Scientific Advisory Body Research Articles

Sensory irritation and use of the best available science in setting exposure limits: Issues raised by a scientific panel review of formaldehyde human research studies

As a high production volume chemical with recognized sensory irritation and widespread exposure, the human health risk potential of formaldehyde has been reviewed by many international regulatory agencies and scientific advisory bodies. A scientific panel, the Human Studies Review Board, under the auspices of the EPA's Toxic Substances Control Act (TSCA) program recently reviewed the sensory irritation studies included in the 2022 Draft Integrated Risk Information System (IRIS) Formaldehyde Hazard Assessment in the context of their use in a weight of evidence evaluation of acute inhalation health effects. This panel issued a series of recommendations on the use of these studies for the purposes of calculating exposure limits (e.g., study design preferences; uncertainty adjustment). Considering that these recommendations might reflect topic areas with varying degrees of scientific consensus, this commentary reflects on commonalities and distinctions amongst international formaldehyde exposure limits based on sensory irritation. Notably, each review panel charged with an assessment of the science recommended that no adjustment was needed to account for either exposure duration or human variability. These areas of scientific consensus should be considered as the best available science for the purposes of setting exposure limits in the anticipated TSCA Risk Evaluation on formaldehyde.

Equilibrium, transient dynamics and sustainable reference points under age-specific natural mortality rates and varying levels of population productivity: The case of the Northern cod stock

Scientific advisory bodies provide scientific advice for sustainable fisheries management based on the precautionary approach and maximum sustainable yield (MSY) reference points, such as spawning stock biomass (SSB) value Blim, and fishing mortality giving MSY, FMSY. The lack of a stock-recruitment function (SRF) to identify a clear breakpoint Blim has recently emerged in important stock collapses. It also precludes the use of equilibrium-based methods to analyze the sustainability of FMSY. Considering a hockey stick (HS) SRF, we propose here an equilibrium-based method that characterizes the equilibriums, their stability properties, transient dynamics, and changes in productivity (including age-specific natural mortality rates). We show that these relevant factors, not taken into account in standard methods, should play a central role in fisheries management and conservation. Considering the Northern cod stock (NCS) (Gadus morhua) by way of illustration, we properly estimate the HS and its associated Blim. We find that the HS fitted by the Fisheries Library in R underestimates Blim. Additionally, we determine the levels of productivity (medium-low or medium-high), and their corresponding growth rates of the SSB, which are consistent with the observed population dynamics. We find that the NCS was managed during the 1980s under myopic (unsustainable) harvest control rules, neglecting high age-specific natural mortality rates. We also find that recovery of the NCS remains a distant prospect, despite the current stable, positive equilibrium (sustainable FMSY).

Public perception of scientific advisory bodies: the case of France’s Covid-19 Scientific Council

Abstract During the Covid-19 pandemic, many governments have resorted to scientific advisory bodies to aid in public health decision-making. What then has been the public’s perception of those new structures of scientific advice? In this article, we draw on a survey conducted in November 2020 among a representative sample of the French adult population (n = 1,004) designed specifically to explore public perceptions of the dedicated Covid-19 Scientific Council created in March 2020 and of scientific advice in general. After only 8 months, three-quarters of French people said they had heard of it, but only a quarter had a positive opinion about its usefulness. Despite the diversity of perceptions of what scientific advice is and should be, it appeared that scientific advice bodies are perceived as useful mainly by a public already largely supportive of the delegation of the management of public life to the government and public institutions.

Mobilization of science advice by the Canadian federal government to support the COVID-19 pandemic response

The procurement and provision of expert-driven, evidence-informed, and independent science advice is integral to timely decision-making during public health emergencies. The 2019 coronavirus disease (COVID-19) pandemic has underscored the need for sound evidence in public health policy and exposed the challenges facing government science advisory mechanisms. This paper is a jurisdictional case study describing (i) the federal science advice bodies and mechanisms for public health in Canada (i.e., the federal science advice “ecosystem”); and (ii) how these bodies and mechanisms have mobilized and evolved to procure expertise and evidence to inform decisions during the first two years of the COVID-19 pandemic. We reviewed publicly accessible Government of Canada documents, technical reports, and peer-reviewed articles available up to December 2021. Canada’s federal landscape of science advisory bodies for public health within the Health Portfolio was largely shaped by Canada’s experiences with the 2003 severe acute respiratory syndrome and 2009 H1N1 outbreaks. In parallel, Canada has a designated science advisory apparatus that has seen frequent reforms since the early 2000s, with the current Office of the Chief Science Advisor created within the Science Portfolio in 2018. The COVID-19 pandemic has further complicated Canada’s science advice ecosystem, with involvement from departments, expert advisory groups, and partnerships within both the federal Health and Science Portfolios. Although the engagement of federal departments outside the health sector is promising, the COVID-19 experience in Canada supports the need to institutionalize science advisory bodies for public health to improve pandemic preparedness and ensure rapid mobilization of well-coordinated and independent advice in future emergencies. This review also identified pressing areas for further inquiry to strengthen science advice for public health in Canada, including to assess the independence of science advisory actors and the interaction between federal and subnational authorities.

