Nanotechnology and International Law Research Guide

Md. Ershadul Karim is a PhD Candidate in Nanotechnology Law and Policy, Faculty of Law, University of Malaya, Malaysia.

Abu Bakar bin Munir is a Professor and former Dean of Faculty of Law, University of Malaya, Malaysia.

Siti Hajar Mohd Yasin is Associate Professor at the Faculty of Law, Universiti Teknologi MARA, Malaysia.

1. Introduction

Nanotechnology is the next wonder after the internet and is referred to as the third industrial revolution. The word ‘nano’ derives from Greek word ‘nanos’, meaning ‘dwarf’ ‘very small man’. This word is used to mean a scale of measurement. Because of number of reasons, it has turned to be the wave of the future and world community is in a race to take lead in this area. The regulatory discussion on nanotechnology mostly rotates around the study of chemical legislation and safety, etc.

For the introductory discussion on nanoscience and nanotechnology, visit European Commission supported project Nanoyou, nanotechnology education resources.

2. Historical Development

The modern history of nanotechnology is considered to be started with the lecture of the Noble laureate Richard Feynman titled ‘There’s Plenty of Room at the Bottom’, delivered at a lecture in a meeting of the American Physical Society at the California Institute of Technology in 1959. Tokyo Science University Professor Norio Taniguchi coined the term nanotechnology.

An authoritative history of nanotechnology development from the 4th Century till date can be found here.

For the historical perspective on use of nanomaterials, please visit read Sciau, P. (2012). Nanoparticles in ancient materials: the metallic luster decoration of medieval ceramics. In A. A. Hashim (Ed.), The Delivery of Nanoparticles: InTech.

3. Nanotechnology Databases

• The Project on Emerging Nanotechnology: [This site contains an inventory of consumer products containing nanoscale materials since 2005. Till date 1,628 consumer products are listed in the database. Also, this is a must consult site on different aspects of nanotechnology].
• The Nanodatabase, developed by the Danish Consumer Council and the Danish Ecological Council in cooperation with the Technical University of Denmark (DTU) Environment. The database contains more than 1200 consumer products containing nanomaterials.
• Nanowerk Nanomaterial Database: A to Z Directory of Nanotechnology Suppliers/Companies, alphabetical list, list of suppliers by country.

4. International Law

4.1 United Nations

• Food and Agriculture Organization of the United Nations page on Nanotechnology.
• FAO/WHO technical paper on State of the art on the initiatives and activities relevant to risk assessment and risk management of nanotechnologies in the food and agriculture sectors.
• World Intellectual Property Organization page on Nanotechnology; Patenting Nanotechnology: Exploring the Challenges.
• UNEP Yearbook 2007 Chapter on Emerging Challenges: Nanotechnology and the Environment.
• United Nations Institute for Training and Research (UNITAR) Nanotechnology and Manufactured Nanomaterials.
• Inter-Organization Programme for the Sound Management of Chemicals (IOMC), was established in 1995 to strengthen cooperation and increase coordination in the field of chemical safety. This is an organization of seven participating organizations i.e. FAO, ILO, OECD, UNEP, UNIDO, UNITAR, WHO and two observer organization UNDP and the World Bank.
• In the 2010 Parma Declaration on Environment and Health, ministers of health and of environment of the 53 Member States of the WHO Regional Office for Europe listed the health implications of nanotechnology and nanoparticles among the key environment and health challenges.

4.2 European Initiatives

• European Commission page on Nanotechnology
• European Policy on Nanotechnology
• European Parliament Report on Nanomaterials in Consumer Products
• Joint Research Centre and Institute for Health and Consumer Protection Workshop Report on Challenges of Regulation and Risk Assessment of Nanomaterials.
• European Commission Communication on Regulatory Aspects of Nanomaterials
• European Commission Directorate-General for the Environment commissioned study report on “Review of Environmental Legislation for the Regulatory Control of Nanomaterials“.
• European Commission Code of Conduct for Responsible nanoscience and nanotechnology research
• European Commission Directorate-General for the Environment commissioned study report on aspects of environmental exposure to nanomaterials. “Environmental Exposure to Nanomaterials – Data Scoping Study“.
• European Commission, DG Research, Unit “Nano and Converging Sciences and Technologies” report on European activities in the field of ethical, legal and social aspects (ELSA) and governance of nanotechnology.
• European NanoSafety Cluster, an initiative of compilation of projects addressing all aspects of nanosafety including toxicology, ecotoxicology, exposure assessment, mechanisms of interaction, risk assessment and standardization.
• European NanoSafety Cluster Compendium, 2012, 2013
• Joint JRC-EASAC Report “Impact of engineered nanomaterials on health: considerations for benefit-risk assessment”
• Framing Nano Report on Mapping Study on Regulation and Governance of Nanotechnologies 2009
• European Project NanoCode is a multistakeholder dialogue providing inputs to implement the European Code of Conduct for Responsible Nanosciences & Nanotechnologies Research. NanoCode report on Mapping Study on Regulation and Governance of Nanotechnologies.
• NANoREG – A common European approach to the regulatory testing of Manufactured Nanomaterials
• Legal appraisal of nano technologies: Existing legal framework, the need for regulation and regulative options at a European and a national level, 2006
• nanopinion is an EC-funded project bringing together 17 partners from 11 countries with the aim of monitoring public opinion on what is hoped from innovation with nanotechnologies. The project is aimed citizens with a special focus on hard-to-reach target groups, which are people who do not normally encounter and give their opinion nanotechnologies at first hand.
• European Agency for Safety and Health at Work, Literature Review on Workplace exposure to nanoparticles, 2009

