Science and policy: valuing framing, language and listening

This paper considers the context for science contributing to policy development and explores some critical issues that should inform science advocacy and influence with policy makers. The paper argues that the key challenges are at least as much in educating conservation scientists and science communicators about society and policy making as they are in educating society and policy makers about science. The importance of developing processes to ensure that scientists and science communicators invest in the development of relationships based on respect and understanding of their audience in both communities and amongst policy makers provides a critical first step. The objectives of the Global Strategy for Plant Conservation acknowledge the importance of developing the capacities and public engagement necessary to implement the Strategy, including knowledge transfer and community capacity building. However, the development of targets to equip institutions and plant conservation professionals to explicitly address the barriers to influencing policy development through knowledge transfer and integration require further consideration.     

Involving society in science: Reflections on meaningful and impactful stakeholder engagement in fundamental research

Open Science calls for transparent science and involvement of various stakeholders. Here are examples of and advice for meaningful stakeholder engagement. Subject Categories: Economics, Law & Politics, History & Philosophy of Science

The concepts of Open Science and Responsible Research and Innovation call for a more transparent and collaborative science, and more participation of citizens. The way to achieve this is through cooperation with different actors or “stakeholders”: individuals or organizations who can contribute to, or benefit from research, regardless of whether they are researchers themselves or not. Examples include funding agencies, citizens associations, patients, and policy makers (https://aquas.gencat.cat/web/.content/minisite/aquas/publicacions/2018/how_measure_engagement_research_saris1_aquas2018.pdf). Such cooperation is even more relevant in the current, challenging times—even apart from a global pandemic—when pseudo‐science, fake news, nihilist attitudes, and ideologies too often threaten social and technological progress enabled by science. Stakeholder engagement in research can inform and empower citizens, help render research more socially acceptable, and enable policies grounded on evidence‐based knowledge. Beyond, stakeholder engagement is also beneficial to researchers and to research itself. In a recent survey, the majority of scientists reported benefits from public engagement (Burns et al, 2021). This can include increased mutual trust and mutual learning, improved social relevance of research, and improved adoption of results and knowledge (Cottrell et al, 2014). Finally, stakeholder engagement is often regarded as an important factor to sustain public investment in the life sciences (Burns et al, 2021).

Stakeholder engagement in research can inform and empower citizens, help render research more socially acceptable and enable policies grounded on evidence‐based knowledge

Here, we discuss different levels of stakeholder engagement by way of example, presenting various activities organized by European research institutions. Based on these experiences, we propose ten reflection points that we believe should be considered by the institutions, the scientists, and the funding agencies to achieve meaningful and impactful stakeholder engagement.     

The application of life cycle assessment to public policy development

Purpose

Despite the potential value it offers, integration of life cycle assessment (LCA) into the development of environmental public policy has been limited. This paper researches potential barriers that may be limiting the use of LCA in public policy development, and considers process opportunities to increase this application.

Methods

Research presented in this paper is primarily derived from reviews of existing literature and case studies, as well as interviews with key public policy officials with LCA experience. Direct experience of the author in LCA projects with public policy elements has also contributed to approaches and conclusions.

Results and discussion

LCAs have historically been applied within a rational framework, with experts conducting the analysis and presenting results to decision-makers for application to public policy development. This segmented approach has resulted in limited incorporation of LCA results or even a broader approach of life cycle thinking within the public policy development process. Barriers that limit the application of LCA within the public policy development process range from lack of technical knowledge and LCA understanding on the part of policy makers, to a lack of trust in LCA process and results. Many of the identified barriers suggest that the failure of LCAs to contribute positively to public policy development is due to the process within which the LCA is being incorporated, rather than technical problems in the LCA itself. Overcoming the barriers to effective use of LCAs in public policy development will require a more normative approach to the LCA process that incorporates a broad group of stakeholders at all stages of the assessment. Specifically, a set of recommendations have been developed to produce a more inclusive and effective process.

Conclusions

In an effort to effectively incorporate LCA within the overall public policy decision-making process, the decision-making process should incorporate a multi-disciplinary approach that includes a range of stakeholders and public policy decision-makers in a collaborative process. One of the most important aspects of incorporating LCA into public policy decisions is to encourage life cycle thinking among policy makers. Considering the life cycle implications will result in more informed and thoughtful decisions, even if a full LCA is not undertaken.

     

A collaboratively-derived science-policy research agenda

The need for policy makers to understand science and for scientists to understand policy processes is widely recognised. However, the science-policy relationship is sometimes difficult and occasionally dysfunctional; it is also increasingly visible, because it must deal with contentious issues, or itself becomes a matter of public controversy, or both. We suggest that identifying key unanswered questions on the relationship between science and policy will catalyse and focus research in this field. To identify these questions, a collaborative procedure was employed with 52 participants selected to cover a wide range of experience in both science and policy, including people from government, non-governmental organisations, academia and industry. These participants consulted with colleagues and submitted 239 questions. An initial round of voting was followed by a workshop in which 40 of the most important questions were identified by further discussion and voting. The resulting list includes questions about the effectiveness of science-based decision-making structures; the nature and legitimacy of expertise; the consequences of changes such as increasing transparency; choices among different sources of evidence; the implications of new means of characterising and representing uncertainties; and ways in which policy and political processes affect what counts as authoritative evidence. We expect this exercise to identify important theoretical questions and to help improve the mutual understanding and effectiveness of those working at the interface of science and policy.     

The challenge of determining the need for remediation following a wide-area biological release

Recovering from a biological attack is a complex process requiring the successful resolution of numerous challenges. The Interagency Biological Restoration Demonstration program is one of the first multiagency efforts to develop strategies and tools that could be effective following a wide-area release of B. anthracis spores. Nevertheless, several key policy issues and associated science and technology issues still need to be addressed. For example, more refined risk assessment and management approaches are needed to help evaluate "true" public health risk. Once the risk is understood, that information can be considered along with the types of characterization activities deemed necessary to determine whether the cost and time of decontamination are actually warranted. This commentary offers 5 recommendations associated with decision making regarding decontamination and clearance options that should accompany a comprehensive risk analysis leading to more effective risk management decisions. It summarizes some of the most important technological gaps that still need to be addressed to help decision makers in their objective of reducing health risks to an acceptable level. The risk management approach described should enable decision makers to improve credibility and gain public acceptance, especially when an adequate science and technology base is available to support the required decisions.     

Scientific dissent and public policy

The temptation to silence dissenters whose non-mainstream views negatively affect public policies is powerful. However, silencing dissent, no matter how scientifically unsound it might be, can cause the public to mistrust science in general.Dissent is crucial for the advancement of science. Disagreement is at the heart of peer review and is important for uncovering unjustified assumptions, flawed methodologies and problematic reasoning. Enabling and encouraging dissent also helps to generate alternative hypotheses, models and explanations. Yet, despite the importance of dissent in science, there is growing concern that dissenting voices have a negative effect on the public perception of science, on policy-making and public health. In some cases, dissenting views are deliberately used to derail certain policies. For example, dissenting positions on climate change, environmental toxins or the hazards of tobacco smoke [1,2] seem to laypeople as equally valid conflicting opinions and thereby create or increase uncertainty. Critics often use legitimate scientific disagreements about narrow claims to reinforce the impression of uncertainty about general and widely accepted truths; for instance, that a given substance is harmful [3,4]. This impression of uncertainty about the evidence is then used to question particular policies [1,2,5,6].The negative effects of dissent on establishing public polices are present in cases in which the disagreements are scientifically well-grounded, but the significance of the dissent is misunderstood or blown out of proportion. A study showing that many factors affect the size of reef islands, to the effect that they will not necessarily be reduced in size as sea levels rise [7], was simplistically interpreted by the media as evidence that climate change will not have a negative impact on reef islands [8].In other instances, dissenting voices affect the public perception of and motivation to follow public-health policies or recommendations. For example, the publication of a now debunked link between the measles, mumps and rubella vaccine and autism [9], as well as the claim that the mercury preservative thimerosal, which was used in childhood vaccines, was a possible risk factor for autism [10,11], created public doubts about the safety of vaccinating children. Although later studies showed no evidence for these claims, doubts led many parents to reject vaccinations for their children, risking the herd immunity for diseases that had been largely eradicated from the industrialized world [12,13,14,15]. Many scientists have therefore come to regard dissent as problematic if it has the potential to affect public behaviour and policy-making. However, we argue that such concerns about dissent as an obstacle to public policy are both dangerous and misguided.Whether dissent is based on genuine scientific evidence or is unfounded, interested parties can use it to sow doubt, thwart public policies, promote problematic alternatives and lead the public to ignore sound advice. In response, scientists have adopted several strategies to limit these negative effects of dissent—masking dissent, silencing dissent and discrediting dissenters. The first strategy aims to present a united front to the public. Scientists mask existing disagreements among themselves by presenting only those claims or pieces of evidence about which they agree [16]. Although there is nearly universal agreement among scientists that average global temperatures are increasing, there are also legitimate disagreements about how much warming will occur, how quickly it will occur and the impact it might have [7,17,18,19]. As presenting these disagreements to the public probably creates more doubt and uncertainty than is warranted, scientists react by presenting only general claims [20].A second strategy is to silence dissenting views that might have negative consequences. This can take the form of self-censorship when scientists are reluctant to publish or publicly discuss research that might—incorrectly—be used to question existing scientific knowledge. For example, there are genuine disagreements about how best to model cloud formation, water vapour feedback and aerosols in general circulation paradigms, all of which have significant effects on the magnitude of global climate change predictions [17,19]. Yet, some scientists are hesitant to make these disagreements public, for fear that they will be accused of being denialists, faulted for confusing the public and policy-makers, censured for abating climate-change deniers, or criticized for undermining public policy [21,22,23,24].…there is growing concern that dissenting voices can have a negative effect on the public perception of science, on policy-making and public healthAnother strategy is to discredit dissenters, especially in cases in which the dissent seems to be ideologically motivated. This could involve publicizing the financial or political ties of the dissenters [2,6,25], which would call attention to their probable bias. In other cases, scientists might discredit the expertise of the dissenter. One such example concerns a 2007 study published in the Proceedings of the National Academy of Sciences USA, which claimed that cadis fly larvae consuming Bt maize pollen die at twice the rate of flies feeding on non-Bt maize pollen [26]. Immediately after publication, both the authors and the study itself became the target of relentless and sometimes scathing attacks from a group of scientists who were concerned that anti-GMO (genetically modified organism) interest groups would seize on the study to advance their agenda [27]. The article was criticized for its methodology and its conclusions, the Proceedings of the National Academy of Sciences USA was criticized for publishing the article and the US National Science Foundation was criticized for funding the study in the first place.Public policies, health advice and regulatory decisions should be based on the best available evidence and knowledge. As the public often lack the expertise to assess the quality of dissenting views, disagreements have the potential to cast doubt over the reliability of scientific knowledge and lead the public to question relevant policies. Strategies to block dissent therefore seem reasonable as a means to protect much needed or effective health policies, advice and regulations. However, even if the public were unable to evaluate the science appropriately, targeting dissent is not the most appropriate strategy to prevent negative side effects for several reasons. Chiefly, it contributes to the problems that the critics of dissent seek to address, namely increasing the cacophony of dissenting voices that only aim to create doubt. Focusing on dissent as a problematic activity sends the message to policy-makers and the public that any dissent undermines scientific knowledge. Reinforcing this false assumption further incentivizes those who seek merely to create doubt to thwart particular policies. Not surprisingly, think-tanks, industry and other organizations are willing to manufacture dissent simply to derail policies that they find economically or ideologically undesirable.Another danger of targeting dissent is that it probably stifles legitimate crucial voices that are needed for both advancing science and informing sound policy decisions. Attacking dissent makes scientists reluctant to voice genuine doubts, especially if they believe that doing so might harm their reputations, damage their careers and undermine prevailing theories or policies needed. For instance, a panel of scientists for the US National Academy of Sciences, when presenting a risk assessment of radiation in 1956, omitted wildly different predictions about the potential genetic harm of radiation [16]. They did not include this wide range of predictions in their final report precisely because they thought the differences would undermine confidence in their recommendations. Yet, this information could have been relevant to policy-makers. As such, targeting dissent as an obstacle to public policy might simply reinforce self-censorship and stifle legitimate and scientifically informed debate. If this happens, scientific progress is hindered.Second, even if the public has mistaken beliefs about science or the state of the knowledge of the science in question, focusing on dissent is not an effective way to protect public policy from false claims. It fails to address the presumed cause of the problem—the apparent lack of understanding of the science by the public. A better alternative would be to promote the public''s scientific literacy. If the public were educated to better assess the quality of the dissent and thus disregard instances of ideological, unsupported or unsound dissent, dissenting voices would not have such a negative effect. Of course, one might argue that educating the public would be costly and difficult, and that therefore, the public should simply listen to scientists about which dissent to ignore and which to consider. This is, however, a paternalistic attitude that requires the public to remain ignorant ‘for their own good''; a position that seems unjustified on many levels as there are better alternatives for addressing the problem.Moreover, silencing dissent, rather than promoting scientific literacy, risks undermining public trust in science even if the dissent is invalid. This was exemplified by the 2009 case of hacked e-mails from a computer server at the University of East Anglia''s Climate Research Unit (CRU). After the selective leaking of the e-mails, climate scientists at the CRU came under fire because some of the quotes, which were taken out of context, seemed to suggest that they were fudging data or suppressing dissenting views [28,29,30,31]. The stolen e-mails gave further ammunition to those opposing policies to reduce greenhouse emissions as they could use accusations of data ‘cover up'' as proof that climate scientists were not being honest with the public [29,30,31]. It also allowed critics to present climate scientists as conspirators who were trying to push a political agenda [32]. As a result, although there was nothing scientifically inappropriate revealed in the ‘climategate'' e-mails, it had the consequence of undermining the public''s trust in climate science [33,34,35,36].A significant amount of evidence shows that the ‘deficit model'' of public understanding of science, as described above, is too simplistic to account correctly for the public''s reluctance to accept particular policy decisions [37,38,39,40]. It ignores other important factors such as people''s attitudes towards science and technology, their social, political and ethical values, their past experiences and the public''s trust in governmental institutions [41,42,43,44]. The development of sound public policy depends not only on good science, but also on value judgements. One can agree with the scientific evidence for the safety of GMOs, for instance, but still disagree with the widespread use of GMOs because of social justice concerns about the developing world''s dependence on the interests of the global market. Similarly, one need not reject the scientific evidence about the harmful health effects of sugar to reject regulations on sugary drinks. One could rationally challenge such regulations on the grounds that informed citizens ought to be able to make free decisions about what they consume. Whether or not these value judgements are justified is an open question, but the focus on dissent hinders our ability to have that debate.Focusing on dissent as a problematic activity sends the message to policy-makers and the public that any dissent undermines scientific knowledgeAs such, targeting dissent completely fails to address the real issues. The focus on dissent, and the threat that it seems to pose to public policy, misdiagnoses the problem as one of the public misunderstanding science, its quality and its authority. It assumes that scientific or technological knowledge is the only relevant factor in the development of policy and it ignores the role of other factors, such as value judgements about social benefits and harms, and institutional trust and reliability [45,46]. The emphasis on dissent, and thus on scientific knowledge, as the only or main factor in public policy decisions does not give due attention to these legitimate considerations.Furthermore, by misdiagnosing the problem, targeting dissent also impedes more effective solutions and prevents an informed debate about the values that should guide public policy. By framing policy debates solely as debates over scientific facts, the normative aspects of public policy are hidden and neglected. Relevant ethical, social and political values fail to be publicly acknowledged and openly discussed.Controversies over GMOs and climate policies have called attention to the negative effects of dissent in the scientific community. Based on the assumption that the public''s reluctance to support particular policies is the result of their inability to properly understand scientific evidence, scientists have tried to limit dissenting views that create doubt. However, as outlined above, targeting dissent as an obstacle to public policy probably does more harm than good. It fails to focus on the real problem at stake—that science is not the only relevant factor in sound policy-making. Of course, we do not deny that scientific evidence is important to the develop.ment of public policy and behavioural decisions. Rather, our claim is that this role is misunderstood and often oversimplified in ways that actually contribute to problems in developing sound science-based policies.? Open in a separate windowInmaculada de Melo-MartínOpen in a separate windowKristen Intemann     

