Application of the dangerous Preparation Directive: consequences on plant protection products in the internal market.

Legislative Decree March 2003, n. 65 brought about implementation of Directive 1999/45/ EC of the European Parliament and of the Council dated 31 May 1999 and Directive 2001/60/EC of the Commission dated 7 August 2001 concerning laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations come into force. Directive 1999/45/EC brought about a series of modifications representing the new regulatory framework for dangerous preparations. The above-mentioned Decree supplies the criteria for the evaluation of hazardous preparations, regardless of their intended use, and completes previously undertaken steps, in strict connection with the analogous Directives of the EU, for the problematic complexity of the classification, packaging and labelling of dangerous substances and preparations. The applicative importance of Directive 99/45/EC derives directly from these innovations. Among these, for the first time, the category of "dangerous for the environment" has been extended also to preparations. Moreover, also for the first time, the scope of the Directive is extended to plant protection products and biocides. This paper provides an overview on the results of the hazard classification procedure carried out at national level for plant protection products in light of the new rules and the outcomes in terms of variations of the labels through comparison between previous and new classification. Furthermore the most significant issue which come up during the classification process and the criteria applied for their solution are also reported.

[A cluster of methanol-related poisonings in Sicily: case characterization and identification of unexpected sources of exposure]. / Un cluster di intossicazioni da metanolo in Sicilia: descrizione dei casi e identificazione delle fonti di esposizione.

OBJECTIVE: To describe methanol poisoning exposures in Italy and to investigate a cluster of methanol-related deaths due to abuse occurred in Sicily among immigrants from East Europe. DESIGN: the human methanol exposures handled by the Poison Control Centre of Milan, the major national centre for toxicological advise active in Italy, were reviewed retrospectively (January 2004-September 2006) and prospectively (October 2006-October 2008). SETTING: For each case of managed human exposure, the Poison Control Centre of Milan uses a standard format to collect patient information, substance/exposure information, clinical effects, therapy, outcomes. The database arising from that procedure was searched for all cases exposed to methanol and/or reporting selected clinical signs (i.e., metabolic acidosis with ocular effects and/or central nervous system depression and/or respiratory depression). Each case was reviewed and classified according to standard criteria. MAIN OUTCOMES: Three commercial products containing more than 70% methanol available on the market in Sicily and associated with lethal exposures due to abuse among immigrants were identified. RESULTS: In the period under study, the Poison Control Centre of Milan examined 29 methanol poisoning exposures (none in 2004, 6 in 2005, 6 in 2006, 15 in 2007, and 2 in 2008). Among them, 17 occurred in Sicily, with a peak of 11 cases in 2007, and 12 in other regions. The patients included 16 men and 13 women with a median age of 49,5 years (range 1-81 years). Fifteen cases were immigrants from East Europe (14 Rumanian and one Polish). Eleven cases reported minor effects, two cases moderate effects, four cases major effects, and 12 cases died. Twelve cases were accidental exposures (5 occurred at work, 3 at home and 4 in other places), while 17 cases were intentional exposures (14 due to abuse, 2 to attempted suicide and 1 to misuse). Minor effects were reported in 11 cases, moderate effects in two cases, major effects in four cases and death in 12 cases. The most frequently reported clinical effects included: coma (13 cases), metabolic acidosis (10 cases), mydriasis (4 cases), visual loss (3 cases), gastric pyrosis (2 cases), constriction of the visual field (2 cases), and vertigo (2 cases). Blood methanol level was reported for 15 cases (< 50 mg/dL in 2 cases; 50-99 mg/dL in 2 cases; 100-499 mg/dL in 4 cases; >500 mg/dL in 1 case; positive, unknown value in 6 cases). All cases due to abuse (n. 14) and, among them, lethal (n. 12) occurred in Sicily and involved immigrants. On the other hand, all methanol poisonings occurring in the other Italian regions involved Italian citizens unintentionally exposed and with minor effects, except for one case of attempted suicide with consequent major effects. The investigations performed in Sicily lead to identifying three locally produced and marketed detergents containing more than 70% methanol, improperly labelled and packaged. Furthermore, a detergent for domestic use was identified containing 25-30% methanol without any labelling information. Two of the detergents containing more than 70% methanol were withdrawn from the market in November 2007, while the other, that was identified later, was withdrawn in July 2008. The detergent for domestic use, containing 25-30% methanol was withdrawn in December 2007. Starting from July 2008, no new cases of methanol poisonings were observed. CONCLUSION: The availability in Sicily of products containing high concentrations of methanol, improperly packaged and labelled, determined a generalised risk of accidental exposures and favoured voluptuary assumption of methanol among selected groups. The observations highlight the importance of a surveillance system of toxic exposures based on the information collected by the Poison Control Centres and its ability to provide timely identification of unexpected and dangerous events and to support preventive actions.