The Dutch see Red: (in)formal science advisory bodies during the COVID-19 pandemic

We analyse the roles, dynamics and logic of science advice in structuring the Dutch response to the COVID-19 pandemic, from January 2020 to December 2020. We address how the Dutch government responded by paying attention to styles of governance and expert advice. We argue that the Dutch response was shaped by the interplay of corporatist, deliberative and neoliberal forms of governance, in particular, how early corporatist tendencies seemed to create consensus during the first phase of the pandemic but quickly led to criticism and tension, most visibly at the onset of the second wave, as corporatist and neoliberal responses conflicted with deliberative and pluralist political engagement. Situating different science advisory bodies in this dynamic, we highlight how science–policy interactions and conflicts that evolved with the dynamics of the pandemic can be understood within this triad and as reflective broadly of the endurance of the Dutch model of polder governance.

Lessons from the UK’s handling of Covid-19 for the future of scientific advice to government: a contribution to the UK Covid-19 Public Inquiry

ABSTRACT Despite strong expertise and a sophisticated scientific advisory system, the UK’s response to the Covid-19 pandemic has been, and continues to be, weak in terms of preventing death and illness, and damage to the economy. This article argues that an important reason for this failure has been that the policies of the UK government have at critical times failed to take adequate account of scientific evidence, while at the same time attempts have been made to blame scientists for resulting policy failures. This paper analyses the role of scientific advice in addressing Covid-19 in the UK and draws three lessons for how such expertise can be better deployed in the future. It argues that: (1) Government scientific advisors and advisory bodies should be more independent of political influence and interference; (2) Government scientific advisors should be empowered to challenge misrepresentation and misuse by decision-makers of the scientific evidence, and undermining of public-health policies; and (3) Government scientific advice should be more transparent and advisors should engage more proactively with the public. Acting on these lessons will be important for ongoing handling of the current crisis, for the current UK Covid-19 Public Inquiry, and for the UK’s preparedness for future crises.

‘Getting the Science Right’? Epistemic Framings of Global Soil and Land Degradation

International environmental advisory bodies are tasked with the daunting challenge of collecting and synthesizing knowledge about a specific issue-area by speaking in one ‘global scientific voice’. However, the ‘type of knowledge’ issuing from these bodies can hardly meet the expectations of ‘getting the science right’, as scientific issues inevitably end up being framed in different ways. Although accounts of contestation between various knowledge claims are abundant in the literature focusing on international advisory bodies, the implications of these tensions for science–policy interplay remain poorly understood. In particular, analyses of and reflections on the relationship between knowledge outputs and particular institutional arrangements are underdeveloped. This paper attempts to address this gap, postulating a link between knowledge outcomes and institutional design. By introducing the concept of ‘epistemic framings’, it explores the different ways in which soil and land degradation issues are framed by scientific advisory bodies at the global level. The analysis, conducted through the Qualitative Content Analysis (QCA) method, suggests that international scientific advisory bodies may frame epistemic issues in ways that are influenced by the policy setting to which they are institutionally bound. Further research on the dynamics of science–policy interaction at the global level could test the assumptions made in this paper and shed light on the structural (including institutional design) and agential factors influencing advisory bodies’ epistemic framings.

EFSA International Workshop on RA of Combined Exposure to Multiple Chemicals

Human Risk Assessment (RA) of combined exposure to multiple chemicals follows the steps of RA namely problem formulation, exposure assessment, hazard assessment and risk characterisation. Over the last decade, scientific advisory bodies have published a range of harmonised guidance documents to provide practical approaches for risk assessors. These include the WHO, the US-EPA, the Joint Research Centre (JRC) of the European Commission, the OECD and the recent EFSA MIXTOX guidance document dealing with harmonised methodologies for the human health, animal health and ecological RA areas. On May 21st 2021, the Scientific Committee of EFSA published a draft guidance document on scientific criteria to group chemicals in assessment groups using hazard-driven criteria and prioritisation methods using exposure-driven and risk-based approaches. The latter guidance and future challenges were the topic of this international workshop which was held online in the afternoons of the 18th, 19th and 20st October 2021. First, a plenary session provided overviews of European and international activities in the field including WHO, OECD, US-EPA, JRC and EFSA. With a total of 118 participants including national and international scientific advisory bodies, academics and researchers, NGOs, industry, risk assessors, risk managers, four discussions groups were created for three break-out group sessions: 1) Hazard-driven criteria for grouping multiple chemicals into assessment groups; 2) Exposure-driven and risk-based criteria for the prioritisation of multiple chemicals 3) Data gaps and future challenges for human health and environmental RA of combined exposure to multiple chemicals to identify priority topics of international relevance and a way forward to address these topics. A final discussion and wrap-up session concluded the meeting. This event report provides a summary of the discussions together with conclusions and recommendations.

