Regulatory Science Research Papers - Academia.edu (original) (raw)

During 2013-2014, debate concerning the risks of the chemical substance Permethrin focused on its changing patterns from widely used insecticide to anti dust mite laundry detergent in Taiwan. This article investigates the changing patterns of Permethrin and examines how environmental activists, chemical manufacturers, and government officials have governed the risks of anti-dust mite laundry detergent through different scientific activities. Data collected from archives and participant observation. I argue that the anti-dust mite laundry detergent has unintentionally endangered the ecological environment, human health, and regulatory policy. The multiple risks of Permethrin, raised by environmental advocates’ civic scientific practice, were reconfigured in chemicals’ shifting contexts of use from insecticide to laundry detergent. This controversy reveals that the regulatory governance of chemical substances in Taiwan is segregated into various governmental agencies and highly dependent on the self-discipline of manufacturers. This study states that, in order to response public concerns about chemical risks, regulatory science has been deeply involved in governing the new risks of anti-dust mite laundry detergent by a specific governmental agency of economic administration. However, this decentralized governance framework impeded the progress in regulating both the commercial practices and the risks of the highly changing assemblage of chemical substances.
透過台灣於2013 年間爆發的洗衣精添加農藥百滅寧爭議，本研究探討
百滅寧成為解決塵蟎過敏風險化學物質的拼裝歷程，分析公民團體、洗衣
精廠商及政府單位如何透過公民科學或管制科學實作，界定和治理化學物
質的風險。本研究採多重研究方法，資料主要來自參與觀察及歷史檔案。
本文發現，百滅寧雖具滅除蟎類的化學特性，其風險卻會隨拼裝脈絡改變，進而產生爭議。防蟎洗衣精爭議起因於公民的科學實作，由上下游新聞與主婦聯盟主動進行議題設定、產出科學證據，並藉自身的經驗知識，界定百滅寧的健康與生態風險，且期許新興科技風險的治理能更為民主。經濟部標準檢驗局作為本爭議之權責單位，其主導的管制科學實作同時涉及國家標準法規、公民科學成果、以及廠商資訊揭露程度的影響。防蟎洗衣精的案例反映出化學物質的治理與化學物質重組拼裝速度間的落差，也彰顯出台灣化學物質分立治理的特性及問題。

Reference conditions are a key concept in the European Water Framework Directive (WFD).
The WFD stipulates that the ecological status of a given water body shall be assessed by quantifying the
deviation from a set of reference conditions that represent the stable state of an ecosystem in the
absence of significant human disturbance. This concept is subject to criticism from several authors,
particularly because global climate change is expected to deeply modify aquatic ecosystems and their
associated biotic communities, regardless of the impacts of human activities at the local scale. In this
paper, a sociologist and an aquatic ecologist examine the socio-economic and scientific construction of
the reference conditions concept and the use of specific, quantifiable indicators. We explain the origin,
successes and limits of the reference conditions concept and raise important questions about applying
this concept in practice. We point out what is ignored by this approach and the challenges it poses for
the implementation of the WFD and the future management of aquatic ecosystems.

- by Gabrielle Bouleau
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- DPSIR, Water Framework Directive, Regulatory Science
- by Jaehwan Hyun
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- Science Policy, Health Policy, Regulatory Science

While gene doping and other technological means of sport enhancement have become a topic of ethical debate, a major outcome from genomic research in sports is often linked to the regulation of doping. In particular, researchers within the field of anti-doping science, a regulatory science that aims to develop scientific solutions for regulating doped athletes, have conducted genomic research on anabolic-androgenic steroids. Genomic knowledge on anabolic-androgenic steroids, a knowledge base that has been produced to improve doping regulation, has caused the ‘geneticization’ of cultural objects such as ethnic identities and dietary habits. Through examining how anti-doping genomic knowledge and its media representation unnecessarily reify cultural objects in terms of genomics, I argue that Ethical, Legal, and Social Implications (ELSI) research programs in human enhancement should include the social impacts of anti-doping science in their discussions. Furthermore, this article will propose that ELSI scholars begin their academic analysis on anti-doping science by engaging with the recent ELSI scholarship on genomics and race and consider the regulatory and political natures of anti-doping research.

