International Organizations and Nanothechnologies: The Challenge of Coordination
MBENGUE, Makane Moïse
International organizations have been debating and monitoring the issue of nanotechnologies for several years. Five international organizations have been quite active in this respect: the Food and Agriculture Organization, the International Labour Organization, the Organization for Economic Cooperation and Development, the United Nations Educational, Scientific and Cultural Organization, and the World Health Organization. Nevertheless, due to their different mandates, the actions of these international organizations have been rather fragmented. In particular, they have been unable to agree on whether a universal regulatory framework is necessary in order to better address the uncertain risks that may derive from nanotechnologies. Furthermore, they have not yet clearly identified the principles of international environmental law (e.g., sustainable development, precautionary principle) that should govern any action in the field of nanotechnologies. Despite this fragmentation, there are international efforts to foster coordination between international organizations, with the establishment of two important fora: the [...]
MBENGUE, Makane Moïse. International Organizations and Nanothechnologies: The Challenge of Coordination. Review of European Community and International Environmental Law (RECIEL) , 2013, vol. 22, no. 2, p. 174-185
DOI : 10.1111/reel.12033
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International Organizations and Nanotechnologies:
The Challenge of Coordination
Makane Moïse Mbengue and Margaux Charles
International organizations have been debating and monitoring the issue of nanotechnologies for several years. Five international organizations have been quite active in this respect: the Food and Agriculture Organization, the International Labour Organization, the Organization for Economic Cooperation and Development, the United Nations Educational, Scien- tific and Cultural Organization, and the World Health Organization. Nevertheless, due to their different mandates, the actions of these international organiza- tions have been rather fragmented. In particular, they have been unable to agree on whether a universal regulatory framework is necessary in order to better address the uncertain risks that may derive from nanotechnologies. Furthermore, they have not yet clearly identified the principles of international envi- ronmental law (e.g., sustainable development, precau- tionary principle) that should govern any action in the field of nanotechnologies. Despite this fragmentation, there are international efforts to foster coordina- tion between international organizations, with the establishment of two important fora: the Inter- organization Programme for the Sound Management of Chemicals and the Inter-governmental Forum on Chemical Safety.
NANOTECHNOLOGY AS A CONCERN OF THE
Nanotechnology could change the world from the bottom up. Nanotechnology could become an instrument of terror- ism. Nanotechnology could lead to the next industrial revo- lution. Nanotechnology could transform the food industry.
Nanotechnology could repair the ozone layer. Nanotechnol- ogy could change everything.1
Nanotechnology can bring great achievements, but it can also be hazardous if not treated with caution.2
Because of the importance of the risks and the uncer- tainty surrounding their impacts on human health and the environment, more and more concerns have arisen at the international level to address the phenomenon of nanotechnologies.
International organizations have been debating the issue for several years in order to identify and define the most appropriate regulatory approach to address the specific characteristics of nanotechnologies and the risks they pose. In their quest, these organizations have been guided mainly by a precautionary approach,3 while keeping in mind the interests and benefits that nanotechnologies can bring about. As such, the ulti- mate aim of international organizations appears to be one of ‘promot[ing] further research but simultane- ously tak[ing] regulatory action to limit or prevent potential harm from uncertain risks’.4
International organizations have not operated in a vacuum. Regulations have been introduced at the national level,inter alia, by Australia, France, Japan, the United Kingdom and the United States, as well as at the regional level within the context of the European Union (EU). However, there are still many disparities between the existing regulations. These disparities reveal a need for the development of a universal legal framework capable of better ensuring the implementa- tion of the precautionary principle and fostering
1United Nations Educational, Scientific and Cultural Organization (UNESCO),The Ethics and Politics of Nanotechnology(UNESCO, 2006), found at: <http://unesdoc.unesco.org/images/0014/001459/
145951e.pdf>, at 3.
2E. Drexler and C. Peterson,Unbounding the Future: The Nanotech- nology Revolution(William Morrow, 1991).
3Because of the status of the precautionary approach/principle as a customary rule of international law, international organizations are also bound to act in accordance with this approach. On the customary nature of the precautionary approach, see International Tribunal on the Law of the Sea, 1 February 2011,Responsibilities and Obliga- tions of States Sponsoring Persons and Entities with Respect to Activities in the Area (Request for Advisory Opinion Submitted to the Seabed Disputes Chamber), found at:<http://www.itlos.org/fileadmin/
itlos/documents/cases/case_no_17/adv_op_010211.pdf>, at para- graph 135: ‘The Chamber observes that the precautionary approach has been incorporated into a growing number of international treaties and other instruments, many of which reflect the formulation of Prin- ciple 15 of the Rio Declaration. In the view of the Chamber, this has initiated a trend towards making this approach part of customary international law.’
4R. Falkner and N. Jaspers, ‘Regulating Nanotechnologies: Risk, Uncertainty and the Global Governance Gap’, 12:2Global Environ- mental Politics(2012), 30, at 33. See also N. de Sadeleer,Imple- menting the Precautionary Principle: Approaches from the Nordic Countries, the EU and USA(Earthscan, 2007), at 158.
RECIEL 22 (2) 2013. ISSN 0962-8797
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legal predictability in the international treatment of nanotechnologies.
The Strategic Approach to International Chemicals Management (SAICM) has been a major attempt to build an appropriate multilateral approach. The SAICM was adopted by the International Conference on Chemicals Management (ICCM) on 6 February 2006 as a policy framework to foster the sound management of chemicals.5 This conference was attended by various international organizations, such as the World Health Organization (WHO) and the United Nations Environ- mental Programme (UNEP), as well as representatives from government and civil society from all relevant sectors, displaying attempts by the international com- munity to involve all relevant actors in the process.6 The SAICM was developed by a multistakeholder and multisectoral preparatory committee with a view to supporting the achievement of the goal agreed at the 2002 Johannesburg World Summit on Sustainable Development of ensuring that, by the year 2020, chemi- cals are produced and used in ways that minimize sig- nificant adverse impacts on the environment and human health.7
On the issue of nanotechnologies, the SAICM recom- mended the development of international technical and regulatory guidance and training materials for the sound management of manufactured nanomaterials. It also invited relevant international organizations to con- tinue to support efforts to facilitate capacity building and information exchange, develop guidance and train- ing materials, and support public dialogue regarding nanotechnologies and manufactured nanomaterials.
