“Risk assessment results allow each facility to decide how to manage its own unique risks, since risk assessment is commonly undertaken to help risk managers understand which, if any, intervention strategies can best serve the needs of food safety or if current risk management actions are adequate. Any hazard that has been determined as of “High” or of “Very high” risk must be controlled by risk management as to be reduced.”
ADDRESSING FOOD SAFETY
Globalization of food markets, in conjunction with advances in the food technology and production systems, with increasing incidences of foodborne diseases and enhanced world-wide public health concern, have increased the challenge to manage food safety risks.
Effective management of risks arising from food related hazards is technically a complex process. A process that has been traditionally the responsibility of the industry that has to operate an array of control measures relating to the food hygiene within an overall regulatory framework.
A “Risk-based” approach is the mean of evaluating and controlling food related hazards to help protecting the health of consumers and ensure fair practices in food trade. Risk analysis includes 3 component parts of
1) risk assessment,
2) risk management and
3) risk communication (Figure 1, FAO/WHO, 2007).
On this article we focus on only on the first part of the “Risk-based approach”: the Risk Assessment.
RISK ASSESSMENT PROCESS
Risk Assessment (RA) is used to evaluate foodborne hazards, the likelihood of exposure to those hazards and the resulting public-health impact, taking into account relevant production, storage and handling practices used throughout the food chain. It is generally recognized to consist of four parts (FAO, 1999):
The identification of biological, chemical, and physical agents capable of causing adverse health effects and which may be present in a particular food or group of foods. Hazard identification is predominately a qualitative process. Information on hazards can be obtained from scientific literature, various databases, and through expert elicitation. Pertinent information may be found in data from basic research and clinical studies, and from epidemiological studies and surveillance.
The qualitative and/or quantitative evaluation of the likely intake of biological, chemical, and physical agents via food.
Fig.1: A schematic representation of the components of risk analysis according to Codex Alimentarius Commission definitions (FAO/WHO, 2009).
The qualitative and/or quantitative evaluation of the nature of the adverse health effects associated with the hazard. The primary component of the hazard characterization is the dose–response relationship, defined as the determination of the relationship between the magnitude of exposure to a chemical, biological, or physical agent and the severity and/or frequency of associated adverse health effects.
The integration of the hazard identification, hazard characterization, and exposure assessment determinations to provide qualitative or quantitative estimates of the likelihood and severity of the adverse effects which could occur in a given population. The degree of confidence in the final estimation of risk will depend on the variability, uncertainty, and assumptions identified in the previous steps of RA.
RISK ASSESSMENT IN A FLOUR MILL
Low-moisture foods and ingredients, like flour, haven’t traditionally entered the discussion in terms of food safety, primarily because these products don’t offer welcoming environments for microorganism growth. Yet flour and flour products have been implicated recently in several food safety incidents, including food borne outbreaks and recalls as this of 2016 concerning contaminated with peanut residue flour.
Incidents related to flour products resulted in consumer mistrusts and revealed that flour-related food safety risks are real and have to be addressed and analyzed. The first step in risk analysis is risk assessment, which helps the flour facility to decide on the level of risk for each hazard and provides complete information to allow the food safety team to make the best possible decisions. As part of it, three basic and simple questions have to be answered:
1. What could go wrong? —Hazard identification
2. How likely is this hazard to emerge?
3. How severe are the adverse health effects if this hazard emerged?
A documented risk assessment must be done and these three questions must be answered for anything that could have a direct effect on safety of flour, including all ingredients, raw materials, packaging, finished products, processes and activities that could result in an increase in a health risk. Hazards that form food safety risk in flour production are intertwined and can be basically classified as physical, biological and chemical.
