Food safety-risk analysis

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A food safety-risk analysis is essential not only to produce or manufacture high quality goods and products to ensure safety and protect public health, but also to comply with international and national standards and market regulations. With risk analyses food safety systems can be strengthened and food-borne illnesses can be reduced. [1] Food safety risk analyses focus on major safety concerns in manufacturing premises—not every safety issue requires a formal risk analysis. Sometimes, especially for complex or controversial analyses, regular staff is supported by independent consultants. [2]

Contents

Risk analysis

Risk analysis is defined for the purposes of the Codex Alimentarius Commission as "A process consisting of three components: risk management, risk assessment, and risk communication." [3] [4]

The diagram above illustrates the relationship between the three components of risk analysis. 3circles diagram color.jpg
The diagram above illustrates the relationship between the three components of risk analysis.

Risk management

Risk management is defined for the purposes of the Codex Alimentarius Commission as "The process, distinct from risk assessment, of weighing policy alternatives, in consultation with all interested parties, considering risk assessment and other factors relevant for the health protection of consumers and for the promotion of fair trade practices, and, if needed, selecting appropriate prevention and control options." [3] [5]

Risk assessment

General characteristics

As defined by the Codex Alimentarius Commission and adopted by international food safety commissions, food safety risk assessment is "The scientific evaluation of known or potential adverse health effects resulting from human exposure to foodborne hazards." [6] The most important aspect of risk assessment in relation to food safety is that it should be rooted in scientific data. Sources of data should be assembled in a systematic manner and should stem from valid scientific studies and communities across the world. A proper risk assessment can be described as being objective and unbiased, with absolute transparency. When at all possible, the assessment should remain independent of risk management as to preserve the integrity of the science and not have influence from regulatory policy and values. All assumptions made throughout the assessment should be well documented by the risk manager and should strive to be as objective, biologically realistic, and consistent as possible. As with any risk assessment performed, incomplete data or gaps in information create degrees of variability and uncertainty. In accounting for these factors, an extensive description of uncertainties in the risk estimate and their origins should be provided, as well as, descriptions of how assumptions being made can increase or decrease the uncertainty of results in the risk assessment. To increase the validity of a risk assessment, it is recommended that the assessment remain open for peer review and editing by food safety and science communities. A proper risk assessment is a constantly revolving process consisting of the following steps: (i) hazard identification, (ii) hazard characterization, (iii) exposure assessment, and (iv) risk characterization. [5]

Hazard identification

"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." This is often considered the most important step in a risk assessment as an unidentified hazard in the early stages of the production process can cause devastating effects in later stages. [5]

Hazard characterization

"The qualitative and/or quantitative evaluation of the nature of the adverse health effects associated with biological, chemical and physical agents which may be present in food. For chemical agents, a dose-response assessment should be performed. For biological or physical agents, a dose-response assessment should be performed if the data are obtainable." In this stage, risk assessors should describe the nature and extent of the adverse health effects known to be associated with the specific hazard. Using toxicity studies and epidemiological data, a dose-response relationship should be established between different levels of exposure to the hazard and the likelihood of different adverse health effects. [5]

Exposure assessment

"The qualitative and/or quantitative evaluation of the likely intake of biological, chemical, and physical agents via food as well as exposures from other sources if relevant." This step characterizes the amount of hazard that is consumed by various members of the exposure populations. Taking into account the food consumption patterns of the target population and levels of hazard in all steps of the production process, an exposure assessment examines the exposure to the hazard over a particular period of time in foods that are actually consumed. The assessment should also account for varying levels of hazard throughout production to estimate the likely hazard level at point of consumption. [5]

Risk characterization

"The qualitative and/or quantitative estimation, including attendant uncertainties, of the probability of occurrence and severity of known or potential adverse health effects in a given population based on hazard identification, hazard characterization and exposure assessment." During this stage, estimates of risk are generated from the outputs of hazard identification, hazard characterization, and exposure assessment. A proper risk characterization should take into account multiple degrees of uncertainty and variability. [5]

