Abstract
Traditionally in the food safety, risk assessment is based on deterministic endpoints, i.e., use of the no observed adverse effect level (NOAEL) and the mean or high level of exposure. Methods to assess the dose responses of toxicity assays have evolved beyond just determination of a NOAEL. Further, as the available data allow, probabilistic and distributional methods can be used to characterize the hazard(s) as well as the exposure(s). These approaches allow for more description of variability in the population and uncertainty in the risk estimates. Additional risk assessment outcomes are also used and reported, such as the margin of exposure (MOE), which gives a relative indication of the level of health concern without actually quantifying the risk. These expansions of risk assessment tools and the information they provide may require additional consideration on the part of risk managers as they evaluate risk management options. Therefore, the choice was made to include discussion on the factors of a risk assessment outcome which could be taken into account in the choice for a relevant risk management option. The example highlighted the importance of establishing maximum levels for arsenic in rice as new work by the FAO/WHO Food Standard Programm. China as the lead country of the new work had been requested to develop a paper to explain whether the MLs would be for total or inorganic arsenic. The work focused on the following aspects: 1) The analytical methods for total and/or inorganic arsenic currently in use, and collaborating or performance test reports at national or international level. 2) Available raw data for total and/or inorganic arsenic in rice used to produce the distribution curve. 3) It is preferable to set MLs specifically for inorganic As rather than total As.
