The FDA’s Office of Food Additive Safety (OFAS) is located within the Center for Food Safety and Applied Nutrition (CFSAN). OFAS is responsible for the premarket evaluation of new food ingredients intended for the US market place. These food ingredients include direct food additives, generally recognized as safe (GRAS) ingredients, biotechnology derived food, and food-contact substances (FCSs) such as packing materials and antimicrobials used in the production of food. The Chemical Evaluation and Risk Estimation System (CERES) was created to facilitate the OFAS safety review processes. CERES serves as a data repository that consolidates data from different sources and organizes the data under one controlled vocabulary. The data sources in CERES include the toxicity and regulatory data from CFSAN’s legacy database called the Priority-Based Assessment of Food Additive (PAFA) database and a CFSAN’s submission repository system called the Food Application Regulatory Management (FARM) system. CERES obtains the chemical data from the CFSAN’s STARI (Scientific Terminology and Regulatory Information) and external sources, such as the ToxCast, Tox21, and COSMOS database. The regulatory and toxicity information is linked in CERES through the tested chemicals. This allows the chemicals to be meaningfully clustered, and the results can be output and readily evaluated using modern cheminformatics tools. The cheminformatics workflows available in CERES include: toxicity predictive QSAR models, chemical/toxicity data export, and compound similarity comparison. CERES is currently being expanded to include new features, including Toxicity Report & Analysis Management (TRAM). The TRAM system will allow the FARM, STARI, and CERES data to automatically synchronize in real-time. It will also contain e-memos, which will allow the OFAS chemistry and toxicology reviewers to directly write their memoranda inside TRAM, where the chemical, toxicity, and regulatory values will be automatically captured into CERES. Additional cheminformatics workflows will also be added. These include: chemical metabolism prediction, a new and expanded TTC (Threshold of Toxicological Concern) decision tree, read-across, weight-of-evidence, and biological/toxicological profile analogue search workflows.

US FDA’s food additive knowledgebase and cheminformatics platform:  Chemical evaluation and risk estimation system

254th National Meeting (2017)

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