The evolution of social networks through the implementation of evidence-informed decision-making interventions: a longitudinal analysis of three public health units in Canada

Background

We studied the evolution of information-seeking networks over a 2-year period during which an organization-wide intervention was implemented to promote evidence-informed decision-making (EIDM) in three public health units in Ontario, Canada. We tested whether engagement of staff in the intervention and their EIDM behavior were associated with being chosen as information source and how the trend of inter-divisional communications and the dominance of experts evolved over time.

Methods

Local managers at each health unit selected a group of staff to get engage in Knowledge Broker-led workshops and development of evidence summaries to address local public health problems. The staff were invited to answer three online surveys (at baseline and two annual follow-ups) including name generator questions eliciting the list of the staff they would turn to for help integrating research evidence into practice. We used stochastic actor-oriented modeling to study the evolution of networks. We tested the effect of engagement in the intervention, EIDM behavior scores, organizational divisions, and structural dynamics of social networks on the tendency of staff to select information sources, and the change in its trend between year 1 and year 2 of follow-up.

Results

In all the three health units, and especially in the two units with higher levels of engagement in the intervention, the network evolved towards a more centralized structure, with an increasing significance of already central staff. The staff showed greater tendencies to seek information from peers with higher EIDM behavior scores. In the public health unit that had highest engagement and stronger leadership support, the engaged staff became more central. In all public health units, the engaged staff showed an increasing tendency towards forming clusters. The staff in the three public health units showed a tendency towards limiting their connections within their divisions.

Conclusions

The longitudinal analysis provided us with a means to study the microstructural changes in public health units, clues to the sustainability of the implementation. The hierarchical transformation of networks towards experts and formation of clusters among staff who were engaged in the intervention show how implementing organizational interventions to promote EIDM may affect the knowledge flow and distribution in health care communities, which may lead to unanticipated consequences.

     

Uncertainty, ecology, sustainability and policy

Using an Australian focus to explore theoretical and policy issues of wider concern, this article examines linkages between public policy and the science of ecology. This is done within the broader framework of sustainability, emphasizing the problem of decision making in the face of uncertainty. Insights from the ecological, risk, sustainability and policy literatures are used. The sustainability-uncertainty problem is characterized, and the adequacy of existing policy support techniques and approaches noted, particularly the precautionary principle. The problem is further defined using the notion of ignorance. The treatment of ignorance and uncertainty in ecology is discussed. We suggest that the science of ecology has had a limited influence on policy formulation and discuss the basis of this using biodiversity conservation and ecosystem management as examples. We conclude by considering challenges for handling risk, uncertainty and ignorance in ecological science for policy formulation. We emphasize the need for improved communication between the science and policy communities, greater recognition of the limits of quantitative techniques in addressing uncertainty, and contingency planning.     

Experts in science communication: A shift from neutral encyclopedia to equal participant in dialogue

Even if the predominant model of science communication with the public is now based on dialogue, many experts still adhere to the outdated deficit model of informing the public. Subject Categories: Genetics, Gene Therapy & Genetic Disease, S&S: History & Philosophy of Science, S&S: Ethics

During the past decades, public communication of science has undergone profound changes: from policy‐driven to policy‐informing, from promoting science to interpreting science, and from dissemination to interaction (Burgess, 2014). These shifts in communication paradigms have an impact on what is expected from scientists who engage in public communication: they should be seen as fellow citizens rather than experts whose task is to increase scientific literacy of the lay public. Many scientists engage in science communication, because they see this as their responsibility toward society (Loroño‐Leturiondo & Davies, 2018). Yet, a significant proportion of researchers still “view public engagement as an activity of talking to rather than with the public” (Hamlyn et al, 2015). The highly criticized “deficit model” that sees the role of experts as educating the public to mitigate skepticism still persists (Simis et al, 2016; Suldovsky, 2016).Indeed, a survey we conducted among experts in training seems to corroborate the persistence of the deficit model even among younger scientists. Based on these results and our own experience with organizing public dialogues about human germline gene editing (Box 1), we discuss the implications of this outdated science communication model and an alternative model of public engagement, that aims to align science with the needs and values of the public.Box 1

The DNA‐dialogue project

The Dutch DNA‐dialogue project invited citizens to discuss and form opinions about human germline gene editing. During 2019 and 2020, this project organized twenty‐seven dialogues with professionals, such as embryologists and midwives, and various lay audiences. Different scenarios of a world in 2039 (https://www.rathenau.nl/en/making‐perfect‐lives/discussing‐modification‐heritable‐dna‐embryos) served as the starting point. Participants expressed their initial reactions to these scenarios with emotion‐cards and thereby explored the values they themselves and other participants deemed important as they elaborated further. Starting each dialogue in this way provides a context that enables everyone to participate in dialogue about complex topics such as human germline gene editing and demonstrates that scientific knowledge should not be a prerequisite to participate.An important example of “different” relevant knowledge surfaced during a dialogue with children between 8 and 12 years in the Sophia Children’s Hospital in Rotterdam (Fig 1). Most adults in the DNA‐dialogues accepted human germline gene modification for severe genetic diseases, as they wished the best possible care and outcome for their children. The children at Sophia, however, stated that they would find it terrible if their parents had altered something about them before they had been born; their parents would not even have known them. Some children went so far to say they would no longer be themselves without their genetic condition, and that their condition had also given them experiences they would rather not have missed.Open in a separate windowFigure 1 Children participating in a DNA‐dialogue meeting. Photographed by Levien Willemse.     

A simple biological indicator of solar ultraviolet radiation

School science laboratory classes and hands-on public engagement activities share many common aims and objectives in terms of science learning and literacy. This article describes the development and evaluation of a microbiology public engagement activity, ‘The Good, the Bad and the Algae’, from a school laboratory activity. The school activity was developed as part of an educational resource which aimed to promote practical microbiology in the classroom. The public engagement activity was derived locally for National Science and Engineering Week 2011 and was subsequently adapted for a national science and engineering fair (The Big Bang 2012 The Big Bang. 2012. About The Big Bang Fair. http://www.thebigbangfair.co.uk/about_us.cfm. [Google Scholar]). The aim of the session was to raise awareness of the importance of algae and to encourage hands-on laboratory examination in a fun and informal manner. Evaluation of the first event, delivered in a workshop format, helped shape the educational resource before publication. The second event was modified to enable delivery to a larger audience. Both events were successful in terms of enjoyment and engagement. Over 2200 people participated in the Big Bang activity over three days, with evaluation indicating 80% of participants had increased awareness/knowledge of algae after the event. The success of both iterations of the activity demonstrates that it is possible to transform a simple school activity into an exciting and effective public engagement activity.     

