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Decision Support for International Agreements Regulating Nanomaterials

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Abstract

Nanomaterials are handled in global value chains for many different products, albeit not always recognisable as nanoproducts. The global market for nanomaterials faces an uncertain future, as the international dialogue on regulating nanomaterials is still ongoing and risk assessment data are being collected. At the same time, regulators and civil society organisations complain about a lack of transparency about the presence of nanomaterials on the market. In the project on Sustainable Nanotechnologies (SUN, www.sun-fp7.eu ), a Decision Support System (SUNDS) has been developed, primarily for confidential use by risk and sustainability managers inside a company or consortium. In this article, we formulate a scenario concerning a potential role for an open access decision support system in negotiations on international agreements regulating trade in nanomaterials. The scenario includes design rules for decision support systems as well as procedures for use of such a system in stakeholder dialogue and policy-making on governance of these and other emerging technologies. This article incorporates analysis of results of stakeholder engagement on nanomaterials as well as literature and internet sources suggested by these stakeholders.

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Notes

  1. http://sunds.dais.unive.it

  2. http://cordis.europa.eu/project/rcn/105226_en.html

  3. https://echa.europa.eu/regulations/reach

  4. http://www.stage-gate.com/resources_stage-gate.php

  5. This was confirmed by several stakeholders participating in the questionnaire and workshops held during the SUN project.

  6. Objective stated at http://cordis.europa.eu/project/rcn/89673_en.html

  7. http://cordis.europa.eu/project/rcn/87963_en.html

  8. http://ec.europa.eu/growth/tools-databases/newsroom/cf/itemdetail.cfm?item_id=9023&lang=en&tpa_id=0

  9. http://ec.europa.eu/research/industrial_technologies/the-policy_en.html

  10. www.nanosafetycluster.eu

  11. The SIA was conducted between September 2014 and April 2016.

  12. http://www.enanomapper.net/

  13. http://www.nanoreg2.eu/

  14. http://www.nanocalibrate.eu/home

  15. Deciding who is qualified to be an expert, and on which aspect, is not straightforward, given the current discussion on the formation and roles of epistemic communities in evidence based decision making [18, 23, 24].

  16. The Business and Industry Advisory Committee to the OECD, http://biac.org/

  17. The Trade Union Advisory Committee to the OECD, http://www.tuac.org/en/public/index.phtml

  18. https://www.corporatebenchmark.org/

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Acknowledgements

We gratefully acknowledge the contributions of the participants during the stakeholder workshop analysed here, and constructive comments by three anonymous reviewers.

Author information

Authors and Affiliations

  1. Malsch TechnoValuation, PO Box 455, 3500 AL, Utrecht, The Netherlands

    Ineke Malsch

  2. Department of Accounting and Finance, Kemmy Business School, University of Limerick, Limerick, Ireland

    Martin Mullins

  3. Department of Environmental Sciences, Informatics and Statistics, Ca’ Foscari University of Venice, via Torino 155, 30172, Mestre-Venezia, Italy

    Elena Semenzin, Alex Zabeo, Danail Hristozov & Antonio Marcomini

Authors
  1. Ineke Malsch
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  2. Martin Mullins
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  3. Elena Semenzin
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  4. Alex Zabeo
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  5. Danail Hristozov
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  6. Antonio Marcomini
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Corresponding author

Correspondence to Ineke Malsch.

Ethics declarations

Conflicts of Interest

The research leading to these results has received funding from the European Union Seventh Framework Programme [FP7/2007–2013] under EC-GA No. 604305 ‘SUN’. This publication reflects the views only of the authors, and the European Commission cannot be held responsible for any use, which may be made of the information contained therein.

Human Participants and/or Animals, and Informed Consent

The research has not involved animals. The participants in the workshop have been asked to give their informed consent to publication of results in anonymised form, and have been given the chance to comment on the draft summary report in the annex before publication.

Appendices

Annex 1: SUN Stakeholder Workshop 3 – Summary Report

Location and date: Heriot Watt University, Edinburgh, 6 October 2016, 9.00-13.30.