5. International and Non-Governmental Organizations and Nanotechnology

• Global List of Nanotechnology Organisations and Efforts [up to 2009]
• OECD Working Party on Manufactured Nanomaterials (WPMN)
• OECD Working Party on Nanotechnology
• OECD Working Party on Nanotechnology, Regulatory Frameworks for Nanotechnology in Foods and Medical Products, Summary results of a survey activity, March 2013
• Global Nanotechnology Network is a platform for addressing global challenges in energy, environment, health care, and public safety.
• Nanotechnology Industries Association, sector-independent, responsible voice for the industrial nanotechnologies supply chains.
• Asia Nano Forum: An Organization of 15 economies [Australia, India, Malaysia, South Korea, Vietnam, Indonesia, New Zealand, Taiwan, China, Iran, Thailand, Hong Kong, Japan, Singapore and UAE] from the Asia and the Pacific Region.
• Asia Pacific Nanotechnology Forum (APNF)
• Pan-American Nanotechnology Network
• Nanosciences African Network (Nanoafnet)
• International Alliance for NanoEHS Harmonization
• International Risk Governance Council (IRGC)
• Nanotechnology, Legal implications of Nanotechnology – see International Center for Technology Assessment page
• Friends of the Earth Nanotechnology Project
• ETC Group on Nanotechnology
• Greenpeace UK page on Nanotechnology
• Center for Food Safety
• Food and Drink Europe
• Nanotechnology Industry Association
• The Innovation Society

6. Risk Assessment and Risk Management

• European Commission’s Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) Report on Risk Assessment of Products of Nanotechnologies (2009)
• Renn, O., & Roco, M. (2006). Nanotechnology risk governance. The International Risk Governance Council, Geneva.

7. Nanotechnology and Standardization

• European Committee for Standardization CEN/TC 352- Nanotechnology
• International Standard Organization Technical Committee on Nanotechnologies (ISO/TC 229 Nanotechnologies)
• International Electrotechnical Commission Technical Committee on Nanotechnology Standardization for Electrical and Electronic Products and System (IEC/TC 113)
• British Standards Institution Standards on Nanotechnology
• Standard Australia page on Nanotechnology

8. Nanotechnology and Trade Union

• European Trade Union Confederation (ETUC)
• European Trade Union Institute
• Australian Council of Trade Unions
• Demands of the Confederation of Dutch Trade Unions FNV directed to the Employers organizations and the Government.

9. Centers on Responsible and Sustainable use Development of Nanotechnology

• The USA National Science Foundation has been funding the Center for Biological and Environmental Nanotechnology (CBEN) at Rice University to develop sustainable nanotechnologies of the improvement of human health and environment. The CBEN subsequently founded the International Council on Nanotechnology (ICON)
• Center for Nanotechnology in Society at Arizona State University
• Center for Nanotechnology in Society at the University of California Santa Barbara
• London School of Economics page on Nanotechnology Policy and Regulation

10. Good Laboratory Practice Guide

• Good Nano Guide
• Occupational Health and Safety Manual

11. National Chapters on Nanotechnology

• The Nanotech Regulatory Document Archive [This is a free, searchable database of policy documents of different countries around the world. The resource is built and maintained by the Center for the Study of Law, Science, & Technology at the Sandra Day O’Connor College of Law at Arizona State University, USA, the Centre of Regulatory Studies in the Monash University Law School, Australia, and the Institute of Environmental and Energy Law at K.U. Leuven, Belgium].
• Nano Statistics: Nano Science, Technology and Industry Scoreboard [This is the Iranian database on nanotechnology containing different information i.e. number of publication in Web of Science Database (WoS), patent information, national expenditure on nanotechnology research and development etc. relating to nanotechnology on different countries of the world].

12. Some Other Important Resources

12.1. Australia

• Seear, K., Petersen, A., & Bowman, D. (2009). The social and economic impacts of nanotechnologies: A literature review. Melbourne: Monash University.
• Ludlow, K., Bowman, D., & Hodge, G. (2007). A review of possible impacts of nanotechnology on Australia’s regulatory framework. Monash Centre for Regulatory Studies, Faculty of Law, Monash University and Institute for Environmental and Energy Law, Faculty of Law, KU Leuven,(September 2007)

12.2. Canada

• Pelley, J., & Saner, M. A. (2009). International approaches to the regulatory governance of nanotechnology. Regulatory Governance Initiative, Carleton University.
• Consumer Council of Canada Report on Nanotechnology and its Impact on Consumers, 2008.

12.3. China

• Jarvis, S.L., Richmond, N., ‘Regulation and Governance of Nanotechnology in China: Regulatory Challenges and Effectiveness

12.4. Denmark

• DHI Water and Environment and the Technical University of Denmark, Survey of nanotechnological consumer products, 2007
• Danish Ministry of the Environment, Survey on Basic Knowledge about Exposure and Potential Environmental and Health Risks for Selected Nanomaterials, 2011.

12.5. France

• Decree no. 2012-232 of 17 February 2012 on the annual declaration on substances at nanoscale in application of article R. 523-4 of the Environment code
• Ministerial Order of 6 August 2012 on the content and the conditions for the presentation of the annual declaration on substances at nanoscale, in application of articles R. 523-12 and R. 523-13 of the Environment code
• Nel, A., Malloy, T., Avery, D., Nasser, E., & Beryt, E. (2013). Implications of the French Registry for Engineered Nanomaterials. ACS Nano, 7(6), 4694-4696.
• France publishes Results from the first Round of its Mandatory Nano Reporting Scheme

12.6. Germany

• Nanotechnology: Health and environmental risks of nanomaterials
• DaNa2.0: Data and knowledge on nanomaterials – processing of socially relevant scientific facts
• Concept of a European Register of Products Containing Nanomaterials; Assessment of Impacts of a European Register of Products Containing Nanomaterials

