see major or modest benefits to the economy. In a survey of Canadian consumer advocates, the applications that were identified as having the greatest benefits were medical devices, drugs, and energy efficiency. The applications that they felt would pose the greatest risks were food, cosmetics and drugs. (Appendix 4) It is interesting that drugs were considered both as a benefit and a risk. This view is consistent with the results of an European survey which found the majority of consumers opposed the use of nanomaterials in food.265 Another main concern related to the privacy implications of certain nanotechnology sensor or surveillance applications which were also a major concern of the American public266. In the survey of Canadians carried out for Consumers Council of Canada (Appendix 3), those surveyed who had heard at least something about the technology were very optimistic. Even though the majority of those who participated indicated that they were not knowledgeable about the technology, 57% of those surveyed indicated that they were not concerned at all about the technology while only 7% indicated that they were very concerned and 34% indicated that they were somewhat concerned. Those with a public school education demonstrated the highest level of concern and those in the 18-29 age group the lowest. The results were similar across the country except for British Columbia where the respondents had higher levels of concern with the technology. These results are overall consistent with early studies that showed that Canadians were optimistic about the technology. These results, however, are very different from those reported in two surveys carried out recently in the United States by Hart267. He reported that the majority of those surveyed (35%) believed that the risks will outweigh the benefits from nanotechnology, that 15% think the benefits will outweigh the risks and that 43% were not sure. It is interesting to note that, although Canadians were supportive of the technology, many of them asked for more oversight and stringent regulations to manage the risks and to deal with ethical issues. In this regard, a majority opted for decisions being based on scientific evidence and expert judgement.268 As the author stated, ―When the

263

Walker Jeff, Report on a Study of Emerging Technologies in Canada and the U.S. Prevailing Views, Awareness and Familiarity, Genome Prairie GELS team, University of Calgary, First Impressions: Understanding the public's views on emerging technologies, http://www.biostrategy.gc.ca/CMFiles/CBS_Report_FINAL_ENGLISH249SFD-9222005-5696.pdf 264

Einsiedel Edna F, In the Public Eye: The early landscape of nanotechnology among Canadian and US Publics, First Impressions: Understanding Public Views on Emerging Technologies, Genome Prairies GELS Team at the University of Calgary, http://www.biostrategy.gc.ca/CMFiles/CBS_Report_FINAL_ENGLISH249SFD-9222005-5696.pdf 265

Halliday Jeff, Consumers Against Nanotech in Food, says Bfr. Nutra ingredients.com, Dec 12, 2007. 266

Scheufele Dietram A. and Bruce V. Lewenstein, The public and nanotechnology: How Citizens Make Sense of Emerging Techniques, J. Nanoparticle Research, Vol 7(6), 2005, 659-667. 267

Peter Hart Associates, Awareness Of And Attitudes Toward Nanotechnology And Federal Regulatory Agencies, Report on a National Survey of Adults on behalf of the Woodrow Wilson International Centre for Scholars, Sept 19, 2007, http://www.nanotechproject.org/78/public-awareness-of-nano-grows-but-majority-unaware 268

Gaskell George and Jonathan Jackson, A Comparative Analysis of Public Opinion: Canada, the USA and the European Union, Genome Prairie GELS team, University of Calgary, First



http://www.nanotechproject.org/78/public-awareness-of-nano-grows-but-majority-unaware



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chips are down, around two-thirds opt for a scientific basis to decision making; just fewer than three-quarters opt for decisions made by experts. To sum up, the majority of people retain confidence in scientific evidence and expert advice‖. A UK study269 outlined both the more general concerns of consumers and the perceived benefits of nanotechnology. For example, they were concerned about many aspects of nanotechnology, including:

Its impact on society as a whole in terms of employment; social freedom and control; the position of the Third World in relation to industrialised nations; and the possibility of corporations gaining influence;

Whether or not nanotechnology, and devices using it, would work, particularly for applications used within the human body;

The long-term and side-effects of nanotechnology: whether enough was being done to establish what these were, and whether or not lessons had been learned from the past (e.g. from nuclear technology);

Whether nanotechnology could be controlled: whether this could be done internationally as well as nationally; and

Whether the public would be involved in the decisions being made and whether the public‘s concerns would be listened to.

Those participating in the consumer jury on nanotechnology also felt that the technology had the potential to benefit society. It is an untried technology with an unknown potential to benefit individuals and their quality of life through the creation of new products and medical treatments.

5.1. Knowledge of Consumers About Nanotechnology

The studies and surveys270,271 that have been carried out indicate that the Canadian consumers have heard little about nanotechnology and are not aware that many nano enhanced consumer products are already being sold. Even after hearing an explanation of nanotechnology, 65% of Canadians surveyed in 2005 reported that they were not very familiar or not at all familiar with the technology while those who were very familiar or somewhat familiar with nanotechnology comprised 35%. In order to determine whether or not the awareness level has changed among Canadians, questions were added to an omnibus survey in September 2007 as described in Appendix 3. The results indicate that over 70% of those surveyed from across the country had little or no awareness of nanotechnology. Males (33%) tended to be more aware of the technology than females

Impressions: Understanding the public's views on emerging technologies http://www.biostrategy.gc.ca/CMFiles/CBS_Report_FINAL_ENGLISH249SFD-9222005-5696.pdf 269

The Royal Society and Royal Academy of Engineering Nanotechnology Working Group Prepared by: BMRB Social Research, Nanotechnology: Views of the General Public Quantitative and Qualitative Research Carried out as part of the Nanotechnology study, Jan 2004, www.nanotec.org.uk/Market%20Research.pdf 270

Walker Jeff, Report on a Study of Emerging Technologies in Canada and the U.S. Prevailing Views, Awareness and Familiarity, Genome Prairie GELS team, University of Calgary, First Impressions: Understanding the public's views on emerging technologies, 271

Einsiedel Edna F, Introduction: Making Sense of Emerging Technologies, First Impressions: Understanding Public Views on Emerging Technologies, Genome Prairies GELS Team at the University of Calgary, http://www.biostrategy.gc.ca/CMFiles/CBS_Report_FINAL_ENGLISH249SFD-

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(15%) and those with university or college education (31%) appeared to have a greater awareness than those with a public school (20%) or high school (14%) education. Not surprisingly, those over 50 years of age (20%) tended to be less knowledgeable about the technology than those in the 18-29 (25%) or the 30-49 (27%) age groups. The results for three of the six regions of the country were very similar (24%-26%) with only Alberta (32%) having a higher awareness and the Atlantic and Manitoba/Saskatchewan with lower levels of reported awareness (17% - 16%). The higher level of awareness in Alberta may be the result of the establishment in 2001 of the National Institute of Nanotechnology (NINT)272 in Edmonton, Alberta and the news coverage that it received. NINT was established in 2001 to be the centerpiece of Canada's emerging nanotechnology sector. It carries out advanced research and fosters innovation in support of a new generation of nanotechnology based firms.

Surveys that were carried out by Peter Hart Research Associates in 2006273 and 2007274 for the Woodrow Wilson International Center for Scholars showed that just over 70% of Americans surveyed heard nothing or very little about nanotechnology. This fact is illustrated in the figure below from Hart‘s 2007 report.

These findings are similar to those in Canada and were supported by work carried out by Jane Macoubrie275 who found that 95% of the Americans surveyed had ―heard almost

272

National Institute of Technology, http://nint-innt.nrc-cnrc.gc.ca 273

Hart Peter, Awareness And Attitudes Toward Nanotechnology, Report on a National Survey of Adults on behalf of the Woodrow Wilson International Centre for Scholars, Sept 2006 http://www.nanotechproject.org/78/public-awareness-of-nano-grows-but-majority-unaware 274

Peter Hart Associates, Awareness Of And Attitudes Toward Nanotechnology And Federal Regulatory Agencies Report on a National Survey of Adults on behalf of the Woodrow Wilson International Centre for Scholars, Sept 19, 2007, http://www.nanotechproject.org/78/public-awareness-of-nano-grows-but-majority-unaware 275