Summary

The aim of the workshop was to generate ideas for potential future uses of the SUNDS DSS. The first version of this tool has been developed in the SUN project, and it will be further developed in the subsequent project CALIBRATE. The following issues were discussed:

  • There is a risk of misinterpretation and bias in case of public use of output. The SUNDS tool consists of a screening level self-assessment tool and a more data-rich tier 2. The quality of the output depends on the quality of the data, which the company or other user inserts. The output cannot be taken at face value by non-experts such as SME owners or politicians, but needs expert interpretation. This introduces a risk that the output of the tool could be biased and misinterpreted by decision-makers.

  • The lack of good quality data and common definitions are more pressing needs than the lack of decision support tools. Several initiatives are underway to develop ontologies, uniform descriptions, nomenclature and definitions in EU funded projects, at the OECD, ISO and other platforms.

  • SUNDS may support in-company teams of experts compiling a REACH dossier. The current design of the tool can be installed by companies in their intranet. Different users can be created who can insert risk assessment experimental results and other data. Similarly, use in an industrial consortium collaborating in data generation may also be possible. Confidentiality and proprietary data issues are barriers preventing more open access applications.

  • Primary insurance companies might be interested to use such a tool, but only to facilitate data collection, not as an expert system. Reinsurance companies would not be interested, as their market is based on differences in risk appetite. Standardisation would eliminate this market. Companies applying for insurance policies could perhaps be offered a discount if they use the tool in generating their risk assessment.

  • In CALIBRATE, a viable business model for exploitation of the tool should be developed, through embedding in appropriate partnerships. On a practical level, services and consultancy fees could be charged to make the tool self-sustainable. On a more strategic level, the tool should be embedded in the right partnerships. Cooperation with ECHA is needed to make the tool useful for SMEs interested in compliance with REACH. For policy-makers, a tool could be useful that supports sustainability impact assessments for international trade agreements.

  • The use of SUNDS could create uncertain judgments in court. For some judges, evidence that a company had used the tool and toggled its risk appetite could be taken as an indicator that the company was aware of the risk. For others, it might be considered an indicator that the company was taking a precautionary approach.

  • How could the design of the SUNDS tool be adapted to accommodate differences in regulatory systems?

  • An additional module could be envisaged that includes a taxonomy of regulatory regimes. This could be useful for supporting joint regulatory risk assessment, for example

    • high and low cost legal systems,

    • open and closed legal systems and

    • strict and low liability system.

  • A common ‘nanoconstitution’ could be envisaged, offering a framework for more specific rules that can be applied to specific nanotechnologies. This could go beyond traditional risk assessment. Such a framework has been developed in the EU funded FramingNano project.

  • A business ethics tool could be useful. It could incorporate a function warning if you are breaking current regulations in any country. Regulatory geography along the supply chain of a product could also be included to warn for non-tariff trade barriers.

  • Could the tool support traceability-by-design of nanoproducts? This might be more easy for end products such as pharmaceuticals and food, than for nanomaterials and chemicals.

  • Viability of a wiki-tool supporting public dialogue on nanorisk governance

  • Confidentiality of data generated by companies is a key bottleneck preventing an open access version of the decision support tool for nano. This data is needed for risk governance and regulation, but companies have valid reasons not to make this data public. However, there are ways to disclose at least some data that are already used.

  • However, an open wiki-like tool could support trust-building in nanotechnology among citizens. This could be primarily in the interest of industry. Current barriers preventing participation of CSOs in risk governance are primarily economic, not legal. Differences in business cultures also influence their willingness to take responsibility for risk governance.

  • Politicians will not use tools, but they may listen to experts who could use the tools.

  • Participants with different backgrounds revealed different evaluations of risks and benefits and different tolerance to uncertainty.

Participants list

 

Dr Francoise Roure

Ministry Economy & Finance, France

Dr Igor Linkov

US Army Corps of Engineers, USA

Dr Florian David-Spickermann

University of Limerick, Ireland and SCOR Reinsurance, Germany

Dr David Carlander

Nanotech Industry Association, Belgium

Prof Dr Martin Mullins

University of Limerick, Ireland

Dr Elena Semenzin

Ca’Foscari University Venice, Italy

Dr Alex Zabeo

Ca’Foscari University Venice, Italy

Ms Stella Stoycheva

Ca’Foscari University Venice, Italy

Dr Ineke Malsch

Malsch TechnoValuation, The Netherlands

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Malsch, I., Mullins, M., Semenzin, E. et al. Decision Support for International Agreements Regulating Nanomaterials. Nanoethics 12, 39–54 (2018). https://doi.org/10.1007/s11569-018-0312-2

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