Exponential growth of new chemicals and evolution of information relevant to risk control.

The number of new chemicals synthesized and marketed increases exponentially. The database CAS REGISTRY at present contains more than 33 million organic and inorganic substances. However, the little information regarding the potential hazard associated with a large amount of chemicals is an old known problem in the European Union and also in the United States. This critical problem may find a solution in the collaboration of the different involved countries and in a planned task setting at international level. Both in the United States (e.g., the "Gore Initiative") and in European Union (the REACH policy) a big effort has been dedicated to this solution, within standardized procedures and an appropriate collaboration.

The ISS National Inventory of Chemical Substances (INSC).

The INSC (Inventario Nazionale delle Sostanze Chimiche), a factual data bank, produced by Istituto Superiore di Sanità (ISS), consists of an electronic tool on chemical information developed for routine and emergency purposes. Historical background, current status and future perspectives of INSC are discussed. The structure and the feature of INSC are briefly examined. Aspects of information retrieval and the criteria for inclusion of data and priority selection are also considered.

The ISS Carcinogens Data Bank (BDC).

The Data Bank on Carcinogens (Banca Dati Cancerogeni, BDC) is a factual data bank, available on the Istituto Superiore di Sanità website, aimed at supporting the risk management decision making of central and local administrators. It can also represent a valuable tool for industry. The available information on carcinogenicity evaluations/classifications produced by European Union and by other institutions (IARC, USEPA, NTP, CCTN) is presented in a concise form accompanied by bibliographic references enabling the users to consult the original sources and, in some cases, to be directly connected to the relevant website. The classifications carried out by each organization in accordance with its own criteria assign the examined agents to specific qualitative categories and do not include quantitative assessment. BDC intends to provide an easy tool for experts, researchers and risk managers dealing with carcinogenic agents.

The ISS Sensitizing Agents Data Bank (BDS).

The Istituto Superiore Sanità has developed a data bank on sensitizing substances (Banca Dati Sensibilizzanti, BDS), available on website (www.iss.it/bdse/), sharing complete, controlled and updated information coming from different sources, such as scientific publications, international agencies and governmental or non governmental organizations. It is worthwhile that the main objective of the BDS is not the classification of sensitizing or potentially sensitizing agents within specific risk classes, but it is essentially to provide concise and non confidential information related to this endpoint. At present, the BDS includes: all the substances officially classified by European Union, (Annex I to Directive 67/548/EEC), some substances listed in I (Directive 67/548/EEC) for endpoints different than "sensitization" but indicated as sensitizers by other relevant institutions, all the substances indicated as sensitizers by relevant agencies or institutions (ACGIH, DFG), some substances indicted as sensitizers by industry and other non-governmental organizations (ETAD and HERA), all the substances regarded as "potentially sensitizing dyes" by the Commission of the European Community for the award of the eco-label to textile products, some substances for which, even in the absence of any categorization by Union, ACGIH or DFG, it is not possible to exclude a sensitizing potential on the basis of reliable documents.

The ISS Reclamation Data Bank.

Since the issue of the first regulations concerning the remediation of contaminated sites, the Istituto Superiore di Sanità, on the basis of specific requests, has drawn up various technical opinions regarding the proposed reference values (quality standards) for soils and underground waters, to be achieved when remediating contaminated sites, for substances for which no standard limit values did not exist at that time. These reference values, widely used throughout the country and accepted and adopted as "remediation aim" values by various territorial bodies responsible for the approval and monitoring of remediation projects, have been collected in a specific reclamation oriented data bank known as the "Banca Dati Bonifiche (BDB)" (Reclamation Data Bank). The BDB contains the related standardized "rationale" for each reference value, in order to serve as a useful reference for the national bodies concerned with the remediation of contaminated sites.

