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Workplace exposure to engineered nanomaterials: The Italian path for the definition of occupational health and safety policies Marco Mirabile ∗ , Fabio Boccuni, Diana Gagliardi, Bruna Maria Rondinone, Sergio Iavicoli INAIL Research Area – Department of Occupational Medicine, Via Fontana Candida 1, Monte Porzio Catone, RM 00040, Italy
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Article history: Received 31 October 2012 Received in revised form 13 January 2014 Accepted 29 January 2014
Keywords: Occupational health and safety Nanotechnologies Stakeholders engagement Legislative framework Emerging risk Participatory decision-making process
a b s t r a c t This study explores the way the publication of a National White Book on health and safety risks that affect workers in jobs involving Nanotechnologies and Nanomaterials influenced the key Italian stakeholders attitude toward this issue and identifies the standpoints and priorities shared among researchers and stakeholders to develop a policy framework to address this issue. The study not only highlights some important assumptions (i.e. the acknowledgment by the key stakeholders of the need for actions and the identification of objectives which can gain a wide consensus) for the establishment of a policy community that sustains the development of a policymaking process on the issue but, through the interaction between stakeholders and OSH researchers, it also identifies some in nuce proposals that represent the starting point for policy interventions aimed at meeting the needs of both stakeholders and scientific community. Results obtained in terms of clarification of interests at stake, identification of potential areas of consensus and level of key national actors’ engagement achieved, show the potentialities of adopting a knowledge based and inclusive approach to policy-making to address the issue of prevention and management of health and safety risks related to technological innovation within a framework of scientific uncertainty. © 2014 Elsevier Ireland Ltd. All rights reserved.
1. Introduction Nanotechnologies bridge a number of scientific disciplines and help add additional value to products. The development of nanotechnologies has spanned over different industrial sectors, including electronics, chemical, pharmaceutical, cosmetic and medical industry, energy, construction and transportation [1,2].
∗ Corresponding author. Tel.: +39 06 97896039; fax: +39 06 94181410. E-mail addresses: [email protected] (M. Mirabile), [email protected] (F. Boccuni), [email protected] (D. Gagliardi), [email protected] (B.M. Rondinone), [email protected] (S. Iavicoli).
Estimates suggest that the market for products incorporating nanotechnologies will reach 3000 billion USD in products by 2020, with up to 6 million people including, researchers and workers, involved in a nanotechnology domain [3]. This scenario, makes dealing with nanotechnologies and nanomaterials (NT&NMs) into a crucial issue, not only for consumers, but also for workers’ health and safety, as some harmful effects of nanomaterials have been observed with in vivo and/or in vitro studies [4,5]. Particularly with regard to workers’ health, the importance to properly tackle risks related to nanotechnologies is due to their specific exposure conditions (in terms of level, modality and duration of exposure) throughout the life
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cycle of Engineered Nanomaterials (ENMs), from research through scale-up, manufacturing, product development, transport, to recycling and waste management [6]. The need of an occupational health and safety policy framework has therefore become very urgent, in order to promote the safe and responsible development of nanotechnologies. Nevertheless, it is not easy to address this issue, since nanotechnologies are relatively new and there is still no comprehensive knowledge of risks associated with the potential exposure to them, and consequently, how these risks can be prevented and managed [7,8]. As a result of this scenario, the sustainable development of NT&NMs entails a crucial challenge: the need to maximize the protection of human health and safety against unpredicted risks related to NT&NMs and, at the same time, to avoid affecting the predicted benefits of their development and use more than what is reasonable and necessary [9]. However at present, a fully satisfactory response to this need has not yet been found. In fact, NT&NMs are in most cases, regulated only according to current norms and laws. Nevertheless the development of a specific regulatory framework, or even the integration of the existing regulatory framework, are widely called upon. For instance, the European Commission (EC) recommends the application and adaptation of the regulatory framework set up for Chemicals by the REACH directive [10]. The debate on different regulatory approaches is still open both at institutional level and among stakeholders and studies on this issue have been promoted in Europe as well as in United States [11,12]. In general, the scientific uncertainty involved in evaluating potentially harmful properties of ENMs complicates and hampers the implementation of proper regulative measures by legislators [13]. In fact, the lack of certain data on risk assessment and management calls for the development of a regulatory framework under pinned by the adoption of the precautionary principle [14,15]. However, it has to be considered that applying the precautionary principle appropriately is a difficult task because it leaves room for the risk of enacting compulsory regulations based on insufficient information [16]. Since the adoption tout court of the precautionary principle needs a full reverse burden of proof that is not scientifically viable, a proper application of this principle requires, on one side, the development of a regulation that is able to capture and balance the plurality of social values and interests involved and, on the other side, the integration of this regulation within a wider policies framework aiming to increase knowledge availability and promote a transparent, responsible and socially accepted use and development of this technological innovation [17–19]. According to these needs, as pointed out, among the others, by EC, the participation in decision-making processes of all stakeholders involved in or concerned by NT&NMs seems to be the most suitable way to address the issue of governing the development of NT&NMs [20]. The adoption of the participative approach is generally considered to be the best method with which to increase the quality of decisions and to resolve conflicts among competitive interests
where risk’s boundaries are unknown and interests and value judgments are potentially different [21–23]. So far for nanotechnology, various attempts have been made, and are still being made, to promote open and transparent policy deliberations and extensive public discourse [24–27]. Nevertheless, even if these engagement exercises aim to influence policy making, research suggests that, until now, they have had little discernible impact on this regard [28]. An effort to develop further practices of stakeholders’ engagement is therefore needed to make the most of the added value that can be gained from adopting a participatory approach to have an effective governance of technological innovation. As suggested by studies on public participation, one way forward should be to move up as much as possible from the public consultation level to the effective and active engagement of key stakeholders in the policy making process [29]. According to this need, the former Italian Institute for Occupational Health and Safety (ISPESL), whose function was transferred to INAIL in 2010 by Italian law, has conducted the study presented here which aims to give a contribution to a better understanding of the prospect for public engagement in policy making both on technological innovation in general and on the specific case of NT&NMs related risks governance. This study is a follow-up of the “White Book on the exposure to engineered nanomaterials and their effects on workers’ health and safety” published in 2010 by INAIL in collaboration with “NanOSH Italia”, a National network involving Occupational Health and Safety (OHS) researchers in the field of nanomaterials to address one of the key emerging priorities for research on OHS identified in Italy [30,31]. The White Book provides a state of the art review, including an analysis of the key issues for the development of relevant research, with the intent of streamlining the dissemination and sharing of available scientific knowledge. This study engaged with Italian social partners, public authorities and representatives of research institutions in a process addressed to share available knowledge provided by the White Book and, in the light of such knowledge explore are their standpoints and priorities and identify if any shared policy options are available. 