Update on EPA NAMs Work Plan Implementation
Citation:
Harrill, A. Update on EPA NAMs Work Plan Implementation. Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) Public Forum, Bethesda, MD, May 20 - 21, 2024. https://doi.org/10.23645/epacomptox.25869109
Impact/Purpose:
Presentation to the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) Public Forum May 2024
Description:
The US EPA wrote the New Approach Methods Work Plan in 2021 to 1. Develop NAMs to address information gaps, 2. Engage and communicate with stakeholders, 3. Establish scientific confidence and demonstrate application, 4. Develop baselines and metrics, and 5. Evaluate regulatory flexibility. NAMs data is often more efficient to obtain than traditional animal study data, uncertainties can be compared to traditional tox study concordance and error estimates. Value of Information (VOI) analysis contextualizes the trade-offs in uncertainty with the return on investment and socioeconomic public health benefits realized by reducing time to a regulatory decision. However, barriers to adoption of NAMs for regulation still necessitate confidence building through ICCVAM, including 1. Case studies, 2. Adding details to assay validation frameworks, and 3. Consensus building and peer review.
URLs/Downloads:
DOI: Update on EPA NAMs Work Plan Implementation
1 ICCVAM PUBLIC FORUM_EPA2024_ALIHARRILL.PDF (PDF, NA pp, 6231.32 KB, about PDF)