Risk communication

Risk communication is defined for the purposes of the Codex Alimentarius Commission as "The interactive exchange of information and opinions throughout the risk analysis process concerning hazards and risks, risk-related factors and risk perceptions, among risk assessors, risk managers, consumers, industry, the academic community and other interested parties, including the explanation of risk assessment findings and the basis of risk management decisions." [3]

Risk communication in food safety went through an evolutionary path and became highly specialised, developed to be a distinguishable and well-grounded area. Consumer science played a crucial role in the evolutionary procedure. Based on literature of the last 40 years, 5 + 1 stages in the evolution of food safety risk communication can be identified: [7] Pre-risk communication era, Deficit model, Dialogue model, Partnership model, and Behavioural insight model. Expected future trends are summarised as a 6th stage, called Controlled risk environment model. The models are differentiated by level of consumer involvement and methodological approach. Despite the observed advancement between the stages, the application of each communication model might have justification under certain circumstances. In practice, the different stages have no clear boundaries, and the models can overlap. An organisation can even move on to the next phase by skipping a previous evolutionary step.

Codex Alimentarius Commission

The Codex Alimentarius Commission "...was created in 1963 by the Food Agriculture Organization (FAO) and the World Health Organization (WHO) to develop food standards, guidelines and related texts such as codes of practice under the Joint FAO/WHO Food Standards Programme. The main purposes of this Programme are protecting health of the consumers and ensuring fair trade practices in the food trade, and promoting coordination of all food standards work undertaken by international governmental and non-governmental organizations." [8] [9]

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A biocide is defined in the European legislation as a chemical substance or microorganism intended to destroy, deter, render harmless, or exert a controlling effect on any harmful organism. The US Environmental Protection Agency (EPA) uses a slightly different definition for biocides as "a diverse group of poisonous substances including preservatives, insecticides, disinfectants, and pesticides used for the control of organisms that are harmful to human or animal health or that cause damage to natural or manufactured products". When compared, the two definitions roughly imply the same, although the US EPA definition includes plant protection products and some veterinary medicines.

Risk assessment determines possible mishaps, their likelihood and consequences, and the tolerances for such events. The results of this process may be expressed in a quantitative or qualitative fashion. Risk assessment is an inherent part of a broader risk management strategy to help reduce any potential risk-related consequences.

<span class="mw-page-title-main">Hazard analysis and critical control points</span> Systematic preventive approach to food safety

Hazard analysis and critical control points, or HACCP, is a systematic preventive approach to food safety from biological, chemical, and physical hazards in production processes that can cause the finished product to be unsafe and designs measures to reduce these risks to a safe level. In this manner, HACCP attempts to avoid hazards rather than attempting to inspect finished products for the effects of those hazards. The HACCP system can be used at all stages of a food chain, from food production and preparation processes including packaging, distribution, etc. The Food and Drug Administration (FDA) and the United States Department of Agriculture (USDA) require mandatory HACCP programs for juice and meat as an effective approach to food safety and protecting public health. Meat HACCP systems are regulated by the USDA, while seafood and juice are regulated by the FDA. All other food companies in the United States that are required to register with the FDA under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, as well as firms outside the US that export food to the US, are transitioning to mandatory hazard analysis and risk-based preventive controls (HARPC) plans.

Acceptable daily intake or ADI is a measure of the amount of a specific substance in food or drinking water that can be ingested (orally) daily over a lifetime without an appreciable health risk. ADIs are expressed usually in milligrams per kilograms of body weight per day.

<span class="mw-page-title-main">Codex Alimentarius</span> Collection of internationally recognized standards

The Codex Alimentarius is a collection of internationally recognized standards, codes of practice, guidelines, and other recommendations published by the Food and Agriculture Organization of the United Nations relating to food, food production, food labeling, and food safety.

<span class="mw-page-title-main">Environmental hazard</span> Harmful substance, a condition or an event

An environmental hazard is a substance, state or event which has the potential to threaten the surrounding natural environment or adversely affect people's health, including pollution and natural disasters such as storms and earthquakes. It can include any single or combination of toxic chemical, biological, or physical agents in the environment, resulting from human activities or natural processes, that may impact the health of exposed subjects, including pollutants such as heavy metals, pesticides, biological contaminants, toxic waste, industrial and home chemicals.