12.7. India

• Regulatory Challenges posed by Nanotechnology Developments in India, The International Development Research Centre, Canada

12.8. Japan

• National Institute of Advanced Industrial Science and Technology Risk Assessment of Manufactured Nanomaterials; Risk Assessments of Three Manufactured Nanomaterials

12.9. Netherlands

• Nanomaterials in waste, Health Council of the Netherlands

12.10. New Zealand

• Gavaghan, C., & Moore, J. (2011). A Review of the Adequacy of New Zealand’s Regulatory Systems to Manage the Possible Impacts of Manufactured Nanomaterials, Otago University Centre for Law and Policy in Emerging Technologies.
• Moore, J. (2012). An evaluation of whether New Zealand’s occupational health and safety law adequately addresses the risks to workers exposed to nanotechnology and Nanoparticles. New Zealand Journal of Employment Relations, 37(1), 100.
• Gavaghan, C., Moore, J. ‘De minimis curat lex : New Zealand law and the challenge of the very small‘, European Journal of Law and Technology, Vol. 2, No.3, 2011

12.11. Switzerland

• Swiss precautionary matrix for synthetic nanomaterials
• Public Reactions to Nanotechnology in Switzerland, 2006

12.12. Sweden

• Proposed National Action Plan for Nanomaterials [main report in Swedish, but summery is available in English]

12.13. Taiwan

• Taiwan Nanotechnology EHS Database
• Taiwan Nanotechnology Industry Development Association, a non-profit organization, founded in 2004 by 57 distinguished members from public associations, industries, universities and research institutions, that aims to facilitate the integration of R & D efforts at universities, research institutions and industry to accelerate the commercialization of nanotechnology and to meet industries’ needs of developing high valued-added products and technology.

12.14. UK

• Nano&Me, Nanotechnology in our lives, wonderful site with easy explanation of complex issues in nanotechnology regulation.
• The Royal Society, the UK national academy of science, and the Royal Academy of Engineering, the UK national academy of engineering Report on Nanoscience and nanotechnologies: opportunities and uncertainties
• Report of Food Standards Agency Regulatory Review (A review of potential implications of nanotechnologies for regulations and risk assessment in relation to food), August 2008.
• Royal Institute of International Affairs Report on Securing the Promise of Nanotechnologies Towards Transatlantic Regulatory Cooperation, September 2009.
• UK Nanotechnologies Strategy: Small Technologies, Great Opportunities, March 2010.

12.15. USA

• The 21st Century Nanotechnology Research and Development Act 2003
• National Nanotechnology Initiative [U.S. Government research and development (R&D) initiative involving the nanotechnology-related activities of 20 department and agency units].
• USA Food and Drug Administration Approach to Regulation of Nanotechnology Products
• USA Congress Report on Regulatory Challenges of Nanomaterials 2008
• USA National Institute for Occupational Safety and Health Report on Managing the Health and Safety Concerns Associated with Engineered Nanomaterials, March 2009
• Principles for Regulation and Oversight of Emerging Technologies
• Fiorino, D. J. (2010). Voluntary initiatives, regulation, and nanotechnology oversight: charting a path. Project on Emerging Nanotechnologies, (19).
• Ninth Circuit Court’s decision on EPA’s approval of nanosilver-based pesticide Natural Resources Defense Council v. United States Environmental Protection Agency, No. 12-70268 (9th Cir. Nov. 7, 2013)
• Barandiaran, J. (2007). The Berkeley City Ordinance on Nanotechnology: Shortcomings, improvements, and implications for risk governance. STEP White Paper Competition. Retrieved December, 6, 2011.
• US Environmental Protection agency nanotechnology white paper, 2007
• City of Berkley, California Municipal Code and Disclosure of Nanomaterials, City of Berkeley Manufactured Nanoscale material Disclosure Guidelines
• Cambridge Public Health Department, Recommendations for a Municipal Health & Safety Policy for Nanomaterials A Report to the Cambridge City Manager July 2008
• Hays, S. A., Robert, J. S., Miller, C. A., & Bennett, I. (2013). Recommendations for a Municipal Health & Safety Policy for Nanomaterials. In Nanotechnology, the Brain, and the Future (pp. 333-356). Springer Netherlands.

13. Journal

• Nanotechnology Law & Business (NLB) is a peer reviewed journal devoted to the legal, business, and policy aspects of small scale technologies. NLB provides valuable expert insights and analysis for all professionals involved in these fast-developing fields.
• European Journal of Law and Technology Special issue on Nanotechnology
• Dossiers of the NanoTrust project of the Institute of Technology Assessment of the Austrian Academy of Sciences are very helpful and informative newsletters.

14. Bibliography

14.1. Books

14.1.1. Encyclopedia, Dictionary and Handbook

• Bezryadin, A., Bollinger, A., Hopkins, D., Murphey, M., Remeika, M., & Rogachev, A. (2003). Dekker Encyclopedia of Nanoscience and Nanotechnology. CRC Press.
• Goddard III, W. A., Brenner, D., Lyshevski, S. E., & Iafrate, G. J. (Eds.). (2007). Handbook of nanoscience, engineering, and technology. CRC press.
• D. Guston (Ed.). (2010). Encyclopedia of nanoscience and society. Thousand Oaks, CA: SAGE Publications, Inc.
• Hari Singh Nalwa (2011), Encyclopedia of Nanoscience and Nanotechnology, American Scientific Publishers.
• Bhushan, B. (2012). Encyclopedia of Nanotechnology. Springer.
• Herrmann, P., & Schmitt, M. (2012). Dictionary of nanotechnology. Beuth Verlag.
• Vogel, U., Savolainen, K., Wu, Q., van Tongeren, M., Brouwer, D., & Berges, M. (Eds.). (2013). Handbook of Nanosafety: Measurement, Exposure and Toxicology. Elsevier.

