The Role of Risk Analysis in Integrated Food Safety Management

Food safety is a shared responsibility among all the stakeholders in the value chain from farm to fork: farmers, suppliers, distributors, manufacturers, retailers, consumers; with government expected to supply the framework in which safety can ultimately be assured.  Risk to consumers can arise from weakness or criminal intent at any point in the chain, and a holistic, science-informed view is needed to consider and manage those risks. Governments, with their responsibility across the whole chain, have recognised the need to consider the totality of the system and, through Codex Alimentarius (Codex), have promoted the science of risk analysis, with component parts of risk assessment, risk management and risk communication (Codex Alimentarius Commission, 1999).  Risk-based approaches allow for the targeting of scarce resources to the issues and factors that contribute the most harm to consumers, and for the recognition of equivalent sanitary and phytosanitary (SPS) outcomes in world trade (as outlined by the World Trade Organisation in the 1995 SPS agreement). Despite the championing of risk analysis by governments, they have neglected to engage in the difficult discussion with society on the level of acceptable risk in risk management activities, and have instead set policies that reflect a ‘zero risk’ mentality while ignoring greater risks elsewhere. For example, the US regulatory approach to L.monocytogenes and E.coli contamination that results in multiple product recalls on the basis of isolation of the organism alone, without due consideration of the likely concentration of the organism at consumption and subsequent health outcomes. These policies play well in the media and deflect criticism from government, but there are both overt and hidden costs; waste in the system e.g. through the disposal of food products that could be rendered safe, and the skewing of resources away from greater (but often less emotive) risks, as researchers and the food industry focus on the current concern, or on a narrow part of the production chain. In a recent report on the public health burden in the US from foodborne pathogens, toxoplasmosis was estimated as causing more illnesses, hospitalisations, and deaths, at greater financial and quality-of-life costs to the taxpayer than either of the above pathogens (Batz et al, 2011), yet receives far less regulatory or public attention.

Industry cannot, however, claim better success. In a drive to reduce costs and increase margins, food manufacturers and retailers have pressurised the system to maximise profit, increasing the complexity of the supply chain and concurrently reducing transparency and speed of traceability, factors that can lead to increased risks to consumers. The ability for one organisation to gain a total system understanding of the entire value chain is compromised and safety is subjugated to suppliers via the setting and application of specifications on raw materials, backed up by testing. While testing can play a valuable role in understanding the inherent risks and in planning and validating risk management actions, it is an accepted maxim that you “can’t test for safety”. Rare hazards and the difficulties in accounting for the physical distribution characteristics in foods means that testing is not a viable risk management option in itself (Bassett et al, 2010). Moreover, while HACCP is a well-proven system for managing hazards when product is in the control of the operator, it can encourage operators to become complacent about the hazards less able to be foreseen, and to not seek out the opportunities afforded by risk analysis principles.

Risk analysis – a Unifying Principle

Government and Industry have underestimated and nearly universally underutilised risk assessment and risk analysis approaches. However, there is an increasing momentum in both the public and private arena to explore the value that these approaches can bring.

Governments and intergovernmental organisations are regrouping around more practical applications after early multi-man-year projects, undertaken in particular by US government agencies and FAO/WHO, saw limited application in practice. There is currently a lot of attention instead on user-friendly risk assessment and risk ranking tools that can assist decisions on priorities and risk management options but that don’t necessarily require expertise in complex mathematical modelling to use e.g. iRisk. Codex has requested that FAO develop a resource for member countries that will help them conduct risk ranking and risk prioritisation, and there is a global effort to integrate risk analysis approaches and build capability in the area, most notably through the World Bank initiative, the Global Food Safety Partnership, currently being established. Information on the availability and utility of existing tools has been collated for ease of reference (; (Bassett et al, 2012)).