Macoubrie Jane (2005), Informed Public Opinions and Trust in Government, Woodrow Wilson International Centre for Scholars, http://www.nanotechproject.org/8/who-do-you-trust-public-attitudes-towards-nanotechnology-government-and-industry

http://nint-innt.nrc-cnrc.gc.ca/







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nothing‖ or only ―a little‖ about nanotechnology. In the United Kingdom, a study carried out for the Royal Society found that of over 1000 participants, 80% had never heard of nanotechnology and over 90% were unable to give even the slightest definition of what the term might mean or involve.276 Consumers for the most part believe that nanotechnology products are far from commercialization and they are not aware that many consumer products are actually on the market. For example in the survey of the Public Interest Network (PIN) and the Canadian Standards Association (CSA) consumer representatives only 22% of those who responded were aware of products on the market. (Appendix 4) It is anticipated that as the public becomes aware of this fact, that it will demand assurances that any associated risks have been identified and assessed before they are made available. The fact that only 17% of the Canadian respondents felt confident in government‘s ability to manage any risks associated with nanotechnology277 is of concern. Results among US consumers were very similar278. Research279 into the information sources that members of the public use to obtain information on complex technical issues indicates that the public relies on the judgment of regulatory authorities, interest groups and, more importantly, the information provided by the media. It is alleged that this makes perfect sense since developing an in-depth understanding of nanotechnology would require significant effort and time on the part of consumers with limited benefit. From a study carried out on the content of Canadian media regarding nanotechnology, it was found that reporting on the issue in Canada is

limited and has been in the domain of science reporters who have presented nanotechnology in a positive light focusing on the potential benefits.280 This, however, is likely to change as the subject moves into the main stream media which tends to focus on controversy such as the harmful impacts of a technology (e.g. toxic characteristics of nanomaterials) and the potential for environmental contamination. One such recent example is the media coverage of a report on cosmetic ingredients including nano particles being found in the water supply in Britain. Newspapers such as the Telegraph ran a headline ―Discarded cosmetics 'threat to drinking water.'‖281 A question about where the respondent obtained information about nanotechnology was included in both the telephone survey of Canadians and the PIN/CSA surveys. The results from these surveys can be found in Appendices 3 and 4 respectively. In the

276

The Royal Society and Royal Academy of Engineering Nanotechnology Working Group Prepared by: BMRB Social Research, Nanotechnology: Views of the General Public Quantitative and Qualitative Research Carried out as part of the Nanotechnology Study, Jan 2004, www.nanotec.org.uk/Market%20Research.pdf 277

Einsiedel Edna F, Introduction: Making Sense of Emerging Technologies, First Impressions: Understanding Public Views on Emerging Technologies, Genome Prairies GELS Team at the University of Calgary, http://www.biostrategy.gc.ca/CMFiles/CBS_Report_FINAL_ENGLISH249SFD-

9222005-5696.pdf 278


Scheufele Dietram A.& Bruce V. Lewenstein, The public and nanotechnology: How Citizens Make Sense of Emerging Techniques, J. Nanoparticle Research, Vol 7(6), 2005, 659-667 280 Laing Andrew, A report on Canadian and American news media coverage of nanotechnology issues , First Impressions: Understanding Public Views on Emerging Technologies, Genome Prairies GELS Team at the University of Calgary, 281

Highfield Roger, Science Editor, Telegraph, Dec. 10, 2007







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survey of the general Canadian public, those surveyed indicated that their primary source of information was television shows and the media in general (51%). Some interesting exceptions to this were found among young people 18 to 29 years of age who reported that their primary source of information was schooling (24%) followed by television (20%) and the internet (16%). For males, television and the media (55%) were more important as sources of information than for females (45%). With respect to education, television was the primary source of information for with those with a public school education (46%). They used it to a greater extent than those with high school (26%) or university/college education (22%). In all parts of Canada, television was the primary source of information for consumers about nanotechnology. The consumer advocates who participated in the PIN/CSA surveys reported that they used a greater variety of sources of information than the general population. For example, 84% of this sub sector of the population used newspaper and magazine articles to obtain information on nanotechnology whereas only 23% of the general population did so. The internet (60%) and radio/television (58%) were reported by this group as the second and third important sources of information. Among the general population 7% indicated that they received the information from the internet and 28% indicated that they obtained the information from radio /television shows. The advocates also reported that they obtained information from scientific, government and NGO reports and publications. The use of these sources by the general population was not investigated. Michelson and Rejeski suggested282 that the combination of an uninformed public lacking trust in government‘s ability to manage any potential risks and the increasing number of products on the market that have not undergone a safety assessment is establishing a dangerous situation. A significant backlash against the technology could result similar in many ways to what occurred with genetically modified organisms and biotechnology

5.2. Ethical, Legal and Social Issues Nanotechnology related ethical, legal and social (NE3LS) issues are starting to emerge and gain public attention.283,284,285,286 as the technology develops and is commercialized. The issues that are unique to nanotechnology appear to include those outlined below.

New environmental, health and safety (EHS) risks where nanomaterials in the environment are taken up by cells and adversely affect animals or plants which are part of the food chain creating unknown effects on human health.

282

Michelson Evan S. and David Rejeski (2006), Falling Through the Cracks? Public perception and the oversight of emerging nanotechnologies, Woodrow Wilson International Center for Scholars. www.nanotechproject.org 283

UNESCO, Division of Ethics of Science and Technology and resulting from the second meeting of the group of experts on the ethics of Nanotechnologies, Outline of a Policy Advice on Nanotechnologies and Ethics, HQ 6-7 December 2005 284


Lewenstein Bruce V. (2005), What Counts as a „Social and Ethical Issue‟ in Nanotechnology?, HYLE--International Journal for Philosophy of Chemistry, Vol. 11, No.1, pp. 5-18 286

ETC Group, The Little Big Down: A Small Introduction to Nano-scale Technologies, June 2004. www.etcgroup.org/en/materials/publications.html?pub_id=104



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Privacy concerns due to the potential through nanotechnology to produce miniaturize devices that can be used for surveillance and eavesdropping purposes that will be difficult to detect.

The role of nanotechnology in augmenting human capabilities – such as strength, sight, hearing, memory and longevity. While some support this idea others fear that this will make us less human or pervert the notion of human dignity. 287

The issue of where the products of nanotechnology will be provided is of concern with respect to third world countries. Third world countries could benefit to the greatest extent from the production of clean water and efficient sources of energy by nanotechnology. However as UNESCO has indicated, one of the main problems with emerging technologies is that they are developed and promoted in more developed countries using resources from less developed countries. The problem is compounded by the fact that the results and products generally do not return to these less developed countries that need them.

The lack of connections being made by government, nongovernmental, business, donors, and academia between the development of nanotechnology and those who are in need of safe water, efficient sources of energy, and health care.

Nanotechnology could create major problems for poorer countries if it makes their labour, commodities, and other exports less necessary in the global market. For example, developing countries might suffer from economic displacement due to the loss of markets for raw materials such as natural rubber.

The difficulty of transferring information about potential risks of the technology to the public in developing countries is another issue that needs to be addressed.

Nanotechnology that is tightly linked to basic scientific research will generate intellectual property that is very valuable and will be protected by patents and intellectual property laws. The ownership of the technology through these mechanisms could significantly affect people‘s ability to use nanotechnology and deepened the divide between developed and developing countries.

The Canadian Institute for Environmental Law and Policy held a stakeholder workshop288 to discuss an appropriate policy framework for nanotechnology. There was a consensus among the participants that an ethical framework should form a basic part of any strategy or policies on nanotechnology for Canada. Four different ethical issues were identified during the workshop that need to be considered including equity (rich/poor); privacy (common good / privacy); security; and humanity (where do you draw the line regarding human enhancement).

5.3. Involvement of Consumers in Decisions

Reports by the Royal Society289 , Swiss Re290 and the Canadian Institute for Environmental Law and Policy (CIELAP)291 recommended that an open public dialogue

287 Allhoff Fritz and Patrick Lin, What‟s So Special about Nanotechnology and Nanoethics?,

International Journal of Applied Philosophy (Fall 2006), Vol. 20, Number 2: 179-190 288 Canadian Institute for Environmental Law and Policy, Stakeholder Meeting on Nanotechnology, Friday March 16 2007, Toronto, Ontario, www.cielap.org. 289


Swiss Re, Nanotechnology. Small matter, many unknowns. Zurich, 2004. 291

Holtz Susan, Canadian Institute for Environmental Law and Policy, Discussion Paper on a Policy Framework for Nanotechnology, March 2007, www.cielap.org