2. Materials and methods The study was conducted in two steps. In the first step, a stakeholder analysis was conducted and a list of key Italian stakeholders was developed, taking into consideration the need to represent all different interests concerned with occupational health issues related to NT&NMs exposure. Afterwards, the identified stakeholders were grouped in three reference groups. Stakeholders having a third party interest, with regard to the issues addressed in the study, were gathered together in the group that was named Institutions & Associations. This included both public institutions endowed with decision-making power over policies affecting the development of NT&NMs and the protection of workers’ health, as well as Italian OHS Professional Associations that have a professional concern in facing the OHS issues
Please cite this article in press as: Mirabile M, et al. Workplace exposure to engineered nanomaterials: The Italian path for the definition of occupational health and safety policies. Health Policy (2014), http://dx.doi.org/10.1016/j.healthpol.2014.01.020
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in an effective manner. The other two groups, named respectively as Industry and Workers, were constituted by representatives of interests in the NT&NMs Industry and major Italian Trade Unions. After having provided a copy of the White Book to the selected stakeholders, they were administered an on-line questionnaire consisting of two parts. The first part aimed to investigate their awareness of the issue of occupational risks related to NT&NMs exposure, and to explore how reading the White Book had influenced such awareness. In the second part they were asked to provide their viewpoint on some key issues for designing policies to foster the sustainable development of NT&NMs such as the following: level of concern for occupational exposure to NT&NMs, approach to policy making to be pursued, key issues to be faced, priority actions to be implemented and communication strategies to be adopted to properly convey available information to different target groups. Respondents to the on-line questionnaire were as follows: 3 from Public Institutions (Ministry of Labour, Ministry of Health and Coordination Body of Italian Regions for OHS), 3 from OHS Professional Associations (Italian Association of Industrial Hygienists, Italian Society of Occupational Medicine and Industrial Hygiene, National Society of OHS Professionals), 6 from the Industry sector (Chemical Industries Federation, Pharmaceutical Industries Federation, National Confederation of Handcrafters and SMEs and the two main nanotechnology-related Industrial Districts) and 4 from Workers’ sector (CGIL, CISL, UIL and CONFSAL which are four out of the five major Italian Trade Unions). In the second step, beginning with the positions expressed by stakeholders on the issues investigated in the survey, a workshop was conducted to start a guided discussion among key players, with the purpose of identifying shared premises and prospects on which to base an inclusive policy-making process related to the sustainable development of NT&NMs. In addition to stakeholders, OSH’s researcher were also involved at this stage, including White Book Authors, representatives of Universities and other Italian research Institutions committed to studying nanomaterials and their potential impact on human health. Researchers were involved to provide a strictly knowledge based view to the discussion. The workshop was based on the European Awareness Scenario Workshop (EASW) methodology adapted by INAIL for the specific purpose of this study. EASW, which was developed by the European Commission DirectorateGeneral XIII in 1994, is a strategic visioning and idea generation process structured through a combination of working group sessions alternating with plenary discussions. In the first working session, participants were required to identify critical points concerning three different policy areas, relevant to a sustainable development of NT&NMs: the “regulatory” area, which concerns voluntary and compulsory regulations that set out limits, procedures and standards; the “active policies” area, which concerns actions for the development of knowledge and tools as well as for the creation of support systems for the definition and implementation of regulations and/or good practices;
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the “communication and information” area, which concerns actions for the dissemination of clear and transparent information and for an appropriate and comprehensive awareness of risks, good practices and opportunities. During this session, participants were divided into two groups: “Stakeholders” and “Experts”. By splitting participants into such groups, it was possible to separate the views of stakeholders and scientific knowledge-holders (Researchers/Experts). Afterwards, critical points identified by each group with respect to the three thematic areas were presented to all the participants in a plenary session. Critical points shared and unshared by the two groups were then highlighted, discussed and refined. A second working group session was then held. In this session, both experts and stakeholders were dispersed into three thematic groups related to the three policy areas previously explored: Regulations, Active Policies and Communication/Information. Each group was required to develop shared proposals for overcoming critical points identified for its assigned policy area. Proposals developed by thematic groups were eventually presented, shared and prioritized in a final plenary session. 3. Results A response rate of 72.7% was obtained (16 questionnaires returned out of 22) from the survey. The distribution of respondents provided a high level of sample representativeness of the different stakeholders’ groups, both from a qualitative and quantitative point of view. A response rate of 50% was obtained by representatives of Institutions, both at the national and regional level, 75% by the OHS Professional Association, 86% by Industry and 80% by Workers. It should be pointed out that two Industry representatives didn’t answer the first section of the questionnaire. Only 3 out of 14 respondents to the first section (21%) reported that they were already fully aware of OHS issues related to NT&NMs before reading the White Book. Nevertheless, almost all respondents (85.7%) say that the White Book provided them with some further relevant information. In the view of 14 out of 16 respondents (87.5%) to the second section of the questionnaire, the OHS risks related to NT&NMs are a key issue to deal with as soon as possible. With regard to public awareness, most respondents (62.5%) believe that public perception pertaining to the importance of the OHS risks related to NT&NMs is lower than it should be. All representatives from the workers group shared this opinion, as well as 4 representatives out of 6 from Institution & Association and 2 out of 6 from Industry also shared this opinion. When asked to point out the most appropriate process to address policy making on NT&NMs, none of the respondents opted for a top–down approach to policy making. Their preferences are split in half over two different bottom–up approaches. Half of them state that a structured process of consultation and discussion with all key stakeholders should be put in place to define a framework of shared policies to be submitted to the decision-maker. On
Please cite this article in press as: Mirabile M, et al. Workplace exposure to engineered nanomaterials: The Italian path for the definition of occupational health and safety policies. Health Policy (2014), http://dx.doi.org/10.1016/j.healthpol.2014.01.020
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Table 1 Responses on policy options (absolute frequencies and percentage by group and priorities). Inst. & Ass.