Political and Institutional Influences on the Use of Evidence in Public Health Policy. A Systematic Review

Background

There is increasing recognition that the development of evidence-informed health policy is not only a technical problem of knowledge exchange or translation, but also a political challenge. Yet, while political scientists have long considered the nature of political systems, the role of institutional structures, and the political contestation of policy issues as central to understanding policy decisions, these issues remain largely unexplored by scholars of evidence-informed policy making.

Methods

We conducted a systematic review of empirical studies that examined the influence of key features of political systems and institutional mechanisms on evidence use, and contextual factors that may contribute to the politicisation of health evidence. Eligible studies were identified through searches of seven health and social sciences databases, websites of relevant organisations, the British Library database, and manual searches of academic journals. Relevant findings were extracted using a uniform data extraction tool and synthesised by narrative review.

Findings

56 studies were selected for inclusion. Relevant political and institutional aspects affecting the use of health evidence included the level of state centralisation and democratisation, the influence of external donors and organisations, the organisation and function of bureaucracies, and the framing of evidence in relation to social norms and values. However, our understanding of such influences remains piecemeal given the limited number of empirical analyses on this subject, the paucity of comparative works, and the limited consideration of political and institutional theory in these studies.

Conclusions

This review highlights the need for a more explicit engagement with the political and institutional factors affecting the use of health evidence in decision-making. A more nuanced understanding of evidence use in health policy making requires both additional empirical studies of evidence use, and an engagement with theories and approaches beyond the current remit of public health or knowledge utilisation studies.     

Shaping the science–industry–policy interface in synthetic biology

Current advances in the emerging field of synthetic biology and the improvements in key technologies promise great impacts, not only on future scientific development, but also on the economy. In this paper we will adopt the triple helix concept for analyzing the early stages of a new field of science and innovation, namely synthetic biology. Synthetic biology is based on the creation and assembly of parts in order to create new and more complex structures and functions. These features of synthetic biology raise questions related to standardization and intellectual property, but also to security and public perception issues that go beyond the classical biotechnology discussions. These issues concern all involved actors in the synthetic biology field and affect the interrelationship between science, industry and policy. Based on the results of the recently finished EU FP-6 funded project TESSY (http://www.tessy-europe.de), the article analyzes these issues. Additionally, it illustrates the setting of clear framework conditions for synthetic biology research and development and the identification and definition of common goals for the future development of the field which will be needed for efficient science–industry–policy interaction. It was shown that it will be crucial to develop approaches that consider the needs of science and industry, on the one hand, and comply with the expectations of society, on the other hand. As synthetic biology is a global activity, the involvement of national decision-makers in international initiatives will further stimulate the development of the field.     

The anglerfish deception. The light of proposed reform in the regulation of GM crops hides underlying problems in EU science and governance

A recent proposal to reform the EU''s policy on the use of genetically modified crops looks good at first sight, but there are dangers for science lurking in the background.Anglerfish are predators that live in the eternal darkness of the deep oceans and have a distinctive way of catching their prey. They use a long light-emitting filament that extends from their head to lure organisms in the darkness. Those attracted to the shimmering light and movement are then unwittingly caught in front of the anglerfish''s wide-open jaws. Such is the nature of the European Commission (EC)''s proposal for a new European Union (EU) policy on the regulation of genetically modified organisms (GMOs)—it looks alluring at first glance, but there are hidden dangers lurking in the background.After years of protracted conflict between the EC and several EU member states over the import of GM food and the use of GM crops in agriculture, a new regulatory approach to the approval and cultivation of GMOs is currently moving through the legislative process. In July 2010, the EC proposed the inclusion of a new article (Article 26b) in Directive 2001/18/EC that regulates the deliberate environmental release of GMOs. It would give member states autonomy to make their own decisions about cultivating GM crops, independently of EC authorizations (EC, 2010). However, member states would not be able to make such decisions on the grounds of scientific assessments of health and environmental risk because these are performed by the EU''s scientific advisory body, the European Food Safety Authority (EFSA). The EC''s rationale for this proposed policy change is to address the bitter resistance to GM crops in some member states and break the resulting long-standing regulatory and policy deadlock.In July 2011, the European Parliament (EP) overwhelmingly voted to endorse the principle of member-state freedom, but rejected the EC''s attempt to completely prevent member states from using scientific arguments to ban GMOs (Sidebar A). Whereas the EC wished to protect a centralized and singular voice of science for EU policy (namely the EFSA), the EP asserted that the different conditions across the EU could allow a rational scientific approach to reach different conclusions, especially on matters of environmental risk. In its amendments, the EP also implicitly accepted other points of criticism of the EFSA and EC processes; for example, that there are normative choices being made in EU GM policy, but under the false name of science.

Sidebar A | Development of the proposal for EU GM regulatory reform

4 December 2008Council identifies areas for improvement in the European Union (EU) framework for authorizing genetically modified organisms (GMOs), including fuller environmental assessment and socio-economic appraisal.2 March 2009A Dutch proposal is made to the Environment Council (of EU Member State Ministers) that the decision to cultivate GM crops should be left to individual member states.24 June 2009A group of 13 member states requests that the European Commission (EC) give member states the freedom to decide on the cultivation of GM plants based on “relevant socio-economic aspects”.3 September 2009EC President José Manuel Barroso suggests “it should be possible to combine a Community authorisation system, based on science, with freedom for Member States to decide whether or not they wish to cultivate GM crops on their territory” (Barroso, 2009).13 July 2010In response to the Council of Ministers, the EC proposes amendments to Directive 2001/18/EC through the addition of Article 26b, allowing member states to restrict or prohibit GMO cultivation on grounds other than adverse effects to health and the environment.September 2010Ad hoc working party is established by COREPER (The Committee of Permanent Representatives of Member State Governments) to consider the EC''s proposal, taking into account the recommendation on coexistence.7 September 2010Delegates to the ad hoc working party raise concerns about the legality of the proposal within international trade law, as well as the need for enhanced clarity on the proposed acceptable grounds for member state restrictions of GMO cultivation.27 September and 14 October 2010Councils on Agriculture and Fisheries and Environment reiterate concerns of the COREPER working party and the opinion of the Council Legal Service is requested.5 November 2010Council Legal Service opinion concludes that the EC''s proposal might not be compatible with international treaties or with the General Agreement on Tariffs and Trade (GATT).23 November 2010Commission Services disagrees with legal service opinion and argues that the EC''s proposal is a way to ensure smooth functioning of the internal market in accordance with Article 114 of the EU Constitution—the 2009 Treaty of Lisbon—and that grounds other than ethics might be invoked; for example, public order or public interest to preserve cultural traditions, or ‘public morals'' as permitted under GATT.8 December 2010COREPER working party argues that a list of grounds that could be used by member states to restrict GMOs under the new proposal needs to be provided by the EC.9 December 2010EU Economic and Social Committee (2011) concludes that the proposal will “create more vagueness than certainty and could in practice result in a proliferation of (legally unstable) measures adopted by States” and also calls for more clearly specified grounds for restrictions.8 February 2011Commission Services (2011) release an open but not exhaustive list of possible reasons that could be invoked to restrict or prohibit GMO cultivation under the new proposal, including: public morals, public order, avoiding presence in other products, social policy objectives, land-use planning, cultural policy and general environmental policy objectives (other than assessment of adverse effects of GMOs on the environment) such as maintenance of certain types of landscape features, ecosystems or ecosystem services.12 April 2011European Parliament (EP) Environment Committee votes to submit to the full EP its amendments to the EC legislative proposal to include scientifically justified environmental impacts complementary to those assessed by the EFSA as legitimate grounds for member state restrictions or prohibitions. This includes prevention of pesticide resistance, invasiveness and/or biodiversity loss; maintenance of seed purity, local biodiversity, unviability of coexistence regimes, ecosystem and agricultural sustainability; and/or presence of persistent uncertainty through data absence or contradictions (Committee on the Environment, Public Health and Food Safety, 2011).5 July 2011 (originally scheduled for 9 June)Parliament plenary vote on the EC''s proposal and the EP Environment Committee amendments. Large majority votes in favour of Environment Committee amendments (548 for, 84 against, 31 abstentions). This Parliamentary verdict goes to the Council of Ministers for agreement on a final legal schedule.There are inherent dangers with the EC''s goal of pursuing a political and economic union for Europe that increasingly depends on claims about a unitary, singular, deterministic and independent quality to scientific risk analysis. We argue that such claims are confused, false and ultimately self-defeating, despite the honourable intent of the original reasons for moving towards political union. …the EC wished to protect a centralized and singular voice of science for EU policy…In recent years, several EU member states have used the ‘safeguard clause'', Article 23 of EC Directive 2001/18, to ban the cultivation of GM crops in their territories, despite safety approvals from the EFSA. Article 23 allows ‘temporary'' prohibitions if there is new scientific knowledge indicating a potential risk to human health or the environment. However, the EFSA has assessed and declared that all such current prohibitions by member states lack sufficient scientific support and are therefore illegal under the original EC authorizations. Nonetheless, various member states uphold these bans, thereby formally violating European law and creating an escalating sense of crisis. This has seen the attempt to establish a centralized authority for the regulation of GMOs fall into disarray, as bans are met with EC legal threats, and these are met with further member state intransigence. Disagreement between the EC and member states has typically focused on the EFSA, which acts as scientific authority to its policy client, the EC''s Directorate-General for Consumer Health and Protection. The EFSA''s central responsibility for risk assessment effectively makes it the EC''s scientific authority for GM policy, and it is the risk science of the EFSA''s GM panel that has been publicly disputed in member states'' justifications of their Article 23 prohibitions.Disputed science is crucial in disagreements over GMOs, but the dispute is not limited to facts revealed by researchIn September 2009, EC President José Manuel Barroso urged a reconsideration of the EU constitutional principle of subsidiarity in GMO policy: “It should be possible to combine a Community authorisation system, based on science, with freedom for Member States to decide whether or not they wish to cultivate GM crops on their territory” (Barroso, 2009). In July 2010, the EC (2010) proposed amendments to Directive 2001/18 to create a formal basis for member states to restrict or prohibit the cultivation in their territory of GMOs authorized at the EU level. The EC proposal turns the existing situation on its head: instead of prohibitions only being permitted on the basis of potential risks to human health or the environment, the new proposal would allow bans only on “grounds other than those related to the assessment of the adverse effect on health and environment” (EC, 2010). The implication is that the EFSA adequately assesses health and environmental risks. Yet, this was, and remains, precisely the main issue for those member states that refuse to accept the scientific adequacy of EFSA authorizations.This separation of risk science from other concerns has been misinterpreted by some commentators as allowing EU member states to make “arbitrary” decisions, “without explanation” and “based on irrational criteria” (Sabalza et al, 2011). This ignores other rational grounds for decision-making—for example, socio-economic and/or ethical considerations. Moreover, it fails to recognize the contingencies that pervade risk assessment: that is, the possibility for divergent scientific assessments depending on different framing commitments, including the way such commitments define relevant factors, interpretive criteria and implicit burden-of-proof assumptions (Wynne, 1989; Stirling, 1998). The impossibility of separating scientific risk knowledge from normative questions, assumptions and commitments is neither a failing of that science nor those institutions. It is an unavoidable reality that needs to be addressed in an enlightened and accountable way.Disputed science is crucial in disagreements over GMOs, but the dispute is not limited to facts revealed by research. It is also about the normative commitments that scientists make and how these shape what are deemed to be salient and reliable facts; for example, the choices made concerning the relevant questions to ask, the appropriate methods to employ, the pertinent baselines for comparison and so on. The EC''s proposal embodies a confusion of risk science with an idealized model of pure scientific research unaffected by normative considerations, and which, therefore, supposedly speaks only in the singular voice of Nature. Thus the EC produces a framework that asserts that current scientific and regulatory institutions, namely the EFSA in this case, are sufficiently capable of exhaustively defining and assessing such risks in an impartial, objective and over-arching way. However, not only are there legitimate scientific differences in environmental, agronomic and health risk assessment situations across Europe, there are also unacknowledged social, ethical and political commitments embedded in the supposedly singular EC risk science (Brunk et al, 1991; EU, 2007). An unavoidable effect of this confusion is that member states'' legitimate differences with EFSA''s ‘science'' (which stands for EC–EU policy), are arbitrarily rendered ‘unscientific'' and illegitimate.The EC''s proposal embodies a confusion of risk science with an idealized model of pure scientific research…The conflation of risk, science and rationality into the combined position that risk represents the only legitimate ground for social concern, current scientific and regulatory institutions are capable of defining and assessing such risks in an impartial and objective way, and scientific risk assessment as performed by existing institutions is the only rational basis for decision-making, is arguably exactly the institutional mindset that has created the current paralysis in EU GMO regulation and policy, and therefore the need for reform. Thus the same mindset that created the paralysing conflict in the first place is informing the EC''s approach to revising legislation.At first sight, then, the EC''s proposal seems to be a positive move to accept different member state policies on GM cultivation, particularly as it includes socio-economic and/or ethical considerations as legitimate grounds for these. Closer examination, however, suggests that it might be a trap. The EC''s proposal attempts to create a rigid boundary between a supposed singular, objective, non-contingent and universal scientific knowledge on risk, and diverse ‘non-scientific'' social, ethical, religious and/or political concerns. This framing of a rigid division between the scientific and ‘non-scientific'', corresponding with a ‘rational (universal)'' over ‘irrational (local)'' standpoint, ignores that risk science is actually shaped by unacknowledged normative commitments and contingencies, which are manifested through uncertainty, ambiguity, indeterminacy and ignorance (Wynne, 1992; Brunk et al, 1991). This scientism as a form of politics undermines an enlightened, scientifically informed democratic cultureThe EC proposal draws on ideals of impartiality in research science (Daston & Galison, 2007; Lacey, 2005), but uses these to claim authority for what is a different knowledge culture, namely regulatory science (Jasanoff, 1990). The EC has been here before (Laurence & Wynne, 1989), and its stance seems to express that economic and political union is achievable through scientific authority—as if science can declare unionist policy ends as a revelation of Nature rather than as a reasonably argued but contestable human aim. This scientism as a form of politics undermines an enlightened, scientifically informed democratic culture.In April 2011, the Environment Committee of the EP recommended significant amendments to the EC''s proposal. These amendments allowed contextually variable definitions of environmental harm, recognized the intertwined character of nature and culture in agriculture, and acknowledged the significance of scientific uncertainties. In doing so, these proposed amendments permitted non-scientific as well as scientific reasons for bans by member states (Committee on the Environment, Public Health and Food Safety, 2011; Sidebar B). On 5 July 2011, the EP followed these recommendations and voted down the original EC proposal (EP, 2011).

