1. introduction
‘Nanotechnology’ is an emerging field which attracts the interest of many because of its potential benefits and concerns regarding its potential environmental, health and safety impacts.Footnote 1 The latter concerns are often raised as a result of the ability of nanotechnology to modify the molecular aspect of nano-objects,Footnote 2 including their physical and chemical properties.Footnote 3 Nano-objects can be used alone, or with other materials to manufacture engineered nanomaterials. These characteristics give engineered nanomaterials novel electrical, catalytic, magnetic, mechanical, thermal or imaging properties that are useful for applications in the commercial, medical, military and environmental sectors.Footnote 4 Because of the same properties, each nano-object can elicit its own unique biological or ecological response.Footnote 5 Furthermore, these properties have the potential to elicit toxicity (or, if modified, reduced toxicity).
Early in their development, immediately after the first products containing engineered nanomaterials entered the market, pleas emerged for some control of the technologies and related products.Footnote 6 Today, with over 1,317 nano-enabled consumer products or product lines already in the market (including textiles, food packaging, cosmetics, luggage, children’s toys, floor cleaners and wound dressings),Footnote 7 exposure to nano-objects has become a regulatory issue. As a result, regulators focus on defining the optimal regulatory or governance approach to oversee the development and safe use of nanotechnologies under conditions of scientific uncertainty.
For more than two decades, information disclosure mechanisms – such as product labelling and certification schemes, and emissions reporting – have been advocated by legal scholars as part of the new ‘reflexive law’ approach for controlling environmental risks in lieu of command-and-control or market-based regulatory approaches.Footnote 8 Whether information disclosure is required to encourage responsible behaviour by businesses, support regulatory decisions, or empower citizens and consumers, it is generally believed that the flow of information will improve environmental outcomes and enhance informed decision-making and democracy. However, more recently some have criticized information disclosure mechanisms as being ineffective.Footnote 9 These scholars focus mainly on the questions of how, by whom, and to whom disclosure is made, highlighting the competing normative rationales within which information disclosure is being embraced and institutionalized.
This article adds to the debate by focusing on the question of what information is disclosed (or not disclosed) and why, highlighting the social-political context within which these decisions are made. It shows that under the hegemonic evidence-based approach, current ‘governance by disclosure’ schemes are unlikely to be effective regardless of the goal they aim to achieve – whether normative (‘right to know’), procedural (‘informed decision’) or substantive (‘environmental improvement’).Footnote 10 None of these presents a viable framework for governance of emerging technologies.
It is argued that justifying disclosure regulation based solely on scientific evidence of risk, rather than considering other societal aspects of nanotechnological development, assumes a private right to innovate that limits the power of governments and citizens to oversee innovation. Governments wishing to prevent potential negative consequences of this type of technology enter into a vicious circle of scientific data collection to lift the veil of uncertainty. However, as this article shows, information-gathering initiatives have not achieved their objectives to date. Even systematic mandatory programmes have limited ability to collect the whole range of risk data that is necessary for quantitative risk assessments. Any attempt to effectively oversee the development of nanotechnologies using an evidence-based approach is unlikely to succeed, because of the major scientific uncertainties in this field. An approach going beyond evidence alone is all the more necessary when the importance of the societal dimensions of impact is taken into account.
This article begins by echoing the demand for more disclosure in the field of nanotechnology. It then analyzes governments’ rationalities (the rhetoric) for justifying specific modes of regulation based on their risk conception in this field. The article further analyzes the regulatory mechanisms that governments adopt to foster their rationalities and the implications of these rationalities on governance by disclosure (the practice). Finally, it discusses the democratic implications of the current ‘governance by disclosure’ approach, pointing to its limited functionality under conditions of scientific uncertainty. The article concludes by suggesting a more democratic conceptualization of ‘governance by disclosure’.