Foster the valorization of good practices Increase funding to public research Adopt measures to reduce entrepreneurial risks Set up incentives to stimulate private research investment
Industry
Workers
Low
Medium
High
Low
Medium
High
Low
Medium
High
–
–
6 (100%)
–
–
6 (100%)
–
2 (50%)
2 (50%)
–
1 (17%)
5 (83%)
–
4 (67%)
2 (33%)
–
–
4 (100%)
–
2 (33%)
4 (67%)
1 (17%)
2 (33%)
3 (50%)
–
1 (25%)
3 (75%)
1 (17%)
2 (33%)
3 (50%)
–
1 (17%)
5 (83%)
1 (25%)
1 (25%)
2 (50%)
the other hand, the remaining 50% believe that the existing three-party Commission on OHS should be involved in the policy making process. Respondents outlined that the most critical issues to be addressed to ensure a safer development of NT&NMs are as following: the procedures for assessing the risks from exposure to nanoparticles (13); the instruments to monitor release of nanoparticles in the workplace (12); the knowledge of risks of inhaled particles (12); the identification of risks related to different stages in the manufacturing processes of NT&NMs (10). With regard to the “active policies” to be implemented to support a sustainable development of NT&NMs, almost all respondents give a high priority to promotion of good practices. There are instead much more differences between the groups’ in the evaluation of the other policy options proposed. All respondents from the Workers group and the most part from the Institutions & Associations group believe that the need for public research investment is a top priority. Instead, most of respondents from the Industry group gave lower priority to this action. At the same time, almost all respondents from this group state that funding private research should be a high priority (Table 1). With regard to the “regulatory framework”, a half of respondents deem that the legislation on chemicals can be extended to NT&NM’s but specific standards and guidelines must be added. Instead, a lower number of respondents (31.3%) believe that NT&NMs should be regulated through a specific, ad hoc, legislation and even a smaller part of respondents (all from industry) claim that an improvement of the regulatory framework is not needed (Table 2). In the opinion of most respondents (68.8%), the communication strategies on NT&NM should be re-modulated, as there is no correlation between the state of knowledge and the information being disseminated. According to their answers, it is necessary to address this problem by undertaking the following actions: ease the access to information on risk assessment and management practices
(this option was selected as important or very important by 86% of respondents); strengthen the training and professional updating for workers and OSH professionals (80%); foster the bidirectional communication between employers and employees (66%). During the workshop, participants were asked to go further in identifying critical points and shared actions to address them. In respect to “active policies”, the main weaknesses identified by the experts’ group were: lack of a clear plan of action for the sustainable development of NT&NMs, lack of support to OSH professionals in dealing with risks relating to NT&NMs as well as good practices to be adopted. Instead, stakeholders focused their attention more on the lack of research funding and difficulties in transferring OHS research outputs to manufacturing process related to NT&NMs. Some shared actions were proposed to address the above weaknesses: to develop a permanent collaboration network between research bodies, public authorities and enterprises’ representatives for identifying shared research funding priorities and sustaining the implementation of OHS research results; to stimulate a more proactive attitude of companies through policies for taxation reduction/insurance premiums “in exchange of” openness and collaboration in research; to develop guidelines on NT&NMs risk assessment and management. Pertaining to “regulations”, both groups believed that the existing normative framework is not adequate to properly address the OHS risks related issues stemming from the development of NT&NMs. They also outlined that the ruling capacity is in general affected by scientific uncertainty on the effect of NT&NMs. The experts group also outlined the need for harmonizing available data, strengthening the relationships between Research Institutions and Nano enterprises to provide more data for research purposes and setting standardized criteria for data sampling and analysis. Stakeholders group instead highlighted that the lack of a clear identification of the risk categories does not allow to clearly understand when the risk assessments are required.
Table 2 Responses on regulatory options (absolute frequencies and percentage by group).
Integrate the legislation on chemicals with specific standards and guidelines Develop an ad hoc regulatory framework Just apply to NM&NTs the legislation on chemicals or other sector legislation Adopt voluntary norms
Inst. & Ass.
Industry
Workers
Total
5 (83%) 1 (17%) – –
2 (33%) 1 (17%) 3 (50%) –
1 (25%) 3 (75%) – –
8 (50%) 5 (31%) 3 (19%) –
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The key action identified by workshop’s participants to address these weaknesses is the setting up of a bridging body between the worlds of research and industry that would support the creation of a common knowledge framework and the shared development of norms and standards. On “communication & information”, difficulties in the dialog between research and enterprise were reported by the experts group, largely due to the lack of a common language. The reliability of information – considering the multidisciplinary nature of the issue and the lack of a critical examination of the existing literature – was felt both by experts and stakeholders as an urgent issue that needs to be addressed. The current lack of specific knowledge generates misleading messages. In the field of communication and information, the need to establish a national authority qualified for examining and validating scientific information was highlighted in order to ensure a continuous update of the state of the art. Furthermore, the production of specific information material should represent the core of a communication strategy aimed to sensitizing the nanomaterials industry, workers and final users. Eventually, the set up of a national database containing information provided by industry on exposure scenarios could aid the researchers to improve their studies on nanomaterial risk assessment and management.