Pesticide residue refers to the pesticides that may remain on or in food after they are applied to food crops. The maximum allowable levels of these residues in foods are often stipulated by regulatory bodies in many countries. Regulations such as pre-harvest intervals also often prevent harvest of crop or livestock products if recently treated in order to allow residue concentrations to decrease over time to safe levels before harvest. Exposure of the general population to these residues most commonly occurs through consumption of treated food sources, or being in close contact to areas treated with pesticides such as farms or lawns.

<span class="mw-page-title-main">ISO 22000</span> Food safety standard

ISO 22000 is a food safety management system by the International Organization for Standardization (ISO) which is outcome focused, providing requirements for any organization in the food industry with objective to help to improve overall performance in food safety. These standards are intended to ensure safety in the global food supply chain. The standards involve the overall guidelines for food safety management and also focuses on traceability in the feed and food chain.

Exposure assessment is a branch of environmental science and occupational hygiene that focuses on the processes that take place at the interface between the environment containing the contaminant of interest and the organism being considered. These are the final steps in the path to release an environmental contaminant, through transport to its effect in a biological system. It tries to measure how much of a contaminant can be absorbed by an exposed target organism, in what form, at what rate and how much of the absorbed amount is actually available to produce a biological effect. Although the same general concepts apply to other organisms, the overwhelming majority of applications of exposure assessment are concerned with human health, making it an important tool in public health.

<span class="mw-page-title-main">The Non-GMO Project</span> Non-profit organization

The Non-GMO Project is a 501(c)(3) non-profit organization focusing on genetically modified organisms. The organization began as an initiative of independent natural foods retailers in the U.S. and Canada, with the stated aim to label products produced in compliance with their Non-GMO Project Standard, which aims to prevent genetically modified foodstuffs from being present in retail food products. The organization is headquartered in Bellingham, Washington. The Non-GMO label began use in 2012 with Numi Organic Tea products.

<span class="mw-page-title-main">Genetically modified soybean</span> Soybean that has had DNA introduced into it using genetic engineering techniques

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<span class="mw-page-title-main">Joint FAO/WHO Expert Committee on Food Additives</span>

The Joint FAO/WHO Expert Committee on Food Additives (JECFA) is an international scientific expert committee that is administered jointly by the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO). It has been meeting since 1956 to provide independent scientific advice pertaining to the safety evaluation of food additives. Its current scope of work now also includes the evaluation of contaminants, naturally occurring toxicants and residues of veterinary drugs in food.

Genetically modified canola is a genetically modified crop. The first strain, Roundup Ready canola, was developed by Monsanto for tolerance to glyphosate, the active ingredient in the commonly used herbicide Roundup.

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<span class="mw-page-title-main">Regulation of genetic engineering</span> Overview of the regulation of genetic engineering

The regulation of genetic engineering varies widely by country. Countries such as the United States, Canada, Lebanon and Egypt use substantial equivalence as the starting point when assessing safety, while many countries such as those in the European Union, Brazil and China authorize GMO cultivation on a case-by-case basis. Many countries allow the import of GM food with authorization, but either do not allow its cultivation or have provisions for cultivation, but no GM products are yet produced. Most countries that do not allow for GMO cultivation do permit research. Most (85%) of the world's GMO crops are grown in the Americas. One of the key issues concerning regulators is whether GM products should be labeled. Labeling of GMO products in the marketplace is required in 64 countries. Labeling can be mandatory up to a threshold GM content level or voluntary. A study investigating voluntary labeling in South Africa found that 31% of products labeled as GMO-free had a GM content above 1.0%. In Canada and the USA labeling of GM food is voluntary, while in Europe all food or feed which contains greater than 0.9% of approved GMOs must be labelled.

<span class="mw-page-title-main">Federal Institute for Risk Assessment</span>

The German Federal Institute for Risk Assessment, abbreviated BfR, is a body under public law of the German federal government with full legal capacity. The institute comes under the portfolio of the Federal Ministry of Food and Agriculture and has the task of providing scientific advice to the federal government on issues relating to food safety, product safety, chemical safety, contaminants in the food chain, animal protection and consumer health protection. Further technical supervision is performed by the Federal Ministry for the Environment, Nature Conservation, Building and Nuclear Safety and the Federal Ministry of Transport.