Woman, alcohol and environment: Emerging risks for health.

Alcohol drinking is one of the most relevant problems in Western Countries but the negative effects of alcohol misuse are often neglected or underestimated with serious consequences for public health. Over the last few years a rapid growth in the number of drinking females and the decrease of their age of first use, have increased the health risk for women and their offspring. Moreover, modern environments facilitate pollutants exposure, further escalating the health risks due to lifestyle habits. This review takes into account the peculiarities of alcohol effects on female health and the risks of teratogenic effects. The possible interaction between alcohol and pollutants exposure is also discussed. The role of biomarkers against alcohol-related damage is presented as an invaluable clinical tool, including early intervention, treatment monitoring and, above all, prevention of prenatal non-reversible damage. Recent alcohol studies show the greater severity of alcohol damage in female subjects and the need of gender-targeted intervention.

[Management and development of the dangerous preparation archive]. / Gestione e sviluppo dell'Archivio preparati pericolosi.

In the year 2000 an archive of dangerous preparations was created at the National Health Institute (Istituto Superiore di Sanità), following a principle included in the Directive 88/379/EEC on dangerous preparations, subsequently modified by the Directive 1999/45/EC, concerning the creation of a data bank on dangerous preparations in each European country. The information stored in the archive is useful for purposes of health consumer's and workers protection and prevention, and particularly in case of acute poisonings. The archive is fully informatised, therefore the companies can send the information using the web and the authorized Poison Centres can find the information on the archive using the web. In each Member State different procedures are in place to comply with the 1999/45/EC Directive; therefore an international coordination could be useful in order to create an European network of national data-banks on dangerous preparations.

[Profile of acute poisoning in Italy. Analysis of the data reported by Poison Centres]. / Profilo delle intossicazioni acute in Italia. Analisi dei dati registrati dai Centri antiveleni.

Information relative to about 400 000 cases of human intoxications, registered by nine Italian Poison Centres between 1991 and 1998 is presented. Data have been collected and elaborated in the framework of an European project on improving the prevention and treatment of acute human poisoning (90/C 329/EEC Resolution). Sex, age group, etiological agent, place and circumstances of poisoning and risk estimation are the parameters analyzed for the characterization of this phenomenon. The following conclusions can be summarized from the overall picture. There is a slight prevalence of males over females (50.0% against 45.7%); 1-4 year age group presents the highest risk (37.0%), followed by 20-49 group (25.8%); drugs and household products are the prevalent causes of intoxications (37.4% and 26.0%, respectively); home is the place where 84.9% of accidents occur. Poisoning is accidental in 73.5% of the cases whilst suicides represent 18.7%. However, the outcome is positive in almost all cases and fatal accidents are not reported in the present casuistry.

Development of carcinogenicity classifications and evaluations: the case of formaldehyde.

In this paper carcinogenicity classification and evaluations case of formaldehyde made by national and international agencies and organizations (such as European Union, International Agency for Research on Cancer, World Health Organization) both in occupational (such as American Conference of Government Industrial Hygienists, National Institute of Occupational Safety and Health and Occupational Health and Safety Administration) and non occupational environment (such as United States Environmental Protection Agency) are proposed. The differences in the database and consequently in the conclusion are described in a short historical review since formaldehyde was considered for the first time as regard as health effects.

Female drinking, environment and biological markers.

The rate of women involved in alcohol abuse is rapidly increasing and the age of first use tends dramatically to decrease. The health and social costs are high both for the adverse effects on physical and psychological woman health, and for the teratogenic effect of alcohol on fetal development. The review takes in account physiological aspects of alcohol effects according to age and gender differences. Interaction between alcohol habit and environment are discussed together with the risk of co-exposure to alcohol and pollutants. The role of biomarkers may be invaluable for clinical utility, prevention and early intervention above all to avoid prenatal, not reversible damages. The update of alcohol studies shows the greater severity of alcohol damage in female and the need of gender-targeted intervention.