4. Conclusion Despite the fact that science is still lacking a clear understanding of NT&NM related risks, stakeholders are aware that it is an issue that needs to be dealt with and further policies are needed to address it properly. Specifically, the majority of them believe that NT&NMs are not an immediate threat, but an issue that may cause future problems if proper policies to support their sustainable and transparent development are not put in place. The willingness of industry representatives to address the issue is quite an unexpected response. On this regard, it’s worth noting that the technology industry is usually inclined to underestimate the risks of NT&NMs [32]. On the other side, although in line with the balanced public perception of nanotechnologies generally reported by surveys on this matter, the workers’ representatives’ attitude to consider the NT&NMs as a not immediate threat is also a valuable hint [33,34]. Not infrequently, within the international debate related to nanotechnology, extreme views calling for a non-negotiable moratorium on NT&NMs have been expressed by Trade Unions and also by consumer associations. It is without doubt that these findings are a favorable premise for having a constructive and proactive debate on how to govern the sustainable development of NT&NMs with respect to OHS. Considering that NT&NMs in general, and even more particularly their possible relationship to workers’ health and safety, are not yet under the glare of national public attention, this study confirms the importance of moving the stakeholder engagement “upstream” before deeply entrenched and polarized positions related to technological innovation appear [35].
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Furthermore, and consistent with literature, we can argue that the upstream positioning of the confrontation among stakeholders allowed the study to identify the shared priorities of action. The positive approach to confrontation and the low level of conflict among stakeholders and between the stakeholders and researchers show that parties were focused more on the interests rather than the positions and still willing to identify a “common ground” for developing mutually beneficial agreements. However, it is worthwhile to highlight the relevant contribution given by the White Book to the effectiveness of the dialog among stakeholders and between them and the scientists. Most of the stakeholders involved in the survey declared that reading the ‘White Book’ helped them to gain a deeper understanding of the issue and to unveil a number of aspects of a generally underestimated matter. Hence, even if some areas of scientific uncertainty on NT&NMs were properly reported, the White Book made the problems behind this technology clearer to the stakeholders by providing a comprehensive and reliable knowledge framework. This was an important output since the stakeholders’ knowledge of and confidence on the issues addressed has a key role for gaining their meaningful engagement in the process [36]. The study also provided some interesting findings about the three key policy areas explored. About the regulation area, the wide majority of the stakeholders agree that the existing regulatory framework is not adequate and therefore efforts have to be made to develop it. Even though different opinions have been expressed on how to effectively and properly regulate the NT&NMs development, stakeholders agree on the path to be followed to gain a shared regulation. It should be based on a bottom-up approach and eased by a subject acting as a trait d’union in charge of strengthening the dialog between OSH research and businesses, aimed to increase the knowledge available to support the regulatory framework development. As concerns active policies to be defined, an undoubtedly large consensus exists about the development and enhancement of good practices. A cross sectional consensus, albeit slighter, can also be found in the need for supporting public research in OHS as well as enterprises engaged in technological innovation development, who bear the burden of coping with the uncertainties of impacts on human health and safety of NT&NMs. A widespread consensus was also reached on the need for appropriate incentives aiming to intensify collaborations between business and research. The improvement of information flow is a high priority for all stakeholders because of the difficulty in accessing available and reliable information. To this aim, a high consensus found the need of a national authority that validates and verifies the scientific information (research data + national/international literature) for a state-of-the-art update and the creation of a database on exposure scenarios provided by organizations for preventive risk assessments. The study then has pointed out not only the premise for developing a shared policy-making process on NT&NMs, but also some clear and shared priorities that offer interesting maneuvering room to favor a policy community
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aggregation to sustain the development of this process. As highlighted by the policy analysis, a policy community is characterized by shared values, a common understanding of the “the rules of the game”, the mutual confidence among members and acknowledgment that cooperation facilitates achievement of the objectives [37,38]. In this view, it must be outlined that the survey reports a wide willingness and interest among stakeholders to be engaged in the policy making process, as they share the belief that it is the best way to ensure a fair balance of various interests at stake. The existence of a relevant policy community can be decisive for the start and success of a policy making process [39,40]. Nevertheless, one of the most important outcomes from the study is the prospect for the application of participative practices to policy making on NT&NMs. It shows that some interesting results can be gained by moving up from the public consultation level to the effective and active engagement of stakeholders in the policy making process. Notwithstanding the study is just a starting point, a follow-up is needed to assess the effective contribution of the study’s results toward the development of a proper policy framework for NT&NMs and OHS. It is important to understand if it is possible to evolve from sharing some sketched ideas to identifying some shared actions and consequently to implement them effectively. To achieve such an aim it would be necessary to involve a wider range of stakeholders. Moreover, further studies are needed to assess the effective impact and added value on decision making and policy effectiveness of such a model of stakeholders’ engagement. It has to be considered that the engagement process was time and resource consuming and a continuous institutional support is thus needed to help sustain its further development. Acknowledgement The authors are grateful to Dr. Aditya Kailash Jain and Dr. Diane Bedrosian for language revision of the manuscript. References [1] Schulte PA, Geraci CL, Hodson L, Zumwalde R, Castranova V, Kuempel E, et al. Nanotechnologies and nanomaterials in the occupational setting. Italian Journal of Occupational and Environmental Hygiene 2010;1(2):63–8. [2] Boccuni F, Rondinone BM, Petyx C, Iavicoli S. Potential occupational exposure to manufactured nanoparticles in Italy. Journal of Cleaner Production 2008;16:949–56. [3] Roco MC, Mirkin CA, Hersam MC. Nanotechnology research directions for societal needs in 2020: summary of international study. Journal of Nanoparticle Research 2011;13:897–919. [4] Maynard AD, Warheit DB, Philbert MA. The new toxicology of sophisticated materials: nanotoxicology and beyond. Toxicological Sciences 2011;120(Suppl. 1):S109–29 [Epub 2010 Dec 22]. [5] Oberdörster G. Safety assessment for nanotechnology and nanomedicine: concepts of nanotoxicology. Journal of Internal Medicine 2010;267(January (1)):89–105. [6] Iavicoli S, Rondinone BM, Boccuni F. Occupational safety and health’s role in sustainable, responsible nanotechnology: gaps and needs. Human and Experimental Toxicology 2009;28:433–43. [7] Trout DB, Schulte PA. Medical surveillance, exposure registries, and epidemiologic research for workers exposed to nanomaterials. Toxicology 2010;269:128–35.
