title: FDA toxicity databases and real-time data entry.
abstract: Structure-searchable electronic databases are valuable new tools that are assisting the FDA in its mission to promptly and efficiently review incoming submissions for regulatory approval of new food additives and food contact substances. The Center for Food Safety and Applied Nutrition's Office of Food Additive Safety (CFSAN/OFAS), in collaboration with Leadscope, Inc., is consolidating genetic toxicity data submitted in food additive petitions from the 1960s to the present day. The Center for Drug Evaluation and Research, Office of Pharmaceutical Science's Informatics and Computational Safety Analysis Staff (CDER/OPS/ICSAS) is separately gathering similar information from their submissions. Presently, these data are distributed in various locations such as paper files, microfiche, and non-standardized toxicology memoranda. The organization of the data into a consistent, searchable format will reduce paperwork, expedite the toxicology review process, and provide valuable information to industry that is currently available only to the FDA. Furthermore, by combining chemical structures with genetic toxicity information, biologically active moieties can be identified and used to develop quantitative structure-activity relationship (QSAR) modeling and testing guidelines. Additionally, chemicals devoid of toxicity data can be compared to known structures, allowing for improved safety review through the identification and analysis of structural analogs. Four database frameworks have been created: bacterial mutagenesis, in vitro chromosome aberration, in vitro mammalian mutagenesis, and in vivo micronucleus. Controlled vocabularies for these databases have been established. The four separate genetic toxicity databases are compiled into a single, structurally-searchable database for easy accessibility of the toxicity information. Beyond the genetic toxicity databases described here, additional databases for subchronic, chronic, and teratogenicity studies have been prepared.
authors.affiliation: Division of Food Contact Notifications, Office of Food Additive Safety, Center for Food Safety and Applied Nutrition, U.S. Food and Drug Administration, 5100 Paint Branch Parkway, HFS-275, College Park, MD 20740, USA. kirk.arvidson@fda.hhs.gov
authors.forename: Kirk B
authors.initials: KB
authors.lastname: Arvidson
mesh_terms: D000818:Animals; D003199:Computer Systems / Q000592:standards* / Q000639:trends; D003628:Database Management Systems / Q000592:standards / Q000639:trends; D016208:Databases, Factual / Q000592:standards* / Q000639:trends; D005503:Food Additives / Q000633:toxicity; D015386:Hazardous Substances / Q000633:toxicity; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards* / Q000639:trends
chemical_list: D005503:Food Additives; D015386:Hazardous Substances