1. Rationalizing Politics The Rise of Social Regulation Science and Policymaking Expertise and Trust The Contingency of Knowledge The Reform Debate An Alternative Approach 2. Flawed Decisions Nitrites 2,4,5-T Love Canal Estimates of Occupational Cancer The Technocratic Response A Critical Counterpoint 3. Science for the People The Rationale for Public Science The "New" Expert Agency Scientific Advice and Open Government Judicial Review of Science Policy The Weakening of the Paradigm 4. Peer Review and Regulatory Science The Traditions of Peer Review Peer Review in Practice Instructive Failures Regulatory Science: Content and Context Implications for Regulatory Peer Review 5. EPA and the Science Advisory Board Early Political Challenges A New Cooperation Boundary Exercises SAB's Impact on Policy Conclusion 6. The Science and Policy of Clean Air CASAC and the NAAQS Process Science and Standards Redefining CASAC's Role The Carbon Monoxide Controversy CASAC's Effectiveness: Bridging Science and Policy 7. Advisers as Adversaries The Scientific Advisory Panel Implementing the Impossible Ethylene Dibromide Dicofol Alar A Fragmentation of Authority 8. FDA's Advisory Network The Scientific Evaluation of Drugs Expertise and Food Safety Advice and Decision 9. Coping with New Knowledge The Quest for Principled Risk Assessment Formaldehyde: An Uncertain Carcinogen Conclusion 10. Technocracy Revisited A Public-Private Partnership for Science Risk Assessment without Politics The Public Board of Inquiry Wider Applications 11. The Political Function of Good Science From Advice to Policy Acceptable Risk Scientific Advice as Legitimation: Negotiation and Boundary Work Defining "Good Science" Normative Implications Conclusion Notes Index

The fifth branch. Science advisers as policymakers

In response to growing concerns regarding mosquito-borne diseases, scientists are developing novel systems of vector control. Early examples include Oxitec's OX513A genetically-engineered mosquito and MosquitoMate's Wolbachia-infected mosquito, and systems using 'gene-drive' are in development. Systems based on genetic engineering are controversial and institutions around the world are grappling with the question of who should have a say in how such technologies are field-tested and used. Based on media coverage and public records, we created comparative timelines of the efforts of Oxitec and MosquitoMate to navigate federal and local governance and bring their products to market in the United States. We analyze these timelines with particular attention to the role of public input in technology governance. These cases illustrate how governance of technology in the US is diverse, complex, and opaque. Further, the public response to proposed field trials of the Oxitec product highlights inconsistencies between public expectations for governance and actual practice. As gene-drive mosquito control products develop, both federal and local agencies will find their legitimacy tested without a better procedure for transparently integrating public input.

/pdf/oxitec-and-mosquitomate-in-the-united-states-lessons-for-the-3jfv8dxetl.pdf

Oxitec and MosquitoMate in the United States: lessons for the future of gene drive mosquito control.

Gene drive technologies represent powerful tools to develop vector control strategies that will complement the current approaches to mitigate arthropod-borne infectious diseases. The characteristics of gene drive technologies have raised additional concerns to those for standard genetically engineered organisms. This generates a need for adaptive governance that has not been met yet because of the rapid rate of progress in gene drive research. For the eventual release of gene drive insects into wild populations, an international governance network would be helpful in guiding scientists, stakeholders, public opinion, and affected communities in its use. We examined the current institutions and governing bodies among various continents that could have an impact on gene drive governance or the potential to adapt to its future use. Possible governance strategies also are proposed that seek to bridge gaps and promote an ethically sound policy framework. Ideally, governance strategies should be developed before or at the same pace as gene drive research to anticipate field releases and maximize their impact as a public health tool. However, this is not likely to happen as it takes years to develop global accords, and some countries may choose to move ahead independently on the new technology.

/pdf/global-governing-bodies-a-pathway-for-gene-drive-governance-9r29ddssnf.pdf

Global Governing Bodies: A Pathway for Gene Drive Governance for Vector Mosquito Control.