Sidebar B | Legal text of the EC legislative proposal and EP amendments

Original wording of the European Commission proposalArticle 26b“Member States may adopt measures restricting or prohibiting the cultivation of all or particular [genetically modified organisms, GMOs] […] in all or part of their territory, provided that:(a) those measures are based on grounds other than those related to the assessment of the adverse effect on health and environment which might arise from the deliberate release or the placing on the market of GMOs”.Amendments voted by the European Parliament“Member States may adopt, after a case-by-case examination, measures restricting or prohibiting the cultivation of particular GMOs or of groups of GMOs defined by crop or trait or of all GMOs […] in all or part of their territory, provided that:(a) those measures are based on(i) duly justified grounds relating to local or regional environmental impacts which might arise from the deliberate release or placing on the market of GMOs, and which are complementary to the environmental impacts examined during the scientific assessment of the impacts on the environment conducted under Part C of this Directive [that is, by the EFSA]; or grounds relating to risk management. Those grounds may include:

• the prevention of the development of pesticide resistance among weeds and pests;
• the invasiveness or persistence of a GM variety, or the possibility of interbreeding with domestic cultivated or wild plants;
• the prevention of negative impacts on the local environment caused by changes in agricultural practices linked to the cultivation of GMOs;
• the maintenance and development of agricultural practices which offer a better potential to reconcile production with ecosystem sustainability;
• the maintenance of local biodiversity, including certain habitats and ecosystems, or certain types of natural and landscape features;
• the absence or lack of adequate data concerning the potential negative impacts of the release of GMOs on the local or regional environment of a Member State, including on biodiversity;

(ii) grounds relating to socio-economic impacts. Those grounds may include:

• the impracticability or the high costs of coexistence measures or the impossibility of implementing coexistence measures due to specific geographical conditions such as small islands or mountain zones;
• the need to protect the diversity of agricultural production; or
• the need to ensure seed purity;

(iii) other grounds that may include land use, town and country planning, or other legitimate factors”.Other significant European Parliament amendments“(2a) The Commission and Member States should ensure, as a priority, the implementation of the Environment Council Conclusions adopted on 4 December 2008, namely a proper implementation of the legal requirements laid down in Annex II of Directive 2001/18/EC for the risk assessment of GMOs. In particular, the long-term environmental effects of GM crops, as well as their potential effects on non-target organisms, should be rigorously assessed; the characteristics of the receiving environments and the geographical areas in which GM plants may be cultivated should be duly taken into account; and the potential environmental consequences brought about by changes in the use of herbicides linked to herbicide-tolerant GM crops should be assessed. More specifically, the Commission should ensure that the new guidelines on GMO risk assessment are adopted. Those guidelines should not be based only on the principle of substantial equivalence or on the concept of a comparative safety assessment, and should make it possible to clearly identify direct and indirect long-term effects, as well as scientific uncertainties. The European Food Safety Authority (EFSA) and the Member States should aim to establish an extensive network of scientific organizations representing all disciplines including those relating to ecological issues, and should cooperate to identify at an early stage any potential divergence between scientific opinions with a view to resolving or clarifying the contentious scientific issues. The Commission and the Member States should ensure that the necessary resources for independent research on the potential risks of GMOs are secured, and that the enforcement of intellectual property rights does not prevent independent researchers from accessing all relevant material.”The justification for the ‘supplementary'' scientific reasons for member state bans was that environmental issues specific to national, regional or local conditions will require scientific data that might not be sufficiently addressed in a risk assessment at the European level. The EP amendments also stated that a lack of relevant information would constitute legitimate grounds for member states to restrict or prohibit the cultivation of GMOs. Other amendments also restate and reinforce the requirement to implement Directive 2001/18 (Sidebar B), for example, including specific legislative requirements to assess long-term risks. Although this legal requirement already exists under Directive 2001/18, complaints continue that long-term and cumulative risks from GMOs have never been adequately considered by the EFSA and consequent EC authorizations. Significantly, the EP also sought to change the legal basis for the proposed new regulation from Article 114 of the EU Lisbon Treaty, which focuses on the establishment of a single market, to Article 192, which grants member states responsibility for the conservation of fauna and flora, land-use or town and country planning. This change recognizes that GMO cultivation and agriculture are closely linked to issues of land-use, the conservation of flora and fauna, and biodiversity. The idea is that closed, expert resolution, using the disinterested and supposedly unitary voice of science, will deliver union by abstract revelation…Whereas the EP voted with a large majority to amend the EC''s proposal, the EC perspective remains alive and the EP''s recommended amendments are now undergoing political bargaining between the Council of Ministers, the EC and the EP. As one participant informed us, the EP version will not necessarily survive into final EU legislation as it is unlikely that the Council will support all of the amendments. If these negotiations fail to reach agreement, an interagency group with members from the EP and the Council of Ministers will prepare a common statement that will then be voted on again by both bodies. Although the EP''s proposed amendments are promising, political negotiation continues and the EC''s approach, which is fundamentally different from the EP''s, might well survive.While the content of any final EU legislative text remains speculative at this point, it is worth considering the EP''s amendments in the light of new EU guidelines for the environmental risk assessment of GM plants, which after a period of feedback and consultation were finalized in May 2011 (EFSA, 2011). It seems that many of the issues that the EP''s amendments outline as potentially valid grounds for member state restrictions or prohibitions already fall within the scope of the EFSA. This includes specific environmental risks, such as invasiveness or weed and pest resistance, and general issues such as the specificities of the receiving environment and the potential for changes in agricultural management practices. The EP also calls for the documentation of any scientific uncertainty and disagreement, which has been EU law, although unimplemented, for nine years.The more controversial that public issues involving science become, the more this aggrandisement of scientific risk assessment becomes appealingOne important and contested issue in the finalized guidelines of the EFSA (2011) is the introduction of a ‘Comparative Safety Assessment'' by the EFSA GM panel (ENSSER, 2011). If the GM crop under assessment passes this first step, no further questions need be asked. Given that comparative baselines are themselves a point of contention and are normative choices that affect the scientific appraisal, this makes the EC''s attempt to assert central singular scientific rule over any possible scientific criticism by member states even more problematic and potentially provocative.Therefore, if the EFSA follows its own guidelines for environmental risk assessment, the concrete issues described in the EP''s amendments could not be considered ‘complementary to'' those assessed by the EFSA. Should this happen, we would return to a situation in which the EFSA is deemed to sufficiently assess environmental risk, and in which member states would effectively be left with no formal basis to contest the quality or content of the agency''s assessment, and therefore could not prohibit or restrict GM cultivation on the basis of an alternative interpretation of the available science as defined by the EFSA. Consistent with our critical analysis of the EC''s proposal, such a final agreement would maintain most of the problematic framing that mistakenly defines ‘science'' performed by the EFSA and endorsed by the EC to be above and before any other normative commitments with respect to GMO risk assessment and policy.It is also worth noting that the very language of ‘complementary'' suggests that EFSA risk assessments might be incomplete, but it does not acknowledge that choices in risk-based science and/or particular framings of a risk assessment might be legitimately different or mutually exclusive between the EFSA and member states. This is true, for example, of the choices of ‘normal baseline'' comparators for defining harm, of protection goals, of the timescales during which to observe effects, of the chosen endpoints, of the relevant test material, or of the required weight of empirical evidence for defining adequate ‘proof'' of harm. The language of ‘complementary'' might be a pragmatic compromise; however, honesty might require ‘alternative'' and the wider corresponding political debate over the hidden normative issues that this deserves.The quality of the risk assessment process will inevitably remain an issue of debate, as will the significance of particular uncertainties or gaps in knowledge, owing to the inherently normative nature of risk-based choices and assumptions. Here, the key issues are to what extent local, regional and national environmental and social conditions and aims can remain valid grounds for member states'' prohibitions; to what extent scientific disagreement over the validity and quality of a risk assessment can be used as valid grounds for member state prohibitions; and whether the knowledge produced and used in risk research and assessment can be acknowledged to be fundamentally different from knowledge as scientific research. This latter admission would also expose the normative public questions that are currently hidden and promoted falsely in the name of science in the EC''s attempt to achieve a unified European policy authority.Recognizing the fundamentally different nature of risk-based regulatory science, particularly the way it makes normative choices and assumptions, requires that risk assessment as a policy tool include broad-based deliberative quality assurance (Wickson, 2009). This is recognized by the EP in its calls to fully involve member states, competent scientific bodies and other relevant stakeholders in the assessment process. Since the EP, in its amendments, also challenged the appropriateness of the EFSA guidelines to have assessment led by the discredited principle of substantial equivalence (or an undefined ‘comparative safety assessment''), it is important that the guidelines themselves also remain open for critical scrutiny.The EC''s constitutional role is that of technical administrator of EU policy. Fearing that the original ideal of political union could disintegrate, the EC has often attempted to sublimate political, institutional and cultural differences into purely technical idioms. The idea is that closed, expert resolution, using the disinterested and supposedly unitary voice of science, will deliver union by abstract revelation rather than by grounded and grinding political negotiation. The tendency to redefine problematic policy issues as scientific questions only, and to assume that public concerns can be correspondingly reduced to scientific unitary terms such as ‘risk'', is understandable. This typically accompanies the increased framing of policy issues as exclusively questions of risk. Although risk has long been identified as an ambiguous combination of both propositional knowledge and value-commitments (EU, 2007; Brunk et al, 1991; Wynne, 1989)—that is, it can only be scientifically defined by first choosing what is ‘at risk'' (worth protecting)—a scientific definition of public concerns has been abetted by policy officials who are anxious to avoid or mitigate political confrontation. The more controversial that public issues involving science become, the more this aggrandisement of scientific risk assessment becomes appealing (Wynne, 2001). We are not suggesting that risks are unimportant. Rather, it is that they do not have singular meaning or definition; nor are they the sole definition of public concerns or of public policy issues.Science for policy cannot be rendered more accountable without also making accountable the policy processes that mutually shape and deploy that scienceBy seeking to establish a clean and final boundary between the social and scientific aspects of decision-making on GMO cultivation, the EC fails to acknowledge and confront the normative dimensions embedded in risk-based science for policy. This discredits the good name of science and costs it public support. The fact that the EP, led by its Environment Committee, has challenged this particular proposal is significant, but will do little to change matters unless the final legislative document incorporates the suggested EP amendments. More broadly, we argue that the EC''s background assumption of apolitical scientific sovereignty over rationally supported policy difference needs to be acknowledged, and altered.Although the precise form of the legislative amendments voted by the EP remains to be seen, the opening up of the EC''s misconceived assertion could be directly pursued through the establishment of more inclusive and plural knowledge assessment processes, under a different understanding of the kinds of knowledge in play. Such developments would increase transparency in political decision-making and its scientific justifications, rather than hiding these under a false mantle of objective, singular and uncontestable science. Science for policy cannot be rendered more accountable without also making accountable the policy processes that mutually shape and deploy that science (Jasanoff, 2004). Pursuing this would, however, require a different vision and practice of European political union; one not based on a habit of false scientific determination (Waterton & Wynne, 1996).Permitting diverse European policy options on GM cultivation and rationally diverse grounds for their justification could improve the potential for a resilient EU socio-agricultural policy portfolio. However, the cultivation of resilient diversity within European agriculture and its supporting sciences depends on the crucial question of whether GM can indeed coexist with alternative approaches, technologies and imaginaries. The scientific and political challenges associated with this, however, are a whole new kettle of fish.? Open in a separate windowFern WicksonOpen in a separate windowBrian Wynne     

