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New Research Collaboration Agreement (RCA) between Prous Institute and the FDA-CFSAN (Center for Food Safety and Applied Nutrition)

2011 Jun 15 |

Washington D.C., USA: The Food and Drug Administration's Center for Food Safety and Applied Nutrition(FDA/CFSAN) and Prous Institute for Biomedical Research (PIBR) will work jointly under a 5 year research collaboration agreement (RCA) to develop hypothesis based in silico predictive tools that are consistent with CFSAN's and FDA’s Critical Path Initiative.This research will benefit CFSAN, the FDA, and the FDA mission through the creation of QSAR models that can ultimately be used in the mandated risk assessment of food contact substances (FCNs) under the Food Contact Notification Program, and for the prioritization of safety concerns related to other consumer products evaluated by CFSAN (e.g., cosmetic ingredients, dietary supplements, and Generally Recognized As Safe (GRAS) substances)). The research involves the use of the Prous Institute's BioEpisteme® program to construct RCA QSAR Models for binary and continuous distribution toxicological endpoints that are used by CFSAN to evaluate the safety of consumer products (i.e., carcinogenicity, genetic toxicity, reproductive toxicity, and developmental toxicity). The BioEpisteme® program and RCA QSAR Models may become a critical component in a consensus prediction strategy that employs a battery of validated in silico tools to provide scientific information on the potential toxicities of substances evaluated in CFSAN’s regulatory and research activities. The RCA research will also attempt to estimate the toxic properties of additional chemicals that may or may not be covered by the software (e.g., FCNs, pesticides, color dyes, and direct food additives).

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