In addition, the SAICM encouraged all stakeholders involved, including international organizations, to facilitate the exchange of information on nanotechnologies and manufactured nanomaterials in order to improve global transparency and improve
decision-making processes.8 The SAICM does not suggest that one specific international organization should formulate universal guidelines, orientations or principles in the field of nanotechnologies. This is due in part to the fact that several international organiza- tions have been, and continue to be, involved in the field of nanotechnologies through different strategies and for different purposes.
This article highlights how the activities of various international organizations are still fragmented, even though there are also certain commonalities. It then emphasizes the importance of coordination with respect to nanotechnologies and examines potential institutional means to ensuring such coordination.
FROM FRAGMENTED ACTIVITIES BY VARIOUS INTERNATIONAL ORGANIZATIONS . . .
As of today, no international institution is solely responsible for the regulation of nanotechnologies. This is due to the recent character of the technology and the fact that the international community is still searching for the most appropriate forum. Several institutions have already started processes with a view to adopting clearer policy – and to a lesser extent clearer regulatory – positions on nanotechnology.
The contribution of international organizations to the universalization of the regulation of nanotechnologies – in terms of adopting a multilateral and comprehen- sive legal instrument – is almost non-existent. Yet, the design of a multilateral framework would help to reduce the gaps as well as discrepancies between domestic regulations covering nanotechnologies. It would also contribute to formulating multilateral rules and principles governing risk assessment and risk man- agement in the field of nanotechnologies, similar to what has been achieved, for instance, with respect to biotechnologies.9
For the time being, international organizations are still at the discovery stage, and their efforts consist mainly of informal discussions and the formulation of ‘soft’
practical guidance and recommendations. Five interna- tional organizations have played a leading role in this respect, acting as ‘science providers’, ‘policy formula- tors’, ‘risk regulators’ and ‘interconnectors’. The five organizations, and these roles, are discussed below.
5Report of the International Conference on Chemicals Management on the Work of Its First Session, Dubai, United Arab Emirates, 4–6 February 2006 (UN Doc. SAICM/ICCM.1/7, 8 March 2006).
6Introductory letter from the UNEP Executive Director and the WHO Director General, found at: <http://www.saicm.org/images/saicm _documents/saicm%20texts/Joint%20UNEP%20-%20WHO%20 letter%20FINAL%20Feb%2008.pdf>.
7One of the actions listed in the 2002 Johannesburg Plan of Imple- mentation is to: ‘Renew the commitment, as advanced in Agenda 21, to sound management of chemicals throughout their life cycle and of hazardous wastes for sustainable development as well as for the protection of human health and the environment, inter alia, aiming to achieve, by 2020, that chemicals are used and produced in ways that lead to the minimization of significant adverse effects on human health and the environment, using transparent science-based risk assessment procedures and science-based risk management proce- dures, taking into account the precautionary approach, as set out in principle 15 of the Rio Declaration on Environment and Develop- ment.’ Johannesburg Plan of Implementation, in: Report of the World Summit on Sustainable Development (UN Doc. A/CONF.199/20, 4 September 2002), at paragraph 23.
8For more details on the SAICM, see: G. Karlaganis and R. Liechti,
‘The Regulatory Framework for Nanomaterials at a Global Level:
SAICM and WTO Insights’, 22:2Review of European, Comparative and International Environmental Law(2013).
9Cartagena Protocol on Biosafety to the Convention on Biological Diversity (Cartagena, 29 January 2000; in force 11 September 2003).
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INTERNATIONAL ORGANIZATIONS AS ‘SCIENCE PROVIDERS’: THE WORLD HEALTH ORGANIZATION (WHO) AND THE FOOD
AND AGRICULTURE ORGANIZATION (FAO)
The WHO is the directing and coordinating authority for health within the UN system. WHO Collaborating Centres for Occupational Health already discussed issues related to occupational health and safety risks of nanotechnology at a meeting in November 2007 in Hel- sinki. The main conclusions were that the lessons learned from years of studying occupational health and safety risks and developing national reports in devel- oped countries needed to be shared with other coun- tries.10 In this context, the WHO attempts to assist emerging and transitional economies to take into con- sideration and to incorporate occupational health and safety issues into their national strategies for the devel- opment of nanotechnologies.11 The WHO recom- mended that emerging countries start to develop nanoresearch, and suggested that an agreement should be reached on common standards for the development of nanotechnologies.12This promotion of standardiza- tion is a key aspect of the work of some international organizations dealing with issues of nanotechnologies.
The issue of food safety is an interesting area where the WHO is undertaking this activity in relation to nanotechnologies.
With a rise in the number of applications of nanotechnologies in the field of agriculture and food production, the WHO and the FAO joined forces to provide their respective member States with sound sci- entific advice on the assessment of foods related to nanotechnologies. In 2010, during a meeting of experts of the WHO and the FAO, the WHO presented a report on food safety implications of nanotechnology applica-
tion in the food and agriculture sectors.13 The major aims of the meeting were: (i) to develop a common view of what the main food safety concerns associated with actual and anticipated nanotechnology applications in the food and agriculture sectors are; (ii) to share lessons learned by those countries that have already initiated programmes to address concerns; (iii) to agree on pri- ority actions that are needed to control possible food safety hazards associated with nanotechnology applica- tions in food and agriculture; and (iv) to develop guid- ance on the possible roles of the FAO and the WHO in promoting sound governance of food safety issues linked to nanotechnology applications.14
A second meeting on nanotechnologies in food and agriculture, convened by both the WHO and the FAO, took place in 2012 in Rome. It held that:
Given that the issues pertaining to food safety continue to evolve, and new issues and technologies continue to emerge, it is critical that the FAO and WHO keep abreast of these new developments and remain in a position to support [the Codex Alimentarius– the body responsible for implement- ing the joint FAO and WHO Food Standards Programme]
and their Member Countries in understanding the implica- tions of such developments and the actions required.15 The goal of the joint action by the WHO and FAO is not yet to formulate strict nanotechnology-related regula- tion(s), but rather to focus on risk assessment and further research on nanotechnologies. Because of their mandate and competences, the FAO and WHO, together, are in the best position to assess and address challenges relating to nanotechnology in the food and agriculture sectors. In particular, if the Codex Alimentariussucceeds in the future in formulating and adopting food safety standards in the field of nanotechnologies, this could result in enhanced legal certainty16and less potential discriminatory measures in the international trade of nanotechnology-enhanced food products.