Science and rock

An innovative partnership between a research institute and a music festival is helping to connect scientists and young people in Portugal. It is also bringing in money to fund research.Science, more than ever, ought to be seen as a socio-cultural activity. It is a collective enterprise involving scientists and the public, aimed at understanding the world and contributing to a better standard of living, either by having an impact on technological developments or health-related issues. Yet, the perception of science and scientists among the public is not always positive. New scientific and technological developments can sometimes be greeted with disinterest, scepticism or even fear, due largely to misinformation, political agendas and a lack of understanding of science in the public sphere. As such, there is a clear need to improve scientific education at all levels, both in schools and universities, as well as among the general public.Informal environments can be important in promoting public engagement with science-related issues. Schools cannot act alone, and evidence shows that non-school settings, which are often overlooked, can strongly stimulate and contribute to science learning [1,2]. Informal environments have two main benefits: the first is the awareness, motivation and excitement that learners experience when discovering science in an informal setting; the second is that people are more comfortable and able to interact more easily with science without feeling overwhelmed.Although tacit and not always as scientifically accurate as more formal education, science learning within informal environments can still have a positive influence on the academic success of students, as well as on the likelihood that they will ultimately consider a science-related career. Such experiences can also promote informed engagement in civic science-related issues such us environmental concerns, policies and fundraising.Importantly, learning science within these environments should be developed through partnerships between scientific institutions, local communities, funding bodies, government agencies and volunteers, all of which need to understand the overall value of science to society to engage with the project [3].Music festivals offer important advantages as informal venues for learning about science because they are interactive. This makes it possible for participants to engage emotionally and cognitively, and encourages them to extend their science learning over time. Importantly, festivals offer access to members of the public who would be unlikely to attend events such as science fairs or science cafés. The UK group Guerilla Science (http://guerillascience.co.uk), for example, has demonstrated the positive impact that these kinds of unexpected encounter with science and art can have on the public perception of science.…non-school settings, which are often overlooked, can strongly stimulate and contribute to science learningIn recent years, commercial brands have begun to see the potential of music festivals as a valuable channel to reach young people. However, rather than using traditional advertising, brands allow consumers to engage with them through different experiences in what is called ‘experimental marketing'' [4,5]. What is not so common, however, is that event organizers give scientists the opportunity to engage young people in the same way.To address this deficit and raise the profile of science at music festivals, António Coutinho, the Director of the Instituto Gulbenkian de Ciência (IGC), and Álvaro Covões, the Director of Everything is New, which organizes the popular Optimus Alive Oeiras music and art festival in Portugal, announced a new partnership between the two organizations in May 2008. In a press conference, the Directors explained the impact that they hoped bringing science to music festivals might have on the public understanding of science, while music journalists were surprised to find themselves interviewing scientists about their daily lives and research. Importantly, the Directors announced that the partnership would include a financial component, such that revenue from the festival would be used to fund fellowships at the IGC.Four years later and the partnership is still going strong. In 2011, the Coldplay concert at Optimus Alive Oeiras was sold out and fans were treated to all their favourite songs. What they were not expecting was that they would also interact with scientists from the IGC. Despite the proximity of the IGC to the festival venue, this was probably the first time that many of them had even thought about the institute, what it does and who works there.At the IGC stand, close to the main stage, science and music mix in unexpected ways. Different science-related activities are used to engage visitors. Revellersqueue to speak with scientists (Fig 1), extract DNA from strawberries by using everyday reagents, make flavoured ice-cream frozen in liquid nitrogen and find out how our genes determine eye colour, the alignment of little fingers, ear shape and the ability to roll your tongue. Visitors can take home a microcentrifuge tube containing strawberry DNA and, hopefully, a desire to know more about science and scientists. There are also ‘sci-arts'' installations and photo exhibitions about the research projects and young scientists sponsored through the partnership.Open in a separate windowFigure 1The Instituto Gulbenkian de Ciência booth at Optimus Alive Oieras in 2009. Festival-goers queue to meet scientists and conduct miniature science experiments, introducing them to science in an informal and enjoyable learning environment. Photo courtesy of Instituto Gulbenkian de Ciência.The highlight of the activities at the festival, however, is probably the ‘speed-dating'' with scientists (Fig 2). This event takes the form of a five-minute conversation between a festival-goer and a scientist in a relaxed and entertaining space. The conversations serve to break down stereotypes of scientists, encourage interest in careers in science and involve the public in scientific research. The questions asked are often insightful, surprising and thoughtful: “will we have a vaccine against cancer?”; “what degree should I take to be a scientist?”; “does a scientist also listen to music?” or even “is it safe to eat genetically modified food?” The IGC researchers who take part range from PhD students and postdocs to group leaders. They all have different backgrounds including biology, physics, bioinformatics, medicine and chemistry. The topics of conversation range from the latest work on genetics or cancer to more general questions about what motivates scientists, the day-to-day life of researchers and how research fits in with a private life. Conversations frequently last more than the allotted five minutes and the visitors have the opportunity to speak with at least three scientists from the IGC.Open in a separate windowFigure 2Speed-dating with scientists. Members of the public get five minutes to sit and talk with an Instituto Gulbenkian de Ciência scientist about life as a researcher, science and the latest research. Conversations often go on for more than five minutes and the interactions are rewarding for all participants. Photo courtesy of Instituto Gulbenkian de Ciência.The feedback from festival-goers is excellent. The opinions offered in the surveys of visitors are overwhelmingly positive: “I loved the enthusiasm of the scientists. Keep going like that. I also want to be a scientist,” wrote one respondent. “Very interesting initiative. I''m not from the natural sciences area but it was great to meet with scientists that open the doors of their research to us. Knowledge is never too much,” commented another. “This initiative was a success and we hope it happens again.” The surveys also reveal that visitors to the IGC space in the last four years—around 600 people each year—are mostly teenagers and young adults: 29% are between 13 and 19 years old, and 51% are between 20 and 29 years old. Only 15% of the visitors are between 30 and 39 years old, 4.5% are over 40 years old, and only 0.5% are under 13 years old.Web-based platforms have also been used successfully to disseminate the activities and results of the initiative. On the music festival website and its Facebook page, which are visited by thousands of people each day, a section on science is highlighted describing the partnership and the activities at the IGC space. Additionally, a Facebook page was created by the IGC, which allows the winners of the fellowships to interact with the general public (www.facebook.com/BolsasOptimusAliveOeirasIGC). On YouTube, three videos of the IGC presence at the festival, prepared by the IGC, are also available (http://www.youtube.com/user/IGCiencia).This feedback and interaction is particularly pleasing, as teenagers are a notoriously difficult audience for science engagement. If we aim to increase the number of people pursuing scientific careers, we must find new ways to attract this age group to science-related issues. According to the European Commission, Europe will need one million more researchers by 2020 than it has at present, and it is urgent that we find new ways to attract young people to careers in science [6]. A study of American teenagers shows that a lack of contact with scientists in their daily lives, and a lack of understanding of what scientists do, discourages young people from pursuing careers in scientific areas. As such, contact with motivated scientists could change these attitudes toward science and scientific careers [7].Having scientists present alongside pop stars is also a good way of showing that scientists spend their free time similarly to other people, by attending social and entertaining activities. Hopefully, this juxtaposition breaks down barriers and engages teenagers from multiple backgrounds with a broad range of interests and musical tastes. Young adults, another age group present at music festivals, are also an extremely important audience for science communication. Although they might have finished their formal education, their interest and engagement in scientific issues is still extremely important to society.Scientists gain important experiences and skills from working at the festival. For the last four years, around 70 scientists per year, mainly from the IGC, have volunteered for the IGC space at the festival (Fig 3). Science communication skills are fundamental to scientific career progress and personal fulfilment. A survey carried out by the European Molecular Biology Organization (EMBO; Heidelberg, Germany) found that senior life scientists believe that PhD and other postgraduate training programmes should give more attention to scientific communication, both public and peer-to-peer, and that these transferrable skills should be developed early and regularly updated [8,9]. Another survey by People Science & Policy (PSP), commissioned by the Royal Society, Research Councils UK and the Wellcome Trust, showed that although lack of time is a constraint, scientists want to engage more with the public, especially with policy-makers, students and industry, and that it is important that scientific institutions and other organizations find ways to facilitate public engagement by scientists [10]. As one volunteer expressed: “I have to acknowledge Everything is New and the IGC for this prestigious opportunity, as this is a new challenge for me and is a way of bringing science closer to the general public.”Open in a separate windowFigure 3The Instituto Gulbenkian de Ciência volunteers at Optimus Alive Oieras in 2009. Photo courtesy of Instituto Gulbenkian de Ciência.In addition to the value of engaging the public with science, the partnership has important financial benefits for the IGC. Fundraising is a key aspect of the partnership, which highlights the importance of private funding for biomedical research in Portugal. Everything is New, the festival promoter, supports two research fellowships per year for graduates in areas such as biodiversity, genetics and evolution. Since 2009, Optimus Alive Oeiras–IGC Research Fellowships have given young science graduates the opportunity to pursue research in areas that interest them (Sidebar A). Each fellowship is for a 12-month period and is carried out partly at the IGC and partly at a foreign institute (