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and information was essential to the public accepting the new technology and related policy decisions. It will be a question of whether or not the public sees the advantages of nanotechnology. Such a recognition very much depends on how well informed the public is and to what degree it is able to make an objective judgement. Those who participated in the PIN/CSA surveys reported that they did not feel adequately informed about the scientific issues (80%), the ethical issues (92%), the legal or regulatory issues (94%), the social aspects (89%) or the environmental issues (95%). Although this survey is not representative of the general population, it does suggest very strongly that there is a significant gap in the information that Canadians are receiving about nanotechnology and associated issues. Not only is it important to engage consumers as suggested by the Royal Society, Swiss Re and CIELAP reports but it is also necessary to take their views into account when deciding on how to develop and manage the technology so the benefits are maximized and the risks minimized. All too often ―public involvement‖ means communicating the final decision or trying to educate consumers in order to promote a particular technology or position. Involvement should really start at the beginning of the decision making

process identifying the issues and helping to set priorities.292 As a coalition of advocacy

groups pointed out, ―We've seen the outcome of unregulated 'miracle technologies' such as synthetic chemicals before in the toxic pollution of entire communities. A portion of the nano research on social and environmental issues should involve active participation by communities, whose insights can help us avoid the catastrophic problems experienced in the past."293 The UK government in response to the recommendations of the Royal Society developed a comprehensive programme to engage the public on the subject of

nanotechnologies294. One initiative ―nanodialogues‖ includes a variety of engagement methods that involve stakeholders and randomly selected participants to explore various issues related to nanotechnology. Another initiative is called ―Small Talk‖ where a project website provides a vast array of resources, data, and advice, to help science communicators plan and deliver successful dialogue events. It will also include a team to map current engagement activities and to identify a comprehensive range of activities and gaps in theory and practice. Engagement of the public on this issue has mainly taken place in Europe and the United States. In engaging the public, a number of innovative processes have been used from nano-juries, citizen consensus conferences, nanocafes to web based dialogues.

The European Commission funded a dialogue on nanotechnologies called Nanologue295 to bring together experts, members of industry and civil society in order to support dialogue on the social, ethical and legal implications of nanoscience and nanotechnologies. Basically, the projects undertaken over a 21 month period under this initiative provided a neutral forum to gather and share

292


International Center for Technology Assessment, Principles for the Oversight of Nanotechnologies and Nanomaterials, July 31, 2007, www.icta.org 294

UK Government, The Government's Outline Programme for Public Engagement on Nanotechnologies, August 2005, www.involve.org.uk 295

www.nanologue.net

http://www.icta.org/

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information and evidence on the many potential impacts of nanotechnologies. Projects included a series of events including an open space conference on nanotechnologies, a conference on the environmental impacts, presentations, a website on nano safety and risks, mapping of research, nanocafe discussions and a report of the findings296:

The Federal Institute of Risk Assessment in Germany launched as a pilot project a "Consumer Conference on the perception of nanotechnology in the areas of foods, cosmetics and textiles". The conference was divided into separate stages over three weekends. During the first two weekends, the participants were introduced to the subject and developed questions and chose the experts to be questioned by them at a three day conference. At a public hearing on the first two days of the conference, the invited experts answered questions. The participants then met in private in order to prepare its consumer vote on nanotechnology. The general public was informed of the outcome of the vote at the end of the conference and it was then passed on to representatives of public agencies, politics and industry for inclusion in risk assessment strategies.297

A similar citizens‘ consensus conference was held in Madison, Wisconsin in order to obtain by an innovative democratic process lay perspectives on the future development of technologies. Citizen panellists received a packet of background reading and then met to discuss the readings and develop a list of questions about the technology. At their second meeting, participants gathered with a group of seven specialists from a range of fields, including engineering, toxicology, policy analysis, communications, and bioethics to answer questions. At the third meeting the citizens developed a number of recommendations covering government and industry oversight, communications, research and research funding and public involvement.298 These specialists addressed the citizens‘ questions in a public forum.

In the UK, Greenpeace, the Guardian and the University of Cambridge held a citizens jury on nanotechnology. The jurors who consisted of 15 randomly selected people from different backgrounds met over 10 evenings to hear and question a variety of witnesses (scientists, civil society representatives,

government advisors). The jury then deliberated and drew up a set of

recommendations299.

Nano Cafes designed by the University of Wisconsin provide an opportunity for people to learn about nanotechnology in a casual atmosphere where they can listen to experts, ask questions and share ideas.

A web dialogue on nanotechnology300 and the consumer was hosted by the Project on Emerging Nanotechnologies of the Woodrow Wilson International Center for

296

, Volker Türk, Claudia Kaiser, Christa Liedtke, Hugh Knowles, Vicky Murray, Stephan Schaller, Holger Wallbaum, and Hans Kastenholz, Andreas R. Köhler, Nanologue, Opinions on the Ethical, Legal and Social Aspects of Nanotechnologies-Results from a Consultation with Representatives from Research, Business and Civil Society, Sept 2005, Nanologue.net, May 2006 297

Federal Institute for Risk Assessment (BfR), Consumer Conference Nanotechnology, Background Information for journalists, 18.11.2006 298

Kleinmanor Daniel and Maria Powell, University of Wisconsin, Report of the Madison Area Citizen Consensus Conference on Nanotechnology, April 2005 299

Greenpeace, the Guardian, University of Cambridge and PEALS, NanoJury UK Oversight Panel, Sept 2005 300

Woodrow Wilson International Center for Scholars and the Consumers Union, Consumers

Talk Nanoweb Dialogue, http://www.webdialogues.net/pen/consumer

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Scholars and the Consumers Union of the US. The purpose of the dialogue was to provide an easily accessible venue for the public to discuss information and share their thoughts about the usage and potential benefits and risks of consumer products made with nanomaterials. It was carried out over a two day period and explored a number of issues with respect to how consumers, citizens, students, researchers, policymakers, scientific experts, and the media learn about and respond to nanotechnology consumer products.

Unfortunately, no such initiatives to engage consumers on this issue have been carried out in Canada.

A statement made by the European Commission 301 on public involvement clearly highlights the importance of involving the public. ―‗Dialogue with the public is essential to focus attention on issues of real concern rather than ―science fiction‖ scenarios.‖ It also may make a significant contribution to building trust in government and nanoscience. 302

301

Commission of the European Communities (2005): Communication from the Commission, Towards a European Strategy for Nanotechnology, COM (2004) 338 final Brussels 12.5.2004


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Chapter 6: Conclusions and Key Findings Nanotechnology has the potential to provide consumers with a number of significant benefits in areas of concern to the public. These include energy efficiency, pollution prevention and clean up, diagnosis and treatment of disease and safe food and water. Nano enhanced products may also play a major role in reducing risks such as injury in car crashes, fire and earthquake damage due to their increased strength, flame resistance and flexibility. However, due to the early stage in the development of nanotechnology, there are also many other issues to be investigated and resolved.

What are its impacts on human health over the short term and long term?

What will be its impact on the environment?

Can any adverse effects be minimized or repaired?

What can be done to manage the technologies while regulatory oversight is being developed?

How will it affect society in Canada and globally?

Will those most in need of the new technology be able to access it? Exaggeration of Benefits and Risks: In some cases the potential benefits are exaggerated while in others the potential risks are exaggerated. These exaggerated claims of benefits and risks are normally not based on sound scientific evidence. This prevents an objective, balanced view of the technology over its life cycle being presented to consumers and the public. Without such objective information, it is very difficult for consumers to make informed decisions about nanotechnology and to have confidence in it. Properties of Nanomaterials: When the size of a material is decreased to the nanoscale, the material has a relatively larger surface area with a greater proportion of its atoms on the surface and because of its small size does not follow the normal laws of physics. The result can be a material which is more chemically reactive and exhibits very different electrical, physical, optical and/or magnetic properties than its larger counterpart. In addition, the nanomaterial may be more toxic and it has the potential of dispersing readily through the body or the air, water and soil in the environment. Application in Consumer Products: Nanomaterials are being used or being considered for use to improve a wide variety of products intended for consumers because of their superior and novel properties. The number of consumer products listed in the Nanotechnology Consumer Product Inventory established by the Woodrow Wilson International Center for Scholars has more than doubled in 18 months from 212 in March 2006 to 585 in October 2007. This inventory captures only those products voluntarily identified by manufacturers to contain nanomaterials and to be commercialized. Currently, most nano enabled consumer products are found in sports equipment, clothing, cosmetics, personal care products and household products. Many more potential consumer products are under development in the food industry, health care field and in environmental protection. The availability of products in Canada roughly follows the American and global trends particularly since products can be obtained over the internet. In a survey of Canadian consumers conducted for this study, it was found that consumers were not aware of the nano enabled consumer products on the market.