2. the demand for governance by disclosure in the field of nanotechnology
Information disclosure has been advocated as a regulatory approach for nanotechnology, based on the reasoning that ‘in the immediate future, the greatest need for “regulation” is to increase the accumulation and dissemination of knowledge about the current state of nanotechnology research, development and applications, and about the risk and benefits of specific products and processes’.Footnote 11
At the 5th International NanoRegulation Conference held in Switzerland in 2009, participants discussed the crucial need for nano-information and nano-communication along the value chain. They recommended a ‘Nano-Information Pyramid’ to provide user-specific data within the value chain.Footnote 12 This pyramid contains four levels (see Figure 1):
• at the bottom, regulators collect safety data from industry to generate a database for registration and further regulation;
Figure 1 Nano-information pyramid
• on the second level, producers provide processors and recyclers with user-specific information on nano-specific properties of the substances, as well as recommendations for their safe use and handling;
• on the third level, industry provides retailers, consumers and recyclers with user-specific information on the properties of the materials and product (including its benefits, risks and recommendations concerning waste treatment), and it addresses questions from users; and
• at the top, product labelling is applied to indicate, in a concentrated manner, certain quality features or environmental, health and safety properties of a product containing engineered nanomaterials. Such product labelling may also certify the safe production of a product, indicating responsible risk management behind the product.Footnote 13
This approach received extensive stakeholder support in Europe. The results of a public online consultation held by the European Commission (EC) on its Strategic Nanotechnology Action Plan 2010–2015, show that Europeans want active communication and dissemination of information. Europeans further support the establishment of an inventory of types and uses of nanomaterials, including safety aspects, as well as the requirement for adequate information on consumer products (for example, claims verification and labelling of the nano-content of consumer products).Footnote 14 Furthermore, most consumer organizations and environmental non-governmental organizations (NGOs) worldwide are forcefully demanding more transparency about products containing nanomaterials.Footnote 15
Despite calls for urgent action, the response by regulatory bodies has been insignificant. An online review I conducted of worldwide nano-specific regulatory initiatives, released between the years 2004 and 2012, identified 105 government agency initiatives (see Figure 2).Footnote 16 Of those, nine adopted disclosure and labelling mechanisms (equivalent to pyramid levels 2, 3 and 4),Footnote 17 and five of those were based on voluntary compliance. By comparison, 51 initiatives (∼48%) were data collection related, with 36 initiatives collecting data for regulatory purposes (level 1 of the pyramid);Footnote 18 six initiatives were classified as product control,Footnote 19 focusing mainly on additional testing requirements as a pre-condition for manufacturing and importing permits, and nine classified as general guidelinesFootnote 20 to provide companies with guidance on how to develop the necessary data. The question is, therefore, why governments focus their efforts on data collection, and are reluctant to require information disclosure along the value chain.
Figure 2 Worldwide government nano-specific regulatory initiatives 2004–2012
To understand ‘modes’ of governments, Rose and Miller suggest analyzing governments’ political rationalities, and governmental technologies which deploy their rationalities.Footnote 21 Following this method of analysis, the following sections discuss government rationalities (based on their risk conception) to justify regulation of nanotechnologies, and the regulatory mechanisms they deploy to foster these rationalities. In this analysis, the article explains how governments approach regulation by disclosure in the field of nanotechnology and how they implement disclosure mechanisms.
3. government rationalities for nanotechnology regulation
The rhetoric used by most governments to describe their vision of nanotechnology governance reflects mainly two risk management approaches: the risk-based approach, which is commonly supported by the United States (US) federal government, and the precautionary approach, which is commonly advocated by the European Union (EU). Literature on risk management approaches tends to describe these two approaches as rivals, leading scholars to argue for transnational divergence in risk management policies.Footnote 22 This article questions this premise by arguing that these two approaches only appear contradictory in theory, while having practical similarities. Both approaches are evidence-based and define the regulatory risk object of nanotechnology in the same way, which in turn implies similar risk governance. The result is an overall transnational policy convergence in the field of nanotechnology.Footnote 23
A preliminary step towards the adoption of any regulatory programme is the justification for government intervention in the market. The rationalities for intervention may vary between fields, countries and individuals, depending on the conceptual risk that constructs the ‘risk object’Footnote 24 that requires control. Renn identifies several approaches to the conception and assessment of risk, which vary in their conceptualization of uncertainty, the scope of negative effects, and the degree to which human knowledge reflects reality. The various conceptions can be divided into four groups – technical, economic, psychological, and social-cultural.Footnote 25 Each conception elicits different risk objects which require different risk analysis approaches.Footnote 26
The international debate over the regulation of genetically modified organism (GMO)- based agro-food products can illustrate how competing risk conceptions eventually define different risk objects and thus different risk analysis approaches. The literature on GMOs illustrates that the objections to biotechnology are based not only on the health risks (physical harm) that this technology might cause, but also on cultural, ethical, religious, ideological, or competitive grounds.Footnote 27 In the absence of sufficient scientific indications of a realistic and serious risk posed by these products to human health or the environment (an a priori requirement to invoke the precautionary principle), other grounds eventually led the EU legislators to impose a de facto moratorium on GMO food. It was not a precautionary principle decision per se, rather a multi-faceted decision not to support the development of such technology. Similarly, nanotechnology-enabled applications also raise societal, legal and ethical concerns, including issues of privacy, human enhancement, intellectual property and international power relationships.Footnote 28 Yet, as demonstrated in this article, so far none of these concerns have influenced the current hegemonic risk conception, which focuses solely on the physical harm of nanotechnologies.