Prioritising investments in classical weed biological control (biocontrol) is a common decision-making challenge: biocontrol programmes can yield substantial benefits but are typically long-term and costly, and the outcome uncertain. Experts are often relied upon to help, but their role is generally restricted to providing facts and judgements to populate an existing prioritisation model, which in turn receives little scrutiny. We developed and applied a new prioritisation framework to guide biocontrol investment decisions by livestock industries that required eliciting experts’ functional understanding (including their in-depth knowledge of the theoretical and practical drivers of weed biocontrol programmes). This consultative and transparent framework drew on expertise from most biocontrol practitioners in Australia through a structured workshop, and the literature. Each of the 75 weed taxa considered was placed in a matrix according to their impact (current or potential) and the prospects of biocontrol achieving pre-defined management goals. There was considerable knowledge uncertainty regarding potential impacts, which is of concern when making pre-emptive investments. Feasibility (likelihood of finding host-specific agents) and likelihood of success (management goals being met, assuming that host-specific agents are available) of biocontrol were both assessed as low for 51 % of taxa. Predicted barriers to successful biocontrol were diverse and idiosyncratic, suggesting that application of more quantitative prioritisation approaches would be challenging. A short-list of 13 weed taxa was identified for further consideration as biocontrol targets, based on the trade-off between potential impact and prospects for biocontrol. Research priorities emerged from the prioritisation process that would maximise investment outcomes for each taxon. Only two short-listed taxa are new targets, reflecting the maturity of the biocontrol discipline targeting weeds of livestock industries in Australia. Accessing the in-depth functional understanding of experts resulted in explicit characterisation of the barriers to successful biocontrol and if/how they might be overcome, improved characterisation of uncertainty, and provided directed guidance for investment. Such an approach would be readily applicable to analogous decision-making challenges in other sectors and countries.

Experts know more than just facts: eliciting functional understanding to help prioritise weed biological control targets

The article explores the rise, regulation and risks of genetically modified (GM) insect technology in global agriculture. It contributes to the debate on the nexus of science, technology and food s...

https://journals.sagepub.com/doi/pdf/10.1177/0971721819890042

The Rise, Regulation and Risks of Genetically Modified Insect Technology in Global Agriculture:

Paul De Barro • Stephen Goldson • Detlef Bartsch • Mikael Hirsch • Martyn Jeggo • John W. Lowenthal • Philip Macdonald • Ryan R. J. McAllister • Rod McCrea • Fiona McFarlane • Cathy Robinson • Kim Ritman • Joe Smith • Rieks Van Klinken • Iain Walker • Juliana Ribeiro Alexandre • Simon Barry • Camilla Beech • Craig Cormick • Peter Kearns • Qu Liang • Aditi Mankad • Sally McCammon • Sylvie Mestdagh • Sorada Tapsuwan • Andrea Walton

Science into policy; improving uptake and adoption of research: outcomes and conclusions

Genetically modified (GM) insects are a potentially valuable new tool for the biological control of insect pests of humans, animals and plants. Considerable progress has been made recently in transfer of GM insects from the laboratory to release and evaluation in the environment. As with other new genetic technologies, regulatory agencies have often found it challenging to determine the regulatory regime under which they should be evaluated, and have either adapted existing regulatory frameworks or adopted new ones. No country has legislation specifically for GM insects. However, irrespective of the regulatory regime under which they are evaluated, the purpose of their regulation remains the same; to protect human health and the environment. Consequently there are evaluation themes common to their regulatory scrutiny, which are elucidated here. There have also been some challenges and issues encountered during the risk evaluation for field release of GM insects, and this paper will highlight some of these to assist others when considering policy, regulation and assessment of GM insects. Useful regulatory and policy precedents also exist from the regulation of biological control agents and the global protection of plants from pests under the International Standards for Phytosanitary Measures (ISPM) framework. Where countries do not have existing regulations, these evaluation instruments could have the potential to be adapted to form a suitable framework for the assessment of risk for GM insects. Finally, some considerations for future policy and regulation in this area are discussed.

Regulatory experience and challenges for the release of GM insects

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Science into policy; improving uptake and adoption of research: outcomes and conclusions

Regulatory experience and challenges for the release of GM insects