CRISPR-based gene drives

Precaution for Responsible Innovation: New Options to Move Forward

chiara.mazzetti@ecologic.eu — Thu, 20 Jan 2022 10:32:52 +0000

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Precaution for Responsible Innovation: New Options to Move Forward

RECIPES Dissemination Conference

On May 11, the RECIPES project has held its dissemination conference “Precaution for Responsible Innovation: New Options to Move Forward”.

At the conference, the RECIPES project presented and discussed some of the ideas on how to improve the use of the precautionary principle that were developed in consultation with several stakeholders at various points during the project period (the RECIPES guidance). The conference brought together around 90 participants from a range of different actor groups including several of those who had participated in one or more of the RECIPES workshops. The conference was carried out in hybrid format, so the participants joined it onsite or online.

Several of the speakers and panellists stressed that the topicality of the precautionary principle has increased in the past, e.g., due to the increasing transgression of planetary boundaries. They considered the principle to be even more important in the future. They appreciated that the RECIPES guidance reconfirms the importance of the precautionary principle and reinstates its innovative potential, especially by stressing its dual role as a legal principle and safeguard and as a policy principle and compass. They identified the RECIPES guidance as a timely document.

It was emphasised that the use of the precautionary principle requires political discussions at all levels (local, regional, national, EU, global). These would need to open up complex issues to the wider public, involve the knowledge and perspectives of a wide diversity of actors, and deal with (uncertain) risks as well as (uncertain) benefits, and address questions such as “(uncertain) risks and potentially serious harm for whom?” and “(uncertain) benefits for whom?” and “what are sustainable and public-interest-oriented pathways out of interlinked multiple crises such as climate change and loss of biodiversity?”.

It was highlighted that recent reports by IPBES, IPCC and UNEP, CBD and WHO on biodiversity, climate change and environment, agree that solutions for these wicked challenges of a systemic nature, characterized by uncertainty, complexity, and ambiguities, can only be achieved by systemic, multidimensional, cross-sectoral, interdisciplinary, transdisciplinary and participative approaches. The benefit of the precautionary principle would be that it enables solutions for (uncertain) risks in a systemic way that not simply shifts responsibility to the individual level.

For more information, you can find the programme of the conference HERE and the presentations held at the conference below. Moreover, you can find statements by some panellists below (the panellists were not asked to provide a written statement but some have made it available to the RECIPES team).

Welcome note by the coordinator: Guidance for the future use of the precautionary principle, Ellen Vos & Kristel de Smedt (University of Maastricht)
The RECIPES engagement approach: Reaching out to society and policy for developing the guidance - Aske Palsberg & Niels-Kristian Tjelle Holm (The Danish Board of Technology Foundation)
Discussion input no. 1 from the RECIPES guidance: The precautionary principle works best in a double role: safeguard and compass - Tijs Sikma (Rathenau Institute)
Discussion input no. 2 from the RECIPES guidance: The precautionary principle is a knowledge and participation issue - Jeroen van der Sluijs (University of Bergen) and Pia-Johanna Schweizer (Institute for Advanced Sustainability Studies)
Intervention by Christine von Weizsäcker
Intervention by Carolina Vigo

In the videos below Christine von Weizsächer and Nina Holland, RECIPES Advisory Board Members, offer their perspectives on the RECIPES project, during the final conference held in May 2022:

Organiser

Dialogik, DBT, IASS, UM, Ecologic Institute with support from KNAW, UiB, K&I and ARC

Contact

Dr. Marion Dreyer, Dialogik

Email: dreyer@dialogik-expert.de

Themes

Artificial Intelligence in healthcare, CRISPR-based gene drives, Endocrine disruptors, Environment, Financial risks and urban waste planning, Genetically Modified Organisms (GMO’s), Glyphosate, Health, Innovation, Microplastics, Nanotechnologies, Neonicotinoid insecticides, Precaution, Regulation, Safety, Science

Interesting for

Policy Makers, Regulatory Authorities & Agencies, Research & Academia, Industry & Business, Funding Sources & Finance, NGOs & Associations, Citizens & Civil Society Organisations

RECIPES Event

Event Date

11 May 2022

Location

Hybrid Format: Online & Brussels

Language

English

European Policy Workshop: “Precaution for responsible innovation”

chiara.mazzetti@ecologic.eu — Thu, 04 Nov 2021 18:26:38 +0000

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European Policy Workshop: “Precaution for responsible innovation”

On February 22 and 23, the RECIPES project will organize the European Policy Workshop: “Precaution for responsible innovation”.