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Workplace exposure to engineered nanomaterials: The Italian path for the definition of occupational health and safety policies Marco Mirabile ∗ , Fabio Boccuni, Diana Gagliardi, Bruna Maria Rondinone, Sergio Iavicoli INAIL Research Area – Department of Occupational Medicine, Via Fontana Candida 1, Monte Porzio Catone, RM 00040, Italy
a r t i c l e
i n f o
Article history: Received 31 October 2012 Received in revised form 13 January 2014 Accepted 29 January 2014
Keywords: Occupational health and safety Nanotechnologies Stakeholders engagement Legislative framework Emerging risk Participatory decision-making process
a b s t r a c t This study explores the way the publication of a National White Book on health and safety risks that affect workers in jobs involving Nanotechnologies and Nanomaterials influenced the key Italian stakeholders attitude toward this issue and identifies the standpoints and priorities shared among researchers and stakeholders to develop a policy framework to address this issue. The study not only highlights some important assumptions (i.e. the acknowledgment by the key stakeholders of the need for actions and the identification of objectives which can gain a wide consensus) for the establishment of a policy community that sustains the development of a policymaking process on the issue but, through the interaction between stakeholders and OSH researchers, it also identifies some in nuce proposals that represent the starting point for policy interventions aimed at meeting the needs of both stakeholders and scientific community. Results obtained in terms of clarification of interests at stake, identification of potential areas of consensus and level of key national actors’ engagement achieved, show the potentialities of adopting a knowledge based and inclusive approach to policy-making to address the issue of prevention and management of health and safety risks related to technological innovation within a framework of scientific uncertainty. © 2014 Elsevier Ireland Ltd. All rights reserved.
1. Introduction Nanotechnologies bridge a number of scientific disciplines and help add additional value to products. The development of nanotechnologies has spanned over different industrial sectors, including electronics, chemical, pharmaceutical, cosmetic and medical industry, energy, construction and transportation [1,2].
∗ Corresponding author. Tel.: +39 06 97896039; fax: +39 06 94181410. E-mail addresses: [email protected] (M. Mirabile), [email protected] (F. Boccuni), [email protected] (D. Gagliardi), [email protected] (B.M. Rondinone), [email protected] (S. Iavicoli).
Estimates suggest that the market for products incorporating nanotechnologies will reach 3000 billion USD in products by 2020, with up to 6 million people including, researchers and workers, involved in a nanotechnology domain [3]. This scenario, makes dealing with nanotechnologies and nanomaterials (NT&NMs) into a crucial issue, not only for consumers, but also for workers’ health and safety, as some harmful effects of nanomaterials have been observed with in vivo and/or in vitro studies [4,5]. Particularly with regard to workers’ health, the importance to properly tackle risks related to nanotechnologies is due to their specific exposure conditions (in terms of level, modality and duration of exposure) throughout the life
0168-8510/$ – see front matter © 2014 Elsevier Ireland Ltd. All rights reserved. http://dx.doi.org/10.1016/j.healthpol.2014.01.020
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cycle of Engineered Nanomaterials (ENMs), from research through scale-up, manufacturing, product development, transport, to recycling and waste management [6]. The need of an occupational health and safety policy framework has therefore become very urgent, in order to promote the safe and responsible development of nanotechnologies. Nevertheless, it is not easy to address this issue, since nanotechnologies are relatively new and there is still no comprehensive knowledge of risks associated with the potential exposure to them, and consequently, how these risks can be prevented and managed [7,8]. As a result of this scenario, the sustainable development of NT&NMs entails a crucial challenge: the need to maximize the protection of human health and safety against unpredicted risks related to NT&NMs and, at the same time, to avoid affecting the predicted benefits of their development and use more than what is reasonable and necessary [9]. However at present, a fully satisfactory response to this need has not yet been found. In fact, NT&NMs are in most cases, regulated only according to current norms and laws. Nevertheless the development of a specific regulatory framework, or even the integration of the existing regulatory framework, are widely called upon. For instance, the European Commission (EC) recommends the application and adaptation of the regulatory framework set up for Chemicals by the REACH directive [10]. The debate on different regulatory approaches is still open both at institutional level and among stakeholders and studies on this issue have been promoted in Europe as well as in United States [11,12]. In general, the scientific uncertainty involved in evaluating potentially harmful properties of ENMs complicates and hampers the implementation of proper regulative measures by legislators [13]. In fact, the lack of certain data on risk assessment and management calls for the development of a regulatory framework under pinned by the adoption of the precautionary principle [14,15]. However, it has to be considered that applying the precautionary principle appropriately is a difficult task because it leaves room for the risk of enacting compulsory regulations based on insufficient information [16]. Since the adoption tout court of the precautionary principle needs a full reverse burden of proof that is not scientifically viable, a proper application of this principle requires, on one side, the development of a regulation that is able to capture and balance the plurality of social values and interests involved and, on the other side, the integration of this regulation within a wider policies framework aiming to increase knowledge availability and promote a transparent, responsible and socially accepted use and development of this technological innovation [17–19]. According to these needs, as pointed out, among the others, by EC, the participation in decision-making processes of all stakeholders involved in or concerned by NT&NMs seems to be the most suitable way to address the issue of governing the development of NT&NMs [20]. The adoption of the participative approach is generally considered to be the best method with which to increase the quality of decisions and to resolve conflicts among competitive interests
where risk’s boundaries are unknown and interests and value judgments are potentially different [21–23]. So far for nanotechnology, various attempts have been made, and are still being made, to promote open and transparent policy deliberations and extensive public discourse [24–27]. Nevertheless, even if these engagement exercises aim to influence policy making, research suggests that, until now, they have had little discernible impact on this regard [28]. An effort to develop further practices of stakeholders’ engagement is therefore needed to make the most of the added value that can be gained from adopting a participatory approach to have an effective governance of technological innovation. As suggested by studies on public participation, one way forward should be to move up as much as possible from the public consultation level to the effective and active engagement of key stakeholders in the policy making process [29]. According to this need, the former Italian Institute for Occupational Health and Safety (ISPESL), whose function was transferred to INAIL in 2010 by Italian law, has conducted the study presented here which aims to give a contribution to a better understanding of the prospect for public engagement in policy making both on technological innovation in general and on the specific case of NT&NMs related risks governance. This study is a follow-up of the “White Book on the exposure to engineered nanomaterials and their effects on workers’ health and safety” published in 2010 by INAIL in collaboration with “NanOSH Italia”, a National network involving Occupational Health and Safety (OHS) researchers in the field of nanomaterials to address one of the key emerging priorities for research on OHS identified in Italy [30,31]. The White Book provides a state of the art review, including an analysis of the key issues for the development of relevant research, with the intent of streamlining the dissemination and sharing of available scientific knowledge. This study engaged with Italian social partners, public authorities and representatives of research institutions in a process addressed to share available knowledge provided by the White Book and, in the light of such knowledge explore are their standpoints and priorities and identify if any shared policy options are available. 