ICCVAM Biennial Report 2016-2017

During 2017, ICCVAM coordinated the development of a strategic roadmap for incorporating new approaches into safety testing of chemicals and medical products in the United States. More about the roadmap >>

Other key accomplishments of ICCVAM and ICCVAM member agencies in support of the ICCVAM mission during 2016 and 2017 include:

• Publication of two guidance documents by EPA in 2016. One included a policy statement to waive all acute dermal lethality studies for pesticide formulations. The other described a transparent, stepwise process for evaluating and implementing alternative methods for six-pack studies, which test for acute systemic toxicity by the oral, dermal, and inhalation routes; skin and eye irritation; and skin sensitization.
• Publication of notices permitting removal of back-titration hamsters for potency testing of vaccines containing Leptospira pomona and Leptospira grippotyphosa by the USDA, further reducing the number of hamsters required for potency testing of leptospirosis vaccines.
• Publication of the Predictive Toxicology Roadmap for integrating predictive toxicology methods into safety and risk assessments by the FDA in 2017.
• Development of a defined approach that combines data from 11 high-throughput screening assays with a computational model to identify chemicals with the potential to interact with the androgen receptor pathway by NICEATM and EPA scientists.
• Development of a defined approach that uses non-animal approaches to predict murine local lymph node assay outcomes and human skin sensitization hazard and potency by NICEATM and ICCVAM scientists.
• Submission of a proposal in 2016 to the OECD by partners in the International Cooperation on Alternative Test Methods, including NICEATM, ICCVAM, EURL ECVAM, and Health Canada, on the development of a performance-based test guideline for defined approaches to skin sensitization testing and assessment. The proposal was approved as part of the OECD workplan in 2017.
• Launch of the Integrated Chemical Environment, a publicly accessible online resource developed to provide high-quality curated data and computational workflows to facilitate chemical safety assessment by NICEATM.