3.1. The Risk-Based Approach
The risk-based approach is traditionally associated with the US. Indeed, the Policy Principles for the US Decision-Making Concerning Regulation and Oversight of Applications of Nanotechnology and Nanomaterials state that ‘regulation should be based on risk, not merely hazard, and in all cases the identification of hazard, risk or harm must be evidence-based’.Footnote 29 It further states that the regulatory approach should be flexible, adaptive, and science-based. Footnote 30
This regulatory approach relies on the liberal rationale of freedom of innovation. It places innovation beyond political control (subject to some boundary conditions for the use of new technology) based on the assumption that society is better off dealing with the consequences than suppressing innovation in the first place.Footnote 31 It further assumes that regulation, which does not determine and justify its objectives scientifically, may hold back technological innovation and economic growth.Footnote 32 This concern is based on two separate conceptions: the first is that regulatory authorities run inefficiently and ineffectively with no consideration of regulatory costs, and therefore burden industry. Thus, deregulation and the adoption of private sector management styles are required.Footnote 33 The second conception, which is common to all science-based governance approaches (including the precautionary approach), is that the scientific process and scientific knowledge – free from political interests and religious prejudice – provide a rational, objective and universal answer to the problem, and therefore justify regulation and enhance trust in authorities.Footnote 34 One consequence of such a regulatory approach is that the burden of proof, and therefore the responsibility to assess the potential risks, falls on the opponents of the technology. Another important consequence is that other social values – such as ethics, religion or culture concerning the development of the technology – cannot justify regulatory action by themselves.
The risk-based approach to regulation adopts a technical conception of risk, which focuses on identifying potential physical harm to human beings or ecosystems, and on analyzing their probabilities of occurring over space and time.Footnote 35 Typically, once such risks are found to be severe enough to justify government intervention, standards to minimize the risks are established. However, under conditions of scientific uncertainty, the establishment of quantitative safety goals become challenging. This difficulty supports the development of a flexible and adaptive strategy to risk control that takes account of experience. Because these mechanisms can modify their behaviour in response to new information, they are better suited to conditions of uncertainty than command-and-control or market-based mechanisms that are established to achieve strict goals.Footnote 36
The effectiveness of this approach relies on its ability to acquire the necessary data from experiment and experience monitoring. If it is impossible to monitor data through experiment, or if the data collected is insufficient for a quantitative risk assessment, the learning process is stuck and the potential risk will be left with a minimum of control, or even completely unregulated.Footnote 37 Therefore, some scholars argue that in practice this approach enables agencies to adopt implementation measures and practices that delay compliance or avoid a fully rigorous application of a statutory provision.Footnote 38 Stewart, for example, refers to adaptive management as ‘a polite term for muddling through’.Footnote 39 He further argues that this approach is incompatible with democratic values of transparency, as it is often carried out in a low visibility fashion, and is largely immune, both practically and legally, to judicial review.Footnote 40
3.2. The Precautionary Approach
The precautionary approach is commonly applied by the EU. According to the EC’s Strategy for Nanotechnology:
Successful exploitation of nanotechnologies needs a sound scientific basis for both consumer and commercial confidence ... A proactive approach should be taken ... Ethical principles must be respected and, where appropriate, enforced through regulation ... The Precautionary Principle, as used up to now, could be applied in the event that realistic and serious risks are identified.Footnote 41
In theory, this regulatory approach relies on the perspective that technological innovation is a ‘social concession’ rather than a private right, and therefore demands sustainability and social responsibility of innovation.Footnote 42 This perspective is based on three pillars. Firstly, public views, ethics, and other societal dimensions should be integrated into decisions concerning research and development policy.Footnote 43 Secondly, the burden of proof and the responsibility for producing scientific evidence is on the producer, manufacturer or importer of the potentially risky product.Footnote 44 Thirdly, when faced with an unacceptable risk (i.e., a realistic and serious risk), scientific uncertainty and public concerns, governments are obliged to respond in accordance with the precautionary principle.Footnote 45
In practice, however, the precautionary approach still relies on a ‘sound science’ perspective on risk (i.e., technical risk conception) for its knowledge base. Public concerns based on cultural, religious or ideology preferences are not (implicitly) acknowledged under this approach.Footnote 46 According to the EC Communication on the precautionary principle, recourse to the precautionary principle as a risk management tool requires that a scientific evaluation, based on all available data, show a potential unacceptable risk to society.Footnote 47 This means that sufficient scientific data should be available to indicate ‘realistic and serious risk’ before any regulatory action is taken. The precautionary principle, as a legal standard, lowers the burden of proof of adverse effects, but it cannot be used to overturn the sequence of risk analysis altogether.Footnote 48
