According to the World Health Organization, 600 million cases of foodborne illnesses outbreaks occur worldwide each year, killing 420,000 people. Solely within the USA, the U.S. Food and Drug Administration (FDA) estimates the number of foodborne illness cases at 48 million, causing 3,000 deaths. In addition, more than 80% of these outbreaks are related to pathogenic organisms like Salmonella, E. coli and Norovirus. The impact on the food industry is tremendous: costly recalls, brand image impact and potential penal sanctions. The question of food safety has never been this ubiquitous and must be treated with the utmost importance: Lives are still at stake!
The presence of foodborne pathogens in food can be very sporadic. In parallel, only a few cells of pathogenic organism can make a consumer sick. This is why traditional finished product testing plans based on sampling are not sufficient to assure product safety. This increasing awareness has created the need to focus on preventive approaches, with process validation being a key tool to achieve such goals.
In addition, the U.S. National Advisory Committee on Microbiological Criteria for Foods (NACMCF) has underlined the limits of sampling in its 1997 HACCP Principles & Application Guidelines: “[…] it is important to recognize that a sampling protocol that is adequate to reliably detect low levels of pathogens is seldom possible because of the large number of samples needed. This sampling limitation could result in a false sense of security by those who use an inadequate sampling protocol. In addition, there are technical limitations in many laboratory procedures for detecting and quantitating pathogens and/or their toxins.”