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HEALTH RISK A RECENT ASSESSMENT OF BEVERAGES
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Benzene is a carcinogen that causes tumors in rodents at multiple sites and leukemia in humans (1). Several international organizations have conducted risk assessments based on exposure to benzene using various models. These models use a number of methods to estimate an exposure level associated with low levels of risk on the basis of cancer and noncancer end points. A risk level for cancer end points may be de ned as a unit risk value over a lifetime; noncancer end points may be de ned as a tolerable daily intake (TDI) or reference dose (Rfd). The uncertainty associated with the dietary exposure and an estimated low dose effect level has resulted in some uncertainty in the assessed health risk from dietary exposure to benzene. In 2006, Health Canada and the US FDA each assessed the risk associated with short-term exposure to beverages containing benzene at trace to low concentrations. In order to conduct the risk assessment, Health Canada used both a TDI value of 0.36 g/kg bw/day benzene that was based on experimental animal data available during the previous 1991 assessment as well as a range of oral slope factors calculated by the US EPA derived on the basis of a human cancer end point (leukemia). The slope factors were used to calculate the oral exposure (0.018 to 0.066 g/kg bw/day) associated with a cancer risk level of 10 6. A worst case probable daily intake (PDI) for children (5 to 11 years of age) was determined on the basis of daily consumption of a cherry- avored beverage with 18 ng/mL benzene. This product contained the highest benzene
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concentration found in the preliminary Health Canada survey. The PDI was determined to be 180 ng/kg bw/day which was equivalent to the dose associated with a lifetime risk of 10 5 and was approximately three times higher than the US EPA-derived dose associated with a cancer risk of 10 6. However, the product was reformulated and the old formulation depleted from the retail market by mid-June 2006. As a result, the potential long-term exposure to benzene from these beverages was much reduced. On the basis of this limited exposure, the health risk was considered negligible over the short-term that these products were available on the market and of relatively low concern to human health over the long term. The FDA also concluded that the concentrations of benzene found in soft drinks and other beverages did not pose a safety concern for consumers (43, 103).
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Regulatory limits for benzene in food and beverages have not been established, except for bottled water where the FDA has adopted the US EPA MCL of 5 ppb as a quality standard (105). In general, the low concentrations found have not generated the level of concern that would warrant the establishment of formal risk management procedures or regulatory limits. Recent reports of elevated levels of benzene in soft drinks and beverages initiated a series of actions by food safety organizations and the beverage industry to verify these ndings, identify the source of contamination, evaluate the health risk, and reduce the concentrations found to meet acceptable quality standards. Guidelines for benzene in drinking water vary from country to country. The WHO guideline for benzene in drinking water is 10 ppb. The United States and Canada established an MCL of 5 ppb (74, 75). Australia and the EU established a reference level of 1 ppb (106, 107). These guidance levels formed the basis for risk management decisions made by food safety organizations and the beverage industry. Several countries conducted surveys to determine the amount of benzene in soft drinks and beverages. Survey results and consumer advisories were published on agency web sites. In addition, guidance documents were developed by the International Council of Beverages Associations and American Beverage Association to educate the beverage industry on strategies for mitigating benzene formation in beverages (95, 96). The guidance documents advised manufacturers that the main factors affecting benzene formation in beverages were the combination of benzoic acid sources and ascorbic acid, heat, and time. Formulation control strategies were recommended to minimize benzene formation. With the exception of South Korea, surveys conducted in several countries found that only a few products contained benzene above established guidance levels for drinking water (38, 43, 77 79, 108). The following summarizes some of the risk management strategies announced on agency web sites:
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