Importantly, the question of what constitutes sufficient scientific data is left open. Because the notions of probability and seriousness of risk under the precautionary principle are too vague to serve as a prescriptive principle for decision-making, some scholars call for a political interpretation of the principle.Footnote 49 Under such interpretation, issues such as the benchmark to invoke the precautionary principle should be decided through public deliberation, assuming that the contributions of public participants will be informed and reasoned.Footnote 50 Some scholars, however, warn that polarization of the precautionary principle will shift the focus from risk prevention to control of innovation, resulting in arbitrary and inconsistent regulation of new technologies.Footnote 51
Once the precautionary principle is invoked, regulatory action should be taken in response to the projected risk. Yet this does not necessarily mean that legally binding measures must always be adopted. For example, a decision to fund a research programme or to inform the public about the possible adverse effects of a product may also be appropriate under the precautionary principle.Footnote 52 The EC’s Strategy explicitly rejects the calls for a moratorium on nano-enabled products, alleging that it would not be proportionate given the social benefits expected from nanotechnology.Footnote 53
4. regulatory mechanisms to foster government rationalities
From the above analysis, it is clear that prior to any risk regulation a ‘risk object’ linked to a physical harm needs to be defined, based on conventional risk assessment methods. This has special significance in areas of scientific uncertainty regarding potential harms. To define nanomaterials as a ‘risk object’ under the technical, evidence-based, conception of risk, there is a need to establish first that a hazard exists by identifying an affected organism and the nature of the damage. Secondly, there is a need to estimate the potential exposure from emissions inventories and life-cycle emissions scenarios of the particles.
According to Wiesner et al., currently the nature of the hazard is one of the prominent unknowns for engineered nanomaterials. Further, given the current lack of measurement and nano-specific metrology, emissions scenarios of nanomaterials are bound to have some degree of uncertainty.Footnote 54 This conclusion is supported by Grieger et al., who screened 31 publications by leading scientists and authorities on the potential risks of engineered nanomaterials. They concluded, in 2009, that knowledge gaps pervade nearly all aspects of basic environmental, health and safety knowledge.Footnote 55 Since 2009, more research has been conducted to identify hazards; however, it is still insufficient for regulatory agencies to initiate evidence-based regulations.Footnote 56 Therefore, from a technical, evidence-based conception of risk, the current state of knowledge raises the question of what risk (if any) should be governed in the field of nanotechnologies and, in turn, what information related to it needs to be disseminated and disclosed.
This means that for governments following such risk conception, at the current state of knowledge, regulatory mechanisms should focus on closing knowledge gaps until there is sufficient knowledge to justify additional regulatory measures. Such regulatory mechanisms either establish research programmes to directly generate necessary environmental, health and safety data, or request other organizations to generate and submit such data to the agencies. Regulators can collect data from industry through various mechanisms that include voluntary or mandatory reporting programmes, manufacturing notifications, test requirements and hazardous substance reporting. Some already exist in current chemicals regulations, which theoretically apply to nanomaterials. Yet reviews of these programmes have identified many loopholes, allowing nano-objects by themselves or embedded in materials (composites, for example) to avoid regulation and information dissemination.Footnote 57
In response, governments have adopted information-gathering initiatives to address nanomaterials specifically.Footnote 58 Still, to date, even the most comprehensive mandatory reporting system under the EU chemical and labelling regulationsFootnote 59 has yielded very little risk data on nanomaterials.Footnote 60 My online review, presented above, found that of the 36 data collection initiatives, 19 initiatives were adopted in Europe, while only 11 were released in the US, five in Australia, and one in Asia.
This result can be expected in light of previous analysis of the regulatory approach, which assumes that countries adopting the precautionary approach will make more effort to collect data under conditions of scientific uncertainty. Still, in terms of level of obligation, in the US (which follows the risk-based approach) most initiatives were mandatory and only three voluntary, whereas in Europe and Australia (which follow the precautionary approach) the majority of the initiatives were voluntary. While this may indicate some gaps between rhetoric and practice, another explanation may lie in the scope of the initiatives. In Europe and Australia most initiatives were sectorial (such as industrial chemicals, food and feed, consumer products, and occupational health), indicating a systematic approach to data collection. In the US, however, most initiatives focused on specific targeted substances or lists of substances, indicating risk hot spots rather than systematic data collection on nanomaterials. This means that the US uses mandatory tools to collect additional data only on a case by case basis where some evidence of risk already exists.
