Tools for better food safety testing

Microbial risk characterization involves estimating the risk to the consumer population or in some cases a subset of the consumer population and prioritizing effective control strategies. Data such as the NOAEL or a benchmark dose from laboratory animal studies are reduced to adjust for uncertainty e.

For many pesticides and environmental compounds, the result is a reference dose or reference concentration. For a drug used in food-producing animals, an allowable daily intake is computed. Alternate endpoints, such as those related to allergenicity or inducement of microbial resistance, may be employed. The potential amount of food consumption is then estimated and the allowable daily intake or reference dose is partitioned across all food items to arrive at a tolerance or a maximum contaminant level goal below which food consumption or exposure is assumed to be safe.

In the European Union and in the Codex Alimentarius, a similar process is used to calculate a maximum residue level. These are all variants of a theme of acceptable exposure or tolerable intake.

Recent work has attempted to directly determine these endpoints using human data that would eliminate the uncertainty of interspecies extrapolations.

A threshold of toxicological concern approach that uses a threshold based on chemical structure—activity relationships in an attempt to integrate all adverse effects has recently been proposed Kroes and Kozianowski, If the compound is a potential carcinogen, the allowable concentration in food may be restricted to that which can be detected analytically using the most sensitive method.

Finally, when the exposure is widespread, the question is often related to estimating the risk to the human population from this ubiquitous exposure e. In this case, exposure and the dose— response data are used to estimate risk to the human population of exposure to specific concentrations, which are then employed in remediation and risk-management strategies to reduce exposures to an acceptable level Dourson et al.

Microbial risk characterization is not as well defined as its chemical counterpart. The goal of finding a risk value endpoint is similar and, in some cases, the methods by which this is obtained are also similar.

In the absence of human- or animal-feeding models, a number of dose—response models based on epidemiological data, animal studies, expert opinions, or combinations thereof are evaluated to determine an endpoint or risk value.

The highly variable nature of the microbial dose and the human response, as well as the fact that each model is based on different biological endpoints, make it extremely difficult to find one model that fits every situation. A variety of data gaps have been identified that must be addressed before microbial risk characterization will be as effective as chemical risk characterization.

As more accurate dose—response models become available, it should be possible to identify the risk-value endpoint needed to achieve a desired public health outcome. This dynamic residue surveillance program monitors domestic, as well as imported, food-animal carcass and egg products for a number of drug, pesticide, and environmental residues.

This surveillance, based on a random statistical sampling protocol for a list of target drugs determined by a multidisciplinary, interagency working group, is designed to assess prevalence and define areas that need further attention. In addition, the National Residue Program undertakes a number of special projects to target specific residue concerns. Samples for these programs are usually collected from healthy animals to provide surveillance data. Because the surveillance sampling is conducted to develop databases for future reference and the product is not traceable, if a violating residue is found, recall does not occur.

The final component of the National Residue Program is enforcement testing, where samples are collected from individual animals or lots that appear suspicious to FSIS inspectors.

This program is also used to follow-up on producers who have a history of violations or to verify HACCP performance. Violative products detected using this system are removed from the food supply because they are considered adulterated. If the product has been distributed into commerce, it may be subject to market recall.

It should be noted that the analytical techniques used for these programs are not the same. Enforcement testing may use rapid screening methods that, if positive, force the carcass to be held until confirmatory tests are conducted at an approved laboratory.

No data from a system analogous to the National Residue Program exist for use in microbial risk assessments. Typically, the results of each microbial risk assessment are validated based on a comparison with current Centers for Disease Control and Prevention estimates for the pathogen of interest. The National Residue Program may represent a useful working model on which a national pathogen system could be based.

Just as the National Residue Program can be used to validate chemical risk assessments, such a national pathogen program would be invaluable in validating microbial risk assessments. The strength of the chemical risk assessment approach is that there is a defined process whereby an acceptable exposure or tolerable intake of a chemical, based on a public health endpoint, can be defined and calculated from either experimental animal or human data.

A specific dose—response relationship is defined for the chemical and adverse effect being modeled. In food safety applications, this allows definition of a tolerance below which lifetime human exposure is not deemed to be of concern to public health.