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When told about them, they indicated that the greatest benefits would come from the use of nanomaterials to improve medical devices, drugs, energy efficiency and general consumer products. The greatest risks would occur in products that were ingested such as food and drugs or applied to the skin such as cosmetics. Impact on Human Health: From the literature reviewed, it is concluded that any adverse impact on human health will be caused by the tiny scale of these materials, their increased reactivity, altered toxicological properties and their ability to penetrate the body by various routes and cross cell membranes. The chance of exposure to nanomaterials can vary significantly depending on how the material is incorporated into a product and its behaviour over the lifecycle of the product. It is unlikely that many uses of nanomaterials in products (e.g. sports equipment or computers) intended for consumers will pose health or safety risks since the nanomaterials are encapsulated in stable matrices and exposure is not anticipated. Potential risks to human health will primarily be related to products where the nanomaterials exist in a free form and exposure is more likely. (E.g. cosmetics, personal care products or cleaning products). It was also shown that the route of exposure can affect the toxicity of the material.

There is considerable uncertainty about the actual risk posed since limited information is available on the potential toxic properties of the materials and actual exposure over the life cycle of the product. There is, however, reason to believe that the novel properties of these materials may result in real, inherent dangers that could adversely impact on human health. The bottom line is that nobody at this stage really knows. Impact on the Environment: Potential release of nanomaterials into the environment could occur during manufacture, production of nano enhanced products, use of the nano enhanced product, disposal or recycling of the nano enhanced product, or activities to clean-up the environment. There appears to be almost no scientific evidence available to evaluate the potential impact of nanomaterials on the environment or life in the environment. Questions about the behaviour of nanomaterials in air, water and soil, their persistence or accumulation in the environment, the release of nanomaterials from disposed products or for remediation purposes have not been answered. Moreover, removing nanomaterials from the environment could be very difficult due to their small size. Some experts and environmental advocates have recommended that the release of nanomaterials into the environment be minimized or banned until these questions are answered.

Gaps in Research: The main research emphasis to date has been on the development and commercialization of the technology and not on risks to human health or the environment. In order for nanotechnologies to fulfil their potential, it is important that research into health, safety and environmental impacts keeps pace with the developments underway and predicted for the future. A number of significant gaps in key areas have been identified.

Lack of commonly accepted definitions and a nomenclature or classification system;

Test procedures and instrumentation to measure, characterize and evaluate the nanomaterials;


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Identification of the potential impact of nanomaterials on the body at the cellular, their toxicity and the resulting risks to human health;

Knowledge about the effect of nanomaterials on all types of biological species in the environment, how they are transported through the environment, and their potential persistence and accumulation in the environment;

A determination of whether or not existing risk assessment tools are appropriate for nanomaterials;

Regulation and Oversight: Regulatory and oversight policies and practices are very much in their early stages and very few government or organizations nationally or internationally offer concrete solutions to known or anticipated problems. Regulators are facing many challenges that make it difficult to draft appropriate regulations – lack of scientific data, definitions, test procedures and instrumentation to identify and assess the materials, the number and diversity of products being developed, and the difficulty in keeping up with the rapid development of products. Currently, most regulation is carried out using existing regulations that were not designed for products of nanotechnology. The development of nanotechnology is expected to impact on a wide range of regulations relating to the safety of products, environmental protection and worker safety. Issues that have been raised about the adequacy of regulations are as follows:

Regulatory frameworks that do not require pre-market evaluation or safety testing of products (e.g., cosmetics, general consumer products) before they are allowed to be sold;

Nanomaterials not being treated as new substances or new classes of materials that require review and oversight different from the same substance in its larger form;

The lack of coordination among existing policies, laws and regulations of different government departments;

The lack of classification systems and definitions to make sure that the appropriate regulations apply to substances/products, that they do not fall between the gaps and that duplication is eliminated;

The need to manage nanomaterials during disposal, destruction or recycling;

Inadequate regulatory and legislative oversight and application of the precautionary approach; and

Nonexistent requirements to label products that contain nanomaterials so that consumers can make informed decisions about the products they purchase and use.

The benefits for consumers will only be realized if consumers are confident that any potential adverse effects are identified, studied and managed. Although Canadian consumers did not think that government exercised adequate regulatory oversight over nanotechnology, they did not trust industry to regulate itself. Regulatory oversight was believed to be critical to managing the technology. The confidence of consumers in this new technology will in the end very much depend on the effectiveness of governments in providing oversight. It will therefore be necessary for regulators to review their regulations to determine whether or not they will be able to address nanomaterials and the products in which they are found. Work is underway by international organizations such as ISO, IEC and OECD to develop definitions, nomenclature and test procedures to classify, to measure and to evaluate nanomaterials which are essential to any type of oversight. Meanwhile industry is


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developing codes of practice to ensure the responsible development of the technology. Many governments have concluded that some form of voluntary stewardship program is likely to be an effective approach at this early stage of development; even though, consumers do not always trust such voluntary approaches. Social and Ethical Issues: It is anticipated that as nanotechnology develops that significant social and ethical concerns will emerge. Concerns about who will control development, who will benefit from it, how an individual‘s privacy will be affected and how it will be used to enhance human capabilities have all been identified. These concerns are very similar to those raised about other new technologies and need to be taken seriously if the technology is to receive wide acceptance by consumers in the long term.

Knowledge of Consumers: The knowledge of consumers about nanotechnology is very low in Canada and around the world. The surveys of the Canadian public and consumer representatives commissioned by this study found a lack of awareness among 70% of those surveyed. Irrespective of the lack of information received and their knowledge of the technology, the majority of Canadians are optimistic about the technology and 58% of them have no concerns. To maintain this attitude much will depend on the information they receive in the future about the associated risks and benefits and their experience with the products that they purchase and use. This suggests that a concerted effort needs to be made by the federal and provincial governments to inform and to engage consumers on the subject. Also, since most Canadians reported that they obtain information about nanotechnology from the media, the attitude of Canadians will also depend on the direction that the media takes in presenting the technology. Efforts to work with and provide balanced information to the media will be crucial in ensuring that the information received by consumers is accurate and balanced. Involvement of the Public: It has been argued that involvement of consumers and the public should start at the beginning of the decision making process when issues are identified and priorities are set. The involvement of Canadian consumers in the issue of nanotechnology is very limited, if not nonexistent. A wide range of novel processes that were effective have been used in Europe and the United States to inform and involve consumers. Such processes may also be suitable for use with Canadian consumers.

Consumer Attitudes and Identified Needs: From the studies and initiatives that have been carried out it would appear that citizens in many countries have a common set of attitudes towards nanotechnology and what is needed.

There is a need for greater transparency and disclosure with respect to which products contain nanomaterials and how industry is using and plans to use the technology.

Little trust in government or industry to manage any potential risks associated with nanotechnologies and the materials produced and a concern that they are not being protected.

More pre-market testing is required to ensure that the nanomaterials and/or the products that include these materials do not pose a risk to human health or the environment.

Third party testing by independent certifying agency to verify the safety of the products.


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There is a need for research to be carried out to determine the longer term risks and impacts on the environment.

Greater engagement of the public in shaping how the technology is developed, managed and regulated is required.

The public is very wary of potentially negative, unintended and long-term consequences of new technologies.

There was less support for the use of nanomaterials in what was considered high exposure applications such as cosmetics.


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Appendix 1. Products Identified in the Nanotechnology Consumer Products Inventory on October 2, 2007.

Category of Consumer Products

No. Sub-Categories

Type of Products

Health and Fitness

356 Personal Care shampoo, toothpaste, hearing aids, soap, insect repellents, anti-bacterial creams

Cosmetics skin creams, cleansers, foundation revitalizes, lip paint, moisturizers, anti-aging products

Sunscreens for adults and children

Sporting Goods golf shafts, skis and snow boards, rackets, sport towels, bicycle parts, bowling balls, ski waxes, hockey sticks, wet suits, water and stain resistant sprays for textiles

Filtration air purifiers, air and water filters for chemical and biological contaminants, cigarette filters

Clothing - anti-bacterial and deodorizing socks, insoles, clothing and elbow and knee guards, water and stain resistant clothing, radiation shield suits

Home and Garden

67 Paint exterior and interior paints, non scratch car paints

Home Furnishings

anti microbial and anti fungal bedding, towels, silver coating material for locks, taps, cutlery, anti microbial upholstery an mattress coatings

Cleaners lens cleaners, fabric softeners, air sanitizers, detergents, anti microbial and odour rubber gloves

Construction wood sealers, batteries in power tools, self cleaning glass

Luxury Anti-microbial watch band, diamonds

Appliances 21 Laundry and clothing care

silver coatings on washing machines to improve sterilization of clothes during washing

Kitchen appliances

Nano silver anti bacterial coatings in refrigerators

Heating, cooling and air

Nano silver liners in ultrasonic humidifiers, air purifiers, filters in air conditioners

Goods for children

17 Basics Sunscreens, anti bacterial fabric softeners, anti bacterial pacifiers, baby mugs and baby bottles,

Toys and games

Water and stain resistant plush toys, odour removal stickers.


