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ABSTRACT:  On occasion, food safety managers may detect an undesirable chemical contaminant or unanticipated chemical substance in a food commodity, ingredient, or finished product, thereby warranting an assessment of the health impact of the substance at the level detected. Many times, such an assessment must be made with limited scientific information. In such situations, food safety managers must expeditiously evaluate the available data and other information and make decisions such as whether to implement a food product recall to protect public health and maintain integrity of and confidence in the food supply.

Under such circumstances, making decisions about risk can be very complicated by the interactions of a number of issues. Interpretation of scientific and public policy can cause confusion as a result of insufficient data for conducting a risk assessment, conflicting data, uncertainty stemming from toxicological issues or temporal constraints, emerging nature of the state of the science, and regulatory constraints (for example, zero tolerance). A user-friendly conceptual framework would aid food safety managers faced with making decisions about the risks of newly detected, undesired chemical substances in foods—whether naturally occurring toxins, direct or indirect food additives, substances arising through food processing, or other substances.

The Institute of Food Technologists (IFT) convened a group of experts to (1) examine the complexities that challenge timely decision-making about such substances when available scientific information is limited and (2) define and develop a workable tool to guide food safety managers in effectively and knowledgeably evaluating available scientific evidence pertinent to assessing the risk from exposure to a chemical substance to make timely decisions. This Expert Report delves into the legal U.S. underpinnings of the risk management of chemical substances in foods, international considerations, risk-benefit evaluation, importance of the food matrix to risks and benefits, risk assessment and management, and the need for a new approach to timely decision-making with limited scientific information. This report includes case studies that demonstrate (1) the various complexities and how sound decision-making with sufficient available pertinent data is reinforced as additional supportive data subsequently become available and (2) the importance of assessing and balancing consideration of risks and benefits from a whole food perspective.