Microbial risk assessment currently suffers from a lack of a standardized process and from a perception that such a process would be expensive and very time consuming. The form of the dose—response relationship is not known and thus is difficult to quantify. Microbial risk assessment is also hampered by the infectious nature of microorganisms, such that some exposure almost always poses some risk. The current level of exposure of the population to a pathogen may be tolerated by most of the population because most people do not experience adverse consequences from the foods they consume every day.

In light of current morbidity and mortality statistics, however, the level of exposure should be less than it is today. Microbial risk assessment may provide the tools needed to help identify the most effective solutions for lowering consumer exposure to foodborne microbiological hazards. In fact, this is the philosophy behind setting microbiological performance standards as a percentage reduction of baseline data that should reduce overall levels of microbial contamination.

From the above discussion, it is clear that QMRA can benefit from accomplishments in chemical quantitative risk assessments in that the lessons learned from the latter can be applied to the new challenges of developing the former.

Risk assessment offers a systematic approach to estimating the impact of pathogenic microorganisms in the food chain. In this way, risk assessment may assist public health decision-making and thus help improve overall public health by reducing the burden of foodborne illness.

Several areas where data gaps exist in current microbial risk assessments have been identified by various groups studying this technique Cassin et al. During hazard identification, gaps in data can significantly impact the resulting risk assessment.

These gaps include, but are not limited to, microorganism variability regarding pathogenicity and infectivity in human hosts; variability of human hosts' susceptibility to illness; complete epidemiological data from outbreak studies, including organism dose and environmental factors of both organism and host; and data on the prevalence of pathogenic microorganisms throughout the food chain.

Exposure-assessment data gaps, in turn, include information on routes of animal infection; prevalence in animal groups e. There are also data gaps in dose—response assessment. These include data on the number of cells of particular microorganisms required to constitute an infective dose, as well as detailed information concerning the dose and the corresponding response of human hosts who are infected. Finally, risk characterization data gaps include association of risk with human health effects, identification of potential risk mitigation strategies, and costs and benefits of mitigation strategies once the strategies are identified.

Some of the information listed above is available for a few microorganisms, whereas for others the data gaps are more significant. Nevertheless, despite these data gaps, there have been and will continue to be advances in the development of microbial risk assessments in foods Cassin et al. Each new risk assessment adds to the information already in place and increases our understanding of the issues, while further defining what information is still lacking.

The list of identified data gaps available at the completion of a microbial risk assessment can assist government and industry in targeting funds to generate missing information. If data are not available for part of a food production chain, it may be possible to simplify the QMRA model such that this part of the chain is excluded.

For example, if data on prevalence of a particular pathogen in a live food-animal population were not available, a QMRA could be constructed such that the start of the process was postslaughter.

This assumes, of course, that pathogen prevalence and concentration data are available for the carcasses. If a QMRA were constructed in this way, important factors that affect pathogen prevalence and concentration in the live animal population obviously would be accounted for in the final assessment results.

Predictive models for the growth and inactivation of pathogens as influenced by environmental conditions have gained increased visibility in the last decade Whiting and Buchanan, b. If information on the behavior of a pathogen in a particular part of the food chain is not available, and a predictive model exists that could represent that part of the chain, then model predictions, rather than actual data, could be used.

For example, data are seldom available on the levels of pathogens in a food just prior to consumption, but if data are available from an earlier part of the chain, and temperature and food composition data are available, predictive models could be used to estimate pathogen levels just prior to consumption.

Limitations of predictive models include the use of models that have not been fully validated and a lack of information on prediction uncertainty. It may be possible to use surrogate data if neither actual data nor predictive models are available.

Examples might be the use of cross-contamination data for generic E. Data gaps may not mean just the lack of a point estimate e. The amount of effort needed to adequately fill a data gap either by combining data from a multitude of sources or conducting original research can make the elimination of data gaps a long process. Another method to reduce and eliminate some of the existing data gaps in QMRAs could be stochastic simulation using probabilistic distributions to replace the data-gap information.