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Category of Consumer Products

No. Sub-Categories

Type of Products

Electronics and Computers

46 Cameras and film

Photo paper and image sensor

Video Organic Light Emitting Diodes (OLED), surface conductor electron emitting display (SED), Xbox

Audio Hearing aids, coatings for guitar strings, IPod nanos,

Mobile Devices and communications

Cellular memory, anti bacterial mobile phones, OLEDs,

Computer Hardware

Mouse and keyboards with antibacterial nano coating, flash memory, processors, hard drive, metal nano dot memory, laptop computers

Television Scratch resistant coatings

Display Conductive surfaces, OLED, protective films for electronic displays

Food and Beverage

66 cooking Antibacterial utensils, cutting boards, nano silver sterilizing spray, frying oil

Storage Antibacterial food containers, storage bags, plastic wrap,

Food Canola Active Oil, Chocolate shakes, nanotea

Supplements Micelle carrier for a higher and faster intestinal and dermal resorption and penetration of active ingredients, nano-structured bioregulators, silver, gold, platinum, titanium, zinc and copper mineral supplements, anti-aging nutrients, vitamin sprays, tooth powders

Automotive 33 Maintenance and assessment

Air filters and purifiers, catalysts to improve fuel consumption, head gasket and block sealers, lubricants, self-cleaning glass, flares,

Exteriors waxes and car washes, sunscreen sprays for cars, ,scratch resistant paints, tires


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Appendix 2. Nanomaterials in Consumer Products: Study of European Parliament303

Nanomaterial Product Category Examples of Consumer Product

Metal Oxides Titanium dioxide (TiO2)

Personal care products and cosmetics Household products and home improvement Textiles and shoes

Sunscreen Self-cleaning glass Cloth

Zinc dioxide (ZnO2)

Personal care products and cosmetics


Iron oxides (FeO, Fe2O3, Fe3O4)


Lipstick

Aluminum oxide (Al2O3) Electronics and computers Motor vehicles

Solar cells Catalytic exhaust gas converter

Silica (SiO2) Textiles and shoes Sports goods

Textiles Tennis racket, tennis balls

Zirconia (ZrO2) Electronics and computers

Scratch resistance coatings

Cerium oxides (CeO2, Ce2O3)

Motor vehicles Fuel additive

Metals Silver (Ag)

Electronics and computers Household products and home improvement Textiles and shoes Filtration, purification, neutralisation and sanitisation

Optoelectronics, anti-bacterial electronics Cleaning products, food storage containers Socks Air filtration and conditioning devices

Gold (Au)


Home pregnancy test Catalytic applications

Nickel (Ni)

Electronics and computers Personal care products and cosmetics

Batteries Wound dressings

Cadmium telluride (CdTe)

Electronics and computers

Electronic and optical devices

Gallium arsenide (GaAs) Electronics and computers

Electronic and optical devices

Nanowires (e.g. different Electronics and Electronic equipment

303



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metals – including silicon, cobalt, gold and copper- , oxides, sulphides and nitrides)

computers

Organic nanomaterials Nano-vitamins


Bronzer or highlighter, eye shadow, glitter, acne treatment, facial cleanser, facial moisturizer, sunscreen or tanning oil

Nanoclays

Household products and home improvement Motor vehicles Sporting goods

Construction materials Car bumpers, Tennis balls

Carbon nanotubes (CNT) (single-wall SWNT or multi-wall MWNT)

Textiles and shoes Electronics and computers Sporting goods, Household products and home Improvement, Filtration, purification, neutralisation and sanitisation, Miscellaneous

Clothes Electronic equipment, batteries, fuel cells Bicycle frames, baseball bats, badminton rackets, hockey sticks Concrete products Water purification devices Coatings , paper, film

Fullerenes (e.g. C60)

Personal care products and cosmetics Electronics and computers Miscellaneous

Anti-aging, facial moisturizer and around-eye cream Electronic equipment

Nanospheres, nanosomes, liposome‘s, delivery systems and capsules filled with e.g. arnica, barley-germ, wheat-germ, germal ii, lyphazome, retinol, alpha-bisabolol, calendula, centella asiatica, ginseng, witch hazel, sodium lactate, urea, hyaluronic acid, fulvic acid, vitamins (pro-vitamin b5, vitamin a, vitamin e)


Around-eye cream, facial anti-aging, moisturising products, nail treatment products, body firming lotion, anti itch or rash cream, skin fading or lighting products, hair-loss treatment, body wash, sunscreen and tanning oil, and after sun product

Quantum dots

containing e.g. CdSe, ZnS,

Te, etc.

Electronics and

computers

LEDs

Carbon black Motor vehicles Tyres

Carbide (tungsten,

tantalum, titanium, silicon)

(also silicon nitride)

Household products

and home

improvement

Cutting tools

Springs, ball bearings, valve

lifters


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Appendix 3. Telephone Survey of Consumers NANOTECHNOLOGY STUDY - OCTOBER 2007 Carried out by Omnitel National

Telephone Omnibus for the Consumers Council of Canada. Those among the Canadian public that were very familiar or somewhat familiar with nanotechnology comprised 35% of those surveyed in 2005. In order to determine whether or not the awareness level has changed among Canadians, questions were added to an omnibus survey as described below. For those surveyed who reported that they had read or heard about nanotechnology, further questions to obtain an indication of where they learned of the technology, their knowledge level and their concern about the technology were asked. A summary of the methodology used and results obtained is presented below.

Omnitel Methology304:

Method of Interviewing

Data collection is conducted via telephone interviewing from central location dialing

facilities in Toronto, Montreal, Edmonton, Sudbury & Canso. Over 580 CATI (Computer

Assisted Telephone Interviewing) stations are available to facilitate timely completion. The

fieldwork for this project commenced on October 10th and was completed on October

17th, 2007.

Quality Control

The Maritz Research commitment to excellence on custom studies applies equally to

Omnitel. All interviewers are fully briefed by experienced supervisory staff to ensure that

there is a thorough understanding of study requirements and flow of the questionnaire. All

interviewing is monitored on-site to ensure optimum quality and efficiency.

304

Maritz Rearch, Omitel(Wave II) [KC 5143] Nanotechnology Study-October 2007, Report to the Consumers Council of Canada


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Sampling Techniques

Omnitel sample is generated from a database of all published Canadian telephone

numbers; almost 9 million records nation-wide. Randomizing the final digits of the

telephone number ensures full coverage of Canadian households for any sample drawn

from the database. This includes unlisted numbers and numbers not allocated at the time

of the database‘s compilation. This sampling technique is designed to ensure that each

Canadian household with a telephone has an equal probability of being selected for an

interview.

Respondent Selection

A respondent within a household is selected using the Next Birthday Criteria, that is on the

basis of "being the individual in the household whose birthday falls soonest after today's

date. Interviewers must adhere to strict quotas within region to ensure that an equal

number of interviews with male and female respondents are obtained. Respondents must

indicate their age prior to proceeding with the questionnaire, however, there are no

particular age quotas implemented. Qualification is based simply on being 18 years of age

or older.

Data Analysis & Delivery

All data is entered, verified and edited prior to being transferred to our DEC Micro VAX II

computer. Standard deliverables are in cross-tabular format and include the following

standard banners:

Total Gender Age

Region Community Size Language

Education Employment Status Job Description

Marital Status Household Composition Family Income

Chief Income Earner Principal Grocery Shopper Home Ownership

Primary Dwelling Type Internet Access

Questions

Q1. How much would you say you have read or heard about nanotechnology? BASE: TOTAL SAMPLE Possible Responses: Read or heard a lot Read or heard some Read or heard a little No idea what it is

Q2. BASE: Those who have read or heard about nanotechnology.


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An explanation of nanotechnology was provided to those who indicated that they had read or heard about nanotechnology to any degree before a series of questions on sources of information, knowledge and concern about the technology were presented.

Nanotechnology is the science of the extremely tiny. It involves measuring, predicting and constructing materials on the scale of 1 to 100 nanometres. At this size, materials can take on unique chemical, electrical and physical properties. To put this into perspective, the width of a human hair is approximately 80,000 nanometres. Nanomaterials today can be found in many consumer products including stain resistant clothing, sunscreens, cosmetics, drugs and sports equipment. Where did you first learn about nanotechnology? Possible Responses: Television Show Magazines Information articles Schooling or training Just informed Newspaper information articles Discussions with other people Internet Books Commercial advertisement Radio Program Electronics Sporting Equipment Do not know Q3. BASE: Those who have read or heard about nanotechnology How knowledgeable would you say you are about nanotechnology? Possible Responses: Very knowledgeable Somewhat Knowledgeable Not very knowledgeable Not at all knowledgeable

Do not know Q4. BASE: Those who have read or heard about nanotechnology In general, how concerned are you about the use of products and methods that involve nanotechnology? Possible Responses: Very concerned Somewhat concerned Not at all concerned Do not know.


