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Risk Analysis, what for? (RA) can be defined like a process or technique used to measure the effect of the unknown, identifying the possible threats, analyse them and find measures to apply to eliminate or reduced this possible threat. This technique is used by a broad diversity of organisations, private and governmental ones (NATO, FAO, WHO, EFSA, OIE, ECDC), in the food safety sector in Spain by AESA/AESAN.
. There are four stages to define in the RA system: hazard identification, risk assessment, risk management and risk communication. For a Risk to exist there has to be a hazard, which needs to be identified in the first instance.
A hazard can be defined as a situation, or a condition that can make damage or make some kind of losses, to humans being, animals or environment (ISDR)
. Hazard identification is a process or steps to take to permit us identify the possible threat in a situation. It is possible to link a particular hazard to a potential risk, but it's not possible to identify all the hazards
Risk assessment can be defined as the estimation, qualitative or quantitative, of the risk resulting from the hazard. There is two main processes qualitative and quantitative that must be specific depending on the situation.
Risk management is the application of the necessary measures to evaluated, monitoring and take effective control of the risks, to minimize the possible negative impact of the development of this risk.(5,6)
Risk communication tries to give a clear picture about the risk. This process requires a clear and exposed communication between all the parties involved, (stakeholders). This only can be achieved if some requisite take place: exchange of information, recognition of the grade and appreciation of risk, understanding the effects of options and create support for decisions. This can be achieved through meetings, discussions, interviews, web-blogs, Radio, TV.
The following diagram shows the relationship between the three components of RA. (7).
In Spain RA has become strategically important in veterinary and animal health (9).It is now a common tool in veterinary public health and used by governmental bodies that play a role in imposing regulations designed to protect animals or human health (AESA, MARM, RASVE, SIR, etc.).
In the veterinarian field the RA can be conducted by two main systems.They are based on two models, one adopted by the Office International des Epizooties (OIE) and the one used by the Codex Alimentarius. Under the umbrella of the FAO/WHO Food Standards Programme, in 1963 was elaborated the Codex Alimentarius Commission with the mission of created procedures and codes of practice to regulated the food standards. (8).
The RA system of the Codex has these main points:
These definitions can be found in the Procedural Manual (13th Edition) of the Codex (REF).
The Procedural Manual (13th Edition) of the Codex provides these definitions:
Risk Assessment: A scientifically based process consisting of the following steps: hazard identification, hazard characterization, exposure assessment,
and risk characterization.
Risk Management: The process of evaluate alternatives policy, in consultation with all interested parties, considering risk assessment and other factors relevant for the health protection, the promotion of fair trade practices, prevention and control options.
Risk Communication: The interactive exchange of information throughout the RA process concerning risk, related factors and risk perceptions, among assessors, managers, consumers, industry, and other interested parties, including the risk assessment findings and risk management initials decisions.
The system used by the OIE, the C&M model, comprises of the following components: (Apx 1)
These definitions can be found in the â€¦â€¦â€¦..of the OIE (REF). (10)
The OIE defines Hazard identification as "the process of identifying the pathogenic agents which could potentially be introduced to the commodity considered for importation". Hazard identification is an added component in this system. "It is a process used to identify hazards in a given situation that 'may pose a change in risk to animal or human health". (10)
Risk assessment is described as "the evaluation of the likelihood and the biological and economic consequences of entry, establishment, or spread of a pathogenic agent within the territory of an importing country".
Risk management is "the process of identifying, selecting and implementing measures that can be applied to reduce the level of risk".
Risk communication is "the interactive exchange of information on risk among risk assessors, risk managers and other interested parties".
The main difference between the two systems is that the OIE has the hazard identification as a stage of the RA. The Codex system has the hazard identification as a part of the risk assessment (Apx 2).
The Codex risk assessment stages: The OIE risk assessment stages:
Hazard identification Release assessment
Hazard characterisation Exposure assessment
Exposure assessment Consequence assessment
Risk characterization Risk estimate
The perception about hazard differs between the Codex and the OIE. The Codex is determined in the relation cause/effect and the severity of the possible consequences. The main pointing the codex is the identification of the hazard, which is measure by descriptive categories; high, medium, lowâ€¦
The objective of the OIE is the possible pathogens which represent a possible hazard in animals and animal's product, and the management of this risk. The main point for the OIE is the assessment of the Risk release. In the OIE the RA is definitive linked with the cost /benefit of the measure to control this risk.
The Codex highlights the relationship dose/response with the exposure assessment and defined as 'hazard characterisation'. The OIE take into account all harmful effect. The Codex considers the effect of the consequence of the modification in the dose of the risk, (pathogen, toxin, or antibiotics residues ).
In Spain the OIE system is used by the authorities to develop qualitative RA of the risks at the introduction of infect contagious diseases into Spain and the rest of Europe from Morocco, Africa. In this kind of analysis different parameters are used: Prevalence of infection, volume of trade, capacity of the virus to survive, the seasons and climatic conditions and potential for infection. The magnitude of the consequences goes in hand with the probability of transmission and spread. This is normally linked with costs and benefits of the decisions taken and the possible economic lost consequences of no action.
Usually RA take place during an Outbreak of animal disease in counties closed to the own borders. The quicker approach is a qualitative RA.
The Codex is concerned about food safety. The Programme are designed for protecting the public health and ensuring reasonable manage process in the food trade, promoting harmonization in food standards in the work undertaken by international governmental and private organizations. This Analysis is normally quantitative. It uses different tools and methods, such as the Monte Carlo methodology. The data comes from different sources that usually are collated into a model to predict prevalence and quantity.