In published risk assessments, probability distributions have been used to estimate the parameters associated with various parts of a QMRA, for example, the dose—response curve Cassin et al. It follows that in places where data gaps exist, probabilistic models could be useful in providing information that helps to fill the data gap.

In order to accomplish this, one of two conditions would need to be met. The other condition relies on the use of probability distributions where variance—which arises from both uncertainty and variability—is large e. If either of these conditions were met, then the use of a probability distribution would be a valid method to fill a data gap.

Some data gaps can be filled through the use of expert opinions and consults sometimes referred to as qualitative risk assessment IFT, Some opponents of using qualitative risk assessment as a component of a QMRA state that the former dilutes the latter's effectiveness, scientific basis, and end use of the resulting risk estimate. However, without the use of these qualitative expert consults, it is likely that some of these data gaps would continue to exist for some time.

Those involved in qualitative consults often have a qualitative feel for the data needed that is based on previous experience that has a foundation in quantitative research Busta, ; IFT, Therefore, to include qualitative information from expert consults in a QMRA where data gaps exist and are difficult to fill seems both reasonable and scientifically sound. It should be noted that it is best to use standardized methods for eliciting expert opinion to enhance transparency and avoid introducing any potential bias into the process, and that techniques are available for pooling different opinions from a range of experts Vose, As noted above, most QMRAs will have data gaps.

These data gaps should not prevent a risk assessment from being initiated and completed and from serving a useful purpose. However, these data gaps must be communicated to those requesting the QMRA, so that they will be aware of its limitations. The inherently iterative nature of risk assessments allows continual updating as more and better-quality data become available, thereby increasing their effectiveness as a qualitative tool for policy-making. Table 3. Since the field of microbial risk assessment as applied to food is relatively new, there are few case histories that detail how QMRA can successfully impact policy-making.

In a few short years, QMRA has become the new way of organizing and interpreting data to enhance food safety. The action plan also states that the SERA predicts that multiple interventions could achieve a more substantial reduction in S.

Enteritidis illnesses than could any one intervention alone, and then goes on to lay out such a broad-based policy approach. Finally, the action plan also indicates that the research needs identified in the SERA have been incorporated into the plan. Various European countries have also developed risk assessments suited to various products, pathogens, and processing systems.

Clearly, each of these major risk assessments was undertaken to help make sound policy. If one considers the pace with which QMRAs are being conducted around the world, the next decade should provide some interesting examples of their impact on the promulgation of sound science-based food safety policies.

Historically the major advances in consumer protection have resulted from the development and implementation of selected, targeted control measures at one or more steps along the food continuum.

However, more often than not, the goal of such control measures has not been expressed in a numerical value e. This does not mean that control measures cannot be taken. Some examples of measures that might result in safer food without quantitative performance criteria include binomial slaughtering, where pathogen-free herds are slaughtered before those that are infected to prevent cross-contamination; vaccination programs to prevent infection in animals; and consumer information programs that target high-risk populations.

Efficient communication to all stakeholders of the reason for, and expected outcomes of, food safety control measures has been an important aspect of the acceptance of the measures. Any food safety criterion, the effectiveness of which is not readily observable, should be coupled with some sort of verification measure to ensure that the criterion actually has an effect.

Because the pace of the regulatory process seldom matches that of innovation and scientific advancement, regulatory policies should ideally be designed with this understanding in mind. Good science-based policies should allow flexibility and encourage innovation, with minimal regulatory revisions. This implies a regulatory framework that specifies results, but not the methods used to achieve these results.

FSOs are also important because they allow translation of public health goals e. This is a novel approach that may allow regulators to address the inherent weakness of HACCP, that defines a CCP as any point, stage, or step along the food production and processing chain where a hazard can be prevented, eliminated, or reduced to an acceptable level, but it leaves the acceptable level undefined.

An FSO provides the basis for defining this level. An FSO is a statement of the maximum frequency or concentration of a microbiological hazard in a food at the time of consumption that provides the appropriate level of protection ICMSF, FSOs are specified at the point of consumption, and they provide flexibility to food processors because various means of meeting an FSO may be practical and available for the same product.

