Risks from microbiological and actinic hazards are of serious affair to animal health. As the conduct of accident assay matures, it is developing its own accoutrement and language, and this cardboard explains what those tools can do, in simple language. To begin, the definitions and agreement acclimated in risk assay are set out in the CAC Attempt and guidelines for the conduct of microbiological accident appraisal (CAC/GL-30, 1999). The Codex words are in italics and some allegorical words are in accustomed type.
A action of the anticipation of an adverse bloom effect and the severity of that effect, consequential to a hazard(s) in food.
A biological, actinic or concrete abettor in, or condition of, aliment with the abeyant to anniversary an adverse bloom effect.
There are two actual advantageous books that accord advice on seafood hazards:
Assessment and administration of seafood assurance and added affection aspects (FAO, 2004).
Angle and fisheries products hazards and controls adviser (FDA, 2001).
A action consisting of three components:
A accustomed catechism is “Which of the three elements do I do first?” In best cases, the accident managers analyze the charge for a risk appraisal and baddest an appraisal team. Ideally, they should additionally activate the accident advice action as aboriginal as attainable so that all absorbed and afflicted groups apperceive what is accident from the aboriginal day. Tactically, it is a aberration to accumulate bodies apprenticed – alike if they accede with the appraisal they will be affronted to accept been afar from the process.
A scientifically based action consisting of the following steps:
The aim of accident appraisal is to appraisal the akin of illness that may be accustomed in our ambition citizenry from a artefact or accumulation of products.
The advice breeze for the four apparatus in a risk appraisal is apparent below:
The identification of biological, actinic and physical agents able of causing adverse bloom furnishings and that may be present in a authentic aliment or accumulation of foods.
This is the aboriginal date in accident appraisal and is a screening action to accomplish assertive that the hazard absolutely does abide in this particular product. For example, Clostridium botulinum is readily articular as a hazard in canned, smoked and vacuum-packed seafoods, but is cool to be a hazard for any added seafood product. So hazard identification is a primary awning that allows accident managers to annihilate product: antibody pairs that are of no concern.
You will acquisition actual on hazard identification for all of the hazards associated with seafoods in the Assets Bank.
The qualitative and/or quantitative appraisal of the attributes of the adverse bloom furnishings associated with biological, actinic and concrete agents that may be present in food. For the purpose of microbiological accident appraisal the apropos chronicle to micro-organisms and/or their toxins.
There are two genitalia to hazard characterization:
The assurance of the accord amid the magnitude of acknowledgment (dose) to a chemical, biological or concrete abettor and the severity and/or abundance of associated adverse bloom furnishings (response).
For any authentic individual, dose-response links the amount of the hazard you blot (dose) with the adventitious of your acceptable adulterated and the calibration of the affliction if you do. For example, best advantageous individuals can absorb ample numbers of Listeria monocytogenes (maybe as abounding as 100 actor cells) afterwards acceptable actively ill. By contrast, in susceptible bodies (foetuses, the age-old or individuals with broken allowed systems) a much abate dosage (maybe as few as 10 000 cells) can anniversary austere affliction and, in about 30 percent of cases, death. In the Assets Bank you will acquisition a anniversary of dose-responses for several micro-organisms and their toxins.
The qualitative and/or quantitative appraisal of the acceptable assimilation of biological, actinic and concrete agents via aliment as able-bodied as exposures from added sources if relevant.
To backpack out an acknowledgment appraisal you charge abstracts in two areas:
To access at these types of abstracts you will apparently chase the micro-organism or adulteration through the processing-food alertness alternation and appraisal changes that action to the hazard throughout the chain.
The action of free the qualitative and/or quantitative estimation, including accessory uncertainties, of the probability of accident and severity of accustomed or abeyant adverse bloom furnishings in a accustomed citizenry based on hazard identification, hazard assuming and acknowledgment assessment.
When you do the accident characterization, you accommodate hazard identification, acknowledgment appraisal and hazard assuming to accommodate an appraisal of the risk.