The workshop aims to review the pre-final version of the RECIPES guidance on how to ensure the PP’s ability to drive responsible innovation. It will take place online and will address, as main target groups, EU policy makers, European agencies, EU policy support organizations and bodies and similar experts.

Participants will have the chance to discuss a pre-final version of the RECIPES guidance (Sent in advance to registered guests). A series of Break-out sessions taking place on both days will allow participants to discuss the guidance to further improve its clarity, plausibility, policy relevance and future-orientation, as well as to brainstorm on the exploitation of the document.

For more information, you can find the programme of the Workshop HERE.

The workshop will be moderated by the RECIPES partners.

Organiser

Dialogik, DBT, IASS with support from UM, KNAW, UiB, K&A and ARC

Contact

Frank Dratsdrummer, Doalogik

Email: dratsdrummer@dialogik-expert.de

Themes

Artificial Intelligence in healthcare, CRISPR-based gene drives, Endocrine disruptors, Environment, Financial risks and urban waste planning, Genetically Modified Organisms (GMO’s), Glyphosate, Governance, Health, Innovation, Microplastics, Nanotechnologies, Neonicotinoid insecticides, Precaution, Regulation, Safety, Science

Interesting for

Policy Makers, Regulatory Authorities & Agencies, Research & Academia

RECIPES Event

Event Date

22 February 2022 - 23 February 2022

Location

Online

Language

English

Analysis of the case studies

chiara.mazzetti@ecologic.eu — Thu, 11 Mar 2021 10:02:10 +0000

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Analysis of the case studies

To fully understand the complexities and the controversies around the application of the precautionary principle, the RECIPES project conducted nine case studies. The aim was to understand and explain the potential differences in the application depending on the topic and the context. A comparison across the different cases indicates that the application of the precautionary principle had positive effects on innovation and contributed to more responsible pathways.

Back in 2019, the RECIPES project finalised the selection of the case studies and developed a conceptual framework focusing on the role of the case studies within the project as well as a methodological framework for the individual case study analyses.

An overview of all case studies can be found HERE, while the conceptual framework and the methodological framework can be found HERE.

Gender Analysis

The RECIPES project is committed to take gender aspects into account when conducting its research. To this end, a note has been developed to inform case study authors on how to reflect gender considerations in the different research steps. The note is available HERE.

Case Studies documentation

Over the course of 2020, the case study authors have engaged in research and drafting. They prepared a report, a factsheet and a short video for all nine cases:

Case study 1: CRISPR-based gene drives
Case study 2: Genetically modified organisms
Case study 3: Endocrine disruptors
Case study 4: Neonicotinoid insecticides
Case study 5: Nanotechnologies
Case study 6: Glyphosate
Case study 7: Financial risks in water infrastructure planning
Case study 8: The use of artificial intelligence in healthcare
Case study 9: Microplastics in food products and cosmetics

All case studies have been bundled in one report, which can be found HERE.

As a last step, the RECIPES project compared the different case studies and identified complexities and controversies surrounding the application of the precautionary principle in the different cases. The report, which combines the inter-case study analysis and the identification of cross-cutting issues is available HERE.

Lessons learnt

When comparing the nine case studies, the RECIPES project identified several lessons learnt in regard to the relevance of the precautionary principle, procedures for its application and effects of the precautionary principle. Lessons learnt include the following:

Relevance: It is necessary to take a broader array of potential consequences into account when developing a new technology and to openly communicate the limitations of scientific knowledge as well as of technological solutions.
Procedures: Although deliberative methods and procedures have proven valuable for public involvement, more guidance is needed on the scope of procedures and methods to acknowledge differences e.g. in the evidence base.
Effects: While the case studies indicated that there is a need to stimulate pathways for innovation, more empirical research is required to test the claim that the precautionary principle hinders innovations in the European Union.