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Results

Question 1. . How much would you say you have read or heard about nanotechnology? BASE: TOTAL SAMPLE

Number Read or heard a lot

Read or heard some

Read or Heard a little

No idea what it is

Do not know/ refused

Total 1000 7% 17% 31% 40% 5%

Male 500 11% 22% 28% 33% 4%

Female 500 3% 12% 32% 46% 6%

18-29 years 181 9% 16% 34% 38% 3%

30-49 years 392 7% 20% 35% 34% 4%

50 yr plus 427 6% 14% 24% 47% 7%

Atlantic 125 5% 12% 33% 44% 6%

Quebec 250 6% 18% 23% 47% 5%

Ontario 250 9% 17% 30% 39% 5%

Man/Sask 125 5% 11% 36% 41% 7%

Alberta 125 9% 23% 32% 31% 5%

B.C. 125 6% 18% 41% 32% 3%

Public school

109 8% 12% 35% 36% 9%

High School 276 3% 11% 31% 49% 5%

Univ/college 578 9% 22% 29% 36% 4%

The results indicate that over 70% of those surveyed from across the country had not read or heard anything at all about the technology or only a little. Males (33%) tended to have read or heard a lot or some about the technology while only 15% of females had read or heard a lot or some. A greater percentage of those with university or college education (31%) read or heard a lot or some than those with a public school (20%) or high school (14%) education. Not surprisingly, those over 50 years of age (20%) tended to have read or heard less about the technology that those in the 18-29 (25%) or 30-49 years of age (27%) categories. The results for Quebec, Ontario and British Columbia were very similar (24%-26%) with only Alberta (32%) having a higher awareness and the Atlantic and Manitoba/Saskatchewan with lower levels of reported awareness (17%- 16%). The higher level of awareness in Alberta may be the result of the establishment of the new National Institute of Nanotechnology in Edmonton and the news coverage that it received. .


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Question 2. Where did you first learn about nanotechnology? BASE: Those who have read or heard about nanotechnology.

Part 1. Sex, Age and Education

Sex Age Education

Total Male Fe-male

18-29

30-49

50 + Public School

High School

Univ/ coll

Total 541 301 240 107 234 200 57 125 343

Television Show

25% 28% 22% 20% 29% 24% 43% 26% 22%

Magazine information articles

15% 18% 11% 12% 15% 16% 10% 8% 18%

Newspaper information articles

8% 7% 9% 2% 8% 11% 3% 4% 10%

Radio Program

3% 2% 3% 9% 7% 7% 1% 3% 3%

Total Media

51% 55% 45% 43% 59% 58% 57% 41% 53%

Schooling or Training

10% 11% 9% 24% 8% 3% 2% 10% 11%

Books 6% 7% 5% 4% 6% 8% 7% 4% 7%

Internet 7% 8% 5% 16% 4% 4% 8% 7% 7%

Just Informed

8% 6% 10% 4% 9% 8% 7% 12% 7%

Discussions with others

7% 4% 12% 9% 7% 7% 5% 8% 8%

Commercial Advertise-ments

3% 3% 2% - 3% 3% 4% 2% 2%

Electronics - 1% - 1% 1%

Sporting goods

- - - 1%

Total all other sources

41% 40% 43% 57% 37% 34% 33% 44% 42%

Do not know

8% 7% 10% 6% 9% 10% 10% 15% 5%

With respect to the source of information about nanotechnology, those surveyed indicated that the primary source of information was television shows and the media in general. Some interesting exceptions to this were found among young people 18 to 29 years of age who reported that their primary source of information was schooling followed by television and the internet. For males television and the media were more


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important as a source of information than for females. With respect to education, television was the primary source of information for those with a public school education (43%) using it to a greater extent than those with high school (26%) or university education (22%). Those with a university or college education tended to use magazines and newspapers to a greater extent than the others. Part 2. Information Sources by Provinces

Total ATL QC ON MN SK

AB BC

Total 541 64 121 134 67 78 77

Television Show

25% 17% 22% 27% 25% 22% 33%

Magazine information articles

15% 9% 14% 17% 10% 14% 15%

Newspaper information articles

8% 3% 8% 7% 3% 11% 10%

Radio Program

3% 8% 7% 8% 8% 12% 2%

Total Media

51% 37% 51% 59% 46% 59% 60%

Schooling or Training

10% 10% 14% 7% 14% 18% 5%

Books 6% 5% 4% 7% 11% 2% 9%

Internet 7% 6% 4% 8% 5% 9% 6%

Just Informed

8% 17% 8% 6% 10% 4% 9%

Discussions with others

7% 8% 7% 8% 8% 12% 2%

Commercial Advertisements

3% 3% 3% 3% 2% 2% 2%

Electronics - 1% 2%

Sporting goods

- 2%

Total all other sources

41% 51% 41% 39% 52% 47% 33%

Do not know

8% 12% 13% 6% 10% 4% 7%

Across the country, television was the primary source of information about nanotechnology. In the Atlantic Region and Manitoba/ Saskatchewan, although television was the most predominant source of information, the media in general was not


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as important a source of information as other sources such as schooling, books, informing themselves, etc. The internet was not a primary source of information on the subject for those interviewed. Question 3. BASE: Those who have read or heard about nanotechnology How knowledgeable would you say you are about nanotechnology?

Number Very Know-ledgeable

Somewhat Know-ledgeable

Not very know-ledgeable

Not at all know-ledgeable

Do not know

Total 550 3% 21% 43% 32% 1%

Male 301 4% 29% 40% 27% 1%

Female 240 2% 12% 46% 39% 1%

18-29 years 107 2% 27% 41% 31% -

30-49 years 234 4% 20% 45% 31% -

50 yr plus 200 2% 20% 41% 35% 2%

Atlantic 64 6% 22% 36% 36% -

Quebec 121 3% 20% 39% 36% 1%

Ontario 134 2% 23% 48% 27% 1%

Man/Sask 67 2% 25% 37% 36% -

Alberta 78 1% 25% 43% 30% -

B.C. 77 5% 16% 41% 38% -

Public school

57 2% 15% 48% 33% 2%

High School 125 2% 23% 33% 42% -

Univ/college 343 3% 23% 45% 29% -

Overall, the percentage of those surveyed who reported that they were very or somewhat knowledgeable about nanotechnology (24%) was actually lower than the percentage of those in 2005 who reported that they were knowledgeable or somewhat knowledgeable about the technology. Males reported that they were very or somewhat knowledgeable (33%) to a much greater extent than females (14%) and younger adults in the 18-29 age group (29%) reported to be more knowledgeable that those in the 30-49 (24%) and 50+ (22%) age groups. Participants with a high school or university/college education appear to have a higher level of knowledge 25% and 26% respectively than participants with a public school education (17%).


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Question 4. BASE: Those who have read or heard about nanotechnology In general, how concerned are you about the use of products and methods that involve nanotechnology?

Number Very Concerned

Somewhat Concerned

Not at all concerned

Do not know/ refused

Total 541 7% 34% 57% 2%

Male 301 6% 33% 59% 1%

Female 240 8% 34% 54% 4%

18-29 years 107 8% 27% 63% 2%

30-49 years 234 8% 35% 55% 2%

50 yr plus 200 4% 37% 55% 4%

Atlantic 64 9% 34% 56% 1%

Quebec 121 6% 30% 62% 2%

Ontario 134 6% 35% 56% 3%

Man/Sask 67 7% 30% 60% 2%

Alberta 78 7% 32% 60% 1%

B.C. 77 9% 38% 50% 3%

Public school

57 13% 42% 37% 8%

High School 125 7% 28% 62% 3%

Univ/college 343 6% 35% 59% 1%

Even though, the majority of interviewees reported themselves to be not very knowledgeable or not at all knowledgeable about the technology, 57% of them responded that they were not all concerned about the technology. Those with a public school education demonstrated the highest level of concern and those in the 18-29 age group the lowest. This is consistent with early studies that showed that Canadians were optimistic about emerging technologies.