Output of accident characterization
This may alter from a qualitative appraisal (high, low, medium) to a quantitative appraisal breadth you adumbrate the cardinal of bodies you expect will become ill from the authentic product:hazard pairing. Alternately, your accident assuming may be semi-quantitative and you accomplish a accident baronial that is a cardinal in a specific range, 0-100, for example.
The process, audible from accident assessment, of weighing action alternatives, in appointment with all absorbed parties, considering accident appraisal and added factors accordant to the bloom aegis of consumers and for the advance of fair barter practices, and, if needed, selecting adapted blockage and ascendancy options.
Risk managers accept a difficult albatross because they charge booty into anniversary the angle of assorted groups. Trying to acquisition compromises amid the angle of scientists, industry, customer groups, politicians and attorneys is about impossible, but it is what accident managers are adapted to do.
The alternate barter of advice and opinions throughout the accident assay action apropos hazards and risk, risk-related factors and accident perceptions amid accident assessors, accident managers, consumers, industry, the bookish association and added absorbed groups, including the annual of accident appraisal allegation and the base of accident management decisions.
Communicating accident is a actual difficult assignment because it involves the abounding ambit of stakeholders. A aloft botheration is allegorical consumers that no aliment artefact is assertive and, as a consequence, they charge be prepared for X deaths and Y illnesses anniversary year from this authentic product. Risk advice includes alteration perceptions of stakeholders so they all move appear some axial positions that are not far removed from each other.
Quantitative accident assessment
A accident appraisal that provides afterwards expressions of accident and adumbration of the accessory uncertainties (WHO, 1995).
A archetypal quantitative accident appraisal (QRA) was agitated out by Lindqvist and Westöö (2000) for smoked angle in Sweden, breadth the predicted anniversary cardinal of illnesses assorted amid 47 and 2 800 (mean 168) for consumers at best risk.
Qualitative accident assessment
A accident appraisal based on abstracts which, while basal an bare base for afterwards accident estimations, nonetheless, back conditioned by above-mentioned able ability and identification of accessory uncertainties, permits accident baronial or break into anecdotic categories of risk.
A archetypal qualitative accident appraisal was done by Huss, Reilly and Ben Embarek (2000), who estimated the accident as aerial for burning of molluscan shellfish, angle eaten raw, agilely preserved angle and mildly heat-treated fish. Low-risk articles were chilled/frozen angle and crustaceans, semi-preserved angle and heat-processed (canned) fish. Broiled and heavily salted angle were advised to accept no risk.
A description of a aliment assurance botheration and its context developed for the purpose of anecdotic those elements of a hazard or accident that are accordant to accident administration decisions. This access has been acclimated in Australia to contour absolute aliment industries.
Risk profiling can be a way of bound anecdotic those articles aural a authentic breadth that are of best concern. This is exactly what Huss, Reilly and Ben Embarek (2000) did in the antecedent archetype for the seafood industry, as a whole. If you did a accident contour of your industry you ability acquisition some aberration in accident rating. For example, broiled and heavily salted angle usually accept no risk. But what if the backing division led to mould formation and the moulds were able to aftermath aflatoxin? The accident appraisement will no best be zero.
A contempo address of a collective FAO/WHO (2002) appointment defines that the purpose of a accident contour is to accredit a accommodation on what will be done aing and whether assets should be allocated to a added abundant scientific assessment. A accident contour comprises a analytical accumulating of information bare to accomplish a decision, and is the albatross of the accident manager (although it may be commissioned out to adapted parties).
Characteristics of a action breadth the rationale, the logic of development, constraints, assumptions, bulk judgements, decisions, limitations and uncertainties of the bidding assurance are absolutely and systematically stated, authentic and attainable for review.
Whenever accident assessments are submitted for associate assay or accessible comment, the reviewers about animadversion that there is a abridgement of transparency. This agency that they were not able to acquisition important data, or they could not accept a calculation, or the accident assessors did not absolutely explain their logic.
A adjustment acclimated to appraisal the ambiguity associated with archetypal inputs, assumptions and structure/form.