The RECIPES project also compared the results of the case study analysis with the results of the stocktake of the precautionary principle conducted in 2019. The results of the stocktake can be found HERE. The comparison of results can be found HERE.

Authors

Please refer to the individual reports for the list of authors.

ISBN/ISSN/DOI

N/A

Themes

Interesting for

Policy Makers, Regulatory Authorities & Agencies, Research & Academia, Industry & Business, Funding Sources & Finance

Case Study

Report

Publishing Date

11 March 2021

Language

English

RECIPES e-Conference

chiara.mazzetti@ecologic.eu — Fri, 21 Aug 2020 13:37:37 +0000

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RECIPES e-Conference

On 4 and May 2020, the RECIPES e-Conference took place. During the first day, members of the Advisory Board provided feedback on the nine draft case studies on the precautionary principle and gave input to the scenarios on the future application of the precautionary principle that will be developed with stakeholders during workshops in June and September 2020. On the second day, the consortium discussed the cross-case comparison and prepared the scenario workshops.

Nearly one and a half years after the RECIPES project was kicked off in Maastricht, the Consortium convened virtually to look at interim results and discuss the next steps.

On the first day, the Advisory Board members were invited to provide feedback on the nine draft RECIPES case studies on the precautionary principle. In parallel sessions, the case study authors presented their preliminary findings and discussed remaining issues with the Advisory Board members as well as with Consortium members.

A more detailed overview of the case studies can be found here.

The first day was also used to receive feedback from the Advisory Board members on the draft scenarios prepared by the Consortium that will be discussed during scenario workshops in June and September 2020. The draft scenarios for the future application of the precautionary principle included the continuation of the current practice as a baseline and the focus on precaution or the focus on innovation as two possible directions.

During the second day, the Consortium reflected on the feedback received from the Advisory Board members and discussed the next steps, i.e. the finalization of the case studies, the cross-case comparison as well as the preparation of the scenario workshops.

An overview of the steps can be found here.

The RECIPES project is funded under the European Union's Horizon 2020 Programme for Research and Innovation and is implemented by 11 consortium partners from all geographical regions of Europe. Involved are three leading academic groups in the field of the precautionary principle (from Maastricht University, University of Bergen, and Humboldt-University Berlin), three major European players in Technology Assessment (Rathenau Institute, the Danish Board of Technology and the Austrian Academy of Sciences) and five leading non-profit research institutes (Dialogik, Ecologic Institute, IASS, ARC-FUND and K&I).

Organiser

IASS and Maastricht University

Contact

Prof. Dr. Ellen Vos and Dr. Kristel de Smedt
law-recipes@maastrichtuniversity.nl

Themes

CRISPR-based gene drives, Endocrine disruptors, Financial risks and urban waste planning, Genetically Modified Organisms (GMO’s), Glyphosate, Innovation, Nanotechnologies, Neonicotinoid insecticides, Precaution

Interesting for

Policy Makers, Regulatory Authorities & Agencies, Research & Academia, Funding Sources & Finance, NGOs & Associations

RECIPES Event

Event Date

4 May 2020 - 5 May 2020

Location

Online

Language

English

Case Study on CRISPR-based gene drives

chiara.mazzetti@ecologic.eu — Tue, 16 Jun 2020 11:32:36 +0000

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Case Study on CRISPR-based gene drives

About the case

Synthetic gene drives based on the CRISPR-cas9 genetic engineering method could be used to spread artificially modified genes through wild populations faster. The main promise of this technology is that it spreads itself: the gene drive is inherited by each next generation of offspring. This could make it possible to enhance, suppress or perhaps even eliminate a population. So far, CRISPR-cas9 based gene drives research has been limited to the lab, and has focused mainly on mosquito species that transmit malaria.

