The Place of Law in Technology Transitions: A Case Study from Chemical Risk Assessment

Abstract Chemical exposure can produce devasting harm to human health and the environment. The EU regulation requires the testing of substances to ascertain whether they exhibit hazards such that appropriate risk management measures must be applied. Traditionally, toxicity testing has involved using animals as a surrogate for humans. Over the years, the EU has adopted a long-standing policy commitment to comply with the 3Rs principle to Replace, Reduce and Refine the use of animals for the purposes of scientific testing with the aim of full replacement. However, the progress away from mammalian use in hazard assessment is painfully slow, notwithstanding the development of a variety of new approach methodologies (NAMs) central to the transition away from animal testing. This study employs insights from the literature on technology transitions to explore the limited take-up of NAMs into regulatory science. It argues that the development of NAMs is not a linear process and the change to NAMs is impacted not only by scientific barriers but more often by wider technical and social barriers to transition. Such barriers arise from different levels of interaction between various actors, aligning with the conceptual framework that is not technologically deterministic. This article focuses on legal and regulatory influences at the multi levels before suggesting that law may stifle rather than accommodate or facilitate beneficial and ethical technological development.