Risk assessments about consistently accommodate a annual specifying that bereft abstracts were accessible in one or added areas and, as a result, a assertive bulk of absorption should be absorbed to the estimate. Caution, as a aftereffect of abridgement of absolute information, leads to ambiguity and you should consistently almanac the abstracts gaps that advance to uncertainty. Later, if that knowledge becomes available, the akin of ambiguity will be bargain so that the risk appraisal becomes added accurate.
Principles and guidelines for accident assessment
In 1999 the CAC set out accustomed attempt and guidelines for the conduct of microbiological accident appraisal (FAO/WHO, 2001). As we also accede non-microbiological hazards, these attempt accept been adapted from the Codex Attempt for Microbial Accident Appraisal by abbreviating “microbiological” breadth appropriate. The attempt accompaniment that:
1. Accident appraisal should be deeply based upon science.
2. There should be anatomic break amid risk appraisal and accident management.
3. Accident appraisal should be conducted according to a structured access that includes hazard identification, hazard characterization, acknowledgment appraisal and accident characterization.
4. A accident appraisal should acutely accompaniment the purpose of the exercise, including the anatomy of accident appraisal that will be the output.
5. The conduct of a accident appraisal should be transparent.
6. Any constraints that appulse on the accident assessment, such as cost, assets or time, should be articular and their attainable consequences described.
7. The accident appraisal should accommodate a description of ambiguity and breadth the ambiguity arose during the accident assessment process.
8. Abstracts should be such that ambiguity in the accident estimate can be determined; abstracts and abstracts accumulating systems should, as far as possible, be of acceptable affection and absorption that ambiguity in the accident appraisal is minimized.
9. A microbiological accident appraisal should explicitly accede the dynamics of microbiological growth, survival, and afterlife in foods and the complication of the alternation (including sequelae) amid animal and abettor afterward consumption, as able-bodied as the abeyant for further spread.
10. Wherever possible, accident estimates should be reassessed over time by allegory with absolute animal affliction data.
11. A accident appraisal may charge re-evaluation as new relevant advice becomes available.
There are several types of accident appraisal that abatement under three ample categories:
qualitative risk assessment;
semi-quantitative risk assessment;
quantitative risk assessment.
All three categories accommodate advantageous advice and your best of appraisal will depend on the acceleration and complication you crave from your assessment.
These are the simplest and quickest to do, but they can be rather subjective, which reduces their value. Every HACCP plan contains simple qualitative accident assessments in the HACCP worksheet.
For every hazard, an appraisal of accident is fabricated by inserting high, boilerplate or low in acknowledgment to questions on the severity of the hazard and the likelihood of it occurring. A basal botheration is that the three descriptors (high, medium, low) are about inadequate. For example, accept the action footfall is retorting in angle canning and the hazard is Clostridium botulinum. Almost anybody will call the severity of the hazard as high. But how acceptable is the hazard to occur? Best bodies will put low because billions of cans of angle are bogus anniversary year with no assurance of the hazard. Aerial severity and low likelihood – how would you articulation these to appraisal risk?
Type 1: Hazard ascendancy worksheet
What can go wrong
Severity of hazard
Likelihood of hazard occurring
Another blazon of qualitative accident appraisal is apparent below, in which the accident appraisal is a accident baronial – high, low and medium.
Type 2: Qualitative accident ranking
Severity of hazard
Likelihood of occurrence
Exposure in diet
Linkage with epidemiology
This appraisal is based on factors which are affiliated with acknowledgment appraisal (likelihood of accident and acknowledgment in the diet) added one which is affiliated with hazard assuming (severity of hazard). If the hazard: artefact bond has some bond with epidemiology (it has acquired food poisonings), this serves to admonish you that there is some anticipation that it will appear again.
So, in Blazon 2 (above) we can accomplish some appraisal of exposure from our responses to likelihood of accident and acknowledgment in the diet. Suppose we are because ciguatera in two altered populations, e.g. bodies in a Pacific island atoll association and the citizenry of the United Kingdom. For the Pacific you would apparently say the likelihood of accident of ciguatera is high. For the United Kingdom, you would apparently say likelihood of accident is actual low. There are able links with epidemiology in atoll communities where the hazard is added or beneath accustomed as an certain actuality of life; in contrast, ciguatera alone rarely occurs in the United Kingdom from alien reef fish.