10See WHO,Activities on Nanotechnologies in the IOMC Organiza- tions (WHO, undated), found at <http://www.who.int/iomc/events/
nanotechnology.pdf>, at 2. See also WHO, Implementation of the Global Plan of Action of Workers’ Health in the European Region.
Report of the 6th Meeting of European Network of WHO Collaborat- ing Centres in Occupational Health, Madrid, Spain, 14–16 October 2008 (WHO, 2008), found at: <http://www.euro.who.int/__data/
assets/pdf_file/0006/117087/E94071.pdf>, at 18 (‘nanosafety is an important issue, as long as we do not know the hazards and health outcomes’).
11The WHO is currently preparing guidelines on ‘Protecting Workers from Potential Risks of Manufactured Nanomaterials’ (‘the WHO/
NANOH Guidelines’). See:<http://www.who.int/occupational_health/
12Ibid. See also FAO and WHO,State of the Art on the Initiatives and Activities Relevant to Risk Assessment and Risk Management of Nanotechnologies in the Food and Agriculture Sectors (FAO and WHO, 2012), found at:<http://www.who.int/foodsafety/biotech/
FAO_WHO_Nano_Paper_Public_Review_20120608.pdf>, at 1 and 20.
13FAO and WHO,FAO/WHO Expert Meeting on the Application of Nanotechnologies in the Food and Agriculture Sectors: Potential Food Safety Implications, Meeting Report (FAO and WHO, 2010), found at:<http://www.fao.org/docrep/012/i1434e/i1434e00.pdf>.
14Ibid., at 6.
15FAO and WHO, Joint FAO/WHO Meeting, Nanotechnologies in Food and Agriculture, Meeting Report (27 March 2012), found at:
Nano_Report_Final_20120625.pdf>, at 1. See also, FAO and WHO, FAO/WHO Expert Meeting on the Application of Nanotechnologies in the Food and Agriculture Sectors: Potential Food Safety Implications, Meeting Report(FAO and WHO, 2009), found at:<http://www.evira.fi/
fao_who_nano_expert_meeting_report_final__2_.pdf>, at 59: ‘The outcomes of the joint FAO/WHO Experts Meeting on the applications of nanotechnologies in food and agriculture sectors could be used to identify any need for specific regulatory provisions in the Codex Alimentarius.’
16See, e.g., FAO and WHO, n. 12 above, at 1: ‘[I]t was recognized that there was a need for clear and internationally recognized defini- tions and that gaps in definitions in the food area could be addressed by the Codex Alimentarius Commission.’
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For the time being, both the WHO and the FAO are engaged in follow-up activities related to the strategies, regulations and risk assessment or risk management measures adopted by some of their member States. A recent report focuses, for instance, on the national strategies adopted in countries such as Australia, Brazil, Canada, China, Indonesia, Japan, Malaysia, Mexico, New Zealand, Republic of Korea, South Africa, Switzerland and the United States.17This is, of course, a very soft type of international supervision; the idea is only to conduct a survey of State practice but not to put regulatory constraints on WHO and FAO member States. Nevertheless, it allows international organiza- tions such as the WHO and FAO to identify best prac- tices at the international level with respect to nanotechnologies and to foster cooperation with a view to possibly formulating universal standards or prin- ciples or even adopting a legally binding global instru- ment. The 2001 FAO International Treaty on Plant Genetic Resources for Food and Agriculture,18 for instance, could serve as a model to develop a multilat- eral system for the access to nanotechnologies in the field of food and agriculture and to share the benefits derived from that access.
INTERNATIONAL ORGANIZATIONS AS ‘POLICY FORMULATORS’: THE UNITED NATIONS EDUCATIONAL, SCIENTIFIC AND CULTURAL
In 1998, UNESCO established the World Commission on the Ethics of Scientific Knowledge and Technology (COMEST). COMEST is an advisory body and forum of reflection dealing with several areas, such as environ- mental and scientific ethics. Without having the same decision-making power, COMEST is – at least in its composition – built upon the same model as some envi- ronmental governance bodies dealing with scientific issues, such as the Intergovernmental Panel on Climate Change or, more recently, the Intergovernmental Plat- form on Biodiversity and Ecosystem Services. Like these scientific bodies, COMEST is composed of a group of specialists coming from various disciplines, includ- ing the natural sciences, engineering, law, philosophy and politics.19This shows that the international regula- tion of nanotechnologies, similarly to the regulation of
climate change or biodiversity, would benefit from institutional patterns in which science, law, ethics and politics are mutually supportive.
Issues concerning nanotechnology and ethics were first raised during the third session of COMEST. The Com- mission’s decision to act on nanotechnologies was implicitly governed by a precautionary approach, as revealed by the introductory words of the then- chairperson of COMEST: ‘[T]he mandate of COMEST include a watchdog role, in order to detect the early signs of risk. It is therefore logical that the Commission addresses the issue of nanotechnology.’20These words also show that international organizations and/or the (subsidiary) bodies that they set up foresee their role in the field of nanotechnologies as providing scientific guidance and not necessarily as ‘law-makers’.21
In 2005, a group of experts was established in order to assist COMEST to draft a ‘policy document’ on ethics and nanotechnology. The policy document would serve as ‘Policy Advice on Nanotechnologies’ to the Director General of UNESCO. This proves that there are at least attempts to draft informal regulations of nanotechnologies within some international organiza- tions. The work of the group of experts is of particular interest as it focused on the need to develop policy guidelines concerningrisk communicationin the field of nanotechnologies. This can be contrasted with the group of experts established by the WHO and the FAO, which emphasized risk assessment and risk manage- ment. A meeting of the group of experts in 2006 made several recommendations, one of which concerned the
‘vital’22need to conduct ‘an early, informed, interdisci- plinary, and public debate on the ethical issues raised by nanotechnologies’.23
The group of experts went as far as addressing the fragmented activities by the various international
17Ibid., at 4–12.
18International Treaty on Plant Genetic Resources for Food and Agriculture (Rome, 3 December 2001; in force 29 June 2004).