Industry is moving at a slower pace, perhaps still limited by the belief reflected in the common refrain, “Risk Analysis is done by governments, Hazard Analysis is done by industry”, one that I have heard often in my 15+ years working in food safety risk analysis. While the phrases ‘risk assessment’ and ‘risk-based’ are now found more commonly in industry and industry organisation communications, deep understanding and application is currently limited to a few larger companies. There are a small number of industry-focused publications that have attempted to demonstrate the business value derived from using risk assessment approaches; benefits such as support for new product and process design and optimisation, quality improvements, safe and extended shelf-life setting, and inputs into HACCP implementation, to name a few. The International Life Sciences Institute (ILSI) Europe is currently embarking on the development of guidance for specific industry sectors on the application of risk assessment, which aims to highlight these advantages and provide guidance for SMEs to take advantage of the tools and techniques available.

There are also efforts within industry to reduce the complexity of risk management systems. There has been a call for integrated management systems (e.g. Dalling & Holt, 2012) that integrate the management of operational risk for the different disciplines required in business, to improve the management of those risks and bring efficiency and simplicity to business processes. The cross food industry Global Food Safety Initiative aims to bring convergence between food safety management systems, thereby reducing redundancy and improving efficiencies. Common methodologies and approaches are required to link the various disciplines involved in food safety and achieve the integration, convergence and simplification needed to drive improvement in risk management systems. Risk analysis provides a common framework with which to achieve these aims, as it:

-        is applicable across disciplines

-        provides for the focus of resources on the greatest risks

-        informs the most effective risk management options

-        is compatible with cost-benefit analysis to optimise control options

-        is scalable in complexity depending on situation

-        can be applied in automated models and software

-        leads to optimisation of system design

-        is accepted by national and global governmental organisations

Jo Head (Head Consultancy) in her paper “Put Our Heads Together – Food Safety Revolution not Evolution“ has set out a vision to fundamentally change food safety management from a substantially reactive endeavour enacted at an individual business level to a science- and evidence-driven activity that operates across the entire industry. In it she outlines and calls for smarter tools to achieve this vision; tools based on risk analysis methods. This revolution is necessary and timely and can deliver not just better risk management but greater efficiency, transparency and reduced complexity in supply chains, all of which deliver better bottom line results. I encourage you to get on board.

John Bassett, May 2013

About the author:

John Bassett is an independent consultant on food safety and risk assessment, with over 15 years experience in both government and industry risk assessment and risk management. He advises the UK government on food safety via appointment to the Advisory Committee on the Microbiological Safety of Food and served on the UK Spongiform Encephalopathy Advisory Committee. Most recently he led the Microbiological Safety team in Unilever’s Safety and Environmental Assurance Centre (SEAC) delivering microbiological risk assessments for Unilever’s global food, home and personal care categories. He has a global regulatory and industry network, with international presentations and publications on food safety and risk assessment. In addition to working for industry clients, he is currently involved on the ILSI Europe expert group for Industrial Microbiological Risk Assessment, and is working with the UN Food and Agriculture Organisation (FAO) on risk-ranking materials for Codex Alimentarius. A veterinarian by background, he is also involved in discussions with veterinary and public health colleagues on the ‘One Health’ agenda, which aims to join-up efforts across animal and public health to improve management of zoonotic disease, including foodborne illnesses.


Bassett J, Jackson T, Jewell K, Jongenburger I, & Zwietering M. (2010). Impact of Microbial Distributions on Food Safety. ILSI Europe Report Series (p. 64). Retrieved from Distribution 2010.pdf

Bassett J, Lindqvist R, Nauta M, & Zwietering M. (2012). Tools for Microbiological Risk Assessment. ILSI Europe Report Series (p. 40). Retrieved from Tools.pdf

Batz MB, Hoffmann SA, Morris JGJ, & Morris Jr JG. (2011). Ranking the Risks: The 10 Pathogen-Food Combinations with the Greatest Burden on Public Health (p. 70). Gainesville, FL: University of Florida. Retrieved from

Codex Alimentarius Commission. (1999). Principles and guidelines for the conduct of microbiological risk assessment. CAC/GL (Vol. 30, pp. 1–6).

Dalling I, & Holt B (2012). Management Integration: Benefits, Challenges and Solutions. International Institute of Risk and Safety Management (p. 27). Retrieved from