FSOs are quantitative and verifiable, are limited to food safety, and do not address concerns for quality. Regulatory agencies could use FSOs to define the level of control of a hazard expected in a food product at the time of consumption. They could also be used to subsequently evaluate the adequacy of a facility's control system to achieve the FSO given all the relevant assumptions about transportation and retail and consumer handling of the product.

FSOs differ from the microbiological criteria that have been traditionally used to determine the acceptance of food products. Traditional microbiological criteria specify details such as a sampling plan and the method of sample preparation and analysis, whereas FSOs do not prescribe a particular analytical method.

Microbiological criteria are typically used to determine the safety or quality of a batch of food products, and as such provide a snapshot limited to the time the food was produced, but are not typically used in such a way as to provide information on process stability and capability. A review of any individual plant's food safety management system using an FSO approach could provide an assessment of long-term control.

Regulatory agencies may find that FSOs represent a useful concept for establishing a theoretical framework to relate performance standards to public health objectives. Conceptually, an FSO would be established on the basis of a quantitative risk assessment of the hazard of interest and would be consistent with the level of consumer protection that the regulatory agency deems appropriate to fulfill the public health objective.

From there, the regulatory agency could establish a performance standard that would ensure control of the hazard at the processing plant so that the product would be consistent with the FSO when it reached the consumer.

It would then be the processor's decision what process or combination of processes to apply and what additional parameters e.

FSOs offer one practical, if yet unproven, means to convert public health goals into values or targets that can be used by regulatory agencies and industry. For example, a public health goal may be to reduce the incidence of foodborne illness attributed to pathogen a by 50 percent e. A regulatory agency or manufacturer could not design a control system that would be certain to meet such a goal. However, if this goal were translated into a numerical measure of the microbial hazard's frequency or concentration at the time of consumption e.

For newly emerging food safety concerns, however, there may be so little information available that it is difficult or impossible to relate the public health objective to an eventual FSO. In such a situation, qualitative risk assessments and, in some cases, simple dose—response estimates, could be used to set an FSO. In this manner, depending on the urgency or the complexity of the situation, an FSO may be derived from a quantitative risk assessment or from expert opinion.

The FSO may be based on a realistic estimate of the risk. However, if time is short, it could also be based on a detailed examination of the frequency or levels of a hazard that can be expected to protect consumers. FSOs should be considered interim standards that could be adjusted to be more or less stringent as more information becomes available. Examples of criteria that are continually updated include the International Organization for Standardization ISO standards, which are reviewed every five years.

Following review, these standards are accepted, revised, or eliminated Cianfrani et al. FSOs can play an important role in modern food safety management by linking information from the risk assessment processes with measures to control the identified risk.

As more information becomes available, risk assessments should be updated and FSOs adjusted accordingly. Thus, the FSO concept may be a useful tool for developing policies that are consistent with current science and could offer an alternative approach to food safety management focusing on the protection of human health, while offering flexibility in achieving that goal. The level of a microbial contaminant in a food at the point of consumption is related to 1 the initial level of that contaminant in the food, 2 the sum total of contaminant reductions occurring up to the point of consumption, and 3 the sum total of contaminant increases up to the point of consumption.

It also should be noted that controlling initial levels, preventing an increase in levels, and reducing levels of the hazard are all important in meeting the FSO, and that increases can occur from growth as well as from recontamination.

The FSO is a new concept that builds on, rather than replaces, existing food safety terminology and concepts. FSOs have been discussed by a number of countries around the world, and internationally within Codex Alimentarius, specifically by the Codex Committee on Food Hygiene Woteki, This approach, outlined below, integrates risk assessment and current hazard-management practices into a framework that could be used to achieve public health goals in a science-based, flexible manner.

This approach also shows how FSOs relate to many existing food safety concepts:. Assemble epidemiological information indicating a need for improved control. Assess possible risk-management options, including an appropriate level of protection ALOP. The FSO concept was first introduced because of the difficulty in using public health goals e. The ALOP is an expression of a public health risk—that is, the achieved or achievable level proposed following consideration of public health impact, technological feasibility, economic implications, and comparison with other risks in everyday life—while an FSO expresses the level of a hazard in relation to this risk.