2. Materials and methods The study was conducted in two steps. In the first step, a stakeholder analysis was conducted and a list of key Italian stakeholders was developed, taking into consideration the need to represent all different interests concerned with occupational health issues related to NT&NMs exposure. Afterwards, the identified stakeholders were grouped in three reference groups. Stakeholders having a third party interest, with regard to the issues addressed in the study, were gathered together in the group that was named Institutions & Associations. This included both public institutions endowed with decision-making power over policies affecting the development of NT&NMs and the protection of workers’ health, as well as Italian OHS Professional Associations that have a professional concern in facing the OHS issues
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in an effective manner. The other two groups, named respectively as Industry and Workers, were constituted by representatives of interests in the NT&NMs Industry and major Italian Trade Unions. After having provided a copy of the White Book to the selected stakeholders, they were administered an on-line questionnaire consisting of two parts. The first part aimed to investigate their awareness of the issue of occupational risks related to NT&NMs exposure, and to explore how reading the White Book had influenced such awareness. In the second part they were asked to provide their viewpoint on some key issues for designing policies to foster the sustainable development of NT&NMs such as the following: level of concern for occupational exposure to NT&NMs, approach to policy making to be pursued, key issues to be faced, priority actions to be implemented and communication strategies to be adopted to properly convey available information to different target groups. Respondents to the on-line questionnaire were as follows: 3 from Public Institutions (Ministry of Labour, Ministry of Health and Coordination Body of Italian Regions for OHS), 3 from OHS Professional Associations (Italian Association of Industrial Hygienists, Italian Society of Occupational Medicine and Industrial Hygiene, National Society of OHS Professionals), 6 from the Industry sector (Chemical Industries Federation, Pharmaceutical Industries Federation, National Confederation of Handcrafters and SMEs and the two main nanotechnology-related Industrial Districts) and 4 from Workers’ sector (CGIL, CISL, UIL and CONFSAL which are four out of the five major Italian Trade Unions). In the second step, beginning with the positions expressed by stakeholders on the issues investigated in the survey, a workshop was conducted to start a guided discussion among key players, with the purpose of identifying shared premises and prospects on which to base an inclusive policy-making process related to the sustainable development of NT&NMs. In addition to stakeholders, OSH’s researcher were also involved at this stage, including White Book Authors, representatives of Universities and other Italian research Institutions committed to studying nanomaterials and their potential impact on human health. Researchers were involved to provide a strictly knowledge based view to the discussion. The workshop was based on the European Awareness Scenario Workshop (EASW) methodology adapted by INAIL for the specific purpose of this study. EASW, which was developed by the European Commission DirectorateGeneral XIII in 1994, is a strategic visioning and idea generation process structured through a combination of working group sessions alternating with plenary discussions. In the first working session, participants were required to identify critical points concerning three different policy areas, relevant to a sustainable development of NT&NMs: the “regulatory” area, which concerns voluntary and compulsory regulations that set out limits, procedures and standards; the “active policies” area, which concerns actions for the development of knowledge and tools as well as for the creation of support systems for the definition and implementation of regulations and/or good practices;
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the “communication and information” area, which concerns actions for the dissemination of clear and transparent information and for an appropriate and comprehensive awareness of risks, good practices and opportunities. During this session, participants were divided into two groups: “Stakeholders” and “Experts”. By splitting participants into such groups, it was possible to separate the views of stakeholders and scientific knowledge-holders (Researchers/Experts). Afterwards, critical points identified by each group with respect to the three thematic areas were presented to all the participants in a plenary session. Critical points shared and unshared by the two groups were then highlighted, discussed and refined. A second working group session was then held. In this session, both experts and stakeholders were dispersed into three thematic groups related to the three policy areas previously explored: Regulations, Active Policies and Communication/Information. Each group was required to develop shared proposals for overcoming critical points identified for its assigned policy area. Proposals developed by thematic groups were eventually presented, shared and prioritized in a final plenary session. 3. Results A response rate of 72.7% was obtained (16 questionnaires returned out of 22) from the survey. The distribution of respondents provided a high level of sample representativeness of the different stakeholders’ groups, both from a qualitative and quantitative point of view. A response rate of 50% was obtained by representatives of Institutions, both at the national and regional level, 75% by the OHS Professional Association, 86% by Industry and 80% by Workers. It should be pointed out that two Industry representatives didn’t answer the first section of the questionnaire. Only 3 out of 14 respondents to the first section (21%) reported that they were already fully aware of OHS issues related to NT&NMs before reading the White Book. Nevertheless, almost all respondents (85.7%) say that the White Book provided them with some further relevant information. In the view of 14 out of 16 respondents (87.5%) to the second section of the questionnaire, the OHS risks related to NT&NMs are a key issue to deal with as soon as possible. With regard to public awareness, most respondents (62.5%) believe that public perception pertaining to the importance of the OHS risks related to NT&NMs is lower than it should be. All representatives from the workers group shared this opinion, as well as 4 representatives out of 6 from Institution & Association and 2 out of 6 from Industry also shared this opinion. When asked to point out the most appropriate process to address policy making on NT&NMs, none of the respondents opted for a top–down approach to policy making. Their preferences are split in half over two different bottom–up approaches. Half of them state that a structured process of consultation and discussion with all key stakeholders should be put in place to define a framework of shared policies to be submitted to the decision-maker. On
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Table 1 Responses on policy options (absolute frequencies and percentage by group and priorities). Inst. & Ass.
