UPDATE: Researching Nanotechnology and Selected Legal and Regulatory Issues

By Mohammad Ershadul Karim

Dr. Mohammad Ershadul Karim is a Senior Lecture at the Faculty of Law, University of Malaya, Kuala Lumpur, Malaysia, and a non-practicing lawyer enrolled with the Bangladesh Supreme Court.

Published May/June 2023

(Previously updated in May 2016)

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1. Introduction

The word ‘nano’ is derived from the Greek word ‘nanos’, meaning ‘dwarf’ or ‘very small man’. In the study of nanoscience and technology, this word is used to indicate a scale of measurement. Nanotechnology, according to the European Commission, is a branch of science and engineering that is devoted to designing, producing, and using structures, devices, and systems by manipulating atoms and molecules at the nanoscale, i.e., having one or more dimensions of the order of 100 nanometres (100 millionths of a millimeter) or less. In layman’s term, it is the study of nanoscale chemicals. To the scientists, everything we see, touch, can feel is made of chemicals; and if we can manipulate these chemicals at the atomic and molecule scale, we can theoretically control everything. Nanotechnology thus was hailed as the next wonder after the Internet because of its limitless potentials. At the beginning of this century, most of the developed countries started initiatives to exploit nanotechnologies treating these as ‘the wave of the future’. The policymakers and stakeholders involved in dealing with nanoparticles and nanomaterials have frequently endorsed nanotechnologies as important catalysts that promise to play a crucial role in harnessing the potentials of the so-called fourth industrial revolution.

The legal and regulatory discussion on nanotechnology mostly rotates around the study of chemical substances, the environment, occupational health and safety, product liability, and consumer protection etc. For someone without scientific and technological knowledge, including people with a legal background, a good starting point is the basics of nanoparticles, nanomaterials, nanoscience and nanotechnologies. Some introductory discussions on nanoscience and nanotechnology can be found on the website of the United States National Nanotechnology Initiative and the European Union.

2. Historical Development

The use of materials at the nanoscale is not something new or innovative; rather, people of ancient civilizations in Egypt, Rome, China, and India had techniques for using nanoscale materials in different products. However, the modern study of nanotechnology allows scientists to intentionally manipulate materials at the nanoscale (between 1-100 nanometer).

It is widely accepted that the modern history of nanotechnology started with the groundbreaking 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. Norio Taniguchi, a Professor of Tokyo Science University, coined the term ‘nanotechnology’ for the first time in 1974. The invention of extremely powerful microscopes has tremendous impacts on the advancement of nanoscience and technology.

Nanomaterials are ubiquitous in nature and scientists have already discovered the nanoscale formation of various things available in the nature such as milk, volcanic ashes, dust, fumes, etc. Even though there are debates about whether nanomaterials are a unique or simple fabrication of structures already designed in nature, scholars from various disciplines such as physics, chemistry, biology and material science have been working relentlessly in shaping the modern world of nanoscience and nanotechnologies. A complete history of involving the developments in these fields is difficult to share, but the National Nanotechnology Initiative of the United States has attempted to cover an authoritative history of nanotechnology development from the 4th century until the present. Researchers have also attempted to explore the history of nanoscience and nanotechnology and the historical development of nanoparticles in ancient materials.

Though nanomaterials are ubiquitous in nature and the people of the ancient civilizations used to know the technique to exploit different types of nanomaterials and used these in various products; apparently, the modern and more systematic move in this regard started with the enactment of the 21st Century Nanotechnology Research and Development Act, 2003 by the Congress of the United States of America. Following this, regulators from different parts of the world, mostly from developed countries though, initiated a similar move. Since then, the global community has been witnessing the development of various nanomaterials and nano-enabled products.