Regulatory science, which generates knowledge relevant for regulatory decision‐making, is different from standard academic science in that it is oriented mainly towards the attainment of non‐epistemic (practical) aims. The role of uncertainty and the limits to the relevance of academic science are being recognized more and more explicitly in regulatory decision‐making. This has led to the introduction of regulation‐specific scientific methodologies in order to generate decision‐relevant data. However, recent practical experience with such non‐standard methodologies indicates that they, too, may be subject to important limitations. We argue that the attainment of non‐epistemic values and aims (like the protection of human health and the environment) requires not only control of the quality of the data and the methodologies, but also the selection of the level of regulation deemed adequate in each specific case (including a decision about which of the two, under‐regulation or over‐regulation, would be more acceptable).

- by Javier Rodríguez-Alcázar and +2
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- Philosophy of Science, Science, Technology and Society, Regulatory Science

This article examines the traditional characterization of the philosophy of science as a normative discipline. Several under-standings of this discipline are discussed; each of them offering a different answer to the question whether, and how, a genuinely normative philosophy of science might be possible. Among these views, I choose one variety of naturalism that differs from others in its commitment with the discussion of science's aims and values, either epistemic or non-epistemic. Finally, the need for this inclusion is illustrated with the example of the so-called " regulatory science ".
En este artículo se examina la tradicional caracterización de la filosofía de la ciencia como una disciplina normativa. Se discuten varias concepciones de esta disciplina, cada una de las cuales ofrece una respuesta diferente a la pregunta de si es posible, y cómo, una filosofía de la ciencia genuinamente normativa. De entre esas concepciones, se opta por una forma de naturalismo que se diferencia de otras en la exigencia de que la normatividad de la filosofía de la ciencia incluya la discusión de los objetivos y valores, epistémicos o no, de la ciencia. La necesidad de esta inclusión se ilustra, finalmente, con el ejemplo de la actividad conocida como " ciencia reguladora ".

- by Javier Rodríguez-Alcázar
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- Philosophy of Science, Normativity, Regulatory Science

Environmental bureaucrats focused on catalytic converters to reduce nitrogen oxides and hydrocarbon in tailpipe emissions which allegedly caused smog in America. This paper lays out the reasons behind the delay in the introduction of catalytic converters and traces the process of its acceptance as “the” pollution control technology to convert pollutants with catalysts. Previous research pointed out strict legislations and health-centered regulation that achieved policy goals without consideration for economic costs and technical feasibility. The history of the controversial introduction of catalytic converters shows that technical feasibility, economy, and international energy situations still left important marks on policy decisions. The co-production of air pollution regulation and pollution control technology innovation came out after lively debate which in turn changed environmental research and government regulation. Intra-agency debates on possible sulfuric acid increases made EPA administrators permit delays in enforcing deadlines for emission reduction. After congressional hearings, lawsuits, and press conferences, the pollution control technology approach became mainstream over the community health approach and the focus of regulation shifted from health to technology. This paper debunks the formal narrative of successful introduction despite corporate resistance and consumer disinterest and argues that environmental regulation and pollution control technologies were co-produced in 1970s America.

This paper analyses the possible impact of TTIP's so-called Regulatory Cooperation on the implementation of the precautionary principle in the EU. The European Commission argues that regulatory cooperation will not impinge on the application of the precautionary principle because, first, it does not change the legislative framework of precautionary legislation and, second, the right to regulate will be safeguarded by the TTIPs horizontal chapters. In this paper I argue, however, that these guarantees are insufficient. Given the methodological and institutional constraints presented by the TTIP's institutional design, in the longer run regulatory cooperation will undermine the precautionary approach to regulation in the EU.