A hypothetical dose—response curve for a certain infectious pathogen is shown in Figure 3. The FSO has been established at fold less than this dose i. This example could be representative for E. Relating a food safety objective and a hypothetical dose—response curve for a pathogen.

Once an FSO has translated a public health goal into a quantifiable standard, hazard control and monitoring practices must be developed. However, it is important to note that other food safety concepts can be combined with this scheme to achieve the desired results in the farm-to-table approach to food safety; for example, implementing good agricultural practices may provide microbiologically safer foods. GMPs, in turn, are important to minimize the hazard and prevent recontamination after processing.

HACCP manages the application of control methods, ensuring that the process is effective. Additionally, there is little or no guidance on the level of hazard control expected in an adequately designed and implemented HACCP plan. Because the FSO must be met at the time of consumption, but regulatory action must take place at other locations in the food production and distribution chain, it may be necessary to introduce additional terms that represent various microbiological objectives throughout the food-processing chain.

These examples might include slaughter safety objectives, processing safety objectives analogous to the current Salmonella performance standard , transportation safety objectives, or retail safety objectives.

Alternatively, if no growth of the pathogen is projected, the processing safety objective would be the same as the FSO. At certain points in the processing of a food, control measures can be applied to prevent an unacceptable increase in a hazard, eliminate it, or reduce it to an acceptable level.

Each CCP must include parameters with defined critical limits. Similar critical limits would define the degree of hazard control necessary to meet a processing safety objective i. Process or product criteria, respectively, would define the process variables or product characteristics that will achieve the performance criteria or standard.

Finally, microbiological criteria and testing may be used to further verify that a processing safety objective has been met. As many of these concepts are relatively new, there is clearly a need for further discussion relating to the terminology to be used in this area. The following examples show various ways in which FSOs can be related to performance criteria.

Although FSOs should be quantitative and verifiable, this does not always imply that they must be verified by microbiological testing. For example, an FSO for low-acid canned foods could be established in terms of the probability of a viable spore of C.

A performance criterion could be used to limit recontamination and growth of a particular pathogen at any point after processing. If the heating step produces a 3-log 10 reduction, the greatest expected concentration after heating will be 0.

The criterion limit for recontamination could be less than 0. The required performance criterion would be expressed as:. Therefore, based on these calculations, the process must result in an overall reduction of greater than or equal to 5 log 10 i. This corresponds to a performance criterion of a 5-D reduction of the pathogen and could be achieved by one control hurdle measure or a combination of hurdles. A 5-D reduction is currently required for the control of enteric pathogens such as salmonellae and E.

It might be useful to consider what an appropriate FSO for such a product might be. If the initial level of salmonellae or E. This would not be adequate to ensure the safety of the juice considering the total quantity of juice consumed on a daily basis by a diverse population of consumers, including some who may be at higher risk.

The alternatives would be either to control the incoming juice to maintain a lower initial pathogen level or to apply a reduction step that would achieve greater than a 5-D reduction.

In the case of a new or emerging pathogen, establishment of an interim FSO could be an initial step to communicate to the food industry or to countries exporting food products to the United States the acceptable maximum level of a hazard.

As further knowledge about the hazard, the food, and conditions leading to illness become available, and effective control measures can be determined, the interim FSO can be adjusted. In the past, governments have used various mechanisms to bring about the changes necessary to reduce or eliminate the risk of disease.

In some cases, modifications in commercial practices are necessary, including the adoption of new or more reliable technologies. These approaches are not inconsistent with the use of FSOs. As is currently done with some performance standards, FSOs also could be used to promote change in an industry and enhance the safety of certain products. Many examples could be cited where epidemiological data have linked certain foods to foodborne illness. Government risk managers could use an FSO to communicate the level of control expected and thereby compel change on the part of the industry.

A particular FSO may require some processors to modify their operation, implement more effective technologies, adopt tighter control systems, or even cease operation. FSOs are simply the latest tool available in a growing food safety toolkit. There may be situations where FSOs are not appropriate. Such would be the case if the potential microbiological hazards associated with a food represent so little risk that an FSO is not needed e.

