Risks are increasingly regulated by international standards, and scientists play a key role in standardization. This fascinating book exposes the action of 'invisible colleges' of scientists loose groups of prominent scientific experts who combine practical experience of risk and control with advisory responsibility in the formulation of international standards. Drawing upon the domains of medicines, 'novel foods' and food hygiene, David Demortain investigates new regulatory concepts emerging from invisible colleges, highlighting how they shape consensus and pave the way for international standards. He explores the relationship between science and regulation from theoretic and historic perspectives, and illustrates how scientific experts integrate regulatory actors in commonly agreed modes of control and structures of regulatory responsibilities. Sociological and political implications are also discussed. Using innovative methodologies and an extensive insight into food and pharmaceutical regulation, this book will provide a much-needed reference tool for scholars and students in a range of fields encompassing science and technology studies, public policy, risk and environmental regulation, and transnational governance. Contents: 1. Risk Regulation From Controversies to Common Concepts 2. Communities, Networks and Colleges: Expert Collectives in Transnational Regulation 3. From Qualifying Products to Imputing Adverse Events: A Short History of Risk Regulation 4. Drawing Lessons: Medical Professionals and the Introduction of Pharmacovigilance Planning 5. Modelling Regulation: HACCP and the Ambitions of the Food Microbiology Elite 6. The Value of Abstraction: Food Safety Scientists and the Invention of Post-market Monitoring 7. Exploring Invisible Colleges: Sociology of the Standardising Scientist 8. Scientists, Standardisation and Regulatory Change: The Emergent Action of Invisible Colleges Appendix 1. Research Strategy and Methodology References Index

How the US Environmental Protection Agency designed the governance of risk and forged its legitimacy over the course of four decades. The US Environmental Protection Agency was established in 1970 to protect the public health and environment, administering and enforcing a range of statutes and programs. Over four decades, the EPA has been a risk bureaucracy, formalizing many of the methods of the scientific governance of risk, from quantitative risk assessment to risk ranking. Demortain traces the creation of these methods for the governance of risk, the controversies to which they responded, and the controversies that they aroused in turn. He discusses the professional networks in which they were conceived; how they were used; and how they served to legitimize the EPA. Demortain argues that the EPA is structurally embedded in controversy, resulting in constant reevaluation of its credibility and fueling the evolution of the knowledge and technologies it uses to produce decisions and to create a legitimate image of how and why it acts on the environment. He describes the emergence and institutionalization of the risk assessment-risk management framework codified in the National Research Council's Red Book, and its subsequent unraveling as the agency's mission evolved toward environmental justice, ecological restoration, and sustainability, and as controversies over determining risk gained vigor in the 1990s. Through its rise and fall at the EPA, risk decision-making enshrines the science of a bureaucracy that learns how to make credible decisions and to reform itself, amid constant conflicts about the environment, risk, and its own legitimacy.