Other ICCVAM Agency Activities Promoting Alternative Methods
U.S. Environmental Protection Agency (EPA): EPA is continuing to expand acceptance of alternative methods for acute toxicity testing for pesticides.
In June 2014, EPA staff viewed the webinar “Validation and Utilization of Alternative Test Methods” presented by NICEATM Director Warren Casey, Ph.D. The webinar provided an overview of internationally accepted non-animal methods for identification of substances causing skin or eye irritation. Casey also discussed current efforts to develop integrated testing strategies that use data from multiple sources to arrive at a hazard classification decision for potential skin sensitizers. This approach could reduce or eliminate animal testing for this purpose.
In December 2014, EPA published the report “Process for Establishing and Implementing Alternative Approaches to Traditional In Vivo Acute Toxicity Studies,” which describes a transparent, stepwise process for evaluating and implementing alternative tests for acute oral, dermal, inhalation toxicity, along with skin and eye irritation and skin sensitization (often referred to as the “six-pack studies”). Included in this report is a discussion of the three major phases of this process and the implications for reporting information under section 6(a)(2) of the Federal Insecticide, Fungicide, and Rodenticide Act.
U.S. Food and Drug Administration (FDA): FDA convened the workshop, Methods for Thrombogenicity Testing of Medical Devices, on April 14, 2014, at the FDA White Oak Campus in Silver Spring, Maryland. Participants discussed optimizing the conduct of current in vivo tests and the identification of alternative in vitro tests that could provide equivalent or improved clinical insights into the potential for blood clot formation caused by medical devices.
National Institute of Environmental Health Sciences and EPA: NICEATM and EPA are co-organizing a webinar series and workshop on In Vitro to In Vivo Extrapolation for High Throughput Prioritization and Decision Making. The webinars and workshop aim to address the capabilities and limitations of in vitro to in vivo extrapolation (IVIVE) within the context of risk decision making. The webinar series will present the current state of the science and the in-person workshop will facilitate discussions that follow up and build on information presented in the webinars. Workshop participants will (1) review the state of the science to form recommendations on the best practices for using IVIVE in chemical screening and risk decision making, (2) identify areas that require additional data and/or research, and (3) highlight examples of how best to apply IVIVE in a tiered risk decision-making strategy.
National Library of Medicine (NLM): In 2014, the NLM updated the Hazardous Substances Data Bank (HSDB), a part of NLM’s Toxicology Data Network (TOXNET®), to enhance its records for chemicals and substances. Improvements include the creation of new subheadings in the human and non-human toxicity excerpts to allow users to more efficiently locate data from in vitro and other alternative methods. Coverage includes results from methods validated by ICCVAM and the European Union Reference Laboratory for Alternatives to Animal Testing.
In Vitro to In Vivo Extrapolation for High Throughput Prioritization and Decision Making
This series of four webinars began in October 2015 and will culminate in a February 17-18, 2016, workshop at the U.S. Environmental Protection Agency in Research Triangle Park, North Carolina.