The 100th of the world’s worst invasive alien species

Biological invasions are among the greatest threats to global biodiversity, but in contrast to most other global threats, they suffer from specific communication issues. Our paper presents the first new addition to the widely cited IUCN list of “100 of the world’s worst invasive species”, a list created a decade ago in response to these communication issues. We briefly present this list, the recent removal of one species from that list, and the rationale to include a novel, 100th species to replace it. The new species of this list, giant salvinia (Salvinia molesta), was chosen by the community of invasion biologists (over 650 experts from over 60 countries). This new addition to the list will draw public attention to the damage caused by invasive alien species and it will help stimulate the necessary discussion of this critical issue in science and policy circles.     

Using Win-Win Strategies to Implement Health in All Policies: A Cross-Case Analysis

Background

In spite of increasing research into intersections of public policy and health, little evidence shows how policy processes impact the implementation of Health in All Policies (HiAP) initiatives. Our research sought to understand how and why strategies for engaging partners from diverse policy sectors in the implementation of HiAP succeed or fail in order to uncover the underlying social mechanisms contributing to sustainable implementation of HiAP.

Methods

In this explanatory multiple case study, we analyzed grey and peer-review literature and key informant interviews to identify mechanisms leading to implementation successes and failures in relation to different strategies for engagement across three case studies (Sweden, Quebec and South Australia), after accounting for the role of different contextual conditions.

Findings

Our results yielded no support for the use of awareness-raising or directive strategies as standalone approaches for engaging partners to implement HiAP. However, we found strong evidence that mechanisms related to “win-win” strategies facilitated implementation by increasing perceived acceptability (or buy-in) and feasibility of HiAP implementation across sectors. Win-win strategies were facilitated by mechanisms related to several activities, including: the development of a shared language to facilitate communication between actors from different sectors; integrating health into other policy agendas (eg., sustainability) and use of dual outcomes to appeal to the interests of diverse policy sectors; use of scientific evidence to demonstrate the effectiveness of HiAP; and using health impact assessment to make policy coordination for public health outcomes more feasible and to give credibility to policies being developed by diverse policy sectors.

Conclusion

Our findings enrich theoretical understanding in an under-unexplored area of intersectoral action. They also provide policy makers with examples of HiAP across wealthy welfare regimes, and improve understanding of successful HiAP implementation practices, including the win-win approach.     

The use of research evidence in public health decision making processes: systematic review

Background

The use of research evidence to underpin public health policy is strongly promoted. However, its implementation has not been straightforward. The objectives of this systematic review were to synthesise empirical evidence on the use of research evidence by public health decision makers in settings with universal health care systems.

Methods

To locate eligible studies, 13 bibliographic databases were screened, organisational websites were scanned, key informants were contacted and bibliographies of included studies were scrutinised. Two reviewers independently assessed studies for inclusion, extracted data and assessed methodological quality. Data were synthesised as a narrative review.

Findings

18 studies were included: 15 qualitative studies, and three surveys. Their methodological quality was mixed. They were set in a range of country and decision making settings. Study participants included 1063 public health decision makers, 72 researchers, and 174 with overlapping roles. Decision making processes varied widely between settings, and were viewed differently by key players. A range of research evidence was accessed. However, there was no reliable evidence on the extent of its use. Its impact was often indirect, competing with other influences. Barriers to the use of research evidence included: decision makers'' perceptions of research evidence; the gulf between researchers and decision makers; the culture of decision making; competing influences on decision making; and practical constraints. Suggested (but largely untested) ways of overcoming these barriers included: research targeted at the needs of decision makers; research clearly highlighting key messages; and capacity building. There was little evidence on the role of research evidence in decision making to reduce inequalities.

Conclusions

To more effectively implement research informed public health policy, action is required by decision makers and researchers to address the barriers identified in this systematic review. There is an urgent need for evidence to support the use of research evidence to inform public health decision making to reduce inequalities.     

The 'atom-splitting' moment of synthetic biology. Nuclear physics and synthetic biology share common features

Synthetic biology and nuclear physics share many commonalities in terms of public perception and funding. Synthetic biologists could learn valuable lessons from the history of the atomic bomb and nuclear power.On 16 July 1945, in the desert of New Mexico, the first nuclear bomb was exploded. It was a crucial moment in the history of the physical sciences—proof positive of the immense forces at work in the heart of atoms—and inevitably changed the world. In 2010, a team at the J. Craig Venter Research Institute in the USA first created artificial life by inserting a synthetic 1.08 megabase pair genome into a mycoplasma cell that lacked its own. They demonstrated that this new cell with its man-made genome was capable of surviving and reproducing [1]. It was a colossal achievement for biology, and its significance might well rank alongside the detonation of the first atomic bomb in terms of scientific advance.…as with post-war physics, synthetic biology''s promises of a brighter future might not all materialize and could have far-reaching effects on society, science and politicsThere are several similarities between twentieth century physics, and twentieth and twenty-first century biology. The nuclear explosion in New Mexico was the result of decades of research and the first splitting of an atom in Otto Hahn''s laboratory in 1938. It ushered in an era of new ideas and hopes for a brighter future built on the power of the atom, but the terrible potential of nuclear weapons and the threat of nuclear warfare ultimately overshadowed these hopes and changed the course of science and politics. The crucial achievement of synthetic life is a strikingly similar event; the culmination of decades of research that started with its own atom-splitting moment: recombinant DNA technology. It promises to bring forth a new era for biology and enable a huge variety of applications for industry, medicine and the military. However, as with post-war physics, synthetic biology''s promises of a brighter future might not all materialize and could have far-reaching effects on society, science and politics. Biology should therefore take note of the consequences of nuclear physics'' iconic event in 1945 for science, politics and society.To appreciate the similarities of these breakthroughs and their consequences for society, it is necessary to understand the historical perspective. The pivotal discoveries for both disciplines were related to fundamental elements of nature. The rise of nuclear physics can be traced back to the discovery of neutrons by James Chadwick in 1932 [2]. Neutrons are essential to the stability of atoms as they insulate the nucleus against the repulsive forces of its positively charged protons. However, the addition of an extra neutron can destabilize the nucleus and cause it to split, releasing more neutrons and a tremendous amount of energy. This nuclear fission reaction was first described by Otto Hahn and Fritz Strassmann in 1938. Leo Szilard realized the possibility of using the neutrons released from the fission of heavy atoms to trigger a nuclear chain reaction to release huge quantities of energy. The first successful chain reactions took place in 1942 in Germany at Leipzig University in the laboratory of Robert Döpel, and in the USA at the University of Chicago in the so-called Chicago Pile-1 reactor, developed by Enrico Fermi. These first nuclear reactors provided the proof of concept for using a nuclear chain reaction as a source of energy. However, even before that, Albert Einstein and Leo Szilard wrote to US President Franklin D. Roosevelt in 1939, suggesting that the US government should develop a new powerful bomb based on nuclear fission. President Roosevelt created the Manhattan Project, which developed the first atomic bomb in 1945.Similarly to nuclear physics, the advent of rDNA technology has concerned the public…The Cold War and the mutually assured nuclear destruction between the USA and the USSR fanned widespread fears about a nuclear Third World War that could wipe out human civilization; Robert Oppenheimer, one of the physicists who developed the atomic bomb, was actually among the first to warn of the spectre of nuclear war. By contrast, the civilian use of nuclear physics, mainly in the form of nuclear reactors, promised a brave new future based on harnessing the power of the atom, but it also generated increasing concerns about the harmful effects of radioactivity, the festering problems of nuclear waste and the safety of nuclear power plants. The nuclear disasters at the Chernobyl reactor in 1986 and the Fukushima power plant in 2011 heightened these concerns to the point that several nations might now abandon nuclear energy altogether.The fundamental discovery in biology, crucial to the creation of synthetic organisms was the double helix structure of DNA in 1953 by Francis Crick and James Watson [3]. The realization that DNA molecules have a universal chemical structure to store and pass on genetic information was the intellectual basis for the development of recombinant DNA (rDNA) technology and genetic engineering. Twenty years after this discovery, Stanley Cohen and Herbert Boyer first transferred DNA from one organism into another by using endonucleases and DNA ligases [4]. This early toolkit was later expanded to include DNA sequencing and synthesizing technologies as well as PCR, which culminated in the creation of the first artificial organism in 2010. Craig Venter''s team synthesized a complete bacterial chromosome from scratch and transferred it into a bacterial cell lacking a genome: the resulting cell was able to synthesize a new set of proteins and to replicate. This proof of concept experiment now enables scientists to pursue further challenges, such as creating organisms with fully designed genomes to achieve agro-biotechnological, commercial, medical and military goals.Similarly to nuclear physics, the advent of rDNA technology has concerned the public, as many fear that genetically modified bacteria could escape the laboratory and wreak havoc, or that the technology could be abused to create biological weapons. Unlike with nuclear physics, the scientists working on rDNA technology anticipated these concerns very early on. In 1974, a group of scientists led by Paul Berg decided to suspend research into rDNA technology to discuss possible hazards and regulation. This discussion took place at a meeting in Asilomar, California, in 1975 [5].A pertinent similarity between these two areas of science is the confluence of several disciplines to create a hybrid technoscience, in which the boundaries between science and technology have become transient [6]. This convergence was vital for the success of both nuclear physics and later synthetic biology, which combines biotechnology, nanotechnology, information technologies and other new fields that have been created along the way [7]. In physics, technoscience received massive support from the government when the military potential of nuclear fission was realized. Although the splitting of the atom took place before the Manhattan Project, the Second World War served as a catalyst to combine research in nuclear physics with organized and goal-directed funding. As most of this funding came from the government, it changed the relationship between politics and research, as scientists were employed to meet specific goals. In the wake of the detonation of the first atomic bombs, the post-war period was another watershed moment for politics, technoscience, industry and society as it generated new and more intimate relationships between science and governments. These included the appointment of a scientific advisor to the President of the USA, the creation of funding organizations such as the National Science Foundation, or research organizations such as the National Aeronautics and Space Administration, and large amounts of federal funding for technoscience research at private and public universities. It also led to the formation of international organizations such as the civilian-controlled International Atomic Energy Agency [6].There is no global war to serve as a catalyst for government spending on synthetic biology. Although the research has benefited tremendously from government agencies and research infrastructure, the funding for Venter''s team largely came from the private sector. In this regard, the relationship between biological techno-science and industry might already be more advanced than with the public sector given the enormous potential of synthetic life for industrial, medical and environmental applications.Research and innovation at universities has always played a vital role in the success of industry-based capitalism [8]; technoscience is now the major determinant of a knowledge-based economy or ''technocapitalism'' [9]. At the heart of technocapitalism are private and public organizations, driven by research and innovation, which are in sharp contrast to industrial capitalism, where the factories were production-driven and research was of less importance [10]. Furthermore, synthetic biology might provide valuable resources to the scientific community and thereby generate new research opportunities and directions for many biological fields [11].However, given the far-reaching implications of creating synthetic life and the risk of abuse, it is probable that the future relationship between synthetic biology and government will include issues of national security. In the light of potential misuse of synthetic biology for bioterrorism, and the safety risks involved in commercial applications, synthetic biology will eventually require some government regulation and oversight. In contrast to nuclear physics, in which the International Atomic Energy Commission was established only after the atomic bomb, the synthetic biology community should hold a new Asilomar meeting to address concerns and formulate guidelines and management protocols, rather than waiting for politicians or commercial enterprises to regulate the field.So far, synthetic biology differs from nuclear physics in terms of handling information. The Manhattan Project inevitably created a need for secrecy as it was created at the height of the Second World War, but the research maintained this shroud of secrecy after the war. After the bombing of Hiroshima and Nagasaki in August 1945, the US government released carefully compiled documents to the American public. The existence of useable nuclear power had been secret until then, and the control of information ensured that the public further supported or tolerated the technology of nuclear fission and the subsequent use of atomic bombs [12]. This initially positive view changed in the ensuing decades with the threat of a global nuclear war.…synthetic biology has side-stepped the mistakes of nuclear physics and might well achieve a more balanced public integration of future developmentsInformation management in synthetic biology differs from nuclear physics, in that most of the crucial breakthroughs are immediately published in peer-reviewed journals and covered by the media. The value of early public discourse on science issues is evident from the reaction towards genetically modified crops and stem cell research. In this regard, synthetic biology has side-stepped the mistakes of nuclear physics and might well achieve a more balanced public integration of future developments.The main issues that might threaten to dampen public support for synthetic biology and favourable public perception are ethics and biosecurity concerns. Ethical concerns have already been addressed in several forums between scientists and public interest groups; this early engagement between science and society and their continuing dialogue might help to address the public''s ethical objections. In terms of biosecurity, biology might learn from nuclear physics'' intimate entanglement with politics and the military. Synthetic biologists should maintain control and regulation of their research and avoid the fate of nuclear physicists, who were recruited to fight the Cold War and were not free to pursue their own research. For synthetic biology to stay independent of government, industry and society, it must capitalize on its public engagement and heed the lessons and mistakes of nuclear physics'' atom-splitting moment. It should not just evaluate, discuss and address the risks for human or environmental health or biosafety concerns, but should also evaluate potential risks to synthetic biology research itself that could either come from falling public acceptance or government intrusion.? Open in a separate windowAlex J ValentineOpen in a separate windowAleysia KleinertOpen in a separate windowJerome Verdier     

