To investigate the relation between environmental lead and risk of birth de
fects in humans, we examined the prevalence at birth of congenital anomalie
s in an industrial area of northern Italy heavily polluted with lead. Throu
gh a population-based registry of birth defects, we identified anomalies di
agnosed during three consecutive periods characterized by decreasing enviro
nmental lead exposure, 1982-1986, 1987-1990 and 1991-1995. In the lead-poll
uted area, we observed an excess risk of cardiovascular defects which decre
ased from 2.59 [95% confidence interval (CI) 1.68-3.82] in the first period
to 1.18 (95% CI 0.62-2.06) and 0.97 (95% CI 0.57-1.54) in the subsequent p
eriods. We also found an excess risk of oral clefts and musculoskeletal ano
malies, with decreasing trends over time. We could not identify homogeneous
patterns of temporal variation for other congenital anomalies, neither did
we detect cases of neural tube defects. These results appear to support an
association between severe parental lead exposure and specific birth defec
ts. (C) 2001 Elsevier Science B.V. All rights reserved.