Analysis activities for the National Toxicology Program (NTP)

National Institute Of Environmental Health Sciences

Investigators

Linked publications & trials

Abstract

OHAT has developed a systematic review framework, the OHAT Approach, to address environmental health questions by extending approaches developed for clinical medicine to the greater range of data relevant to environmental health sciences (e.g., human, animal, and mechanistic studies). OHAT adapted guidance from authorities on systematic-review and sought advice during development of the OHAT Approach through consultation with technical experts in systematic review and human health assessment, as well as NTP scientific advisory groups and the public. The approach includes a seven-step framework for evaluating the scientific literature and reaching conclusions in NTP literature-based, non-cancer health assessments. In FY2014, OHAT held a webinar to present lessons learned in applying the OHAT Approach to case studies as part of exploring the methods and published the OHAT Approach. ORoC is following its review process to evaluated selected candidate substances for listing in or removal from the RoC. ORoC considered the potential for human exposure to these substances, developed monographs that evaluated the publicly available, peer-reviewed scientific data from federal and nongovernment sources regarding carcinogenicity, genotoxicity, and biological mechanism (modes of action in the body) in humans and/or animals, and recommended a listing status for the RoC. In FY2014, ORoC held external scientific peer review for the draft RoC monographs on four candidate substances, shared this information with the NTP Board of Scientific Counselors and NTP agency partners, and prepared the draft 13th RoC for approval by the HHS Secretary. NICEATM is working with ICCVAM to develop alternative test methods for regulatory use. These include toxicity tests for short-term exposure to a substance by ingestion or skin contact, and safety tests for biologics, such as vaccines. In FY2014, NICEATM held workshops on (1) translational alternative models and biomarkers predictive of drug or chemical cardiovascular risk, (2) aquatic models and 21st century toxicology, (3) alternatives to a test for particular vaccines, and (4) how scientific progress in adverse outcome pathway concepts can improve regulatory assessment of chemical toxicity. NICEATM also hosted a public forum for ICCVAM to receive input on its activities and plans.