Renegotiating GM crop regulation. Targeted gene-modification technology raises new issues for the oversight of genetically modified crops

Targeted genetic modification, which enables scientists to genetically engineer plants more efficiently and precisely, challenges current process-based regulatory frameworks for genetically modified crops.In 2010, more than 85% of the corn acreage and more than 90% of the soybean acreage in the USA was planted with genetically modified (GM) crops (USDA, 2010). Most of those crops contained transgenes from other species, such as bacteria, that confer resistance to herbicides or tolerance to insect pests, and that were introduced into plant cells using Agrobacterium or other delivery methods. The resulting ‘transformed'' cells were regenerated into GM plants that were tested for the appropriate expression of the transgenes, as well as for whether the crop posed an unacceptable environmental or health risk, before being approved for commercial use. The scientific advances that enabled the generation of these GM plants took place in the early 1980s and have changed agriculture irrevocably, as evidenced by the widespread adoption of GM technology. They have also triggered intense debates about the potential risks of GM crops for human health and the environment and new forms of regulation that are needed to mitigate this. There is also continued public resistance to GM crops, particularly in Europe.Plant genetic engineering is at a technological inflection pointPlant genetic engineering is at a technological inflection point. New technologies enable more precise and subtler modification of plant genomes (Weinthal et al, 2010) than the comparably crude methods that were used to create the current stock of GM crops (Fig 1A). These methods allow scientists to insert foreign DNA into the plant genome at precise locations, remove unwanted DNA sequences or introduce subtle modifications, such as single-base substitutions that alter the activity of individual genes. They also raise serious questions about the regulation of GM crops: how do these methods differ from existing techniques and how will the resulting products be regulated? Owing to the specificity of these methods, will resulting products fall outside existing definitions of GM crops and, as a result, be regulated similarly to conventional crops? How will the definition and regulation of GM crops be renegotiated and delineated in light of these new methods?Open in a separate windowFigure 1Comparing traditional transgenesis, targeted transgenesis, targeted mutagenesis and gene replacement. (A) In traditional transgenesis, genes introduced into plant cells integrate at random chromosomal positions. This is illustrated here for a bacterial gene that confers herbicide resistance (Herb^r). The plant encodes a gene for the same enzyme, however due to DNA-sequence differences between the bacterial and plant forms of the gene, the plant gene does not confer herbicide resistance (Herb^s). (B) The bacterial herbicide-resistance gene can be targeted to a specific chromosomal location through the use of engineered nucleases. The nucleases recognize a specific DNA sequence and create a chromosome break. The bacterial gene is flanked by sequences homologous to the target site and recombines with the plant chromosome at the break site, resulting in a targeted insertion. (C) Engineered nucleases can be used to create targeted gene knockouts. In this illustration, a second nuclease recognizes the coding sequence of the Herb^s gene. Cleavage and repair in the absence of a homologous template creates a mutation (orange). (D) A homologous DNA donor can be used to repair targeted breaks in the Herb^s gene. This allows sequence changes to be introduced into the native plant gene that confer herbicide resistance. Only a single base change is needed in some instances.Of the new wave of targeted genetic modification (TagMo) techniques, one of the most thoroughly developed is TagMo, which uses engineered zinc-finger nucleases or meganucleases to create DNA double-stranded breaks at specific genomic locations (Townsend et al, 2009; Shukla et al, 2009; Gao et al, 2010). This activates DNA repair mechanisms, which genetic engineers can use to alter the target gene. If, for instance, a DNA fragment is provided that has sequence similarity with the site at which the chromosome is broken, the repair mechanism will use this fragment as a template for repair through homologous recombination (Fig 1B). In this way, any DNA sequence, for instance a bacterial gene that confers herbicide resistance, can be inserted at the site of the chromosome break. TagMos can also be used without a repair template to make single-nucleotide changes. In this case, the broken chromosomes are rejoined imprecisely, creating small insertions or deletions at the break site (Fig 1C) that can alter or knock out gene function.TagMo technology would, therefore, challenge regulatory policies both in the USA and, even more so, in the [EU]…The greatest potential of TagMo technology is in its ability to modify native plant genes in directed and targeted ways. For example, the most widely used herbicide-resistance gene in GM crops comes from bacteria. Plants encode the same enzyme, but it does not confer herbicide resistance because the DNA sequence is different. Yet, resistant forms of the plant gene have been identified that differ from native genes by only a few nucleotides. TagMo could therefore be used to transfer these genes from a related species into a crop to replace the existing genes (Fig 1D) or to exchange specific nucleotides until the desired effect is achieved. In either case, the genetic modification would not necessarily involve transfer of DNA from another species. TagMo technology would, therefore, challenge regulatory policies both in the USA and, even more so, in the European Union (EU). TagMo enables more sophisticated modifications of plant genomes that, in some cases, could be achieved by classical breeding or mutagenesis, which are not formally regulated. On the other hand, TagMo might also be used to introduce foreign genes without using traditional recombinant DNA techniques. As a result, TagMo might fall outside of existing US and EU regulatory definitions and scrutiny.In the USA, federal policies to regulate GM crops could provide a framework in which to consider the way TagMo-derived crops might be regulated (Fig 2; Kuzma & Meghani, 2009; Kuzma et al, 2009; Thompson, 2007; McHughen & Smyth, 2008). In 1986, the Office of Science and Technology Policy established the Coordinated Framework for the Regulation of Biotechnology (CFRB) to oversee the environmental release of GM crops and their products (Office of Science and Technology Policy, 1986). The CFRB involves many federal agencies and is still in operation today (Kuzma et al, 2009). It was predicated on the views that regulation should be based on science and that the risks posed by GM crops were the “same in kind” as those of non-GM products; therefore no new laws were deemed to be required (National Research Council, 2000).Open in a separate windowFigure 2Brief history of the regulation of genetic engineering (Kuzma et al, 2009). EPA, Environmental Protection Agency; FIFRA, Federal Insecticide, Fungicide and Rodenticide Act; FDA, Food and Drug Administration; FPPA, Farmland Protection Policy Act; GMO, genetically modified organism; TOSCA, Toxic Substances Control Act; USDA, United States Department of Agriculture.Various old and existing statutes were interpreted somewhat loosely in order to oversee the regulation of GM plants. Depending on the nature of the product, one or several federal agencies might be responsible. GM plants can be regulated by the US Department of Agriculture (USDA) under the Federal Plant Pest Act as ‘plant pests'' if there is a perceived threat of them becoming ‘pests'' (similarly to weeds). Alternatively, if they are pest-resistant, they can be interpreted as ‘plant pesticides'' by the US Environmental Protection Agency (EPA) under the Federal Insecticide, Fungicide, and Rodenticide Act. Each statute requires some kind of pre-market or pre-release biosafety review—evaluation of potential impacts on other organisms in the environment, gene flow between the GM plant and wild relatives, and potential adverse effects on ecosystems. By contrast, the US Food and Drug Administration (FDA) treats GM food crops as equivalent to conventional food products; as such, no special regulations were promulgated under the Federal Food Drug and Cosmetic Act for GM foods. The agency established a pre-market consultation process for GM and other novel foods that is entirely voluntary.…TagMo-derived crops come in several categories relevant to regulation…Finally, and important for our discussion, the US oversight system was built mostly around the idea that GM plants should be regulated on the basis of characteristics of the end-product and not on the process that is used to create them. In reality, however, the process used to create crops is significant, which is highlighted by the fact that the USDA uses a process-based regulatory trigger (McHughen & Smyth, 2008). Instead of being inconsequential, it is important for oversight whether a plant is considered to be a result of GM.How will crops created by TagMo fit into this regulatory framework? If only subtle changes were made to individual genes, the argument could be made that the products are analogous to mutated conventional crops, which are neither regulated nor subject to pre-market or pre-release biosafety assessments (Breyer et al, 2009). However, single mutations are not without risks; for example, they can lead to an increase in expressed plant toxins (National Research Council, 1989, 2000, 2002, 2004; Magana-Gomez & de la Barca 2009). Conversely, if new or foreign genes are introduced through TagMo methods, the resulting plants might not differ substantially from existing GM crops. Thus, TagMo-derived crops come in several categories relevant to regulation: TagMo-derived crops with inserted foreign DNA from sexually compatible or incompatible species; TagMo-derived crops with no DNA inserted, for instance those in which parts of the chromosome have been deleted or genes inactivated; and TagMo-derived crops that either replace a gene with a modified version or change its nucleotide sequence (Fig 1).TagMo-derived crops with foreign genetic material inserted are most similar to traditional GM crops, according to the USDA rule on “Importation, Interstate Movement, and Release Into the Environment of Certain Genetically Engineered Organisms”, which defines genetic engineering as “the genetic modification of organisms by recombinant DNA (rDNA) techniques” (USDA, 1997). In contrast to conventional transgenesis, TagMo enables scientists to predefine the sites into which foreign genes are inserted. If the site of foreign DNA insertion has been previously characterized and shown to have no negative consequences for the plant or its products, then perhaps regulatory requirements to characterize the insertion site and its effects on the plant could be streamlined.TagMo might be used to introduce foreign DNA from sexually compatible or incompatible species into a host organism, either by insertion or replacement. For example, foreign DNA from one species of Brassica—mustard family—can be introduced into another species of Brassica. Alternatively, TagMo might be used to introduce foreign DNA from any organism into the host, such as from bacteria or animals into plants. Arguments have been put forth advocating less stringent regulation of GM crops with cisgenic DNA sequences that come from sexually compatible species (Schouten et al, 2006). Russell and Sparrow (2008) critically evaluate these arguments and conclude that cisgenic GM crops may still have novel traits in novel settings and thus give rise to novel hazards. Furthermore, if cisgenics are not regulated, it might trigger a public backlash, which could be more costly in the long run (Russell & Sparrow, 2008). TagMo-derived crops with genetic sequences from sexually compatible species should therefore still be considered for regulation. Additional clarity and consistency is needed with respect to how cisgenics are defined in US regulatory policy, regardless of whether they are generated by established methods or by TagMo. The USDA regulatory definition of a GM crops