A Risk Sciences International glossary definition

new approach methodologies [NAMs]

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New Approach Methodologies (NAMs) refer to innovative scientific techniques, tools, and strategies developed to assess chemical safety without relying on traditional animal testing. These approaches aim to enhance the efficiency, ethical standards, and scientific relevance of hazard and risk assessment processes, particularly in regulatory contexts. NAMs encompass a broad array of technologies and practices, including:

  • In vitro methods: Laboratory tests using cultured human or animal cells or tissues to evaluate biological responses.
  • In silico models: Computational approaches such as quantitative structure–activity relationships (QSARs), physiologically based pharmacokinetic (PBPK) modeling, and artificial intelligence-based predictions.
  • Omics technologies: Genomics, proteomics, metabolomics, and transcriptomics to study molecular-level changes.
  • High-throughput screening (HTS): Automated testing of thousands of chemicals across multiple biological targets.
  • Integrated approaches to testing and assessment (IATA): Structured strategies combining various NAMs and existing data to guide decision-making.

Context

NAMs have gained prominence due to ethical concerns over animal welfare, regulatory pressures (e.g., EU’s REACH regulation and the U.S. EPA’s 2025 goal to eliminate mammalian testing for pesticides), and the need for faster, more human-relevant data. While NAMs may not yet fully replace animal models across all domains, they are increasingly accepted for prioritization, screening, and certain risk assessment tasks.

Application

Risk Sciences International (RSI) and similar organizations may use NAMs to inform evidence-based decision-making, especially in contexts where rapid assessment or data-poor environments prevail. Regulatory agencies are progressively integrating NAMs into frameworks such as chemical prioritization and emergency response planning.

Synonyms:
alternative methods, non-animal testing methods, next-generation risk assessment tools, in vitro and in silico approaches, human-relevant testing strategies
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