14.1.2. General

• Drexler, K. E., & Minsky, M. (1990). Engines of creation. London: Fourth Estate.
• Miller, J. C., Serrato, R., Represas-Cardenas, J. M., & Kundahl, G. (2004). The handbook of nanotechnology: Business, policy, and intellectual property law. John Wiley & Sons.
• Shelley, T. (2006). Nanotechnology: new promises, new dangers. Zed Books.
• Mader, K., Brune, H., Ernst, H., Grunwald, A., Grünwald, W., Hofmann, H., … & Wyrwa, D. (2006). Nanotechnology: assessment and perspectives (Vol. 27). Springer.
• Hodge, G. A., Bowman, D., & Ludlow, K. (Eds.). (2007). New global frontiers in regulation: The age of nanotechnology. Edward Elgar Publishing.
• Roco, M. C., & Bainbridge, W. S. (Eds.). (2007). Nanotechnology: Societal Implications: I: Maximising Benefits for Humanity; II: Individual Perspectives (Vol. 2). Springer.
• Boucher, P. M. (2008). Nanotechnology: legal aspects. CRC Press.
• Allhoff, F., Lin, P., & Moore, D. (2009). What is nanotechnology and why does it matter: from science to ethics. John Wiley & Sons.
• Arnaldi, S., Lorenzet, A., & Russo, F. (Eds.). (2009). Technoscience in Progress: Managing the Uncertainty of Nanotechnology. IOS Press.
• Liu, L. (2009). Emerging Nanotechnology Power: Nanotechnology R&D and Business Trends in the Asia Pacific Rim: World Scientific.
• Binns, C. (2010). Introduction to nanoscience and nanotechnology (Vol. 14). Wiley.
• Bowman, D. M., & Maynard, A. D. (2010). International handbook on regulating nanotechnologies. Edward Elgar Limited.
• Sutton, V. (2011). Nanotechnology Law and Policy. Carolina Academic Press.
• Murashov, V., & Howard, J. (2011). Nanotechnology standards. Springer.
• Brazell, L. (2012). Nanotechnology Law. Best Practices, Kluwer Law International.
• Dana, D. (Ed.). (2012). The Nanotechnology Challenge: Creating Legal Institutions for Uncertain Risks. Cambridge University Press.
• Grunwald, A. (2012). Responsible Nanobiotechnology: Philosophy and Ethics. CRC Press.
• Hunt, G., & Mehta, M. (Eds.). (2013). Nanotechnology:” Risk, Ethics and Law”. Routledge.
• Asmatulu R. (2013). Nanotechnology Safety, Elsevier.
• Throne-Holst, H., Soto, E., Strandbakken, P., & Scholl, G. (2013). Consumers and Nanotechnology: Deliberative Processes and Methodologies. CRC Press.
• Gordijn, B., & Cutter, A. M. (Eds.). (2014). In Pursuit of Nanoethics. Springer Netherlands.

14.1.3. Regulations

• Matsuura, J. H. (2006). Nanotechnology regulation and policy worldwide: Artech House London.

14.1.4. Environmental and Health Aspects

• Maynard, A. D., & Pui, D. Y. (Eds.). (2007). Nanotechnology and occupational health. Springer.
• Kaiser, M. (Ed.). (2009). Governing future technologies: nanotechnology and the rise of an assessment regime (Vol. 27). Springer.
• Lead, J. R., & Smith, E. L. (Eds.). (2009). Environmental and human health impacts of nanotechnology. Hoboken (NJ): Wiley.
• Sellers, K., Mackay, C., Bergeson, L. L., Clough, S. R., Hoyt, M., Chen, J., Henry, K., & Hamblen, J. (2010). Nanotechnology and the Environment. CRC Press.
• Ramachandran, G. (2011). Assessing nanoparticle risks to human health. William Andrew.
• Fadeel, B., Pietroiusti, A., & Shvedova, A. A. (Eds.). (2012). Adverse Effects of Engineered Nanomaterials: Exposure, Toxicology, and Impact on Human Health. Academic Press.
• Shatkin, J. A. (2012). Nanotechnology: health and environmental risks. CRC Press.
• Malsch, I., & Emond, C. (Eds.). (2013). Nanotechnology and Human Health. CRC Press.

14.1.5. Societal Aspects

• Allhoff, F. (Ed.). (2007). Nanoethics: the ethical and social implications of nanotechnology. John Wiley & Sons.
• Fritz Allhoff & Patrick Lin (Ed.). (2008) Nanotechnology & Society: Current and Emerging Ethical Issues. Springer
• Fisher, E., Selin, C., & Wetmore, J. M. (Eds.). (2008). The Yearbook of Nanotechnology in Society, Volume I: Presenting Futures (Vol. 1). Springer Science+ Business Media BV.
• Cozzens, S. E., & Wetmore, J. M. (Eds.). (2010). Nanotechnology and the challenges of equity, equality and development (Vol. 2). Springer.
• Maclurcan, D., & Radywyl, N. (Eds.). (2011). Nanotechnology and global sustainability. CRC Press.
• Maclurcan, D. (2012). Nanotechnology and Global Equality. CRC Press.
• Khan, A. S. (Ed.). (2012). Nanotechnology: Ethical and Social Implications. CRC Press.