Under most of these initiatives, industry was asked to report only existing information, and few required generation of additional data. The information requested is mainly on basic data such as information on the company, substance identification, type and quantity of use. Some initiatives also requested more specific data, such as substance characterization, physical-chemical properties, fate and behaviour, measurement and detection techniques, and risk management practices.Footnote 61
In summary, with respect to governance by disclosure, the most important question that regulation should currently address is disclosure of ‘what’: that is, what kind of information is relevant and meaningful to disclose? Only once this question is answered, is it possible to ask ‘by who?’ and ‘to whom?’. Although both regulatory approaches share the technical, evidence-based risk conception, they differ slightly in the sufficiency thresholds for scientific evidence in support of risk regulation. This variation may anticipate slight differences between the risk-based approach and the precautionary approach with regard to disclosure along the value chain. Under the risk-based approach, information dissemination mechanisms will be adopted only if they can support a substantive goal of preventing or mitigating significant environmental harm, for example, by warning workers or consumers to take protective measures when using a nano-product with a known and established risk. When the level of risk is still unknown, governments that follow this approach are unlikely to adopt disclosure mechanisms to facilitate ‘right to know’ or ‘informed choice’ goals. Therefore, blanket labelling requirements of nanomaterials in products are unlikely, because they are not grounded in scientific evidence and thus may cause unnecessary fear without promoting health or safety.Footnote 62 Indeed, to date no labelling scheme has been adopted by US government agencies.
On the other hand, the precautionary approach may go beyond substantive goals to pursue procedural (and, to a lesser extent, normative) goals if sufficient data exists to indicate realistic and serious risk. Therefore, once the precautionary principle is invoked, regulation may require dissemination of preliminary findings (emphasizing the state of scientific uncertainty) along the value chain. Furthermore, in areas of high public concern (such as food and cosmetics), where there is some indication of severe risk, governments may be willing to require product labelling as a more proportionate measure in lieu of a product ban. However, governments are unlikely to require labelling without a scientific cause for concern.Footnote 63
Indeed, until recently, government initiatives for nano-labelling schemes were based on voluntary compliance, and focused on either ‘positive labelling’, identifying nanomaterials (for example, nano-enabled), Footnote 64 or ‘negative labelling’, declaring that no nanomaterials had been used (for example, nano-free).Footnote 65 After 2009, some governments began to adopt mandatory schemes. Since nanomaterials do not have a uniformly accepted definition, each labelling initiative defines them differently for its own purposes. Most notable are the EU’s new cosmetic products regulation,Footnote 66 new food information to consumers regulation,Footnote 67 and new biocidal products regulation,Footnote 68 which require cosmetics manufacturers, food business operators responsible for providing food information to consumers, and those authorized to place nanobiocidal products on the market to label all nanoparticles contained in products marketed within the EU with the word ‘nano’ in brackets.Footnote 69
Still, the effectiveness of these legislative enactments is still in doubt as a result of scientific-technical limitations related to the measurement of nanomaterials. A recent report by the EC Joint Research Centre concluded that ‘[n]one of the currently available methods can determine whether all kinds of potential nanomaterials meet the regulatory definition or not’.Footnote 70 Furthermore, while such blanket labelling requirements aim to foster a normative ‘right to know’ goal, as the EC recently has admitted: ‘nano-ingredient labelling has been introduced [only] in products of relevance to consumers, notably food and cosmetics’.Footnote 71 The EC Communication further states that ‘current knowledge about nanomaterials does not suggest risks which would require information about all products in which nanomaterials are used’.Footnote 72 Their scope is therefore very limited.
5. democratic implications of current approaches to disclosure
Having discussed the rationale behind the two major government approaches to risk management, and the regulatory mechanisms adopted to foster them, this section now considers their democratic implications. The analysis focuses on the lessons that can already be drawn from the worldwide implementation of information-gathering initiatives since 2006. While a few initiatives to facilitate disclosure along the value chain have also been adopted, they have not yet been fully implemented, and it is therefore too early to draw any conclusions on their effectiveness.
The discussion starts by investigating whether the information-gathering initiatives were effective in achieving their own goals, and then analyzes their democratic implications. In 2009, the Working Party on Manufactured Nanomaterials (WPMN) of the Organisation for Economic Co-operation and Development (OECD) conducted its first analysis of information-gathering initiatives for manufactured nanomaterials.Footnote 73 This report concluded that the overall objectives of such initiatives are:
(1) to provide governments with a baseline of information that will inform the development or adequacy of regulatory programmes to address potential risks; and
(2) to provide the public and stakeholders with the maximum information available, while protecting legitimate confidential information, to allow their engagement in discussions and decisions concerning such materials.Footnote 74
The first objective explicitly states that the output of the information-gathering initiative should be to support additional regulatory actions. The second acknowledges the importance of broad stakeholder engagement in decision-making on the future development of these technologies (that is, not only technical expert opinion matters, but also those of the public). This section now addresses the question of whether the implemented initiatives have achieved these objectives.
