Balkan Endemic Nephropathy (BEN), a chronic renal disease of unknown aetiology, is found in geographically close areas of Bulgaria, Romania, Serbia, Croatia, Bosnia and Herzegovina, Slovenia, and the former Yugoslav Republic of Macedonia. Ochratoxin A (OTA), a secondary metabolite of Aspergillus and Penicillium species and a natural contaminant of food and feed, is a putative cause of BEN. Some studies have found a geographic covariation between OTA content in food/feed and BEN manifestation; others have not. In May 2000, using a competitive direct ELISA assay for OTA (detection limit 1 microg kg(-1)), we investigated OTA contamination in 165 samples of home-produced food (beans, potatoes, corn, wheat, flour) and feed from households in villages from the BEN region (Vratza district) of north-western Bulgaria. Samples were collected from: (a) BEN villages (n = 8), and therein from BEN households (20), and BEN-free households (16) (within-village controls, WVC households); and (b) BEN-free villages (7) and therein BEN-free households (22) (between-village controls, BVC). BEN households consistently had a higher proportion of OTA-positive samples than WVC households, but similar (for some foods) or lower (for other foods) proportions to BVC households. The proportion of OTA-positive samples was also higher in BVC than in WVC households. Furthermore, BEN households had a similar proportion of OTA-positive samples to the pooled, WVC and BVC, group of households. OTA-exposure estimates, derived from our OTA-concentration findings and the reported average per capita monthly consumption of basic foods in rural Bulgaria, showed the highest OTA intake in BEN households (1.21 microg day(-1)), versus 1.03 microg day(-1) in BVC and 0.71 microg day(-1) in WVC households. These OTA intakes are higher than those in the EU, and are close to the upper limits acceptable to several food-safety organizations. The results indicate that OTA may not alone cause BEN; only synergistically with other environmental toxicants and/or predisposing genotypes may do so.