14.2. Articles

14.2.1. General

• Fiedler, F. A., & Reynolds, G. H. (1993). Legal problems of nanotechnology: an overview. S. cal. interdisc. LJ, 3, 593.
• Moore, F. N. (2002). Implications of nanotechnology applications: using genetics as a lesson. Health Law Rev, 10(3), 9-15.
• Nicolau, D. (2004). Challenges and opportunities for nanotechnology policies: an Australian perspective. Nanotech. L. & Bus., 1, 446.
• Castro, F. (2004). Legal and Regulatory concerns facing Nanotechnology. J. Intell. Prop., 4, 140.
• Pinson, R. D. (2004). Is nanotechnology prohibited by the biological and chemical weapons conventions. Berkeley J. Int’l L., 22, 279.
• Thayer, J. D. (2005). The SPS Agreement: Can It Regulate Trade in Nanotechnology?. Duke L. & Tech. Rev., 2005, 15-26.
• Van Calster, G. (2006). Regulating nanotechnology in the European Union. Nanotech. L. & Bus., 3, 359.
• Van Calster, G. (2006). Regulating nanotechnology in the European Union. European Environmental Law Review, 238.
• Ludlow, K. (2007). The Readiness of Australian Food Regulation for the Use of Nanotechnology in Food and Food Packaging, U. Tas. L. Rev., 26, 177.
• Munir, A. B., & Yasin, S. H. M. (2007). Nanotechnology in healthcare: are existing laws adequate?. European journal of health law, 14(3), 261-272.
• Michelson, E. S. (2008). Globalization at the nano frontier: The future of nanotechnology policy in the United States, China, and India. Technology in Society, 30(3), 405-410.
• Hansen, S. F., Maynard, A., Baun, A., & Tickner, J. A. (2008). Late lessons from early warnings for nanotechnology. Nature nanotechnology, 3(8), 444-447.
• Paradise, J., Wolf, S. M., Ramachandran, G., & Kokkoli, E. (2008). Developing oversight frameworks for nanobiotechnology. Minn. JL Sci. & Tech., 9, 399.
• Rakhlin, M. (2008). Regulating nanotechnology: a private-public insurance solution. Duke L. & Tech. Rev., 1.
• Throne-Holst, H., & Strandbakken, P. (2009). “Nobody Told Me I was a Nano-Consumer:” How Nanotechnologies Might Challenge the Notion of Consumer Rights. Journal of consumer policy, 32(4), 393-402.
• Fairbrother, A., & Fairbrother, J. R. (2009). Are environmental regulations keeping up with innovation? A case study of the nanotechnology industry. Ecotoxicology and environmental safety, 72(5), 1327-1330.
• D’Silva, J., & Bowman, D. M. (2010). To Label or Not to Label-It’s More than a Nano-Sized Question. Eur. J. Risk Reg., 420.
• Faunce, T. A., & Nasu, H. (2010). Nanotechnology and the International Law of Weaponry: Towards International Regulation of Nano-Weapons. Journal of Law, Information and Science, 20, 21-54.
• Helwegen, W. (2010). The research exemption from a nanotechnology perspective, European Intellectual Property Review, 32:341-351
• Malloy, T. F. (2011). Nanotechnology regulation: a study in claims making. ACS nano, 5(1), 5-12.
• Marchant, G., & White, A. (2011). An international nanoscience advisory board to improve and harmonize nanotechnology oversight. Journal of Nanoparticle Research, 13(4), 1489-1498. doi: 10.1007/s11051-011-0226-1
• Jennifer Nash (2012), The Massachusetts Toxics Use Reduction Act: A Model for Nanomaterials Regulation?, Harvard Kennedy School.
• Nasu, H. (2012). Nanotechnology and challenges to international humanitarian law: a preliminary legal assessment. International Review of the Red Cross, 94(886), 653-672.
• Pertoldi-Bianchi, S. (2012). The Extended Producer Responsibility in Waste Regulations In a Multilevel Global Approach: Nanotechnology as a Case Study. European Energy and Environmental Law Review, 21(5), 198-219.
• Fleege, L., & Lawrenz, F. (2012). An Empirical Examination of the Current State of Publically Available Nanotechnology Guidance Materials. The Journal of Law, Medicine & Ethics, 40(4), 751-762.
• Dana, D. A. (2012). The Case for an Information-Forcing Regulatory Definition of Nanomaterials, The. Pace Envtl. L. Rev., 30, i.