Foster the valorization of good practices Increase funding to public research Adopt measures to reduce entrepreneurial risks Set up incentives to stimulate private research investment
Industry
Workers
Low
Medium
High
Low
Medium
High
Low
Medium
High
–
–
6 (100%)
–
–
6 (100%)
–
2 (50%)
2 (50%)
–
1 (17%)
5 (83%)
–
4 (67%)
2 (33%)
–
–
4 (100%)
–
2 (33%)
4 (67%)
1 (17%)
2 (33%)
3 (50%)
–
1 (25%)
3 (75%)
1 (17%)
2 (33%)
3 (50%)
–
1 (17%)
5 (83%)
1 (25%)
1 (25%)
2 (50%)
the other hand, the remaining 50% believe that the existing three-party Commission on OHS should be involved in the policy making process. Respondents outlined that the most critical issues to be addressed to ensure a safer development of NT&NMs are as following: the procedures for assessing the risks from exposure to nanoparticles (13); the instruments to monitor release of nanoparticles in the workplace (12); the knowledge of risks of inhaled particles (12); the identification of risks related to different stages in the manufacturing processes of NT&NMs (10). With regard to the “active policies” to be implemented to support a sustainable development of NT&NMs, almost all respondents give a high priority to promotion of good practices. There are instead much more differences between the groups’ in the evaluation of the other policy options proposed. All respondents from the Workers group and the most part from the Institutions & Associations group believe that the need for public research investment is a top priority. Instead, most of respondents from the Industry group gave lower priority to this action. At the same time, almost all respondents from this group state that funding private research should be a high priority (Table 1). With regard to the “regulatory framework”, a half of respondents deem that the legislation on chemicals can be extended to NT&NM’s but specific standards and guidelines must be added. Instead, a lower number of respondents (31.3%) believe that NT&NMs should be regulated through a specific, ad hoc, legislation and even a smaller part of respondents (all from industry) claim that an improvement of the regulatory framework is not needed (Table 2). In the opinion of most respondents (68.8%), the communication strategies on NT&NM should be re-modulated, as there is no correlation between the state of knowledge and the information being disseminated. According to their answers, it is necessary to address this problem by undertaking the following actions: ease the access to information on risk assessment and management practices
(this option was selected as important or very important by 86% of respondents); strengthen the training and professional updating for workers and OSH professionals (80%); foster the bidirectional communication between employers and employees (66%). During the workshop, participants were asked to go further in identifying critical points and shared actions to address them. In respect to “active policies”, the main weaknesses identified by the experts’ group were: lack of a clear plan of action for the sustainable development of NT&NMs, lack of support to OSH professionals in dealing with risks relating to NT&NMs as well as good practices to be adopted. Instead, stakeholders focused their attention more on the lack of research funding and difficulties in transferring OHS research outputs to manufacturing process related to NT&NMs. Some shared actions were proposed to address the above weaknesses: to develop a permanent collaboration network between research bodies, public authorities and enterprises’ representatives for identifying shared research funding priorities and sustaining the implementation of OHS research results; to stimulate a more proactive attitude of companies through policies for taxation reduction/insurance premiums “in exchange of” openness and collaboration in research; to develop guidelines on NT&NMs risk assessment and management. Pertaining to “regulations”, both groups believed that the existing normative framework is not adequate to properly address the OHS risks related issues stemming from the development of NT&NMs. They also outlined that the ruling capacity is in general affected by scientific uncertainty on the effect of NT&NMs. The experts group also outlined the need for harmonizing available data, strengthening the relationships between Research Institutions and Nano enterprises to provide more data for research purposes and setting standardized criteria for data sampling and analysis. Stakeholders group instead highlighted that the lack of a clear identification of the risk categories does not allow to clearly understand when the risk assessments are required.
Table 2 Responses on regulatory options (absolute frequencies and percentage by group).
Integrate the legislation on chemicals with specific standards and guidelines Develop an ad hoc regulatory framework Just apply to NM&NTs the legislation on chemicals or other sector legislation Adopt voluntary norms
Inst. & Ass.
Industry
Workers
Total
5 (83%) 1 (17%) – –
2 (33%) 1 (17%) 3 (50%) –
1 (25%) 3 (75%) – –
8 (50%) 5 (31%) 3 (19%) –
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The key action identified by workshop’s participants to address these weaknesses is the setting up of a bridging body between the worlds of research and industry that would support the creation of a common knowledge framework and the shared development of norms and standards. On “communication & information”, difficulties in the dialog between research and enterprise were reported by the experts group, largely due to the lack of a common language. The reliability of information – considering the multidisciplinary nature of the issue and the lack of a critical examination of the existing literature – was felt both by experts and stakeholders as an urgent issue that needs to be addressed. The current lack of specific knowledge generates misleading messages. In the field of communication and information, the need to establish a national authority qualified for examining and validating scientific information was highlighted in order to ensure a continuous update of the state of the art. Furthermore, the production of specific information material should represent the core of a communication strategy aimed to sensitizing the nanomaterials industry, workers and final users. Eventually, the set up of a national database containing information provided by industry on exposure scenarios could aid the researchers to improve their studies on nanomaterial risk assessment and management.