Outcome of the public consultation on the draft EFSA ‘Guidance Document on Scientific criteria for grouping chemicals into assessment groups for human risk assessment of combined exposure to multiple chemicals’

The European Food Safety Authority (EFSA) carried out a public consultation to receive input from the scientific community and all interested parties on the draft guidance of the working group of the Scientific Committee ‘Guidance Document on Scientific criteria for grouping chemicals into assessment groups for human risk assessment of combined exposure to multiple chemicals’. The background and the Terms of Reference were prepared by EFSA staff and the working group of the Scientific Committee was set up in 2019. The draft guidance was developed by the working group and endorsed by the Scientific Committee for public consultation at its plenary meeting of 17 April 2021. The written public consultation for this document was opened from 29 May to 10 July 2021. EFSA received responses from 12 interested parties (industry, industry associations, NGOs, consultancy companies, national scientific advisory bodies and individual scientists). EFSA and its Scientific Committee wish to thank all stakeholders for their contributions. In addition, EFSA organised an International Workshop on “Risk Assessment of Combined Exposure to Multiple Chemicals” on 18, 19 and 20 October 2021 to discuss specifically hazard-based criteria and prioritisation methods from the guidance document as well future challenges in the area of risk assessment of combined exposure to multiple chemicals. This report presents the comments received from the public consultation and the international workshop and addressed after consideration by the working group of the Scientific Committee and by the Scientific Committee at its Plenary meeting of 17 November 2021.

Ethics and Responsibility of Scientific Researchers in a Pandemic Era.

The purpose of this paper is to critique the links between science and scientific researchers, politics and capital surrounding vaccines and vaccination in a pandemic era. It also introduces standards for adapting ethical guidelines for research under public health emergencies to specific circumstances and contexts. It also introduces ethical standards to be applied to scientific research. that is, scientific relevance, social value, cooperative partnerships, reasonable risk-benefit costs, fair and voluntary participation, independent review, and equal moral respect for participants and affected communities. It also outlines the COVID-19 (coronavirus disease 2019) pandemic-consent and other research procedure modifications proposed by Oregon Health and Science University (OHSU). We are on the lookout for powerful capital and hegemonic groups inseparable from politics and important decision makers in the pandemic era - that is, scientists, supporters, and scientific civic groups. It underscores the need for an independent and formal scientific advisory body with the right balance between science and politics.

New WHO Science Council takes on genomic technologies

A scientific advisory body set up by the World Health Organization met for the first time April 27 and began discussing how genomic technologies could be better used in global health. The WHO’s dir...

Policy responses and government science advice for the COVID 19 pandemic in the Philippines: January to April 2020

In this paper we examine two policy questions about the COVID 19 pandemic in the Philippines. These are science informed policy questions that will have to take into consideration a large degree of uncertainties in outcomes. The first question is on when to lift the Enhanced Community Quarantine (ECQ) as informed by epidemiological modelling. The second deals on how the Philippines can respond to a future pandemic crisis. We review the Philippine government's responses and introduce the complicating scientific, social, and political contexts for both questions and address proposals for strengthening the science advisory structures. We propose a permanent science advisory body for emergencies with the widest source of expertise as needed.

Canary in the Coal Mine: Using Early Data to Aid Policy Makers Manage the Spread of Covid-19 Pandemic

When would the COVID-19 outbreak peak? What is the transmission-rate? How long will the outbreak last? As the COVID-19 pandemic grows around the world, governments and businesses are interested in the answers to these questions. While sophisticated epidemiological studies have appeared in the press, majority of the world cannot run these models, interpret the numbers, and translate them to policy decisions. Consequently, governments and businesses must rely on scientific advisory bodies to enact policies. The wait between translation of scientific insights to actionable policies are leading to loss of precious time. Our work shows that using a classical new-product forecasting model from the marketing domain, policy makers can generate directional outlooks in the early period of the outbreak, especially when lack of data prevents sophisticated epidemiological models to be deployed. With as little as 2-4 weeks of new case data, this model can be implemented on a spreadsheet and answer all the three questions for an outbreak at a country, region, or county level. We test the model on the outbreak data from Hubei province, Korea, Italy, France, India and United States and find meaningful directional outlooks that can be translated to effective policies.