This Analysis takes into account the predictable exposures and other factors such consumer types, genders, health status etc. They included the effect of the uncertainty and variability. For all this is necessary to use mathematical and probabilistic models developed by computers programmes.
One example is the QRA of the impact on human health on resistance of Salmonella Enteriditis and S. Tiphimurium in poultry products and eggs. Here they investigate how the use of antibiotic favours the emerging resistance in pathogens that could be transmitted to humans and animals through the food supply .This quantitative study gives a numeric value to the risk, because sufficient data is available (11,12,13,15 )
There are different types of RA: From Qualitative (descriptive), semi- quantitative to quantitative RA (deterministic/ stochastic).
Qualitative RA is used in areas of the food security, human and animal health services. For every hazard established, an estimated risk is made on the severity of the likelihood of the hazard occurring. However, the classifications used are often inadequate as the likelihood of a hazard to occur is never precise.. Also a probability database is not required, but there needs to be sufficient information that let us establish the likelihood and the effect of the risk problem.
This method can be subjective, which reduces its significance.
The envisaged goal is important to carry out the appropriate activities that will lead to the expected outcomes. The Quantitative RA system, used the Covello - Merkhofe, works with simulation modelling. The Monte Carlo simulation is a reliable tool, flexible, is simple to test and to describe and less influence to human mistake in the progression of the model.
it is desirable to check it to observe if the model do come with something totally unrealistic.
This method is also subjective due to the chance to select the distribution during the description of the data.
The semi QRA is a clear approach for the effective control of a range of risk issues. It is commonly used in commercial projects. The SQRA produces a arithmetical risk estimation establish on a combination of qualitative and quantitative data.
The problem is that due to a lack of obtainable data, only excessive risk will be avoided with this method. It is therefore not fully acknowledged worldwide.
All this models need to be reviewed after the first stage of the assessment has been carried out.
In Spain, as in the rest of EU, RA is utilised in a variety of areas such as education, engineering, science, environment, private and public governmental agencies (health service, military, banking, trade, etc.). Spain has to follow a specific EU legislation in activities related to food production.
The use of the ARICPC, Spanish version of the HACCP, became compulsory by the Real Decreto 2207 in 1995,on 28 December. The Regulation (EC) No 852/2004 of the European Parliament and Council of 29 April 2004 are now actually in force.
Hazard Analysis Critical Control Point (HACCP) is globally recognised as the most excellent system of assuring product preserve by controlling food borne cover hazards. This legislation specifies the compulsory nature of the application of the risk analysis of these kinds of processes bearing in mind the protection of the population;
The (EC) 178/2002, Article 6 (Risk Analysis), Paragraph 1 states: "In order to achieve the general objective of a high level of protection of human health and life, food law shall be based on risk analysis except where it is not appropriate to the circumstances or the nature of the measure".
In Spain the HACCP system is used by the regional governments to regulate the food industry in a broad spectrum of activities: Bakers, ice cream, fishery products, dairy products, meat and meat products, pre-cooked meals, water, preserved food, beer, sugar, wine, oil, juice, vegetables, eggs, catering, spirit, sweets and pastries, abattoirs, cutting plants, butcher shops, restaurants, coffee shops, barsâ€¦etc. In all this activities there is a Risk to identify, the risk in food or 'agro food' risks. There are nutritional risks, chemical risks (arsenic, nitrates, nitrites, cadmium) physical risks (temperatures, ionising radiations), biological risks (Salmonellas, Campylobacter, E. Coli, C. Burnetii, TSE) ,pesticides, veterinarian drugs residues.
The residues from pharmaceutical production, from hospitals, illegal drugs, Veterinary medicine use, like antibiotics and steroids, and farming activities.(pict1)
Other areas, where RA is applied, are those derived from animal diseases outbreaks. In March 2009 there was a higher risk that the Serotype 4 or the Bluetongue (which had been eradicated from Spain) could come back from the North of Africa because of the wind carrying the infected vector over.
This was outlined in the last RA by 'Sanidad Animal' so they could take the necessary measures. By the Order ARM/575/2010, in all the south of Spain, all livestock had to be vaccinated against the serotype 4 of Bluetongue, to stop the spread of the disease.
Possible animal health or animal related human health hazards, that require RA, may include new or unusual infections in animals such as Bluetongue in the north European cattle, West Nile virus infection in Europe, or increases in endemic zoonotic diseases like Leishmaniasis, an infection caused by a protozoan parasite of the genus Leishmania (14).
The amount of hazards both related to animal diseases and food safety, represents really a long list .It is important for the body control, first to identify which of the hazards are most likely to represent and immediate threat.
The following stage will be to formulate the right question, which could be very simple and straightforward. For instance: which risks are you or your organisation interested in? Is there a case to do a Risk Assessment? What outcome is expected? Zero risk or acceptable risk?
The right questions will lead to relevant information already made available. However, if the questions lack in timing and don't deliver the correct definition of the hazard/s involved, and this is not sorted at an early stage, the following part of the assessment could be biased or completely compromised.
The whole information and data accessible will define the pathway to taken. If the hazard is a disease, it is important to obtain a wide range of information from different sources, to gain an overall picture of the hazard presented and the possible risks estimated from the result of the evaluation of data collated. This process is time consuming, demands expertise, resources and financial backing. Financial and human resources are fundamental to avoid unreported health status. Developing countries don't necessarily have the support and resources available to apply the necessary systems effectively and rely strongly on outside support. Generally a lack of finances stops the development of specialist colleges and institutions.
"PREVENTION IS BETTER THAN CURE"
"Adagiorum Collectanea" 1536, Erasmo de Rotterdam (Róterdam, 1466/69)