The Case Study factsheet can be downloaded HERE

The full Case Study can be downloaded HERE

A precautionary approach can lead to more responsible innovation when precaution and the interests of a broad group of stakeholders, including nature and future generations, are taken into account from the very start of the innovation process.

Brief summary of the case study

The precautionary principle is relevant to this case because the release of gene drives into the environment also gives rise to potential systemic risks. At the same time, experience with current methods of risk assessment offers little knowledge about how to assess the risks associated with gene drives. The past years have therefore witnessed a heated debate around how to govern a technology designed to actively spread itself in nature.

The main research aim of this case study is to understand the complexities and controversies around the possible application of the precautionary principle to CRISPR-cas9 based gene drives. The study focuses on the risk governance of gene drives at the EU level, while taking into account the broader international context.

A short video from the case study author

In this video, Dr. Rosanne Edelenbosch, researcher at the Rathenau Institute, gives a short introduction into the many uncertainties and complexities in the governance of gene drives. Is it possible to develop safe gene drives?

Partner: Rathenau Institute

Authors

Rosanne Edelenbosch, Rathenau Institute
Tijs Sikma, Rathenau Institute
Petra Verhoef, Rathenau Institute

Contributors
Jeroen van der Sluijs & Laura Drivdal, University of Bergen
Ventselav Kozarev & Zoya Damianova, ARC Fund
Kristel de Smedt, Maastricht University
Siebe Rozendal, IASS Potsdam
Michelle Habets, Rathenau Institute

With thanks to:

RECIPES advisory board members

Credits

Video recording: Dr. Rosanne Edelenbosch (Rathenau Institute)

Animation: Lena Aebli (Ecologic Institute)

Produced by Ecologic Institute 2020, www.ecologic.eu

Themes

CRISPR-based gene drives, Innovation

Interesting for

Policy Makers, Regulatory Authorities & Agencies, Research & Academia, Industry & Business

Case Study

Video

Publishing Date

21 October 2020

Language

English

Case Studies: Conceptual and methodological frameworks

chiara.mazzetti@ecologic.eu — Mon, 06 Jan 2020 14:52:58 +0000

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Case Studies: Conceptual and methodological frameworks

One of the RECIPES project’s aims is to understand and explain the differences in the application of the precautionary principle in 9 different case topics, in a way that reflects the particular context of the case and the arguments for invoking the precautionary principle.

In this video, Joe Rini, Research Associate at the IASS Potsdam and coordinator of the nine case studies, explains how the principle is applied in different contexts and thematic areas.

The Conceptual framework for comparative multiple case study analysis, part of the “Multiple case-study analysis” module, focuses on how the case study component fits into the overall RECIPES project, on the results of a literature review, on the case study methodology, and on the key risk properties of complexity, uncertainty, and ambiguity. Together with the case study methodology, this report lays the foundation for carrying out the case study research, as well as the comparative analysis of the 9 case studies and transitioning these findings into the rest of the RECIPES project.

The goal of the “Multiple case-study analysis” is to perform 9 case studies and a comparison of the different cases in order to develop scenarios on the future application of the precautionary principle. This will feed into the design of new tools and guidelines for the precautionary principle in respect of reconciling precaution and innovation.

Each case study topic consists of different technological risks, at different stages of development and deployment, and with completely different legal frameworks. As a result, the project team developed a flexible methodological framework that allows the research teams to learn as much as possible about the case topic using the appropriate and relevant sources. The comparative case analysis employs a number of strategies including pair-wise peer review, iterating the analysis against case study researchers, and remaining open to the best way to compare and contrast the cases.

In this project phase, researchers seek to link the precautionary principle and innovation considerations to the key risk properties of complexity, uncertainty, and ambiguity, which represent challenges for the understanding and the ability to communicate effectively about risk and innovation.

Complexity refers to the difficulty of identifying and quantifying causal links between a multitude of potential candidates and specific adverse effects. It includes the interplay of human agency within the context of regulation, innovation, legal decision-making, changing societal values, and vested interests, which result in higher-level complexity than the technological system alone.