Three Decades of Learning-by-Doing: The Evolving Climate Change Mitigation Policy of the European Union

This chapter traces the evolution of EU climate change mitigation policy over the past 30 years. It divides the development of EU climate policy into four phases and highlights their links with the international climate policy process under the United Nations Framework Convention on Climate Change (UNFCCC). The chapter also analyses the future prospects of EU climate policy in light of the European Commission’s 2019 proposal for a European Green Deal. The chapter shows that in the past three decades, the EU has developed an extensive climate policy framework that reflects the special nature of the EU as a supranational construct of 27 Member States. The EU framework can offer useful lessons for other jurisdictions on how a group of socially and economically diverse countries can cooperate intensively to mitigate climate change. It also includes many important lessons in terms of the governance structures used and alignment with international climate change treaties. However, the chapter also identifies gaps and important room for improvement. These relate to comprehensiveness (such as providing incentives for negative emissions) and governance (such as a long-term target enshrined in law and the creation of an independent scientific advisory body). Furthermore, while the EU’s climate policy framework can be praised for using internal fairness and equity criteria for allocating responsibilities between the Member States and compensating those with fewer resources or critically affected interests, the EU’s mitigation ambition is not based on any explicit criteria for global fairness and equity, and the bloc’s ambition is arguably not in line with the 1.5/2°C temperature goal included in the Paris Agreement.

Performance Evaluation of LC-MS Methods for Multimycotoxin Determination

Abstract The co-occurrence of regulated mycotoxins in foods and feeds, together with modified (“masked”) and emerging mycotoxins, has been increasingly reported worldwide in recent years. Therefore, sensitive, accurate, and validated methods for the simultaneous determination of these hazardous contaminants in different matrices are highly demanded to fulfil regulatory requirements and to carry out reliable surveillance programs. In these last years, LC-MS methodologies for multimycotoxin screening and/or quantification are being routinely used in control laboratories. However, to date, only one European Standard for multimycotoxin determination is based on LC-MS (EN 16877:2016). The need for standardized LC-MS methods for multimycotoxin determination has been highlighted by regulatory authorities and scientific advisory bodies, including the U.S. Food and Drug Administration and the European Commission. The European Committee for Standardization (CEN) has issued calls for tender for the development of standardized LC-MS methods for mycotoxins in food and animal feeding stuffs. As deliverables, some LC-MS based methods for multimycotoxin determination are currently under approval as European Standards. In addition, the European Commission has recently established specific criteria with which screening methods for mycotoxins, including LC-MS methods, have to comply for use for regulatory purposes. Validation procedures by single-laboratory and collaborative trials have been defined. This paper provides insights and advances on guidelines and tools for performance evaluation of LC-MS methods intended for quantitative determination and for semiquantitative screening of multimycotoxins. In particular, performance criteria set in the European Union and the United States are critically overviewed, and expectations, needs, and future challenges relevant to LC-MS methods for multimycotoxin determination are also discussed.

Fit for Purpose: An Evolutionary Strategy for the Implementation and Verification of the Treaty on the Prohibition of Nuclear Weapons

ABSTRACTThe Treaty on the Prohibition of Nuclear Weapons requires States Parties to designate a “competent international authority or authorities” for negotiating and verifying the irreversible elimination of nuclear-weapons programs. Ensuring that such an authority or authorities is able to be fit for purpose when required to meet these tasks will be crucial for both the future implementation and legitimacy of the Treaty. To address this challenge, this article proposes the early creation of a two-part organizational structure, comprising an implementation support unit and a dedicated scientific and technical advisory body, to begin the process of institutionalizing the treaty, and build the technical basis for meeting its verification goals should a nuclear-weapon-possessing state decide to join. The article then discusses how such two-part structure could be scaled-up as a standing international organization tasked with the coordination of an ad hoc inspectorate, which would also cooperate and complement the work of existing nuclear verification organizations, such as the International Atomic Energy Agency. This evolutionary and adaptive strategy to institution building could empower the new Treaty by supporting the emergence of a new regime complex for nuclear disarmament, while taking into account the initially limited financial and technical resources of its member states.

Communicating to and engaging with the public in regulatory science.

