New approach methodologies in food safety: A survey and commentary on industry adoption, barriers, and the path to
Ivan Rusyn1, Kevin Boyd2, Christine Crincoli3
1Department of Veterinary Physiology and Pharmacology, Texas A&M University, College Station, TX, 77843, USA.
Abstract:
New approach methodologies (NAMs) are increasingly recognized as essential tools for modernizing regulatory science, yet their adoption in food safety risk assessment is not well characterized. To address this gap, we conducted a landscape analysis of NAMs use across the food industry. An anonymous survey was conducted between February and April 2026 with responses from seventeen international companies. Fourteen respondents reported using NAMs in the previous five years. Conventional cell-based assays, in silico toxicodynamic models, threshold of toxicological concern frameworks, and physiologically based pharmacokinetic (PBPK) modeling represented the most adopted approaches. More advanced platforms such as organ-on-chip systems were not routinely used. NAMs were predominantly applied to internal screening and prioritization, with ten companies reporting either experience with or interest in regulatory submissions incorporating NAMs-derived data. Novel food ingredients was the primary application area. Despite the interest in NAMs, significant barriers persist to their use in regulatory submissions, including challenges in data interpretation, limited availability of formally validated or qualified methods, high cost, and lack of specialized expertise to generate and interpret data. Regulatory acceptance emerged as the dominant factor influencing both internal adoption and submission decisions. Respondents indicated strong willingness to engage regulators through voluntary data-sharing mechanisms under appropriate "safe-space" conditions. These findings indicate that NAMs use in the food sector is established, but remains constrained and that progress toward broader regulatory integration will depend on fit-for-purpose guidance, clearly defined contexts of use, and improved frameworks for evidence integration.
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