19See Statutes of the COMEST, adopted by the Executive Board of UNESCO at its 154th Session (7 May 1998), found at: <http://
www.unesco.org/new/en/social-and-human-sciences/themes/global- environmental-change/comest/statutes-of-the-comest/>, Article 3.4:
‘The members of the Commission shall be chosen from among eminent personalities in the fields of science, professional engineer- ing, law, philosophy, culture, religion or politics, having the compe- tence and the authority necessary to fulfill the functions entrusted to
the Commission, taking due account of geographical distribution and ensuring coverage of the various disciplines and schools of thought.’
20COMEST, COMEST 3rd Session, Proceedings, 1–4 December 2003, Rio de Janeiro, Brazil, Proceedings(2003), found at:<http://
unesdoc.unesco.org/images/0013/001343/134391e.pdf>, at 29 (emphasis added).
21Cf. J. Alvarez,International Organizations as Law-makers(Oxford University Press, 2005).
22COMEST, COMEST Extraordinary Session, 27–28 June 2006, Paris, France, Proceedings(2006), found at:<http://unesdoc.unesco .org/images/0015/001514/151443e.pdf#page=13>, at 15.
23Ibid. The policy document further points out that ‘as many relevant interlocutors as possible, including scientists, ethicists, philosophers, policy-makers, and society as a whole should be included in these discussions’ and stressed ‘the urgency of launching such a debate in order to avoid possible manipulations and distortions, particularly in the media, as well as misunderstandings amongst the general public, as had been the case with genetically modified organisms. Some members stressed the importance of ensuring that the benefits and not only potential risks of nanotechnologies are duly considered within the framework of the debates.’
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organizations in the field of nanotechnologies.
However, rather than preventing further fragmenta- tion, the recommendations of the group of experts exac- erbated it:
Considering that the few intergovernmental organizations currently addressing nanotechnologies are not universal in nature, and none of these organizations are dealing with the emerging ethical issues of this field as their core purpose, the majority of the members agreed that the issues related to ethics and nanotechnologies are appropriately placed within the mandate of COMEST. It was stressed that UNESCO will likely play a leading role in this area.24
Nevertheless, the recommendations of the group of experts insisted on the importance of tackling the topic of nanotechnologies ‘from a global perspective’.25 On the basis of these recommendations, a ‘Policy Advice on Nanotechnologies and Ethics’ was drafted.26 Most interestingly, the draft plays a pioneering role – within the realms of international organizations – in insisting explicitly on the necessity to study and discuss the applicability of the precautionary principle to better identify the environmental and health issues raised by nanotechnologies.27The draft policy document was the basis for a consultation process which allowed the development of a set of recommendations for the 34th UNESCO general conference.28 Yet the conference did not adopt any specific resolution concerning nanotechnologies. Only thecommuniquéof the Minis- terial Round Table on Science and Technology for Sus- tainable Development, which took place during the general conference, recognized that ‘there are emerging technologies such as nanotechnologies . . . that are relevant for the sustainability of energy and the environment’.29
In 2006, UNESCO published the report‘The Ethics and Politics of Nanotechnology’,30in which it stressed the need for international action in order to reduce gaps in terms of nanotechnology-related standards. The report held that issues relating to the safety, toxicity and envi- ronmental impacts of nanomaterials are obviously important and require further research and greater international vigilance. UNESCO has been more proac-
tive than the WHO and the FAO by suggesting that the adoption of universal standards might be warranted in relation to nanotechnologies. This is perhaps due to the broad experience of UNESCO in standard setting, as reflected by the several legal instruments that were adopted in the area of bioethical principles. These include the 1997 Universal Declaration on the Human Genome and Human Rights,31 the 2003 International Declaration on Human Genetic Data32 and the 2005 Universal Declaration on Bioethics and Human Rights.33Although these instruments can be viewed as
‘soft law’, this approach could be transposed to the area of nanotechnologies. UNESCO could play a decisive role in this regard. An international expert meeting for the Arab region held in Qatar in May 2009 by UNESCO resulted in a consensus that a declaration on the ethics of nanotechnologies would be valuable, certainly at the regional level and possibly at the international level.34 But consensus in the Arab region does not entail global consensus and, therefore, it remains to be seen to which extent other UNESCO member States would agree on the need for a declaration concerning nanotechnologies.
COMEST has intensified its work on nanotechnology by setting up a Working Group on Nanotechnologies and Converging Technologies in June 2009. However, this working group has achieved nothing concrete so far.35COMEST perceives its role as elaborating ethical
26Outline of a Policy Advice on Nanotechnologies and Ethics, Draft Version (December 2005), found at: <http://www.unesco.org/new/
27Ibid., at point 4.2.
28COMEST, Background, found at:<http://www.unesco.org/new/en/
29Ministerial Round Table on Science and Technology for Sustain- able Development, in: UNESCO, Records of the General Confer- ence, 34th Session (Paris, 16 October–2 November 2007), Volume I:
Resolutions(UNESCO, 2007), found at:<http://unesdoc.unesco.org/
images/0015/001560/156046E.pdf>, at 178.
30See UNESCO, n. 1 above.
31Universal Declaration on the Human Genome and Human Rights, in: UNESCO, Records of the General Conference, 29th Session (Paris, 21 October–12 November 1997), Volume I: Resolutions (UNESCO, 1997), found at: <http://unesdoc.unesco.org/images/
0011/001102/110220e.pdf>, at 41.
32International Declaration on Human Genetic Data, in: UNESCO, Records of the General Conference, 32nd Session (Paris, 29 September–17 October 2003), Volume I: Resolutions (UNESCO, 2003), found at: <http://unesdoc.unesco.org/images/0013/001331/
133171e.pdf>, at 39.
33Universal Declaration on Bioethics and Human Rights, in:
UNESCO,Records of the General Conference, 33rd Session (Paris, 3–21 October 2005), Volume I: Resolutions(UNESCO, 2005), found at: <http://unesdoc.unesco.org/images/0014/001428/142825e.pdf>, at 74.
34COMEST,Ethical Issues in Science Governance and the Science–
Society Relationship, 8th Ordinary Session, Bratislava, Slovakia, 27–29 May 2013, Draft Report(2013) (‘COMEST,Ethical Issues’), found at:<http://unesdoc.unesco.org/images/0022/002209/220999e .pdf>, at 25, footnote 22.