3. Selective Databases on Nanomaterials and Nano-Enabled Products

An understanding of nanomaterials and nano-enabled products may help us explore relevant legal and regulatory issues. The Woodrow Wilson International Center for Scholars through the Project on Emerging Nanotechnology developed a Consumer Products Inventory for the first time in 2005. Initially, there were some concerns and limitations of the inventory as the listing was voluntary and the list of the consumer nano-enabled products was listed as and when these were shared by the manufacturers. Subsequently, the organisers updated their methodology and currently one may get information of more than 1600 nano-enabled products in the inventory. Federal Environment Agency of Germany subsequently shared the Concept for a European Register of Products Containing Nanomaterials and Assessment of Impacts of a European Register of Products Containing Nanomaterials. At present, it is possible to find out various databases containing information on various aspects of nanotechnologies, nanomaterials, and nanoparticles. Some of these are shared below:

Nanotechnologies and manufactured nanomaterials have the prospect of attaining almost all the goals listed in the United Nations Sustainable Development Goals. Nanomaterials are nanoscale chemicals. Considering the various stages in the cradle-to-grave lifecycle of nanomaterials—i.e., research and development, production and manufacturing, transportation, use by the consumers, and end use disposal of nano-enabled products and the stakeholders or parties involved in these various stages—one can anticipate various legal and regulatory issues in this regard. Looking at these from both public and private law angles can also help explore relevant legal and regulatory issues. The following section contains some important reference materials in this regard issued by authoritative international organisations.

4.1. United Nations

Various specialized agencies of the United Nations Organisation (UN) have been working on and publishing important policy documents within their mandated areas to promote and exploitation of nanomaterials.

4.2. European Initiatives

Europe, as a region and continent, has realized the importance of nanotechnologies and has taken various initiatives aiming to exploit nanomaterials for the betterment of Europe. Nevertheless, since the findings of various scientific literature revealed that some of the nanomaterials widely used in consumer products may have an adverse effect on human health and environmental components, various European entities have already reviewed relevant sectoral laws. For example, European Commission, DG Research, Unit published a report on European activities in the field of ethical, legal and social aspects (ELSA) and governance of nanotechnology, 2008.

A list of other similar initiatives:

Various initiatives have been taken through various institutions by adopting different arrangements and allocating a considerable amount of budget, aiming at guiding the global community in shaping the legal and regulatory landscape of nanotechnologies and nanomaterials.

The European Commission considers nanotechnology as a key enabling technology and is convinced that this has great potential potentials though there are safety concerns. One of the main contributions in this regard is the recommendation on the definition of ‘nanomaterials’ based on the size of particles in 2011. An implementation guidance was also released. That recommended definition guided European regulators and others. The recommended definition was reviewed and revised in 2022 retaining the principal features of the old definition. According to the Commission’s updated recommendation on the definition of nanomaterial, 2022, ‘Nanomaterial’ means a natural, incidental or manufactured material consisting of solid particles that are present, either on their own or as identifiable constituent particles in aggregates or agglomerates, and where 50 % or more of these particles in the number-based size distribution fulfil at least one of the following conditions: (a) one or more external dimensions of the particle are in the size range 1 nm to 100 nm; (b) the particle has an elongated shape, such as a rod, fibre or tube, where two external dimensions are smaller than 1 nm and the other dimension is larger than 100 nm; (c) the particle has a plate-like shape, where one external dimension is smaller than 1 nm and the other dimensions are larger than 100 nm.

The European Commission has funded the establishment of a European Union Observatory for Nanomaterials, which provides information about existing nanomaterials on the EU market. This initiative, hosted and maintained by the European Chemicals Agency, offers interesting reading about the safety, innovation, research and uses of nanomaterials.

The Joint Research Centre of the European Commission (JRC) provides independent, evidence-based knowledge and science, and advice to support European Union policy. JRC’s Nanomaterials Repository hosts a repository of representative industrial nanomaterials and provides a compilation of links to information sources relevant to nanomaterials. The JRC has already provided scientific and technical advice concerning nanomaterials to other Commission Services (e.g., DG Internal Market, Industry, Entrepreneurship and SMEs, DG Environment and DG Health and Food Safety) and regulatory agencies (European Chemical Agency, European Food Safety Authority and European Medicines Agency). JRC has also developed an open access Nanobiotechnology Laboratory with state-of-the-art facilities for interdisciplinary studies with a special emphasis on the characterisation of nanomaterials, nanomedicines, advanced materials, and micro(nano)plastics.