Uncertainty is the key risk property in invoking the Precautionary Principle, as its purpose is to allow decision-makers to act despite scientific uncertainty (lack of knowledge about the outcomes or likelihoods, or both, of an event or process). In contrast, risk describes situations where possible outcomes are known, and the likelihoods of those outcomes can be described. Given the subjective complexity faced by decision-makers in the case study topics, the project highlights the functional uncertainty that emerges from highly complex technologies and societal processes.

Ambiguity refers to the fact that outcomes are potentially uncertain, and that different groups will value these outcomes differently. It is present in how scientists and risk specialists evaluate the same evidence, and in how outcomes as risks are evaluated. It implies the need to engage societal stakeholders in the discussion about the harms and benefits of technological innovations and other risks.

Part of this report also concentrates on innovation, as a crucial element for human and societal improvement, which must be regulated to prevent harm, thus leading to a complex interplay between regulation and innovation.

The Methodological framework for the case study analysis details the methodological framework for carrying out the case study research foreseen by the RECIPES project. The document serves both as a methodological framework – an explanation of what to consider in each section – and as a template for delivering the final analysis at the end of the case study research.

Authors

Dino Trescher

Credits

With thanks to: Project coordination by Maastricht University

Valuable input provided by the RECIPES research partners at Maastricht University, DBT, Rathenau Institute, and Humboldt University

Attachments

Conceptual Framework for comparative multiple case study analysis

Themes

CRISPR-based gene drives, Endocrine disruptors, Environment, Financial risks and urban waste planning, Genetically Modified Organisms (GMO’s), Glyphosate, Governance, Health, Nanotechnologies, Neonicotinoid insecticides, Precaution, Regulation, Safety, Science

Interesting for

Policy Makers, Research & Academia, Industry & Business

Case Study

Report

Publishing Date

6 January 2020

Language

English

Rathenau Institute meets the Norwegian Health Directorate and experts

chiara.mazzetti@ecologic.eu — Mon, 02 Dec 2019 18:20:25 +0000

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Rathenau Institute meets the Norwegian Health Directorate and experts

Presentation of the RECIPES project

On November 25, 2019, the Rathenau Institute welcomed the Norwegian Health Directorate and about 25 of their experts to The Hague. This meeting was set up to exchange ideas about cutting edge developments, ethical aspects and policymaking in the area of medical technology, biotechnology and digitalization of health care.

The Norwegian delegation consisted of members of the Health directorate and a group of expert advisors, with a background in medicine, genetics, ethics and law. The meeting proved to be an excellent opportunity for gaining further insight into stakeholder views on the precautionary principle.

Tijs Sikma and Rosanne Edelenbosch presented the RECIPES project, for which the Rathenau Institute is conducting two case studies. Tijs gave the Norwegians a general outline of the project and presented the conceptual core of the precautionary principle developed during work package 1 of. He also presented the results of the successful dialogue meeting with Dutch citizens on the precautionary principle. Rosanne discussed the Rathenau case on new gene-editing techniques. CRISPR-based gene drives has been hailed as a ‘gene editing revolution’, making genetic modification more specific, easy to use and broadly accessible. The question is if these new technologies are in fact actually different from the old, or whether it is just the societal and political debate that has changed. By zooming in on different applications of CRISPR for human health, Rathenau will research how CRISPR is associated with risks that are uncertain, complex and ambiguous.

Caution was thrown to the wind by the Norwegians when they offered the speakers a ‘Norwegian’ gift, the cheese slicer. This demonstrates how Europeans can have varying cultural appreciations of technology, as any Dutchman will tell you they themselves invented this handy tool.

Organiser

Maastricht University, Faculty of Law

Contact

Petra Verhoef | Email: p.verhoef@rathenau.nl

Themes

Governance, Health, Innovation, CRISPR-based gene drives, Precaution, Regulation

Interesting for

Policy Makers, Regulatory Authorities & Agencies, Research & Academia

External Event

Event Date

25 November 2019

Location

The Hague

Language

English

RECIPES' General Assembly: setting the steps ahead

chiara.mazzetti@ecologic.eu — Tue, 29 Oct 2019 15:38:21 +0000

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RECIPES' General Assembly: setting the steps ahead

Nine months from the beginning of the RECIPES project (REconciling sCience, Innovation and Precaution through the Engagement of Stakeholders), the Consortium convened in Brussels to look at interim results and discuss the next steps.