35See COMEST,Summary Report on Activities since the 5th Ordi- nary Session of COMEST, 6th Ordinary Session, Kuala Lumpur, Malaysia, 16–19 June 2009 (2009), at 8, found at <http://www .unesco.org/new/fileadmin/MULTIMEDIA/HQ/SHS/pdf/Summary- report-of-activities.pdf>. In 2011, COMEST decided to merge its working groups on Science Ethics and on Nanotechnologies and Converging Technologies into a new ‘Science Ethics Working Group’
with a specific focus, in addition to general science ethics concerns, on nanotechnologies and converging technologies. See COMEST, Summary Report on Decisions Adopted at the 7th Ordinary Session, Doha, Qatar, 9–12 October 2011 (2011) (‘COMEST, 2011 Sum- mary Report’), found at: <http://www.unesco.org/new/fileadmin/
MULTIMEDIA/HQ/SHS/pdf/Summary-Report-on- Decisions_COMEST_2011.pdf#page=9>, at 3.
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principles.36 In this context, it is less concerned with developing a set of legal rules and more with raising awareness among actors participating in the develop- ment of nanotechnology. Surprisingly enough, COMEST has recently suggested that nanotechnologies do not deserve a specific regulatory framework (even to cover ethical aspects). According to COMEST:
[N]anotechnologies should be regarded not as asui generis area calling for development of anad hocethical framework, but rather as one set of issues to which a general ethical framework to guide scientific activity needs to apply. Con- versely, science ethic principles developed to address spe- cific features of nanotechnologies should be considered as prima facie applicable to other areas with similar back- ground features.37
This strong position shows signs of fragmentation withinUNESCO when it comes to developing an appro- priate framework for dealing with nanotechnologies;
different organs and bodies within the same organiza- tion do not seem to have the same agenda. The approach is thus not always consistent, constant and coherent. Given the specificities of nanotechnologies and the uncertainties associated with them, it seems more adequate to design a special policy and regulatory framework for nanotechnologies and not to treat them as any other new technology. Besides the ‘declaration’
type of framework, UNESCO could encourage COMEST to adopt a ‘Framework of Ethical Principles and Responsibilities’ such as the one it formulated in the area of climate change adaptation.38This would better reflect the initial approach of COMEST, which at one point went as far as recommending the creation of an International Commission for Nanotechnologies and Ethics within UNESCO.39
INTERNATIONAL ORGANIZATIONS AS ‘RISK REGULATORS’: THE INTERNATIONAL LABOUR ORGANIZATION (ILO)
ILO activities in the field of nanotechnologies started in March 2005 when its governing body decided to hold a meeting of experts ‘to examine instruments, knowl-
edge, advocacy, technical cooperation and international collaboration as tools with a view to developing a Policy Framework for hazardous substances’.40The aim of the meeting of experts was to determine how ILO instru- ments and other tools concerning occupational safety and health and hazardous substances could be har- nessed into a new policy framework and action plan.
The ILO prepared a background information paper as a basis for the meeting of experts in order to facilitate the adoption of a ‘policy framework for hazardous substances’.41 By contrast, the recent approach of COMEST, which suggested not according special regu- latory treatment to nanotechnology, the background paper stressed ‘the special case of nanomaterials’42 and thereby acknowledged the need to address nanotechnologies in any policy or regulatory frame- work that would be covered by the ILO or by other international organizations.
Like the WHO, FAO and UNESCO, the ILO also sub- scribes to the precautionary approach in the field of nanotechnologies. The background paper implicitly highlighted the importance of the precautionary approach when referring to the ‘still insufficient data to characterize the health and environmental effects asso- ciated with exposure to such [nano]materials’,43 and when urging the attainment of ‘a deeper understanding of the biological responses and toxicity of a selected set of nanomaterials, in order to build an adequate knowl- edge base for the development of validated and harmo- nized testing methods and exposure management tools’.44Finally, as in the case of the WHO and FAO, the background paper viewed the role of the ILO as limited to the monitoring and the follow-up of national and international activities related to safety in the applica- tion of nanotechnologies.
The final report of the meeting of experts touches upon several aspects of the international regulation of nanotechnologies by international organizations. The examples of the WHO, FAO and UNESCO show that most international organizations are still undecided on the appropriate legal framework to regulate nanotechnologies, and still have doubts about the use- fulness of crafting universal legal instruments to deal with nanotechnologies. Against this background, it is surprising that during the meeting of experts debate
36COMEST,Summary Report on Decisions, Adopted at the 2012 Extraordinary Session, Paris, France 2–4 July 2012 (2012), found at: <http://unesdoc.unesco.org/images/0021/002197/219791e.pdf>, at 7.
37COMEST,Ethical Issues, n. 34 above, at 25.
38The Framework of Ethical Principles and Responsibilities for Climate Change Adaptation can be found in: COMEST, 2011 Summary Report, n. 35 above, at 9–10.
39COMEST,Nanotechnologies and Ethics: Policies and Actions – COMEST Policy Recommendations (UNESCO, 2007), found at:
<http://unesdoc.unesco.org/images/0015/001521/152146e.pdf>, at 7: ‘Recognizing that nanotechnologies are developing at a very fast pace, UNESCO should establish an International Commission for Nanotechnologies and Ethics to continuously monitor and respond in a timely manner to emerging and evolving ethical issues in this field.’
40International Labour Office (ILO), Governing Body,Report of the Committee on Sectoral and Technical Meetings and Related Issues (March 2005), found at:<http://www.ilo.org/public/english/standards/
relm/gb/docs/gb292/pdf/gb-13.pdf>, at 8.
41ILO,Background Information for Developing an ILO Policy Frame- work for Hazardous Substances(ILO, 2007), found at:<http://www .ilo.org/wcmsp5/groups/public/—ed_dialogue/—sector/documents/
42Ibid., at 11.
43Ibid., at 13.
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arose regarding the adequate legal framework to address nanotechnology. For instance, the spokesper- son for the worker experts underlined that nanotech- nology should be the subject of a new and specific ILO instrument.45The government expert from India opted for another approach and suggested ‘updating and revising [ILO] Conventions Nos 170 and 174 to take account of technological developments, for example, nanotechnology’.46
Despite the tergiversations, the ILO might play the role of ‘risk regulator’ in the field of nanotechnologies through the adoption of legally binding instruments.
