In 2007 the National Research Council published the seminal report “Toxicity Testing in the 21st Century: A Vision and a Strategy” that envisioned using human-based assay and model information to provide a more efficient, predictive, and economic system for assessing the effects of chemicals on human health. Over the ensuing decade, significant investments in technology development and biomedical research have resulted in many scientific advances necessary for implementing the vision outlined in the 2007 report. However, these advances have not yet resulted in a concomitant increase in our ability to more accurately predict potential adverse human health effects caused by exposure to chemicals.
Achieving the full potential to improve and protect human health offered by these advances in science and technology necessitates a national strategy for the safe, effective, and timely implementation of human-based, predictive approaches for toxicity testing. To initiate this process, ICCVAM is coordinating the development of a strategic roadmap for incorporating new approaches into safety testing of chemicals and medical products in the United States. The vision and mission for this effort are as follows:
Vision: To establish new approaches for evaluating the safety of chemicals and medical products in the United States that will increase confidence in alternative methods and improve their relevance to human health outcomes while maximizing efficiency and maintaining a commitment to replace, reduce, and refine animal use.
Mission: Federal agencies, the regulated community, non-governmental organizations, and other technical experts will work together to explore new approaches for evaluating the safety of chemicals and medical products that will (1) help guide the development of new tools to support regulatory and research needs; (2) use knowledge of human and animal biology as appropriate to help establish confidence in new approaches; and (3) facilitate and encourage the implementation and use of these new approaches by Federal agencies and regulated industries.
Developing a Strategic Roadmap To Establish New Approaches for Evaluating the Safety of Chemicals and Medical Products in the United States
Presentation by NICEATM Director Warren Casey, Ph.D., Society of Toxicology Annual Meeting, March 2017
This effort will continue throughout 2017, and updates and additional information will be posted on this webpage. Announcements of relevant activities will be sent via the NICEATM News email list: subscribe to NICEATM News.
Interested persons are invited to provide input relevant to this effort. Submit comments by email to ICCVAMquestionsniehs@niehs.nih.gov by August 31. Comments should include the commenter's name, affiliation (if applicable), mailing address, telephone, email, and sponsoring organization (if any). Comments submitted will be posted on this page, therefore no proprietary, classified, confidential, or sensitive information should be included in comments. View NTP guidelines for public comments.
Three public meetings in 2017 will provide opportunities to comment on topics relevant to this effort.
Details on both these meetings will be posted on the linked pages when they are available.