14.2.2. Nanotechnology Regulations

• David Forrest. (1989). Regulating Nanotechnology Development, Foresight Institute.
• Lin-Easton, P. C. (2001). It’s Time for Environmentalists to Think Small-Real Small: A Call for the Involvement of Environmental Lawyers in Developing Precautionary Policies for Molecular Nanotechnology. Geo. Int’l Envtl. L. Rev., 14, 107.
• Reynolds, G. H. (2003). Nanotechnology and regulatory policy: three futures. Harvard Journal of Law and Technology, 17, 179.
• Haim, R., Petschow, U., Steinfeldt, M., & von Gleich, A. (2004). Nanotechnology and Regulation within the Framework of the Precautionary Principle. Schriftenreihe des IÖW, 173(04).
• Segal, S. H. (2004). Environemental Regulation of Nanotechnology: Avoiding Big Mistakes for Small Machines. Nanotech. L. & Bus., 1, 290.
• Marchant, G. E., & Sylvester, D. J. (2006). Transnational models for regulation of nanotechnology. The Journal of Law, Medicine & Ethics, 34(4), 714-725.
• Abbott, K. W., Marchant, J. D., Gary, E., & Sylvester, D. J. (2006). A framework convention for nanotechnology?. Environmental law reporter, 36.
• Wilson, R. F. (2006). Nanotechnology: the challenge of regulating known unknowns. The Journal of Law, Medicine & Ethics, 34(4), 704-713.
• Bowman, D. M., & Hodge, G. A. (2006). Nanotechnology: Mapping the wild regulatory frontier. Futures, 38(9), 1060-1073.
• Helland, A., Kastenholz, H., Thidell, A., Arnfalk, P., & Deppert, K. (2006). Nanoparticulate materials and regulatory policy in Europe: an analysis of stakeholder perspectives. Journal of Nanoparticle Research, 8(5), 709-719.
• Abbott, K. W., Marchant, J. D., Gary, E., & Sylvester, D. J. (2006). A framework convention for nanotechnology?. Environmental law reporter, 36.
• Romig Jr, A. D., Baker, A. B., Johannes, J., Zipperian, T., Eijkel, K., Kirchhoff, B., … & Walsh, S. (2007). An introduction to nanotechnology policy: Opportunities and constraints for emerging and established economies. Technological Forecasting and Social Change, 74(9), 1634-1642.
• Lin, A. C. (2007). Size matters: regulating nanotechnology. Harv. Envtl. L. Rev., 31, 349.
• Dawson, S. (2007). Proposal for an International Framework Convention to Assess the Environmental Risk of Commercially Available Nanomaterials, A. U. Balt. J. Envtl. L., 15, 129.
• Bowman, D. M., & Hodge, G. (2007). A small matter of regulation: An international review of nanotechnology regulation. Columbia Sci Technol Law Rev, 8(1).
• Wardak, A., Gorman, M. E., Swami, N., & Rejeski, D. (2007). Environmental Regulation of Nanotechnology and the TSCA. Technology and Society Magazine, IEEE, 26(2), 48-56.
• Faunce, T. A. (2007). Nanotherapeutics: new challenges for safety and cost-effectiveness regulation in Australia. Medical Journal of Australia, 186(4), 189.
• De Ville, K. A. (2008). Law, regulation and the medical use of nanotechnology. In Emerging Conceptual, Ethical and Policy Issues in Bionanotechnology (pp. 181-200). Springer Netherlands.
• Bowman, D. M., & Hodge, G. A. (2008). ‘Governing’ nanotechnology without government?. Science and Public Policy, 35(7), 475-487.
• Besley, J. C., Kramer, V. L., & Priest, S. H. (2008). Expert opinion on nanotechnology: risks, benefits, and regulation. Journal of Nanoparticle Research, 10(4), 549-558.
• Guerra, G. (2008). European regulatory issues in nanomedicine. NanoEthics, 2(1), 87-97.
• Powell, M. C., Griffin, M. P., & Tai, S. (2008). Bottom-up risk regulation? How nanotechnology risk knowledge gaps challenge federal and state environmental agencies. Environmental management, 42(3), 426-443.
• D’Silva, J., & Van Calster, G. (2009). Taking temperature—A review of European Union regulation in nanomedicine. European journal of health law, 16(3), 249-269.
• Ludlow, K., Bowman, D. M., & Kirk, D. D. (2009). Hitting the mark or falling short with nanotechnology regulation?. Trends in biotechnology, 27(11), 615-620.
• Ponce, A. (2009). The EU Approach to Regulating Nanotechnology. ETUI Working Paper 2010.05.
• Corley, E. A., Scheufele, D. A., & Hu, Q. (2009). Of risks and regulations: how leading US nanoscientists form policy stances about nanotechnology. Journal of Nanoparticle Research, 11(7), 1573-1585.
• Marchant, G. E., Sylvester, D. J., & Abbott, K. W. (2009). What does the history of technology regulation teach us about nano oversight?. The Journal of Law, Medicine & Ethics, 37(4), 724-731.
• Stokes, E. (2009). Regulating nanotechnologies: sizing up the options. Legal Studies, 29(2), 281-304.
• Lee, M. (2010). Risk and beyond: EU regulation of nanotechnology. Eur Law Rev, 35(6), 799-821.
• Perez, O. (2010). Precautionary Governance and the Limits of Scientific Knowledge: A Democratic Framework for Regulating Nanotechnology. UCLA J. Envtl. L. & Pol’y, 28, 29.
• Marchant, G. E. (2010). New Soft Law Approach to Nanotechnology Oversight: A Voluntary Product Certification Scheme, A. UCLA J. Envtl. L. & Pol’y, 28, 123.
• Tyshenko, M. G., Farhat, N., Lewis, R., & Shilnikova, N. (2010). Applying a precautionary risk management strategy for regulation of nanotechnology. International Journal of Nanotechnology, 7(2), 243-264.
• Abbott, K. W., Merchant, G. E., & Corley, E. A. (2011). Soft Law Oversight Mechanisms for Nanotechnology. Jurimetrics, 52, 279.
• George, A. (2011). International handbook on regulating nanotechnologies. Prometheus, 29(3), 319-324.
• Huang, C., Notten, A., & Rasters, N. (2011). Nanoscience and technology publications and patents: a review of social science studies and search strategies. The Journal of Technology Transfer, 36(2), 145-172.
• Micallef-Borg, C., & Van Calster, G. (2011). Non-Contractual Liability as an Instrument for Regulating Nano and New Technologies–A Thorough Review Using National and European Union Tort Law. Available at SSRN 1934730.
• Malloy, T. (2012). Soft Law and nanotechnology: A functional perspective. Jurimetrics, 52(3), 12-02.
• Paradise, J. (2012). Reassessing Safety for Nanotechnology Combination Products: What Do Biosimilars Add to Regulatory Challenges for the FDA?. St. Louis University Law Journal, 56(2).
• Stokes, E. (2012). Nanotechnology and the products of inherited regulation. Journal of law and society, 39(1), 93-112.
• Lerer, D. (2012). Big Things in Small Packages: Evaluating the City of Berkeley’s Nanotechnology Ordinance Effectiveness as a Model of Targeted Transparency. Pace Envtl. L. Rev., 30, i.
• Kaddour, N. (2012). No Laws in Nanoland: How to Reverse the Trend: The French Example. Pace Envtl. L. Rev., 30, i.
• Rucinski, T. L. (2012). Searching for the Nano-needle in a Green Haystack: Researching the Environmental, Health, and Safety Ramifications of Nanotechnology. Pace Envtl. L. Rev., 30, i.
• Karlaganis, G., & Liechti, R. (2013). The Regulatory Framework for Nanomaterials at a Global Level: SAICM and WTO Insights. Review of European, Comparative & International Environmental Law, 22(2), 163-173.
• Brosset, E. (2013). The Law of the European Union on Nanotechnologies: Comments on a Paradox. Review of European, Comparative & International Environmental Law, 22(2), 155-162.
• Malsch, I. (2013). Governing nanotechnology in a multi-stakeholder world. Nanoethics, 7(2), 161-172.
• Del Castillo, A. M. P. (2013). The European and Member States’ Approaches to Regulating Nanomaterials: Two Levels of Governance. NanoEthics, 7(3), 189-199.
• Elizabeth Vogelezang-Stoute, ‘Regulating Nanomaterials. Bottlenecks and Perspectives in EU Legislation on Chemicals and Products’ (2012) 21 European Energy and Environmental Law Review, Issue 1, pp. 41–50
• Reese, M. (2013). Nanotechnology: Using Co-regulation to Bring Regulation of Modern Technologies into the 21st Century. Health Matrix, 23, 537-607.

