March 10, 2027 – 9:00 a.m. - 5:00 p.m.
March 11, 2027 – 9:00 a.m. - 5:00 p.m. 
March 12, 2027 – 9:00 a.m. - 1:00 p.m.

Food and Drug Administration, Wiley Building, Auditorium 1A003
5001 Campus Dr, College Park, MD 20740

Links to registration and agenda will be placed here when available.

This three-day workshop will bring together federal scientists, international regulatory partners, academic researchers, and industry stakeholders to advance the development, qualification, and regulatory integration of New Approach Methods (NAMs) for food chemical and dietary supplement safety assessment.

Hosted by the Food and Drug Administration Human Foods Program (HFP) and National Institutes of Health Office of Research Innovation, Validation, and Application (ORIVA), the workshop builds on HFP's Engaging NAMs for Toxicant Regulation and Effects (ENTRÉE) pilot program, the Expanded Decision Tree, internal in silico and in vitro NAMs development, as well as ongoing collaborations with the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), European Food Safety Authority, International Liaison Group on Methods for Risk Assessment of Chemicals in Food, and the Johns Hopkins Center for Alternatives to Animal Testing. 

The goals of the workshop are to:

• Present the current state of the science for NAMs relevant to food chemical safety
• Identify critical data and knowledge gaps where NAMs can improve or refine regulatory risk assessment
• Establish best practices for bench-level NAM development and regulatory deployment, including study design, appropriate analytical methods, and data integrity
• Discuss qualification pathways (e.g., ENTRÉE) and what regulators need from NAM developers
• Strengthen domestic and international partnerships to accelerate NAM qualification and regulatory acceptance
• Identify priority areas and next steps for collaborative action

Tentative Sessions (subject to change)

Day 1: Landscape, Regulatory Frameworks, and Priority Gaps

Session 1: Opening Plenary — Welcome and Scene-Setting
Session 2: The FDA NAMs Landscape — Where Are We Now?
Session 3: Gap Analysis: Where NAMs Are Needed Most — Regulatory Priority Areas
Session 4: Poster Session and Networking Reception (tentative)

Day 2: Science Sessions — NAM Platforms, Biomarkers, and Bench-Level Principles

Session 5: Microphysiological Systems (MPS) for Chemical Risk Assessment — Organs-on-Chip and Multi-Organ Platforms
Session 6: Biomarkers in NAMs: Translational Challenges and Opportunities — From Bench Signal to Regulatory Endpoint
Session 7: Bench-Level Principles for NAM Development: Rigor, Reproducibility, and Regulatory Readiness — How to Build a NAM That Regulators Can Trust
Session 8: Computational NAMs and Artificial Intelligence — In Silico Tools for Food Chemical Safety

Day 3: Qualification Pathways, International Harmonization, and the Path Forward

Session 9: Qualification Frameworks: From Data to Regulatory Decision — What Does It Take to Qualify a NAM?
Session 10: International Harmonization and Collaborative Science — Working Together Across Borders
Session 11: Stakeholder Perspectives and Partnership Models — Building the Ecosystem for NAM Qualification
Session 12: Synthesis and Path Forward — Closing Plenary