https://ntp.niehs.nih.gov/go/n543606

Key NICEATM and ICCVAM Accomplishments and Impact

Key accomplishments of ICCVAM, ICCVAM member agencies, and NICEATM in support of the ICCVAM mission during 2024 and 2025 include:

  • Updated validation guidance by ICCVAM and ICCVAM Method Developers Forum. “Validation, Qualification, and Regulatory Acceptance of New Approach Methodologies: A Report of the ICCVAM Validation Workgroup,” developed by ICCVAM with input from 17 federal agencies, offers recommendations on how to establish confidence in new approach methodologies (NAMs). Publication of the report was followed by the August 2024 ICCVAM Method Developers Forum, which provided an opportunity for NAMs developers to present new methods to identify potential carcinogens to relevant stakeholders.
  • ICCVAM review proposing approaches to addressing barriers to adoption of NAMs. A review by the ICCVAM Consideration of Alternative Methods Workgroup (Oyetade et al. 2025) identifies five key barriers to the adoption of NAMs encountered by a variety of stakeholder groups and proposes approaches to address these barriers.
  • Launch of the NIH Complement Animal Research in Experimentation (Complement-ARIE) program. Complement-ARIE will accelerate the development, standardization, validation, and use of human-based NAMs and significantly advance the understanding of human health and disease by providing a range of ready and standardized biomedical research models.
  • Shift toward adoption of alternatives by FDA and NIH. Policy shifts by the U.S. Food and Drug Administration and the National Institutes of Health (Scheufen Tieghi et al. 2025) will prioritize the development of predictive systems that use computer modeling and in vitro organ and cell testing.
  • International acceptance of a defined approach to estimate skin sensitization potency. The Skin Allergy Risk Assessment – Integrated Chemical Environment (SARA-ICE) defined approach for skin sensitization (Reinke et al. 2025) was accepted by OECD in an update to its Guideline 497 for defined approaches to identify skin sensitizers. SARA-ICE is the first defined approach that provides a numerical estimate of potency to be accepted as an OECD guideline test.
  • Validation of a thyroid microtissue model. NICEATM coordinated an interlaboratory validation study led by the U.S. Environmental Protection Agency of the utility of a thyroid 3D microtissue model for evaluating chemical effects on thyroid hormone synthesis and tissue viability (Deisenroth et al. 2026). The study established standard operating procedures that were successfully applied in multiple laboratories, and consistent results were generated among the testing laboratories.
  • Launch of the CAMERA resource. CAMERA is an interactive database and user interface that provides online access to validated alternative methods for U.S. regulatory and other applications. It is being developed by NICEATM, with an ICCVAM steering committee.