A new paradigm for regulatory sciences

Regul Toxicol Pharmacol. 2023 Dec:145:105524. doi: 10.1016/j.yrtph.2023.105524. Epub 2023 Nov 2.

Abstract

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 authorities 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.

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

Publication types

  • Review

MeSH terms

  • Hazardous Substances
  • Humans
  • Science*

Substances

  • Hazardous Substances