5.1. Objective 1: Developing Baseline Information for Regulatory Development
Based on the stated purposes of the information-gathering initiatives adopted to date, governments have focused their efforts almost exclusively on the first objective, namely building baseline information to assist the development of adequate regulation.Footnote 75 However, no indication has been given as to how governments have used or intend to use the collected data in the development of regulation. A minor exception is the 2006 German Corporation Survey,Footnote 76 aimed at and followed by the publication of guidance for the handling and use of nanomaterials in the workplace.Footnote 77 Among the various reasons for the failure of the information-gathering initiatives in the field of nanotechnologies to achieve this goal, the main two are low participation and the quality of information.
Participation
The ineffectiveness of the voluntary information-gathering initiatives may be linked to the low rate of participation in these programmes. In the United Kingdom (UK), for example, only 11 companies and two academic institutes signed up to a two-year programme (2006–08).Footnote 78 In the US, only 31 organizations submitted information to a two-year programme (2008–10) covering about 132 nanoscale materials under the basic phase, and only four companies agreed to participate in the in-depth phase.Footnote 79 In Australia’s Information Call-In, 20 companies responded in 2006,Footnote 80 and only seven in 2008.Footnote 81
In its analysis, the OECD WPNM recommended that ‘in the case of voluntary information-gathering initiatives, authorities should clearly indicate how they intend to measure progress and the success of the programme, when and how they will be assessed, and the steps that will be taken if objectives are not met’. Additionally, ‘consideration should be given to supplementing voluntary initiatives with mandatory reporting’.Footnote 82 None of the nanomaterials voluntary reporting schemes threatened mandatory reporting requirements if the objectives were not met. Yet, after evaluating the disappointing results, the governments leading all three initiatives indicated that they are to consider additional means to collect data.Footnote 83
In May 2011 the US Environmental Protection Agency (EPA) issued a significant new use rule (SNUR) under section 5(a)(2) of the Toxic Substances Control Act (TSCA)Footnote 84 for the chemical substance identified generically as multi-walled carbon nanotubes (MWCNT).Footnote 85 SNURs aim to provide the EPA with a basic set of information on MWCNT, to help to evaluate the intended uses of this nanoscale material and take action to prohibit or limit activities that may present an unreasonable risk to human health or the environment. In January 2011, Australia adjusted the New Chemical processes under the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) to require all producers or importers of nano-forms of new chemicals (even of small amounts of nanomaterials) to go through a full risk assessment process and provide all information required by the law for conventional chemicals. NICNAS may require additional information on a case by case basis as necessary for the assessment of the chemical.Footnote 86
From a review of the documents relevant to the development and implementation of information-gathering schemes, it is evident that countries watch and mimic each other’s steps. Whilst no government sets out to burden the nanotechnology industry in a particular country over another, the ineffectiveness of information-gathering programmes has led governments to consider mandatory requirements.
The information call-in programme in California (US), for example, is mandatory, and all viable companies and research organizations responded. Yet, no further indication has been given so far as to how the collected data is evaluated and used for regulatory or other purposes.Footnote 87 This leads to questioning whether lack of participation really is a significant obstacle, and whether mandatory participation would lead to sufficient data collection to enable the assessment of health and environmental risk.
Quality of information
The Californian example suggests another explanation for the failure of reporting programmes (voluntary or mandatory) in achieving their objectives; this relates to the quality of the information submitted. Beaudrie and Kandlikar found that the California DTSC Information Call-In programme has not been successful in acquiring the full range of nanomaterial property and toxicology data required to permit a full risk assessment.Footnote 88 Similarly, the OECD WPMN survey of nine information-gathering schemes found that ‘even those with higher response rates indicated that the data received was not as detailed as originally hoped, or was incomplete’.Footnote 89 Variability in the level of reporting and quality of information makes the submitted information insufficient to support informed decision.Footnote 90 Further, with respect to nanomaterials, even with quality assurance mechanisms, the lack of or inadequate nanomaterial characterizations make it almost impossible to determine the potential hazards.Footnote 91
The absence of sufficient scientific data appears also to be true for the new EU chemical legislation on Registration, Evaluation, Authorization and Restriction of Chemical Substances (REACH) and Classification, Labelling and Packaging of Substances and Mixtures (CLP).Footnote 92 It has been suggested that current reporting under REACH–CLP is unlikely to provide the full range of information needed by regulators to assess the potential risks to public health and the environment from nanomaterials.Footnote 93 This is because current test guidelines that support REACH do not require nano-specific information and the information collected, based on conventional chemicals, may not be appropriate for the assessment of risks associated with nanomaterials. Recently, the European Chemicals Agency (ECHA) has begun to update guidance on information requirements specific to nanomaterials for REACH.Footnote 94
While some progress has been made in terms of nanomaterials characterization, many uncertainties remain in this area, making it very complicated to conduct risk assessment for nanomaterials. It is therefore somewhat unrealistic to expect that, at a time of such major scientific uncertainty, data collected under information-gathering initiatives would provide a sound scientific basis for policy.