14.2.3. Patent and Nanotechnology

• Bawa, R. (2004). Nanotechnology Patenting in the US. Nanotech. L. & Bus., 1, 31.
• Sabety, T. (2004). Nanotechnology innovation and the patent thicket: Which IP policies promote growth. Alb. LJ Sci. & Tech., 15, 477.
• Lemley, M. A. (2005). Patenting nanotechnology. Stanford Law Review, 601-630.
• Zekos, G. I. (2006). Nanotechnology and biotechnology patents. International Journal of Law and Information Technology, 14(3), 310-369.
• Zekos, G. I. (2006). Patenting abstract ideas in nanotechnology. The Journal of World Intellectual Property, 9(1), 113-136.
• Bowman, D. M. (2007). Patently obvious: Intellectual property rights and nanotechnology. Technology in Society, 29(3), 307-315.
• Kallinger, C., Veffkind, V., Michalitsch, R., & Verbandt, Y. (2008). Patenting nanotechnology: a European patent office perspective. Nanotech. L. & Bus., 5, 95.
• Barpujari, I. (2010). The patent regime and nanotechnology: issues and challenges. Journal of Intellectual Property Rights, 15(3), 206-213.
• Schellekens, M. (2010). Patenting nanotechnology in Europe: making a good start? An analysis of issues in law and regulation. The Journal of World Intellectual Property, 13(1), 47-76.
• Huang, C., Notten, A., & Rasters, N. (2011). Nanoscience and technology publications and patents: a review of social science studies and search strategies. The Journal of Technology Transfer, 36(2), 145-172.

14.2.4 Environmental and Health Implications of Nanotechnology

• Colvin, V. L. (2003). The potential environmental impact of engineered nanomaterials. Nature biotechnology, 21(10), 1166-1170.
• Hoet, P. H., Nemmar, A., & Nemery, B. (2004). Health impact of nanomaterials?. Nature Biotechnology, 22(1), 19-19.
• Warheit, D. B., Sayes, C. M., Reed, K. L., & Swain, K. A. (2008). Health effects related to nanoparticle exposures: environmental, health and safety considerations for assessing hazards and risks. Pharmacology & therapeutics, 120(1), 35-42.
• Grassian, V. H. (Ed.). (2008). Nanoscience and nanotechnology: environmental and health impacts. John Wiley & Sons.
• Köhler, A. R., & Som, C. (2008). Environmental and health implications of nanotechnology—Have innovators learned the lessons from past experiences?. Human and ecological risk assessment, 14(3), 512-531.
• Xia, T., Li, N., & Nel, A. E. (2009). Potential health impact of nanoparticles. Annual review of public health, 30, 137-150.
• Elder, A., Lynch, I., Grieger, K., Chan-Remillard, S., Gatti, A., Gnewuch, H., E. Kenawy & Shvedova, A. (2009). Human health risks of engineered nanomaterials. In Nanomaterials: Risks and benefits (pp. 3-29). Springer Netherlands.
• Savolainen, K., Pylkkänen, L., Norppa, H., Falck, G., Lindberg, H., Tuomi, T., … & Seipenbusch, M. (2010). Nanotechnologies, engineered nanomaterials and occupational health and safety–A review. Safety science, 48(8), 957-963.
• Theodore, L., & Stander, L. (2012). Regulatory Concerns and Health/Hazard Risks Associated with Nanotechnology. Pace Envtl. L. Rev., 30, i.

14.2.5. Societal Implications of Nanotechnology

• Roco, M. C. (2003). Broader societal issues of nanotechnology. Journal of Nanoparticle Research, 5(3-4), 181-189.
• Macnaghten, P., Kearnes, M. B., & Wynne, B. (2005). Nanotechnology, governance, and public deliberation: what role for the social sciences?. Science communication, 27(2), 268-291.
• Bennett, I., & Sarewitz, D. (2006). Too little, too late? Research policies on the societal implications of nanotechnology in the United States. Science as Culture, 15(4), 309-325.
• Currall, S. C. (2009). Nanotechnology and society: New insights into public perceptions. Nature Nanotechnology, 4(2), 79.
• Kahan, D. M. (2009). Nanotechnology and society: The evolution of risk perceptions. Nature nanotechnology, 4(11), 705-706.
• Roco, M. C., Harthorn, B., Guston, D., & Shapira, P. (2011). Innovative and responsible governance of nanotechnology for societal development. In Nanotechnology Research Directions for Societal Needs in 2020 (pp. 561-617). Springer Netherlands.
• Roco, M. C., Mirkin, C. A., & Hersam, M. C. (2011). Nanotechnology research directions for societal needs in 2020: summary of international study. Journal of Nanoparticle Research, 13(3), 897-919.