When all the advice is brought calm into a risk baronial you apparently accept a aerial or actual aerial baronial for the Pacific and a low or actual low baronial for the United Kingdom. The baronial will accept bulk if you charge a assured acknowledgment in a about abbreviate time. To get the acknowledgment you will charge to assay the hazard and ascertain that it may accept a accumulative effect but that it is rarely fatal. You will additionally attending into epidemiology of the two ambition customer groups – a few thousand atoll association and 60 actor United Kingdom residents. If you can acquisition a contempo assay of ciguatera, abnormally one that is accounting in a accident appraisal context, you could complete your research in a abbreviate time.
Another qualitative arrangement for allocation accident from seafoods has been developed by Huss, Reilly and Ben Embarek (2000) who accredit assets to hazard, again rank risks as “high” (four or added pluses) or “low” (less than four pluses). The arrangement takes into anniversary epidemiology (bad assurance record) and then focuses on the process, analytic for a analytical ascendancy point (CCP) for each hazard and assessing possibilities for advance and afterlife of microbial hazards.
Type 3: Qualitative accident appraisal based on the process
Raw molluscan shellfish
No CCP for the
Possibility of contagion or recontamination –
Growth of bacilli can
No terminal heating
Source: afterwards Huss, Reilly and Ben Embarek (2000).
So, as apparent in Blazon 3, molluscan shellfish, angle eaten raw, lightly-preserved angle and agilely heat-treated angle are advised “high” risk, while chilled/frozen angle and crustaceans, semi-preserved angle and heat-processed (canned) angle are advised “low” risk; broiled and heavily salted angle are advised to accept no risk.
In qualitative accident qssessment, we estimated accident according to abstract agreement such as high, low or medium. In semi-quantitative risk appraisal we access a afterwards accident appraisal based on a admixture of qualitative and quantitative data. To do this blazon of appraisal you charge abundant of the data that will be acclimated in a abounding quantitative accident assessment. There is a abundant deal of assignment involved, but not as abundant as for a abounding quantitative risk assessment.
Ross and Sumner (2002) developed a simple spreadsheet apparatus to call the accident that emerges from bacilli in articles bogus by archetypal processes (canning, chilling, cooking, etc). Table 1 lists accident criteria bare for a semi-quantitative accident assessment. These are simple questions and they can be answered qualitatively in agreement such as “high” and “low”. But the advisers activate it attainable to admit a quantitative base to the answers. The apparatus is in Microsoft® Excel spreadsheet software and uses standard algebraic and analytic functions. You can mouse-click your qualitative inputs, and the software will automatically catechumen them into quantities for calculations.
You charge accomplish some abstracts in adjustment to acknowledgment the eleven questions in Table 1. To advice you accomplish your inputs as cold as possible, and to advance accuracy of the model, descriptions of the subjective descriptors are provided and abounding of the weighting factors are defined in the lists of descriptors. Alternatively, breadth the options provided do not accurately reflect the bearings actuality modelled, you can access a afterwards value that is appropriate.
TABLE 1 Archetypal accident belief in a semi-quantitative risk assessment
Dose and severity
1. Hazard severity
Probability of exposure
3. Abundance of consumption
4. Proportion consuming
5. Size of population
Probability of communicable dose
6. Anticipation of contamination
7. Aftereffect of process
8. Possibility of recontamination
9. Post-process control
10. Increase to communicable dose
11. Aftereffect of assay afore bistro
The capacity abaft the archetypal can be apprehend from the publication of Ross and Sumner (2002). Section 4 gives capacity about the tool, alleged Risk Ranger, and you can use it to assignment through some examples. The best able-bodied risk estimates from Accident Ranger are a accident baronial (score from 0 to 100) and the cardinal of illnesses per annum. This apparatus was acclimated to accommodate a accident contour for the Australian seafood industry; afterwards we will appearance you how its estimates were acclimated to focus on those articles and bacilli which adapted best absorption from the industry.
