August 1, 2015  --  We call our readers’ attention to a timely and important peer-reviewed article pointing out one of the most basic principles of Food Safety and Food Liability Management that has appeared in advance copy (scheduled for February 2016 publication) in Food Control.

The principles expounded in this article were major themes in a science-based audit management lecture that I delivered to Italian exporters at an industry meeting in April 2015 in Sicily. For my development of these ideas, I am of course indebted to Doug Powell’s earlier Food Control article cited below.

These are the key principles:

ONE   Start with “Management” – the HACCP Plan – “What does the business do on the factory floor to implement Food Safety Culture?”

TWO   Before even starting to think about a situation, always ask, “What is the product and what is the Kill-Step?” As an example, let us consider Food Safety issues related to Dried Lentils as contrasted with Ready-to-Eat (RTE) Cooked Shrimp. This is a perfect example – one product is High-Risk (Listeria and no pre-consumption Kill-Step) the other is Low-Risk (low level possible contamination with natural and anthropogenic chemical poisons). You open cooked shrimp and serve it – I don’t know anyone who eats uncooked Lentils! One has no immediate pre-consumption Kill-Step, the other is impossible to eat without the Kill-Step (Of course it can become contaminated by improper storage and handling after cooking.)  These two products require very different levels of Risk-Management vigilance.

THREE   You cannot achieve Food Safety through Finished Product Testing – it is “magical thinking” to believe that you can reach statistical certainty through this process. Safety for the consumer – and for your company and your career (if you are a food executive)  – can only be accomplished through process management systems. Testing has a place – but a limited place – good process management is the key.

FOUR    When a problem is presented – the Regulatory Food Scientist  starts with the HACCP Plan before she or he does anything else. This will, of course be called the Risk-Based Preventative Controls (RBPC) Plan starting in 2016. There is no better indicator of the competence of management than the HACCP Plan. A well prepared HACCP Plan based on established Food Science principles is the best indication possible, to potential buyers, insurance carriers, and regulatory authorities, that management is proactively  addressing and controlling risk. By contrast a poorly-documented and poorly-prepared HACCP Plan is a warning to alert buyers (and to regulators) that Food Safety problems may be anticipated with respect to your products.  

FIVE   Finally, remember, if you are an importer you are required to have on file in your principal US office a copy of every HACCP Plan for every product you import. If an FDA inspection finds missing or inadequate HACCP Plans, then a Warning Letter may be issued. Warning Letters are permanently and publicly posted by FDA on its website - available to your customers and your insurance carrier.

Here is the abstract of the article:

Zwietering, M.H., Jacxsens, L., et al., Relevance of microbial finished product testing in food safety management, Food Control, v. 60, p. 31, February 2016.


Management of microbiological food safety is largely based on good design of processes, products and procedures. Finished product testing may be considered as a control measure at the end of the production process. However, testing gives only very limited information on the safety status of a food. If a hazardous organism is found it means something, but absence in a limited number of samples is no guarantee of safety of a whole production batch. Finished product testing is often too little and too late. Therefore most attention should be focused on management and control of the hazards in a more pro-active way by implementing an effective food safety management system. For verification activities in a food safety management system, finished product testing may however be useful. For three cases studies; canned food, chocolate and cooked ham, the relevance of testing both of finished products and the production environment is discussed. Since the level of control of different processes can be largely different it is beneficial if the frequency of sampling of finished products and production environments would be related to the associated human health risk, which can be assessed on the basis of risk assessment and epidemiological data.

Here is the citation to the Powell article cited above.

Powell, Erdozan, et al., Audits and Inspections are never enough: A critique to enhance food safety, Food Control, v. 30, pp. 686-691, 2013.

It is highly recommended that our Regulatory-Scientist readers with access to electronic scientific journal services read both articles in their entirety. The full texts cannot be posted here, of course, because of Copyright restrictions.