Assessing the food safety risk of ochratoxin A in coffee: A toxicology-based approach to food safety planning.

Under the Food Safety Modernization Act (FSMA) and preventive controls (PCs) regulations, food manufacturers must consider whether PCs are needed for potential hazards present in food. The mycotoxin ochratoxin A (OTA) is considered a chemical hazard under FSMA. It is produced by several fungal species and can be present in various agricultural commodities, including coffee. OTA presents a unique scenario in food safety, because it is known to be a potential risk; because heating may destroy it, but not completely; and because the hazard profile suggests it is not acutely toxic at the occurrence levels in coffee, although at high exposure levels, it is potentially nephrotoxic and carcinogenic in animal models. In the absence of US compliance levels, it is important for the risk assessor and risk manager to determine whether PCs are warranted. To address this complex situation in the coffee industry, we combined food safety and toxicology risk assessment principles to examine the available information on OTA hazard and risk in coffee. Exposure and health-based benchmarks for OTA in coffee, established by reviewing peer-reviewed literature, food recall databases, and authoritative reviews, resulted in large margins-of-exposure for both single and repeated exposure scenarios. Furthermore, no evidence was identified from historical data to suggest OTA is acutely toxic in humans from coffee consumption or other exposure sources. Therefore, findings from this assessment indicate that no PC is warranted for US coffee manufactures, based on the low severity and likelihood of risk according to margin-of-exposure estimates and historical data.