- by Marija Bartl
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- European Studies, European Union, Precautionary Principle, Cost-Benefit Analysis
- by Alessia Farano
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- States of Emergency, Biopower and Biopolitics, Science and Law, Regulatory Science

This chapter consists of a brief discussion on some juridical aspects concerning scientists’ responsibility in risk prevention processes. After proposing some introductory considerations on scientists’ responsibility as such, the author deals with the L’Aquila earthquake crisis of 2009, when a strong quake destroyed significant parts of L’Aquila (Italy) and surrounding villages, killing more than 300 people. The chapter focuses on the relations between scientific knowledge, normative expectations, decision-making and criminal negligence for ‘failed’ risk assessment and management, paying particular attention to the role of ‘regulatory science’ in constructing the ‘reasonable person’ normative standard of care in the theory of criminal negligence. This allows explaining why the first judgement in the L'Aquila trial (2012) is not convincing, having misunderstood how policy-relevant science should participate in prevention processes and the construction of normative standards. In his conclusions, the author suggests some reasons for the recent tendency to blame experts when natural or technological disasters occur.

- by Andrea Perin
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- Criminal Law, Ethics, Disaster Studies, Disaster risk management

This article provides an overview of the regulation of medical devices and drugs in the European Union and the US. It is important for all stakeholders involved in bringing a medical device or drugs to market to have an understanding of the regulatory requirements involved in this process. This article demonstrates that the regulation of these products is an extremely complex process.

Resumen: Análisis teórico de las regulaciones de las declaraciones de salud estadounidense y europea. Desde los estudios sobre comunicación y comprensión públicas de la ciencia, identificamos las estrategias base de sus normativas sobre presentación de este tipo de información en el etiquetado alimentario. Atendiendo a investigaciones empíricas sobre percepción e intención de compra, valoramos en qué medida sus enfoques comunicativos ayudan a alcanzar los objetivos reguladores. Resultados: ambas regulaciones tienen diferencias de enfoque dependientes de distintos objetivos políticos; los estudios disponibles apuntan al fracaso de tales objetivos en ambos casos; ello parece deberse a subyacentes concepciones clásicas sobre comunicación y enculturación científicas. Palabras clave: declaraciones de salud, etiquetado, comunicación científica, compresión pública de la ciencia, intención de compra.

This policy commentary deals with two key issues within regulatory science related to the best methods for measuring regulatory compliance: Program monitoring paradigms and the relationship of regulatory compliance/licensing with program quality. Examples from program monitoring paradigms include: 1) Substantial versus Monolithic. 2) Differential Monitoring versus One size fits all monitoring. 3) "Not all standards are created equal" versus "All standards are created equal". 4) "Do things well" versus "Do no harm". 5) Strength based versus Deficit based. 6) Formative versus Summative. 7) Program Quality versus Program Compliance. 8) 100-0 scoring versus 100 or 0 scoring. 9) QRIS versus Licensing. 10) Non-Linear versus Linear. Examples from the relationship of regulatory compliance/licensing with program quality include: 1) "Do no harm" versus "Do good". 2) Closed system versus Open system. 3) Rules versus Indicators. 4) Nominal versus Ordinal measurement. 5) Full versus Partial compliance. 6) Ceiling effect versus No Ceiling effect. 7) Gatekeeper versus Enabler. 8) Risk versus Performance.

A theoretical analysis of the American and European Health claims regulations. Following the studies on public communication and understanding of science, I identify the underlying regulatory strategies for the regulations on the presentation of this kind of information on food labelling. Based on empirical studies on perception and purchase intention, I assess the extent to which their communicative approaches contribute to achieving the regulatory objectives. Results: Both regulations follow different approaches depending on their different political objectives; The available studies point to the failure of these objectives in both cases; This seems to be due to underlying classical conceptions about science communication and enculturation.

ABSTRACT: Literature data relevant to the decision to allow a waiver of in vivo used, pyrazinamide can be classified as a narrow therapeutic index (NTI) drug, which is n al of n in vitro rather than in vivo study results for the approval of new immediate release (IR) solid oral A project of the International Pharmaceutical FederationJournal of Pharmaceutical Sciences, Vol. 97, 3709–3720 (2008) 2008 Wiley-Liss, Inc. and the American Pharmacists AssociationA biowaiver monograph of pyrazinamide based o literature data together with some addition experimental data is presented. The risks basing a bioequivalence (BE) assessment o FIP, Groupe BCS, www.fip.org/bcs. This article reflects the scientific opinion of the authors and not the policies of regulating agencies.

- by S. Stavchansky
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- Permeability, Absorption, Dissolution, Solubility
- by Eva Sirinathsinghji
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- Corruption, Pesticides, Corporate Corruption, Glyphosate