Indeed, the recommendations of the meeting of experts mention the possibility of adopting ‘global framework agreements’47to tackle and manage risks deriving from new technologies, including nanotechnologies.
Without doubt, it is in the context of its role as a ‘risk regulator’ that the ILO prepared a new report in 2010 on ‘emerging risks and new patterns of prevention in a changing world of work’, in which it advocated implic- itly – as in the case of the WHO and the FAO – the adoption of a precautionary approach in relation to nanotechnology. The report points out that nanotech- nology ‘is an emerging technology and the risks associ- ated with the manufacturing and uses of nanomaterials are largely unknown’48 and that ‘little is known about the health and environmental impact of these new materials’.49 Nevertheless, one might be surprised by the reluctance of international organizations such as the ILO to refer explicitly to the precautionary
‘approach’ or ‘principle’. The precautionary principle is crystallizing as a norm of customary international law and, as a consequence, should be implemented by inter- national organizations when dealing with unknown risks as those associated with nanomaterials. Yet, certain international organizations prefer to use more cautious language and avoid acknowledging that they apply a precautionary approach.
The ILO’s report is illustrative of this trend. It refers to
‘new patterns of prevention’50to designate precaution- ary measures. The report makes a distinction between
‘traditional prevention and control tools’ which apply to
‘well known hazards and risks’51and ‘new patterns of prevention’ that are ‘strategies and tools designed to
anticipate, identify, evaluate and control emerging risks’52 arising from innovative technologies such as nanotechnologies. Those strategies and tools designed to ‘anticipate’ emerging risks (i.e., unknown risks) are necessarily linked to a precautionary approach and not to a preventive approach per se. Like Mr Jourdain, international organizations have been ‘speaking prose without knowing anything about it’.53There is thus a need for international organizations to adopt a seman- tic shift when dealing with nanotechnologies. Preven- tion is not adequate to address the peculiar risks deriving from nanotechnologies. Precaution should be the guiding principle. Its policy and legal implications are different from those of the principle of prevention54 and are more suitable for addressing scientific uncer- tainty in the context of nanotechnologies.
INTERNATIONAL ORGANIZATIONS AS ‘INTERCONNECTORS’: THE ORGANISATION FOR ECONOMIC CO-OPERATION AND
The OECD is a key player in the development of an international regulatory framework for nanotechnol- ogy. It launched its activities on nanotechnology in June 2005 when the OECD Chemicals Committee held a ‘Special Session on the Potential Implications of Manufactured Nanomaterials for Human Health and Environmental Safety’. A year later, the OECD Working Party on Manufactured Nanomaterials (WPMN) was established as a subsidiary body of the Chemicals Com- mittee. It aims to ensure that the approach to hazard, exposure and risk assessment is of a high, science- based and internationally harmonized standard. The WPMN comprises delegates from ministries and agen- cies that are responsible for the safety of human health and the environment. The mandate of the WPMN is to
‘promote international co-operation in health and envi- ronmental safety related aspects of manufactured nanomaterials . . ., in order to assist in the safe devel- opment of manufactured nanomaterials, while avoiding non-tariff barriers to trade’.55 In this context, three broad areas have been covered by the WPMN: identifi- cation, characterization, definitions, terminology and
45ILO, Final Report, Meeting of Experts to Examine Instruments, Knowledge, Advocacy, Technical Cooperation and International Col- laboration as Tools with a View to Developing a Policy Framework for Hazardous Substances, Geneva, 10–13 December 2007(ILO, 2008), at 13.
46Ibid., at 14.
47Ibid., at 25.
48ILO,Emerging Risks and New Patterns of Prevention in a Chang- ing World of Work(ILO, 2010), found at:<http://www.ilo.org/public/
portugue/region/eurpro/lisbon/pdf/28abril_10_en.pdf>, at 3.
49Ibid., at 3.
50Ibid., at 13.
51Ibid. (emphasis added).
52Ibid. (emphases added).
53Molière,The Middle Class Gentleman(trans. Ph. Dwight Jones), found at: <http://www.fullbooks.com/The-Middle-Class-Gentleman- Le-Bourgeois1.html>.
54On the difference between prevention and precaution, see M.M.
Mbengue, L’Anticipation du Risque Environnemental et Sanitaire.
Essai sur une Théorie du Risque en Droit International Public (Pedone, 2009), at 157. See also, A. Trouwborst, ‘The Relationship between the Precautionary Principle and the Preventative Principle in International Law and Associated Questions’, 2:2 Erasmus Law Review(2009), 105.
55Organisation for Economic Co-operation and Development (OECD),Manufactured Nanomaterials: Work Programme 2006–2008
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standards; testing methods and risk assessment; and information sharing, cooperation and dissemination.56 In addition to the WPMN, the OECD Committee for Science and Technology Policy established in 2007 a body to deal specifically with issues related to nano- technology – the Working Party on Nanotechnology (WPN). The objective of the WPN is to advise on rel- evant emerging policy issues in science, technology and innovation related to the responsible development and use of nanotechnology.57It also seeks to promote inter- national cooperation that facilitates research, develop- ment, and the responsible commercialization and utilization of nanotechnology.
In its ‘vision statement’, the WPN perceives nanotech- nology as a factor that could contribute to sustainable development. The ‘vision statement’ underlines that:
Nanotechnology is likely to offer a wide range of benefits, including helping to address a range of societal and environ- mental challenges,e.g.in providing renewable energy and clean water, in improving health and longevity, as well as in addressing issues relating to the environment.58
This is sustainable development at its best. Surprisingly enough, however, the WPN does not refer explicitly to the ‘concept’59 or ‘objective’60 of sustainable develop- ment when addressing the potential of nanotechnology.
The OECD seems to be hesitant to integrate the inter- national discourses on sustainable development or on environmental governance in its work in the area of nanotechnologies. Like other international organiza- tions that are reluctant to make an explicit reference to the precautionary approach when dealing with nanotechnologies, the OECD opts for semantic pru- dence in a context where major uncertainties on the risks and benefits associated with nanotechnology still prevail.