is vague, and the EPA has a broad categorical exemption in its rules for GM crops with sequences from sexually compatible species (EPA, 2001).Public failures will probably ensue if TagMo crops slip into the market under the radar without adequate oversightThe deletion of DNA sequences by TagMo to knock out a target gene is potentially of great agronomic value, as it could remove undesirable traits. For instance, it could eliminate anti-nutrients such as trypsin inhibitors in soybean that prevent the use of soy proteins by animals, or compounds that limit the value of a crop as an industrial material, such as ricin, which contaminates castor oil. Many mutagenesis methods yield similar products as TagMos. However, most conventional mutagenesis methods, including DNA alkylating agents or radioactivity, provide no precision in terms of the DNA sequences modified, and probably cause considerable collateral damage to the genome. It could be argued that TagMo is less likely to cause unpredicted genomic changes; however, additional research is required to better understand off-target effects—that is, unintended modification of other sites—by various TagMo platforms.We propose that the discussion about how to regulate TagMo crops should be open, use public engagement and respect several criteria of oversightGenerating targeted gene knockouts (Fig 1C) does not directly involve transfer of foreign DNA, and such plants might seem to warrant an unregulated status. However, most TagMos use reagents such as engineered nucleases, which are created by rDNA methods. The resulting product might therefore be classified as a GM crop under the existing USDA definition for genetic engineering (USDA, 1997) since most TagMos are created by introducing a target-specific nuclease gene into plant cells. It is also possible to deliver rDNA-derived nucleases to cells as RNA or protein, and so foreign DNA would not need to be introduced into plants to achieve the desired mutagenic outcome. In such cases, the rDNA molecule itself never encounters a plant cell. More direction is required from regulatory agencies to stipulate the way in which rDNA can be used in the process of generating crops before the regulated status is triggered.TagMo-derived crops that introduce alien transgenes or knock out native genes are similar to traditional GM crops or conventionally mutagenized plants, respectively, but TagMo crops that alter the DNA sequence of the target gene (Fig 1D) are more difficult to classify. For example, a GM plant could have a single nucleotide change that distinguishes it from its parent and that confers a new trait such as herbicide resistance. If such a subtle genetic alteration were attained by traditional mutagenesis or by screening for natural variation, the resulting plants would not be regulated. As discussed above, if rDNA techniques are used to create the single nucleotide TagMo, one could argue that it should be regulated. Regulation would then focus on the process rather than the product. If single nucleotide changes were exempt, would there be a threshold in the number of bases that can be modified before concerns are raised or regulatory scrutiny is triggered? Or would there be a difference in regulation if the gene replacement involves a sexually compatible or an incompatible species?Most of this discussion has focused on the use of engineered nucleases such as meganucleases or zinc-finger nucleases to create TagMos. Oligonucleotide-mediated mutagenesis (OMM), however, is also used to modify plant genes (Breyer et al, 2009). OMM uses chemically synthesized oligonucleotides that are homologous to the target gene, except for the nucleotides to be changed. Breyer et al (2009) argue that OMM “should not be considered as using recombinant nucleic acid molecules” and that “OMM should be considered as a form of mutagenesis, a technique which is excluded from the scope of the EU regulation.” However, they admit that the resulting crops could be considered as GM organisms, according to EU regulatory definitions for biotechnology. They report that in the USA, OMM plants have been declared non-GM by the USDA, but it is unclear whether the non-GM distinction in the USA has regulatory implications. OMM is already being used to develop crops with herbicide tolerance, and so regulatory guidelines need to be clarified before market release.In turning to address how TagMo-related oversight should proceed, two questions are central: how are decisions made and who is involved in making them? The analysis above illustrates that many fundamental decisions need to be made concerning the way in which TagMo-derived products will be regulated and, more broadly, what constitutes a GM organism for regulatory purposes. These decisions are inherently values-based in that views on how to regulate TagMo products differ on the basis of understanding of and attitudes towards agriculture, risk, nature and technology. Neglecting the values-based assumptions underlying these decisions can lead to poor decision-making, through misunderstanding the issues at hand, and public and stakeholder backlash resulting from disagreements over values.Bozeman & Sarewitz (2005) consider this problem in a framework of ‘market failures'' and ‘public failures''. GM crops have exhibited both. Market failures are exemplified by the loss of trade with the EU owing to different regulatory standards and levels of caution (PIFB, 2006). Furthermore, there has been a decline in the number of GM crops approved for interstate movement in the USA since 2001. Public failures result from incongruence between actions by decision-makers and the values of the public. Public failures are exemplified by the anti-GM sentiment in the labelling of organic foods in the USA and court challenges to the biosafety review of GM crops by the USDA''s Animal and Plant Health Inspection Service (McHughen & Smyth, 2008). These lawsuits have delayed approval of genetically engineered alfalfa and sugar beet, thus blurring the distinction between public and market failures. Public failures will probably ensue if TagMo crops slip into the market under the radar without adequate oversight.The possibility of public failures with TagMo crops highlights the benefits of an anticipatory governance-based approach, and will help to ensure that the technology meets societal needsAnticipatory governance is a framework with principles that are well suited to guiding TagMo-related oversight and to helping to avoid public failures. It challenges an understanding of technology development that downplays the importance of societal factors—such as implications for stakeholders and the environment—and argues that societal factors should inform technology development and governance from the start (Macnaghten et al, 2005).Anticipatory governance uses three principles: foresight, integration of natural and social science research, and upstream public engagement (Karinen & Guston, 2010). The first two principles emphasize proactive engagement using interdisciplinary knowledge. Governance processes that use these principles include real-time technology assessment (Guston & Sarewitz, 2002) and upstream oversight assessment (Kuzma et al, 2008b). The third principle, upstream public engagement, involves stakeholders and the public in directing values-based assumptions within technology development and oversight (Wilsdon & Wills, 2004). Justifications for upstream public engagement are substantive (stakeholders and the public can provide information that improves decisions), instrumental (including stakeholders and the public in the decision-making process leads to more trusted decisions) and normative (citizens have a right to influence decisions about issues that affect them).TagMo crop developers seem to be arguing for a ‘process-based'' exclusion of TagMo crops from regulatory oversight, without public knowledge of their development or ongoing regulatory communication. We propose that the discussion about how to regulate TagMo crops should be open, use public engagement and respect several criteria of oversight (Kuzma et al, 2008a). These criteria should include not only biosafety, but also broader impacts on human and ecological health and well-being, distribution of health impacts, transparency, treatment of intellectual property and confidential business information, economic costs and benefits, as well as public confidence and values.We also propose that the CFRB should be a starting point for TagMo oversight. The various categories of TagMo require an approach that can discern and address the risks associated with each application. The CFRB allows for such flexibility. At the same time, the CFRB should improve public engagement and transparency, post-market monitoring and some aspects of technical risk assessment.As we have argued, TagMo is on the verge of being broadly implemented to create crop varieties with new traits, and this raises many oversight questions. First, the way in which TagMo technologies will be classified and handled within the US regulatory system has yet to be determined. As these decisions are complex, values-based and have far-reaching implications, they should be made in a transparent way that draws on insights from the natural and social sciences, and involves stakeholders and the public. Second, as products derived from TagMo technologies will soon reach the marketplace, it is important to begin predicting and addressing potential regulatory challenges, to ensure that oversight systems are in place. The possibility of public failures with TagMo crops highlights the benefits of an anticipatory governance-based approach, and will help to ensure that the technology meets societal needs.So far, the EU has emphasized governance approaches and stakeholder involvement in the regulation of new technologies more than the USA. However, if the USA can agree on a regulatory system for TagMo crops that is the result of open and transparent discussions with the public and stakeholders, it could take the lead and act as a model for similar regulation in the EU and globally. Before this can happen, a shift in US approaches to regulatory policy would be needed.? Open in a separate windowJennifer KuzmaOpen in a separate windowAdam Kokotovich     

Cultivating participatory policy processes for genetic resources policy: lessons from the Genetic Resources Policy Initiative (GRPI) project

The purpose of the paper is to draw lessons and document experiences from the Genetic Resources Policy Initiative (GRPI) project, a project which has been underway in six countries and two sub-regions during the last 5 years. Its focus has been to experiment an approach to participatory policy processes, coined by the project, called the multi-stakeholder, multi-disciplinary and multi-sector or in short the 3M. This approach, which was demand-driven due to the nature of the policy problems being examined, aims to create a platform to address competing interests inherent in genetic resources issues from multiple perspectives. It is meant to enable different stakeholders to balance issues they diverge and/or converge upon in genetic resources management, thereby harmonizing trade-offs, objectives and strategies. Experiences from the project in applying the 3M in Egypt, Nepal, Vietnam Peru and Zambia highlight several lessons in participatory policy processes. The experiences show that the success or otherwise of participatory policy making processes is dependent on various factors that have to do with stakeholder capacities, process orientation, shared understanding versus vested interests and institutional functions. They highlight that the most effective approach to stakeholder engagement in policy processes is to construct them around an actively engaged ‘process leader’ that possesses, or has the potential to champion the process by mobilising the required cognitive knowledge and institutional engagement. They further suggest that since genetic resources policy issues are cross-cutting, they will demand a more holistic approach with a clear identification of impact pathways through which policy changes can be expected to influence the outcome variables. Since policy making processes are perpetual, the question of sustaining project ideas and recommendations beyond the life of a project has to be part of the planning exercise in any participatory genetic resources policy research and formulation.