The FDA has recognized potential biological hazards associated to flour in its document “Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry” (2014). Furthermore, biological risks of great importance for flour safety that must be taken into account are fungi, pest and biological contaminated water supply. Growth of fungi results not only in quality deterioration of flour but also in the production of the toxic compounds mycotoxins which pose high heat resistance. For instance species such as Aspergillus spp. and Penicillium spp. can produce aflatoxins as by-products while Fusarium graminearum may result in the production of deoxynivalenol (DON, type of vomitoxin) and zearalenone. The fungi usually develop on the grain, in the field or in storage and the mycotoxin (when produced) may pass to the flour after milling. Vertebrate pests, rats and birds, on the other hand, threaten the flour safety seriously by contaminating the flour by microorganism and parasites. Rodents may be found in and around flourmills while birds are found almost in any mill and can easily contaminate the receiving pit and other areas with droppings that usually contain Salmonella. Water may come in contact with the grain in two points: at irrigation in the field and for moistening the grain before milling, in the mill. In both cases water may contaminate the grain and flour if it contains biological hazards (and chemical hazards too).
Regarding chemical hazards, mycotoxins mentioned above, consist an important risk element associated with the grain. Other ingredient-related chemical hazards are: 1) pesticide residues and heavy metals, 2) radiological hazards in ingredients sourced from areas near a nuclear accident, 3) ingredients contaminated with food allergens, 4) alkaloids of the weeds and 5) migration of chemical substances from materials like packaging. As for process-related chemical hazards a common finding of concern is undeclared food allergens due to mislabeling or cross-contact. A case that resulted into a recall in Greece involved soy allergen found in wheat flour, caused by cross-contact in lines and storage silos of the grains. Other process-related common cases include: a) improper addition or over dosage of fortificants or other additives, b) contamination with cleaners or sanitizers, c) use of contaminated water supply and d) residues of fungicides, pesticides, insecticides and lubricants.
Physical hazards include all foreign bodies such as sticks, stones, sand, glass, plastic, metal, insects, hair, impurities, wood, paint etc. The foreign matters usually are a result of building or equipment that are poorly designed or selected. In other cases, foreign matters are a result of preventive measures that are poorly applied like pest exclusion, pest management, cleaning, maintenance etc.
Last but not least risks associated with economically motivated adulteration must be taken into account.
Following the identification of hazards in concern, managers must characterize each associated risk by integrating exposure assessment (how likely?) and hazard characterization (how severe?). For risk characterization, a quantitative risk assessment may be performed, where numerical values are assigned to severity and likelihood of occurrence which multiplied together establish a risk score. Alternatively, a qualitative approach can be chosen, using a matrix for assessing risk like the one proposed by FAO/WHO (2009) and seen in Table 3.
OUTCOMES OF RISK ASSESSMENT
Risk characterization is the final step in the risk assessment process. Risk assessment results allow each facility to decide how to manage its own unique risks, since risk assessment is commonly undertaken to help risk managers understand which, if any, intervention strategies can best serve the needs of food safety or if current risk management actions are adequate. Any hazard that has been determined as of “High” or of “Very high” risk must be controlled by risk management as to be reduced. After all, risk assessment and risk management, are all about choosing the best way to reduce risks and protect the public health.
FAO [Food and Agricultural Organization of the United Nations], 1999. Principles and guidelines for the conduct of microbiological risk assessment. In Codex Alimentarius Food Hygiene Basic Texts, 2nd edition, pp. 53–62, Rome.
FAO/WHO [Food and Agriculture Organization of the United Nations/World Health Organization], 2007. Codex Alimentarius principles for risk analysis, (Procedural Manual of the Codex Alimentarius Commission), Seventeenth Edition, pp. 112-190. Joint FAO/WHO Food Standards Programme, Rome.
FAO/WHO [Food and Agriculture Organization of the United Nations/World Health Organization], 2009. Risk Characterization of Microbiological Hazards in Food: Guidelines. Microbiological Risk Assessment Series No. 17, Rome.
Harris, L. J., and S. Yada, 2019. Flour and cereal grain products: foodborne illness outbreaks and product recalls [Tables and references]. In Flour & Cereal Grains – Outbreaks and Recalls. Updated 2/26/2019.
U.S. FDA [U.S. Food and Drug Administration], 2014. Hazard analysis and risk- based preventive controls for human food: Draft guidance for industry. Published online at www.fda.gov/downloads/Food/Guidance Regulation/UCM517402.pdf. FDA, Silver Spring, MD.