4.4 Article

A new paradigm for regulatory sciences

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ACADEMIC PRESS INC ELSEVIER SCIENCE
DOI: 10.1016/j.yrtph.2023.105524

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Paradigm; Paradigm shift; Revolution; Regulatory sciences; New approach methodologies; Non -animal methods; Modern technology; Thomas Kuhn

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Regulatory science aims to identify, assess, and manage harm caused by exposure to hazardous substances. However, existing legal frameworks often struggle to adapt to evolving scientific advancements, highlighting the need to incorporate modern technology to fulfil regulatory requirements effectively.
Regulatory science, rooted in legal requirements, provides a mechanism for identifying, assessing, and managing harm to humans and the environment from exposure to hazardous substances. A challenge for regulatory au-thorities is that many governing laws reflect the scientific paradigm of the mid-20th century. By the nature of legislative processes, most laws are not able to readily adapt to incorporate scientific advances that are inherent in an ever-evolving paradigm. Consequently, the issue of rigid legal frameworks has become prominent in global discussions related to the incorporation of reliable and relevant modern technology to fulfill regulatory needs. To explore this issue, we apply Thomas Kuhn's The Structure of Scientific Revolutions as a conceptual framework to help understand the natural progression of scientific paradigms (from normal science, to anomaly, to crisis, to revolution, and finally to a new normal), identify where we are now in the paradigm cycle, and to explore a path towards a revolution that enables timely implementation of the best available science to fulfil legal requirements.

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