The European Commission also published a Code of Conduct for Responsible nanoscience and nanotechnology research in 2008. A project titled NanoCode involving multi-stakeholders was also taken to define and develop a framework aimed at supporting the successful integration and implementation of the Code of Conduct at the European level and beyond.

Other initiatives:

4.3. Timeline: Nanotechnology Policy and Regulation

See a timeline of nanotechnology policy and regulation in Canada, Australia, the European Union, the United Kingdom, and the United States. This timeline contains important events since 1936 which help shape the development of nanotechnology policy and regulation in these countries.

4.4. Canada-United States Regulatory Cooperation Council (RCC) Nanotechnology Initiative

The United States and Canada have established the Canada-United States Regulatory Cooperation Council (RCC) Nanotechnology Initiative to spur economic growth in each country; fuel job creation; lower costs for consumers, producers, and governments; and particularly help small and medium-sized businesses. The initiative also intends to eliminate unnecessary burdens on cross-border trade, reduce costs, foster cross-border investment, and promote certainty for businesses and the public by coordinating, simplifying and ensuring the compatibility of regulations, where feasible. Both countries are committed to working through the RCC to provide early notice of regulations with potential effects across their shared border, to strengthen the analytic basis of regulations, and to help make regulations more compatible.

5. International and Non-Governmental Organizations and Nanotechnology

Some international, both intergovernmental and non-governmental, organisations have been playing a crucial role in helping shape the legal and regulatory aspects of nanomaterials and nanotechnologies.

6. Risk Assessment and Risk Management

The assessment and management of various types of risks are crucial for the sustainable and responsible development of nanotechnologies and their commercial success. Various organisations have developed some guidelines and produced some reports in this regard.

7. Nanotechnology and Standardization

Standards are crucial for the sustainable and responsible development of nanotechnologies and their commercial success. Various national and international stand development organisations have developed standards in this regard:

8. Nanotechnology, Occupational Health and Trade Union

Workers and employees dealing with nanomaterials in research or production processes may be exposed to nanoparticles in several ways. Although the potential health effects of such exposure are not fully understood for the time being, scientific studies indicate that at least some of these materials are biologically active, may readily penetrate intact human skin, and have produced toxicologic reactions in the lungs of exposed experimental animals. As a result, to the regulators of most of the developed countries, the protection of these groups of people from the adverse effects of nanomaterials is a priority and therefore, the regulators have taken various measures and issued guidance documents in this regard. For example, the U.S. National Institute for Occupational Safety and Health (NIOSH) established the Nanotechnology Research Center (NTRC) in 2004 to identify critical issues related to potential worker exposure to nanomaterials. Some relevant guidance documents are listed below:

9. Guidance Documents

Different authorities have issued different Guidance/Guidelines which are instrumental in the responsible and sustainable development of nanotechnology. Many of these Guidances are available in resources shared under different places of this Guide and some can be found on the website of GoodNanoGuide. Some other Guidance Documents/Guidelines are shared below.

9.1. Australia

9.2. Germany

German Federal Institute for Occupational Safety (BAuA)’s Safe handling of nanomaterials and other advanced materials in workplaces.

9.3. USA

The US FDA issued the following Guidances, which are non-binding recommendations, for the industry.

9.4. Others

10. National Chapters on Nanotechnology

11. Some Relevant Important Resources

11.1. General

11.2. Australia

11.3. Belgium

11.4. Canada

11.5. China

11.6. Denmark

11.7. India

11.8. New Zealand

11.9. Switzerland

11.10. UK

11.11. USA

11.12. Others

11.13. Journals

12. Bibliography

12.1. Books

12.1.1. Encyclopedia, Dictionary and Handbook

12.1.2. General

12.1.3. Regulations

12.1.4. Environmental and Health Aspects

12.1.5. Societal Aspects

12.2. Articles

12.2.1. General

12.2.2. Nanotechnology Regulations

12.2.3. Patent and Nanotechnology

12.2.4. Environmental and Health Implications of Nanotechnology

12.2.5. Societal Implications of Nanotechnology

12.2.6. Risk, Exposure Assessment, and Management

12.2.7. Nanotechnology and Occupational Health

12.2.8. Nano Food Regulation