5.2. Objective 2: Enhancing Public and Stakeholder Engagement
The second objective of information-gathering initiatives is to provide the public and stakeholders with the most information available while protecting legitimate confidential information to allow their engagement in discussions and decisions concerning such materials. Two elements are incorporated in this objective: the public’s right to know and the public’s right to engage in the decision-making process, which means that not only technical expertise is necessary but also a wide range of stakeholders should also be included in the process to build trust in the agency programme. Although most government rhetoric has leant towards transparency and openness all along,Footnote 95 as discussed below in practice very few attempts have been made to incorporate public views in the decision-making process.
Public Right to Know
The principle of the public’s ‘right to know’ is embodied in many laws, and it is based on the democratic theory that ‘the public, as a sovereign, must have all information available in order to instruct its servants, the government’.Footnote 96 Placed in the nanotechnology context, people have, for example, the right to know what nano-based chemicals they may be exposed to from the products they use, not only for making informed consumer choices but also for deciding upon the future of this technology.
According to the analysis of information-gathering initiatives by the OECD WPMN, ‘authorities should identify clearly how information collected under the initiative will be made public’.Footnote 97 Hansen and Tickner argue that a key part of any effort to improve and ensure transparency is giving the public and other stakeholders access to raw data.Footnote 98 Yet, in most information-gathering initiatives in the field of nanotechnology, companies were allowed to protect confidential information, and subsequently governments published only a summary of the information available to the public.Footnote 99 Even where raw data was published, much of the submitted information was not released to the public under the Confidential Business Information (CBI) provisions.Footnote 100 Some argue that even if the public were to be given access to raw data, this would have no real meaning to the lay person.Footnote 101 Nevertheless, availability provides a step towards building trust, and some NGOs employ experts to evaluate and translate data to the public. Environmental and community organizations have played a significant role in the US Toxic Release Inventory (TRI)Footnote 102 data, generating reports and profiles of toxic pollution and leading polluters.Footnote 103 While arguing that more transparency of raw data is important, transparency may empower and work as a transformative mechanism only when the disclosed information is valuable, accessible, comprehensible and comparable.Footnote 104 Otherwise, there is a risk of ‘drowning in disclosure’ of misinformation and disinformation.Footnote 105 So, for example, while the ECHA is compiling an inventory of nanomaterials included in REACH registration dossiers and CLP notifications at the request of the EC,Footnote 106 according to Otto Linher of the EC’s Directorate General (DG) Enterprise, ‘the Commission doesn’t have a position on whether there should be a harmonised inventory at the EU level’.Footnote 107 Meanwhile, inventories are developed independently by various organizations, collecting nano-related information in an inconsistent way with limited usefulness.
Public Right to Engage
In one of his early reports on Managing the Effects of Nanotechnology, Davies notes that ‘social values, apart from scientific questions, are an inextricable part of assessing risks [citation omitted], and the public needs to be involved in assessing [nanotechnology’s] risks, as well as in defining the measures to be taken to deal with the risks’.Footnote 108 In the same line of thought, Hansen and Tickner propose that representatives of the public should be involved in the design of the reporting format, as well as in reviewing submissions, reviews and reports.Footnote 109 However, under the technical, evidence-based approach to risk assessment, only technical experts are considered to be eligible sources of data for the construction of the risk object of nanomaterials. This excludes social-cultural expertise in risk evaluation, as well as the voice of the lay public.Footnote 110
Although stakeholders have been given the opportunity to comment on the design of some of the information-gathering initiatives, in many cases it is difficult to track whether comments have been implemented.Footnote 111 For example, in relation to the US EPA Nanoscale Materials Stewardship Program, Richard Dension, representing Environmental Defense, argued for the need to determine specific deadlines for data submission (three months) as well as regulatory backstops (mandatory rules).Footnote 112 Dension further argued against the possibility to claim CBI extensively and to submit the information in any form and format. While the importance of these comments to building public trust is obvious, they seem to have been ignored.
Once information-gathering schemes have been initiated, representatives of public interest groups are often not included to evaluate the submitted data. Lacking the ability to review the scientific data on which risk assessments are based leaves the public disengaged from the process.Footnote 113 The lack of broad stakeholder engagement may have negative impacts on the future development of this technology.