Notwithstanding this semantic prudence, the OECD’s WPN is perhaps one of the key international bodies that has sought to link nanotechnologies to fundamental issues of sustainable development. That is why the OECD can be described as an ‘interconnector’ in the area of nanotechnologies. For instance, the WPN has developed work on the potential impact of nanotech-
nology on better and more affordable access to water.61 Such an activity can contribute to the realization of the human right to water at the international level. In the same vein, the WPN has also dealt with the impact of nanotechnologies on food and medical products.62 These activities can lead to a better implementation of the right to health as well as the right to food at the international level. The WPN went as far as promoting public participation – albeit without mentioning Prin- ciple 10 of the 1992 Rio Declaration on Environment and Development63– and adopted an informal instru- ment in this regard: the ‘Planning Guide for Public Engagement and Outreach in Nanotechnology’,64which encompasses eight key points to assist policy makers in establishing activities for communication and outreach in nanotechnology.65
Similar to the WHO, FAO and UNESCO, the OECD has followed up on the regulatory strategies developed by OECD member States in the field of nanotechnologies.
Several reports of both the WPMN and the WPN provide an inventory of regulatory approaches, legisla- tive regimes and government-sponsored scientific research. These follow-up activities can help to identify the current state of existing regulations on nanotech- nology issues, determine best and worst practices, and show commonalities and differences between the regu- latory approaches of different countries. This might constitute a significant basis for formulating interna- tional standards in the area of the regulation of nanotechnologies.
The OECD has been ‘working closely’66with other inter- national organizations. Nevertheless, this cooperation
(OECD, 2008), found at: <http://search.oecd.org/officialdocuments/
displaydocumentpdf/?doclanguage=en&cote=env/jm/mono(2008)2>, at 9.
56J.A. Shatkin,Nanotechnology: Health and Environmental Risks, 2nd edn (CRC Press, 2013), at 243.
57OECD Working Party on Nanotechnology (WPN), Vision Statement, found at: <http://www.oecd.org/sti/nano/oecdworking partyonnanotechnologywpnvisionstatement.htm>, at paragraph 3.
58Ibid., at paragraph 2.
59ICJ 25 September 1997,Gabcˇíkovo-Nagymaros Project(Hungary v. Slovakia),  ICJ Rep 7, at paragraph 140.
60ICJ 20 April 2010,Pulp Mills on the River Uruguay(Argentina v.
Uruguay),  ICJ Rep 14, at paragraph 177.
61OECD,Fostering Nanotechnology to Address Global Challenges:
Water (OECD, 2011), at 14. The report emphasizes the linkage between nanotechnology and the human right to water. For instance, it states: ‘In March 2008, the UN Human Rights Council adopted a resolution establishing an Independent Expert on the human right to water and sanitation, a mechanism exclusively dedicated to issues related to the right to safe drinking water and sanitation. The resolu- tion also confirms that governments have obligations to ensure access to safe drinking water and sanitation under international human rights law.’ Ibid.
62OECD,Regulatory Frameworks for Nanotechnology in Foods and Medical Products(OECD, 2013).
63Rio Declaration on Environment and Development, in Report of the UN Conference on Environment and Development (UN Doc.
A/CONF.151/26/Rev. 1 (Vol. I), 14 June 1992), Annex, Principle 10.
64OECD,Planning Guide for Public Engagement and Outreach in Nanotechnology(OECD, 2012), at 5. The WPN justifies the formula- tion of a Planning Guide as follows: ‘[S]trategies for outreach and public engagement in nanotechnology have been identified as impor- tant elements of government policies regarding nanotechnology. The need to clarify how to communicate, with whom, and how to engage a wide audience in the debate on nanotechnology, and the develop- ment of policies related to it, has been a major point of discussion amongst policy makers.’ Ibid., at 3.
65Ibid., at 12–15.
66OECD,Current Developments in Delegations and other Interna- tional Organizations on the Safety of Manufactured Nanomaterials – Tour de Table(OECD, 2013), at 91.
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does not necessarily ensure ‘coordination’ between the various international organizations involved in the field of nanotechnologies. The approach of the OECD has so far been to report on the nanotechnology-related actions taken by other international organizations. For instance, it has been reporting on the activities by the North Atlantic Treaty Organization, whose work in the area of nanotechnology is not widely known.
Interestingly, the OECD has been keen to pursue genuine coordination with the International Standard- ization Organization (ISO) – a nongovernmental inter- national institution – rather than with other intergovernmental organizations. One OECD report indicates that:
[C]lose co-ordination with the [ISO] has been established since the beginning of the WPMN. To illustrate the co-ordination, a ‘co-ordination paper’ was jointly prepared by the OECD Secretariat and the Chair of the Technical Committee 229 of ISO.67
The same report also explains that it ‘has been recognised by participants of both bodies [OECD and ISO] that there is a need for co-ordination to avoid duplication and take advantage of potential synergies’.68
This rationale of synergies should also govern the actions of international organizations with respect to nanotechnologies. As long as the activities of various international organizations remain fragmented, it will be difficult to develop an effective and comprehensive regulatory framework on nanotechnologies. Coordina- tion might – in the mid-term – allow for such a result.
But are international organizations ready for coordina- tion in terms of nanotechnology regulation? The next section will look into this question.
. . . TO COORDINATION OF
INTERNATIONAL ORGANIZATIONS IN THE FIELD OF
Looking at the nanotechnology-related activities of the five international organizations discussed above, it appears that they mostly carry out activities indepen- dently from each other. International organizations do not seem ready to take collective action as long as they do not truly succeed in grasping nanotechnology and in understanding the risks, benefits and uncertainties associated with the various nanotechnologies.
Moreover, apart from the EU, and to a very small extent the OECD, none of the existing international organiza-
tions is moving clearly and strongly in a regulatory direction, meaning that the impact of their work in terms of regulating nanotechnologies is still relatively small. The fragmentation of activities prevents the design of a universal and comprehensive regulatory framework on nanotechnologies. Such a universal and comprehensive framework could contribute to reducing the legal uncertainties that derive from increasing and diverging domestic regulations, to formulate rules and principles on risk assessment and risk management in the field of nanotechnologies, and most notably to prevent discrimination in international trade. Real efforts to foster coordination between international organizations in relation to nanotechnologies might lead to the adoption of such a universal framework or at least to the formulation of common guidelines and principles by international organizations.
Two types of coordination can be distinguished: formal and informal coordination. Formal coordination refers to a type of coordination of a purely intergovernmental or inter-organizational (in the sense of international organizations) character. Informal coordination involves States, international organizations and non- State actors. Informal coordination depends on institu- tions that often do not adhere to the classical model of international organizations, and is rather based on public–private partnerships.