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Appendix 4. Public Interest Network Survey In order to determine the knowledge level of consumer advocates and the information that they need to represent consumers‘ interests effectively a survey of consumer advocates was carried out electronically over the Consumer Council of Canada‘s Public Interest Network and the forum for Canadian Standards Association‘s Consumer Representatives. A basic explanation of nanotechnology was presented to each participant at the start of the questionnaire. The questionnaires were made available in both English and French and were distributed during the month of September 2007. The respondents were not selected randomly but self-selected. The results although not statistically valid for all consumers provide a strong indication of the knowledge sources of information and information needs of those more actively involved in representing the interests of consumers. One hundred and nine responses were received back.

4.1. Questionnaires in English and French.

a) English Questionnaire for Consumer Advocates.

Purpose: To determine what information consumer advocates need in order to effectively represent consumers in decisions being made by government, industry or the standards community about the management of Nanotechnologies.

Basic Explanation of Nanotechnology. Nanotechnology is a new manufacturing technology that allows industry to make materials and devices on the extremely small scale of atoms and molecules. Materials and devices created through this technology have unique physical, chemical, and biological properties that are very different from the same material at larger size. Rather than shape what nature offers, we can do it ourselves by arranging atoms and molecules. The potential benefits of nanotechnology include the use of nano-materials in products to make them stronger, lighter and more efficient. Some examples are food containers that kill bacteria, stain-resistant clothing, high performance sporting goods, faster, smaller computers, and more effective sunscreens. Nanotechnology also has the potential in the future to provide new and better ways to treat disease, clean up the environment, enhance national security, and provide cheaper energy. While there has not been conclusive research on the potential risks of nanotechnology, there are concerns that some of the same unique properties that make nano-materials useful might make them harmful. It is thought that some nano-materials may be harmful to humans if they are inhaled, ingested or absorbed through the skin. In addition, they maybe harmful to the environment. Questions:

1. Would you say that you are knowledgeable about nanotechnology? (Please check

off the one that most closely reflects your knowledge) a. Very familiar ______


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b. Somewhat familiar ______ c. Not very familiar ______ d. No idea what it is ______

2. Do you feel adequately informed about the following issues associated with the

development and commercialization of nanotechnology? (Please check off all sources)

a. Scientific yes ____ no ____ b. Ethical yes ____ no ____ c. Legal and/or regulatory yes ____ no ____ d. Social aspects yes ____ no ____ e. Environmental yes ____ no ____

3. Where do you learn about new technologies such as nanotechnology? (Please

check off all sources) a. school/training ______ b. work responsibilities ______ c. Scientific publications or conferences ______ d. Articles in magazines or newspapers ______ e. Radio or television shows ______ f. Information on the internet g. commercial advertisements ______ h. reports/information from government, ______ i. reports/information from ______ Non-governmental Organizations j. own initiative searching for the information, ______ k. other __________________________________________ 4. Do you know where to go to get information about nanotechnology?

Yes ______ No ______

5. Is this something that you would have the time to do?

Yes ______ No ______

6. Materials produced by nanotechnologies are used in a number of products intended

for consumers. Products where they are used include but are not limited to

medical devices to diagnose or treat diseases,

improved drugs or delivery of drugs,

food with improved nutritional qualities,

food packaging that detects contamination,

cosmetics that are transparent and have improved skin penetration,

general consumer products (textiles that do not stain, stronger sports equipment, self cleaning windows, improved car tires),

improved energy efficiency (e.g. solar panels, fuel cells),

water purifiers and faster and


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smaller electronic equipment.

Are you aware of any products on the Canadian market that utilize nanotechnologies? Please list any that you have seen or heard about.

7. There are a number of products listed above utilizing nanotechnologies. Which ones

do you think will have the greatest benefits for consumers?

8. What types of products utilizing nanotechnologies do you think may pose the greatest risks to consumers?

9. Are you aware of anything that industry or governments are doing to manage this

technology?

No _____ Don‘t know _____ Yes _____ If yes, please specify

10. If you are involved in consultations to manage nanotechnology, you will probably be

asked what you think Government or industry should be doing to manage this technology. For example, should they be:

Developing specific regulations for products containing nanoparticles or materials, Increasing safety testing before products are marketed, Supplying product information or labeling products so people can choose, Carrying out post market surveillance to track product risks in the market, Allowing industry to regulate itself, or Encouraging the development of voluntary safety standards for nanotechnology?

In order to be able to effectively represent the interests of consumers in consultations about nanotechnology and to provide an informed response to these types of questions, what information would you need? Thank you very much for your participation.

b) Questions en francais

Questions potentielles pour les défenseurs des intérêts des consommateurs Objet : Déterminer l‘information dont les défenseurs des intérêts des consommateurs ont besoin pour représenter efficacement les consommateurs lorsque le gouvernement, l‘industrie ou les organismes responsables des normes prennent des décisions à propos de la gestion des nanotechnologies.

Qu’est-ce que la nanotechnologie? La nanotechnologie est une nouvelle technologie de fabrication qui permet à l‘industrie de fabriquer des matériaux et des dispositifs à une échelle atomique ou moléculaire


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extrêmement petite. Les matériaux et les dispositifs créés par l‘entremise de cette technologie ont des propriétés physiques, chimiques et biologiques uniques qui sont très différentes de celles du même matériau d‘une taille supérieure. Plutôt que façonner ce que la nature crée, nous pouvons le faire nous-mêmes en réorganisant les atomes et les molécules. Les avantages potentiels de la nanotechnologie comprennent l‘utilisation de nanomatériaux dans des produits pour les rendre plus robustes, plus légers et plus efficaces. Par exemple, il existe maintenant des contenants alimentaires qui tuent les bactéries, des vêtements qui résistent aux taches, des articles de sport haute performance, des ordinateurs plus petits et plus rapides, des écrans solaires plus efficaces. La nanotechnologie peut également, dans le futur, procurer de meilleures méthodes ou de nouveaux moyens pour traiter les maladies, nettoyer l‘environnement, améliorer la sécurité nationale et fournir une énergie plus économique. Bien qu‘il n‘existe aucune recherche concluante sur les risques potentiels liés à la nanotechnologie, on se préoccupe du fait que les propriétés uniques qui rendent les nanomatériaux utiles peuvent les rendre nocifs. On pense que certains nanomatériaux peuvent être nocifs pour les humains s‘ils sont inhalés, ingérés ou absorbés par la peau. De plus, ils pourraient être nocifs pour l‘environnement. Questions :

1. Diriez-vous que vous connaissez bien la nanotechnologie? (Veuillez cocher la

réponse qui correspond le mieux à vos connaissances.) Je connais très bien ______ Je connais assez bien ______ Je ne connais pas beaucoup ______ J‘ignore de quoi il s‘agit. ______

2. Croyez-vous être adéquatement informé à propos des aspects relatifs au développement et à la commercialisation de la nanotechnologie? (Veuillez cocher toutes les sources d‘information.)

scientifiques oui ____ non ____ moraux oui ____ non ____ juridiques et/ou réglementaires oui ____ non ____ sociaux oui ____ non ____ environnementaux oui ____ non ____

3. Où avez-vous entendu parler des nouvelles technologies, notamment la notechnologie? (Veuillez cocher toutes les sources.)

école/formation ______ responsabilités au travail ______ publications scientifiques ou conférences ______ articles dans des revues ou des journaux ______ émission de radio ou de télévision ______ information sur l‘Internet publicités commerciales ______ rapports/information du gouvernement ______ rapports/information d‘organismes ______ non gouvernementaux


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propre initiative, recherche d‘information ______ autre __________________________________________

4. Savez-vous où obtenir de l‘information à propos de la nanotechnologie? Oui ______ Non ______

5. Disposez-vous du temps nécessaire pour trouver de l‗information?

Oui ______ Non ______

6. Les matériaux fabriqués grâce aux nanotechnologies sont utilisés dans plusieurs produits destinés aux consommateurs. Ces produits comprennent, sans s‘y limiter, ce qui suit :

- dispositifs pour établir des diagnostics ou traiter des maladies, - médicaments améliorés et administration ciblée des médicaments, - aliments ayant de meilleures valeurs nutritives, - emballages alimentaires qui décèlent la contamination, - produits de beauté qui sont transparents et pénètrent mieux dans la peau, - biens de consommations en général (textiles qui ne tachent pas, articles

de sport plus robustes, fenêtres auto-nettoyantes, pneus d‘automobile améliorés),

- efficacité énergétique améliorée (par ex.: panneaux solaires, piles à combustible),

- purificateurs d‘eau; et - équipement électronique plus rapide et plus petit.

Avez-vous connaissance de produits sur le marché canadien qui utilisent les nanotechnologies? Veuillez énumérer tous les produits que vous avez vus ou dont vous avez entendu parler.

