Meta-Regulation and Nanotechnologies: The Challenge of Responsibilisation Within the European Commission’s Code of Conduct for Responsible Nanosciences and Nanotechnologies Research

Indeed it has been estimated that costs for toxicity testing of existing nanoparticles available in the United States will range from $249 million to $1.18 billion and the time taken to complete testing will be significant (35–43 years) [10].

The “More than Moore” domain refers to a set of technologies that enable non-digital micro/nanoelectronic functions such as radio frequency (RF) communication, power control, passive components, sensors and actuators. These technologies are based on, or derive from, silicon technology but do not necessarily scale with Moore’s Law. “Beyond Moore” refers to a set of disruptive functions—from progress in nanometre-sized functions—that, in the long term, will complement or replace conventional silicon technology.

Our argumentation is based on reviews of the literature, policy documents and empirical studies.

With this broad view on regulatory activities, we follow Parker who maintains that meta-regulation can entail any form of regulation that regulates any other form of regulation [41]. Narrow views focus only on oversight [30] or on enforcement activities [1, 7].

See, for instance, the Responsible Care programme [14].

Along a continuum of forms of regulation, starting with complete discretion to acting according to self-interest (‘freedom’), and ending with command and control, to aligning to social goals (‘control’), meta-regulation can be placed in the middle (15).

These studies review process-oriented regulation which includes management-based regulation and meta-regulation [23]. Process-oriented regulation involves the steering of the regulatory process. Unlike management-based regulation, meta-regulation focuses on systematic regulatory learning which seems crucial for the regulation of emerging technologies with complex uncertainties.

For meta-regulation in general see [47].

Other meta-regulatory instruments include voluntary reporting schemes such as the Defra programme which aim at facilitating the collection of data on the potential hazards posed by engineered nanoparticles (see [6]).

Meaning, for example, is defined as follows: ‘N&N research activities should be comprehensible to the public. They should respect fundamental rights and be conducted in the interest of the well-being of individuals and society in their design, implementation, dissemination and use’ [23:6]. Innovation is described as follows: ‘Governance of N&N research activities should encourage maximum creativity, flexibility and planning ability for innovation and growth’ [23:7].

Thus, for example, for the good governance of N&N research, N&N research organisations and researchers ‘should ensure that scientific data and results are duly peer-reviewed before being widely disseminated outside the scientific community in order to ensure their clarity and balanced presentation’ [23:7].

The Code is also meant to provide guidelines for responsible nanoresearch to employers and all individual and civil society organisations involved or interested in nanoscience and nanotechnologies research (“all stakeholders”).

Such a performance agreement, for instance, commits meta-regulators to giving particular rewards and incentives, while it commits self-regulators to information provision and certain self-regulatory activities.

The use of mediators is proposed as a means of enabling more ‘genuine’ deliberation [3]. Mediators are expected to stimulate responsibilisation by translating various interests and ‘world views’ in order to facilitate communication across the different stakeholders.

Recent research shows that weak forms of rewards such as public recognition call responsibilisation into question [14].

The aim of the NanoCode project—funded by the European Commission’s Framework Programme 7 (FP7)—was to develop a strategic framework (the MasterPlan) aimed at guiding the further development and implementation of the Code of Conduct, in addition to the development of a practical implementation assistance tool to help stakeholders assess their performance in complying with the Code’s principles. A March 2011 Synthesis Report [24] presents the findings of the international, quantitative and qualitative NanoCode survey about the Code. The results summarised in the Synthesis Report and MasterPlan offer insight into stakeholders’ patterns of awareness, their expectations, attitudes and appraisals. In all, 304 European and international experts contributed to the NanoCode survey in the period August-October 2010. In addition, around 150 experts were involved in qualitative interviews or focus groups in the different countries between October 2010 and January 2011. All project partners contributed to identifying relevant stakeholders and prepared a catalogue of national stakeholders, in addition to participants from different national organisations. Furthermore, each partner was responsible for inviting the identified experts to participate in the electronic survey through a personal mailing procedure. Key experts were defined as persons with a role in planning, managing or funding of activities in research and development (R&D), its safety, quality of corporate responsibility or communication issues in their organisation; or a role in planning or managing of international/national/regional or sector specific regulations, guidelines, voluntary measures and policies or funding strategies. A large number of stakeholders (62 %) were involved in research (in academia, industry and public research institutions), 16 % derived from business and the rest belonged to institutions (governmental departments and agencies, R&D governing bodies, regulatory and standards agencies, etc.) and civil society (non-governmental organisations (NGOs), consumer associations, labour associations). According to the report, the results show a “surprisingly unambiguous tendency”, given the large and heterogeneous sample.

The FramingNano project [53] was another FP7 project which had the objective of defining a governance framework aimed at supporting responsible development of nanoscience and nanotechnology through international multi-stakeholder dialogue amongst the scientific, industrial, non-governmental and broader public communities. A multi-step approach was taken in the FramingNano project, which included a two-stage Delphi exercise and a multi-stakeholder workshop used to collect the opinions of stakeholders. Stakeholder opinions on regulation included opinions on the EC Code.

Countries were distinguished between those with relevant activities in N&N (Type A countries such as France, Switzerland, the UK, the Netherlands, Germany, etc.) and those with a quantitatively lower level of activity in N&N (Type B countries such as Italy, Spain, Czech Republic, Argentina, South Africa, etc.)

See http://​www.​framingnano.​eu/​index.​php?​option=​com_​content&​task=​view&​id=​163&​Itemid=​84

The number of stakeholders is not provided.

No additional information concerning who exactly these readers are or how many is provided.

http://​ec.​europa.​eu/​research/​consultations/​pdf/​nano-consultation_​en.​pdf

http://​ec.​europa.​eu/​research/​consultations/​nano-code/​results_​en.​pdf

The report points out that the innovation principle appears to be meant to primarily address Member States who are invited to ensure that innovation is pursued to the benefit of society and individuals.

The number or percentage of survey participants is not provided.

In addition, the CodeMeter provides context information about important elements of the guidelines, offers hints as to how to improve compliance and enables monitoring and documentation of compliance over time.

A number of options were identified in the NanoCode consultation, ranging from weak forms of incentives to stronger enforcing and monitoring mechanisms (disincentives) and encompassing the following: a positive label of Code compliance, priority in public research funding, compliance for public research funding, a whitelist/blacklist, and turning the Code into a standard for quality control. Mandatory rules for the implementation of the Code suggested by FramingNano stakeholders included verification that the code is followed by industry stakeholders in the production process, mandatory legislation requiring industry to implement a code, and the use of the code in applications for EU proposals.

Soft measures included the implementation of an internet homepage, as a forum for frequently asked questions and a platform for stakeholders to exchange experiences with the implementation of the Code and the organisation of regular meetings of different stakeholders to discuss various issues regarding the implementation of the Code.

See http://​www.​nanopodium.​nl/​CieMDN/​content/​NanoCode_​Country_​Report_​NL_​Final.​pdf

See also DEEPEN report (Davies et al. [16]). Davies et al. argue that filling in what responsible development means in practice is made more difficult by a lack of consensus regarding the meaning of terms such as ‘responsibility’, ‘socially acceptable’; the same may be true for the specific responsibilities of the stakeholders.

Of course it may be the case that it would be premature to have such teeth in such an instrument given the lack of certainty concerning risks that still persists.

See: http://​www.​observatorynano.​eu/​project/​filesystem/​files/​ObservatoryNano_​Nanotechnologies​_​RegulationAndSta​ndards_​2012.​pdf