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In June 2016, the U.S. Congress passed the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which amended the Toxic Substances Control Act, the primary chemicals management law in the United States. A key provision of the Lautenberg Chemical Safety Act required the EPA to develop a strategic plan to promote the development and implementation of alternative test methods and strategies to reduce, refine, or replace vertebrate animal testing. EPA collected public comment on draft goals and objectives for the strategic plan during the second half of 2017, an effort that included a public meeting convened in November 2017 at NIH. A first draft of the strategic plan will be completed by April 2018, with the final to be published by June 2018.
The EPA Hazard and Science Policy Committee supports implementation of the vision of the 2007 National Academy of Science report, Toxicity Testing in the 21st Century. One approach being taken is to waive toxicity studies that do not provide useful information. The committee reviews data waiver requests for a variety of toxicity studies, primarily immunotoxicity, acute and subchronic neurotoxicity, developmental, reproductive, and subchronic inhalation toxicity studies, and grants waivers where appropriate to avoid unnecessary testing.
A report released in January 2017 by the National Academies of Sciences, Engineering, and Medicine makes recommendations on the best ways to incorporate emerging science into risk-based evaluations of chemical safety. The report, Using 21st Century Science to Improve Risk-related Evaluations, was prepared at the request of the four Tox21 partner organizations: NTP at NIEHS, EPA, NCATS, and FDA. The new report discusses both the inherent opportunities and the challenges that will need to be met to achieve the vision described in two earlier National Research Council reports, Toxicity Testing in the 21st Century and Exposure Science in the 21st Century.
In December 2017, FDA announced publication of FDA’s Predictive Toxicology Roadmap for integrating predictive toxicology methods into safety and risk assessments.
The Predictive Toxicology Roadmap presents a framework for new or enhanced FDA engagement in the science of toxicology that includes six elements:
FDA plans a workshop for 2018 to support efforts to foster opportunities for sharing ideas, discussing new technologies, and highlighting collaborations to develop and test new methods. A post on the FDA Voice blog provides links to the Predictive Toxicology Roadmap and related activities.
The FDA participates on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). ICH brings together regulatory authorities and the pharmaceutical industry to discuss scientific and technical aspects of drug registration. The organization plays an important role in ensuring that safe, effective, and high-quality medicines are developed and registered in the most resource-efficient manner.
During 2016 and 2017, FDA collaborated with ICH partners to develop and update two guidance documents for safety testing with 3Rs relevance.
The FDA Center for Devices and Radiological Health (CDRH) is continuing to expand acceptance of alternative information and non-animal testing to support biocompatibility evaluations of medical devices.
NIEHS offers grants to U.S. small businesses to support development of novel testing approaches using state-of-the-art technologies. Some of this funding is provided through an omnibus solicitation of grant applications offered by the U.S. Department of Health and Human Services. Grants awarded under this program support development of cell-based assays to assess eye irritation, neurotoxicity, cardiotoxicity, skin and eye corrosivity, and DNA damage, as well as organotypic assays to assess cardiotoxicity, hepatotoxicity, and male reproductive toxicity.
During 2016 and 2017, NIEHS also issued the following Requests for Application for grants targeted towards specific testing applications:
More information about NIEHS small business grants is available on the NIEHS website. Current funding opportunities are listed on the NTP website.
In October 2016, the National Library of Medicine (NLM) released an extensive update of its 20-year-old online ToxTutor course. ToxTutor is a self-paced tutorial for users of toxicology resources, including NLM chemical and toxicology databases. The 2016 update incorporated advances in the science of toxicology, provided more information on alternatives to animal testing, and featured responsive design to support use on mobile devices. Additional content was added in September 2017 and included sections covering basic physiology, toxicokinetics, absorption, distribution, biotransformation, excretion, and cellular toxicology. If a certificate of completion is needed, the tutorial can be completed through a free learning management system. ToxTutor is being used in academic courses, for training in companies and elsewhere, and is approved for some continuing education contact hours. Additional topics will be included in future updates.