No abstract

The primary endpoint, '%PSADT > 2y', did not meet the pre-specified decision criteria. Further prospective study with revised program and endpoint is needed.

No abstract

The intake of total aflatoxins (AFT) and aflatoxin B(1) (AFB(1)) from food in Japan was estimated from AFT and AFB(1) concentration and frequency data in 24 foods (884 samples) from a 3-year retail market survey from the summer of 2004 to the winter of 2006, and by food consumption data from the National Health and Nutrition Survey performed in 2005. The AFT and AFB(1) survey revealed that peanut, peanut products, cocoa, chocolate, pistachio, white pepper, red pepper, almond, job's tears, buckwheat and corn grits are considered to be contributors of AFT (or AFB(1)) intake in Japan (maximum AFB(1) (AFT) levels ranged from 0.21 to 28.0 microg kg(-1) (from 0.21 to 9.0 microg kg(-1))) in AFT-contaminated food. A probabilistic approach using the Monte Carlo method was carried out to simulate an estimate of the AFT (or AFB(1)) intake distributions in each age group in Japan. In this study, AFB(1) intake ranged from 0.003 to 0.004 ng kg(-1) body weight day(-1) (from lower to upper limits), and the potential risk for cancer using a formula devised by the Joint Food and Agricultural Organization/World Health Organization (FAO/WHO) Expert Committee on Food Additives (JECFA) was estimated at 0.00004-0.00005 person/year/100,000 persons, even though this was in the higher levels (95.0th percentile) of the consumer population. The results suggest that the current dietary intake of AFB(1) in Japan has no appreciable effect on health.

A survey was undertaken of aflatoxin B1 (AFB1), B2 (AFB2), G1 (AFG1), G2 (AFG2), ochratoxin A (OTA), and fumonisin B1 (FB1), B2 (FB2) and B3 (FB3) contamination of various retail foods in Japan during 2004-05. The mycotoxins were analysed by high-performance liquid chromatography (HPLC), liquid chromatography/mass spectrometry (LC/MS) or high-performance thin-layer chromatography (HPTLC). Aflatoxins (AFs) were detected in ten of 21 peanut butter and in 22 of 44 bitter chocolate samples; the highest level of AFB1, 2.59 microg kg(-1), was found in peanut butter. Aflatoxin contamination was not observed in corn products (n = 55), corn (n = 110), peanuts (n = 120), buckwheat flour (n = 23), dried buckwheat noodles (n = 59), rice (n = 83) or sesame oil (n = 20). OTA was detected in 120 out of 192 samples of oatmeal, wheat flour, rye, buckwheat flour, raw coffee, roasted coffee, raisin, beer, wine and bitter chocolate, but not in rice or corn products. OTA levels in the positive samples were below 13 microg kg(-1). AFs and OTA intakes through the consumption of foods containing cacao were estimated using the data for mycotoxin contamination in bitter chocolate and those for the consumption of foods containing cacao in Japan.