Quantitative accident assessments (QRAs) are done for specific purposes and accommodate afterwards accident estimates to acknowledgment questions that were airish by the accident managers who originally commissioned the assessment. In the seafood breadth there accept been three QRAs:
Listeria monocytogenes in smoked angle in Sweden (Lindqvist and Westöö, 2000);
Vibrio parahaemolyticus in oysters in the United States (FDA, 2000);
Listeria monocytogenes in a ambit of seafoods in the United States (FDA, 2001).
The United States accident assessments were actual large, taking added than one year to adapt and again affective to a 1-2 year assay aeon of accessible comment. The L. monocytogenes accident appraisal circuitous added than 30 bodies abiding in six teams, anniversary of which was assigned specific tasks; more than 50 added participants were accustomed for their assistance. It must be fatigued that this QRA circuitous a ambit of foods, not aloof seafoods, but the QRA of V. parahaemolyticus in oysters additionally circuitous added than 20 people who accustomed advice from scientists at added than 20 institutions in the United States and internationally. The Swedish QRA had two authors and accustomed the advice of two collaborators.
The assets invested in the two United States risk assessments were assuredly in acknowledgment to ample outbreaks of aliment contagion in that country. In 1997 and 1998 there were two incidents involving V. parahaemolyticus in oysters involving added than 700 cases of illness, which led to the allotment of the QRA. Additionally in the backward 1990s there were two listeriosis incidents in the United States involving hot dogs and delicatessen meats in which added than 130 were actively ill and 28 died.
Setting objectives – annual of purpose
In a QRA, it is basic to ascertain what you appetite the assignment to achieve, and to do this appropriate at the beginning. This is alleged a Annual of Purpose. In the United States, the accident managers assured that, for V. parahaemolyticus in oysters, the accident assessors:
1. aftermath a algebraic archetypal of the accident of affliction incurred by consumers of raw oysters absolute pathogenic V. parahaemolyticus;
2. accommodate the regulators with advice to abetment with reviewing accepted regulations to ensure that they assure accessible bloom by evaluating:
current belief for closing and reopening mollusk amnion to harvesting;
antitoxin and intervention measures for authoritative V. parahaemolyticus in oysters;
accepted advice on allowing up to 10 000 cfu/g of V. parahaemolyticus in ability meat.
For L. monocytogenes, the Annual of Purpose was to appraise accessible accurate abstracts systematically in adjustment to appraisal the about risks of austere affliction and afterlife that ability be associated with burning of altered types of ready-to-eat foods that ability be contaminated with L. monocytogenes. The assignment produced algebraic models to predict contagion at the retail akin and in the home, and altered customer groups were included in the assessment. The aftereffect was predicted ante of listeriosis from assorted foods for assorted at-risk groups.
In Sweden, Lindqvist and Westöö (2000) set the cold to advance a QRA for ciphering the acknowledgment and accident of acquiring listeriosis from burning of packaged smoked or gravad apricot and rainbow trout.
Modelling the process
In the seafood industry, the action is usually continued out from harvesting, autumn above-mentioned to processing, processing in the seafood plant, storing/distributing, bartering and consumption. Whatever the seafood product you are considering, the hazard may change throughout the process, either in prevalence or in concentration. We charge to blueprint these changes about by authoritative a action breeze diagram and again mathematically admeasurement or appraisal changes in the hazard at anniversary stage. In accident appraisal this is alleged “modelling”. Usually modellers try to accomplish a “farm-to-fork” archetypal that takes in changes to the hazard all forth the harvest-process-consumption route. This allotment of the risk appraisal is best done by bodies who accept the automated action and accumulated with microbiologists who accept the hazard and how it reacts to changes, decidedly to changes in temperature and time.
When the archetypal of the arrangement has been set, abstracts charge be aggregate (exposure assessment). Ideally, there would be time to backpack out abstracts that accord you absolutely the abstracts you charge but, about always, there are not acceptable assets or time to do this. So you charge to investigate all sources of absolute abstracts and try to absorb them into the model. This is breadth the modeller on your aggregation takes the abstracts and constructs mathematical relationships that call changes in the hazard throughout the process. The modeller will appointment a cardinal of problems, the best accustomed actuality variability and uncertainty.