4. Conclusion Despite the fact that science is still lacking a clear understanding of NT&NM related risks, stakeholders are aware that it is an issue that needs to be dealt with and further policies are needed to address it properly. Specifically, the majority of them believe that NT&NMs are not an immediate threat, but an issue that may cause future problems if proper policies to support their sustainable and transparent development are not put in place. The willingness of industry representatives to address the issue is quite an unexpected response. On this regard, it’s worth noting that the technology industry is usually inclined to underestimate the risks of NT&NMs [32]. On the other side, although in line with the balanced public perception of nanotechnologies generally reported by surveys on this matter, the workers’ representatives’ attitude to consider the NT&NMs as a not immediate threat is also a valuable hint [33,34]. Not infrequently, within the international debate related to nanotechnology, extreme views calling for a non-negotiable moratorium on NT&NMs have been expressed by Trade Unions and also by consumer associations. It is without doubt that these findings are a favorable premise for having a constructive and proactive debate on how to govern the sustainable development of NT&NMs with respect to OHS. Considering that NT&NMs in general, and even more particularly their possible relationship to workers’ health and safety, are not yet under the glare of national public attention, this study confirms the importance of moving the stakeholder engagement “upstream” before deeply entrenched and polarized positions related to technological innovation appear [35].
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Furthermore, and consistent with literature, we can argue that the upstream positioning of the confrontation among stakeholders allowed the study to identify the shared priorities of action. The positive approach to confrontation and the low level of conflict among stakeholders and between the stakeholders and researchers show that parties were focused more on the interests rather than the positions and still willing to identify a “common ground” for developing mutually beneficial agreements. However, it is worthwhile to highlight the relevant contribution given by the White Book to the effectiveness of the dialog among stakeholders and between them and the scientists. Most of the stakeholders involved in the survey declared that reading the ‘White Book’ helped them to gain a deeper understanding of the issue and to unveil a number of aspects of a generally underestimated matter. Hence, even if some areas of scientific uncertainty on NT&NMs were properly reported, the White Book made the problems behind this technology clearer to the stakeholders by providing a comprehensive and reliable knowledge framework. This was an important output since the stakeholders’ knowledge of and confidence on the issues addressed has a key role for gaining their meaningful engagement in the process [36]. The study also provided some interesting findings about the three key policy areas explored. About the regulation area, the wide majority of the stakeholders agree that the existing regulatory framework is not adequate and therefore efforts have to be made to develop it. Even though different opinions have been expressed on how to effectively and properly regulate the NT&NMs development, stakeholders agree on the path to be followed to gain a shared regulation. It should be based on a bottom-up approach and eased by a subject acting as a trait d’union in charge of strengthening the dialog between OSH research and businesses, aimed to increase the knowledge available to support the regulatory framework development. As concerns active policies to be defined, an undoubtedly large consensus exists about the development and enhancement of good practices. A cross sectional consensus, albeit slighter, can also be found in the need for supporting public research in OHS as well as enterprises engaged in technological innovation development, who bear the burden of coping with the uncertainties of impacts on human health and safety of NT&NMs. A widespread consensus was also reached on the need for appropriate incentives aiming to intensify collaborations between business and research. The improvement of information flow is a high priority for all stakeholders because of the difficulty in accessing available and reliable information. To this aim, a high consensus found the need of a national authority that validates and verifies the scientific information (research data + national/international literature) for a state-of-the-art update and the creation of a database on exposure scenarios provided by organizations for preventive risk assessments. The study then has pointed out not only the premise for developing a shared policy-making process on NT&NMs, but also some clear and shared priorities that offer interesting maneuvering room to favor a policy community
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aggregation to sustain the development of this process. As highlighted by the policy analysis, a policy community is characterized by shared values, a common understanding of the “the rules of the game”, the mutual confidence among members and acknowledgment that cooperation facilitates achievement of the objectives [37,38]. In this view, it must be outlined that the survey reports a wide willingness and interest among stakeholders to be engaged in the policy making process, as they share the belief that it is the best way to ensure a fair balance of various interests at stake. The existence of a relevant policy community can be decisive for the start and success of a policy making process [39,40]. Nevertheless, one of the most important outcomes from the study is the prospect for the application of participative practices to policy making on NT&NMs. It shows that some interesting results can be gained by moving up from the public consultation level to the effective and active engagement of stakeholders in the policy making process. Notwithstanding the study is just a starting point, a follow-up is needed to assess the effective contribution of the study’s results toward the development of a proper policy framework for NT&NMs and OHS. It is important to understand if it is possible to evolve from sharing some sketched ideas to identifying some shared actions and consequently to implement them effectively. To achieve such an aim it would be necessary to involve a wider range of stakeholders. Moreover, further studies are needed to assess the effective impact and added value on decision making and policy effectiveness of such a model of stakeholders’ engagement. It has to be considered that the engagement process was time and resource consuming and a continuous institutional support is thus needed to help sustain its further development. Acknowledgement The authors are grateful to Dr. Aditya Kailash Jain and Dr. Diane Bedrosian for language revision of the manuscript. References [1] Schulte PA, Geraci CL, Hodson L, Zumwalde R, Castranova V, Kuempel E, et al. Nanotechnologies and nanomaterials in the occupational setting. Italian Journal of Occupational and Environmental Hygiene 2010;1(2):63–8. [2] Boccuni F, Rondinone BM, Petyx C, Iavicoli S. Potential occupational exposure to manufactured nanoparticles in Italy. Journal of Cleaner Production 2008;16:949–56. [3] Roco MC, Mirkin CA, Hersam MC. Nanotechnology research directions for societal needs in 2020: summary of international study. Journal of Nanoparticle Research 2011;13:897–919. [4] Maynard AD, Warheit DB, Philbert MA. The new toxicology of sophisticated materials: nanotoxicology and beyond. Toxicological Sciences 2011;120(Suppl. 1):S109–29 [Epub 2010 Dec 22]. [5] Oberdörster G. Safety assessment for nanotechnology and nanomedicine: concepts of nanotoxicology. Journal of Internal Medicine 2010;267(January (1)):89–105. [6] Iavicoli S, Rondinone BM, Boccuni F. Occupational safety and health’s role in sustainable, responsible nanotechnology: gaps and needs. Human and Experimental Toxicology 2009;28:433–43. [7] Trout DB, Schulte PA. Medical surveillance, exposure registries, and epidemiologic research for workers exposed to nanomaterials. Toxicology 2010;269:128–35.
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