14.2.6. Risk, Exposure Assessment, and Management

• Dreher, K. L. (2004). Health and environmental impact of nanotechnology: toxicological assessment of manufactured nanoparticles. Toxicological Sciences, 77(1), 3-5.
• Thomas, K., & Sayre, P. (2005). Research strategies for safety evaluation of nanomaterials, Part I: evaluating the human health implications of exposure to nanoscale materials. Toxicological Sciences, 87(2), 316-321.
• Holsapple, M. P., Farland, W. H., Landry, T. D., Monteiro-Riviere, N. A., Carter, J. M., Walker, N. J., & Thomas, K. V. (2005). Research strategies for safety evaluation of nanomaterials, part II: toxicological and safety evaluation of nanomaterials, current challenges and data needs. Toxicological Sciences, 88(1), 12-17.
• Balshaw, D. M., Philbert, M., & Suk, W. A. (2005). Research strategies for safety evaluation of nanomaterials, Part III: nanoscale technologies for assessing risk and improving public health. Toxicological Sciences, 88(2), 298-306.
• Renn, O., & Roco, M. (2006). Nanotechnology risk governance. The International Risk Governance Council, Geneva.
• Tsuji, J. S., Maynard, A. D., Howard, P. C., James, J. T., Lam, C. W., Warheit, D. B., & Santamaria, A. B. (2006). Research strategies for safety evaluation of nanomaterials, part IV: risk assessment of nanoparticles. Toxicological sciences, 89(1), 42-50.
• Wiesner, M. R., Lowry, G. V., Alvarez, P., Dionysiou, D., & Biswas, P. (2006). Assessing the risks of manufactured nanomaterials. Environmental science & technology, 40(14), 4336-4345.
• Marchant, G. E., Sylvester, D. J., & Abbott, K. W. (2008). Risk management principles for nanotechnology. Nanoethics, 2(1), 43-60.
• O’Brien, N., & Cummins, E. (2008). Recent developments in nanotechnology and risk assessment strategies for addressing public and environmental health concerns. Human and Ecological Risk Assessment, 14(3), 568-592.
• Wardak, A., Gorman, M. E., Swami, N., & Deshpande, S. (2008). Identification of Risks in the Life Cycle
  of Nanotechnology‐Based Products. Journal of Industrial Ecology, 12(3), 435-448.
  Satterfield, T., Kandlikar, M., Beaudrie, C. E., Conti, J., & Harthorn, B. H. (2009). Anticipating the perceived risk of nanotechnologies. Nature Nanotechnology, 4(11), 752-758.
• Linkov, I., Satterstrom, F. K., Monica Jr, J. C., & Foss, S. (2009). Nano risk governance: current developments and future perspectives. Nanotech. L. & Bus., 6, 203.
• Grieger, K. D., Hansen, S. F., & Baun, A. (2009). The known unknowns of nanomaterials: Describing and characterizing uncertainty within environmental, health and safety risks. Nanotoxicology, 3(3), 222-233.
• Morimoto, Y., Kobayashi, N., Shinohara, N., Myojo, T., Tanaka, I., & Nakanishi, J. (2010). Hazard assessments of manufactured nanomaterials. J Occup Health, 52(6), 325-334.
• van Broekhuizen, P., & Reijnders, L. (2011). Building blocks for a precautionary approach to the use of nanomaterials: positions taken by trade unions and environmental NGOs in the European nanotechnologies debate. Risk Analysis, 31(10), 1646-1657.
• Tyshenko, M. G., & Krewski, D. (2008). A risk management framework for the regulation of nanomaterials. International Journal of Nanotechnology, 5(1), 143-160.

14.2.7. Nanotechnology and Occupational Health

• Munir, A. B., Yasin, M., & Hajar, S. (2008). Nanotechnology: regulatory challenges to occupational safety and health. Policy and Practice in Health and Safety, 6(1), 97-113.
• Murashov, V., Schulte, P., Geraci, C., & Howard, J. (2011). Regulatory approaches to worker protection in nanotechnology industry in the USA and European Union. Industrial health, 49(3), 280-296.
• Savolainen, K., Pylkkänen, L., Norppa, H., Falck, G., Lindberg, H., Tuomi, T., … & Seipenbusch, M. (2010). Nanotechnologies, engineered nanomaterials and occupational health and safety–A review. Safety science, 48(8), 957-963.
• Schulte, P., Geraci, C., Zumwalde, R., Hoover, M., & Kuempel, E. (2008). Occupational risk management of engineered nanoparticles. Journal of occupational and environmental hygiene, 5(4), 239-249.
• Schulte, P. A., Geraci, C. L., Murashov, V., Kuempel, E. D., Zumwalde, R. D., Castranova, V., … & Martinez, K. F. (2014). Occupational safety and health criteria for responsible development of nanotechnology. Journal of Nanoparticle Research, 16(1), 1-17.

14.2.8. Nano Food Regulation

• Chau, C. F., Wu, S. H., & Yen, G. C. (2007). The development of regulations for food nanotechnology. Trends in Food Science & Technology, 18(5), 269-280.
• Cushen, M., Kerry, J., Morris, M., Cruz-Romero, M., & Cummins, E. (2012). Nanotechnologies in the food industry–Recent developments, risks and regulation. Trends in food science & technology, 24(1), 30-46.