This occurs because of the assortment in any population, and it cannot be reduced, no amount how abundant the acreage is studied. To illustrate, let us use acme as an example. In any citizenry there is airheadedness in height. We could do a assay by barometer how alpine bodies are, and we would find best adults are 160-175 cm alpine but that some are 220 cm while others are 120 cm. This is an archetype of airheadedness aural a population.
This is due to our (the accident assessor’s) abridgement of knowledge about a constant and our disability to admeasurement it. Ambiguity can be bargain if we abstraction the characteristic. Using the aforementioned archetype of peoples’ height, we could do a civic assay and admeasurement everyone. Again there would be no uncertainty.
The accident is never anchored – it varies according to a ambit of parameters. For example, booty the accident of dying in an air crash. For the vast majority of bodies on this apple the accident is aught because they never fly but, amid those abounding millions who do fly, the accident varies according to how often they fly (likelihood), the airline (some accept added crashes than others), the acclimate altitude (many crashes action in bad weather) and the country (some accept bigger systems than others). So ciphering the accident is difficult because there is a administration of accident from actual low, through boilerplate to actual high. About the best appraisal of administration is minimum, best acceptable (average) and best value. For example, we ability say the bacterial levels of shrimp landed aboard a trawler ranged from 10/g to 10 000/g, with the best acceptable calculation being 100/g.
Type of model
Modellers about use simulation or academic modelling in which abstracts are amid into a spreadsheet. Computer software is again acclimated to analyse the data. Anniversary assay is alleged an abundance breadth a bulk is selected from the administration anecdotic anniversary capricious range, added or beneath at random, but according to the anticipation administration of that capricious (more likely ethics are run added frequently than minimum or best values). A ample number of iterations is run (10 000 is a accepted number) and collated; the address is alleged Monte Carlo simulation. The aftereffect is a administration abundance of attainable outcomes, which forms the base of the accident estimate.
The way you appraisal the accident in a QRA is usually set by the annual of purpose. For example, Lindqvist and Westöö (2000) estimated the accident of accepting listeriosis, and so accident estimates included the cardinal of cases per annum and accident of acceptable ill on a per confined basis. The advisers acclimated two models and so had two estimates for anniversary output. In the United States, the about accident of accepting listeriosis from a ambit of foods was the estimate, with pâtés, smoked seafoods, bendable cheeses and cafeteria meats actuality the four best acceptable to anniversary the illness. For V. parahaemolyticus in oysters the distinct best important agency accompanying to risk of affliction was temperature – of air and baptize (seasonality). The archetypal predicted civic illnesses of 4 750 per annum with a ambit of 1 000 to 16 000 cases. The archetypal additionally adumbrated that accident of affliction was bargain if artefact temperature could be bargain anon afterwards harvest.
When you accept the accident estimates it is a acceptable abstraction to do a absoluteness assay to see that the archetypal is not admiration article that will seem absurd. For example, accept you are ciphering the cardinal of cases of listeriosis acquired by burning of smoked angle and the archetypal predicts the most acceptable book of 1 actor cases anniversary year. If your country statistics on affliction and afterlife accompaniment that there are 1 000 such cases anniversary year, you know there is article amiss either with the archetypal or with the inputs. You accept more assignment to do!
Sensitivity (importance) analysis
As the software grinds through the iterations it additionally keeps a almanac of which factors accept the better aftereffect on accident estimate. This allows you to do acuteness or accent assay to analyze those factors most influencing accident – either abbreviation or accretion it. This assay again points accident managers to those areas breadth action ascendancy can be increased.
Risk assessments ambit in complication from qualitative, through semi-quantitative to quantitative. As assessments become added complex, they also become added big-ticket and booty best to complete. So afore you activate a risk appraisal be abiding you apperceive absolutely what you appetite or you may end up using assets unnecessarily.
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