The Food Safety Modernization Act (FSMA), signed into law in 2011, is the most significant food safety regulation adopted in the U.S. since 1958.  An important contribution of FSMA is the requirement that the food industry help the U.S. FDA increase the agency’s capacity to prevent food safety risks.  This public health benefit will be partially achieved through food safety plans, which include a hazard analysis and risk-based preventive controls.  This presentation will use ochratoxin A (OTA) in coffee as an example of the important role toxicologists should play in determining suitable hazard control steps. OTA is a mycotoxin produced by several fungal species that can sometimes be found in various agricultural commodities, including green coffee beans.  The FDA has not identified a regulatory limit for OTA in green coffee beans; however, some authoritative agencies (JECFA, EFSA) have established tolerable weekly intakes of 100-120 ng OTA/kg-BW based on renal toxicity observed in pigs.  In preparation for characterizing significant chemical hazards under FSMA, the coffee industry assembled a group of coffee scientists, as well as several toxicologists, to review all available information on the potential hazard of OTA in green coffee and its hazard potential in coffee following roasting.  The key assessment steps included:  determining the hazard potential of OTA, identifying the factors associated with OTA development, evaluating potential control measures and identifying the appropriate level of documentation. Through this consultation, it was determined that existing published data substantiate that the concentration of OTA in green coffee, if present, is typically low (generally <10 µg/kg) and levels are reduced substantially (65-100%) following roasting. The application of risk-based decision making led to the conclusion that good agricultural control (to reduce OTA in green coffee beans) and typical roasting will be sufficient to effectively minimize the hazard without implementation of critical control parameters for OTA.