What can Prudent Public Regulators Learn from the United Kingdom Government’s Nanotechnological Regulatory Activities?

Following Black, we regard regulation as “intentional attempts to control or order people or states of affairs (albeit mindful of the unintended consequences of those intentions)” [5]. Public regulation refers to sustained and focused control exercised by a public agency, on the basis of a legislative mandate, over activities that are generally regarded as desirable to society ([42]: 363). By private regulation we understand sustained and focused control of social conduct and states of affairs exercised by a private organisation, on the basis of its statutory mandate.

Nanotechnology is described as an emerging engineering discipline that applies methods from nanoscience to create products. Nanotechnologies refer to technologies of the very small, with dimensions in the range of nanometers. See the report of the British Royal Society and the Royal Academy of Engineering (2004), available at: http://​www.​nanotec.​org.​uk. A clear and consistent definition of ‘nano’ still is missing. Nanotechnology is an interesting example of the converging technologies, which connect diverse disciplines of science. In the case of nanotechnology physics, chemistry, genetics, information and communication technologies and cognitive sciences are connected.

Basically, public regulation is regarded as a means to correct perceived deficiencies in the market system in meeting certain collective interests ([34]: 2). According to economic theory, the many types of public regulation (i.e. legislation, incentives, communication) can be assigned to the categories of economic or social regulation [45]. The public interest justification for social regulation, which refers to such matters as health and safety, environmental protection, and consumer protection, tends to centre on two types of market failures. These are information asymmetries and spill-over effects (or externalities), which adversely affect individuals who are not involved in the transactions. The primary rationale for economic regulation refers to the fact that monopolies of industries are in general regarded as undesirable.

This refers to a certain interpretation of the precautionary principles that is often mentioned in nano-debates [19, 23, 28, 37].

However, recently scientific instruments to assess exposure to engineered nanomaterials in air and water, to evaluate their toxicity and to predict their impact on the environment and human health have been discussed [30].

In literature, the numbers of existing nanoproducts vary from 300 to 500 (Woodrow Wilson International Center 2006, available at http://​www.​nanotechproject.​org; Information Society 2006, available at http://​www.​innovationsociet​y.​ch; [26, 27, 30].

In this approach, nanotechnological risk problems are categorized according to the knowledge about the behaviour of nanostructures and about human responses to appraised hazards properties of nanotechnological development. This categorization is refined by relating the general categories to the generations of nanotechnological development. Regarding the knowledge about the impact of nanoproducts the study distinguishes between simple, complex, uncertain and ambiguous risk problems. According to the IRGC classification ([25]: 24), there is uncertainty and increasing complexity in the first generation (stable behaviour of nanostructures; after 2000). In the second generation (after 2005) the nanostructures’ properties are designed to change during operation, so behaviour is variable and potentially unstable. The integration of passive and active nanostructures in the third generation (after 2010) is expected to lead to unpredictable behaviour because of the complexity of systems with many components and types of interactions. Unpredictable behaviour is as well expected from the fourth generation applications (after 2015), in which fundamentally new functions and processes emerge from engineered nanosystems and architectures that are created from individual molecules or supramolecular components.

The current public governance debate is about shifts in coordination and steering methods, and about shifts in approaches and instruments of collective action ([35]: 58). It is a reaction on the critique on the functioning of governments (i.e. to provide remedies for problems of effectiveness and efficiency of collective action) and an attempt to link the contemporary state to the contemporary society.

By soft law we understand rules of conduct which in principle have no legally binding force, but which nevertheless have effects in legal practice [46]. Examples of soft law are: public and private action plans related to nanotechnology, codes of conduct and standards.

By co-evolution we understand co-development and mutual shaping of governance structures. Institutional structures are modulated by all governance actors who are part of the coordination process related to social action [38]. In our case actors are: regulators, scientists, technologists, entrepreneurs, and citizens. Co-evolution implies mutual dependencies, but also partly autonomy of regulatory actors. Established structures, rules, methods, and policies are seen as undergoing a continuous process of revision.

According to the White Paper on European Governance, crucial principles of good governance are openness, participation and accountability [18].

The case study is based on policy documents and literature.

Prince Charles was alleged by the Mail on Sunday (27th of April) as having serious concerns over nanotechnologies, because of ‘Grey Goo fears’, a scenario whereby self-replicating nano-machines consume the entire biosphere (see, [12]). Greenpeace UK expressed similar concerns.

Available online at http://​www.​nanotec.​org.​uk/​finalReport.​htm.

Available online at http://​www.​dti.​gov.​uk/​science/​.

The Council for Science and Technology is the UK Government’s top-level advisory body on science and policy issues.

See note 15.

Only 37 stakeholders replied.

See note 15, Government Response to Call for Evidence by the CST, chapter 2 (11).

HSE is a UK regulatory authority which is responsible for the negotiation, agreement and enforcement of implemented EU regulation and other UK regulation concerning chemicals, workplace exposure, control of accident hazards etc.

Available at http://​www.​dti.​gov.​uk/​science.

See Government Response to Call for Evidence by the CST, chapter 2.

See [6].