Various project findings have been presented and discussed in detail by the Consortium partners. Furthermore, critical input was provided by the Advisory Board Members, including Howard Chase, Senior Director of Government Affairs for The Dow Chemical Company, Nina Holland from the Corporate Europe Observatory, Marian Schaapman, Head of the Health & Safety and Working Conditions Unit of the Research Department of the European Trade Union Institute (ETUI), and Christine von Weizsäcker.

Suggestions and additional valuable information was provided on three main project findings:

- The Report on “The effect of the Precautionary Principle (PP) since 2000
- Media analysis conducted on Le Monde, The Guardian and The Suddeutsche Zeitung
- The 10 citizens’ meetings conducted in Bulgaria, Norway, Italy, Denmark and the Netherlands

The objective of the report on the effect of the PP, which is currently undergoing revisions, is to examine the effect and the application of the PP since 2000 by combining legal analysis, desk research and a narrative literature review, and to clarify the relationship between precaution and innovation.

Results from the media analysis on articles about the PP have been presented. The analysis covered how the public debate has been framed and how it has changed since 2000. The analysis has been conducted by the IASS, the University of Bergen and Maastricht University. Furthermore, the analysis looks at what values and presumptions European citizens have in regards to the PP. The analysis included articles from Le Monde, The Guardian and The Suddeutsche Zeitung.

Partners also reported from citizen interviews held in May/June 2019. In general, the participants’ view on precaution and innovation was that they were not in contradiction with each other and some consensus consisted of the need to look at innovation and precaution on a case-by-case basis.

As a next step, eight case studies will be conducted in the next months. These cover the following aspects:

- New Gene-Editing techniques (CRISPR-Cas9)
- Genetically Modified organisms (GMO’s)
- Endocrine Disruptors
- Neonicotinoid insecticides
- Nano-technologies
- Glyphosate
- Finance, risks and urban water infrastructure
- Artificial Intelligence

The case studies will be conducted to understand and explain the potential differences in the application of the precautionary principle, in a way that reflects the particular context of the case and the arguments for invoking the precautionary principle.
A more detailed overview of the case studies can be found HERE.

Organiser

Maastricht University, Faculty of Law

Contact

Prof. Dr. Ellen Vos and Dr. Kristel de Smedt

Email: law-recipes@maastrichtuniversity.nl

Further Links

RECIPES' Case Studies

Themes

Endocrine disruptors, Financial risks and urban waste planning, Genetically Modified Organisms (GMO’s), Glyphosate, Innovation, Nanotechnologies, Neonicotinoid insecticides, CRISPR-based gene drives, Precaution, Regulation, Science

Interesting for

Policy Makers, Regulatory Authorities & Agencies, Research & Academia, Industry & Business

RECIPES Event

Event Date

24 September 2019 - 25 September 2019

Location

Brussels

Language

English

RECIPES' Case Studies: Aligning Precaution and Innovation

chiara.mazzetti@ecologic.eu — Tue, 29 Oct 2019 15:21:20 +0000

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RECIPES' Case Studies: Aligning Precaution and Innovation

How can we ensure that innovative products and solutions are fostered and encouraged when their impacts on human health and the environment are not fully known? The Precautionary Principle (PP) enables authorities to take precautionary measures by means of pre-damage control when scientifically plausible but uncertain that a new technology or product may cause harm.

The precautionary principle has become a general principle in EU law, gaining importance and thus dividing political and scientific camps into two main views. One side believes that acknowledging the scientific potential of innovative solutions but remaining cautious is vital to ensuring certain products or technological choices are safe – innovation is not always a one-track road to the future. The other believes that this “precautionism” stifles technological innovation and hinders effective competition of different players. Thus, there have been attempts to establish an “innovation principle” that complements the precautionary principle, hoping to allow for an ideal combination of precaution and innovation.

