[The study of congenital anomalies in contaminated sites of interest for environmental remediation].

SENTIERI Project (Mortality study of residents in Italian polluted sites) studies mortality of residents in 44 sites of national interest for environmental remediation (Italian polluted sites, IPSs). A development of the Project is the investigation of adverse reproductive effects. This issue is of the utmost importance in the field of environmental epidemiology, both in analytical studies and in surveillance activity. An environmental factor can be at play either as a preconception mutagen (maternal or paternal exposure) or as a postconceptional teratogen. The US-Agency for Toxic Substances and Disease Registry (ATSDR) and the US-Environmental Protection Agency (USEPA), indicate as a priority the study of congenital anomalies (CA) and reproductive disorders. The choice of congenital anomalies to be included in the study is mainly based on the results of the evaluation of the epidemiological evidence completed for SENTIERI Project. The epidemiological knowledge on congenital anomalies in polluted sites is lacking, therefore main groups of CA will also be included for descriptive purposes. Data on CA are produced by seven registers located in Italy, either in regional or sub-regional areas, which are included in the National Committee of Congenital Malformations Registers hosted by the National Center for Rare Diseases at Istituto Superiore di Sanità. The study periods are: a) 1995-2002 (1996-2002 for the Region Campania), namely the same years as SENTIERI mortality study; b) for the years 2003-2008 different time windows will be chosen on the basis of data availability in single registers. Registers of CA are active in 16 out of 44 polluted sites included in SENTIERI, for a total of 119 municipalities. In each polluted site the number of expected cases for each CA will be estimated from the prevalence at birth of the same anomaly as from regional registers active in the polluted site at study. For a description of SENTIERI, refer to the 2010 Supplement of Epidemiology & Prevention devoted to the Project.