Tolerable weekly intake (TWI) estimates the amount per unit body weight of a potentially harmful substance or contaminant in food or water that can be ingested over a lifetime without risk of adverse health effects. TWI is generally preceded by "provisional" to indicate insufficient data exists, increasing uncertainty. The term TWI should be reserved for when there is a well-established and internationally accepted tolerance, backed by sound and uncontested data. Although similar in concept to tolerable daily intake (TDI), which is of the same derivation of acceptable daily intakes (ADIs), TWI accounts for contaminants that do not clear the body quickly and may accumulate within the body over a period of time. An example is heavy metals such as arsenic, cadmium, lead, and mercury. The concept of TWI takes into account daily variations in human consumption patterns.

National Food Chain Safety Office (Nébih/NFCSO) is the integrated food safety authority of Hungary, established on 15 March 2012.

An occupational risk assessment is an evaluation of how much potential danger a hazard can have to a person in a workplace environment. The assessment takes into account possible scenarios in addition to the probability of their occurrence, and the results. The five types of hazards to be aware of are safety, chemicals, biological, physical, and ergonomic.

Threshold dose is the minimum dose of drug that triggers minimal detectable biological effect in an animal. At extremely low doses, biological responses are absent for some of the drugs. The increase in dose above threshold dose induces an increase in the percentage of biological responses. Several benchmarks have been established to describe the effects of a particular dose of drug in a particular species, such as NOEL(no-observed-effect-level), NOAEL(no-observed-adverse-effect-level) and LOAEL(lowest-observed-adverse-effect-level). They are established by reviewing the available studies and animal studies. The application of threshold dose in risk assessment safeguards the participants in human clinical trials and evaluates the risks of chronic exposure to certain substances. However, the nature of animal studies also limits the applicability of experimental results in the human population and its significance in evaluating potential risk of certain substances. In toxicology, there are some other safety factors including LD50, LC50 and EC50.

References

  1. ↑ Food Safety Risk Analysis
  2. ↑ "Government of Alberta, Agriculture and Rural Development:Appendix D – Food Safety Risk analysis. Available Online. Accessed May 2,2012" (PDF). Archived from the original (PDF) on 10 April 2012. Retrieved 3 May 2012.
  3. 1 2 3 Archived 18 May 2010 at the Wayback Machine About Risk Analysis in Food. World Health Organization/Food and Agriculture Organization of the United Nations. Available online . Retrieved 6 July 2010.
  4. ↑ 5 [ permanent dead link ] Joint FAO/WHO Food Standards Programme. Codex Alimentarius Commission. Procedural Manual. 12th ed. Rome: Food and Agriculture Organization of the United Nations : World Health Organization, 2001. Available online . Accessed 11/12/03.
  5. 1 2 3 4 5 6 [ permanent dead link ] Food Safety Risk Analysis: A Guide for National Food Safety Authorities. Food and Agriculture Organization of the United Nations. Available online. Retrieved 6 July 2010.
  6. ↑ "World Health Organization". Risk Assessment. Archived from the original on 29 October 2014. Retrieved 11 December 2015.
  7. ↑ Kasza, Gyula; Csenki, Eszter; Szakos, Dávid; Izsó, Tekla (1 August 2022). "The evolution of food safety risk communication: Models and trends in the past and the future". Food Control. 138: 109025. doi: 10.1016/j.foodcont.2022.109025 . ISSN   0956-7135. S2CID   248223805.
  8. ↑ Food and Agriculture Organization of the United Nations and World Health Organization. Understanding the Codex Alimentarius. Rome: Food and Agriculture Organization of the United Nations : World Health Organization, 1999. Available online: Accessed 11/17/03.
  9. ↑ "Codex Alimentarius". Archived from the original on 7 January 2012. Retrieved 26 May 2010. Codex Alimentarius Commission. Accessed 06/09/10.

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