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      Health risk assessment of ochratoxin A for all age-sex strata in a market economy


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          In order to manage risk of ochratoxin A (OTA) in foods, we re-evaluated the tolerable daily intake (TDI), derived the negligible cancer risk intake (NCRI), and conducted a probabilistic risk assessment. A new approach was developed to derive ‘usual’ probabilistic exposure in the presence of highly variable occurrence data, such as encountered with low levels of OTA. Canadian occurrence data were used for various raw food commodities or finished foods and were combined with US Department of Agriculture (USDA) food consumption data, which included data on infants and young children. Both variability and uncertainty in input data were considered in the resulting exposure estimates for various age/sex strata. Most people were exposed to OTA on a daily basis. Mean adjusted exposures for all age-sex groups were generally below the NCRI of 4ng OTA kg bw −1, except for 1–4-year-olds as a result of their lower body weight. For children, the major contributors of OTA were wheat-based foods followed by oats, rice, and raisins. Beer, coffee, and wine also contributed to total OTA exposure in older individuals. Predicted exposure to OTA decreased when European Commission maximum limits were applied to the occurrence data. The impact on risk for regular eaters of specific commodities was also examined.

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          Calculation of Benchmark Doses from Continuous Data

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            Evolution of science-based uncertainty factors in noncancer risk assessment.

            The science behind the use of uncertainty factors has progressed considerably. Increased knowledge of inter- and intraspecies sensitivity, mechanisms of action, and detailed evaluation of data bases can support the use of data-derived uncertainty factors, which ultimately results in a risk assessment with greater confidence. Papers that highlight available data for each of several areas of uncertainty are discussed, indicating that choice of the appropriate factor requires scientific judgement on a case-by-case basis. Case studies from EPA and Health Canada risk values illustrate the use of data in chemical specific risk assessments to support the selection of uncertainty factors other than the default value of 10-fold. In the case studies, the types of data that have been used to support a change in the default value are explicitly reviewed, as well as why the data support a different uncertainty factor, how the uncertainty was reduced, and what assumptions have been satisfied or replaced. Incorporation of all available scientific data into the risk assessment process fosters increased research and ultimately reduces uncertainty. The results of this review support the use of data-derived uncertainty factors when appropriate scientific data are available.
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              Risk assessment of the mycotoxin ochratoxin A.

              Ochratoxin A (OA) is a mycotoxin which has been found to occur in foods of plant origin, in edible animal tissues, as well as in human blood sera and tissues. The ability of OA to move up the food chain is aided by its long half-life in certain edible animal species. In this report, an evaluation of the health risks to Canadians due to the presence of OA in food products is presented. The first part of the report deals with the physicochemical aspects, mycology, laboratory production, analytical methods, and natural occurrence in plant products, animal products, and human tissues. The stability of OA in foods and feeds, the effects of food processing, and the removal from foods and feeds by physiochemical means are also discussed. From these data, the worst case estimate for the daily exposure of Canadians to OA, from the consumption of pork-based food products and cereal foods, is approximately 5 ng OA/kg body wt (mean of eaters) for young children, the highest consumption group on a body weight basis. The second part of the report deals with the metabolic disposition as well as the available toxicity database for OA in laboratory animals, farm animals, and humans. The major target for OA toxicity in all mammalian species tested is the kidney, and endemic nephropathies affecting livestock as well as humans have been attributed to OA. OA is also teratogenic, and in the fetus the major target is the developing central nervous system. Recent studies have provided "clear evidence" of the carcinogenicity of OA in two rodent species. OA was found to be nonmutagenic in various microbial and mammalian gene mutation assays, but weak genotoxic activity to mammalian cells was noted. In addition, OA was found to suppress immune function. Based on the NTP carcinogenicity study with OA in rats, the estimated tolerable daily intake in humans ranges from 0.2 to 4.2 ng OA/kg body wt, depending on the method of extrapolation used. In view of the toxic properties of OA, it is recommended that exposure to OA be kept to a minimum. In Canada, further monitoring programs are required to better define the overall residue profile of OA in cereal grains, animal feeds, animal food products, and human blood. Such data are required to better assess dietary exposure and to ascertain the need for regulatory controls or other control mechanisms.

                Author and article information

                Food Addit Contam Part A Chem Anal Control Expo Risk Assess
                Food Addit Contam Part A Chem Anal Control Expo Risk Assess
                Food Additives & Contaminants. Part A, Chemistry, Analysis, Control, Exposure & Risk Assessment
                Taylor & Francis
                19 December 2009
                February 2010
                : 27
                : 2
                : 212-240
                Health Canada, HPFB, Food Directorate, Bureau of Chemical Safety, Ottawa, Canada; 251 Sir Frederick Banting Drive, Tunney's Pasture, Postal Locator: 2204C, Ottawa, ON, K1A 0L2, Canada
                Author notes
                [* ]Corresponding author. Email: kuiper.tineke@ 123456gmail.com
                © 2010 Taylor & Francis

                This is an open access article distributed under the Supplemental Terms and Conditions for iOpenAccess articles published in Taylor & Francis journals , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                : 22 October 2008
                : 27 March 2009
                Research Article

                Environmental chemistry
                risk metrics,ochratoxin a (ota),soy formula,tolerable daily intake (tdi),margin of exposure (moe),renal cancer,risk management,mycotoxin,negligible cancer risk intake (ncri),guidelines,exposure,children,probabilistic


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