7. La liste ci-dessus comprend plusieurs produits utilisant les nanotechnologies. À votre avis, quels sont ceux qui seront les plus avantageux pour les consommateurs?

8. À votre avis, quels genres de produits utilisant les nanotechnologies peuvent présenter les plus grands risques pour les consommateurs?

9. Avez-vous connaissance de mesures prises par l‘industrie ou le gouvernement pour gérer cette technologie?

Non _____ Je ne sais pas _____ Oui _____ Si oui, veuillez préciser.

10. Si vous participez aux consultations relatives à la gestion de la nanotechnologie, on vous demandera probablement ce que le gouvernement ou l‘industrie doit faire, à votre avis, pour gérer cette technologie. Par exemple, doivent-ils :

a. Élaborer une réglementation spécifique pour les produits contenant des nanoparticules ou des nanomatériaux?


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b. Procéder à plus d‘essais de sécurité avant de mettre les produits sur le marché?

c. Fournir de l‘information sur le produit ou étiqueter les produits de manière que le consommateur puisse faire un choix?

d. Effectuer une surveillance après-vente pour assurer le suivi des risques que représente un produit commercialisé?

e. Permettre à l‘industrie de s‘auto-réglementer? ou f. Encourager l‘élaboration de normes de sécurité volontaires pour la

nanotechnologie?

Pour être en mesure de représenter efficacement les intérêts des consommateurs lors des consultations relatives à la nanotechnologie et de donner des réponses avisées à ce genre de questions, de quelle information avec-vous besoin? Merci beaucoup de votre collaboration.

4.2. Results Question 1. Would you say that you are knowledgeable about nanotechnology? Responses 109

Number Percentage

Total 109

Very Familiar 2 2%

Somewhat Familiar 32 29%

Not very familiar 58 53%

No idea what it is 17 16%

70% of the consumer representatives who responded reported that they were not very familiar or had no idea of what it is consistent with the results of the telephone survey. In the survey of the general public, 71% of the respondents reported that they had read or heard nothing or very little about the technology. Question 2. Do you feel adequately informed about the following issues associated with the development and commercialization of nanotechnology? (Please check off all sources) Responses 91

Yes No

Scientific 20% 80%

Ethical 8% 92%


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Legal and/or regulatory 6% 94%

Social Aspects 11% 89%

Environmental 5% 95%

The results show that those who responded did not feel adequately informed about any of the issues associated with nanotechnology. Question 3. Where do you learn about new technologies such as nanotechnology? (Please check off all sources) Responses. 91

Source of Information PIN survey

School/training 7%

Work Responsibilities 16%

Scientific publications or conferences 25%

Articles in newspapers or magazines 84%

Radio or Television Shows 58%

Information on the internet 60%

Commercial advertisements 9%

Reports information from governments 25%

Reports/information from NGOs 31 %

Own Initiative searching for information 42%

Other – communication with others 9%

The sources of information that are used by consumer advocates are broader and different from the sources of information used by the general public. For example this subsection of the population uses newspaper and magazine articles extensively (84%) while only 23% of the general public reported that it did so. Another major difference is the use of the internet as a source of information. Consumer advocates (60%) reported that they used it to learn about nanotechnology while only 7% of the general public claimed to do so. Radio and television were a source of information for consumer as well as the general public. Question 4. Do you know where to go to get information about nanotechnology? Responses 109.

Yes 52% No 48%

Question 5. Is this something that you would have the time to do? Responses 109

Yes 47% No 53%

Question 6. Materials produced by nanotechnologies are used in a number of products intended for consumers. Products where they are used include but are not limited to

- medical devices to diagnose or treat diseases, - improved drugs or delivery of drugs, - food with improved nutritional qualities,


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- food packaging that detects contamination, - cosmetics that are transparent and have improved skin penetration, - general consumer products (textiles that do not stain, stronger sports equipment,

self cleaning windows, improved car tires), - improved energy efficiency (e.g. solar panels, fuel cells), - water purifiers and faster and - smaller electronic equipment.

Are you aware of any products on the Canadian market that utilize nanotechnologies? Please list any that you have seen or heard about. Responses 59 skipped question 36 Not aware of any products 78% Aware of products 22% Products listed included: self cleaning windows, medical devices, energy devices,

nutritionally improved foods such as milk and bread, stain resistant and water repellent clothing, cosmetics, fuel cells, computers, electronic equipment, sunscreens, water purifiers,

Question 7. There are a number of products listed above utilizing nanotechnologies. Which ones do you think will have the greatest benefits for consumers? Responses 92 Medical Devices 54% Improved drugs 42% Nutritious food or enhanced food 10% Food packaging that detects contamination 19% Energy efficiency 40% Water purifiers 18% General consumer products 23% Computers/electronics 21% Expressed concerns about nanomaterials 9% in food, food packaging and consumer products, Didn‘t know 6% Question 8. What types of products utilizing nanotechnologies do you think may pose the greatest risks to consumers? Responses 92 Medical Devices 3% Improved drugs 32% Nutritious food or enhanced food 58% Food packaging that detects contamination 15% Energy Efficiency 0% Water purifiers 8% General consumer products 13% Computers/electronics 1% Cosmetics 32% Military Weapons 3% Don‘t know 26%


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Question 9. Are you aware of anything that industry or governments are doing to manage this technology? Responses 95

No 67% Don‘t know 31% Yes 3% If yes, please specify. NRC and Standards Council of Canada

Question 10. If you are involved in consultations to manage nanotechnology, you will probably be asked what you think Government or industry should be doing to manage this technology? For example, should they be:

Developing specific regulations for products containing nanoparticles or materials,

Increasing safety testing before products are marketed,

Supplying product information or labeling products so people can choose,

Carrying out post market surveillance to track product risks in the market,

Allowing industry to regulate itself, or

Encouraging the development of voluntary safety standards for nanotechnology?

In order to be able to effectively represent the interests of consumers in consultations about nanotechnology and to provide an informed response to these types of questions, what information would you need? Responses 96 Needed information specified by respondents included: Basic explanation and description of nanotechnology 20% The benefits of the technology 17% The potential risks of the technology 41% The uses and potential uses of the technology 20% Research on the subject 15% The safety testing that is carried out before and/or after 26% a product is placed on the market Standards 7% Regulation and government actions to manage the technology 28% Labeling of the products 16% Don‘t know 7%


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Appendix 5. Information Sources Canadian Government Biotechnology Portal

www.bioportal.gc.ca

Canadian Institute for Environmental Law and Policy

www.cielap.org

Canadian Nanobusiness Alliance www.nanobusiness.ca

Cientifica www.cientifica.eu

Consumers Union www.consumerunion.org

Environmental Defense www.environmentaldefense.org

Environmental Defense – Dupont Nano Risk Framework

www.NanoRiskFramework.com

Environmental Protection Agency www.epa.gov/oppt/nano

ETC Group, www.etcgroup.org

European Commission‘s Nanalogue www.nanologue.net

European Nanotechnology Gateway www.nanoforum.org

Friends of the Earth www.foe.org

Government of Canada‘s Nanoportal www.nanoportal.gc.ca

Greenpeace www.greenpeace.org.uk

Institut de recherche Robert- Sauvé en santé et en sécurité du travail,

www.irsst.qc.ca

Meridian Institute www.nanoandthepoor.org

NanotechWeb http://www.nanotechweb.org

National Institute of Nanotechnology http://nint-innt.nrc-cnrc.gc.ca

OECD Programme on Safety of Manufactured Nanomaterials

www.oecd.org/env/nanosafety www.oecd.org/env/nanosecurite

Royal Society and Royal Academy of Engineering Report

www.nanotec.org.uk/final/Report.htm

Safenano website www.safenano.org

United Kingdom Government, The Government's Outline Programme for Public Engagement on Nanotechnologies

www.involve.org.uk

U.S. National Nanotechnology Initiative http://nano.gov/html/facts/whatIsNano.html

Woodrow Wilson International Center for Scholars‘ Project on Emerging Nanotechologies

www.nanotechproject.org

http://www.bioportal.gc.ca/


http://www.nanobusiness.ca/

http://www.cientifica.eu/

http://www.consumerunion.org/

http://www.environmentaldefense.org/


http://www.epa.gov/oppt/nano




http://www.foe.org/

http://www.nanoportal.gc.ca/




http://www.nanotechweb.org/

http://nint-innt.nrc-cnrc.gc.ca/

http://www.oecd.org/env/nanosafety

http://www.oecd.org/env/nanosecurite


http://www.safenano.org/

http://www.involve.org.uk/

http://nano.gov/html/facts/whatIsNano.html


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