The project RECIPES – REconciling sCience, Innovation and Precaution through the Engagement of Stakeholders – aims to propose ideas on how to align the precautionary principle with the goals of innovation to ensure sustainable and safe solutions, while fostering social awareness and responsibility in the EU in research and innovation.

Specifically, RECIPES plans an analysis of legal and policy initiatives on the precautionary principle and an examination of the application of the principle based on nine case studies. Based on the outcome, the project team will develop scenarios for the future of the precautionary principle and help introduce mechanisms for public involvement and decision-making. RECIPES will provide a platform for the co-creation of tools and guidelines to help policy-makers and stakeholders align risk assessment with the potential benefits of innovation.

The case studies all represent issues with high stakes and are thus particularly well suited for illuminating the complexity and controversy around the precautionary principle. In this short video, Joe Rini, Research Associate at the IASS Potsdam coordinates the analysis of 9 case studies showing how the principle is applied in different contexts and thematic areas.

Case Study 1: CRISPR-based gene drives
New gene-editing techniques such as CRISPR-Cas, hailed as a “gene editing revolution”, have increased the precision and ease of use of genetic modification. However, although societal and political debate about the risks of these technologies is less heated than past discussions about other gene editing methods, the extent to which these techniques substantially differ remains contested. Moreover, widespread availability of technologies for editing plant, animal and even human DNA-material increases the scope of application. Examples of possible real-world applications are CRISPR-Cas9 gene drives that make it possible to quickly adapt the DNA within populations of disease-transmitting insects, gene therapy and human germ line editing. Uncertainty about potentially serious and systemic risks make this case relevant to the precautionary principle. (Partner: Rathenau Instituut)

Case Study 2: Genetically Modified organisms (GMOs)
Genetically Modified Organisms (GMOs) are organisms (with the exception of human beings) in which the genetic material has been altered in a way that does not occur naturally. One of the biggest uses of this technology can be seen in food production, where the yield is increased through genetically modified disease resistance or herbicide tolerance. However, risks include the uncontrollable spreading and crossbreeding of wild-type plants with genetically modified ones as well as global health implications as untested GMO crops enter the food production cycle. The scope of this impact makes this case study particularly relevant to the precautionary principle. (Partner: The Applied Research and Communications Fund)

Case Study 3: Endocrine Disruptors
ECD stands for endocrine disrupting chemicals, a subject of much scientific and political controversy. These chemicals can be found in plastic, paint, toys, clothing, and other daily life objects and are yet to be fully researched or even properly defined. Some ECDs can be causally linked to disorders in the endocrine (hormonal) system, leading for example to precocious puberty, breast- and prostate cancer, infertility, obesity or diabetes. Important actors such as the World Health Organisation or the European Parliament warn of the “severe and irreversible effects on humans and wildlife”, especially as a variety of ECDs are already in use and have not been adequately tested, making this another highly relevant case study for the precautionary principle. (Partner: Maastricht University)

Case Study 4: Neonicotinoid insecticides
Neonicotinoid insecticides, nicknamed neonics, have rapidly become the most widely used class of insecticides, employed as plant protection product and biocide. These neurotoxic chemicals are absorbed by crops to make them toxic to harmful insects, however, neonics also end up in pollen, nectar, soil, water, and other unintended areas, harming not just plague insects, but also pollinators such as bees and a wide range of other beneficial terrestrial and aquatic insects. The large scale use of neonics may pose substantial risks to food production and ecosystem functioning, as well as poorly explored health risks to human neuro-developmental disorders such as autism. This multi-causality and complex risk development makes the use of neonicotinoid insecticides decidedly relevant to the precautionary principle. (Partner: Centre for the Study of the Sciences and the Humanities, University of Bergen)