Firstly, the technology may not account for overall social prosperity. As Feenberg argues, ‘public intervention may actually improve technology by addressing problems ignored by vested interests entrenched in the design process’.Footnote 114 By accounting for social dimensions of the technology at the start, the public may affect the very definition of the function that ought to be fulfilled by the technology and the quality of the environment associated with the production and use of the devices, avoiding future public rejection of the technology.Footnote 115
Secondly, it may lead to mistrust in the nanotechnology industry and in the ability of governments to protect the public from potential risks. It is well documented in the literature of public perception and risk communication that the general climate of distrust that exists between the public, industry and risk management professionals is the result of ineffective risk communication efforts.Footnote 116 This ‘trust deficit’ can be avoided by facilitating more public engagement in the decision-making process.Footnote 117
6. conclusion
Examining current government rhetoric and practices to oversee the development of nanotechnologies indicates more convergence than divergence in transnational policy approaches. This is the result of the evidence-based approach for risk assessment, which is shared by the EU and US. Yet, as this article demonstrates, this approach has fundamental limitations to effectively overseeing the development of emerging technologies under scientific uncertainty. This is not only because of faults in design and implementation or power inequalities, but also because of an inherent limitation of current knowledge. At this time, the premise that ‘a more data-intensive world will facilitate qualitative performance measurement, comparative analysis, and the benchmarking of result’Footnote 118 does not seem to hold true for nanotechnology.
Information-gathering initiatives have not achieved their objectives to date. While the low rate of participation in voluntary programmes has been the most frequently mentioned reason for their failure, this article argues that this is not accurate. Even systematic mandatory schemes have limited ability to collect the whole range of risk data necessary for quantitative risk assessment. The main reason for the failure of the information-gathering initiatives in the field of nanotechnology is their unrealistic objectives. Any attempt to effectively oversee the development of nanotechnologies using an evidence-based approach is unlikely to succeed because of the major scientific uncertainties in this field. Another reason for the failure of these programmes is that they have the potential to create mistrust instead of building trust in the technology. To date, scientific data provision to the government is an opaque process and the relevant stakeholders cannot assess its accuracy and relevance.
Nevertheless, experience has shown that technological innovation sometimes has latent adverse effects (as in the cases of asbestos, dichlorodiphenyltrichloroethane (DDT) and polychlorinated biphenyls (PCBs)).Footnote 119 Furthermore, public concerns that are not addressed on time may significantly affect the future market of the new technologies (as in the case of GMOs).These lessons suggest that in formulating public policy for nanotechnologies, the risk assessment process should not only be structured in narrow scientific terms but should also include other relevant societal dimensions.Footnote 120
Challenges remain in democratizing the regulatory decision-making process, especially in highly technical areas.Footnote 121 This article attempts neither to solve these challenges nor to call for such comprehensive public deliberation. Rather, it argues that information disclosure has a normative role to change the rules of the game and engage more stakeholders in the fundamental societal decisions regarding the development of new technologies. Information disclosure should not only describe mechanisms to ensure access to information to enable informed decision-making and to protect consumers’ right to know, as it has mainly done so far. Instead of being viewed as a vehicle for the transfer of scientific knowledge to support informed decision-making, it should also be viewed as a medium to enhance responsible development through transparency and open public dialogue.
To this end, information must flow in two directions and not only top-down from regulatory agencies/industry, in order to ‘educate’ the public. ‘Democratizing’ disclosure mechanisms means including a wider segment of society in deciding the scope of disclosure. This includes accounting for social views when deciding what to disclose and not only how, by who and to whom. It might be less ambitious than democratizing the entire risk management process in terms of architecture, but it may be more challenging in terms of political will. In addition to reorganization and financial and human resources, it requires a values change in our risk conception. It requires including not only technical-scientific parameters, but also societal aspects in the definition of the risk object.
Disclosure mechanisms should act as an intermediate medium, which transfers knowledge among all stakeholders through nets of ‘epistemic communities’.Footnote 122 In this way, diverse social, cultural and ethical viewpoints that are brought to the table may yield a better understanding of society’s views. The accumulation of different points of view would facilitate production of a better definition of the regulatory risk object and a more refined prioritization of regulatory objectives.Footnote 123 Prioritization would not necessarily be based on the level of scientific risk, but would reflect the kind of potential risks that society is willing to take to enjoy the potential benefits of technological advancement. For example, this process can reveal that society is willing to take significant environmental, health and safety risks for the benefit of finding a cure for currently incurable diseases, but is unwilling to take any risk for the benefit of having transparent sunscreen lotion or longer-lasting food.Footnote 124
This movement towards a more deliberative process should not be seen as an obstacle to technological innovation; on the contrary, technology may find more society-friendly directions in which to evolve, while reducing future public objection.
