US federal agencies to guide development of non-animal tests

United States regulators and industry are to steer the future development and implementation of new non-animal tests, according to a draft US strategic roadmap for alternative approaches, developed by the US Interagency Coordinating Committee on the Validation of Alternative Methods (Iccvam). “What makes this approach very different is that what we are doing is driven by the federal agencies,” said Warren Casey, director of the US National Toxicology Program’s Interagency Centre for the Evaluation of Alternative Toxicological Methods (Niceatm), which provides scientific and operational support for the committee. Importantly, Iccvam expects the approach to increase the rate at which new non-animal test methods are accepted by regulators. “If the regulators are driving the validation, everything goes really fast,” said Dr Casey. “It’s completely reversing the current model of validation, which is basically bottom up,” he told Chemical Watch. “Somebody has a technology that they think can be applied to the toxicology and they start finding a method they think they can replace … The regulators are never heavily involved so we end up with methods that they don’t want.” With the new approach, “not only are we starting things with the regulators, we are also tying in with industry very early on to see what they would use and how they would use it,” he added. Dr Casey presented the draft roadmap at an Iccvam public forum on 23 May. Its goals are to: help agencies and industry guide the development of new tools that support regulatory and research needs; use “timely, flexible and robust” practices to establish confidence in new methods; and encourage the adoption and use of new approaches by federal agencies and industry. It also lists objectives, such as communicating the needs of federal agencies to test developers. Lack of communication is the “number one complaint” from test method developers and industry, says Dr Casey. “They need agencies to be very clear about what the testing requirements are and how they are being used.” The roadmap describes a need to identify and collate sources of high quality human toxicological data, relevant to assessment of new alternative methods. Some human data sources exist, said Dr Casey, but “pulling those together and getting them into a format that’s suitable for regulators and toxicologists is a different issue.” Although the plan focuses on the US, global harmonisation, he said, is critical, and a key goal is “the acknowledgement that we have to have international harmonisation for any of this to work”. NGO involvement The roadmap takes into account the views of NGO People for the Ethical Treatment of Animals (Peta). These include expanding programmes that are working well in one agency and incorporating them into others, said Peta International Science Consortium associate director, Amy Clippinger. The roadmap is open for consultation until 31 August. It will then be discussed at the Scientific Advisory Committee on Alternative Toxicological Methods, which advises both Iccvam and Niceatm, in September, and is due for publication in December. Further information is available at: ICCVAM strategic roadmap

Chemical Watch, 25 May 2017 ; ;