Project description

There has been considerable work over the past 20 years designed to bring about a paradigm shift in regulatory toxicology from chemical risk management decisions based on data from animal studies to a “Next Generation Risk Assessments” (NGRAs) system founded on New Approach Methods (NAMs).

The perceived potential benefits of NAMs that are driving the paradigm shift include better protection of humans and the environment, the reduction of animal testing, and ultimately, a faster and more cost-effective test systems for evaluating chemical safety.

The “Collaboration to Harmonise the Assessment of Next Generation Evidence” (CHANGE) project is a new initiative that seeks to design system-level interventions for bringing forward the date of effective use of NAMs. CHANGE includes an international, interdisciplinary, and cross-sectorial group of actors from the regulatory toxicology community involved in several previous and ongoing projects and initiatives to support the shift towards implementation of NAMs. The participants are from Asia, Australia, Europe, and the United States, and cover most parts of the regulatory toxicology system, at both the national and international level. The project is managed by the Norwegian Scientific Committee for Food and Environment (VKM) and supported by the Evidence-Based Toxicology Collaboration (EBTC; Johns Hopkins Bloomberg School of Public Health).

CHANGE will host three annual workshops to i) explore (2024) the systemic structures of regulatory toxicology to identify barriers for implementation of NAMs deemed important by groups creating NAM data and the groups using the data and opportunities for interventions, ii) reflect (2025) on the importance for uptake and implementation of NAMs data in risk assessment and risk management to gain consensus on what is actually important, and iii) decide (2026) what should be done to break down the barriers by prioritising practically achievable steps for action and developing recommendations.

The first workshop will take place in Oslo in June (18-20).

While all NAM definitions include in silico, in vitro, ex vivo and in chemico approaches, some also cover in vivo reduction and refinement approaches.