Case Study 5: Nanotechnologies
The introduction of nanotechnologies is characterized through a high degree of uncertainty. Developments in the fields of nanotechnology, nano-biotechnology, enhancement technologies and synthetic biology call into question the nature of how to approach the regulation of these new technologies, when the long-term effects are yet to be observed. Depending on the nature of the material, the processing and its use/misuse, the implied possible effects vary strongly. A discussion on the fields of application and the definition and standardization of various materials is in place, but the information gathered through various research is ambiguous, uncertain and non-standardized, thus making this a suitable study for the precautionary principle. (Partner: Institute of Technology Assessment of the Austrian Academy of Sciences)

Case Study 6: Glyphosate
Glyphosate is one of the world’s most widely used herbicides, used in European agriculture to control weeds in a wide range of crops. The substance’s license was recently renewed, causing outrage and controversy due to its assumed connection to carcinogenic effects on humans and animals. Studies have both proven and disproven these carcinogenic effects, calling into question whether the substance should be discontinued until full safety is established. Additionally, glyphosate may be a hazard to habitats and biodiversity in farmlands and aquatic ecosystems, as it is non-selective and potentially harmful. Due to these potential impacts on health and biodiversity and the degree of uncertainty, the precautionary principle applies. (Partner: Maastricht University)

Case Study 7: Financial risks in water infrastructure planning
Due to the European Urban Waste Water Directive (UWWTD) many cities in Europe face the extremely costly challenge of adapting their aging water infrastructures to meet environmental standards. This requires immense precaution due to high costs and planning risks, making cities dependent on innovation in financial and governance practices. These major projects require citizen involvement and the balancing of innovation and precaution in order to overcome long-term challenges such as balanced city budgets and tackling climate change. (Partner: Humboldt-Universität zu Berlin)

Case Study 8: The use of Artificial Intelligence in healthcare
Artificial Intelligence is often characterized as a transformational technology for the twenty-first century. Healthcare could be the domain in which AI will have the most impact, transforming practices in, amongst others, the fields of diagnosis, prognosis, prevention, allocating resources, organizing files and automated operations. At the same time, the application and possible dependency on AI systems within this critical domain could also negatively impact patient safety, privacy and fair decision making. The question is to what extent these uncertain risks may justify an invocation of the precautionary principle and how this should be balanced with the large benefits AI systems are thought to offer. (Partner: Rathenau Instituut)

Case Study 9: Microplastics in food products and cosmetics
Microplastics are small pieces of plastics, usually defined as smaller than 5 millimeters. They enter the environment via two routes. Primary microplastics are intentionally added to products, as is done in cosmetic products, to increase certain product characteristics. Secondary microplastics, which constitute the biggest part of the environmental pollution, are pieces of plastic that break down from larger plastics as used for example in packaging materials. As part of the plastic pollution in the ocean, also known as the Plastic Soup, microplastics contributeto a large environmental problem. Via the consumption of sea food and drinking water, microplastics also end up in the intestinal tract of humans. The large amount of microplastics, together with its very long degradation time, makes it a very unpredictable situation. At this moment, the use of microplastics is not yet regulated and the scientific evidence on health effects is very slim. Nevertheless, the European Chemical Agency is working on a proposal to ban additionally added microplastics via the REACH regulation. (Partner: Maastricht University)

Authors

Petra Verhoef, Rathenau Institute
Ventseslav Kozarev, Applied Research and Communications Fund (ARC)
Kristel de Smedt, Maastricht University (UM)
Jeroen van der Slujis, University of Bergen (UiB)
Anna Pavlicek, Institute of Technology Assessment (OEAW)
Harald Mieg, Humboldt-Universität Berlin
Miriam, Urling, Maastricht University (UM)
Chiara Mazzetti, Ecologic Institute

Attachments

Selection of Case Studies

Themes

CRISPR-based gene drives, Endocrine disruptors, Financial risks and urban waste planning, Genetically Modified Organisms (GMO’s), Glyphosate, Nanotechnologies, Neonicotinoid insecticides

Interesting for

Policy Makers, Regulatory Authorities & Agencies, Research & Academia, Industry & Business

Case Study

Publishing Date

29 October 2019

Language

English