This paper presents selected highlights from the ‘Engaging with society’ session of EFSA's third Scientific Conference ‘Science, Food and Society’ (Parma, Italy, 18–21 September 2018). The social dimension for scientific advisory bodies largely concerns science communication and public engagement. The political, economic and technological transformation of contemporary societies is challenging conventional structures and approaches in these areas. The disintermediation of communication and the proliferation of misinformation, it is argued, herald the onset of the post‐truth society. A better understanding of the way individuals consume information today has led to the development of tools to guide mediators such as journalists and communication specialists in countering these trends. Public engagement can reinforce confidence in regulatory bodies and potentially contribute to the quality of the scientific process. Scientific advisory bodies in Europe have created strategies and mechanisms to engage the public that are designed to increase transparency and representativeness. To be effective, several engagement mechanisms are needed, although factors such as resource constraints, institutional culture and public/stakeholder attitudes may limit their development. In conclusion, a more vigorous role for social research is needed to place scientific risk assessment within broader socio‐economic and political contexts. Social science expertise can help to define more impactful public information strategies and to explore the potential opportunities that engaged stakeholders and citizens can make to sustain and strengthen regulatory science.

Un train de nuit en plein jour : l’évolution de l’expertise économique au Bureau central néerlandais de planification 1945-1977

The Dutch Central Planning Bureau (CPB) is the most prominent scientific advisory body of the Dutch government on economic issues. By providing a macroeconomic framework the CPB plays an important role in the preparation and coordination of social and economic policy. With the figures and forecasts it offers to national media and politicians, the CPB is also an influential actor in public debates. In both instances, the expertise that the bureau offers is strongly based on the macroeconomic models it employs. By discussing two periods in the history of the CPB, this article will investigate how the CPB gained this important role in Dutch politics and what the relation is between its modelling practices and economic expertise. The first period deals with the CPB’s initial attempts of gaining a foothold in policymaking circles from 1945 to 1955. The second period concerns the CPB’s interventions in public debates on unemployment and the growth of the public sector in the 1970s. Making use of two theoretical notions from sociology, policy device and public interventions, I will argue that the introduction of new macroeconomic models was crucial to the impact of the CPB’s interventions in both periods. Furthermore, I will argue that by targeting a broader audience in the 1970s, the CPB started to shift the mode of their expertise, from a facilitating role towards a watchdog role.

Performance Evaluation of LC-MS Methods for Multimycotoxin Determination.

The co-occurrence of regulated mycotoxins in foods and feeds, together with modified ("masked") and emerging mycotoxins, has been increasingly reported worldwide in recent years. Therefore, sensitive, accurate, and validated methods for the simultaneous determination of these hazardous contaminants in different matrices are highly demanded to fulfil regulatory requirements and to carry out reliable surveillance programs. In these last years, LC-MS methodologies for multimycotoxin screening and/or quantification are being routinely used in control laboratories. However, to date, only one European Standard for multimycotoxin determination is based on LC-MS (EN 16877:2016). The need for standardized LC-MS methods for multimycotoxin determination has been highlighted by regulatory authorities and scientific advisory bodies, including the U.S. Food and Drug Administration and the European Commission. The European Committee for Standardization (CEN) has issued calls for tender for the development of standardized LC-MS methods for mycotoxins in food and animal feeding stuffs. As deliverables, some LC-MS based methods for multimycotoxin determination are currently under approval as European Standards. In addition, the European Commission has recently established specific criteria with which screening methods for mycotoxins, including LC-MS methods, have to comply for use for regulatory purposes. Validation procedures by single-laboratory and collaborative trials have been defined. This paper provides insights and advances on guidelines and tools for performance evaluation of LC-MS methods intended for quantitative determination and for semiquantitative screening of multimycotoxins. In particular, performance criteria set in the European Union and the United States are critically overviewed, and expectations, needs, and future challenges relevant to LC-MS methods for multimycotoxin determination are also discussed.

A systematic approach to monitoring high preharvest aflatoxin levels in maize and peanuts in Africa and Asia

Aflatoxin in maize and peanuts remains a critical problem in much of Africa and Asia. Many countries in these regions lack a systematic preharvest approach for providing government agencies with warnings of a potential threat to human and animal health resulting from excessive levels of aflatoxin in crops at harvest. This paper sets out an approach to such a system. It is based on the establishment of a surveillance system in each community to monitor aflatoxin contamination resulting from drought stress before harvest and advise on remedial actions. The system should be under the control of a central government coordinator. If severe drought stress occurs, the coordinator would arrange for samples of the affected crop to be provided to a central aflatoxin laboratory established and controlled by the relevant government department. Assays from the central laboratory would be sent via the central coordinator to a government scientific advisory body, which would recommend appropriate remedial action to be taken at government level.