Quantitative risk assessment of aflatoxicosis associated with milk consumption in Italy (2000-2004)

Marcello Trevisani; Andrea Serraino; Alessandra Canever; Giorgio Varisco; Paolo Boni

Quantitative risk assessment of aflatoxicosis associated with milk consumption in Italy (2000-2004)

In: Towards a risk based chain control

Authors:

Marcello Trevisani

Marcello Trevisani ¹Department of Veterinary Public Health and Animal Pathology, Faculty of Veterinary Medicine, University of Bologna, via Tolara di Sopra 50, 40137 Ozzano Emilia, Bologna, Italy, marcello. trevisani@unibo.it

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Andrea Serraino

Andrea Serraino ¹Department of Veterinary Public Health and Animal Pathology, Faculty of Veterinary Medicine, University of Bologna, via Tolara di Sopra 50, 40137 Ozzano Emilia, Bologna, Italy, marcello. trevisani@unibo.it

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Alessandra Canever

Alessandra Canever ¹Department of Veterinary Public Health and Animal Pathology, Faculty of Veterinary Medicine, University of Bologna, via Tolara di Sopra 50, 40137 Ozzano Emilia, Bologna, Italy, marcello. trevisani@unibo.it

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Giorgio Varisco

Giorgio Varisco ²Istituto Zooprofilattico Sperimentale della Lombardia e dell’ Emilia, Italy

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, and

Paolo Boni

Paolo Boni ²Istituto Zooprofilattico Sperimentale della Lombardia e dell’ Emilia, Italy

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Type:: Chapter

Pages:: 91–114

DOI:: https://doi.org/10.3920/9789086865833_007

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Information was gathered to assess the risk of aflatoxin contamination in milk and to give the public managers tools for the evaluation of mitigation strategies that have already been imposed or could be imposed to reduce risk. The assessment concerns milk for direct consumption produced in Italy, from 2001 to 2004, and also provides an estimated uncertainty associated with available data and determines whether available data have been critical and have driven the overall risk assessment. Data relative to milk contamination were generated by two independent control systems, namely a monitoring scheme conducted by nationally relevant private industry during the period January 2001-July 2004 and an extensive surveillance system implemented by Public Veterinary Services during the period September 2003-July 2004 as a consequence of critical environmental conditions leading to an “aflatoxin crisis in milk”. Both concerned raw milk produced in the North and Centre of Italy during the last five years and consist of more than 9,000 samples of milk which were analysed in two laboratories using validated ELISA methods. The mean estimated level of aflatoxin M1 in milk observed during the crisis period was approximately 0.035 μg/kg in both data sets (Industry and Public sampling plans) and 95^th percentile values were 0.073 and 0.080 μg/kg respectively. These values were higher than those relative to data recorded before September 2003 (mean = 0.027 μg/kg; 95^th percentile = 0.080 μg/kg). The data have been evaluated for their capability of representing the overall variability of aflatoxin level in milk produced in the region and the associated degree of uncertainty (accuracy and bias) of the analytical methods.

The relative amount of milk presenting different levels of aflatoxin contamination has also been considered because the monitoring data provided by Industry were correlated with records of milk weight. Any processing steps, apart from mixing, is capable of producing change in aflatoxin level in the production of pasteurised or UHT milk. A mixing model considering the capacity of storage tanks at the processing plant and the relative weight of bulk milk supplied with different aflatoxin levels has produced probability distributions for aflatoxin in milk. An exposure assessment concerning aflatoxin M1 in milk has been carried out by using the contamination data in combination with milk consumption observed in the Italian population. To this end data on milk consumption of the Italian Institute of Nutrition have been used to produce second order parametric probability distributions for children (1-9 y) adolescents (10-17 y) adults (18-64 y) and the elderly (>= 65 y). The aflatoxin M1 hazard was characterized by using the carcinogen potency estimates outlined by the WHO panel of experts. This panel has recently analysed all available toxicological studies concerning aflatoxin M1 and has used the comparative experimental studies with aflatoxin B1 to estimate its relative carcinogen potency. The carcinogen potency ranges should encompass the different sensitivities to aflatoxin observed in the human population. The genotypic and phenotypic variability is at the basis of these differences, but a mechanistic modelling of cancer initiation and progression, which could directly account for them, cannot be accomplished at present, because probabilistic quantitative data are inadequate for risk assessment.

Carriers of the Hepatitis B virus are significantly more susceptible to aflatoxin carcinogenicity than healthy individuals and their prevalence in the population has been accounted for in the risk assessment. However, many factors, including body weight, milk consumption and prevalence of Hepatitis B carriers, which are dependent on the age of exposed individuals are correlated and consequently have to be analysed. In order to assess the risk for the different age classes, we relied on: (1) the recent statistics relative to the prevalence of Viral Hepatitis infections in Italy in different age classes published by the Public Authorities, (2) the estimates of body weight based on results of a cross-sectional study of the Italian Society of Paediatric Endocrinology and Diabetes and on reports of the Italian Institute of Statistics, and (3) milk consumption data reported in a study by the Italian Institute of Nutrition. The integration of the distributions generated in the exposure assessment and in the hazard characterization by use of iterative simulations (Monte-Carlo LHS) have shown that due to the low prevalence of Hepatitis Virus carriers, the estimates of risk never give cause for any serious concern. The mean risk estimates for the number of cases of hepatocarcinoma per million people, possibly related to aflatoxin contamination in milk, ranged from 5.77・10^-3 to 1.17・10^-3. On the basis of the contamination level observed over the last four years in children (who as a result of high intake and lower body weight are more susceptible), the possibility of milk consumption related HCC in children is irrelevant (p <0.01% or: having 0.04 extra cases per million children per year).

The monitoring strategies and the veterinary provisions taken during the crisis period have proved to be adequate to manage the risk. Continuing monitoring of aflatoxin content in milk as part of industry driven quality system has proved to be very important for rapid alert and for producing the most valuable data for quantitative risk assessment.

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Towards a risk based chain control

Series: ECVPH Food safety assurance, Volume: 4

E-Book ISBN:: 9789086865833

Publisher:: Wageningen Academic

Print Publication Date:: 10 Oct 2006

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- Life Sciences

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Quantitative risk assessment of aflatoxicosis associated with milk consumption in Italy (2000-2004)

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Towards a risk based chain control

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