THE INTERORGANIZATION PROGRAMME FOR THE SOUND MANAGEMENT OF CHEMICALS (IOMC)
The work of the IOMC illustrates a trend towards increasing coordination. The objective of the ‘Memo- randum of Understanding concerning Establishment of the IOMC’69 is to put in place guiding rules and prin- ciples for the cooperation and coordination of the activities of the participant organizations (POs) in the IOMC. These POs are the FAO, the ILO, UNEP, the United Nations Industrial Development Organization (UNIDO), the United Nations Institute for Training And Research (UNITAR)70, the WHO, the World Bank71 and the OECD. The United Nations Development Pro- gramme (UNDP) is participating as an observer orga- nization. Other international organizations can become POs in the IOMC subject to the unanimous consent of the current POs.72
67Ibid., at 91–92.
68Ibid., at 92.
69Memorandum of Understanding concerning Establishment of the IOMC, found at: <http://www.who.int/iomc/participants/iomc-mou .pdf>.
70UNITAR joined the IOMC in 1997.
71The World Bank joined the IOMC in 2010.
72Memorandum of Understanding concerning Establishment of the IOMC, n. 69 above, Article 1.3.
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Albeit recognizing the possibility for each of the POs to act separately, the IOMC gives a particular weight to coordination. The memorandum of understanding establishing the IOMC states that:
The purpose of the Programme is topromote coordination of the policies and activities pursued by the Participating Organizations,jointly and separately, to achieve the sound management of chemicals in relation to human health and the environment.73
The WHO is the administering organization for the IOMC and provides secretariat services to the Inter- organization Coordinating Committee (IOCC), which is the main decision-making body of the IOMC. As its name suggests, the IOCC aims mainly at increasing coordination in the field of chemical safety. Several functions of the IOCC allow it to ensure coordination.
For instance, the IOCC can make ‘recommendations on thedistribution of workamong the Participating Orga- nizations with regard to the sound management of chemicals’74, ‘recommend common policies to be pursued by the Participating Organizations’75 and
‘encourage the Participating Organizations to under- take joint programmesfor the sound management of chemicals’.76
The involvement of the IOMC in the area of nanotechnologies is mainly through its link with the SAICM. The IOMC was a co-convenor, together with UNEP and the Intergovernmental Forum on Chemical Safety (IFCS), of the first International Conference on Chemical Safety (ICCM) held in Dubai (United Arab Emirates) in 2006 that finalized and endorsed the SAICM. Because of this inherent link between the IOMC and the SAICM, the IOMC has been actively involved in the implementation and monitoring of some of the SAICM ‘emerging policy issues’ that were defined during the second session of ICCM (ICCM2). In particular, there was a call for appropriate international action in relation to nanotechnologies.77
In this context, the IOMC has advocated for enhanced coordination among international organizations. For instance, the ‘Joint Statement by the Executive Heads of Agencies Cooperating in the IOMC’78is a real hymn to coordination:
We, the organizations cooperating in the Inter-Organization Programme for the Sound Management of Chemicals (IOMC), affirm our commitment to work together to strengthen the sound management of chemicals and to con- tribute to the achievement of SAICM within our mandates and in accordance with decisions of our governing bodies.
Together, we renew our commitmentto promote coordina- tion of policies and activities, pursued jointly or separately, in order to achieve the sound management of chemicals. We will cooperate to ensure the most effective use of our human, technical and financial resources and will further exploit the synergies between our organizations and other organizations.79
This is a great move towards coordination. Yet, it remains to be seen whether the organizations can realize these objectives. Instances of formal coordina- tion remain rare in the international institutional system when it comes to nanotechnologies. One example of strong formal coordination that is quite often referred to is the cooperation between UNITAR and OECD, within the framework of the IOMC, to raise awareness in countries about nanotechnology and manufactured nanomaterials, including the implica- tions for developing and transition countries ‘as nano- based or nano-containing products are traded across borders’.80
The IOMC is an adequate international platform for fostering effective and efficient coordination between international organizations in the field of nanotechnologies. However, it is also the victim of an international agenda that is characterized by uncertainty and inconsistency in the field of nanotechnologies. This inconsistency becomes clear, for example, when considering that only UNITAR – which is a UN programme and not an international organizationper se– and the OECD are truly engaged with coordination and have fully committed to imple- ment the SAICM, and hence also the SAICM’s acti- vities related to emerging policy issues such as nanotechnologies and nanomaterials. Indeed, the board of trustees of UNITAR officially endorsed the SAICM in April 2006, while the OECD Council adopted a resolution in 2008 making the implementation of SAICM objectives an integral part of the OECD chemi- cals programme.81 The other POs to the IOMC are rather absent and can be said to be still searching for a nanotechnology-related identity. The 2012 SAICM progress report on nanotechnologies and manufactured nanomaterials points out that the FAO and the WHO
‘[continue] to keep abreast of developments in the nanotechnology area relevant to food safety with a view to further defining the roles of their organizations in
73Ibid., Article 2.2 (emphases added).
74Ibid., Article 5.1(c) (emphasis added).
75Ibid., Article 5.1(d) (emphasis added).
76Ibid., Article 5.1(e) (emphasis added).
77See Resolution II/4 on Emerging Policy Issues, in: Report of the International Conference on Chemicals Management on the Work of Its Second Session, Geneva, 11–15 May 2009 (UN Doc. SAICM/
ICCM.2/15, 27 May 2009), at 37.
78Participation in the Implementation of the Strategic Approach to International Chemicals Management, Joint Statement by the Executive Heads of Agencies Cooperating in the Inter-organization Programme for the Sound Management of Chemicals, Dubai (Feb- ruary 2006) found at: <http://www.who.int/iomc/IOMC_SAICM _Statement_FINAL_IOMC_website.pdf>.
79Ibid., at 1 (emphases added).
80UNITAR, Nanotechnologies and Manufactured Nanomaterials, found at:<http://www.unitar.org/cwm/nano>.
81Progress Report on Nanotechnologies and Manufactured Nanomaterials, Note by the Secretariat (UN Doc. SAICM/ICCM.3/17, 21 June 2012), at paragraph 1.
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