In other cases, the sources of a pathogen are so variable that identifying the foods for which FSOs should be set is not possible.

An example of the latter is shigellosis, which can be transmitted by many routes, many of which are more important than food e. Further, if a particular industry has been operating successfully for many years without FSOs, their introduction may offer no significant public health advantage.

Examples of such industries include the pasteurized milk industry and the low-acid canned food industry. The introduction of FSOs may lead to additional regulatory confusion, as FSOs for different products, developed at different points in time or by different expert groups, are compared.

For example, if one set of FSOs were developed from the USDA Salmonella performance standard for raw meat and poultry— which allows some level of contamination—while another set of FSOs were developed from the FDA Salmonella performance standard for raw seafood— which does not allow any contamination—these two FSOs for the same pathogen in different products would be different. There are also examples of foods recently regulated by performance standards, such as the 5-D process performance standard for fresh juice and the Salmonella performance standard for raw meat and poultry.

It is reasonable to expect that both these performance standards have resulted or will result in improved public health, even though the interventions—at the processing plant— are separated in time and space from the effect—at the point of consumption. If these products were to be processed in ways that achieve an FSO, which is by definition at the point of consumption, this would introduce an additional layer of complexity. Juice producer 1: This producer squeezes the juice on site using tree-picked apples.

Historical data collected by the processor over a number of years indicates that generic E. The pH of the juice is always 4. The juicer applies a 5-D i. Juice producer 2: This juicer is producing a melon juice with a pH of 6. Historical data collected by the company over a number of years indicates that generic E. He achieves a 7-log 10 treatment using a 3-log 10 thermal process combined with a 4-log 10 ultraviolet treatment i.

While the net effect is identical, the additional complexity makes the regulatory verification of compliance significantly more difficult. The trade-offs between encouraging innovation and managing regulatory complexity will need to be evaluated carefully if FSOs are to be used successfully. Additional limitations to the rapid adoption of FSOs include the lack of definitive data on the initial level of the hazard H o for many foods, and the lack of familiarity of many food-processing companies, particularly small- and medium-sized ones, with the FSO concept.

Definitive instructions for food processors on what is needed to document achievement of an FSO are also lacking. Another limitation is that the measurements required to define whether an FSO is in fact working are rarely obtained directly. In order to validate or verify that a product meets an FSO or that overall progress has been achieved, the FSO needs to be linked to a contamination level in production, such as a processing safety objective, and that is where the level of contamination should be monitored.

Government enforcement necessarily must focus on compliance at the level of production or retail sale because inspection is not possible literally at the point of consumption.

One of the major benefits of the FSO concept is the flexibility it affords to producers to utilize different means of achieving the same ultimate level of food safety at the time of consumption. However, the practical need for government to measure compliance earlier in the product cycle than the point of consumption necessarily limits this flexibility.

FSOs may also be problematic because they introduce additional computational complexities and because the databases needed to calculate microbial concentrations at the point of consumption may not be adequate. Our powerful knowledge management platform, enables you to choose different features to transform compliance information into user-friendly actionable knowledge Transparency-One : discover, analyze and monitor all suppliers, ingredients and facilities in your supply chain with SGS Transparency-One — a digital solution that can be combined with blockchain technology, helping businesses to build consumer trust.

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Contact Us. The operator is required to keep track of and sync multiple transfers and incubation timing throughout the process. As with Listeria , perhaps more important to the brand and reputation of the laboratory and its customer, the potential for an error to occur at some point in the overall process is decreased with the Atlas System, as shown through comparison of the total number of potential defects and calculated RPN for each method studied.

Conclusion In an industry highly dependent on product testing to ensure consumer risk is as low as possible it is necessary to understand and evaluate the error potential in all test methodologies in order to make an informed decision on the right pathogen testing system. The Roka Atlas System has been shown through this strict FMEA and resultant comparison analysis to induce significantly less risk into the testing process for both Salmonella and Listeria. By decreasing the process steps required, human interaction with the sample is decreased significantly resulting in fewer potential errors and the ability to use testing personnel in more efficient ways.

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